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    June 2019

    Research on Human Subjects: Is Your Institution Complying With Federal Rules?

    Federal law mandates that Institutional Review Boards (IRBs) pre-approve research on humans. Because of their complex research programs, most large research universities have well-developed IRB protocols, but many smaller institutions do not. IRBs review research proposals to ensure they meet safety standards, do not present conflicts of interest, and properly obtain consent from research subjects. Federal agencies have suspended government-funded human subject research at institutions that failed to follow IRB protocols.


    Background

    Federal regulations define research on humans broadly to encompass everything from medical research to surveys and interviews. A researcher, often called an “investigator,” can be a faculty or staff member or a student. Federal regulations stipulate how IRBs should be comprised and operate. Each IRB must:

    • have at least five members, including one individual who is not affiliated with the institution
    • be diverse in race, gender, and cultural background
    • include at least one scientist and one nonscientist

    It is the job of the IRB to determine 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. 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. Expedited review is permissible for research posing minimal risk to participants, such as surveys or interviews to study behavior or collect data. The third level of review, exemptions, allows for a very brief review. Exemptions are allowed for educational tests, surveys, or interviews that collect information but do not identify the participants. The Revised Common Rule, which went into effect January 21, 2019, broadened the types of research available for exemptions. For details, see the Office for Human Protections Q&A.


    Model Procedures

    Many institutions have established sound IRB procedures that can serve as models. For example, some smaller institutions such as 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.


    Conclusion

    Human subject research is a sensitive area. Institutions should comply with federal IRB protocols to ensure public trust. Failure to do so can result in negative publicity and federal disciplinary action that could damage future research efforts.


    Additional Resources

    Cornell University's Frequently Asked Questions about IRBs

    Office for Human Research Protections: Educational Resources for IRB Members

    Office for Human Research Protections: Human Subject Regulations Decision Charts


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