Comply With Federal Rules on Human Subject Research
If your institution conducts human subject research, ensure it has Institutional Review Boards (IRBs) with well-developed protocols. Federal law mandates that IRBs pre-approve research on humans. Failing to comply with IRB protocols betrays public trust and can result in negative publicity and federal disciplinary action — such as suspension of government-funded human subject research — that could damage future research efforts.
IRBs review research proposals to ensure they meet safety standards, don’t present conflicts of interest, and properly obtain consent from research subjects. Because of their complex research programs, most large research universities have well-developed IRB protocols, but some smaller institutions don’t.
What Must IRBs Include?
Federal regulations, which apply to projects sponsored by multiple federal agencies, stipulate how to comprise and operate IRBs for research on humans — which includes everything from medical research to surveys and interviews. Each IRB must:
- Have at least five members, including one person unaffiliated with the institution.
- Be diverse in race, gender, and cultural background.
- Include at least one scientist and one non-scientist.
The IRB determines whether investigators will minimize risks to participants and fully inform subjects of the study’s potential risks and benefits. In addition, investigators must establish steps to manage unanticipated problems and accurately report income sources and professional affiliations that could pose a conflict of interest.
Levels of IRB Review
IRBs have three possible levels of review:
- Full review is compulsory for research posing more than minimal risk to human participants, such as studies involving invasive medical procedures, vulnerable populations, or sensitive topics such as depression or substance abuse.
- Expedited review is permissible for research posing minimal risk to participants, such as surveys or interviews to study behavior or collect data.
- Exemptions allow for a brief review. This might include educational tests, surveys, or interviews that collect information but don’t identify participants. The Revised Common Rule, which took effect in January 2019, broadened the types of research available for exemptions. For details, see the Office for Human Protections Q&A.
Model Procedures
As you review your own process, examine sound IRB procedures from other institutions. For example, Middlebury College and the University of Richmond use a preliminary review process in which an IRB member determines the appropriate level of review for all human subject research proposals. In contrast, larger institutions such as Cornell University and American University require investigators to decide whether to request a full review, expedited review, or an exemption, and a full IRB determines whether the requested level is appropriate.
Additional Resources
Office for Human Research Protections (OHRP): Educational Resources for IRB Members
About the Author
-
Alyssa Keehan, Esq., CPCU, ARM
Director of Risk Management Research & Consulting
Alyssa oversees the development of UE’s risk management content and consulting initiatives, ensuring reliable and trustworthy guidance for our members. Her areas of expertise include campus sexual misconduct, Title IX, threat assessment, campus security, contracts, and risk transfer. She previously handled UE liability claims and held positions in the fields of education and insurance.