clinical research ethics board

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Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

Regulations: Good Clinical Practice and Clinical Trials . Comprehensive list of regulations governing human subject protection and the conduct of clinical trials. Guidance for Institutional Review Boards and Clinical Investigators .  A series of Information Sheets providing the Agency's current guidance on the protection of people who are subjects of research.  Topics include Institutional Review Boards and Sponsor-Investigator-IRB interrelationships, FDA clinical investigator inspections and sanctions, clinical trials protocols, informed consent, and documents necessary for the conduct of clinical trials.

Information for Health Professionals .  Additional links to information on subject protection from FDA and other government agencies.

Clinical Safety Data Management (PDF - 49KB) .   Provides the definitions and terminology associated with clinical safety experience and the standards for expedited reporting of adverse drug reactions that occur during clinical trials.

FDA Compliance Program 7348.809 - BIMO for Institutional Review Boards (PDF - 1050MB).

FDA Compliance Program 7348.811 - Bioresearch Monitoring: Clinical Investigators.

Institutional Review Board Questions: Contact the Office of Good Clinical Practice, 301-796-8340, or [email protected]

Research ethics board approval: What, why, when, how?

At the BC Medical Journal , we often receive submissions from clinicians who want to share their findings, but they aren’t sure how to approach the subject of research ethics. Here is a brief summary for our readers and prospective authors.

What is a research ethics board?

Research ethics boards (REBs) are “autonomous entities whose primary responsibility is to protect the rights and welfare of human participants taking part in research.”[ 1 ] They can also help to ensure that research is of high quality and is clinically important.[ 2 ] The University of British Columbia has several such boards, including Children’s and Women’s, BC Cancer, Providence Health Care, and the UBC Clinical Research Ethics Board. These committees are composed of individuals from varied backgrounds such as physicians, scientists, researchers, ethicists, and community members. There are also private for-profit ethics boards, which adhere to the same principles and are selected by some researchers for expediency or if the researchers are not affiliated with a university.

Why is research ethics approval necessary?

Involuntary studies on human subjects in the past have had horrendous consequences. The Nuremberg trials exposed the “scientific” evils of the Nazi regime and resulted in the creation of the Nuremberg Code in 1947.[ 3 ] Unfortunately, around the world, including in North America, there were many subsequent occurrences of atrocities committed in the name of research. The World Medical Association Declaration of Helsinki (1964, last updated 2013) was created to further address the ethics and safety of human research and its application to special populations.[ 4 ]

Today, the standards for research involving humans adhere to the Tri-Council Policy Statement (TCPS2 2018), which is a product of Canada’s three federal research agencies.[ 5 ] Applications to UBC’s REBs require all team members to have completed a tutorial on the Tri-Council Policy Statement.[ 6 ] The key principle is informed consent, where research participants are fully informed about the potential risks and benefits of the study.

When does a study need research ethics board approval?

In Canada, any research study involving human participants, human tissue, or human data requires research ethics board approval before commencement. If you are undertaking a quality improvement project, it does not require REB oversight. However, it is important to note that REBs cannot review research that has already been done; if there is any doubt about your project constituting research, it is best to consider the intention of the project before beginning. A sorting tool, available on the PHSA website, can be a helpful first step ( https://rc.bcchr.ca/redcap/surveys/?s=HNWAAKFF97 ). If research ethics appear to be required or you are uncertain, contact your local REB.

At the BCMJ , we also receive submissions of quality improvement projects that have been written up for publication. For example, a medical student was supervised by an attending physician to perform a review of treatment times for different diagnoses in the emergency department. This study represents a retrospective chart review, which involved collecting patient data, de-identifying the information, and analyzing the results. Depending on the nature and specifics of the project, the BCMJ may ask the principal investigator to seek confirmation from a local REB that the project was, in fact, quality improvement and, therefore, did not require REB oversight. If the research would have required REB approval, it cannot be granted retrospectively; therefore, the submission would not be accepted for publication.

How can researchers obtain ethics approval?

Research ethics boards have a standardized application process. UBC uses an online platform called Research Information Systems (RISe) to track applications, amendments, and annual renewals. Ethics boards generally allow for two levels of review depending on the type of study: delegated review (subcommittee review of studies deemed minimal risk) and full review (anything beyond minimal risk). The timeline for review and approval can vary due to committee schedules and the number of revisions required, but it may take anywhere from days to months. Researchers affiliated with UBC can get started at www.rise.ubc.ca/guidance-notes-and-tutorials .

Acknowledgments

Dr Dunne would like to thank Ms Jennie Prasad and Dr Marc Levine of the BC Women’s and Children’s Hospital Research Ethics Board for their editorial input on this article. —Caitlin Dunne, MD, FRCSC

1.    UBC Office of Research Ethics. UBC clinical research ethics general guidance notes. Accessed 22 March 2021. https://ethics.research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes#A1 .

2.    Hyer CF. What is an IRB, why do we need it, and what is a private IRB? Foot Ankle Spec 2010;3:91-94.

3.    Shuster E. Fifty years later: The significance of the Nuremberg Code. N Engl J Med 1997;337:1436-1440.

4.    World Medical Association. World Medical Association declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013;310:2191-2194.

5.    Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council. Tri-Council policy statement ethical conduct for research involving humans. 2018. Accessed 21 March 2021. https://ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf .

6.    Panel on Research Ethics. TPS2: CORE – tutorial. Accessed 21 March 2021. http://tcps2core.ca/welcome .

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Caitlin Dunne, MD, FRCSC. Research ethics board approval: What, why, when, how?. BCMJ, Vol. 63, No. 4, May, 2021, Page(s) 149 - Editorials .

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Institutional Review Boards and Ethics Committees

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Institutional review boards (IRBs) are committees established in accordance with US federal regulations to review and monitor clinical trials and other research with human subjects. IRBs evolved from a history of egregious ethical violations in research with human subjects and the ethics codes and declarations that ensued, and were first mandated by US law in 1974, with the passing of the National Research Act. IRBs help to ensure the protection of the rights and welfare of human subjects by applying the ethical principles of the Belmont Report, respect for persons, beneficence, and justice, in their review of research projects. They have the authority to approve, require modifications to, or disapprove proposed research. IRBs review plans to obtain and document informed consent from research participants and can waive the requirements for informed consent in certain circumstances. IRBs may exist within the institution where research is being conducted or institutions can rely on an external IRB with a written agreement. While the term IRB is unique to the USA, clinical trials internationally adhere to the ethical principles of the Declaration of Helsinki, which requires independent review by an ethics committee.

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Dunn, K.R. (2021). Institutional Review Boards and Ethics Committees. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_65-1

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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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Regulatory and Compliance Reviews

For the purposes of clinical trials, regulatory approvals include any approvals by government or health authorities regarding any research that includes human subjects. Additional approvals will be necessary if the research involves the use of an FDA regulated product. The Principal Investigator (PI) is responsible for assessing and addressing all applicable regulatory approvals for the study. The study team initiates the review processes through Institutional Review Board (IRB), Stanford Scientific Review Committee (SRC) and Research Management Group (RMG) submissions. The majority of clinical trials are subject to Food and Drug Administration (FDA) regulations and human subject protection laws. The study team should include FDA approval letters for externally sponsored projects in the initial submissions to IRB and SRC. PI-initiated studies also may involve filings with the FDA prior to IRB review and approval.

The IRB evaluates and approves all protocols involving human subjects research. The SRC provides peer review of all protocols involving cancer patients. With a few exceptions, significant risk device trials conducted under an Investigational Device Exemption (IDE) require additional approval from a local Medicare fiscal intermediary (FI). The Clinical Trial Research Process Manager (CT RPM) verifies alignment of submission information and confirms that all required approvals are secured prior to contract execution.

Regulatory Approvals and Compliance Review Processes

In preparation for study activation, the PI and research team first assess all compliance requirements and then initiate any processes required to obtain the necessary approvals. The PI and/or designee:

• begins the IRB approval process;
• submits minimum documents to Clinical Trial Research Management Group Intake;
• completes all University required training (PI training and Good Clinical Practice/CITI training);
• if necessary, submits a Data Risk for review by University Privacy Office (UPO) and Information Security Office (ISO) under the Office of the Chief Risk Officer;
• if necessary, works with appropriate University and FDA offices to address regulatory requirements and approvals if necessary; and
• accurately fills out the Clinical Trial Proposal Development Routing Form (CT PDRF) , which captures conflict of interest (COI), General Data Protection Regulation (GDPR) and other information. Concurrent submission by the research team to IRB, RMG and SRC (if applicable) expedites the review process.
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Code of Ethics

As the primary resource for clinical research professionals in the pharmaceutical, life sciences, biotechnology, and medical device industries, as well as those in hospital, academic medical centers, and physician office settings. ACRP members depend on the association to promote excellence in clinical research and ensure to the best of its ability that clinical research is performed ethically, responsibly, and professionally everywhere in the world.

In line with ACRP’s mission and vision, ACRP has established a code of ethics that:

• Sets standards and defines best practices for the clinical research profession
• Provides a basis to meet compliance requirements for the profession
• Provides a “seal of approval” for professionals to look for when hiring or using ACRP services
• Gives ACRP members a mechanism to file violations of ACRP’s Code of Ethics
• Outlines the role of ACRP’s Ethics Committee and procedures that address violations of the Association’s Code of Ethics
• Documents, according to the Association’s governance, those who have violated the ACRP Code of Ethics

ACRP strongly encourages its members to review and adhere to the Association’s Code of Ethics.

Report a Violation of ACRP’s Code of Ethics >

ACRP Code of Ethics and Professional Conduct

The Association of Clinical Research Professionals (“ACRP”) is a US registered nonprofit, tax-exempt corporation that functions as a global association of clinical research professionals. ACRP’s vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP’s mission is to promote integrity and excellence in clinical research.  The Academy of Clinical Research Professionals (the “Academy”) similarly is a nonprofit, tax-exempt organization that advances and promotes the professional interests of clinical research professionals and provides certification for such professionals.

This Code of Ethics and Professional Conduct (the “Code”) serves as a code of professional conduct for ACRP members and/or Academy Certificants. ACRP members and Academy Certificants are expected to adhere to this Code in all professional activities and relationships with each other, organizations with which they work, research participants and society in general. The core values of Integrity, Courage, Excellence, Dedication and Collaboration are manifest in the ACRP Code.  The Code also applies to individuals who seek membership in and/or certification by ACRP and the Academy.

This Code is a summary of what ACRP, and the Academy define as essential ethical behavior for clinical research professionals. Compliance with the Code is a requirement for initial and continued ACRP membership and/or certification through the Academy.  ACRP members and Academy Certificants affirm their endorsement of the Code and acknowledge their commitment to uphold its principles by joining and subsequently renewing their membership in ACRP and/or by applying for and maintaining certification from the Academy. Violations of the Code may result in sanctions imposed under the Discipline and Complaints Policy (the “Policy”) adopted by ACRP and the Academy. This Policy was adopted to provide clarity of expected behavior and description of due process accorded to ACRP members and Academy Certificants necessary to protect the integrity, and ensure the efficacy, of the Code.

This Code is intended to be used by current and prospective ACRP members and Academy Certificants in conjunction with applicable national and international frameworks that govern the practice of clinical research, such as professional license requirements, ethical principles, guidelines, and laws and regulations applicable to clinical research, including, but not limited to, principles of the Declaration of Helsinki, Belmont Report, ICH GCP, US Codes of Federal Regulations, WHO “Ethical Standards and Procedures for Research with Human Beings,” and UK Research Governance Framework.

The term “Clinical Research Professional” as used herein encompasses many job titles, disciplines and duties within the profession of clinical research. For the purpose of this Code, the term shall include anyone involved in the design, conduct, reporting, review and oversight of clinical research who is an ACRP member or Academy Certificant or applicant for membership or certification, and those who represent ACRP in any elected or volunteer capacity (e.g. Chapter President, Treasurer, etc. or volunteers to serve on a local or national committee, speakers at a conference or event).

Clinical Research Professionals who are current or prospective members of ACRP and/or Academy Certificants (referred to herein as “Members” and “Certificants”) shall abide by and conform to the following ethical standards:

• B ene ficence and Nonmaleficence

Members and Certificants shall:

• Respect and safeguard the rights and welfare of all individuals with whom they interact professionally, including but not limited to research participants.
• Always consider and act in furtherance of the best interests of research participants and society. Where societal and research participants’ interest conflict, best interests of the participants take precedence.
• Ensure that the aims of all clinical research projects are to advance knowledge and promote the health and well-being of research participants.
• When designing, reviewing, or conducting research, ensure that potential risks of the research are reasonable in relation to the anticipated benefits to the participants and the importance of the knowledge to be gained.
• Ensure that potential risks to research participants are minimized to the greatest extent possible and take all necessary steps to protect the participants at all times.

Steps taken to uphold this ethical principle include, but are not limited to:

• Design and conduct studies where a state of clinical equipoise exists, that is, to test hypotheses that have not yet been adequately tested through current or previous reported research results, to avoid unnecessary risks or inconveniences to participants of redundant research and to maximize often scarce research resources.
• Design and conduct research studies with scientific value.
• Ensure clinical research is conducted in accordance with currently accepted ethical guidelines and standards.
• Never use coercion or undue influence when recruiting research participant Seek autonomous informed and appropriately documented consent from participants or, where applicable, their legally authorized representatives prior to the instigation of any research procedure.
• Never coerce, or attempt to coerce or induce individuals, such as staff members, vendors, contractors, investigators, or regulators, to act in an unethical manner in any respect.
• Avoid using substances, such as alcohol or drugs, while performing professional duties that may impair professional judgment or performance.
• Perform only those duties for which one is appropriately qualified and trained to perform.
• Where an individual is a member of a professional organization with its own licensing requirements and/or code of ethical or professional conduct, operate within the scope of practice and professional standards outlined within those professional guidelines, codes or licenses.
• Report any acts that appear to be unethical or illegal to appropriate organizational, institutional or legal authorities, so long as supported by reasonable evidence.

2. Integrity

• Educate themselves, and where applicable, their students and their colleagues, about responsible research practices.
• Apply sound ethical values, scientific principles and judgment in the design, conduct and analysis of clinical studies, and in interpretation of their results.
• Report research findings accurately and avoid misrepresenting, fabricating or falsifying results.
• Conduct research in accordance with an approved research protocol/plan.
• Make all research data available to authorized persons for verification in accordance with established standards of the clinical research profession.
• Ensure the dissemination of scientifically sound information from clinical trials and other investigations, and
• Not withhold information relevant to full evaluation of the safety, efficacy or utility of clinical interventions, agents or devices under investigation for the benefit of medicine, patients, science and society regardless of the research outcome.

3. Conflicts of Interest

It is recognized that real, potential and apparent conflicts of interest naturally occur from time to time. Conflicts of interest arise when personal, professional, business, political and/or financial influences have the potential to significantly impair professional judgment, and hence lead to consequent acts of research or business misconduct.  Additionally, conflicts of interest may occur in relation to other professional and volunteer obligations, whether with ACRP or the broader research community.

It is essential that Members and Certificants:

• Recognize when they may have a conflict of interest, disclose such conflict as soon as the potential conflict is recognized and be transparent in how the conflict will be managed.
• If participation in any research-related activity that poses a potential conflict of interest situation is unavoidable, ensure that steps are taken to appropriately manage any such conflicts to safeguard quality and credibility of their professional judgment from inappropriate influence so that research participants’ rights and safety are fully protected.
• Do not, under any circumstance, unduly exploit any professional or volunteer relationship to further personal, political or business interest at the expense of other individuals or ACRP. This includes both professional and volunteer activities and cases where volunteer activities, as a professional or other body might pose a potential conflict of interest.
• Respect and adhere to Conflict of Interest policies if they are a member of any professional or industry organization, or an employee of an organization that has internal Conflict of Interest policies.

Steps taken to uphold this ethical principle include but are not limited to:

• Publicly disclose relationships and potential conflicts of interest in publications, speaking engagements, Advisory Boards and any other venue or activity, including any ACRP chapter or other meetings in which the Member or Certificant is perceived as providing subject matter expertise or other authority.
• Retain documentation and use factual quantitative measures to conduct one’s own professional duties and procurement of vendor services.
• Avoid dual relationships that could impair professional judgment or increase the risk of harm to others.
• Avoid performing services for direct competitors without the express knowledge and documented consent of each party, either volunteer or professional Direct competitors are individuals or organizations with whom an exchange of services would create a conflict of interest – a situation in which personal, professional, business, political and/or financial influences have the potential to significantly impair professional judgment, and hence lead to consequent acts of research or business misconduct.

4. Privacy and Confidentiality

Privacy refers to the legal rights of individuals to limit public scrutiny; to limit access to their private acts and their personal information; and to limit disclosure of such personal information. Confidentiality refers to the obligation to protect private information about an individual or organization from unauthorized disclosure.  Clinical research professionals have access to confidential information, whether it is intellectual property of a company or personal health information of research participants and have the responsibility to maintain this confidentiality.

Members and Certificants must:

• Maintain the privacy and confidentiality of research participants and of any confidential information received in connection with the Members and Certificants’ research to the extent required by applicable law(s) and/or signed contractual agreements.
• Maintain the privacy and confidentiality of any non-public information, intellectual property of a company or personal health information of research participants, that they may have access to in their roles as clinical research professionals.
• Store written and/or electronic records in secure locations with access provided only to authorized individuals.
• Collect and transmit only the minimum essential information required to accomplish the task at hand.
• Apply standards of confidentiality to retrospective, current and prospective data collection and protected personal information. Treat all confidential data as if it were your own.
• Ensure an understanding of all elements that could be considered confidential information of any kind.
• Ensure that all aspects of the privacy of research participants and their families is respected prior to, during, and following, any clinical research project.

5. Duties to Society and Compliance with the Law

By the very nature of their work, Members and Certificants are engaged in professional endeavors that enhance knowledge, skill, judgment and intellectual development that strives to contribute to improving the human condition. As such, clinical research professionals must be both aware and conscious of their duty to society and the clinical research arena.

ACRP Members and Certificants shall:

• Uphold the profession’s responsibility to society by promoting ethical and professional practice standards, and
• Be willing to be held professionally accountable for upholding those standards.
• Not participate in criminal, fraudulent, or other illegal activities.
• If faced with a conflict between abiding by two conflicting laws or regulations, or between abiding by a law/regulation and following an ethical principle, consult with experienced, respected professional colleagues and seek their guidance whenever possible.
• Not advocate, sanction, participate in, or condone any act that is prohibited by this Code, unless failure to do so would be seriously detrimental to the rights and well-being of others.

6. Duties to Professional Discipline and Beneficiaries of Practice

• Be personally committed to, and encourage others, to engage in safe, sound research practices consistent with the relevant ethical and scientific standards and the requirements of their professional discipline.
• Uphold standards of equality and nondiscrimination in all professional interactions and cooperate with other professionals as appropriate and ethical.
• Assist colleagues entering the profession by sharing knowledge and understanding of the ethics, responsibilities and needed competencies of their chosen area of research and Where Members or Certificants seek to acquire or maintain a medical or other professional license, additional laws and ethical standards of conduct that are not pertinent to clinical research may apply.
• in addition to adhering to this Code of Ethics and Professional Conduct, abide by their respective discipline’s laws and ethical standards of conduct.
• Take affirmative steps to make it clear to research participants and others that there is a distinction between research and standard therapy. Ensure that the roles and responsibilities of physicians and other health care professionals acting as both investigators and care providers remain clear to all concerned.
• Ensure that all contributory information provided to research participants, their legal representatives and other health care providers not involved with the research is fair, balanced, accurate, understandable and sufficiently comprehensive to enable well-informed decisions about the use of pharmaceuticals, medical devices or other clinical services or intervention
• Ensure that when consent is waived, that reasons for waiver of informed consent are valid, that the waiver reasons and process comply with applicable regulations, e.g. regulations in 21 CFR 50 and 56, and that IRB approval for a waiver has been sought, as is generally applicable.
• If a clinical investigation is conducted or supported by HHS and involves an FDA regulated product, the study is subject to both 45 CFR 46 and part 21 CFR 50 and 56. Where the regulations differ, the regulations that offer the greater protection to human subjects should be followed.

7. Duties to ACRP and the Greater Research Community

While there are many professional and personal benefits to volunteering for leadership positions in the community, members and certificants who volunteer for ACRP committee, officer or Board positions at the local chapter and/or international level, have a duty to act in a professional manner and be mindful that they are acting as a representative of ACRP when fulfilling the requirements of their positions, and as such have some greater duties.

In their leadership/volunteer capacities, Members and Certificants shall:

• Ensure that they have the skills and experience to fulfill the requirements of the position they have volunteered for or actively seek training to gain those skills and/or ask for assistance from ACRP staff or other sources to perform necessary functions.
• Commit to understanding, following and upholding the bylaws of the organization in which they are a leader, in addition to the ACRP Code of Ethics.
• Avoid engaging in self-dealing, as well as actual conflicts of interest relating to business affairs. Additionally, they shall use their best efforts to avoid appearance of impropriety, self-dealing or conflict of interest.
• Avoid representing multiple organizations simultaneously in a manner which could potentially be harmful to ACRP or the other organizations.
• Refrain from publicly (including social media) disparaging ACRP, its staff or its membership and/or disseminating false information about ACRP or its affiliates.

8. Grounds for Disciplinary Action

A Member or Certificant shall be subject to disciplinary action if the actions of such Member or Certificant are determined, in accordance with the Discipline and Complaints Policy, to constitute one or more of the following:

• Gross negligence or willful misconduct in the performance of services, or other unethical or unprofessional conduct based upon demonstrable violations of this Code of Ethics and Professional Conduct.
• Conviction of a Member or Certificant of a felony or other crime of moral turpitude under federal or state law, particularly in a matter related to the conduct of the profession.
• Fraud or misrepresentation in the application or maintenance of ACRP membership, Academy certification, or other professional recognition or credential.

Individuals aspiring to become a Member or Certificant shall ensure awareness of and adherence to this Code as an element of eligibility criteria of Membership and/or Certification.  Applicants who knowingly fail to adhere to the Code shall be ineligible for Membership and/or Certification.

9. Complaints

To file a complaint against a Member or Certificant, or applicant Member or Certificant, please email [email protected] . Complaints will be addressed according to the Discipline and Complaints Policy, available here , developed by the ACRP Professional Ethics Committee.

M ONITORING AND REVIEW SCHEDULE

Review every three years by the ACRP Professional Ethics Committee.

DATE REVIEWED BY COMMITTEE December 14, 2015 November 3, 2017 February 7, 2017 November 11, 2019 February 2020

DATE MODIFIED BY COMMITTEE December 14, 2015 November 3, 2017 November 11, 2019 February 2020

DATE APPROVED BY COMMITTEE December 14, 2015 November 3, 2017 November 11, 2019 February 2020

DATE REVIEWED BY BOARD December 17, 2015 December 13, 2017 December 11, 2019 March 17, 2020 June 17, 2020

DATE MODIFIED BY BOARD December 11, 2019 March 20, 2020

DATE APPROVED BY BOARD October 7, 2007 September 2012 December 17, 2015 December 13, 2017 June 17, 2020

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Ubc clinical research ethics board (creb).

Pia Ganz,  CREB Manager The CREB Manager oversees the functioning of the CREB staff and Board, monitors ethical review process standards, and advises on compliance with ethics policies.    [email protected]  

Elmira Chan,  Pre-Post Review Manager The CREB Pre-Post Review Manager is responsible for managing the review of new minimal risk and full board applications and associated deferral/proviso responses, post-approval activities, and general inquiries.    [email protected]  

Sarah Flann,  Research Ethics Coordinator The CREB Ethics Review Coordinator is responsible for the review of new minimal risk and full board applications and associated deferral/proviso responses, post-approval activities, and general inquiries.  [email protected]  

Janet Lim,  Research Ethics Coordinator The CREB Ethics Review Coordinator is responsible for the review of new minimal risk and full board applications and associated deferral/proviso responses, post-approval activities, and general inquiries.  [email protected]  

Tahira Tejpar, Research Ethics Coordinator The CREB Ethics Review Coordinator is responsible for the review of new minimal risk and full board applications and associated deferral/proviso responses, post-approval activities, and general inquiries.  [email protected] ​​​​

Svitlana Franchuk,  Administrative Assistant The CREB Administrative Assistant is responsible for handling incoming general inquiries, minimal risk post-approval activities, SAEs, and fee payment.   Svitlana is available on Mondays, Wednesdays and Fridays. [email protected]

UBC CREB Office Room 210, Research Pavilion 828 West 10th Avenue  Google Map   Vancouver, BC V5Z 1M9

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UBC Behavioural Research Ethics Office

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UBC Clinical Research Ethics Office

Room 210, Research Pavilion, 828 West 10th Avenue Vancouver, BC Canada V5Z 1M9

UBC receives support for managing its research enterprise from the federal Research Support Fund .

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Ethics in clinical research, ethical guidelines.

The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. The path to finding out if a new drug or treatment is safe or effective, for example, is to test it on patient volunteers. But by placing some people at risk of harm for the good of others, clinical research has the potential to exploit patient volunteers. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.

The ethical guidelines in place today were primarily a response to past abuses, the most notorious of which in America was an experiment in Tuskegee, Alabama, in which treatment was withheld from 400 African American men with syphilis so that scientists could study the course of the disease. Various ethical guidelines were developed in the 20th century in response to such studies. 

Some of the influential codes of ethics and regulations that guide ethical clinical research include:

• Nuremberg Code (1947)
• Declaration of Helsinki (2000)
• Belmont Report  (1979)
• CIOMS (2002)
• U.S. Common Rule (1991)

Using these sources of guidance and others, seven main principles have been described as guiding 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. Answering certain questions will have significant value for society or for present or future patients with a particular illness. An answer to the research question should be important or valuable 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. Only if society will gain useful knowledge — which requires sharing results, both negative and positive — can exposing human subjects to the risk and burden of research be justified.

A study should be designed in a way that will get an understandable answer to the valuable research question. This includes considering whether the question researchers are asking is answerable, whether the research methods are valid and feasible, and whether the study is designed with a clear scientific objective and using accepted principles, methods, and reliable practices. It is also important that statistical plans be of sufficient power to definitively test the objective, for example, and for data analysis. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

Who does the study need to include, to answer the question it is asking? The primary basis for recruiting and enrolling groups and individuals should be the scientific goals of the study — not vulnerability, privilege, or other factors unrelated to the purposes of the study. Consistent with the scientific purpose, people should be chosen in a way that minimizes risks and enhances benefits to individuals and society. Groups and individuals who accept the risks and burdens of research should be in a position to enjoy its benefits, and those who may benefit should share some of the risks and burdens. Specific groups or individuals (for example, women or children) should not be excluded from the opportunity to participate in research without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a drug, device, or procedure being tested is inherent in clinical research — otherwise there would be little point to doing the research. And by definition, there is more uncertainty about risks and benefits in early-phase research than in later research. Depending on the particulars of a study, research risks might be trivial or serious, might cause transient discomfort or long-term changes. Risks can be physical (death, disability, infection), psychological (depression, anxiety), economic (job loss), or social (for example, discrimination or stigma from participating in a certain trial). Has everything been done to minimize the risks and inconvenience to research subjects, to maximize the potential benefits, and to determine that the potential benefits to individuals and society are proportionate to, or outweigh, the risks? Research volunteers often receive some health services and benefits in the course of participating, yet the purpose of clinical research is not to provide health services.

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it even starts, an independent review panel with no vested interest in the particular study 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 volunteers? Has the trial been ethically designed and is the risk–benefit ratio favorable? In the United States, independent evaluation of research projects is done through granting agencies, local institutional review boards (IRBs), and data and safety monitoring boards. These groups also monitor a study while it is ongoing.

For research to be ethical, most agree that individuals 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.

There are exceptions to the need for informed consent from the individual — for example, in the case of a child, of an adult with severe Alzheimer’s, of an adult unconscious by head trauma, or of someone with limited mental capacity. Ensuring that the individual’s research participation is consistent with his or her values and interests usually entails empowering a proxy decision maker to decide about participation, usually based on what research decision the subject would have made, if doing so were possible.

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 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, untoward events, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study.
• Informing them about what was learned from the research. Most researchers do a good job of monitoring the volunteers’ welfare and making sure they are okay. They are not always so good about distributing the study results. If they don’t tell you, ask

For more information about what makes clinical research, we refer you to:

Ezekiel J. Emanuel, MD, PhD; David Wendler, PhD, and Christine Grady, PhD. " What Makes Clinical Research Ethical? " Journal of the American Medical Association, Vol. 283, No. 20, May 24, 2000, pp. 2701-2711.

Dr. Grady is acting chief of the Bioethics Department and head of the Section on Human Subjects Research. Dr. Wendler heads the Unit on Vulnerable Populations. Dr. Emanuel was chief of the CC Bioethics Department  1996-2011.

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This page last updated on 10/21/2021

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Research Ethics Boards

All human research conducted by members of Island Health, or involving Island Health facilities, patients, residents, clients, staff, physicians, current data holdings or other resources, requires ethical approval as part of the Institutional Approval process.

Research Ethics Boards (REBs) are independent committees authorized to review the ethical acceptability of research and to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants. 

Island Health’s REBs are independent in their decision-making, and they are required to operate free of inappropriate influence, including situations of real, potential or perceived conflict of interest. Island Health may not override REB decisions concerning the ethical acceptability of a study.

There are two REBs providing review services for Island Health in accordance with the Tri-Council Policy Statement (TCPS 2), the International Conference on Harmonization Good Clinical Practice Guidelines (ICH-GCP) and the requirements of the US Department of Health and Human Services, as set out in the Federal Policy for the Protection of Human Subjects, 45CFR Part 46, sub-part A. 

Research taking place in additional locations in British Columbia may be eligible for harmonized ethical review . Applications for multi-jurisdictional research will no longer be accepted in any other format than PREP applications on RISe.

Determine your REB

Submit your ethics application to the appropriate Island Health REB.

The CREB reviews research that involves surgery, clinical interventions (the administration or testing of drugs, medical devices, medical imaging or diagnostic techniques, and the taking of blood or other specimens), and the analysis of clinical data. The CREB will also review clinical studies involving registries and/or the linkage of databases.

New research applications for CREB consideration will generally require review at a full board meeting. The deadlines for full board review are listed below. Please note that all electronic submissions are deemed received when they have been acknowledged by the Research Ethics & Compliance Office as fully complete and ready for review.  

CREB Meetings and Deadlines Fees Federal Wide Assurance (FWA)

The HREB reviews research that is predominantly behavioural or social sciences related. Studies may involve the study of patients or healthcare providers and retrospective chart reviews. Studies also may involve interviews, focus groups, observations, the administration of questionnaires or tests, or retrospective chart review (where no clinical interventions are performed as part of the study). 

Minimal risk studies submitted to the HREB are sent for review as they are received. No meeting dates or deadlines apply. Above minimal risk studies are reviewed at the next scheduled HREB meeting. Researchers will be contacted if this is necessary. The deadlines for full board review are listed below. All electronic submissions are deemed received when they have been acknowledged by the Research Ethics & Compliance office as fully complete and ready for review.  

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Research Ethics Board: Overview of the Health Canada and Public Health Agency of Canada REB

• About the REB
• Apply for ethics review
• Continuing ethics review forms
• Policies, guidelines and resources
• Consent process

Research involving humans can greatly benefit human society, but it must be done in a way that protects and respects the research participants. The Health Canada and Public Health Agency of Canada (PHAC) Research Ethics Board (REB) was created to provide this oversight. It reviews all research from Health Canada and PHAC that involves humans (including living individuals, human biological materials and information from or about humans) to ensure that it meets the highest ethical standards, and that the greatest protection is provided to research participants. Specifically, the Health Canada-PHAC REB reviews all research involving humans that is:

• Carried out by Health Canada or PHAC (intramural);
• Performed by Health Canada or PHAC in collaboration with external researchers;
• Carried out on Health Canada or PHAC premises; or
• Conducted under contract to Health Canada or PHAC.

The REB may also review research that is funded by Health Canada or PHAC through grants and contributions to external researchers who do not have access to another research ethics board.

The Health Canada-PHAC REB does not review research that is not carried out by, funded by, or otherwise undertaken in association with Health Canada or PHAC. Research projects not associated with Health Canada or PHAC should be referred to the REB at the lead investigator's institution and/or the REB at the institution(s) where the research is being conducted.

In addition, the Health Canada-PHAC REB does not oversee or regulate other REBs in Canada. Like other Canadian REBs, the Health Canada-PHAC REB is guided by the principles of the second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). TCPS 2 is the official human research ethics policy of the three federal research funding agencies (the Canadian Institutes of Health Research, the Natural Sciences and Engineering Council of Canada, and the Social Sciences and Humanities Research Council of Canada). The Agencies have mandated the Secretariat on Responsible Conduct of Research (SRCR) and the Panel on Research Ethics (PRE) with the evolution, education and interpretation of the policy. Questions about the interpretation of TCPS 2 should be directed to the SRCR at [email protected] .

Human clinical trials are also subject to Health Canada regulatory requirements. For further information regarding these regulatory requirements, researchers may contact the relevant Health Canada clinical trials office as appropriate.

On this page

Applying for ethics review, maintaining ethics approval, closing a study, annual reports of reb activities.

Researchers must obtain ethics approval in writing from the Health Canada-PHAC REB before the research begins. Research approved by another Canadian REB must also be reviewed by the Health Canada-PHAC REB if it involves researchers from Health Canada or PHAC or if it meets any of the other criteria described above.

Full details on the application process can be found in the Apply for ethics review section of the website. Key elements of the application process include:

• Pre-submission consultation with the Health Canada-PHAC Privacy Management Division for a privacy risk assessment
• PHAC departmental approval (for PHAC researchers only)
• Independent scientific peer reviews of the research protocol
• The application form and all required supporting documents (as described in the application form instructions )

The application deadline for initial REB ethics review is 3 weeks before each monthly REB meeting. If an application is deemed to represent minimal risk to participants, it may be sent at the discretion of the REB chair to delegated review (consisting of the Chair or Deputy Chair and one other REB member) rather than full REB review. Note that the application requirements and review process are the same, regardless of the level of risk. However, because delegated review meetings are held more frequently, minimal risk applications are accepted at any time and may be reviewed more quickly.

Applicants are encouraged to contact the REB Secretariat before submitting their proposal to determine the level of risk associated with the study. The REB Secretariat can also provide advice on whether a study meets the definition of research involving humans and therefore requires REB review.

All research approved by the Health Canada-PHAC REB is subject to continuing ethics review by the REB throughout the life of the project. To maintain a valid ethics certificate, applicants are required to submit annual progress reports to the REB, seek approval for amendments to the research protocol, and report any unanticipated issues or events.

Submissions for continuing ethics review are accepted at any time and are normally reviewed within one to two weeks at a delegated review meeting. Information and forms for continuing ethics review are available on the Research Ethics Board: Continuing ethics review forms web page.

Researchers must notify the REB upon completion or termination of their project by submitting a Completion/termination report form (PDF format, 8 pages). Submissions are accepted at any time and are normally reviewed within one to two weeks.

The REB Secretariat produces an annual report for the Deputy Minister of Health and the President of PHAC, summarizing the activities of the Board and the Secretariat during the fiscal year. The reports include details on the number and profile of submissions, outcome of REB reviews, and approval times.

• 2019-20 Annual Report
• 2020-21 Annual Report
• 2021-22 Annual Report
• 2022-23 Annual Report

Health Canada-PHAC Research Ethics Board Secretariat 70 Colombine Driveway, Room 941C, PL: 0909C Brooke Claxton Building, Tunney's Pasture Ottawa, ON K1A 0K9

Telephone: 613-941-5199 Facsimile: 613-941-9093 Email: [email protected]

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Health research ethics board of alberta approves atma's phase ii psilocybin clinical trial with group and individual therapy settings.

This trial will assess the efficacy of psilocybin-assisted therapy in treating mental healthcare professionals suffering from Major Depressive Disorder, in group and individual dosing sessions, commencing Q3 2024.

CALGARY, AB , May 22, 2024 /PRNewswire/ - ATMA Journey Centers Inc. ("ATMA"), a pioneering Canadian company with a primary focus on advancing innovative psychedelic-assisted therapy solutions, has received approvals for its Phase II Psilocybin-assisted Therapy Clinical Trial from the Health Research Ethics Board of Alberta (HREBA) and Health Canada (No Objection Letter). The primary objective of this trial will be to evaluate the potential of psilocybin-assisted therapy in treating frontline mental healthcare professionals diagnosed with Major Depressive Disorder (MDD), administered in either a group or individual setting.

While a considerable portion of the Canadian population continues to struggle with mental distress stemming from the repercussions of COVID-19, healthcare professionals themselves have faced significant mental hurdles. Indeed, despite the immense physical and psychological burdens imposed by the pandemic – both direct and indirect – many mental healthcare professionals have prioritized the well-being of their patients over their own, resulting in an unaddressed need for mental support; healthcare professionals, like the general population, experience psychological trauma leading to mental health challenges. However, evidence suggests that these challenges are more prevalent among frontline workers due to the nature of their work. From compassion fatigue to vicarious traumatization, these workers often do not use effective coping mechanisms to navigate their depression while continuing their professional duties. Consequently, many have inadvertently normalized chronic depression.

As such, the primary objective of this study is to examine the efficacy of psilocybin-assisted therapy in treating frontline mental healthcare workers diagnosed with MDD. This will be accomplished by comparing the scores on standardized self-assessment questionnaires administered to participants before and after their psilocybin session. The secondary exploratory objective of this study is to investigate the effect psilocybin has on personal and professional characteristics that enhance competency as a mental healthcare worker, as well as participants' self-assessment of their competency and confidence in administering psilocybin-assisted therapy.

Additionally, in collaboration with experts in psychedelic group therapy such as Dr. Mark Atkinson of Human Potential Academy and Dr. Simon Ruffell of Onaya Science, ATMA is exploring a novel protocol for this Phase II trial. This sub-group analysis aims to investigate the potential efficacy of psilocybin-assisted therapy through both group and individual administration frameworks. Based on research exploring the potential benefits of group therapy for addressing depression, ATMA's protocol offers options for either individual sessions or a group setting. The group therapy hypothesis suggests that the group approach may foster social connectedness and well-being by inducing states of communitas and facilitating psychological safety, potentially promoting empathy, cooperation, and aiding in psychological integration and self-regulation. Plans are in motion to prepare for future Phase III trials with a focus on refining the group therapy design. Furthermore, although the primary goal of these trials is not necessarily to improve accessibility to psilocybin, there is a possibility that these trials could enhance affordability and accessibility, possibly alleviating the financial burden on both the healthcare system and participants.

Considering the size and nationwide scope of this trial, ATMA has partnered with KGK Science to ensure successful execution. KGK is an experienced clinical research company specializing in product development. With preparations underway for Canada's largest Phase II clinical trial on psilocybin-assisted therapy, this initiative will encompass three sites nationwide, including the ATMA CENA Psychedelic Therapy Clinics in Calgary, AB and London, ON , along with Qi Integrated Health in Vancouver, BC .

The trial will be open to frontline mental healthcare professionals who have completed an approved psychedelic-assisted therapy training program; this includes the 750+ ATMA alumni and others who have equivalent training and meet the other eligibility requirements.  ATMA believes that training in psychedelic therapy as well as a thorough understanding of psychedelic medicines are crucial for participants in this trial. Such training equips participants with the necessary knowledge and skills to navigate the psychedelic experience safely and effectively. It enables them to understand the potential effects of psilocybin on their mental health and well-being, and how to integrate these experiences into their therapeutic journey, which will provide the field with valuable data in terms of the secondary exploratory objective.

Graduates of ATMA's Advanced Psychedelic Therapy Training Program – predominantly qualified therapists with psychedelic-assisted therapy training and facilitating experience – will be offered the opportunity to contribute to ATMA's Phase II and III clinical trial therapist staffing needs, amounting to up to 6,000 hours. ATMA's training program has equipped hundreds of therapists and healthcare practitioners for this role, offering a valuable chance for those interested in the psychedelic-assisted therapy field to gain more experience in this field as clinical trial staff facilitators and therapists.

CEO Vu Tran emphasizes the potential of the group protocol as a pivotal advancement for the psychedelic therapy industry, not only by enhancing accessibility, but also by validating the effectiveness of group healing practices rooted in non-Western and ancient cultures. He highlights the epidemic of loneliness as a contributing factor to the current mental health crisis and advocates for embracing group healing formats as a means of addressing this challenge.

ABOUT ATMA JOURNEY CENTERS INC.

We care about improving the lives and practices of mental healthcare professionals.

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• Ethics in Clinical Research
• Series: Ask the IRB & IBC Experts

What Is Expedited Review?

Expedited review is more than just expedient review. This review is done by a single IRB Board member (reviewer) instead of a convened board. Research must meet the following criteria to be reviewed through an Expedited Review Procedure:

• All added procedures fall into categories 1 – 7 below. 
• When there is no substantial alteration of the research design (Allterations considered substantial may include a significant increase in enrollment, certain financial disclosures, increased volume of blood draw, or inclusion of a new subject population)
• The addition of a new investigator, research site, or change of investigator to previously approved research.
• Approval of a Previously approved change in research for another research site
• Approval of Translated documents
• Must fit into one of the nine categories described below  as per 45 CFR 46.110 and published as a Notice in the Federal Register.

Categories of research that may be reviewed through an Expedited Review Procedure:

• Exception: any research involving legally marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review and will require review by a convened board
• An investigational device exemption application is not required
• The medical device is cleared/approved for marketing and the device is being used in accordance with the cleared/approved indications.
• Healthy, nonpregnant adults who weigh at least 110 pounds. The amounts drawn from these participants cannot be more than 550 ml in an eight-week period, with no more than two blood collections allowed per week.
• Other adults and children. The amounts drawn from these participants must be less than 50 ml or 3 ml per kg (whichever level is lesser applies) per eight-week period, with not more than two blood collections allowed per week.
• The collection is noninvasive (e.g. urine specimens, saliva samples, fingernail or hair clippings).
• The procedure collecting the data is noninvasive (and cannot require sedation or anesthesia).
• The procedure is routinely employed in clinical practice (cannot involve X-rays, microwaves, or require contrast).
• If a medical device is being used, it is cleared/approved for marketing.
• Research involving materials that have been collected retrospectively or prospectively solely for non-research purposes.
• Collection of data from voice recordings, video recordings, or digital or image recordings made for research purposes.
• Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
• The research is permanently closed to enrollment, or no participants have been enrolled and no additional risks have been identified.
• All participants have completed all the research-related interventions.
• The research remains active only for long term follow up or the remaining research activities are limited to data analysis.
• None of the above categories apply.
• The IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks are identified.

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National information: france (last update: january 2023), short description of recs system.

There are 39 Ethics Committees in France. These Committees of Protection of Persons (Comit�s de Protection des Personnes, CPP) divide up into 7 regions all over the country. There are 5 to 6 CPPs per region (except for the Ile de France region around Paris which has 11 Committees) and they are all competent for the whole region. In addition, each committee has a national competence. According to the law of public health (Code de la sant� publique : Chapitre III ; Articles L1123-1 � L1123-14) the Ethics Committees are responsible for decisions concerning interventional studies, standard of care studies, medical and other health products and further research areas (such as genetics or physiology).

The committee for the protection of individuals is composed of 28 members (14 members and 14 deputies) appointed by order of the director general of the regional health agency and divided into two colleges, as follows: - 1st college: eight persons with qualifications and in-depth experience in research involving the human being, including at least four physicians and two persons qualified by their competence in biostatistics or epidemiology; two physicians specializing in general medicine; two hospital pharmacists and two medical auxiliaries; - 2nd college: two persons qualified by their competence in ethical issues; four persons qualified by their competence in human and social sciences or their experience in the field of social action; four persons qualified by their legal competence and four representatives of associations of patients and users of the health system in accordance with the provisions of article L. 1114-1 of the public health code. Each committee includes among its members a person qualified in data protection. The committees usually plan their meetings 6 to 12 months in advance and make the meetings dates available on their website.

Organisation

The Ethics Committees� competences range from ethical, scientific and methodological considerations (e.g. the protection of trial subjects, the protection of human rights, dignity and wellbeing of persons, benefits and risks ratio, the quality of research facilities, qualification and suitability of investigators, subject information and informed consent and the recruitment procedure).

The Competent Authority (CA) is responsible for the pharmaceutical conformity and quality of drugs, the security and safety of drugs, the security and conformity of methods and practices and the general security of subjects. In addition, the CA takes care of the exchange of information and the transfer of RECs opinions and CA authorizations.

Clinical trial sponsors have to submit their protocols both to the relevant regional Ethics Committee (CPP), and to the competent authority. These submissions are made through a dedicated portal, and the protocols are randomly distributed to the CPP. The authorisation to conduct a trial requires both the Ethics Committee (CPP) approval and the Competent Authority (CA) authorization.

The chair of the Ethics Committee (CPP) designates two rapporteurs, one of each college, and all proposals are reviewed by biostatistician. Each committee reviews 5 or 6 clinical trials forms and about 20 substantial amendments by meeting. Of course, the committee�s opinions must be justified. The sponsors can demand a re-examination of their protocols once. In case of a negative opinion the Ministry of Health may assign a different committee.

National Level

Besides the regional Ethics Committees there is also one National Consultative Ethics Committee (Comit� consultatif national d'�thique, CCNE). France was the first country to create such a Committee. Its intended role is to single out issues arising out of progress in the life sciences and make public statements and recommendations. The issues of medically assisted procreation and experiments on humans were the first to be addressed by the CCNE. But its scope of investigation soon extended to other topics, such as research on human embryos, access to genetic information and the concept of consent. The National Committee (CCNE) has currently 45 members and its chair is appointed by the President of France.

Networking between RECs

The French law (March 5, 2012) has established the National Commission for Research Involving the Human Person (CNRIPH). Composed of 22 members, it ensures the coordination and harmonization of the operation of the CPPs, in particular by means of the recommendations that it draws up. In parallel, 20 years ago, the National Conference of CPPs (CNCPP) has been launched. This association gathers 35 out of the 39 CPPs, assembles its members at an annual meeting and exchanges information through its website. CNRIPH together with CNCPP organize training sessions for committee members, academic sponsors, investigators and patients.

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• J Korean Med Sci
• v.38(25); 2023 Jun 26
• PMC10293659

Ethics Committees: Structure, Roles, and Issues

Pankti mehta.

1 Department of Clinical Immunology and Rheumatology, King George’s Medical University, Lucknow, India.

Olena Zimba

2 Department of Clinical Rheumatology and Immunology, University Hospital in Krakow, Krakow, Poland.

3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.

4 Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.

Armen Yuri Gasparyan

5 Departments of Rheumatology and Research and Development, Dudley Group NHS Foundation Trust (Teaching Trust of the University of Birmingham, UK), Russells Hall Hospital, Dudley, UK.

Birzhan Seiil

6 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

Marlen Yessirkepov

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

Graphical Abstract

INTRODUCTION

The journey of the role of ethics in biomedical research began with “The Doctor’s Trial” post-World War II in which 23 doctors and administrators were tried for war crimes, crimes against humanity, and conducting research without informed consent. This judgment, known as the “Nuremberg Code” was one of the first international ethical standards which gave a ten-point rule with respect to the protection of human research participants. The core principle was the requirement of voluntary consent of human subjects and respecting human autonomy. 1 , 2

However, some researchers continued to ignore the code and violations like the Willow Brook Hepatitis Study (1956), Jewish Chronic Disease Study (1963), and 22 others were highlighted by Beecher in 1966. 3 , 4 This led to the composition of the Declaration of Helsinki by the World Medical Association in Finland in 1964 with revisions at regular intervals. 5 This affirmed the principles highlighted in the Nuremberg Code stating that research should be conducted upholding the interests and rights of the human subjects. It proposed for the first time, the submission of a research protocol to an ethics committee (EC) before the initiation of the study ( Fig. 1 ). 6

EC refers to “Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices.” Committees that consider the ethical dimensions of patient care are Clinical ECs whereas committees established to protect the welfare of research subjects are Research ECs. 7 In this review, we will be using the terms ECs and Research ECs interchangeably.

It was in the 1960s that most nations developed guidelines regarding the formation of ECs with the main task of protection of human subjects. 8 EC is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects. ECs can be of two types—Institutional Review Boards (IRBs) or Institutional ECs (IECs) (referred to IRB or IEC by different countries) that are formally constituted by an institution to review research projects for that institute. An independent EC is an autonomous EC that is not part of any institute and performs the same functions independently. It is helpful for institutes that don’t have an IRB.

Despite these regulations, the unethical standards of the Tuskegee Syphilis study emerged in 1972 in which treatment was denied to the participants in order to study the natural course of the disease. This was followed by the conversion of the National Research Act in the USA into law (1974) and the setting up of the national commission of ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ that submitted the Belmont report in 1979. The Belmont report described the role of assessment of risk-benefit of research involving human subjects, appropriate guidelines for selection of human subjects, and definition of informed consent. It was based on the three pillars of ethics- respect, beneficence, and justice. 9 , 10 It stressed the need for the approval of studies by an EC in accordance with the 1975 revision of the World Medical Association in Tokyo. Subsequently, countries like China, India, and South Korea adopted and legalized the need for submission of protocols to ECs from the 1980s onwards. 11 , 12 , 13 , 14

ECs function on six basic principles 15 :

• 1. Autonomy: respect the patient’s right to act on his/her own value and choice.
• 2. Justice: fair treatment of the research subjects.
• 3. Beneficence: work for the benefit of the patient.
• 4. Nonmaleficence: primum non-nocere or first do no harm to the patient.
• 5. Confidentiality: privacy protection.
• 6. Honesty: truthfulness in terms of the study.

Ethics approval is required for most research studies to uphold the above-mentioned principles, and protect the participants as well as the researcher. 16

In this narrative review, we aim to study the structure and function of ECs or IRBs with a focus on the composition, role, violations, and development perspectives of ECs.

Searches through MEDLINE (PubMed) and Scopus were performed in line with previously published recommendations. 17

Articles published till March 15, 2023 were reviewed using the following keywords: ("Ethics Committees, Clinical/classification"[Mesh] OR "Ethics Committees, Clinical/economics"[Mesh] OR "Ethics Committees, Clinical/ethics"[Mesh] OR "Ethics Committees, Clinical/history"[Mesh] OR "Ethics Committees, Clinical/legislation and jurisprudence"[Mesh] OR "Ethics Committees, Clinical/organization AND administration"[Mesh] OR "Ethics Committees, Clinical/standards"[Mesh] OR "Ethics Committees, Clinical/statistics and numerical data"[Mesh] OR "Ethics Committees, Clinical/trends"[Mesh]). Additional searches about subtopics were also carried out (“Data Safety Monitoring Boards” OR “Independent Data Review Committees”, “Institutional Review Boards” OR “Ethics Committees” and “Problems” OR “Issues”).

Articles in languages other than English, and reviews, conference proceedings, and editorials were excluded. Relevant articles searchable at the Directory of Open Access Journals and references of included articles were also processed for eligibility and inclusion for this narrative review. 18 , 19 , 20 , 21

RESEARCH, SUBMISSION PROCESS, AND EXEMPTIONS

IRB approval is required for most research to protect human rights and assess the scientific soundness of the research. For this, we first need to understand what research is. Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” ( Table 1 ). 8

IRB = Institutional Review Board.

An EC approval is required for studies with more than minimal risk to the subjects where the intention is to publish findings or contribute to the scientific knowledge, studies involving the compilation or analysis of data containing patient identifying information, studies with any risk of physical or mental discomfort to participants or their families, and studies on vulnerable groups. 22 Minimal risk refers to the probability of discomfort posed by the research is not greater than that ordinarily encountered in routine daily life activities of an average healthy individual. 5 , 8 , 22

Thus, even surveys and archived data that contain patient identifying information (name, age, address) and sensitive information (illicit drug use, comorbidities, communicable diseases, e.g., HIV AIDS) need ethical approval to uphold the privacy and anonymity of the participants as well as protection the possibility of psychological discomfort to them. 10 , 23 , 24 , 25

Some studies may be exempted from ethical approval including most educational research, case reports on one to three patients (without any hypothesis testing), those that pose no risk to the participants, involve information freely available in the open domain for the community, analysis of open-source datasets or anonymized datasets obtained from other researchers with due informed consent taken at the time of primary data collection, research evaluating the public health programs or government public schemes. 26 , 27 However, a formal exemption is to be decided by the IRB and not the investigator. 8 , 28

For projects requiring an EC approval, the type of reviews includes expedited and a full board review. Expedited review is for research involving no more than minimal risk to the subjects, minor revisions of an already approved study, and is usually conducted by an experienced person or the chair of the IRB. A full board review on the other hand is for research with greater than minimal risk to the subjects or those involving vulnerable populations. This is reviewed extensively by a full IRB meeting.

The documents usually required for a full ethics review include the name of the applicant with designation, approval of the head of the department, research/trial protocol, ethical issues if any, and plans to address them, written informed consent form (and assent forms) in the language the participant understands, data collection tools, patient information sheet, regulatory clearances (e.g., Drug Controller General of India in India for drug trials), finance and funding details, Insurance, statement of conflicts of interest, information about payment or compensation to the subjects, scientific or departmental review board permission, Curriculum Vitae of the investigators, declaration of interests and any other relevant information. 29 , 30 Waivers of consent may be provided for no more than minimal risk to the subjects when the waiver will not endanger the rights and welfare of the subjects like retrospective studies, secondary analysis of data wherein consent had been taken previously, use of open access databases with anonymized data, and emergency research as seen fit by the EC. 31 , 32 In emergencies like the coronavirus disease 2019 pandemic, waivers may be provided if the patient is incapacitated or in life-threatening situations where there is no time for informed consent. Pandemics like these may even call for common documents for risk disclosure and audio/video/electronic consent. 33 , 34

EC PERSONNEL, THEIR EXPERIENCE, AND DUTIES

ECs have the primary responsibility of reviewing research and its alignment with the Good Clinical Practice (GCP) guidelines. 35 The research design must be scientifically sound and conducted in an ethical way to include human subjects with voluntary informed consent.

The composition of ECs varies depending on the country, center, volume, and nature of the research reviewed. However, there are some basic recommendations laid down by national authorities and GCP. 30

• a) Most countries in Europe, the USA, and South Korea have a requirement of at least five members whereas recommendations in China and India need a minimum of seven members and a maximum of 12–15 members. 14 , 36 , 37 , 38 , 39
• b) At least one member who is autonomous, independent of the institution or trial site. It is mandatory that the chairperson of the EC is not part of the institution where the research is to be conducted.

Others include a member secretary from within the institution and members from the scientific field. The composition should have an adequate gender and age representation with a blend of basic scientists, clinician scientists, one legal expert, one social scientist, one philosopher, and one layperson. Review of research involving vulnerable populations like children, pregnant women, handicapped, prisoners, etc., must involve one member with expertise in dealing with that population. 40 , 41 It is also desirable to have a member or expert advisor for special areas of research who has proficiency in that field.

Responsibilities

The chairperson has the primary responsibility of independent and smooth functioning of the EC, ensuring the participation of all members, seeking Conflict of Interests from all members, and handling complaints against the researchers and EC members. 39 It’s the responsibility of the member secretary to schedule EC meetings, handle documentation, organize an effective review of proposals, define and maintain adherence to standard operating procedures (SOPs), train EC members, and assess the need for expedited reviews/exemption from review. 39 The members of the scientific community have the primary responsibility of reviewing the research protocols and their scientific soundness. The non-scientist member is crucial to safeguard the human subjects and practical issues of the research. 40 , 41 However, studies have shown lesser participation by laypersons as compared to scientific members. A study conducted across 10 academic centers across the USA with 20 IRB meetings recorded noted that 29 community members were present in 17 of those meetings. They were primary reviewers in only two of the 93 submitted protocols due to refusal on grounds of lack of knowledge regarding medical research. Even as secondary and tertiary reviewers, they were less active and were more likely to focus on issues related to confidentiality. However, they played a greater role when they were not designated reviewers. 42

The EC or IRBs function to review and approve research protocols, monitor ongoing research involving human subjects with the aims of continual protection of human volunteers, advancement of research, and protecting the institute from litigation. Its main role is the protection of the human rights, autonomy, confidentiality, and welfare of the research subjects especially vulnerable populations. The GCP recommends the following for duties of the IRB ( Table 2 , Fig. 3 ) 35 :

e.g., An immunosuppressive drug “X” being evaluated for patients with Lupus Nephritis.

IRB = Institutional Review Board, SOC = standard of care, GCP = Good Clinical Practice, MMF = mycophenolate mofetil, CYC = cyclophosphamide, ICU = intensive care unit, SOP = standard operating procedure, RCT = randomized controlled trial.

• • The IRB should obtain and review all the necessary documents for the research/trial within a reasonable time and document its views following standardized operating procedures with clear identification of the dates for approval, modifications, disapproval, or termination of an ongoing trial that was initially approved in writing.
• • Qualification of the investigators should be considered for the proposed research.
• • Reviewing of ongoing research as appropriate to the risks involved (at least once a year).
• • Protocols indicating exemption of prior consent of the subject or their legally acceptable representative (e.g., emergency situations) should be assessed in detail for all the regulatory needs.
• • Review the sum and method of compensatory payment to subjects if required.
• • Functions should be performed as per written SOPs which should comply with the GCP guideline.

Most IRBs conduct meetings regularly (one–two per month depending on the number of protocols) and SOPs are followed as per the national governing authority.

An EC review is a continuous process and is needed before the initiation of research, before the extension of the approval period, prior to modifications to an already approved study, for monitoring of any adverse events, and until all the data collection and analysis is complete. 8 An oversight to the monitoring of trials (usually single center, early phase, less risky) is provided by the IRBs through annual reviews, adverse event monitoring, and reporting of undue events by the principal investigator (PI). However, complex clinical trials and/or multicenter, randomized controlled trials, interventional studies with pre-existing concerns about safety, or study participants who might need additional protection through an additional committee referred to as the Data Safety Monitoring Board (DSMB). 43 , 44

RISKS, BENEFITS, CONFIDENTIALITY, AND PRIVACY ISSUES IN RESEARCH PROTOCOLS

The role of the EC is not only to provide direct protection to human subjects from physical or mental harm but also to weigh the risks and benefits involved in the research. It must be assessed if the study is designed to add to the current scientific knowledge base and help society. 8

The research protocol is the document that includes the research question, aims and objectives, a critical literature review, methodology, and statistical plan. It is pertinent that the IRB reviews the protocol with respect to the clarity and focus of the research question; and whether the study design is suitable to answer the same. This is decided by the chair or a special departmental committee ( Table 2 , Fig. 3 ).

Privacy and confidentiality are a part and parcel of every physician-patient relationship. Needless to say, this must be maintained in a researcher-human subject relationship as well. It helps build trust, curbs participant anxiety, maintains their dignity, and above all their autonomy. 10 The International Committee of Medical Journal Editors recommends that authors must ensure that nonessential information like names, initials hospital record numbers, etc., are omitted during data collection, storage, and publication whenever possible. 45 However, there’s an extent to which this confidentiality can be maintained. Information required for scientific purposes (e.g., clinical photographs) or those with mandated legal reporting may breach participant privacy. This needs to be explained to the participant and recorded in written informed consent ( Table 2 ).

The role of the IRB with respect to privacy and confidentiality is to:

• • Review the consent document and assess the sensitivity of the information, the duration for which it will be held, the usefulness of the information, and the ability to protect it.
• • For multicenter projects, review the measures taken by the research team to maintain the privacy of the research subjects including the number of personnel with access to the information, data storage, and transfer.
• • An ongoing review of the research must include monitoring of confidentiality issues to check for maintenance of the same and the need for a revised privacy protection plan.
• • Educate researchers and IRB members regarding the data privacy and protection process. 46

Review of informed consent by IRBs is especially important in low-middle-income countries. There are various issues related to the lack of understanding of the information provided, maintaining privacy due to interference by family members, and the inability to assess risk and benefit by the research participant. IRBs have an additional responsibility to ensure that studies have minimal/no risk to the participant, the consent forms are clear and simple to understand and ensure the proper process of obtaining informed consent is being followed without undue pressure or coercion to participate in the study. 47

VIOLATIONS OF ETHICS APPROVAL RULES AND REGULATIONS

Violations of IRB approval rules like lack of approval, lack of approval of modifications to the protocol, and lack of informed consent can result in dire aftermaths for the authors. It can result in the withdrawal of the article if it’s still in press, retraction if it’s already published, and even removal if it has legal consequences. The number of papers retracted as searched on the retraction database 48 is steadily increasing by the decade from 474 in the 1990s to 6120 in the 2010s. The most common reason for retraction is plagiarism whereas violation of IRB rules accounts for 4–5% of all retractions. 49 , 50 When consultations for ethical inquiries to the Korean Association of Medical Journal Editor were analyzed, the most common reason was duplicate publications (12 of 80) with issues with IRB approval (5 of 80) and informed consent (6 of 80). 51 Some of the examples of types of studies and their reasons for retractions have been summarized in Table 3 .

Violations can be assessed before the studies are published for those with IRB approval. It is the responsibility of the IRBs to monitor whether ongoing studies are abiding by the ethical regulations and whether the approved protocol is being followed. A study conducted in India by an IRB at a tertiary care hospital in Mumbai monitored 12 clinical trials from 2011–2017. The most common violations were related to informed consent, followed by a lack of understanding of protocol and protocol deviations. This was corrected by re-taking of the informed consent and retraining in GCP by the IRB. 52 A similar study in Uganda done from 2007–2010 with monitoring of 40 research projects also found a similar frequency and reasons for violations. 53

Journal editors routinely check if a statement mentioning whether ethics approval was sought has been mentioned in the manuscript. Depending on the journal and type of article, further details of the EC approval can be sought by the journal editorial board. 54

ISSUES AND ONGOING DEVELOPMENTS

ECs were developed to provide ethical oversight to clinical research. But here are various issues associated with the functioning of IRBs.

• • Composition: Most studies indicate a skewed gender representation in the structure IRBs. Further, the participation of laypersons on the board is minimal. 14 , 42 , 55 , 56 , 57
• • Overburdened IRBs, delays, and operational costs: The IRB reviews have been associated with delays from over 4 to 7 months on average from surveys conducted across the USA. 58 , 59 A delay in biomedical research can translate into more than monetary loss as biomedical research saves lives and a delay in the approvals can result in greater loss of life. 60 An older survey conducted across 63 institutions (with 20 being low volume, 24 intermediate volume, and 19 being high volume centers) in the USA in 2005 reported the median amount spent by academic medical centers on IRB was $750,000/year with an average of $559 per review. The main costs are divided across staff salary, board salary, space, outsourcing of the reviews, travel, supplies, and equipment. 61 Over the years, there is a definite increase in the number of ongoing research projects thus increasing these costs further. Furthermore, documentation of Food and Drug Administration (FDA) warning letters to IRBs was predominantly related to paperwork stressing on documentation of reviews and meetings rather than ethical issues. 62 Increasing paperwork further results in delays and added costs. These deficiencies are more marked in developing nations like India and China dealing with issues like lack of regulation, informal ethics reviews, lack of supervision, and insufficient ethics review capacity. 63 , 64
• • Multi-site projects: With multicenter projects on the rise, a single protocol is often reviewed by multiple IRBs. In a review of 17 articles reported from UK, USA and Europe, which underwent multiple IRB reviews of the same protocol there were discrepancies in the judgment. Five of 26 reported rejection at some and acceptance by some IRBs. However, there were great differences in the protocol revisions, consent, patient information sheets, risk-benefit assessment, and compensation arrangements. 65 Keeping these issues in mind, the Common Rule in the USA was revised in 2017 with IRB approval required only from one center for multisite projects. 66 This may be extrapolated to other nations or consideration of an expedited review at other sites when fully reviewed at one IRB can be considered.
• • Independent EC and IEC: Independent ECs have inherent tissues of limitation of knowledge about the local community and use of these may promote IRB shopping. Whereas, local IRBs can have conflicts of interest as colleagues of investigators may be on the review board. Thus, a central IRB can alleviate some of these concerns by avoiding repetitive reviews, minimizing conflicts, and establishing a centralized adverse event reporting system. 67 , 68 , 69 A central IRB can be formed by experts on a particular subject or by a group of institutes like the National Cancer Institute’s Central IRB and the Biomedical Research Alliance of New York respectively. 70 , 71
• • Scientific expertise of the IRB reviewers: The IRB reviewers may lack the scientific expertise to review sophisticated research projects that may affect the quality of the research. 11 , 14 , 57 , 72 Regular training in research ethics and GCP along with adequate consultations with external experts is needed. This can be done at a national, regional, and international level. First, by identifying core issues and then solutions for them by focused training. 73 Training of EC members is conducted across Central Asia and Eastern Europe under the framework of Forum for Ethics Committees in the Confederation of Independent States and Strategic Initiative for Developing Capacity in Ethical Review program that train members regarding GCP, bioethics, the establishment of an EC, review processes and SOPs, choosing independent consultants, and confidentiality agreements. 74
• • Review of studies involving complementary and integrative medicine (CIM) is a challenge due to the lack of quality evidence to support the basis for their use. Moreover, most international regulatory bodies and research regulations do not address CIM, thus leaving the review process and decision-making to the IRBs. However, it is to be emphasized here studies irrespective of the type (modern or CIM) must be reviewed using the same principles of respect, beneficence, and justice. Well-designed studies on CIM are essential to ascertain the health and safety of patients. 75

DSMB is defined by the FDA, USA as “a group of individuals with pertinent scientific expertise that review research data of an ongoing trial on a regular basis, advises the sponsor/or researcher regarding the continuing safety of research subjects and those yet to be recruited into the research trial, and advises as to the continuing validity and scientific merit of the trial.” 76 It’s an autonomous entity independent of the researchers, sponsors, and the IRB so as to control data sharing and protect the authenticity of the clinical trial from unfavorable impact. 35 It was first developed in the USA in the 1960s as the NIH began sponsoring multicenter trials, the first trial was the Coronary Drug Project which used a DSMB for monitoring. 77 Over time, it became a common practice for the sponsors to have experienced scientific personnel serving on these committees. Although the FDA does not mandate DSMB for all trials, DSMBs are generally recommended for large, multi-site studies evaluating treatments that intend to reduce mortality and morbidity.

DSMBs are usually constituted for:

• • The study outcome is such that a highly encouraging or detrimental result is a possibility in an interim analysis that may require an early termination of the study on ethical grounds.
• • When the safety concerns are high, e.g., invasive therapy is administered.
• • Previous data suggesting serious toxicity with the study treatment.
• • Studies involving vulnerable populations.
• • Studies including subjects at an increased risk of death or serious outcomes.
• • Large, multisite, long-duration studies.

In India, it is recommended by the Indian GCP guidelines that the sponsor may establish a DSMB to assess the progress of the trial, and in 2006 Indian Council of Medical Research (ICMR) mandated a DSMB to review data emerging from research on interventions in the emergency setting. 39 These were updated in 2012 by the ICMR to include all stem cell research involving human subjects. The SOPs for the constitution and responsibilities of the DSMB are laid down by the World Health Organization and are similar across USA, Europe, and South Korea. 78 , 79

DSMBs are constituted by scientific members and are appointed by the funding agency, before the recruitment of the first subject in the trial. It can consist of as few as three members and is typically constituted of clinicians and at least one biostatistician. Others that may be included are medical ethicists, other scientists, etc. The most important requisite is that the members should be independent of the sponsors, investigators IRBs, regulatory authorities, and site or study staff. They should have no conflicts of interest with the sponsors, researchers, or study staff.

The functions of the DSMB are:

• • To uphold participant safety.
• • Ensure credibility and integrity of the trial for future subjects.
• • Ensure the timely conclusion of the study so that the results can be disseminated.
• • Identify protocol violations if any.
• • Identify unexpectedly high dropouts and evaluate for the same.
• • Ensure the validity of the results.

The above functions are carried out by an initial organizational meeting to understand the protocol and safety monitoring plan followed by an early safety review meeting to review early safety information. Continuing periodic reviews to assess safety, efficacy, and the progress of the trial are then carried out with reporting of serious adverse events. 44 A final meeting is to be held at the termination of a study. DSMBs function independently of the IRBS but the PIs must submit DSMB reports or minutes to the IRB.

Dramatic instances in which trials have been stopped prematurely on the recommendation of the DSMB include the withdrawal of rofecoxib and celecoxib in two trials on the prevention of colonic polyps due to increased cardiovascular events. 80 , 81

We have come a long way from the horrific ethical compromises in clinical studies in history to establishing adequate safety for the human subjects participating in clinical research today. The establishment of the IRB or EC has ensured safe study designs and the safety of human subjects right from before the study initiation until its completion. This is further supplanted by additional boards like DSMBs. However, we still need studies assessing the outcomes of the ECs on a global basis and addressing various issues that are still pertinent to the working of the ECs. 82

Disclosures: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.
• Data curation: Mehta P.
• Writing - original draft: Mehta P.
• Writing - review & editing: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.

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Health Research Ethics Board of Alberta Approves ATMA’s Phase II Psilocybin Clinical Trial with Group and Individual Therapy Settings May 22, 2024 ATMA News This trial will assess the efficacy of psilocybin-assisted therapy in treating mental healthcare professionals suffering from Major Depressive Disorder, in group and individual dosing sessions, commencing Q3 2024. CALGARY, May 22, 2024 – ATMA Journey Centers Inc. (“ATMA”), a pioneering Canadian company with a primary focus on advancing innovative psychedelic-assisted therapy solutions, has received approvals for its Phase II Psilocybin-assisted Therapy Clinical Trial from the Health Research Ethics Board of Alberta (HREBA) and Health Canada (No Objection Letter). The primary objective of this trial will be to evaluate the potential of psilocybin-assisted therapy in treating frontline mental healthcare professionals diagnosed with Major Depressive Disorder (MDD), administered in either a group or individual setting. While a considerable portion of the Canadian population continues to struggle with mental distress stemming from the repercussions of COVID-19, healthcare professionals themselves have faced significant mental hurdles. Indeed, despite the immense physical and psychological burdens imposed by the pandemic – both direct and indirect – many mental healthcare professionals have prioritized the well-being of their patients over their own, resulting in an unaddressed need for mental support; healthcare professionals, like the general population, experience psychological trauma leading to mental health challenges. However, evidence suggests that these challenges are more prevalent among frontline workers due to the nature of their work. From compassion fatigue to vicarious traumatization, these workers often do not use effective coping mechanisms to navigate their depression while continuing their professional duties. Consequently, many have inadvertently normalized chronic depression. As such, the primary objective of this study is to examine the efficacy of psilocybin-assisted therapy in treating frontline mental healthcare workers diagnosed with MDD. This will be accomplished by comparing the scores on standardized self-assessment questionnaires administered to participants before and after their psilocybin session. The secondary exploratory objective of this study is to investigate the effect psilocybin has on personal and professional characteristics that enhance competency as a mental healthcare worker, as well as participants’ self-assessment of their competency and confidence in administering psilocybin-assisted therapy. Additionally, in collaboration with experts in psychedelic group therapy such as Dr. Mark Atkinson of Human Potential Academy and Dr. Simon Ruffell of Onaya Science, ATMA is exploring a novel protocol for this Phase II trial. This sub-group analysis aims to investigate the potential efficacy of psilocybin-assisted therapy through both group and individual administration frameworks. Based on research exploring the potential benefits of group therapy for addressing depression, ATMA’s protocol offers options for either individual sessions or a group setting. The group therapy hypothesis suggests that the group approach may foster social connectedness and well-being by inducing states of communitas and facilitating psychological safety, potentially promoting empathy, cooperation, and aiding in psychological integration and self-regulation. Plans are in motion to prepare for future Phase III trials with a focus on refining the group therapy design. Furthermore, although the primary goal of these trials is not necessarily to improve accessibility to psilocybin, there is a possibility that these trials could enhance affordability and accessibility, possibly alleviating the financial burden on both the healthcare system and participants. Considering the size and nationwide scope of this trial, ATMA has partnered with KGK Science to ensure successful execution. KGK is an experienced clinical research company specializing in product development. With preparations underway for Canada’s largest Phase II clinical trial on psilocybin-assisted therapy, this initiative will encompass three sites nationwide, including the ATMA CENA Psychedelic Therapy Clinics in Calgary, AB and London, ON, along with Qi Integrated Health in Vancouver, BC. The trial will be open to frontline mental healthcare professionals who have completed an approved psychedelic-assisted therapy training program; this includes the 750+ ATMA alumni and others who have equivalent training and meet the other eligibility requirements.  ATMA believes that training in psychedelic therapy as well as a thorough understanding of psychedelic medicines are crucial for participants in this trial. Such training equips participants with the necessary knowledge and skills to navigate the psychedelic experience safely and effectively. It enables them to understand the potential effects of psilocybin on their mental health and well-being, and how to integrate these experiences into their therapeutic journey, which will provide the field with valuable data in terms of the secondary exploratory objective. Graduates of ATMA’s Advanced Psychedelic Therapy Training Program – predominantly qualified therapists with psychedelic-assisted therapy training and facilitating experience – will be offered the opportunity to contribute to ATMA’s Phase II and III clinical trial therapist staffing needs, amounting to up to 6,000 hours. ATMA’s training program has equipped hundreds of therapists and healthcare practitioners for this role, offering a valuable chance for those interested in the psychedelic-assisted therapy field to gain more experience in this field as clinical trial staff facilitators and therapists. CEO Vu Tran emphasizes the potential of the group protocol as a pivotal advancement for the psychedelic therapy industry, not only by enhancing accessibility, but also by validating the effectiveness of group healing practices rooted in non-Western and ancient cultures. He highlights the epidemic of loneliness as a contributing factor to the current mental health crisis and advocates for embracing group healing formats as a means of addressing this challenge. ABOUT ATMA JOURNEY CENTERS INC. We care about improving the lives and practices of mental healthcare professionals. ATMA is pioneering a healthcare practitioner-centered business model for the psychedelic industry. By providing education, training, clinical trials leading to IP protocols, support services, and developing a network of clinics, we are building and supporting a vast community of psychedelic practitioners in adopting psychedelic-assisted therapy and thereby improving access for many. More News and Media:

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CALGARY, AB, April 11, 2024 /CNW/ – ATMA Journey Centers Inc. (“ATMA”), a pioneering Canadian company with a primary focus on advancing innovative psychedelic-assisted therapy (PaT)

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Introduction, case report, acknowledgements, conflict of interest statement, ethical approval, consent for publication.

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Isolated systematized nevus Unius Lateris: a case report

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Rima Alhalabi, Youlla Oun, Kinda ALshawa, Isolated systematized nevus Unius Lateris: a case report, Oxford Medical Case Reports , Volume 2024, Issue 5, May 2024, omae046, https://doi.org/10.1093/omcr/omae046

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Nevus unius lateris is a rare congenital cutaneous hamartoma derived from the ectoderm and is considered as a verrucous variant of the epidermal nevus. Although it can affect any body part, it rarely involves the head and neck region. When the nevus becomes widely distributed, it usually associated with systemic involvement known as epidermal nevus syndrome. We report here a case of a 7-year-old male patient with a diagnosis of systematized nevus unius lateris, with bilateral involvement of the head and neck and without associated comorbidities, owing to its rarity.

Verrucous epidermal nevus (VEN) is a common benign, noninflammatory malformation that presents at birth or develops in early childhood. However, its diffused linear distribution known as systematized nevus unius lateris is rare. There have been approximately 200 cases reported in the medical literature [ 1 ]. They present as linear or whorled, skin colored to gray-brown and black verrucous papules, which may coalesce to form plaques that tend to follow the lines of Blaschko and are usually associated with systemic abnormalities [ 1 , 2 ]. We present the case of a 7-year-old male patient diagnosed with an isolated systematized nevus unius lateris. To the best of the authors’ knowledge, this is the first report of such a case in the Syrian dermatologic literature.

A 7-year-old male patient presented to the Dermatology Outpatient Department with asymptomatic hyperpigmented verrucous plaques predominantly covering the left half of the trunk, left upper and lower limbs, but sparing palms and soles ( Fig. 1 ).

Hyperpigmented verrucous plaques on ( A ) left side of anterior trunk, left upper and lower limbs; ( B ) left side of posterior trunk, left upper and lower limbs. ( C,D ) bilateral lesions on face. ( E ) bilateral lesions on neck. ( F,G )Sparsely distributed hairs over some parts of the scalp.

Lesions were also present bilaterally on the face, neck and scalp ( Fig. 1 ).

The described lesions were present at birth and progressively increased in size and thickness with age.

The growth and developmental history were normal and there was no history of seizures, learning or hearing difficulties, altered vision or skeletal abnormalities. There was no family history of similar lesions.

Examination showed multiple pigmented, hyperkeratotic papules and plaques arranged in streaks and whorls over the face, neck and left side of the trunk and extremities. The oral and genital mucosa were found to be normal.

On hair examination, the hairs were thin, hypopigmented, sparse and short over some parts of the scalp, while the rest of the scalp had well-developed terminal hairs ( Fig. 1 ). No systemic abnormality was detected.

Routine investigations, including auditory and ophthalmological examinations, brain MRI and skeletal survey were normal. Histopathological examination of lesional biopsy showed hyperkeratosis, acanthosis, papillomatosis and an increase in basal melanin ( Fig. 2 ).

Histologic findings (H&E, ×100). ( A ) Presence of hyperkeratosis, irregular acanthosis and papillomatosis. ( B ) high basal melanin content.

Based on clinical and histopathological features, a diagnosis of isolated systematized nevus unius lateris was made. The patient did not receive any treatment but was advised to see a doctor when changes ocuur in the skin nevus.

Verrucous epidermal nevus (VEN) is a rare cutaneous hamartoma derived from the embryonic ectoderm, with onset usually appearing at birth but may become more obvious later in life [ 2 , 3 ]. VEN is characterized by skin-coloured to tan verrucous papules and plaques that usually arise on the trunk and limbs and are uncommon over the head and neck region. In rare cases, VEN may affect the face, scalp and lobes [ 1 , 4 ].

VEN can be categorized based on its clinical appearance, either as localized linear leasions that occur along the lines of Blaschko or as systematized leasions when there are more than one linear lesion.

The systematized lesions are further divided into two uncommon forms: ‘Nevus Unius Lateris’ which affects one-half of the body, and ‘Icthyosis Hystrix’ which shows bilateral distribution [ 4 , 5 ]. The prevalence of VEN is approximately 1:1000 [ 1 , 5 ], but the specific variant of nevus unius lateris represents only 0.01% of all VEN cases [ 1 ].

Most cases with extensive distribution are generally associated with systemic involvement, such as neural, ocular and skeletal abnormalities, such cases are called epidermal nevus syndrome or Solomon syndrome [ 2 ]. Less commonly, this entity can manifest as an isolated finding [ 1 ]. Neurological disorders are the most common, which can include mental retardation, seizure, epilepsy and brain tumors. Ophthalmological abnormalities may present as coloboma, epidulbar choristomas and corneal opacities. Kyphoscoliosis, vit D-resistant rickets, growth retardation and auditory disturbances have been described in several cases [ 5 ].

Clinical examination is the gold standard for diagnosis to date, although a skin biopsy may be performed to confirm the diagnosis, rule out other causes of verrucous dermatosis following the lines of blaschko and for research purposes [ 1 , 6 ]. Histological findings may include hyperkeratosis, papillomatosis, acanthosis, increased melanin in the basal layer and rarely epidermolytic hyperkeratosis [ 7 ].

Our patient was evaluated as an isolated extended nevus unius lateris that presented with typical lesions widely distributed on one half of the body (trunk, extremities, neck, face, scalp and lobe of the ear), following the lines of Blaschko. No systemic abnormalities were observed by the examination. Biopsy of the lesions also showed typical findings, as an indicated above, which confirmed the diagnosis.

The main clinical differential diagnosis is the verrucous stage of incontinentia pigmenti, which is an x-linked dominant multisystemic genodermatosis. it presents in the first weeks of life, and Skin lesions progress through four different stages (vesicular, verrucous, hyperpigmented and hypopigmented/atrophic), following the lines of Blaschko. Eosinophilic spongiosis is shown on histology [ 3 ]. Skin lesions in our patient did not precede any vesicular stage and he did not have any systemic involvement.

There is no ideal therapy for VEN, and the treatment is mainly symptomatic for cosmetic purposes [ 7 ]. Several therapies have been reported with variable results, including surgical and non-surgical excision such as topical and oral retinoids, topical corticosteroids, 5-fluorouracil, calcipotriol, podophyllin [ 3 ], cryotherapy [ 9 ] and carbon dioxide laser [ 8 ], which are considered less aggressive methods.

Because there is a possibility of malignant transformation in epidermal nevus, we ask the patient to consult a dermatologist periodically when any changes occur in the cutaneous lesions [ 10 ].

Verrucous epidermal nevus, as an isolated systematized nevus unius lateris, has rarely been described. It is important for clinicians to diagnose these cases because, although it is rarely an isolated finding, most patients with extensive unilateral skin involvement are associated with neural, ocular, skeletal and auditory abnormalities. Therefore, auditory and visual screening tests, computed tomography and skeletal survey should be done at birth and later in life to rule out any associated disorders.

There are no acknowledgments.

No conflicts of interest.

No funding sources for this manuscript.

Approval was obtained from the ethics committee of the Faculty of Medicine at Damascus University.

Written informed consent was obtained from the patient’s parents for publication of this case report and any accompanying images.

Kinda ALshawa.

Narine K , Carrera L . Nevus Unius Lateris: a case report . Cureus 2019 ; 11 : e4481 .

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Kaur L , Mahajan BB , Mahajan M , Dhillon SS . Nevus Unius Lateris with bilateral oral mucosal lesions: an unusual presentation . Indian Dermatol Online J 2021 ; 12 : 302 – 6 .

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Bhat YJ , Hassan I , Sajad P , Yaseen A , Mubashir S , Akhter S . et al.  Evaluation of carbon dioxide laser in the treatment of epidermal nevi . J Cutan Aesthet Surg 2016 ; 9 : 183 – 7 .

Panagiotopoulos A , Chasapi V , Nikolaou V , Stavropoulos PG , Kafouros K , Petridis A . et al.  Assessment of cryotherapy for the treatment of verrucous epidermal naevi . Acta Derm Venereol 2009 ; 89 : 292 – 4 .

Yarak S , Machado TY , Ogawa MM , Almeida ML , Enokihara MM , Porro AM . Squamous cell carcinoma arising in a multiple verrucous epidermal nevus . An Bras Dermatol 2016 ; 91 : 166 – 8 .

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