Clinical Researcher—October 2025 (Volume 39, Issue 5)
SPECIAL FEATURE
Muhammad Waseem, MBBS, MS, FAAP, FACEP, FAHA, FSSH, CPI, FACRP
Institutional review boards (IRBs) are federally required committees that evaluate research involving human subjects to safeguard participants’ rights, safety, and well-being. Their oversight guarantees adherence to federal laws, institutional policies, and ethical standards. Before starting any study with human participants, researchers must submit their research plans to the IRB for review and approval. Approval is given only if the IRB concludes that the expected benefits outweigh the potential risks. Conversely, the IRB can deny approval if the study design is flawed in a way that puts participants at risk without a reasonable chance of benefit, either to the participants themselves or to society.
In essence, the IRB serves multiple critical roles:
Ensuring compliance with institutional policies, applicable laws, and established ethical standards;
Conducting both initial and continued reviews of research activities to ensure the ethical treatment of human participants; and
Approving all research involving human subjects before its initiation.
Exploring the History of IRBs
In the United States, the Tuskegee Syphilis Study was a research project conducted by the Public Health Service and the Centers for Disease Control and Prevention from 1932 to 1972. In this study, Black men with syphilis were observed to understand the disease’s natural progression. However, after penicillin was identified as an effective treatment, it was deliberately withheld from participants to continue the research. The unethical nature of this study caused widespread outrage and led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. This Commission developed the Belmont Report, a key ethical guideline for research involving human subjects. This federal document outlined core principles—respect for persons, beneficence, and justice—that guide IRB oversight and the protection of research participants.
Understanding the IRB Composition and Structure
An IRB must have at least five members from diverse professional and personal backgrounds. Each member reviews the scientific validity and ethical aspects of research proposals. Federal regulations require the IRB to include at least one member with a scientific or medical background, one without such background, and one individual who acts as a community representative and is unaffiliated with the institution (see Table 1).
Joining an IRB as a clinical researcher is a valuable way to contribute to the ethical oversight of research involving human subjects. This review provides practical and strategic advice for clinical researchers who want to volunteer, helping them navigate the IRB process.
Table 1: Function and Structure of IRBs
| Regulation | Requirement |
| Membership | At least five members with diverse backgrounds, representing both sexes and more than one professional discipline.
The board must include at least one scientific member, one nonscientific member, and one member who is not affiliated with the institution. Members must possess sufficient qualifications, including diverse experience and expertise, to protect the rights and welfare of research subjects and assess the research’s appropriateness with respect to applicable laws, regulations, institutional policies, and professional standards. At least one member must have specific knowledge about any vulnerable population regularly involved in the research. |
| ——————————————————- | ——————————————————- |
| Function | Follow written procedures for conducting initial and continuing reviews and for reviewing any proposed changes or amendments to the research.
Maintain written procedures for reporting unanticipated problems, potential risks, and instances of noncompliance. A majority of IRB members must be present to constitute a quorum at convened meetings, and research approval requires a majority vote from those in attendance. |
| ——————————————————- | ——————————————————- |
| Review | The IRB has the authority to approve research, require modifications as a condition of approval, or disapprove the research altogether.
It may require informed consent and its documentation, or a waiver may be approved when appropriate. Investigators must be notified in writing of the IRB’s decisions. |
| ——————————————————- | ——————————————————- |
| Criteria for Approval | The IRB must ensure that risks are minimized and that any anticipated benefits and the value of the expected knowledge are reasonable.
Subject selection should be equitable, with consideration given to vulnerable populations. Informed consent must be obtained and documented appropriately. Adequate plans for monitoring the research and protecting participant confidentiality should be established, along with additional safeguards for individuals vulnerable to coercion or undue influence. |
| ——————————————————- | ——————————————————- |
| Authority | Institutional officials may not approve any research disapproved by the IRB.
The IRB has the authority to suspend or terminate research if it involves serious harm to participants or instances of noncompliance. |
——————————————————- ——————————————————-
Adapted from Grady C. 2015. Institutional Review Boards: Purpose and Challenges. Chest 148(5):1148–55. doi:10.1378/chest.15-0706
How to Make Yourself a Good Candidate for IRB Membership
To improve your chances of becoming a strong candidate for an IRB member role, you should demonstrate ethical awareness, subject matter expertise, dedication to human subjects’ protection, and a willingness to participate in thoughtful review processes. The following sections provide some strategies to help you stand out as a compelling candidate.
Evaluate Your Clinical Research Expertise
Before applying to join an IRB, ensure you are familiar with:
- The regulatory framework (e.g., the Common Rule, applicable U.S. Food and Drug Administration regulations, 45 CFR 46 of the Code of Federal Regulations).
- The core ethical principles from the Belmont Report: Respect for Persons, Beneficence, and Justice.
- The IRB’s primary charge: protecting the rights and welfare of human research participants.
Develop Relevant Expertise
- Scientific or Clinical Expertise: If you’re a researcher or clinician, emphasize experience in research design, methodology, and understanding of risk/benefit analysis.
- Vulnerable Populations: Experience working with children, prisoners, pregnant women, or underserved groups is highly valuable.
Demonstrate Ethical Judgment and Impartiality
- Show you can balance scientific value with subject protection.
- Highlight roles where you exercised objective decision-making and evaluated risks or ethical concerns.
Highlight Research or Regulatory Experience
- Mention any experience with clinical trials, consent processes, IRB submissions, or protocol development.
Show Commitment to Diversity and Inclusion
- Emphasize your ability to evaluate equitable subject selection, consider cultural contexts, and advocate for fair treatment of vulnerable populations.
Reach Out to the IRB Office
- E-mail or call the IRB office at your institution to express your interest in volunteering as a member.
- Offer your CV and describe your relevant expertise.
- Ask about open positions and institutional requirements (e.g., conflict of interest disclosures, term lengths).
- If your institution lacks openings, ask to serve as an alternate or ad hoc reviewer.
- You may also explore opportunities with regional IRBs or those affiliated with independent research organizations.
Highlight Your Unique Perspective
Most IRBs seek diverse representation, including:
- Clinicians with frontline insights into the standard of care.
- Experts in research with underserved or vulnerable populations.
- Individuals who can bridge research, clinical care, and community values.
Your perspective is especially valuable if you:
- Work in emergency care, pediatrics, critical care, or community health.
- Have experience with disparities, equity, and inclusion in research.
Be Prepared to Learn and Adapt
Even seasoned researchers will find IRB work intellectually challenging:
- Protocols span many disciplines and methodologies.
- You’ll need to separate your researcher mindset from the reviewer mindset—focusing on ethics, not just feasibility.
Be open to:
- Mentorship from senior IRB members.
- Continuing education in ethics, law, and policy.
Ask yourself the following:
- Can I offer a balanced review that supports research advancement and participant protection?
- Do I have the time and interest to contribute consistently?
Remember that clinical researchers are highly valuable to IRBs because they:
- Understand study design, risk-benefit assessment, and informed consent.
- Can provide critical insight into real-world feasibility and safety issues.
- Help translate complex scientific ideas into ethical considerations.
Seeking Training in Human Research Protections
While IRBs usually offer onboarding, getting training before applying demonstrates initiative. Some valuable sources include:
- The CITI Program (Collaborative Institutional Training Initiative), which is widely used for certification in research involving human subjects.
- The National Institutes of Health (NIH) and Office for Human Research Protections (OHRP) (a part of the U.S. Department of Health and Human Services) offer online training modules.
Level of IRB Review
According to federal regulations and OHRP guidelines, IRB reviews are grouped into three categories: exempt, expedited, and full board review. The level of risk to research participants determines the review category. While the IRB makes the final decision on the appropriate review level for each study, reviewers benefit from a clear understanding of these categories when evaluating the protocols.
Exempt Review
Research projects that qualify for exempt review only need initial approval from the IRB to determine exemption status and do not require ongoing oversight. However, they are still subject to IRB assessment. According to federal guidelines, exempt research must involve no more than minimal risk—defined as the level of risk encountered in everyday life—and must fall within one of the specific exemption categories outlined in the regulations.
Exempt review may include retrospective studies that use data initially collected for non-research purposes. In these cases, obtaining informed consent is often impractical. The main risk involves potential breaches of patient confidentiality; therefore, data should be deidentified after collection. Exempt studies do not require an annual IRB review. Importantly, the IRB must determine the exempt status, not the investigators.
Expedited Review
This applies to research involving no more than minimal risk and prospective data collection. Informed consent is usually required, unless a waiver is granted, which happens only under specific and limited circumstances.
An expedited review allows a designated IRB member to evaluate and approve the research. There are nine specific categories of research, defined by federal regulations, that qualify for this type of review. The full IRB must review any research that does not fall into one of these categories.
Full Board Review
A full IRB review is required for any research that poses more than minimal risk to participants and is often necessary for studies involving vulnerable populations. Examples of procedures considered greater than minimal risk include the use of investigational drugs, invasive tissue sample collection, or the administration of general anesthesia or sedation. Vulnerable groups include pregnant women, fetuses, neonates, children, and prisoners. These studies must undergo annual reviews to assess progress, monitor adverse events, and evaluate the ongoing feasibility and ethical justification. A fully convened IRB quorum must conduct this review and follow a formal process following specific federal regulations.
Regulatory Updates
Single IRB Mandate
The FDA is aligning its guidance to promote the use of a single IRB for multicenter studies, which marks a significant shift for site networks with multiple locations. This change aims to streamline the ethical review process by appointing a single IRB to oversee studies across various sites. The updated guidance cuts down on redundancy, makes compliance easier for sponsors, contract research organizations, and research sites, and standardizes regulatory requirements. It will also improve coordination and efficiency among site networks operating at multiple locations.
Limited IRB Review
For certain exempt research (particularly that involving identifiable data), only limited IRB review is now necessary to safeguard privacy and confidentiality.
Challenges for IRB Members
Serving as an IRB member is a significant yet challenging role, involving various ethical, regulatory, and practical challenges.
Balancing Risks and Benefits
Assessing whether risks to participants are appropriate compared to potential benefits can be challenging, especially in early-stage research or with new interventions. Risk evaluation may become even more difficult when dealing with vulnerable populations or when long-term risks are unknown.
Ensuring Informed Consent is Truly Informed
Assessing consent forms to make sure they are clear, detailed, and non-coercive involves paying attention to literacy, language, and cultural context. It can also be difficult to ensure participants fully understand their rights and risks, especially in stressful situations or emergencies.
Protecting Vulnerable Populations
Extra safeguards are necessary when reviewing protocols involving children, prisoners, pregnant women, the cognitively impaired, and disadvantaged groups. Balancing access to research opportunities with protection from exploitation requires careful ethical consideration.
Staying Current with Regulations
The regulatory landscape is changing (e.g., Revised Common Rule, single IRB requirements, data privacy laws). IRB members must regularly update their knowledge of federal regulations, institutional policies, and new ethical issues (e.g., artificial intelligence in research, genomic data, digital health tools).
Managing Conflicts of Interest
Members must identify and disclose potential personal, professional, or financial conflicts and step back when necessary, recognizing that subtle or indirect conflicts can be challenging.
Time and Workload Demands
Reviewing complex protocols demands careful attention to detail, often within tight deadlines. Managing IRB service alongside clinical, academic, or administrative duties can be overwhelming.
Navigating Institutional Pressures
There may be implicit or explicit pressure to approve research to boost institutional prestige or secure funding. IRB members must stay independent and uphold integrity, sometimes making unpopular decisions to protect participants’ welfare.
Bottom Line
All studies involving human subjects must first undergo an IRB review and obtain approval before data collection begins. It is important to understand that researchers and IRB members share a common goal: to advance scientific knowledge and improve patient care while protecting participants and ensuring ethical treatment. Serving on an IRB is not only a professional honor—it is also chance to uphold research integrity and human dignity. It can enhance your understanding of research ethics and develop you into a more thoughtful clinical research professional.
Sidebar: Checklist for an IRB Review
Protocol Title: Does the title accurately represent the study question?
Objectives: Does the study address a clinically meaningful question?
Background: Is the scientific rationale for the study established?
Is the study objective clearly defined and ethically justified?
Does the research site have access to eligible subjects and adequate study resources?
How was the sample size determined?
Are statistical methods appropriate?
Are the risks to subjects excessive?
Are there any potential benefits of subjects?
What are the plans to protect the privacy interests of subjects?
How will data confidentiality be maintained?
Do all research participants receive the standard of medical care?
Is compensation available for research-related injuries, and how is it provided?
Is there any cost to the subjects?
What is the consent process?
How will subjects from vulnerable populations be protected?
How will the results of the subjects be shared?
More Resources
Ansert E, Cates NK, Crisologo A, Kim PJ. 2024. Navigating Institutional Review Boards. Clin Podiatr Med Surg 41(2):239–46.
Dutka P, Astroth KS. 2022. Navigating the Institutional Review Board Process. Nephrol Nurs J 49(1):67–71.
Muhammad Waseem, MBBS, MS, FAAP, FACEP, FAHA, FSSH, CPI, FACRP, is a Professor of Emergency Medicine and Pediatrics at Weill Cornell Medicine in New York and an Attending Physician and Research Director for Emergency Medicine at Lincoln Medical & Mental Health Center, where he is also Vice Chair of the Institutional Review Board. Among other organizations, he is active with the Society for Simulation in Healthcare, Public Responsibility in Medicine and Research, the American College of Emergency Physicians, the American Academy of Pediatrics, and the American Heart Association.
