• Compliance
  • Insights
  • Higher Ed

Comply With Federal Rules on Human Subject Research

Alyssa Keehan, Esq.
October 2020
What is required to comply with federally mandated Institutional Review Board protocols

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, do not present conflicts of interest, and properly obtain consent from research subjects. Note that because of their complex research programs, most large research universities have well-developed IRB protocols but many smaller institutions don’t.

What Must IRBs Include?

Federal regulations stipulate how IRBs should be comprised and operate when it comes to 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 use three levels of review:

  1. Full review is compulsory for research posing more than minimal risk to human participants, such as studies that involve invasive medical procedures, vulnerable populations, or sensitive topics such as depression or substance abuse.
  2. Expedited review is permissible for research posing minimal risk to participants, such as surveys or interviews to study behavior or collect data.
  3. 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

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