Should an institution consider a proposal’s scientific or scholarly validity when reviewing research? Yes, according to the Association for the Accreditation of Human Research Protection Programs (AAHRPP). You may recall a) AAHRPP is the organization that accredits us and b) we are in the throes of a reaccreditation process right now.
Specifically, AAHRPP expects us to have, and follow, “written policies and procedures for reviewing the scientific or scholarly validity of a proposed research study.” This review is to be “coordinated with the ethics review process.”
Two of the IRB’s criteria for approval specifically mention scientific or scholarly validity:
- Risks to participants are minimized by using procedures consistent with sound research design and that do not unnecessarily expose participants to risk [45CFR46.111(a)(1)]
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants and the importance of the knowledge that may reasonably be expected to result. [45CFR46.111(a)(2)]
AAHRPP advises that the organization can use several different mechanisms to evaluate scientific or scholarly validity, including funding agency reviews, or reviews by organizational scientific review committees. The Cancer Institute’s Protocol Review and Monitoring Committee is an example of the latter at UAMS. The IRB may also draw on its own knowledge and expertise in this assessment. When considering scientific and scholarly merit, the IRB should keep in mind the risks of the proposal. More flexibility may be appropriate in the consideration of a very low-risk study than in one involving higher risks. For example, some of the projects we see in the office involve retrospective chart reviews looking at the merits of a particular clinical procedure that’s already in use. We figure we already know that the procedure works, because otherwise we wouldn’t be using it. However, given the very low-risk nature of a retrospective chart review, we can determine that these risks are in line with the knowledge that may result and approve the research as is. But if an investigator is proposing a potentially risky intervention to illustrate that something we’re already doing routinely is indeed effective, the IRB may require some changes before it will approve the study.