research and ethical considerations

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National Institute of Environmental Health Sciences

Your environment. your health., what is ethics in research & why is it important, by david b. resnik, j.d., ph.d..

December 23, 2020

The ideas and opinions expressed in this essay are the author’s own and do not necessarily represent those of the NIH, NIEHS, or US government.

When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": norms for conduct that distinguish between acceptable and unacceptable behavior.

Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?

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One plausible explanation of these disagreements is that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences. For example, two people could agree that murder is wrong but disagree about the morality of abortion because they have different understandings of what it means to be a human being.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers have urged citizens to disobey laws they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of protesting laws or expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming , one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

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Many different disciplines, institutions , and professions have standards for behavior that suit their particular aims and goals. These standards also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical standards govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. There is even a specialized discipline, research ethics, which studies these norms. See Glossary of Commonly Used Terms in Research Ethics and Research Ethics Timeline .

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research , such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating , falsifying, or misrepresenting research data promote the truth and minimize error.

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Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work , such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship , copyright and patenting policies , data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely.

Third, many of the ethical norms help to ensure that researchers can be held accountable to the public . For instance, federal policies on research misconduct, conflicts of interest, the human subjects protections, and animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research. People are more likely to fund a research project if they can trust the quality and integrity of research.

Finally, many of the norms of research promote a variety of other important moral and social values , such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety. Ethical lapses in research can significantly harm human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety of staff and students.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Many government agencies have ethics rules for funded researchers.

• National Institutes of Health (NIH)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• Nuremberg Code
• World Medical Association's Declaration of Helsinki

Ethical Principles

The following is a rough and general summary of some ethical principles that various codes address*:

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Transparency

Disclose methods, materials, assumptions, analyses, and other information needed to evaluate your research.

Accountability

Take responsibility for your part in research and be prepared to give an account (i.e. an explanation or justification) of what you did on a research project and why.

Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for Colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

* Adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

Ethical Decision Making in Research

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case:

The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to test. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.

Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct , which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive : honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:

Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.

Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.

There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as " other deviations " from acceptable research practices and include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other serious deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical or moral dilemmas . Consider the following case:

Dr. Wexford is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal. She is planning to publish many other papers from her dataset. She receives a request from another research team that wants access to her complete dataset. They are interested in examining the relationship between pesticide exposures and skin cancer. Dr. Wexford was planning to conduct a study on this topic.

Dr. Wexford faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data with the other research team. Her funding agency may also have rules that obligate her to share data. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority. It seems that there are good arguments on both sides of this issue and Dr. Wexford needs to take some time to think about what she should do. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers.

The following are some step that researchers, such as Dr. Wexford, can take to deal with ethical dilemmas in research:

What is the problem or issue?

It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.

What is the relevant information?

Many bad decisions are made as a result of poor information. To know what to do, Dr. Wexford needs to have more information concerning such matters as university or funding agency or journal policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, the impact of the potential publications, etc.

What are the different options?

People may fail to see different options due to a limited imagination, bias, ignorance, or fear. In this case, there may be other choices besides 'share' or 'don't share,' such as 'negotiate an agreement' or 'offer to collaborate with the researchers.'

How do ethical codes or policies as well as legal rules apply to these different options?

The university or funding agency may have policies on data management that apply to this case. Broader ethical rules, such as openness and respect for credit and intellectual property, may also apply to this case. Laws relating to intellectual property may be relevant.

Are there any people who can offer ethical advice?

It may be useful to seek advice from a colleague, a senior researcher, your department chair, an ethics or compliance officer, or anyone else you can trust. In the case, Dr. Wexford might want to talk to her supervisor and research team before making a decision.

After considering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, or consider other ethical rules. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should consider the following questions in order to explain how he or she arrived at his or her decision:

• Which choice will probably have the best overall consequences for science and society?
• Which choice could stand up to further publicity and scrutiny?
• Which choice could you not live with?
• Think of the wisest person you know. What would he or she do in this situation?
• Which choice would be the most just, fair, or responsible?

After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with a gut feeling or intuition, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational, however. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.

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Most academic institutions in the US require undergraduate, graduate, or postgraduate students to have some education in the responsible conduct of research (RCR) . The NIH and NSF have both mandated training in research ethics for students and trainees. Many academic institutions outside of the US have also developed educational curricula in research ethics

Those of you who are taking or have taken courses in research ethics may be wondering why you are required to have education in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research..

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the evidence produced so far shows that misconduct is a very rare occurrence in research, although there is considerable variation among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of researchers per year (based on self-reports of misconduct on anonymous surveys). See Shamoo and Resnik (2015), cited above.

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt, despite some highly publicized scandals. Even if misconduct is only a rare occurrence, it can still have a tremendous impact on science and society because it can compromise the integrity of research, erode the public’s trust in science, and waste time and resources. Will education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.

According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct, such as pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers (see Shamoo and Resnik 2015). Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics can be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect traditions and practices that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. Another example where there may be some ignorance or mistaken traditions is conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finder’s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. Scientists must deal with a number of different controversial topics, such as human embryonic stem cell research, cloning, genetic engineering, and research involving animal or human subjects, which require ethical reflection and deliberation.

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Ethical Considerations – Types, Examples and Writing Guide

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Ethical Considerations

Ethical considerations in research refer to the principles and guidelines that researchers must follow to ensure that their studies are conducted in an ethical and responsible manner. These considerations are designed to protect the rights, safety, and well-being of research participants, as well as the integrity and credibility of the research itself

Some of the key ethical considerations in research include:

• Informed consent: Researchers must obtain informed consent from study participants, which means they must inform participants about the study’s purpose, procedures, risks, benefits, and their right to withdraw at any time.
• Privacy and confidentiality : Researchers must ensure that participants’ privacy and confidentiality are protected. This means that personal information should be kept confidential and not shared without the participant’s consent.
• Harm reduction : Researchers must ensure that the study does not harm the participants physically or psychologically. They must take steps to minimize the risks associated with the study.
• Fairness and equity : Researchers must ensure that the study does not discriminate against any particular group or individual. They should treat all participants equally and fairly.
• Use of deception: Researchers must use deception only if it is necessary to achieve the study’s objectives. They must inform participants of the deception as soon as possible.
• Use of vulnerable populations : Researchers must be especially cautious when working with vulnerable populations, such as children, pregnant women, prisoners, and individuals with cognitive or intellectual disabilities.
• Conflict of interest : Researchers must disclose any potential conflicts of interest that may affect the study’s integrity. This includes financial or personal relationships that could influence the study’s results.
• Data manipulation: Researchers must not manipulate data to support a particular hypothesis or agenda. They should report the results of the study objectively, even if the findings are not consistent with their expectations.
• Intellectual property: Researchers must respect intellectual property rights and give credit to previous studies and research.
• Cultural sensitivity : Researchers must be sensitive to the cultural norms and beliefs of the participants. They should avoid imposing their values and beliefs on the participants and should be respectful of their cultural practices.

Types of Ethical Considerations

Types of Ethical Considerations are as follows:

Research Ethics:

This includes ethical principles and guidelines that govern research involving human or animal subjects, ensuring that the research is conducted in an ethical and responsible manner.

Business Ethics :

This refers to ethical principles and standards that guide business practices and decision-making, such as transparency, honesty, fairness, and social responsibility.

Medical Ethics :

This refers to ethical principles and standards that govern the practice of medicine, including the duty to protect patient autonomy, informed consent, confidentiality, and non-maleficence.

Environmental Ethics :

This involves ethical principles and values that guide our interactions with the natural world, including the obligation to protect the environment, minimize harm, and promote sustainability.

Legal Ethics

This involves ethical principles and standards that guide the conduct of legal professionals, including issues such as confidentiality, conflicts of interest, and professional competence.

Social Ethics

This involves ethical principles and values that guide our interactions with other individuals and society as a whole, including issues such as justice, fairness, and human rights.

Information Ethics

This involves ethical principles and values that govern the use and dissemination of information, including issues such as privacy, accuracy, and intellectual property.

Cultural Ethics

This involves ethical principles and values that govern the relationship between different cultures and communities, including issues such as respect for diversity, cultural sensitivity, and inclusivity.

Technological Ethics

This refers to ethical principles and guidelines that govern the development, use, and impact of technology, including issues such as privacy, security, and social responsibility.

Journalism Ethics

This involves ethical principles and standards that guide the practice of journalism, including issues such as accuracy, fairness, and the public interest.

Educational Ethics

This refers to ethical principles and standards that guide the practice of education, including issues such as academic integrity, fairness, and respect for diversity.

Political Ethics

This involves ethical principles and values that guide political decision-making and behavior, including issues such as accountability, transparency, and the protection of civil liberties.

Professional Ethics

This refers to ethical principles and standards that guide the conduct of professionals in various fields, including issues such as honesty, integrity, and competence.

Personal Ethics

This involves ethical principles and values that guide individual behavior and decision-making, including issues such as personal responsibility, honesty, and respect for others.

Global Ethics

This involves ethical principles and values that guide our interactions with other nations and the global community, including issues such as human rights, environmental protection, and social justice.

Applications of Ethical Considerations

Ethical considerations are important in many areas of society, including medicine, business, law, and technology. Here are some specific applications of ethical considerations:

• Medical research : Ethical considerations are crucial in medical research, particularly when human subjects are involved. Researchers must ensure that their studies are conducted in a way that does not harm participants and that participants give informed consent before participating.
• Business practices: Ethical considerations are also important in business, where companies must make decisions that are socially responsible and avoid activities that are harmful to society. For example, companies must ensure that their products are safe for consumers and that they do not engage in exploitative labor practices.
• Environmental protection: Ethical considerations play a crucial role in environmental protection, as companies and governments must weigh the benefits of economic development against the potential harm to the environment. Decisions about land use, resource allocation, and pollution must be made in an ethical manner that takes into account the long-term consequences for the planet and future generations.
• Technology development : As technology continues to advance rapidly, ethical considerations become increasingly important in areas such as artificial intelligence, robotics, and genetic engineering. Developers must ensure that their creations do not harm humans or the environment and that they are developed in a way that is fair and equitable.
• Legal system : The legal system relies on ethical considerations to ensure that justice is served and that individuals are treated fairly. Lawyers and judges must abide by ethical standards to maintain the integrity of the legal system and to protect the rights of all individuals involved.

Examples of Ethical Considerations

Here are a few examples of ethical considerations in different contexts:

• In healthcare : A doctor must ensure that they provide the best possible care to their patients and avoid causing them harm. They must respect the autonomy of their patients, and obtain informed consent before administering any treatment or procedure. They must also ensure that they maintain patient confidentiality and avoid any conflicts of interest.
• In the workplace: An employer must ensure that they treat their employees fairly and with respect, provide them with a safe working environment, and pay them a fair wage. They must also avoid any discrimination based on race, gender, religion, or any other characteristic protected by law.
• In the media : Journalists must ensure that they report the news accurately and without bias. They must respect the privacy of individuals and avoid causing harm or distress. They must also be transparent about their sources and avoid any conflicts of interest.
• In research: Researchers must ensure that they conduct their studies ethically and with integrity. They must obtain informed consent from participants, protect their privacy, and avoid any harm or discomfort. They must also ensure that their findings are reported accurately and without bias.
• In personal relationships : People must ensure that they treat others with respect and kindness, and avoid causing harm or distress. They must respect the autonomy of others and avoid any actions that would be considered unethical, such as lying or cheating. They must also respect the confidentiality of others and maintain their privacy.

How to Write Ethical Considerations

When writing about research involving human subjects or animals, it is essential to include ethical considerations to ensure that the study is conducted in a manner that is morally responsible and in accordance with professional standards. Here are some steps to help you write ethical considerations:

• Describe the ethical principles: Start by explaining the ethical principles that will guide the research. These could include principles such as respect for persons, beneficence, and justice.
• Discuss informed consent : Informed consent is a critical ethical consideration when conducting research. Explain how you will obtain informed consent from participants, including how you will explain the purpose of the study, potential risks and benefits, and how you will protect their privacy.
• Address confidentiality : Describe how you will protect the confidentiality of the participants’ personal information and data, including any measures you will take to ensure that the data is kept secure and confidential.
• Consider potential risks and benefits : Describe any potential risks or harms to participants that could result from the study and how you will minimize those risks. Also, discuss the potential benefits of the study, both to the participants and to society.
• Discuss the use of animals : If the research involves the use of animals, address the ethical considerations related to animal welfare. Explain how you will minimize any potential harm to the animals and ensure that they are treated ethically.
• Mention the ethical approval : Finally, it’s essential to acknowledge that the research has received ethical approval from the relevant institutional review board or ethics committee. State the name of the committee, the date of approval, and any specific conditions or requirements that were imposed.

When to Write Ethical Considerations

Ethical considerations should be written whenever research involves human subjects or has the potential to impact human beings, animals, or the environment in some way. Ethical considerations are also important when research involves sensitive topics, such as mental health, sexuality, or religion.

In general, ethical considerations should be an integral part of any research project, regardless of the field or subject matter. This means that they should be considered at every stage of the research process, from the initial planning and design phase to data collection, analysis, and dissemination.

Ethical considerations should also be written in accordance with the guidelines and standards set by the relevant regulatory bodies and professional associations. These guidelines may vary depending on the discipline, so it is important to be familiar with the specific requirements of your field.

Purpose of Ethical Considerations

Ethical considerations are an essential aspect of many areas of life, including business, healthcare, research, and social interactions. The primary purposes of ethical considerations are:

• Protection of human rights: Ethical considerations help ensure that people’s rights are respected and protected. This includes respecting their autonomy, ensuring their privacy is respected, and ensuring that they are not subjected to harm or exploitation.
• Promoting fairness and justice: Ethical considerations help ensure that people are treated fairly and justly, without discrimination or bias. This includes ensuring that everyone has equal access to resources and opportunities, and that decisions are made based on merit rather than personal biases or prejudices.
• Promoting honesty and transparency : Ethical considerations help ensure that people are truthful and transparent in their actions and decisions. This includes being open and honest about conflicts of interest, disclosing potential risks, and communicating clearly with others.
• Maintaining public trust: Ethical considerations help maintain public trust in institutions and individuals. This is important for building and maintaining relationships with customers, patients, colleagues, and other stakeholders.
• Ensuring responsible conduct: Ethical considerations help ensure that people act responsibly and are accountable for their actions. This includes adhering to professional standards and codes of conduct, following laws and regulations, and avoiding behaviors that could harm others or damage the environment.

Advantages of Ethical Considerations

Here are some of the advantages of ethical considerations:

• Builds Trust : When individuals or organizations follow ethical considerations, it creates a sense of trust among stakeholders, including customers, clients, and employees. This trust can lead to stronger relationships and long-term loyalty.
• Reputation and Brand Image : Ethical considerations are often linked to a company’s brand image and reputation. By following ethical practices, a company can establish a positive image and reputation that can enhance its brand value.
• Avoids Legal Issues: Ethical considerations can help individuals and organizations avoid legal issues and penalties. By adhering to ethical principles, companies can reduce the risk of facing lawsuits, regulatory investigations, and fines.
• Increases Employee Retention and Motivation: Employees tend to be more satisfied and motivated when they work for an organization that values ethics. Companies that prioritize ethical considerations tend to have higher employee retention rates, leading to lower recruitment costs.
• Enhances Decision-making: Ethical considerations help individuals and organizations make better decisions. By considering the ethical implications of their actions, decision-makers can evaluate the potential consequences and choose the best course of action.
• Positive Impact on Society: Ethical considerations have a positive impact on society as a whole. By following ethical practices, companies can contribute to social and environmental causes, leading to a more sustainable and equitable society.

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Nih clinical research trials and you, guiding principles for ethical research.

Pursuing Potential Research Participants Protections

“When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science.

NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:

Social and clinical value

Scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent.

• Respect for potential and enrolled subjects

Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.

A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants  (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.

Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

Respect for potential and enrolled participants

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

• respecting their privacy and keeping their private information confidential
• respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty
• informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating
• monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study
• informing them about what was learned from the research

More information on these seven guiding principles and on bioethics in general

This page last reviewed on March 16, 2016

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Ensuring ethical standards and procedures for research with human beings

Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review.

WHO works with Member States and partners to promote ethical standards and appropriate systems of review for any course of research involving human subjects. Within WHO, the Research Ethics Review Committee (ERC) ensures that WHO only supports research of the highest ethical standards. The ERC reviews all research projects involving human participants supported either financially or technically by WHO. The ERC is guided in its work by the World Medical Association Declaration of Helsinki (1964), last updated in 2013, as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2016).

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• Council of Europe (Oviedo Convention - Protocol on biomedical research)
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Ethical Issues in Research

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• Juwel Rana 2 , 3 , 4 ,
• Segufta Dilshad 2 &
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The most important human endeavor is the striving for morality in our actions. Our inner balance and even our very existence depend on it. Only morality in our actions can give beauty and dignity to life – Albert Einstein.

Ethics ; Methodology ; Mixed-method research ; Observation ; Qualitative research ; Quantitative research ; Research ; Research design ; Research ethics

Ethics is a set of standards, a code, or value system, worked out from human reason and experience, by which free human actions are determined as ultimately right or wrong, good, or evil. If acting agrees with these standards, it is ethical, otherwise unethical.

Scientific research refers to a persistent exercise towards producing new knowledge to unveil a new stream of ideas in academia for humankind.

Research ethics refer to some of the genres that researchers follow to protect the rights in developing research strategies and building a trusted relationship between the...

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Bulmer M (1982) Social Research Ethics: An Examination of the Merits of Covert Participant Observation. Holmes & Meier Publishers

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Butler I (2002) A Code of Ethics for Social Work and Social Care Research. Br J Soc Work [Internet]. 32(2):239–48. Available from: https://doi.org/10.1093/bjsw/32.2.239

Fisher CB, Anushko AE (2008) The SAGE Handbook of Social Research Methods [Internet]. London: SAGE Publications Ltd; p. 95–109. Available from: https://methods.sagepub.com/book/the-sage-handbook-of-socialresearch-methods

Hill J, Wright LT (2001) A qualitative research agenda for small to medium-sized enterprises. Mark Intell Plan 19(6):432–443

Homan R (1991) The ethics of social research. Addison-Wesley Longman Limited

Israel M, Hay I (2006) Research ethics for social scientists. Sage

Kimmel AJ (1988) Ethics and values in applied social research. 1st ed. SAGE Publications Inc

Orb A, Eisenhauer L, Wynaden D (2001) Ethics in qualitative research. J Nurs Scholarsh 33(1):93–96

Principles of research ethics [Internet]. Lund Research Ltd. 2012 [cited 2020 Dec 15]. Available from: https://dissertation.laerd.com/principles-of-research-ethics.php

Robley LR (1995) The ethics of qualitative nursing research. J Prof Nurs 11(1):45–48

Wiles R, Charles V, Crow G, Heath S (2006) Researching researchers: lessons for research ethics. Qual Res. 6(3):283–99

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Department of Public Health, School of Health and Life Sciences, North South University, Dhaka, Bangladesh

Juwel Rana & Segufta Dilshad

Department of Biostatistics and Epidemiology, School of Health and Health Sciences, University of Massachusetts Amherst, Amherst, MA, USA

Department of Research and Innovation, South Asia Institute for Social Transformation (SAIST), Dhaka, Bangladesh

Space and Environment Research Center (SERC), Rajshahi, Bangladesh

Md. Ali Ahsan

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Rana, J., Dilshad, S., Ahsan, M.A. (2021). Ethical Issues in Research. In: Farazmand, A. (eds) Global Encyclopedia of Public Administration, Public Policy, and Governance. Springer, Cham. https://doi.org/10.1007/978-3-319-31816-5_462-1

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DOI : https://doi.org/10.1007/978-3-319-31816-5_462-1

Received : 01 February 2021

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Published : 05 March 2021

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Ethical considerations in research: Best practices and examples

To conduct responsible research, you’ve got to think about ethics. They protect participants’ rights and their well-being - and they ensure your findings are valid and reliable. This isn’t just a box for you to tick. It’s a crucial consideration that can make all the difference to the outcome of your research.

In this article, we'll explore the meaning and importance of research ethics in today's research landscape. You'll learn best practices to conduct ethical and impactful research.

Examples of ethical considerations in research

As a researcher, you're responsible for ethical research alongside your organization. Fulfilling ethical guidelines is critical. Organizations must ensure employees follow best practices to protect participants' rights and well-being.

Keep these things in mind when it comes to ethical considerations in research:

Voluntary participation

Voluntary participation is key. Nobody should feel like they're being forced to participate or pressured into doing anything they don't want to. That means giving people a choice and the ability to opt out at any time, even if they've already agreed to take part in the study.

Informed consent

Informed consent isn't just an ethical consideration. It's a legal requirement as well. Participants must fully understand what they're agreeing to, including potential risks and benefits.

The best way to go about this is by using a consent form. Make sure you include:

• A brief description of the study and research methods.
• The potential benefits and risks of participating.
• The length of the study.
• Contact information for the researcher and/or sponsor.
• Reiteration of the participant’s right to withdraw from the research project at any time without penalty.

Anonymity means that participants aren't identifiable in any way. This includes:

• Email address
• Photographs
• Video footage

You need a way to anonymize research data so that it can't be traced back to individual participants. This may involve creating a new digital ID for participants that can’t be linked back to their original identity using numerical codes.

Confidentiality

Information gathered during a study must be kept confidential. Confidentiality helps to protect the privacy of research participants. It also ensures that their information isn't disclosed to unauthorized individuals.

Some ways to ensure confidentiality include:

• Using a secure server to store data.
• Removing identifying information from databases that contain sensitive data.
• Using a third-party company to process and manage research participant data.
• Not keeping participant records for longer than necessary.
• Avoiding discussion of research findings in public forums.

Potential for harm

​​The potential for harm is a crucial factor in deciding whether a research study should proceed. It can manifest in various forms, such as:

• Psychological harm
• Social harm
• Physical harm

Conduct an ethical review to identify possible harms. Be prepared to explain how you’ll minimize these harms and what support is available in case they do happen.

Fair payment

One of the most crucial aspects of setting up a research study is deciding on fair compensation for your participants. Underpayment is a common ethical issue that shouldn't be overlooked. Properly rewarding participants' time is critical for boosting engagement and obtaining high-quality data. While Prolific requires a minimum payment of £6.00 / $8.00 per hour, there are other factors you need to consider when deciding on a fair payment.

First, check your institution's reimbursement guidelines to see if they already have a minimum or maximum hourly rate. You can also use the national minimum wage as a reference point.

Next, think about the amount of work you're asking participants to do. The level of effort required for a task, such as producing a video recording versus a short survey, should correspond with the reward offered.

You also need to consider the population you're targeting. To attract research subjects with specific characteristics or high-paying jobs, you may need to offer more as an incentive.

We recommend a minimum payment of £9.00 / $12.00 per hour, but we understand that payment rates can vary depending on a range of factors. Whatever payment you choose should reflect the amount of effort participants are required to put in and be fair to everyone involved.

Ethical research made easy with Prolific

At Prolific, we believe in making ethical research easy and accessible. The findings from the Fairwork Cloudwork report speak for themselves. Prolific was given the top score out of all competitors for minimum standards of fair work.

With over 25,000 researchers in our community, we're leading the way in revolutionizing the research industry. If you're interested in learning more about how we can support your research journey, sign up to get started now.

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• Introduction
• Conclusions
• Article Information

PRO indicates patient-reported outcome.

a See eTable 1 in the Supplement for details regarding Delphi survey and consensus meeting participant characteristics.

b Six additional stakeholders provided comments prior to or after the meeting.

Acknowledgements

eFigure. Decision Tree for Inclusion/Exclusion of Candidate Items

eTable 1. Delphi Survey and Consensus Meeting Participants Characteristics

eTable 2. Consensus Meeting Notes and Outcomes of Voting for the PRO Ethics Guidelines

eTable 3a. Eight Items (Items 2-17) Which Fulfilled the Inclusion Criteria at the Delphi Exercise Stage

eTable 3b. Nine Items Proposed for Inclusion to Discuss at the Consensus Meeting

eTable 4a. Excluded Candidate Items at the Delphi Exercise Stage

eTable 4b. Excluded Candidate Items That Were Merged With Other Items and/or Were Covered by Existing Items

• Electronic Symptom Monitoring With Patient-Reported Surveys and Outcomes Among Patients With Metastatic Cancer JAMA Original Investigation June 28, 2022 This randomized clinical trial assesses the effect of using weekly electronic patient-reported outcome surveys to monitor symptoms, compared with usual care, on physical function, symptom control, and health-related quality of life among patients receiving treatment for metastatic cancer. Ethan Basch, MD, MSc; Deborah Schrag, MD, MPH; Sydney Henson, BS; Jennifer Jansen, MPH; Brenda Ginos, MS; Angela M. Stover, PhD; Philip Carr, MPH; Patricia A. Spears, BS; Mattias Jonsson, BA; Allison M. Deal, MS; Antonia V. Bennett, PhD; Gita Thanarajasingam, MD; Lauren J. Rogak, MA; Bryce B. Reeve, PhD; Claire Snyder, PhD; Deborah Bruner, PhD; David Cella, PhD; Lisa A. Kottschade, MSN; Jane Perlmutter, PhD; Cindy Geoghegan, MA; Cleo A. Samuel-Ryals, PhD; Barbara Given, PhD; Gina L. Mazza, PhD; Robert Miller, MD; Jon F. Strasser, MD; Dylan M. Zylla, MD; Anna Weiss, MD; Victoria S. Blinder, MD; Amylou C. Dueck, PhD
• Patient-Reported Outcome Measures in Clinical Research JAMA JAMA Guide to Statistics and Methods August 2, 2022 This Guide to Statistics and Methods provides an overview of patient-reported outcome measures for clinical research, emphasizes several important considerations when using them, and points out their limitations. Kevin P. Weinfurt, PhD; Bryce B. Reeve, PhD
• Stability of Changes in Health Status JAMA Viewpoint September 13, 2022 This Viewpoint explores how patient-reported response to treatment informs understanding of clinically meaningful outcomes to help establish patient expectations, inform clinical decision-making, and ensure treatment is sound. Muhammad Shahzeb Khan, MD, MSc; Javed Butler, MD, MPH, MBA
• Sharing of Individual Patient-Level Data by Trialists of Randomized Clinical Trials JAMA Research Letter May 16, 2023 This study describes access to individual patient-level data from randomized clinical trials during the COVID-19 pandemic to determine whether the intent to share what was reported in the registry, publication, or preprint was consistent with actual data access. Laura C. Esmail, PhD; Philipp Kapp, MSc; Rouba Assi, PharmD, MSc; Julie Wood, BA; Gabriela Regan, BA; Philippe Ravaud, MD, PhD; Isabelle Boutron, MD, PhD

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Cruz Rivera S , Aiyegbusi OL , Ives J, et al. Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research : The PRO Ethics Guidelines . JAMA. 2022;327(19):1910–1919. doi:10.1001/jama.2022.6421

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Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research : The PRO Ethics Guidelines

• 1 Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom
• 2 Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, United Kingdom
• 3 DEMAND Hub, University of Birmingham, Birmingham, United Kingdom
• 4 National Institute for Health and Care Research (NIHR) Applied Research Centre West Midlands, Birmingham, United Kingdom
• 5 Centre for Ethics in Medicine, Bristol Medical School, University of Bristol, Bristol, United Kingdom
• 6 Warwick Medical School, University of Warwick, Coventry, United Kingdom
• 7 NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia
• 8 School of Population and Global Health, McGill University, Montreal, Quebec, Canada
• 9 A J Hunn Associates, London, United Kingdom
• 10 PRO Center of Excellence, Global Commercial Strategy Organization, Janssen Global Services, Warrington, United Kingdom
• 11 Division of Pediatric Haematology-Oncology, IWK Health Care Centre, Dalhousie University, Halifax, Nova Scotia, Canada
• 12 Observational and Pragmatic Research Institute, Midview City, Singapore
• 13 US Food and Drug Administration, Silver Spring, Maryland
• 14 European Organization for Research and Treatment of Cancer, Brussels, Belgium
• 15 Medicines and Healthcare Products Regulatory Agency, London, United Kingdom
• 16 Health Research Authority, London, United Kingdom
• 17 Patient partner, University of Birmingham, Birmingham, United Kingdom
• 18 Fast Track Research Ethics Committee, Health Research Authority, London, United Kingdom
• 19 JAMA Network, Chicago, Illinois
• 20 RTI Health Solutions, Research Triangle, North Carolina
• 21 Aparito Limited, Wrexham, Wales, United Kingdom
• 22 MRC-Versus Arthritis Centre for Musculoskeletal Ageing Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom
• 23 NIHR Birmingham Biomedical Research Centre, University Hospital Birmingham and University of Birmingham, Birmingham, United Kingdom
• 24 NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospital Birmingham and University of Birmingham, Birmingham, United Kingdom
• 25 Aetion, Washington, DC
• 26 Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan
• 27 Global Patient-Centred Outcomes Research & Policy, UCB, Belgium, Brussels
• 28 Nature Medicine , New York, New York
• 29 Department of Cardiology, Odense University Hospital, Odense, Denmark
• 30 Clinical Institute, University of Southern Denmark, Odense, Denmark
• 31 Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois
• 32 Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia
• 33 Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, Rhode Island
• 34 University of North Carolina at Chapel Hill
• 35 Consumer Forum, National Cancer Research Institute, London, United Kingdom
• 36 Patient Involvement Network, Health Research Authority, London, United Kingdom
• 37 Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom
• 38 Health Data Research United Kingdom, London, United Kingdom
• 39 UK SPINE, University of Birmingham, Birmingham, United Kingdom
• Original Investigation Electronic Symptom Monitoring With Patient-Reported Surveys and Outcomes Among Patients With Metastatic Cancer Ethan Basch, MD, MSc; Deborah Schrag, MD, MPH; Sydney Henson, BS; Jennifer Jansen, MPH; Brenda Ginos, MS; Angela M. Stover, PhD; Philip Carr, MPH; Patricia A. Spears, BS; Mattias Jonsson, BA; Allison M. Deal, MS; Antonia V. Bennett, PhD; Gita Thanarajasingam, MD; Lauren J. Rogak, MA; Bryce B. Reeve, PhD; Claire Snyder, PhD; Deborah Bruner, PhD; David Cella, PhD; Lisa A. Kottschade, MSN; Jane Perlmutter, PhD; Cindy Geoghegan, MA; Cleo A. Samuel-Ryals, PhD; Barbara Given, PhD; Gina L. Mazza, PhD; Robert Miller, MD; Jon F. Strasser, MD; Dylan M. Zylla, MD; Anna Weiss, MD; Victoria S. Blinder, MD; Amylou C. Dueck, PhD JAMA
• JAMA Guide to Statistics and Methods Patient-Reported Outcome Measures in Clinical Research Kevin P. Weinfurt, PhD; Bryce B. Reeve, PhD JAMA
• Viewpoint Stability of Changes in Health Status Muhammad Shahzeb Khan, MD, MSc; Javed Butler, MD, MPH, MBA JAMA
• Research Letter Sharing of Individual Patient-Level Data by Trialists of Randomized Clinical Trials Laura C. Esmail, PhD; Philipp Kapp, MSc; Rouba Assi, PharmD, MSc; Julie Wood, BA; Gabriela Regan, BA; Philippe Ravaud, MD, PhD; Isabelle Boutron, MD, PhD JAMA

Question   What ethical considerations should be considered by researchers, research ethics committees, and funders when conducting or reviewing patient-reported outcome (PRO) clinical research?

Findings   An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodology; 14 items addressing ethical considerations were recommended for inclusion in the PRO ethics guidelines.

Meaning   Addressing the items in the PRO ethics guidelines has the potential to improve the quality of PRO in clinical research while promoting and protecting participant autonomy and protecting participant and researcher welfare.

Importance   Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.

Objective   To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.

Evidence Review   The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network’s guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.

Findings   Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.

Conclusions and Relevance   The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Patient-reported outcomes (PROs) are used in clinical research and routine care to provide information on the physical, functional, and psychological effects of disease and treatment from the patient perspective. 1 PRO data can inform health care decisions, regulatory decisions, health care policy, and cost-effectiveness analyses. PROs can also be used for audit/benchmarking and monitoring of symptoms to provide timely care tailored to individual needs. 1 , 2 Notwithstanding the potential benefits of incorporating PROs in research and routine practice, ethical considerations have been highlighted. 3 For example, the PRO content of clinical trial protocols and reporting of PRO results is commonly inadequate. A 2019 evaluation of 160 cancer trials showed nearly 50 000 participants were included in studies that failed to publish their PRO data. 4

The increasing use of PROs may lead to uncertainties for patients about why data are being collected and used. There is a lack of guidance on how research personnel should manage situations in which PRO data reveal concerning levels of psychological distress or physical symptoms. 5 If concerning data are not managed appropriately, those data could lead to suboptimal participant care or biased trial results. 6 In addition, PRO research may not reflect the perspectives of underserved groups such as older individuals, socioeconomically disadvantaged populations, and racial and ethnic minority groups, which could threaten the scientific validity of results. 3 , 7

Ethical issues should be resolved with justifications that use established principles, theories, and values, as well as consider individual and societal welfare. 3 In 2018, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)-PRO Extension was developed to provide PRO trial protocol guidance. 8 These guidelines were not, however, developed specifically for the use of research ethics committees (RECs) and limited attention has been given to the ethical dimensions of PROs in clinical research. 7 Thus, there is a need to develop ethical guidelines to address this. The aim of this international effort was to develop consensus-based guidelines for the specific use of PROs in clinical research.

The PRO ethics guidelines were developed through an international Delphi process following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network’s framework for guideline development ( Figure ). 9

The PRO Ethics Steering Group, formed by 11 international experts with patient and public involvement (Acknowledgements in the Supplement ), was established to oversee the design and conduct of the study.

Ethical approval was given by the University of Birmingham Ethical Review Board (ERN_21-0075).

Candidate items were identified by the steering group from the SPIRIT-PRO Extension 8 guidelines and Supplement 3 of the accompanying SPIRIT-PRO Extension article. 8 Explanation of the candidate items was derived from lay terminology of the SPIRIT-PRO Extension. 10 The candidate items were supplemented with items generated from a systematic review of articles describing the ethical implications of PROs in clinical research. The protocol for the systematic review was registered on PROSPERO (registration No. CRD42020176177). The databases MEDLINE (Ovid), EMBASE, Allied and Complementary Medicine Database (AMED), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) Plus were searched from inception until March 2020 with the keywords patient reported outcome* and ethic* .

Publications were deemed eligible if they discussed ethical implications and/or guidance in the context of PRO clinical trials research, routine clinical practice, and broader PRO research. Two reviewers (SCR and OLA) independently conducted title and abstract screening before full-text screening to determine eligibility. Discrepancies were resolved through the involvement of a third reviewer (MJC). Text excerpts on ethical considerations of PRO research from the included studies were independently extracted by the 2 investigators (SCR and OLA) into a qualitative data analysis software package (NVivo 12; QSR International). Both reviewers independently generated categories and themes under the thematic analysis approach. The review identified 14 relevant articles, including qualitative reports, opinion and debate articles, and special communications that discussed the ethical implications of PRO research.

Based on the review, 6 candidate items were identified, and 17 items were drawn from the SPIRIT-PRO Extension guidelines 8 and Supplement 3 of that article.

In 2021, 201 international multidisciplinary individuals with interest in PRO research were invited to participate in the online Delphi process to vote on the candidate items and propose additional items. These participants comprised individuals responsible for developing PRO research submissions for ethical review, those undertaking ethical review, or using of data arising from PRO research. Potential participants were identified and contacted via the PRO Ethics Operations Group (S.C.R., M.J.C., O.L.A., A.P.D.) and the Health Research Authority (HRA). A snowballing technique and social media (LinkedIn and Twitter) were used to identify further participants. Participant characteristics are described in eTable 1 in the Supplement . DelphiManager software (version 5.0), developed and maintained by the COMET (Core Outcome Measures in Effectiveness Trials) Initiative, was used to undertake the 2 Delphi surveys. 11

Participants were provided with written information about the study prior to consenting to participate. Participants voted anonymously on a 9-point scale (1-3: not important; 4-6: important but not critical; and 7-9: important and critical) on the importance of the 23 items presented. Ninety-six responses were received for round 1 of the Delphi and 85 responses (89% of participants from round 1) were received for round 2. Participants were advised if they did not complete round 2, their round 1 responses would be retained. During round 1, participants had the option to suggest additional items. During round 2, 12 additional items were included. Anonymized item-level round 1 scores per participant group were presented to Delphi panelists for their consideration prior to round 2 voting.

The operations group mapped the 35 candidate PRO ethics items to existing HRA guidance from the UK, as an initial indicator of what may already be covered in existing ethics guidance, 12 removing duplicates and revising wording to aid clarification. The operations group presented the consensus delegates with recommendations for the inclusion or exclusion of items based on the decision tree (eFigure in the Supplement ). The COMET Initiative guidance informed the inclusion criteria (eMethods in the Supplement ). 13

An online consensus meeting took place in October 2021 hosted by the University of Birmingham, UK. Twenty-five international participants purposively selected from the Delphi survey attended the consensus meeting, comprising 7 clinical trialists/health academic researchers, 4 ethicists/members of an ethical review panel, 2 health care professionals, 3 PRO researchers from industry, 2 journal editors, 4 patients and members of the public, 1 policy maker, 1 regulator, and 1 bioethicist (eTable 1 in the Supplement ). Delegates were presented with candidate items and anonymously voted using the Zoom poll tool. Participants had the following voting options: include, exclude, or further discussion required (see the Participation in the Voting Process section, eMethods in the Supplement , for further details).

The aim of the meeting was to seek consensus on the content of the PRO ethics guidelines. Consensus panelists considered the focus of the guidelines and agreed that the guidelines covered ethical considerations when undertaking PRO clinical research. In addition, participants discussed the wording and explanatory text of each item. A threshold of 70% or more was prespecified to demonstrate consensus when voting on the items (see the Consensus Meeting section, eMethods in the Supplement , for further details). The items were presented alongside the overall Delphi score and the number of participant groups whereby 70% or more of respondents scored an item as important and critical.

Following the consensus meeting, attendees commented on the wording and agreed on the final version of the PRO ethics guidelines. Final edits were made to improve clarity and were approved by the steering group and patient partners. The eMethods section in the Supplement provides further information on methods.

The final PRO ethics guidelines identified 14 key questions that capture core ethical issues ( Table ). The items incorporated content from 14 of the 35 original candidate items, comprising 6 items that were merged during the consensus meeting and 8 items that were not modified (see eTables 2 and 3a and 3b in the Supplement ). Further details about the 21 excluded items are presented in eTables 4a and 4b in the Supplement . An explanation describing each item with supporting evidence is presented below. The items are presented in accordance with SPIRIT-PRO Extension subheadings and findings from the systematic review.

Explanation: Evidence suggests that many trials include PROs without specifying the PRO-specific research question and without a rationale or reference to PROs in related studies. 4 , 14 , 15 Researchers should carefully consider the PRO-specific research question to inform the selection of measures and methodological approach to help ensure results are meaningful. 8 In addition, patients and research personnel should understand why PRO data are being collected and how their data will be used, and this should be communicated effectively. 4 , 14 , 15 This can help build trust, particularly when participants may share potentially sensitive information. Why data are being collected and how these data will be used should be clearly explained in the information sheet, by research personnel, or both during the consent process.

Explanation: Clearly defined PRO objectives and hypotheses inform study design, including the selection of key PRO concepts and measures, time points for assessment, and analyses. 16 Poorly defined PRO objectives or hypotheses may affect the quality of research design and reporting. Poor science undermines participant consent (failing to respect autonomy) and exposes participants to unnecessary risk or burden because the results are ultimately not usable or not generalizable.

Explanation: Researchers should consider PRO-specific eligibility requirements at the design stage of the study and robustly justify excluding a subpopulation. It would undermine the principle of justice to exclude eligible people either directly or indirectly (eg, as a result of a failure to consider PRO accessibility or other equity, diversity, and inclusion issues). 17

Explanation: The PRO concept and analysis metric should be clearly outlined and aligned with the PRO objectives and hypothesis to ensure that they capture outcomes that matter to patients and other key interested groups, such as clinicians, regulators, and policy makers. Defining and justifying the selection of PRO instrument(s) are important aspects of ethical research. If possible, the PRO measure should be validated in the target population. The number of questionnaires used, acceptability of the questions, and participant burden should be considered carefully. PRO measures ideally should be used in accordance with existing user manuals to promote data quality and ensure standardized scoring. 8 When a PRO is being considered for a new population, representative patient input should be obtained about the suitability and appropriateness of the questions to determine whether the questions are relevant to the target population. 18

Explanation: Providing the schedule of PRO assessments in the study protocol and participant information sheet is the first step to ensuring potential participants understand the commitment and effort involved in taking part in the PRO study. A robust consent process includes information provision and checks on understanding. A poor process compromises respect for participant autonomy. 19 , 20

Explanation: Exposing participants to the risks and burdens of PRO research is only justifiable if these are outweighed by the potential value of the PRO data. A sample size that is too small may produce inconclusive and, therefore, not valuable results. A sample size that is too large will expose more participants than necessary to risks and burdens and incur unnecessary costs. 21 Item 14 of the SPIRIT-PRO Extension indicates that if PROs are the primary outcome of a study, a priori sample size calculation should be provided for that specific end point. If PROs are a secondary outcome, the sample size should provide enough power to test the principal PRO hypothesis. 8 This would not be required for exploratory PRO end points.

Explanation : Research personnel should understand how and where PRO data will be collected, and clear communication of this to potential participants is an essential component of a robust informed consent process. The mode(s) of administration should be influenced by the setting in which PRO data will be collected (eg, telephone or electronic completion may be more feasible from home) and the needs of the target population. 22 Ideally, participants from the target population would provide input on modes. Offering alternative modes of completion may help improve response rates and promote inclusivity and equity—all of which improve the quality of the results. 23 Item 18a(ii) of the SPIRIT-PRO Extension provides further information regarding the modes of PRO administration and setting for PRO randomized clinical trials. 8

Explanation: Responding to PRO alerts (concerning levels of psychological distress or physical symptoms that require timely response) 6 may protect the safety and welfare of participants, 17 which is an important ethical consideration. The research protocol should state whether, why, and by whom PRO data will be monitored during the study and this information should be shared with participants. 5 , 6 In low-risk studies in which alerts for concerning symptoms are not anticipated, PRO monitoring may not be necessary. Similarly, protocols should state whether research data will be shared with the patient’s care team or entered in the electronic medical record. Alternative support mechanisms (eg, 24-hour helpline) for participants should be outlined. All research personnel involved in the management of PRO alerts should receive appropriate training and have clear pathways for support. 24 , 25 Evidence suggests research personnel handle such data inconsistently, which may lead to inequitable patient care, cointervention bias, and confusion. 6 In addition, personnel in charge of collecting PRO data may feel emotional and/or ethical burden while dealing with concerning PRO data (eg, reports from trial participants of low self-esteem, depression, or risk of self-harm or suicide). 25

Explanation: PRO protocols should promote participant inclusivity while recruiting a diverse population that is representative of patients with the condition of interest. Barriers to participation, such as access to technology in rural areas, areas of socioeconomic disadvantage, or both, as well as disability, language, and cultural requirements, should be addressed to promote fairness and ensure results are as accurate and generalizable as possible. 26 For example, a clinical trial of adults receiving chemotherapy at 50 community cancer centers promoted inclusivity by offering internet and no-internet (automated telephone call) options to complete PROs remotely. Thirty-five percent of the participants chose the automated call (no-internet) option vs 65% who chose internet-based completion. 27 Without an alternative PRO mode, more than one-third of the vulnerable population may have been excluded.

Researchers may consider different modes of completion (item 7) to promote inclusivity and should be explicit about how the PRO strategy promotes or hinders the goal of recruiting a diverse sample representative of the target population. For instance, trials involving participants with different languages require the availability of validated language and culturally adapted PRO questionnaires, while some participants may need physical help or other types of assistance in responding (eg, turning pages, holding a pen, assistance with a telephone or computer keyboard). 8 , 16 , 24

Explanation: PROs should be acceptable to the population in which they will be administered, both in terms of the questions they ask and the overall burden to the patient (eg, is the completion time for the PRO measure acceptable). 28 The degree of participant burden depends on the frequency and timing of PRO assessments and on issues such as participant cognition, illness severity, treatment toxicity, and literacy. 16 Researchers should consider issues such as whether the questionnaire(s) capture important and relevant concepts to interested groups (such as overall health-related quality of life, specific domain or symptoms as described in item 4) and whether PROs include overlapping content and/or particularly sensitive questions. It is also important to consider the length, number of questionnaires, and end points, with respect to burden for subgroups of participants and if the mode of delivery (item 7) and schedule of assessments (item 5) are appropriate. If researchers demonstrate acceptable participant burden via robust involvement from representatives of the target patient population in the PRO selection process, RECs should not override the PRO strategy without strong ethical justification (eg, RECs should avoid automatically rejecting a proposal with a large number of PROs if justification is provided).

Short questionnaires minimize participant burden and assure greater completeness of PRO data while minimizing missing data. 29 However, patient input during the selection of PRO measures is key because participants may be willing to complete lengthy questionnaires if they understand the value of data collection and how the data will be used. 30 Thus, the views of the affected population are authoritative in this regard. Failure to seek participant input to core design issues, such as concepts to measure that matter most to patients, selection of questionnaires, time points, and mode of assessment, may lead to poor concordance, and therefore flawed results that cannot inform clinical practice. Poorly designed studies mislead participants who participate to help others and misuse research resources.

Explanation: It is well recognized in research governance that participants who lack capacity (eg, young children and adults who are cognitively impaired) are potentially vulnerable, and their interests in the context of research need to be protected. However, it is also important that such people are not unjustifiably excluded from relevant research. PRO research needs to meet the same well-defined standards.

These individuals may require a proxy: someone else to report the participant’s outcomes on their behalf. 8 This is different to assisting a participant to document their own answers (see item 9). 31 , 32 The correct administration of PRO tools when proxies need to be used contributes to the collection of robust and reliable data. The justification for including vulnerable participants in research is that it will either benefit them directly or it will benefit the population to which they belong. 33

In many research contexts, it is reasonable to anticipate the need for proxy response throughout all or some of the research (although the possibility can never be excluded) and this should be clearly documented in the research protocol. Researchers should be aware that proxy reporting is acceptable in some contexts and not in others. For example, the European Medicines Agency discourages proxy reporting because their data are often subject to biases and should only be used if it is the only effective means of obtaining vital information that might otherwise be lost. 28 The US Food and Drug Administration also discourages the use of proxy-reported outcomes to inform labeling claims, recommending observer reports for observable phenomenon only (eg, vomiting, but not nausea) instead. 16 However, in palliative care, collecting both proxy and observer measures is acceptable. 34

It is important to recognize that lack or loss of capacity to consent to research participation will not always be accompanied by an inability to self-complete PROs (with or without assistance), and appropriate support for such participants should be specified.

Explanation: Patient and public involvement refers to the partnership between patients, members of the public, and researchers in the codevelopment of research. 35 Patients and members of the public have unique insight derived from their lived experiences making research more relevant and enhancing the design, conduct, and quality of the research. 36 - 38 Incorporating these insights into research can make it prima facie more ethical in 2 ways: by democratizing the research agenda and/or helping to improve participant-facing documents and processes. 39

The inclusion of patient and/or public involvement should be considered best practice during the study design stage. Involvement of individuals with the disease can provide valuable insights into their lived experience and help ensure the research is relevant to their needs and acceptable, while public involvement may generate broader insights from a societal perspective. In addition, their inclusion should be integral to all the stages of research. The inclusion of patient involvement, public involvement, or both in the development of the PRO strategy may help to ensure that research measures what matters to patients, thereby maximizing its beneficial effect. It is also the best means of ensuring that PRO tools, and how they are administered, are acceptable (see item 10), and thereby may be influential in maximizing the response rate (see item 13). For example, recent patient involvement in the Therapies for Long COVID Study has led to the development of a new Symptom Burden Questionnaire because existing measures were felt to omit key symptoms experienced by those with the condition. 40

Explanation: Missing PRO data are a major problem in clinical research. 23 , 41 Missing data are normally caused by a combination of factors relating to methodology, logistic, administrative, and patient-related issues. 41 Protocols should describe how missing data will be minimized. Missing PRO data can complicate interpretation, lead to invalid conclusions, or may mean that the PRO data are not published. 4 , 42 , 43 When this occurs, it undermines the consent of participants who took part in the study and wastes research resources.

Although not all missing PRO data can be avoided, different strategies exist to mitigate this problem. 23 Specific recommendations related to data collection and management include using the minimum number of questionnaires appropriate to address the PRO research question, establishing standardized and documented PRO administration procedures, engaging and educating participants in the study by providing updates or incentives, using active quality assurance measures (such as monitoring of completion rates, reminders for upcoming or missed assessments), appointing a dedicated staff member responsible for PRO assessment at each center, training staff, and offering alternative modes of administration. 23 , 31 Reminders, notifications, or follow-up calls may be used to minimize missing data. Although different strategies exist to minimize avoidable PRO missing data, participants should be notified and provide consent, prior to accepting being part of the study, about the mechanisms the study will follow.

Explanation: The dissemination of PRO findings is essential to achieve beneficial outcomes. PRO data are, however, commonly omitted from primary and secondary publications. 4 Failing to report PRO data could limit the interpretation of the results and may hinder the translation of PRO findings into clinical practice, resulting in lost opportunities to benefit patients and the perpetuation of harmful practices. Failure to disseminate PRO findings is disrespectful of participants’ time, effort, and contribution to research. It may also undermine participants’ consent if they were misinformed about dissemination plans. 43 Sharing a summary of the PRO research results in accessible plain language for use by patients, participants, and members of the public promotes autonomy by empowering patients in shared decision-making around their care. 44

It is recommended that PRO findings should be incorporated into the main research publication or reported in a secondary publication providing a detailed explanation of the PRO data. 45 The CONSORT-PRO Extension guideline was developed to address the reporting of PRO trial data. The CONSORT-PRO provides evidence-based recommendations to improve completeness of reporting randomized clinical trials with either a primary or secondary PRO end point. 46

The Table shows an implementation tool for PRO researchers and RECs to be completed by research teams preparing PRO research or by reviewers.

The PRO ethics guidelines provide international consensus-based recommendations on questions that should be asked of a study’s design to facilitate the evaluation of its ethical acceptability. The guidelines highlight the ethical imperative to conduct robust science and the ethical issues to consider in the design and review of PRO clinical research. While a number of ethical issues identified are not unique to PROs and apply to research more widely, they raise particular challenges in the context of PROs, which is the focus of the work developed. The PRO ethics guidelines comprise 14 items to consider for use alongside the existing SPIRIT-PRO and CONSORT-PRO Extension guidelines 8 , 46 and other ethical recommendations relevant to the jurisdiction of interest. 12 , 47 , 48

The guidelines do not aim to mandate how ethical research should look, nor to mandate the correct response to the questions it asks. Instead, the guidelines aim to highlight issues that should be considered by research groups and ethics committees, including patients, research participants, and the public.

The recommendations within the PRO ethics guidelines reflect widely accepted ethical norms encapsulated in instruments such as the Declaration of Helsinki, 49 the Belmont Report, 50 and the Council for International Organizations of Medical Sciences guidelines. 51 The recommendations are in line with the 3 principles of respect of persons, concern for welfare, and justice outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 48 and the widely used 4 principles of biomedical ethics: autonomy, justice, beneficence, and nonmaleficence. 19 As such, the guiding ethical questions presented here do not set out any new ethical ideas, but rather specify widely accepted norms in the context of PROs and frame them in a way that is accessible to PRO researchers and useful for reviewers of PRO research.

The use of the PRO ethics guidelines has the potential to reduce participant risk and burden. In addition, addressing the items of the PRO ethics guidelines may help promote and protect participant autonomy and the welfare of participants and researchers. Furthermore, it may promote inclusive, equitable PRO research; the sharing of PRO research findings with participants and patients; and minimization of research waste ( Box ).

Aims of the PRO Ethics Guidelines

Maximize beneficial effect from research resources

Promote and protect participant autonomy

Protect participant research welfare

Promote accessible research

Minimize participant burden and harm

Minimize participant risk

Promote high-quality research

Disseminate PRO research

The Table provides an implementation tool for PRO researchers to reflect how each item has been addressed prior to ethical submission and for RECs to make notes on the research submitted and discuss in detail any relevant points at the ethics meeting. This tool is a starting point and can be tailored according to the users’ needs. Collaborations with national and international networks are being planned to promote the implementation of the PRO ethics guidelines.

This study has several limitations. First, the review identified only limited literature on which to base items for inclusion in the Delphi. Therefore, some relevant candidate items may not have been included; however, additional items were proposed by the steering group, and further items were informed by the SPIRIT-PRO Extension work, based on an extensive review of PRO protocol guidance. Furthermore, participants had the opportunity to propose additional items during round 1 of the Delphi process. Second, only literature available until March 2020 was considered in development of the guidelines. However, an updated search was performed on March 23, 2022; an additional 569 articles were screened and no further relevant literature was identified. Third, because participants ranked items according to their general importance, it is possible that some items might be less relevant for certain types of trials.

The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Corresponding Author: Melanie J. Calvert, PhD, Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham B15 2TT, England ( [email protected] ).

Accepted for Publication: April 5, 2022.

Author Contributions: Drs Cruz Rivera and Calvert had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Cruz Rivera, Aiyegbusi, Ives, Mercieca-Bebber, Hunn, Bhatnagar, Bottomley, Campbell, Collis, Golub, von Hildebrand, Mahendraratnam, Wilson, Stover, Calvert.

Acquisition, analysis, or interpretation of data: Cruz Rivera, Aiyegbusi, Ives, Draper, Mercieca-Bebber, Ells, Hunn, Scott, Fernandez, Dickens, Anderson, Bottomley, Campbell, Collett, Craig, Davies, Gosden, Gnanasakthy, Haf Davies, Lord, Miyaji, Monteiro, Morel, Zwisler, Peipert, Roydhouse, Wilson, Yap, Calvert.

Drafting of the manuscript: Cruz Rivera, Draper, Hunn, Dickens, Anderson, Campbell, Collett, Collis, Davies, Gosden, Gnanasakthy, Haf Davies, Monteiro, Stover, Calvert.

Critical revision of the manuscript for important intellectual content: Aiyegbusi, Ives, Draper, Mercieca-Bebber, Ells, Hunn, Scott, Fernandez, Dickens, Anderson, Bhatnagar, Bottomley, Campbell, Craig, Golub, von Hildebrand, Lord, Mahendraratnam, Miyaji, Monteiro, Morel, Zwisler, Peipert, Roydhouse, Wilson, Stover, Yap, Calvert.

Statistical analysis: Bottomley, Haf Davies, Calvert.

Obtained funding: Mercieca-Bebber, Calvert.

Administrative, technical, or material support: Aiyegbusi, Dickens, Gosden, Haf Davies, von Hildebrand, Mahendraratnam.

Supervision: Calvert.

Other - patient partner: Collis.

Other - patient viewpoint and contributor: Wilson.

Other - statistical advice: Yap.

Other - consensus meeting participation: Roydhouse.

Other - Providing options and opinions: Haf Davies.

Other - helped with formulation of interpretation and analysis regarding ethical values/principles: Draper.

Other - Delphi panel member, reviewed and commented on the study documents and publications: Scott.

Conflict of Interest Disclosures: Dr Cruz Rivera reported receiving funding from UK SPINE and European Regional Development Fund–Demand Hub and personal fees from Merck. Dr Aiyegbusi reported receiving grants from the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, NIHR Applied Research Collaboration West Midlands, UK Research and Innovation (UKRI), Health Foundation, Janssen, Gilead, and GlaxoSmithKline and personal fees from Gilead Sciences Ltd, Merck, and GlaxoSmithKline outside the submitted work. Dr Draper reported receiving unrelated research funding from UK SPINE (UKRI), AHRC, and the University of Warwick and being a member of the Defence Medical Services ethics committee, Birmingham Women’s and Children’s NHS Foundation Trust clinical ethics committee, and NHS Blood and Transplant Deceased Donor Family Tissue Advisory Group. Dr Scott reported receiving a pension from Janssen and holding stock in Johnson & Johnson. Drs Ells and Fernandez are members of the Canadian Interagency Panel on Research Ethics, which is responsible for the interpretation and evolution of the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans . Ms Anderson reported receiving funding from the Health Education England/NIHR Integrated Clinical Academic Program Clinical Doctoral Research Fellowship. Dr Haf Davies reported owning an ePRO software platform called Atom5 through Aparito. Dr Lord reported being a member of the Nuffield Bioethics Working Group on the Future of Ageing. Dr Mahendraratnam reported owning stock options at Aetion Inc. Mr Miyaji reported grants (paid to the Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo) from AC Medical, A2 Healthcare, New Age Trading, Japan Tobacco Inc, Japan Media Corp, Medidata Solutions, Ono Pharmaceutical, FMD K&L Japan, 3H Medi Solution, NOBORI, Medrio Inc, Welby Inc, Nipro Corp, and Intellim and personal fees from Pfizer Japan Inc, Takeda Pharmaceutical Co, Merck, Ayumi Pharmaceutical, and Welby Inc. Dr Morel reported owning shares of UCB Pharma. Dr Zwisler reported being chair of the national clinical coordinating group on PRO in cardiac diseases. Dr Peipert reported receiving unrelated research funding from the National Cancer Institute, the National Institutes of Health, the Food and Drug Administration, the ECOG-ACRIN Medical Research Foundation, the Peter G. Peterson Foundation, Veloxis Pharmaceuticals, Pfizer, and the Northwestern University George M. O’Brien Kidney Core Center. He has received unrelated personal fees from AstraZeneca, IMPAQ International, and FACIT.org; in addition, he is the International Society for Quality of Life Research’s psychometric special interest group chair. Through his institution, he is supported by unrelated grants and contracts from Bristol Myers Squibb, Clovis Oncology, Pfizer, and Veloxis Pharmaceuticals. Dr Roydhouse reported receiving unrelated personal fees in the last 24 months from Amgen. Through her institution, she is supported by an unrelated Select Foundation Fellowship and has received unrelated research funding from the Royal Hobart Hospital and the Food and Drug Administration. Dr Stover reported receiving unrelated consulting fees or speaking honoraria in the last 24 months from Navigating Cancer, Association of Community Cancer Centers, Genentech, Purchaser Business Group on Health, and Henry Ford Cancer Center and unrelated research funding from Sivan Innovation and UroGen Pharma Ltd. Dr Yap reported receiving unrelated consulting fees and speaking honoraria from Faron Pharmaceuticals and Celgene, respectively, and being an expert advisor for the Medicines and Healthcare products Regulatory Agency’s Clinical Trials, Biologicals and Vaccines Expert Advisory Group and a funding panel member for the Medical Research Council Experimental Medicine and Cancer Research UK Clinical Research Committee. Dr Calvert reported serving as director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, director of the Centre for Patient Reported Outcome Research, and an NIHR senior investigator and receiving funding from the NIHR, UK Research and Innovation (UKRI), NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre, NIHR ARC West Midlands, UK SPINE, European Regional Development Fund–Demand Hub and Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, Janssen, GlaxoSmithKline, and Gilead. Dr Calvert has received personal fees from Astellas, Aparito Ltd, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GlaxoSmithKline, and the Patient-Centered Outcomes Research Institute outside the submitted work. In addition, a family member owns shares in GlaxoSmithKline. No other disclosures were reported.

Funding/Support: This work was sponsored by the University of Birmingham, the NIHR Birmingham Biomedical Research Centre, UK Research and Innovation, UK SPINE, and the European Regional Development Fund.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Several authors are employees of the University of Birmingham; however, beyond the declared author contributions, the sponsor had no additional role.

Disclaimer: The views expressed in this article are those of the author(s) and not necessarily those of national agencies (eg, the NIHR, Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Health Research Authority, Canadian Institutes of Healthcare Research, the Department of Health and Social Care, Canadian Interagency Panel on Research Ethics, or the Canadian Tri-Council Policy Statement 2. Dr Golub is Executive Deputy Editor of JAMA but was not involved in any of the decisions regarding review of the manuscript or its acceptance.

Additional Information: Dr Scott retired from Janssen Global Services in March 2021; however, she was still involved in the development of the guideline until its final stage. Coauthor Amanda Hunn, MA, died February 8, 2022.

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What Are the Ethical Considerations in Research Design?

When I began my work on the thesis I was always focused on my research. However, once I began to make my way through research, I realized that research ethics is a core aspect of the research work and the foundation of research design.

Research ethics play a crucial role in ensuring the responsible conduct of research. Here are some key reasons why research ethics matter:

Let us look into some of the major ethical considerations in research design.

Ethical Issues in Research

There are many organizations, like the Committee on Publication Ethics , dedicated to promoting ethics in scientific research. These organizations agree that ethics is not an afterthought or side note to the research study. It is an integral aspect of research that needs to remain at the forefront of our work.

The research design must address specific research questions. Hence, the conclusions of the study must correlate to the questions posed and the results. Also, research ethics demands that the methods used must relate specifically to the research questions.

Voluntary Participation and Consent

An individual should at no point feel any coercion to participate in a study. This includes any type of persuasion or deception in attempting to gain an individual’s trust.

Informed consent states that an individual must give their explicit consent to participate in the study. You can think of consent form as an agreement of trust between the researcher and the participants.

Sampling is the first step in research design . You will need to explain why you want a particular group of participants. You will have to explain why you left out certain people or groups. In addition, if your sample includes children or special needs individuals, you will have additional requirements to address like parental permission.

Confidentiality

The third ethics principle of the Economic and Social Research Council (ESRC) states that: “The confidentiality of the information supplied by research subjects and the anonymity of respondents must be respected.” However, sometimes confidentiality is limited. For example, if a participant is at risk of harm, we must protect them. This might require releasing confidential information.

Risk of Harm

We should do everything in our power to protect study participants. For this, we should focus on the risk to benefit ratio. If possible risks outweigh the benefits, then we should abandon or redesign the study. Risk of harm also requires us to measure the risk to benefit ratio as the study progresses.

Research Methods

We know there are numerous research methods. However, when it comes to ethical considerations, some key questions can help us find the right approach for our studies.

i. Which methods most effectively fit the aims of your research?

ii. What are the strengths and restrictions of a particular method?

iii. Are there potential risks when using a particular research method?

For more guidance, you can refer to the ESRC Framework for Research Ethics .

Ethical issues in research can arise at various stages of the research process and involve different aspects of the study. Here are some common examples of ethical issues in research:

Institutional Review Boards

The importance of ethics in research cannot be understated. Following ethical guidelines will ensure your study’s validity and promote its contribution to scientific study. On a personal level, you will strengthen your research and increase your opportunities to gain funding.

To address the need for ethical considerations, most institutions have their own Institutional Review Board (IRB). An IRB secures the safety of human participants and prevents violation of human rights. It reviews the research aims and methodologies to ensure ethical practices are followed. If a research design does not follow the set ethical guidelines, then the  researcher will have to amend their study.

Applying for Ethical Approval

Applications for ethical approval will differ across institutions. Regardless, they focus on the benefits of your research and the risk to benefit ratio concerning participants. Therefore, you need to effectively address both in order to get ethical clearence.

Participants

It is vital that you make it clear that individuals are provided with sufficient information in order to make an informed decision on their participation. In addition, you need to demonstrate that the ethical issues of consent, risk of harm, and confidentiality are clearly defined.

Benefits of the Study

You need to prove to the panel that your work is essential and will yield results that contribute to the scientific community. For this, you should demonstrate the following:

i. The conduct of research guarantees the quality and integrity of results.

ii. The research will be properly distributed.

iii. The aims of the research are clear and the methodology is appropriate.

Integrity and transparency are vital in the research. Ethics committees expect you to share any actual or potential conflicts of interest that could affect your work. In addition, you have to be honest and transparent throughout the approval process and the research process.

The Dangers of Unethical Practices

There is a reason to  follow ethical guidelines. Without these guidelines, our research will suffer. Moreover, more importantly, people could suffer.

The following are just two examples of infamous cases of unethical research practices that demonstrate the importance of adhering to ethical standards:

• The Stanford Prison Experiment (1971) aimed to investigate the psychological effects of power using the relationship between prisoners and prison officers. Those assigned the role of “prison officers” embraced measures that exposed “prisoners” to psychological and physical harm. In this case, there was voluntary participation. However, there was disregard for  welfare of the participants.
• Recently, Chinese scientist He Jiankui announced his work on genetically edited babies . Over 100 Chinese scientists denounced this research, calling it “crazy” and “shocking and unacceptable.” This research shows a troubling attitude of “do first, debate later” and a disregard for the ethical concerns of manipulating the human body Wang Yuedan, a professor of immunology at Peking University, calls this “an ethics disaster for the world” and demands strict punishments for this type of ethics violation.

What are your experiences with research ethics? How have you developed an ethical approach to research design? Please share your thoughts with us in the comments section below.

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Ethical Considerations In Psychology Research

Saul Mcleod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul Mcleod, PhD., is a qualified psychology teacher with over 18 years of experience in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

Learn about our Editorial Process

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

On This Page:

Ethics refers to the correct rules of conduct necessary when carrying out research. We have a moral responsibility to protect research participants from harm.

However important the issue under investigation, psychologists must remember that they have a duty to respect the rights and dignity of research participants. This means that they must abide by certain moral principles and rules of conduct.

What are Ethical Guidelines?

In Britain, ethical guidelines for research are published by the British Psychological Society, and in America, by the American Psychological Association. The purpose of these codes of conduct is to protect research participants, the reputation of psychology, and psychologists themselves.

Moral issues rarely yield a simple, unambiguous, right or wrong answer. It is, therefore, often a matter of judgment whether the research is justified or not.

For example, it might be that a study causes psychological or physical discomfort to participants; maybe they suffer pain or perhaps even come to serious harm.

On the other hand, the investigation could lead to discoveries that benefit the participants themselves or even have the potential to increase the sum of human happiness.

Rosenthal and Rosnow (1984) also discuss the potential costs of failing to carry out certain research. Who is to weigh up these costs and benefits? Who is to judge whether the ends justify the means?

Finally, if you are ever in doubt as to whether research is ethical or not, it is worthwhile remembering that if there is a conflict of interest between the participants and the researcher, it is the interests of the subjects that should take priority.

Studies must now undergo an extensive review by an institutional review board (US) or ethics committee (UK) before they are implemented. All UK research requires ethical approval by one or more of the following:

• Department Ethics Committee (DEC) : for most routine research.
• Institutional Ethics Committee (IEC) : for non-routine research.
• External Ethics Committee (EEC) : for research that s externally regulated (e.g., NHS research).

Committees review proposals to assess if the potential benefits of the research are justifiable in light of the possible risk of physical or psychological harm.

These committees may request researchers make changes to the study’s design or procedure or, in extreme cases, deny approval of the study altogether.

The British Psychological Society (BPS) and American Psychological Association (APA) have issued a code of ethics in psychology that provides guidelines for conducting research.  Some of the more important ethical issues are as follows:

Informed Consent

Before the study begins, the researcher must outline to the participants what the research is about and then ask for their consent (i.e., permission) to participate.

An adult (18 years +) capable of being permitted to participate in a study can provide consent. Parents/legal guardians of minors can also provide consent to allow their children to participate in a study.

Whenever possible, investigators should obtain the consent of participants. In practice, this means it is not sufficient to get potential participants to say “Yes.”

They also need to know what it is that they agree to. In other words, the psychologist should, so far as is practicable, explain what is involved in advance and obtain the informed consent of participants.

Informed consent must be informed, voluntary, and rational. Participants must be given relevant details to make an informed decision, including the purpose, procedures, risks, and benefits. Consent must be given voluntarily without undue coercion. And participants must have the capacity to rationally weigh the decision.

Components of informed consent include clearly explaining the risks and expected benefits, addressing potential therapeutic misconceptions about experimental treatments, allowing participants to ask questions, and describing methods to minimize risks like emotional distress.

Investigators should tailor the consent language and process appropriately for the study population. Obtaining meaningful informed consent is an ethical imperative for human subjects research.

The voluntary nature of participation should not be compromised through coercion or undue influence. Inducements should be fair and not excessive/inappropriate.

However, it is not always possible to gain informed consent.  Where the researcher can’t ask the actual participants, a similar group of people can be asked how they would feel about participating.

If they think it would be OK, then it can be assumed that the real participants will also find it acceptable. This is known as presumptive consent.

However, a problem with this method is that there might be a mismatch between how people think they would feel/behave and how they actually feel and behave during a study.

In order for consent to be ‘informed,’ consent forms may need to be accompanied by an information sheet for participants’ setting out information about the proposed study (in lay terms), along with details about the investigators and how they can be contacted.

Special considerations exist when obtaining consent from vulnerable populations with decisional impairments, such as psychiatric patients, intellectually disabled persons, and children/adolescents. Capacity can vary widely so should be assessed individually, but interventions to improve comprehension may help. Legally authorized representatives usually must provide consent for children.

Participants must be given information relating to the following:

• A statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive.
• Purpose of the research.
• All foreseeable risks and discomforts to the participant (if there are any). These include not only physical injury but also possible psychological.
• Procedures involved in the research.
• Benefits of the research to society and possibly to the individual human subject.
• Length of time the subject is expected to participate.
• Person to contact for answers to questions or in the event of injury or emergency.
• Subjects” right to confidentiality and the right to withdraw from the study at any time without any consequences.

Debriefing after a study involves informing participants about the purpose, providing an opportunity to ask questions, and addressing any harm from participation. Debriefing serves an educational function and allows researchers to correct misconceptions. It is an ethical imperative.

After the research is over, the participant should be able to discuss the procedure and the findings with the psychologist. They must be given a general idea of what the researcher was investigating and why, and their part in the research should be explained.

Participants must be told if they have been deceived and given reasons why. They must be asked if they have any questions, which should be answered honestly and as fully as possible.

Debriefing should occur as soon as possible and be as full as possible; experimenters should take reasonable steps to ensure that participants understand debriefing.

“The purpose of debriefing is to remove any misconceptions and anxieties that the participants have about the research and to leave them with a sense of dignity, knowledge, and a perception of time not wasted” (Harris, 1998).

The debriefing aims to provide information and help the participant leave the experimental situation in a similar frame of mind as when he/she entered it (Aronson, 1988).

Exceptions may exist if debriefing seriously compromises study validity or causes harm itself, like negative emotions in children. Consultation with an institutional review board guides exceptions.

Debriefing indicates investigators’ commitment to participant welfare. Harms may not be raised in the debriefing itself, so responsibility continues after data collection. Following up demonstrates respect and protects persons in human subjects research.

Protection of Participants

Researchers must ensure that those participating in research will not be caused distress. They must be protected from physical and mental harm. This means you must not embarrass, frighten, offend or harm participants.

Normally, the risk of harm must be no greater than in ordinary life, i.e., participants should not be exposed to risks greater than or additional to those encountered in their normal lifestyles.

The researcher must also ensure that if vulnerable groups are to be used (elderly, disabled, children, etc.), they must receive special care. For example, if studying children, ensure their participation is brief as they get tired easily and have a limited attention span.

Researchers are not always accurately able to predict the risks of taking part in a study, and in some cases, a therapeutic debriefing may be necessary if participants have become disturbed during the research (as happened to some participants in Zimbardo’s prisoners/guards study ).

Deception research involves purposely misleading participants or withholding information that could influence their participation decision. This method is controversial because it limits informed consent and autonomy, but can provide otherwise unobtainable valuable knowledge.

Types of deception include (i) deliberate misleading, e.g. using confederates, staged manipulations in field settings, deceptive instructions; (ii) deception by omission, e.g., failure to disclose full information about the study, or creating ambiguity.

The researcher should avoid deceiving participants about the nature of the research unless there is no alternative – and even then, this would need to be judged acceptable by an independent expert. However, some types of research cannot be carried out without at least some element of deception.

For example, in Milgram’s study of obedience , the participants thought they were giving electric shocks to a learner when they answered a question wrongly. In reality, no shocks were given, and the learners were confederates of Milgram.

This is sometimes necessary to avoid demand characteristics (i.e., the clues in an experiment that lead participants to think they know what the researcher is looking for).

Another common example is when a stooge or confederate of the experimenter is used (this was the case in both the experiments carried out by Asch ).

According to ethics codes, deception must have strong scientific justification, and non-deceptive alternatives should not be feasible. Deception that causes significant harm is prohibited. Investigators should carefully weigh whether deception is necessary and ethical for their research.

However, participants must be deceived as little as possible, and any deception must not cause distress.  Researchers can determine whether participants are likely distressed when deception is disclosed by consulting culturally relevant groups.

Participants should immediately be informed of the deception without compromising the study’s integrity. Reactions to learning of deception can range from understanding to anger. Debriefing should explain the scientific rationale and social benefits to minimize negative reactions.

If the participant is likely to object or be distressed once they discover the true nature of the research at debriefing, then the study is unacceptable.

If you have gained participants’ informed consent by deception, then they will have agreed to take part without actually knowing what they were consenting to.  The true nature of the research should be revealed at the earliest possible opportunity or at least during debriefing.

Some researchers argue that deception can never be justified and object to this practice as it (i) violates an individual’s right to choose to participate; (ii) is a questionable basis on which to build a discipline; and (iii) leads to distrust of psychology in the community.

Confidentiality

Protecting participant confidentiality is an ethical imperative that demonstrates respect, ensures honest participation, and prevents harms like embarrassment or legal issues. Methods like data encryption, coding systems, and secure storage should match the research methodology.

Participants and the data gained from them must be kept anonymous unless they give their full consent.  No names must be used in a lab report .

Researchers must clearly describe to participants the limits of confidentiality and methods to protect privacy. With internet research, threats exist like third-party data access; security measures like encryption should be explained. For non-internet research, other protections should be noted too, like coding systems and restricted data access.

High-profile data breaches have eroded public trust. Methods that minimize identifiable information can further guard confidentiality. For example, researchers can consider whether birthdates are necessary or just ages.

Generally, reducing personal details collected and limiting accessibility safeguards participants. Following strong confidentiality protections demonstrates respect for persons in human subjects research.

What do we do if we discover something that should be disclosed (e.g., a criminal act)? Researchers have no legal obligation to disclose criminal acts and must determine the most important consideration: their duty to the participant vs. their duty to the wider community.

Ultimately, decisions to disclose information must be set in the context of the research aims.

Withdrawal from an Investigation

Participants should be able to leave a study anytime if they feel uncomfortable. They should also be allowed to withdraw their data. They should be told at the start of the study that they have the right to withdraw.

They should not have pressure placed upon them to continue if they do not want to (a guideline flouted in Milgram’s research).

Participants may feel they shouldn’t withdraw as this may ‘spoil’ the study. Many participants are paid or receive course credits; they may worry they won’t get this if they withdraw.

Even at the end of the study, the participant has a final opportunity to withdraw the data they have provided for the research.

Ethical Issues in Psychology & Socially Sensitive Research

There has been an assumption over the years by many psychologists that provided they follow the BPS or APA guidelines when using human participants and that all leave in a similar state of mind to how they turned up, not having been deceived or humiliated, given a debrief, and not having had their confidentiality breached, that there are no ethical concerns with their research.

But consider the following examples:

a) Caughy et al. 1994 found that middle-class children in daycare at an early age generally score less on cognitive tests than children from similar families reared in the home.

Assuming all guidelines were followed, neither the parents nor the children participating would have been unduly affected by this research. Nobody would have been deceived, consent would have been obtained, and no harm would have been caused.

However, consider the wider implications of this study when the results are published, particularly for parents of middle-class infants who are considering placing their young children in daycare or those who recently have!

b)  IQ tests administered to black Americans show that they typically score 15 points below the average white score.

When black Americans are given these tests, they presumably complete them willingly and are not harmed as individuals. However, when published, findings of this sort seek to reinforce racial stereotypes and are used to discriminate against the black population in the job market, etc.

Sieber & Stanley (1988) (the main names for Socially Sensitive Research (SSR) outline 4 groups that may be affected by psychological research: It is the first group of people that we are most concerned with!

• Members of the social group being studied, such as racial or ethnic group. For example, early research on IQ was used to discriminate against US Blacks.
• Friends and relatives of those participating in the study, particularly in case studies, where individuals may become famous or infamous. Cases that spring to mind would include Genie’s mother.
• The research team. There are examples of researchers being intimidated because of the line of research they are in.
• The institution in which the research is conducted.

salso suggest there are 4 main ethical concerns when conducting SSR:

• The research question or hypothesis.
• The treatment of individual participants.
• The institutional context.
• How the findings of the research are interpreted and applied.

Ethical Guidelines For Carrying Out SSR

Sieber and Stanley suggest the following ethical guidelines for carrying out SSR. There is some overlap between these and research on human participants in general.

Privacy : This refers to people rather than data. Asking people questions of a personal nature (e.g., about sexuality) could offend.

Confidentiality: This refers to data. Information (e.g., about H.I.V. status) leaked to others may affect the participant’s life.

Sound & valid methodology : This is even more vital when the research topic is socially sensitive. Academics can detect flaws in methods, but the lay public and the media often don’t.

When research findings are publicized, people are likely to consider them fact, and policies may be based on them. Examples are Bowlby’s maternal deprivation studies and intelligence testing.

Deception : Causing the wider public to believe something, which isn’t true by the findings, you report (e.g., that parents are responsible for how their children turn out).

Informed consent : Participants should be made aware of how participating in the research may affect them.

Justice & equitable treatment : Examples of unjust treatment are (i) publicizing an idea, which creates a prejudice against a group, & (ii) withholding a treatment, which you believe is beneficial, from some participants so that you can use them as controls.

Scientific freedom : Science should not be censored, but there should be some monitoring of sensitive research. The researcher should weigh their responsibilities against their rights to do the research.

Ownership of data : When research findings could be used to make social policies, which affect people’s lives, should they be publicly accessible? Sometimes, a party commissions research with their interests in mind (e.g., an industry, an advertising agency, a political party, or the military).

Some people argue that scientists should be compelled to disclose their results so that other scientists can re-analyze them. If this had happened in Burt’s day, there might not have been such widespread belief in the genetic transmission of intelligence. George Miller (Miller’s Magic 7) famously argued that we should give psychology away.

The values of social scientists : Psychologists can be divided into two main groups: those who advocate a humanistic approach (individuals are important and worthy of study, quality of life is important, intuition is useful) and those advocating a scientific approach (rigorous methodology, objective data).

The researcher’s values may conflict with those of the participant/institution. For example, if someone with a scientific approach was evaluating a counseling technique based on a humanistic approach, they would judge it on criteria that those giving & receiving the therapy may not consider important.

Cost/benefit analysis : It is unethical if the costs outweigh the potential/actual benefits. However, it isn’t easy to assess costs & benefits accurately & the participants themselves rarely benefit from research.

Sieber & Stanley advise that researchers should not avoid researching socially sensitive issues. Scientists have a responsibility to society to find useful knowledge.

• They need to take more care over consent, debriefing, etc. when the issue is sensitive.
• They should be aware of how their findings may be interpreted & used by others.
• They should make explicit the assumptions underlying their research so that the public can consider whether they agree with these.
• They should make the limitations of their research explicit (e.g., ‘the study was only carried out on white middle-class American male students,’ ‘the study is based on questionnaire data, which may be inaccurate,’ etc.
• They should be careful how they communicate with the media and policymakers.
• They should be aware of the balance between their obligations to participants and those to society (e.g. if the participant tells them something which they feel they should tell the police/social services).
• They should be aware of their own values and biases and those of the participants.

Arguments for SSR

• Psychologists have devised methods to resolve the issues raised.
• SSR is the most scrutinized research in psychology. Ethical committees reject more SSR than any other form of research.
• By gaining a better understanding of issues such as gender, race, and sexuality, we are able to gain greater acceptance and reduce prejudice.
• SSR has been of benefit to society, for example, EWT. This has made us aware that EWT can be flawed and should not be used without corroboration. It has also made us aware that the EWT of children is every bit as reliable as that of adults.
• Most research is still on white middle-class Americans (about 90% of research is quoted in texts!). SSR is helping to redress the balance and make us more aware of other cultures and outlooks.

Arguments against SSR

• Flawed research has been used to dictate social policy and put certain groups at a disadvantage.
• Research has been used to discriminate against groups in society, such as the sterilization of people in the USA between 1910 and 1920 because they were of low intelligence, criminal, or suffered from psychological illness.
• The guidelines used by psychologists to control SSR lack power and, as a result, are unable to prevent indefensible research from being carried out.

American Psychological Association. (2002). American Psychological Association ethical principles of psychologists and code of conduct. www.apa.org/ethics/code2002.html

Baumrind, D. (1964). Some thoughts on ethics of research: After reading Milgram’s” Behavioral study of obedience.”.  American Psychologist ,  19 (6), 421.

Caughy, M. O. B., DiPietro, J. A., & Strobino, D. M. (1994). Day‐care participation as a protective factor in the cognitive development of low‐income children.  Child development ,  65 (2), 457-471.

Harris, B. (1988). Key words: A history of debriefing in social psychology. In J. Morawski (Ed.), The rise of experimentation in American psychology (pp. 188-212). New York: Oxford University Press.

Rosenthal, R., & Rosnow, R. L. (1984). Applying Hamlet’s question to the ethical conduct of research: A conceptual addendum. American Psychologist, 39(5) , 561.

Sieber, J. E., & Stanley, B. (1988). Ethical and professional dimensions of socially sensitive research.  American psychologist ,  43 (1), 49.

The British Psychological Society. (2010). Code of Human Research Ethics. www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf

Further Information

• MIT Psychology Ethics Lecture Slides

BPS Documents

• Code of Ethics and Conduct (2018)
• Good Practice Guidelines for the Conduct of Psychological Research within the NHS
• Guidelines for Psychologists Working with Animals
• Guidelines for ethical practice in psychological research online

APA Documents

APA Ethical Principles of Psychologists and Code of Conduct

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Research Methodology

Discourse Analysis

Phenomenology In Qualitative Research

Ethnography In Qualitative Research

Narrative Analysis In Qualitative Research

Thematic Analysis: A Step by Step Guide

Metasynthesis Of Qualitative Research

Frequently asked questions

What are ethical considerations in research.

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Frequently asked questions: Methodology

Attrition refers to participants leaving a study. It always happens to some extent—for example, in randomized controlled trials for medical research.

Differential attrition occurs when attrition or dropout rates differ systematically between the intervention and the control group . As a result, the characteristics of the participants who drop out differ from the characteristics of those who stay in the study. Because of this, study results may be biased .

Action research is conducted in order to solve a particular issue immediately, while case studies are often conducted over a longer period of time and focus more on observing and analyzing a particular ongoing phenomenon.

Action research is focused on solving a problem or informing individual and community-based knowledge in a way that impacts teaching, learning, and other related processes. It is less focused on contributing theoretical input, instead producing actionable input.

Action research is particularly popular with educators as a form of systematic inquiry because it prioritizes reflection and bridges the gap between theory and practice. Educators are able to simultaneously investigate an issue as they solve it, and the method is very iterative and flexible.

A cycle of inquiry is another name for action research . It is usually visualized in a spiral shape following a series of steps, such as “planning → acting → observing → reflecting.”

To make quantitative observations , you need to use instruments that are capable of measuring the quantity you want to observe. For example, you might use a ruler to measure the length of an object or a thermometer to measure its temperature.

Criterion validity and construct validity are both types of measurement validity . In other words, they both show you how accurately a method measures something.

While construct validity is the degree to which a test or other measurement method measures what it claims to measure, criterion validity is the degree to which a test can predictively (in the future) or concurrently (in the present) measure something.

Construct validity is often considered the overarching type of measurement validity . You need to have face validity , content validity , and criterion validity in order to achieve construct validity.

Convergent validity and discriminant validity are both subtypes of construct validity . Together, they help you evaluate whether a test measures the concept it was designed to measure.

• Convergent validity indicates whether a test that is designed to measure a particular construct correlates with other tests that assess the same or similar construct.
• Discriminant validity indicates whether two tests that should not be highly related to each other are indeed not related. This type of validity is also called divergent validity .

You need to assess both in order to demonstrate construct validity. Neither one alone is sufficient for establishing construct validity.

• Discriminant validity indicates whether two tests that should not be highly related to each other are indeed not related

Content validity shows you how accurately a test or other measurement method taps  into the various aspects of the specific construct you are researching.

In other words, it helps you answer the question: “does the test measure all aspects of the construct I want to measure?” If it does, then the test has high content validity.

The higher the content validity, the more accurate the measurement of the construct.

If the test fails to include parts of the construct, or irrelevant parts are included, the validity of the instrument is threatened, which brings your results into question.

Face validity and content validity are similar in that they both evaluate how suitable the content of a test is. The difference is that face validity is subjective, and assesses content at surface level.

When a test has strong face validity, anyone would agree that the test’s questions appear to measure what they are intended to measure.

For example, looking at a 4th grade math test consisting of problems in which students have to add and multiply, most people would agree that it has strong face validity (i.e., it looks like a math test).

On the other hand, content validity evaluates how well a test represents all the aspects of a topic. Assessing content validity is more systematic and relies on expert evaluation. of each question, analyzing whether each one covers the aspects that the test was designed to cover.

A 4th grade math test would have high content validity if it covered all the skills taught in that grade. Experts(in this case, math teachers), would have to evaluate the content validity by comparing the test to the learning objectives.

Snowball sampling is a non-probability sampling method . Unlike probability sampling (which involves some form of random selection ), the initial individuals selected to be studied are the ones who recruit new participants.

Because not every member of the target population has an equal chance of being recruited into the sample, selection in snowball sampling is non-random.

Snowball sampling is a non-probability sampling method , where there is not an equal chance for every member of the population to be included in the sample .

This means that you cannot use inferential statistics and make generalizations —often the goal of quantitative research . As such, a snowball sample is not representative of the target population and is usually a better fit for qualitative research .

Snowball sampling relies on the use of referrals. Here, the researcher recruits one or more initial participants, who then recruit the next ones.

Participants share similar characteristics and/or know each other. Because of this, not every member of the population has an equal chance of being included in the sample, giving rise to sampling bias .

Snowball sampling is best used in the following cases:

• If there is no sampling frame available (e.g., people with a rare disease)
• If the population of interest is hard to access or locate (e.g., people experiencing homelessness)
• If the research focuses on a sensitive topic (e.g., extramarital affairs)

The reproducibility and replicability of a study can be ensured by writing a transparent, detailed method section and using clear, unambiguous language.

Reproducibility and replicability are related terms.

• Reproducing research entails reanalyzing the existing data in the same manner.
• Replicating (or repeating ) the research entails reconducting the entire analysis, including the collection of new data . 
• A successful reproduction shows that the data analyses were conducted in a fair and honest manner.
• A successful replication shows that the reliability of the results is high.

Stratified sampling and quota sampling both involve dividing the population into subgroups and selecting units from each subgroup. The purpose in both cases is to select a representative sample and/or to allow comparisons between subgroups.

The main difference is that in stratified sampling, you draw a random sample from each subgroup ( probability sampling ). In quota sampling you select a predetermined number or proportion of units, in a non-random manner ( non-probability sampling ).

Purposive and convenience sampling are both sampling methods that are typically used in qualitative data collection.

A convenience sample is drawn from a source that is conveniently accessible to the researcher. Convenience sampling does not distinguish characteristics among the participants. On the other hand, purposive sampling focuses on selecting participants possessing characteristics associated with the research study.

The findings of studies based on either convenience or purposive sampling can only be generalized to the (sub)population from which the sample is drawn, and not to the entire population.

Random sampling or probability sampling is based on random selection. This means that each unit has an equal chance (i.e., equal probability) of being included in the sample.

On the other hand, convenience sampling involves stopping people at random, which means that not everyone has an equal chance of being selected depending on the place, time, or day you are collecting your data.

Convenience sampling and quota sampling are both non-probability sampling methods. They both use non-random criteria like availability, geographical proximity, or expert knowledge to recruit study participants.

However, in convenience sampling, you continue to sample units or cases until you reach the required sample size.

In quota sampling, you first need to divide your population of interest into subgroups (strata) and estimate their proportions (quota) in the population. Then you can start your data collection, using convenience sampling to recruit participants, until the proportions in each subgroup coincide with the estimated proportions in the population.

A sampling frame is a list of every member in the entire population . It is important that the sampling frame is as complete as possible, so that your sample accurately reflects your population.

Stratified and cluster sampling may look similar, but bear in mind that groups created in cluster sampling are heterogeneous , so the individual characteristics in the cluster vary. In contrast, groups created in stratified sampling are homogeneous , as units share characteristics.

Relatedly, in cluster sampling you randomly select entire groups and include all units of each group in your sample. However, in stratified sampling, you select some units of all groups and include them in your sample. In this way, both methods can ensure that your sample is representative of the target population .

A systematic review is secondary research because it uses existing research. You don’t collect new data yourself.

The key difference between observational studies and experimental designs is that a well-done observational study does not influence the responses of participants, while experiments do have some sort of treatment condition applied to at least some participants by random assignment .

An observational study is a great choice for you if your research question is based purely on observations. If there are ethical, logistical, or practical concerns that prevent you from conducting a traditional experiment , an observational study may be a good choice. In an observational study, there is no interference or manipulation of the research subjects, as well as no control or treatment groups .

It’s often best to ask a variety of people to review your measurements. You can ask experts, such as other researchers, or laypeople, such as potential participants, to judge the face validity of tests.

While experts have a deep understanding of research methods , the people you’re studying can provide you with valuable insights you may have missed otherwise.

Face validity is important because it’s a simple first step to measuring the overall validity of a test or technique. It’s a relatively intuitive, quick, and easy way to start checking whether a new measure seems useful at first glance.

Good face validity means that anyone who reviews your measure says that it seems to be measuring what it’s supposed to. With poor face validity, someone reviewing your measure may be left confused about what you’re measuring and why you’re using this method.

Face validity is about whether a test appears to measure what it’s supposed to measure. This type of validity is concerned with whether a measure seems relevant and appropriate for what it’s assessing only on the surface.

Statistical analyses are often applied to test validity with data from your measures. You test convergent validity and discriminant validity with correlations to see if results from your test are positively or negatively related to those of other established tests.

You can also use regression analyses to assess whether your measure is actually predictive of outcomes that you expect it to predict theoretically. A regression analysis that supports your expectations strengthens your claim of construct validity .

When designing or evaluating a measure, construct validity helps you ensure you’re actually measuring the construct you’re interested in. If you don’t have construct validity, you may inadvertently measure unrelated or distinct constructs and lose precision in your research.

Construct validity is often considered the overarching type of measurement validity ,  because it covers all of the other types. You need to have face validity , content validity , and criterion validity to achieve construct validity.

Construct validity is about how well a test measures the concept it was designed to evaluate. It’s one of four types of measurement validity , which includes construct validity, face validity , and criterion validity.

There are two subtypes of construct validity.

• Convergent validity : The extent to which your measure corresponds to measures of related constructs
• Discriminant validity : The extent to which your measure is unrelated or negatively related to measures of distinct constructs

Naturalistic observation is a valuable tool because of its flexibility, external validity , and suitability for topics that can’t be studied in a lab setting.

The downsides of naturalistic observation include its lack of scientific control , ethical considerations , and potential for bias from observers and subjects.

Naturalistic observation is a qualitative research method where you record the behaviors of your research subjects in real world settings. You avoid interfering or influencing anything in a naturalistic observation.

You can think of naturalistic observation as “people watching” with a purpose.

A dependent variable is what changes as a result of the independent variable manipulation in experiments . It’s what you’re interested in measuring, and it “depends” on your independent variable.

In statistics, dependent variables are also called:

• Response variables (they respond to a change in another variable)
• Outcome variables (they represent the outcome you want to measure)
• Left-hand-side variables (they appear on the left-hand side of a regression equation)

An independent variable is the variable you manipulate, control, or vary in an experimental study to explore its effects. It’s called “independent” because it’s not influenced by any other variables in the study.

Independent variables are also called:

• Explanatory variables (they explain an event or outcome)
• Predictor variables (they can be used to predict the value of a dependent variable)
• Right-hand-side variables (they appear on the right-hand side of a regression equation).

As a rule of thumb, questions related to thoughts, beliefs, and feelings work well in focus groups. Take your time formulating strong questions, paying special attention to phrasing. Be careful to avoid leading questions , which can bias your responses.

Overall, your focus group questions should be:

• Open-ended and flexible
• Impossible to answer with “yes” or “no” (questions that start with “why” or “how” are often best)
• Unambiguous, getting straight to the point while still stimulating discussion
• Unbiased and neutral

A structured interview is a data collection method that relies on asking questions in a set order to collect data on a topic. They are often quantitative in nature. Structured interviews are best used when: 

• You already have a very clear understanding of your topic. Perhaps significant research has already been conducted, or you have done some prior research yourself, but you already possess a baseline for designing strong structured questions.
• You are constrained in terms of time or resources and need to analyze your data quickly and efficiently.
• Your research question depends on strong parity between participants, with environmental conditions held constant.

More flexible interview options include semi-structured interviews , unstructured interviews , and focus groups .

Social desirability bias is the tendency for interview participants to give responses that will be viewed favorably by the interviewer or other participants. It occurs in all types of interviews and surveys , but is most common in semi-structured interviews , unstructured interviews , and focus groups .

Social desirability bias can be mitigated by ensuring participants feel at ease and comfortable sharing their views. Make sure to pay attention to your own body language and any physical or verbal cues, such as nodding or widening your eyes.

This type of bias can also occur in observations if the participants know they’re being observed. They might alter their behavior accordingly.

The interviewer effect is a type of bias that emerges when a characteristic of an interviewer (race, age, gender identity, etc.) influences the responses given by the interviewee.

There is a risk of an interviewer effect in all types of interviews , but it can be mitigated by writing really high-quality interview questions.

A semi-structured interview is a blend of structured and unstructured types of interviews. Semi-structured interviews are best used when:

• You have prior interview experience. Spontaneous questions are deceptively challenging, and it’s easy to accidentally ask a leading question or make a participant uncomfortable.
• Your research question is exploratory in nature. Participant answers can guide future research questions and help you develop a more robust knowledge base for future research.

An unstructured interview is the most flexible type of interview, but it is not always the best fit for your research topic.

Unstructured interviews are best used when:

• You are an experienced interviewer and have a very strong background in your research topic, since it is challenging to ask spontaneous, colloquial questions.
• Your research question is exploratory in nature. While you may have developed hypotheses, you are open to discovering new or shifting viewpoints through the interview process.
• You are seeking descriptive data, and are ready to ask questions that will deepen and contextualize your initial thoughts and hypotheses.
• Your research depends on forming connections with your participants and making them feel comfortable revealing deeper emotions, lived experiences, or thoughts.

The four most common types of interviews are:

• Structured interviews : The questions are predetermined in both topic and order. 
• Semi-structured interviews : A few questions are predetermined, but other questions aren’t planned.
• Unstructured interviews : None of the questions are predetermined.
• Focus group interviews : The questions are presented to a group instead of one individual.

Deductive reasoning is commonly used in scientific research, and it’s especially associated with quantitative research .

In research, you might have come across something called the hypothetico-deductive method . It’s the scientific method of testing hypotheses to check whether your predictions are substantiated by real-world data.

Deductive reasoning is a logical approach where you progress from general ideas to specific conclusions. It’s often contrasted with inductive reasoning , where you start with specific observations and form general conclusions.

Deductive reasoning is also called deductive logic.

There are many different types of inductive reasoning that people use formally or informally.

Here are a few common types:

• Inductive generalization : You use observations about a sample to come to a conclusion about the population it came from.
• Statistical generalization: You use specific numbers about samples to make statements about populations.
• Causal reasoning: You make cause-and-effect links between different things.
• Sign reasoning: You make a conclusion about a correlational relationship between different things.
• Analogical reasoning: You make a conclusion about something based on its similarities to something else.

Inductive reasoning is a bottom-up approach, while deductive reasoning is top-down.

Inductive reasoning takes you from the specific to the general, while in deductive reasoning, you make inferences by going from general premises to specific conclusions.

In inductive research , you start by making observations or gathering data. Then, you take a broad scan of your data and search for patterns. Finally, you make general conclusions that you might incorporate into theories.

Inductive reasoning is a method of drawing conclusions by going from the specific to the general. It’s usually contrasted with deductive reasoning, where you proceed from general information to specific conclusions.

Inductive reasoning is also called inductive logic or bottom-up reasoning.

A hypothesis states your predictions about what your research will find. It is a tentative answer to your research question that has not yet been tested. For some research projects, you might have to write several hypotheses that address different aspects of your research question.

A hypothesis is not just a guess — it should be based on existing theories and knowledge. It also has to be testable, which means you can support or refute it through scientific research methods (such as experiments, observations and statistical analysis of data).

Triangulation can help:

• Reduce research bias that comes from using a single method, theory, or investigator
• Enhance validity by approaching the same topic with different tools
• Establish credibility by giving you a complete picture of the research problem

But triangulation can also pose problems:

• It’s time-consuming and labor-intensive, often involving an interdisciplinary team.
• Your results may be inconsistent or even contradictory.

There are four main types of triangulation :

• Data triangulation : Using data from different times, spaces, and people
• Investigator triangulation : Involving multiple researchers in collecting or analyzing data
• Theory triangulation : Using varying theoretical perspectives in your research
• Methodological triangulation : Using different methodologies to approach the same topic

Many academic fields use peer review , largely to determine whether a manuscript is suitable for publication. Peer review enhances the credibility of the published manuscript.

However, peer review is also common in non-academic settings. The United Nations, the European Union, and many individual nations use peer review to evaluate grant applications. It is also widely used in medical and health-related fields as a teaching or quality-of-care measure. 

Peer assessment is often used in the classroom as a pedagogical tool. Both receiving feedback and providing it are thought to enhance the learning process, helping students think critically and collaboratively.

Peer review can stop obviously problematic, falsified, or otherwise untrustworthy research from being published. It also represents an excellent opportunity to get feedback from renowned experts in your field. It acts as a first defense, helping you ensure your argument is clear and that there are no gaps, vague terms, or unanswered questions for readers who weren’t involved in the research process.

Peer-reviewed articles are considered a highly credible source due to this stringent process they go through before publication.

In general, the peer review process follows the following steps: 

• First, the author submits the manuscript to the editor.
• Reject the manuscript and send it back to author, or 
• Send it onward to the selected peer reviewer(s) 
• Next, the peer review process occurs. The reviewer provides feedback, addressing any major or minor issues with the manuscript, and gives their advice regarding what edits should be made. 
• Lastly, the edited manuscript is sent back to the author. They input the edits, and resubmit it to the editor for publication.

Exploratory research is often used when the issue you’re studying is new or when the data collection process is challenging for some reason.

You can use exploratory research if you have a general idea or a specific question that you want to study but there is no preexisting knowledge or paradigm with which to study it.

Exploratory research is a methodology approach that explores research questions that have not previously been studied in depth. It is often used when the issue you’re studying is new, or the data collection process is challenging in some way.

Explanatory research is used to investigate how or why a phenomenon occurs. Therefore, this type of research is often one of the first stages in the research process , serving as a jumping-off point for future research.

Exploratory research aims to explore the main aspects of an under-researched problem, while explanatory research aims to explain the causes and consequences of a well-defined problem.

Explanatory research is a research method used to investigate how or why something occurs when only a small amount of information is available pertaining to that topic. It can help you increase your understanding of a given topic.

Clean data are valid, accurate, complete, consistent, unique, and uniform. Dirty data include inconsistencies and errors.

Dirty data can come from any part of the research process, including poor research design , inappropriate measurement materials, or flawed data entry.

Data cleaning takes place between data collection and data analyses. But you can use some methods even before collecting data.

For clean data, you should start by designing measures that collect valid data. Data validation at the time of data entry or collection helps you minimize the amount of data cleaning you’ll need to do.

After data collection, you can use data standardization and data transformation to clean your data. You’ll also deal with any missing values, outliers, and duplicate values.

Every dataset requires different techniques to clean dirty data , but you need to address these issues in a systematic way. You focus on finding and resolving data points that don’t agree or fit with the rest of your dataset.

These data might be missing values, outliers, duplicate values, incorrectly formatted, or irrelevant. You’ll start with screening and diagnosing your data. Then, you’ll often standardize and accept or remove data to make your dataset consistent and valid.

Data cleaning is necessary for valid and appropriate analyses. Dirty data contain inconsistencies or errors , but cleaning your data helps you minimize or resolve these.

Without data cleaning, you could end up with a Type I or II error in your conclusion. These types of erroneous conclusions can be practically significant with important consequences, because they lead to misplaced investments or missed opportunities.

Data cleaning involves spotting and resolving potential data inconsistencies or errors to improve your data quality. An error is any value (e.g., recorded weight) that doesn’t reflect the true value (e.g., actual weight) of something that’s being measured.

In this process, you review, analyze, detect, modify, or remove “dirty” data to make your dataset “clean.” Data cleaning is also called data cleansing or data scrubbing.

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

In multistage sampling , you can use probability or non-probability sampling methods .

For a probability sample, you have to conduct probability sampling at every stage.

You can mix it up by using simple random sampling , systematic sampling , or stratified sampling to select units at different stages, depending on what is applicable and relevant to your study.

Multistage sampling can simplify data collection when you have large, geographically spread samples, and you can obtain a probability sample without a complete sampling frame.

But multistage sampling may not lead to a representative sample, and larger samples are needed for multistage samples to achieve the statistical properties of simple random samples .

These are four of the most common mixed methods designs :

• Convergent parallel: Quantitative and qualitative data are collected at the same time and analyzed separately. After both analyses are complete, compare your results to draw overall conclusions. 
• Embedded: Quantitative and qualitative data are collected at the same time, but within a larger quantitative or qualitative design. One type of data is secondary to the other.
• Explanatory sequential: Quantitative data is collected and analyzed first, followed by qualitative data. You can use this design if you think your qualitative data will explain and contextualize your quantitative findings.
• Exploratory sequential: Qualitative data is collected and analyzed first, followed by quantitative data. You can use this design if you think the quantitative data will confirm or validate your qualitative findings.

Triangulation in research means using multiple datasets, methods, theories and/or investigators to address a research question. It’s a research strategy that can help you enhance the validity and credibility of your findings.

Triangulation is mainly used in qualitative research , but it’s also commonly applied in quantitative research . Mixed methods research always uses triangulation.

In multistage sampling , or multistage cluster sampling, you draw a sample from a population using smaller and smaller groups at each stage.

This method is often used to collect data from a large, geographically spread group of people in national surveys, for example. You take advantage of hierarchical groupings (e.g., from state to city to neighborhood) to create a sample that’s less expensive and time-consuming to collect data from.

No, the steepness or slope of the line isn’t related to the correlation coefficient value. The correlation coefficient only tells you how closely your data fit on a line, so two datasets with the same correlation coefficient can have very different slopes.

To find the slope of the line, you’ll need to perform a regression analysis .

Correlation coefficients always range between -1 and 1.

The sign of the coefficient tells you the direction of the relationship: a positive value means the variables change together in the same direction, while a negative value means they change together in opposite directions.

The absolute value of a number is equal to the number without its sign. The absolute value of a correlation coefficient tells you the magnitude of the correlation: the greater the absolute value, the stronger the correlation.

These are the assumptions your data must meet if you want to use Pearson’s r :

• Both variables are on an interval or ratio level of measurement
• Data from both variables follow normal distributions
• Your data have no outliers
• Your data is from a random or representative sample
• You expect a linear relationship between the two variables

Quantitative research designs can be divided into two main categories:

• Correlational and descriptive designs are used to investigate characteristics, averages, trends, and associations between variables.
• Experimental and quasi-experimental designs are used to test causal relationships .

Qualitative research designs tend to be more flexible. Common types of qualitative design include case study , ethnography , and grounded theory designs.

A well-planned research design helps ensure that your methods match your research aims, that you collect high-quality data, and that you use the right kind of analysis to answer your questions, utilizing credible sources . This allows you to draw valid , trustworthy conclusions.

The priorities of a research design can vary depending on the field, but you usually have to specify:

• Your research questions and/or hypotheses
• Your overall approach (e.g., qualitative or quantitative )
• The type of design you’re using (e.g., a survey , experiment , or case study )
• Your sampling methods or criteria for selecting subjects
• Your data collection methods (e.g., questionnaires , observations)
• Your data collection procedures (e.g., operationalization , timing and data management)
• Your data analysis methods (e.g., statistical tests  or thematic analysis )

A research design is a strategy for answering your   research question . It defines your overall approach and determines how you will collect and analyze data.

Questionnaires can be self-administered or researcher-administered.

Self-administered questionnaires can be delivered online or in paper-and-pen formats, in person or through mail. All questions are standardized so that all respondents receive the same questions with identical wording.

Researcher-administered questionnaires are interviews that take place by phone, in-person, or online between researchers and respondents. You can gain deeper insights by clarifying questions for respondents or asking follow-up questions.

You can organize the questions logically, with a clear progression from simple to complex, or randomly between respondents. A logical flow helps respondents process the questionnaire easier and quicker, but it may lead to bias. Randomization can minimize the bias from order effects.

Closed-ended, or restricted-choice, questions offer respondents a fixed set of choices to select from. These questions are easier to answer quickly.

Open-ended or long-form questions allow respondents to answer in their own words. Because there are no restrictions on their choices, respondents can answer in ways that researchers may not have otherwise considered.

A questionnaire is a data collection tool or instrument, while a survey is an overarching research method that involves collecting and analyzing data from people using questionnaires.

The third variable and directionality problems are two main reasons why correlation isn’t causation .

The third variable problem means that a confounding variable affects both variables to make them seem causally related when they are not.

The directionality problem is when two variables correlate and might actually have a causal relationship, but it’s impossible to conclude which variable causes changes in the other.

Correlation describes an association between variables : when one variable changes, so does the other. A correlation is a statistical indicator of the relationship between variables.

Causation means that changes in one variable brings about changes in the other (i.e., there is a cause-and-effect relationship between variables). The two variables are correlated with each other, and there’s also a causal link between them.

While causation and correlation can exist simultaneously, correlation does not imply causation. In other words, correlation is simply a relationship where A relates to B—but A doesn’t necessarily cause B to happen (or vice versa). Mistaking correlation for causation is a common error and can lead to false cause fallacy .

Controlled experiments establish causality, whereas correlational studies only show associations between variables.

• In an experimental design , you manipulate an independent variable and measure its effect on a dependent variable. Other variables are controlled so they can’t impact the results.
• In a correlational design , you measure variables without manipulating any of them. You can test whether your variables change together, but you can’t be sure that one variable caused a change in another.

In general, correlational research is high in external validity while experimental research is high in internal validity .

A correlation is usually tested for two variables at a time, but you can test correlations between three or more variables.

A correlation coefficient is a single number that describes the strength and direction of the relationship between your variables.

Different types of correlation coefficients might be appropriate for your data based on their levels of measurement and distributions . The Pearson product-moment correlation coefficient (Pearson’s r ) is commonly used to assess a linear relationship between two quantitative variables.

A correlational research design investigates relationships between two variables (or more) without the researcher controlling or manipulating any of them. It’s a non-experimental type of quantitative research .

A correlation reflects the strength and/or direction of the association between two or more variables.

• A positive correlation means that both variables change in the same direction.
• A negative correlation means that the variables change in opposite directions.
• A zero correlation means there’s no relationship between the variables.

Random error  is almost always present in scientific studies, even in highly controlled settings. While you can’t eradicate it completely, you can reduce random error by taking repeated measurements, using a large sample, and controlling extraneous variables .

You can avoid systematic error through careful design of your sampling , data collection , and analysis procedures. For example, use triangulation to measure your variables using multiple methods; regularly calibrate instruments or procedures; use random sampling and random assignment ; and apply masking (blinding) where possible.

Systematic error is generally a bigger problem in research.

With random error, multiple measurements will tend to cluster around the true value. When you’re collecting data from a large sample , the errors in different directions will cancel each other out.

Systematic errors are much more problematic because they can skew your data away from the true value. This can lead you to false conclusions ( Type I and II errors ) about the relationship between the variables you’re studying.

Random and systematic error are two types of measurement error.

Random error is a chance difference between the observed and true values of something (e.g., a researcher misreading a weighing scale records an incorrect measurement).

Systematic error is a consistent or proportional difference between the observed and true values of something (e.g., a miscalibrated scale consistently records weights as higher than they actually are).

On graphs, the explanatory variable is conventionally placed on the x-axis, while the response variable is placed on the y-axis.

• If you have quantitative variables , use a scatterplot or a line graph.
• If your response variable is categorical, use a scatterplot or a line graph.
• If your explanatory variable is categorical, use a bar graph.

The term “ explanatory variable ” is sometimes preferred over “ independent variable ” because, in real world contexts, independent variables are often influenced by other variables. This means they aren’t totally independent.

Multiple independent variables may also be correlated with each other, so “explanatory variables” is a more appropriate term.

The difference between explanatory and response variables is simple:

• An explanatory variable is the expected cause, and it explains the results.
• A response variable is the expected effect, and it responds to other variables.

In a controlled experiment , all extraneous variables are held constant so that they can’t influence the results. Controlled experiments require:

• A control group that receives a standard treatment, a fake treatment, or no treatment.
• Random assignment of participants to ensure the groups are equivalent.

Depending on your study topic, there are various other methods of controlling variables .

There are 4 main types of extraneous variables :

• Demand characteristics : environmental cues that encourage participants to conform to researchers’ expectations.
• Experimenter effects : unintentional actions by researchers that influence study outcomes.
• Situational variables : environmental variables that alter participants’ behaviors.
• Participant variables : any characteristic or aspect of a participant’s background that could affect study results.

An extraneous variable is any variable that you’re not investigating that can potentially affect the dependent variable of your research study.

A confounding variable is a type of extraneous variable that not only affects the dependent variable, but is also related to the independent variable.

In a factorial design, multiple independent variables are tested.

If you test two variables, each level of one independent variable is combined with each level of the other independent variable to create different conditions.

Within-subjects designs have many potential threats to internal validity , but they are also very statistically powerful .

Advantages:

• Only requires small samples
• Statistically powerful
• Removes the effects of individual differences on the outcomes

Disadvantages:

• Internal validity threats reduce the likelihood of establishing a direct relationship between variables
• Time-related effects, such as growth, can influence the outcomes
• Carryover effects mean that the specific order of different treatments affect the outcomes

While a between-subjects design has fewer threats to internal validity , it also requires more participants for high statistical power than a within-subjects design .

• Prevents carryover effects of learning and fatigue.
• Shorter study duration.
• Needs larger samples for high power.
• Uses more resources to recruit participants, administer sessions, cover costs, etc.
• Individual differences may be an alternative explanation for results.

Yes. Between-subjects and within-subjects designs can be combined in a single study when you have two or more independent variables (a factorial design). In a mixed factorial design, one variable is altered between subjects and another is altered within subjects.

In a between-subjects design , every participant experiences only one condition, and researchers assess group differences between participants in various conditions.

In a within-subjects design , each participant experiences all conditions, and researchers test the same participants repeatedly for differences between conditions.

The word “between” means that you’re comparing different conditions between groups, while the word “within” means you’re comparing different conditions within the same group.

Random assignment is used in experiments with a between-groups or independent measures design. In this research design, there’s usually a control group and one or more experimental groups. Random assignment helps ensure that the groups are comparable.

In general, you should always use random assignment in this type of experimental design when it is ethically possible and makes sense for your study topic.

To implement random assignment , assign a unique number to every member of your study’s sample .

Then, you can use a random number generator or a lottery method to randomly assign each number to a control or experimental group. You can also do so manually, by flipping a coin or rolling a dice to randomly assign participants to groups.

Random selection, or random sampling , is a way of selecting members of a population for your study’s sample.

In contrast, random assignment is a way of sorting the sample into control and experimental groups.

Random sampling enhances the external validity or generalizability of your results, while random assignment improves the internal validity of your study.

In experimental research, random assignment is a way of placing participants from your sample into different groups using randomization. With this method, every member of the sample has a known or equal chance of being placed in a control group or an experimental group.

“Controlling for a variable” means measuring extraneous variables and accounting for them statistically to remove their effects on other variables.

Researchers often model control variable data along with independent and dependent variable data in regression analyses and ANCOVAs . That way, you can isolate the control variable’s effects from the relationship between the variables of interest.

Control variables help you establish a correlational or causal relationship between variables by enhancing internal validity .

If you don’t control relevant extraneous variables , they may influence the outcomes of your study, and you may not be able to demonstrate that your results are really an effect of your independent variable .

A control variable is any variable that’s held constant in a research study. It’s not a variable of interest in the study, but it’s controlled because it could influence the outcomes.

Including mediators and moderators in your research helps you go beyond studying a simple relationship between two variables for a fuller picture of the real world. They are important to consider when studying complex correlational or causal relationships.

Mediators are part of the causal pathway of an effect, and they tell you how or why an effect takes place. Moderators usually help you judge the external validity of your study by identifying the limitations of when the relationship between variables holds.

If something is a mediating variable :

• It’s caused by the independent variable .
• It influences the dependent variable
• When it’s taken into account, the statistical correlation between the independent and dependent variables is higher than when it isn’t considered.

A confounder is a third variable that affects variables of interest and makes them seem related when they are not. In contrast, a mediator is the mechanism of a relationship between two variables: it explains the process by which they are related.

A mediator variable explains the process through which two variables are related, while a moderator variable affects the strength and direction of that relationship.

There are three key steps in systematic sampling :

• Define and list your population , ensuring that it is not ordered in a cyclical or periodic order.
• Decide on your sample size and calculate your interval, k , by dividing your population by your target sample size.
• Choose every k th member of the population as your sample.

Systematic sampling is a probability sampling method where researchers select members of the population at a regular interval – for example, by selecting every 15th person on a list of the population. If the population is in a random order, this can imitate the benefits of simple random sampling .

Yes, you can create a stratified sample using multiple characteristics, but you must ensure that every participant in your study belongs to one and only one subgroup. In this case, you multiply the numbers of subgroups for each characteristic to get the total number of groups.

For example, if you were stratifying by location with three subgroups (urban, rural, or suburban) and marital status with five subgroups (single, divorced, widowed, married, or partnered), you would have 3 x 5 = 15 subgroups.

You should use stratified sampling when your sample can be divided into mutually exclusive and exhaustive subgroups that you believe will take on different mean values for the variable that you’re studying.

Using stratified sampling will allow you to obtain more precise (with lower variance ) statistical estimates of whatever you are trying to measure.

For example, say you want to investigate how income differs based on educational attainment, but you know that this relationship can vary based on race. Using stratified sampling, you can ensure you obtain a large enough sample from each racial group, allowing you to draw more precise conclusions.

In stratified sampling , researchers divide subjects into subgroups called strata based on characteristics that they share (e.g., race, gender, educational attainment).

Once divided, each subgroup is randomly sampled using another probability sampling method.

Cluster sampling is more time- and cost-efficient than other probability sampling methods , particularly when it comes to large samples spread across a wide geographical area.

However, it provides less statistical certainty than other methods, such as simple random sampling , because it is difficult to ensure that your clusters properly represent the population as a whole.

There are three types of cluster sampling : single-stage, double-stage and multi-stage clustering. In all three types, you first divide the population into clusters, then randomly select clusters for use in your sample.

• In single-stage sampling , you collect data from every unit within the selected clusters.
• In double-stage sampling , you select a random sample of units from within the clusters.
• In multi-stage sampling , you repeat the procedure of randomly sampling elements from within the clusters until you have reached a manageable sample.

Cluster sampling is a probability sampling method in which you divide a population into clusters, such as districts or schools, and then randomly select some of these clusters as your sample.

The clusters should ideally each be mini-representations of the population as a whole.

If properly implemented, simple random sampling is usually the best sampling method for ensuring both internal and external validity . However, it can sometimes be impractical and expensive to implement, depending on the size of the population to be studied,

If you have a list of every member of the population and the ability to reach whichever members are selected, you can use simple random sampling.

The American Community Survey  is an example of simple random sampling . In order to collect detailed data on the population of the US, the Census Bureau officials randomly select 3.5 million households per year and use a variety of methods to convince them to fill out the survey.

Simple random sampling is a type of probability sampling in which the researcher randomly selects a subset of participants from a population . Each member of the population has an equal chance of being selected. Data is then collected from as large a percentage as possible of this random subset.

Quasi-experimental design is most useful in situations where it would be unethical or impractical to run a true experiment .

Quasi-experiments have lower internal validity than true experiments, but they often have higher external validity  as they can use real-world interventions instead of artificial laboratory settings.

A quasi-experiment is a type of research design that attempts to establish a cause-and-effect relationship. The main difference with a true experiment is that the groups are not randomly assigned.

Blinding is important to reduce research bias (e.g., observer bias , demand characteristics ) and ensure a study’s internal validity .

If participants know whether they are in a control or treatment group , they may adjust their behavior in ways that affect the outcome that researchers are trying to measure. If the people administering the treatment are aware of group assignment, they may treat participants differently and thus directly or indirectly influence the final results.

• In a single-blind study , only the participants are blinded.
• In a double-blind study , both participants and experimenters are blinded.
• In a triple-blind study , the assignment is hidden not only from participants and experimenters, but also from the researchers analyzing the data.

Blinding means hiding who is assigned to the treatment group and who is assigned to the control group in an experiment .

A true experiment (a.k.a. a controlled experiment) always includes at least one control group that doesn’t receive the experimental treatment.

However, some experiments use a within-subjects design to test treatments without a control group. In these designs, you usually compare one group’s outcomes before and after a treatment (instead of comparing outcomes between different groups).

For strong internal validity , it’s usually best to include a control group if possible. Without a control group, it’s harder to be certain that the outcome was caused by the experimental treatment and not by other variables.

An experimental group, also known as a treatment group, receives the treatment whose effect researchers wish to study, whereas a control group does not. They should be identical in all other ways.

Individual Likert-type questions are generally considered ordinal data , because the items have clear rank order, but don’t have an even distribution.

Overall Likert scale scores are sometimes treated as interval data. These scores are considered to have directionality and even spacing between them.

The type of data determines what statistical tests you should use to analyze your data.

A Likert scale is a rating scale that quantitatively assesses opinions, attitudes, or behaviors. It is made up of 4 or more questions that measure a single attitude or trait when response scores are combined.

To use a Likert scale in a survey , you present participants with Likert-type questions or statements, and a continuum of items, usually with 5 or 7 possible responses, to capture their degree of agreement.

In scientific research, concepts are the abstract ideas or phenomena that are being studied (e.g., educational achievement). Variables are properties or characteristics of the concept (e.g., performance at school), while indicators are ways of measuring or quantifying variables (e.g., yearly grade reports).

The process of turning abstract concepts into measurable variables and indicators is called operationalization .

There are various approaches to qualitative data analysis , but they all share five steps in common:

• Prepare and organize your data.
• Review and explore your data.
• Develop a data coding system.
• Assign codes to the data.
• Identify recurring themes.

The specifics of each step depend on the focus of the analysis. Some common approaches include textual analysis , thematic analysis , and discourse analysis .

There are five common approaches to qualitative research :

• Grounded theory involves collecting data in order to develop new theories.
• Ethnography involves immersing yourself in a group or organization to understand its culture.
• Narrative research involves interpreting stories to understand how people make sense of their experiences and perceptions.
• Phenomenological research involves investigating phenomena through people’s lived experiences.
• Action research links theory and practice in several cycles to drive innovative changes.

Hypothesis testing is a formal procedure for investigating our ideas about the world using statistics. It is used by scientists to test specific predictions, called hypotheses , by calculating how likely it is that a pattern or relationship between variables could have arisen by chance.

Operationalization means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioral avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalize the variables that you want to measure.

When conducting research, collecting original data has significant advantages:

• You can tailor data collection to your specific research aims (e.g. understanding the needs of your consumers or user testing your website)
• You can control and standardize the process for high reliability and validity (e.g. choosing appropriate measurements and sampling methods )

However, there are also some drawbacks: data collection can be time-consuming, labor-intensive and expensive. In some cases, it’s more efficient to use secondary data that has already been collected by someone else, but the data might be less reliable.

Data collection is the systematic process by which observations or measurements are gathered in research. It is used in many different contexts by academics, governments, businesses, and other organizations.

There are several methods you can use to decrease the impact of confounding variables on your research: restriction, matching, statistical control and randomization.

In restriction , you restrict your sample by only including certain subjects that have the same values of potential confounding variables.

In matching , you match each of the subjects in your treatment group with a counterpart in the comparison group. The matched subjects have the same values on any potential confounding variables, and only differ in the independent variable .

In statistical control , you include potential confounders as variables in your regression .

In randomization , you randomly assign the treatment (or independent variable) in your study to a sufficiently large number of subjects, which allows you to control for all potential confounding variables.

A confounding variable is closely related to both the independent and dependent variables in a study. An independent variable represents the supposed cause , while the dependent variable is the supposed effect . A confounding variable is a third variable that influences both the independent and dependent variables.

Failing to account for confounding variables can cause you to wrongly estimate the relationship between your independent and dependent variables.

To ensure the internal validity of your research, you must consider the impact of confounding variables. If you fail to account for them, you might over- or underestimate the causal relationship between your independent and dependent variables , or even find a causal relationship where none exists.

Yes, but including more than one of either type requires multiple research questions .

For example, if you are interested in the effect of a diet on health, you can use multiple measures of health: blood sugar, blood pressure, weight, pulse, and many more. Each of these is its own dependent variable with its own research question.

You could also choose to look at the effect of exercise levels as well as diet, or even the additional effect of the two combined. Each of these is a separate independent variable .

To ensure the internal validity of an experiment , you should only change one independent variable at a time.

No. The value of a dependent variable depends on an independent variable, so a variable cannot be both independent and dependent at the same time. It must be either the cause or the effect, not both!

You want to find out how blood sugar levels are affected by drinking diet soda and regular soda, so you conduct an experiment .

• The type of soda – diet or regular – is the independent variable .
• The level of blood sugar that you measure is the dependent variable – it changes depending on the type of soda.

Determining cause and effect is one of the most important parts of scientific research. It’s essential to know which is the cause – the independent variable – and which is the effect – the dependent variable.

In non-probability sampling , the sample is selected based on non-random criteria, and not every member of the population has a chance of being included.

Common non-probability sampling methods include convenience sampling , voluntary response sampling, purposive sampling , snowball sampling, and quota sampling .

Probability sampling means that every member of the target population has a known chance of being included in the sample.

Probability sampling methods include simple random sampling , systematic sampling , stratified sampling , and cluster sampling .

Using careful research design and sampling procedures can help you avoid sampling bias . Oversampling can be used to correct undercoverage bias .

Some common types of sampling bias include self-selection bias , nonresponse bias , undercoverage bias , survivorship bias , pre-screening or advertising bias, and healthy user bias.

Sampling bias is a threat to external validity – it limits the generalizability of your findings to a broader group of people.

A sampling error is the difference between a population parameter and a sample statistic .

A statistic refers to measures about the sample , while a parameter refers to measures about the population .

Populations are used when a research question requires data from every member of the population. This is usually only feasible when the population is small and easily accessible.

Samples are used to make inferences about populations . Samples are easier to collect data from because they are practical, cost-effective, convenient, and manageable.

There are seven threats to external validity : selection bias , history, experimenter effect, Hawthorne effect , testing effect, aptitude-treatment and situation effect.

The two types of external validity are population validity (whether you can generalize to other groups of people) and ecological validity (whether you can generalize to other situations and settings).

The external validity of a study is the extent to which you can generalize your findings to different groups of people, situations, and measures.

Cross-sectional studies cannot establish a cause-and-effect relationship or analyze behavior over a period of time. To investigate cause and effect, you need to do a longitudinal study or an experimental study .

Cross-sectional studies are less expensive and time-consuming than many other types of study. They can provide useful insights into a population’s characteristics and identify correlations for further research.

Sometimes only cross-sectional data is available for analysis; other times your research question may only require a cross-sectional study to answer it.

Longitudinal studies can last anywhere from weeks to decades, although they tend to be at least a year long.

The 1970 British Cohort Study , which has collected data on the lives of 17,000 Brits since their births in 1970, is one well-known example of a longitudinal study .

Longitudinal studies are better to establish the correct sequence of events, identify changes over time, and provide insight into cause-and-effect relationships, but they also tend to be more expensive and time-consuming than other types of studies.

Longitudinal studies and cross-sectional studies are two different types of research design . In a cross-sectional study you collect data from a population at a specific point in time; in a longitudinal study you repeatedly collect data from the same sample over an extended period of time.

There are eight threats to internal validity : history, maturation, instrumentation, testing, selection bias , regression to the mean, social interaction and attrition .

Internal validity is the extent to which you can be confident that a cause-and-effect relationship established in a study cannot be explained by other factors.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
• If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

A confounding variable , also called a confounder or confounding factor, is a third variable in a study examining a potential cause-and-effect relationship.

A confounding variable is related to both the supposed cause and the supposed effect of the study. It can be difficult to separate the true effect of the independent variable from the effect of the confounding variable.

In your research design , it’s important to identify potential confounding variables and plan how you will reduce their impact.

Discrete and continuous variables are two types of quantitative variables :

• Discrete variables represent counts (e.g. the number of objects in a collection).
• Continuous variables represent measurable amounts (e.g. water volume or weight).

Quantitative variables are any variables where the data represent amounts (e.g. height, weight, or age).

Categorical variables are any variables where the data represent groups. This includes rankings (e.g. finishing places in a race), classifications (e.g. brands of cereal), and binary outcomes (e.g. coin flips).

You need to know what type of variables you are working with to choose the right statistical test for your data and interpret your results .

You can think of independent and dependent variables in terms of cause and effect: an independent variable is the variable you think is the cause , while a dependent variable is the effect .

In an experiment, you manipulate the independent variable and measure the outcome in the dependent variable. For example, in an experiment about the effect of nutrients on crop growth:

• The  independent variable  is the amount of nutrients added to the crop field.
• The  dependent variable is the biomass of the crops at harvest time.

Defining your variables, and deciding how you will manipulate and measure them, is an important part of experimental design .

Experimental design means planning a set of procedures to investigate a relationship between variables . To design a controlled experiment, you need:

• A testable hypothesis
• At least one independent variable that can be precisely manipulated
• At least one dependent variable that can be precisely measured

When designing the experiment, you decide:

• How you will manipulate the variable(s)
• How you will control for any potential confounding variables
• How many subjects or samples will be included in the study
• How subjects will be assigned to treatment levels

Experimental design is essential to the internal and external validity of your experiment.

I nternal validity is the degree of confidence that the causal relationship you are testing is not influenced by other factors or variables .

External validity is the extent to which your results can be generalized to other contexts.

The validity of your experiment depends on your experimental design .

Reliability and validity are both about how well a method measures something:

• Reliability refers to the  consistency of a measure (whether the results can be reproduced under the same conditions).
• Validity   refers to the  accuracy of a measure (whether the results really do represent what they are supposed to measure).

If you are doing experimental research, you also have to consider the internal and external validity of your experiment.

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

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Cover Story

Five principles for research ethics

Cover your bases with these ethical strategies

By DEBORAH SMITH

Monitor Staff

January 2003, Vol 34, No. 1

Print version: page 56

13 min read

• Conducting Research

Not that long ago, academicians were often cautious about airing the ethical dilemmas they faced in their research and academic work, but that environment is changing today. Psychologists in academe are more likely to seek out the advice of their colleagues on issues ranging from supervising graduate students to how to handle sensitive research data , says George Mason University psychologist June Tangney, PhD.

"There has been a real change in the last 10 years in people talking more frequently and more openly about ethical dilemmas of all sorts," she explains.

Indeed, researchers face an array of ethical requirements: They must meet professional, institutional and federal standards for conducting research with human participants, often supervise students they also teach and have to sort out authorship issues, just to name a few.

Here are five recommendations APA's Science Directorate gives to help researchers steer clear of ethical quandaries:

1. Discuss intellectual property frankly

Academe's competitive "publish-or-perish" mindset can be a recipe for trouble when it comes to who gets credit for authorship . The best way to avoid disagreements about who should get credit and in what order is to talk about these issues at the beginning of a working relationship, even though many people often feel uncomfortable about such topics.

"It's almost like talking about money," explains Tangney. "People don't want to appear to be greedy or presumptuous."

APA's Ethics Code offers some guidance: It specifies that "faculty advisors discuss publication credit with students as early as feasible and throughout the research and publication process as appropriate." When researchers and students put such understandings in writing, they have a helpful tool to continually discuss and evaluate contributions as the research progresses.

However, even the best plans can result in disputes, which often occur because people look at the same situation differently. "While authorship should reflect the contribution," says APA Ethics Office Director Stephen Behnke, JD, PhD, "we know from social science research that people often overvalue their contributions to a project. We frequently see that in authorship-type situations. In many instances, both parties genuinely believe they're right." APA's Ethics Code stipulates that psychologists take credit only for work they have actually performed or to which they have substantially contributed and that publication credit should accurately reflect the relative contributions: "Mere possession of an institutional position, such as department chair, does not justify authorship credit," says the code. "Minor contributions to the research or to the writing for publications are acknowledged appropriately, such as in footnotes or in an introductory statement."

The same rules apply to students. If they contribute substantively to the conceptualization, design, execution, analysis or interpretation of the research reported, they should be listed as authors. Contributions that are primarily technical don't warrant authorship. In the same vein, advisers should not expect ex-officio authorship on their students' work.

Matthew McGue, PhD, of the University of Minnesota, says his psychology department has instituted a procedure to avoid murky authorship issues. "We actually have a formal process here where students make proposals for anything they do on the project," he explains. The process allows students and faculty to more easily talk about research responsibility, distribution and authorship.

Psychologists should also be cognizant of situations where they have access to confidential ideas or research, such as reviewing journal manuscripts or research grants, or hearing new ideas during a presentation or informal conversation. While it's unlikely reviewers can purge all of the information in an interesting manuscript from their thinking, it's still unethical to take those ideas without giving credit to the originator.

"If you are a grant reviewer or a journal manuscript reviewer [who] sees someone's research [that] hasn't been published yet, you owe that person a duty of confidentiality and anonymity," says Gerald P. Koocher, PhD, editor of the journal Ethics and Behavior and co-author of "Ethics in Psychology: Professional Standards and Cases" (Oxford University Press, 1998).

Researchers also need to meet their ethical obligations once their research is published: If authors learn of errors that change the interpretation of research findings, they are ethically obligated to promptly correct the errors in a correction, retraction, erratum or by other means.

To be able to answer questions about study authenticity and allow others to reanalyze the results, authors should archive primary data and accompanying records for at least five years, advises University of Minnesota psychologist and researcher Matthew McGue, PhD. "Store all your data. Don't destroy it," he says. "Because if someone charges that you did something wrong, you can go back."

"It seems simple, but this can be a tricky area," says Susan Knapp, APA's deputy publisher. "The APA Publication Manual Section 8.05 has some general advice on what to retain and suggestions about things to consider in sharing data."

The APA Ethics Code requires psychologists to release their data to others who want to verify their conclusions, provided that participants' confidentiality can be protected and as long as legal rights concerning proprietary data don't preclude their release. However, the code also notes that psychologists who request data in these circumstances can only use the shared data for reanalysis; for any other use, they must obtain a prior written agreement.

2. Be conscious of multiple roles

APA's Ethics Code says psychologists should avoid relationships that could reasonably impair their professional performance or could exploit or harm others. But it also notes that many kinds of multiple relationships aren't unethical--as long as they're not reasonably expected to have adverse effects.

That notwithstanding, psychologists should think carefully before entering into multiple relationships with any person or group, such as recruiting students or clients as participants in research studies or investigating the effectiveness of a product of a company whose stock they own.

For example, when recruiting students from your Psychology 101 course to participate in an experiment, be sure to make clear that participation is voluntary. If participation is a course requirement, be sure to note that in the class syllabus, and ensure that participation has educative value by, for instance, providing a thorough debriefing to enhance students' understanding of the study. The 2002 Ethics Code also mandates in Standard 8.04b that students be given equitable alternatives to participating in research.

Perhaps one of the most common multiple roles for researchers is being both a mentor and lab supervisor to students they also teach in class. Psychologists need to be especially cautious that they don't abuse the power differential between themselves and students, say experts. They shouldn't, for example, use their clout as professors to coerce students into taking on additional research duties.

By outlining the nature and structure of the supervisory relationship before supervision or mentoring begins, both parties can avoid misunderstandings, says George Mason University's Tangney. It's helpful to create a written agreement that includes both parties' responsibilities as well as authorship considerations, intensity of the supervision and other key aspects of the job.

"While that's the ideal situation, in practice we do a lot less of that than we ought to," she notes. "Part of it is not having foresight up front of how a project or research study is going to unfold."

That's why experts also recommend that supervisors set up timely and specific methods to give students feedback and keep a record of the supervision, including meeting times, issues discussed and duties assigned.

If psychologists do find that they are in potentially harmful multiple relationships, they are ethically mandated to take steps to resolve them in the best interest of the person or group while complying with the Ethics Code.

3. Follow informed-consent rules

When done properly, the consent process ensures that individuals are voluntarily participating in the research with full knowledge of relevant risks and benefits.

"The federal standard is that the person must have all of the information that might reasonably influence their willingness to participate in a form that they can understand and comprehend," says Koocher, dean of Simmons College's School for Health Studies.

APA's Ethics Code mandates that psychologists who conduct research should inform participants about:

The purpose of the research, expected duration and procedures.

Participants' rights to decline to participate and to withdraw from the research once it has started, as well as the anticipated consequences of doing so.

Reasonably foreseeable factors that may influence their willingness to participate, such as potential risks, discomfort or adverse effects.

Any prospective research benefits.

Limits of confidentiality, such as data coding, disposal, sharing and archiving, and when confidentiality must be broken.

Incentives for participation.

Who participants can contact with questions.

Experts also suggest covering the likelihood, magnitude and duration of harm or benefit of participation, emphasizing that their involvement is voluntary and discussing treatment alternatives, if relevant to the research.

Keep in mind that the Ethics Code includes specific mandates for researchers who conduct experimental treatment research. Specifically, they must inform individuals about the experimental nature of the treatment, services that will or will not be available to the control groups, how participants will be assigned to treatments and control groups, available treatment alternatives and compensation or monetary costs of participation.

If research participants or clients are not competent to evaluate the risks and benefits of participation themselves--for example, minors or people with cognitive disabilities--then the person who's giving permission must have access to that same information, says Koocher.

Remember that a signed consent form doesn't mean the informing process can be glossed over, say ethics experts. In fact, the APA Ethics Code says psychologists can skip informed consent in two instances only: When permitted by law or federal or institutional regulations, or when the research would not reasonably be expected to distress or harm participants and involves one of the following:

The study of normal educational practices, curricula or classroom management methods conducted in educational settings.

Anonymous questionnaires, naturalistic observations or archival research for which disclosure of responses would not place participants at risk of criminal or civil liability or damage their financial standing, employability or reputation, and for which confidentiality is protected.

The study of factors related to job or organization effectiveness conducted in organizational settings for which there is no risk to participants' employability, and confidentiality is protected.

If psychologists are precluded from obtaining full consent at the beginning--for example, if the protocol includes deception, recording spontaneous behavior or the use of a confederate--they should be sure to offer a full debriefing after data collection and provide people with an opportunity to reiterate their consent, advise experts.

The code also says psychologists should make reasonable efforts to avoid offering "excessive or inappropriate financial or other inducements for research participation when such inducements are likely to coerce participation."

4. Respect confidentiality and privacy

Upholding individuals' rights to confidentiality and privacy is a central tenet of every psychologist's work. However, many privacy issues are idiosyncratic to the research population, writes Susan Folkman, PhD, in " Ethics in Research with Human Participants " (APA, 2000). For instance, researchers need to devise ways to ask whether participants are willing to talk about sensitive topics without putting them in awkward situations, say experts. That could mean they provide a set of increasingly detailed interview questions so that participants can stop if they feel uncomfortable.

And because research participants have the freedom to choose how much information about themselves they will reveal and under what circumstances, psychologists should be careful when recruiting participants for a study, says Sangeeta Panicker, PhD, director of the APA Science Directorate's Research Ethics Office. For example, it's inappropriate to obtain contact information of members of a support group to solicit their participation in research. However, you could give your colleague who facilitates the group a letter to distribute that explains your research study and provides a way for individuals to contact you, if they're interested.

Other steps researchers should take include:

Discuss the limits of confidentiality. Give participants information about how their data will be used, what will be done with case materials, photos and audio and video recordings, and secure their consent.

Know federal and state law. Know the ins and outs of state and federal law that might apply to your research. For instance, the Goals 2000: Education Act of 1994 prohibits asking children about religion, sex or family life without parental permission.

Another example is that, while most states only require licensed psychologists to comply with mandatory reporting laws, some laws also require researchers to report abuse and neglect. That's why it's important for researchers to plan for situations in which they may learn of such reportable offenses. Generally, research psychologists can consult with a clinician or their institution's legal department to decide the best course of action.

Take practical security measures. Be sure confidential records are stored in a secure area with limited access, and consider stripping them of identifying information, if feasible. Also, be aware of situations where confidentiality could inadvertently be breached, such as having confidential conversations in a room that's not soundproof or putting participants' names on bills paid by accounting departments.

Think about data sharing before research begins. If researchers plan to share their data with others, they should note that in the consent process, specifying how they will be shared and whether data will be anonymous. For example, researchers could have difficulty sharing sensitive data they've collected in a study of adults with serious mental illnesses because they failed to ask participants for permission to share the data. Or developmental data collected on videotape may be a valuable resource for sharing, but unless a researcher asked permission back then to share videotapes, it would be unethical to do so. When sharing, psychologists should use established techniques when possible to protect confidentiality, such as coding data to hide identities. "But be aware that it may be almost impossible to entirely cloak identity, especially if your data include video or audio recordings or can be linked to larger databases," says Merry Bullock, PhD, associate executive director in APA's Science Directorate.

Understand the limits of the Internet. Since Web technology is constantly evolving, psychologists need to be technologically savvy to conduct research online and cautious when exchanging confidential information electronically. If you're not a Internet whiz, get the help of someone who is. Otherwise, it may be possible for others to tap into data that you thought was properly protected.

5. Tap into ethics resources

One of the best ways researchers can avoid and resolve ethical dilemmas is to know both what their ethical obligations are and what resources are available to them.

"Researchers can help themselves make ethical issues salient by reminding themselves of the basic underpinnings of research and professional ethics," says Bullock. Those basics include:

The Belmont Report. Released by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979, the report provided the ethical framework for ensuing human participant research regulations and still serves as the basis for human participant protection legislation (see Further Reading).

APA's Ethics Code , which offers general principles and specific guidance for research activities.

Moreover, despite the sometimes tense relationship researchers can have with their institutional review boards (IRBs), these groups can often help researchers think about how to address potential dilemmas before projects begin, says Panicker. But psychologists must first give their IRBs the information they need to properly understand a research proposal.

"Be sure to provide the IRB with detailed and comprehensive information about the study, such as the consent process, how participants will be recruited and how confidential information will be protected," says Bullock. "The more information you give your IRB, the better educated its members will become about behavioral research, and the easier it will be for them to facilitate your research."

As cliché as it may be, says Panicker, thinking positively about your interactions with an IRB can help smooth the process for both researchers and the IRBs reviewing their work.

Further reading

American Psychological Association. (2002). Ethical principles of psychologists and code of conduct. American Psychologist, 57 (12).

Sales, B.D., & Folkman, S. (Eds.). (2000). Ethics in research with human participants . Washington, DC: American Psychological Association.

APA's Research Ethics Office in the Science Directorate; e-mail ; Web site: APA Science .

The National Institutes of Health (NIH) offers educational materials on human subjects .

NIH Bioethics Resources Web site .

The Department of Health and Human Services' (DHHS) Office of Research Integrity Web site .

DHHS Office of Human Research Protections Web site .

The 1979 Belmont Report on protecting human subjects .

Association for the Accreditation of Human Research Protection Programs Web site: www.aahrpp.org .

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Ethical Considerations

Ethical Considerations can be specified as one of the most important parts of the research. Dissertations may even be doomed to failure if this part is missing.

According to Bryman and Bell (2007) [1] the following ten points represent the most important principles related to ethical considerations in dissertations:

• Research participants should not be subjected to harm in any ways whatsoever.
• Respect for the dignity of research participants should be prioritised.
• Full consent should be obtained from the participants prior to the study.
• The protection of the privacy of research participants has to be ensured.
• Adequate level of confidentiality of the research data should be ensured.
• Anonymity of individuals and organisations participating in the research has to be ensured.
• Any deception or exaggeration about the aims and objectives of the research must be avoided.
• Affiliations in any forms, sources of funding, as well as any possible conflicts of interests have to be declared.
• Any type of communication in relation to the research should be done with honesty and transparency.
• Any type of misleading information, as well as representation of primary data findings in a biased way must be avoided.

In order to address ethical considerations aspect of your dissertation in an effective manner, you will need to expand discussions of each of the following points to at least one paragraph:

1. Voluntary participation of respondents in the research is important. Moreover, participants have rights to withdraw from the study at any stage if they wish to do so.

2. Respondents should participate on the basis of informed consent. The principle of informed consent involves researchers providing sufficient information and assurances about taking part to allow individuals to understand the implications of participation and to reach a fully informed, considered and freely given decision about whether or not to do so, without the exercise of any pressure or coercion. [2]

3. The use of offensive, discriminatory, or other unacceptable language needs to be avoided in the formulation of Questionnaire/Interview/Focus group questions.

4. Privacy and anonymity or respondents is of a paramount importance.

5. Acknowledgement of works of other authors used in any part of the dissertation with the use of Harvard/APA/Vancouver referencing system according to the Dissertation Handbook

6. Maintenance of the highest level of objectivity in discussions and analyses throughout the research

7. Adherence to Data Protection Act (1998) if you are studying in the UK

In studies that do not involve primary data collection, on the other hand, ethical issues are going to be limited to the points d) and e) above.

Most universities have their own Code of Ethical Practice. It is critically important for you to thoroughly adhere to this code in every aspect of your research and declare your adherence in ethical considerations part of your dissertation.

My e-book,  The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance  offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline. John Dudovskiy

[1] Bryman, A. &  Bell, E. (2007) “Business Research Methods”, 2nd edition. Oxford University Press.

[2] Saunders, M., Lewis, P. & Thornhill, A. (2012) “Research Methods for Business Students” 6th edition, Pearson Education Limited.

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Ethical Considerations in Research | Types & Examples

Published on 7 May 2022 by Pritha Bhandari .

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviours, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to:

• Protect the rights of research participants
• Enhance research validity
• Maintain scientific integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research aims with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

Prevent plagiarism, run a free check.

Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process, so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

• What the study is about
• The risks and benefits of taking part
• How long the study will take
• Your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information – for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymise data collection. For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymisation is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants, but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study, as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources, counselling, or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine scientific integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information – for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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Ethical challenges of researchers in qualitative studies: the necessity to develop a specific guideline

Mahnaz sanjari.

1 Nursing PhD Candidate, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran

Fatemeh Bahramnezhad

Fatemeh khoshnava fomani, mahnaz shoghi.

2 Assistant Professor, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran

Mohammad Ali Cheraghi

3 Associate Professor, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.

Considering the nature of qualitative studies, the interaction between researchers and participants can be ethically challenging for the former, as they are personally involved in different stages of the study. Therefore, formulation of specific ethical guidelines in this respect seems to be essential. The present paper aimed to discuss the necessity to develop explicit guidelines for conducting qualitative studies with regard to the researchers’ role. For this purpose, a literature review was carried out in domestic and international databases by related keywords.

Health care providers who carry out qualitative research have an immense responsibility. As there is no statistical analysis in qualitative studies, the researcher has to both evaluate what he or she observes and to interpret it. Providing researchers with the necessary skills and applying stringent supervision can lead to better extraction of reliable information from qualitative studies. This article presents a debate in order to illustrate how researchers could cover the ethical challenges of qualitative studies and provide applicable and trustworthy outcomes.

Researchers face ethical challenges in all stages of the study, from designing to reporting. These include anonymity, confidentiality, informed consent, researchers’ potential impact on the participants and vice versa. It seems of paramount importance that health care providers, educators and clinicians be well informed of all the different aspects of their roles when acting as qualitative researchers. Hence, these adroit roles need to be well defined, and the use of practical guidelines and protocols in all stages of qualitative studies should be encouraged.

Introduction

In the recent millennium, the constant trend of change in the demands of the community as well as transforming the trend of knowledge production has highlighted the necessity for researchers to adopt a more comprehensive approach. Increasingly, many academic disciplines are utilizing qualitative research (QR) as the qualitative method investigating the why and how of the process of a developed concept ( 1 , 2 ). Qualitative research is sometimes defined as interpretive research, and as interpretations can be incorrect or biased, the findings may be controversial ( 3 ). However, qualitative research is not only useful as the first stage of quantitative research, but can also play a key role in ‘validating’ it or in providing a different viewpoint on the same social phenomena ( 4 ).

Qualitative studies tend to use methods that result in text production rather than numerical outputs. Given that the researcher is considered to be the research instrument, and the plan of inquiry needs to be developed and altered as the study progresses, a qualitative researcher cannot depend upon traditional approaches to address certain concerns such as bias and credibility. Therefore, learning from a series of mistakes is often considered an integral part of qualitative research ( 5 , 6 ).

In this study, a literature review was carried out in international electronic databases including PubMed, Web of Sciences, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, Ebsco, EMBASE and Science Direct without any time limitation, using the search terms “qualitative research”, “researchers’ role”, “ethical challenges” and “ethical guidelines”. These keywords were also searched on national electronic databases including Scientific Information Database (SID), Iran Medex and Medical Articles Library (Medlib) using the same strategy.

Authors of the present article endeavor to shine a light on the ethical issues affecting researchers and propose strategies to face the ethical challenges of qualitative studies, so as to provide applicable and trustworthy outcomes. This could be the basis for the formulation of specific ethical guidelines in this regard.

An overview on qualitative research in health care

Up to the 1970s, qualitative research was solely employed by anthropologists and sociologists. During the 1970s and 1980s, however, it was favored by various disciplines and experts of different branches of science and humanity such as health care, psychology , nursing, management, political science , education, and communication studies ( 2 , 7 ).

Qualitative research has been conducted in the field of nursing in order to identify, describe and explain related concepts, experiences and phenomena and to develop the nursing knowledge. Nursing professionals simultaneously introduced qualitative research to their peers. Since 1970, qualitative research has been performed to achieve the concepts of patient care and other main perceptions in the nursing profession. Qualitative studies provide nurses with sensitivity to the lived experiences of individuals from different nursing care aspects ( 4 , 8 ).

Role of researchers in qualitative studies

In the case of nurses who perform qualitative research, ethical issues are raised when the nurse-patient relationship in the research area leads to some degree of therapeutic communication for the participants ( 9 ). Thus, nurse researchers must be aware of the impact of the questioning on the participants, and in order to decrease such harmful effects on human subjects, the “reflexive approach” is recommended ( 10 ).

In qualitative studies researchers are often required to clarify their role in the research process ( 11 ). In the QR procedure the researcher is involved in all stages of the study from defining a concept to design, interview, transcription, analysis, verification and reporting the concepts and themes. Therefore, whenever instruments are involved in qualitative research, a human being will be an integral part of the process ( 12 ).

It is argued that humans have increasingly become the “instrument of choice” for naturalistic research due to certain characteristics: they are highly responsive to environmental stimuli, have the ability to interact with the situation, pull together different pieces of information at multiple levels simultaneously, and perceive situations holistically; moreover, they are able to process findings the instant they become available, can present immediate feedback, and feel unusual responses. Nevertheless, researchers need to improve the abilities that make them appropriate human instruments and consequently, their interpersonal skills are of major importance in natural settings and study processes ( Table 1 ) ( 13 , 14 ).

Researcher’s role in qualitative methods at a glance

Ethical challenges in qualitative studies:

The researcher-participant relationship.

The relationship and intimacy that is established between the researchers and participants in qualitative studies can raise a range of different ethical concerns, and qualitative researchers face dilemmas such as respect for privacy, establishment of honest and open interactions, and avoiding misrepresentations ( 19 ). Ethically challenging situations may emerge if researchers have to deal with contradicting issues and choose between different methodological strategies in conflict arises. In such cases, disagreements among different components such as participants, researchers, researchers’ discipline, the funding body and the society may be inevitable ( 20 , 21 ). Some important ethical concerns that should be taken into account while carrying out qualitative research are: anonymity, confidentiality and informed consent ( 22 ).

According to Richards and Schwartz’ findings ( 22 ), the term ‘confidentiality’ conveys different meanings for health care practitioners and researchers. For health care practitioners, confidentiality means that no personal information is to be revealed except in certain situations. For researchers, however, the duty of confidentiality is less clear and involves elaboration of the form of outcome that might be expected from the study ( 22 , 23 ).

The researcher must endeavor to minimize the possibility of intrusion into the autonomy of study participants by all means. When highly sensitive issues are concerned, children and other vulnerable individuals should have access to an advocate who is present during initial phases of the study, and ideally, during data gathering sessions. It is sometimes even necessary that the researcher clarify in writing which persons can have access to the initial data and how the data might be used ( 24 , 25 ).

Informed consent has been recognized as an integral part of ethics in research carried out in different fields. For qualitative researchers, it is of the utmost importance to specify in advance which data will be collected and how they are to be used ( 26 ). The principle of informed consent stresses the researcher’s responsibility to completely inform participants of different aspects of the research in comprehensible language. Clarifications need to include the following issues: the nature of the study, the participants’ potential role, the identity of the researcher and the financing body, the objective of the research, and how the results will be published and used ( 27 ).

Informed consent naturally requires ongoing negotiation of the terms of agreement as the study progresses ( 26 ). Many people consider it necessary to participate in research that their peers, community and/or society may benefit from. Therefore, qualitative health researchers need to clarify that the research they carry out will benefit science and can contribute to the improvement of health policy ( 5 ).

Research design

The qualitative method is utilized to explain, clarify and elaborate the meanings of different aspects of the human life experience. Therefore, researchers can interpret people’s experiences because they are involved in human activities. The principle of ‘no harm’ to participants ought to be considered by researchers, who should be aware of the potential harms that might be inflicted upon study subjects. Obviously, sometimes a conflict between the right to know (defended on the basis of benefits to the society) and the right of privacy (advocated based on the rights of the individual) may happen ( 27 , 28 ).

There are several effective strategies to protect personal information, for instance secure data storage methods, removal of identifier components, biographical details amendments and pseudonyms (applicable to names of individuals, places and organizations) ( 27 ). Researchers have the responsibility of protecting all participants in a study from potentially harmful consequences that might affect them as a result of their participation. It is getting increasingly common for research ethics committees to seek documented proof of consent in a written, signed, and ideally, witnessed form. Researchers can only do their best to protect their respondent’s identity and hold the information strictly confidential as there would be no guarantee for it otherwise ( 29 ). Furthermore, in investigations of sensitive topics where written consent puts the informants at risk, audio recorded oral consent would be more appropriate ( 30 ).

Development of personal relationships with participants may be inevitable while collecting certain data. Therefore, researchers should seriously consider the potential impact they may have on the participants and vice versa, and details of such interactions should be clearly mentioned in research proposals ( 23 ). Overall, the role of the researcher as (a) stranger, (b) visitor, (c) initiator, (d) insider-expert or other should be well defined and explained ( 3 ). As Brenner quoted Kvale state that, preparing an ethical protocol can cover issues in a qualitative research project from planning through reporting ( 30 ).

Data gathering and data analysis

In qualitative research, data are collected with a focus on multifaceted interviews and narratives to produce a description of the experiences. The researchers, therefore, play the role of a mediator between the experiences of the respondents and the community of concerned people ( 28 , 31 ). The post-interview comment sheet could assist the researcher to note the feelings of informants, as well as interpretations and comments that occurred during the interview ( 32 ).

Data collection needs to be as overt as possible, and findings should be recorded. Although there is no guarantee of absolute confidentiality, openly recording field notes assists participants to decide what they wish to have on the record. In health care research, the problem may be even more exaggerated as the researcher is sometimes the health provider as well ( 33 ).

In comparison with other research methods, ethnography has singular characteristics. When a researcher aims to study the culture of certain people, living amongst them is inevitable. This method of collecting data is a subject of debate from an ethical point of view. Long presence of the researcher amongst people of a particular culture necessitates informed consent. Participants should always be aware of the information that has been obtained and is being recorded, and consent to it. Sometimes this cannot be achieved easily and conflicts may happen, as in studies of cultural and ethnic characteristics ( 18 ).

The physical presence of the researchers within the culture requires them to be responsible for their role and potential consequences on the field. For instance, when criminals or a group of war veterans suffering from a disease are the subject of a study, the risks involved in living amongst them should be considered. Ethnographers must be vigilant about any distractions stemming from close interactions that can be potentially harmful to participants in the long run ( 33 , 34 ). Researchers can benefit from supervision sessions directed at learning, mentoring and skill development, all of which can foster their ability to carry out research without risking their health. Adequate professional supervision (which may be outside of the university) can be of service to researchers in dealing with the potential stress associated with the study ( 35 – 37 ).

In order to gain explicit data, ethnographers need to know the role of instrument details. There are eleven steps defined in ethnography which are meant to assist researchers. These steps include participant observation, ethnographic record, descriptive observation, taxonomic analysis, selected observation, componential analysis, discovering the cultural theme, cultural inventory, and finally writing ethnography ( 38 , 39 ).

Researchers should always be aware of the precise reason for involvement in a study in order to prevent undesirable personal issues. The probability of exposure to vicarious trauma as a result of the interviews needs to be evaluated. Interviewers should be properly scheduled to provide the researcher with sufficient recovery time and reduce the risk of emotional exhaustion, while allowing ample time for analysis of the objective and emotional aspects of the research. It is also necessary for the researcher to be familiar with signs of extreme fatigue and be prepared to take necessary measures before too much harm is done ( 40 – 42 ).

In qualitative studies, researchers have a great responsibility and play many different roles. It is argued that qualitative research that deals with sensitive topics in depth can pose emotional and other risks to both participants and researchers. Clear protocols for dealing with distress should be in place so that both parties involved in research can use them if necessary. It is not usually easy to predict what topics are likely to lead to distress, and researchers should therefore receive sufficient training in predicting traumatic situations.

Preventive measures for researchers who carry out sensitive qualitative studies should include official arrangements for a peer support program consisting of a list of researchers who are involved, or a constellation of researcher support activities aiming at improving psychological fitness in the form of a professional confidence building module. Other such measures include offering adequate supervision to provide opportunities for self-development and self-care, and facilitating the process of self-reflection and self-monitoring.

Strategies for emotional distancing need to be considered and adopted if the research topic or participants have the potential to be emotionally challenging. An appropriate planning should be in place before the commencement of the fieldwork, and it must be perfectly clear how the study should be conducted and what level of relationship development is necessary. Measures must also be taken so that levels of self-disclosure, objective displays of emotion during the interviews, and strategies to end the relationships are well defined and communicated.

One of the most prominent tasks of qualitative researchers is to minimize the flaws in observation and endeavor to gain truthful knowledge. Therefore, it is necessary for researchers to continuously update their investigation skills in terms of methodology and find novel techniques to better carry out studies in the field of health and sociology.

As explained before, qualitative research is carried out in natural settings, which requires researchers to work in close collaboration with other members of the team and under direct supervision to discuss and resolve issues as they arise. Therefore, development of practical strategies and communicating them to researchers can be of great benefit and assist them in conducting more perceptive qualitative studies. It is noteworthy that such research should be directed towards making a difference in people’s lives, improving care delivery in different settings and at all levels, and providing a framework for health sciences without any ethical disturbances.

As a result of the extensive body of research in the field of medical sciences, patients comprise a large proportion of the public who are frequently subjects of studies. Research Ethics Committees are formed to provide independent advice to participants, researchers, funders/sponsors and healthcare organizations on the extent to which research proposals comply with universally endorsed ethical standards.

In the history of social and medical science, there have been a few research studies that seriously injured people, and many more in which their welfare was not sufficiently protected. Nations and research associations have taken steps to prevent hurtful and intrusive research. To return to the matter of privacy, the researcher should not rely solely on the informant to identify possible intrusion, but needs to work at anticipating it in advance. Confidentiality does not necessarily preclude intrusion, as anonymity by itself is not enough to protect a person’s privacy or prevent disclosure of personal issues. Investigators should refrain from soliciting private information that is not closely related to the research question.

Considering the aforementioned challenges, it is recommended to conduct further research in order to provide meticulous and explicit ethical protocols, guidelines and codes with respect to qualitative studies.

Acknowledgments

The authors would like to offer special thanks to Dr. Ali Tootee for his assistance in the language editing of this article.