One of the IRB’s responsibilities in its research reviews is to assess a proposal’s risks and benefits. For each study, the IRB is to determine that risks to participants are minimized by using procedures consistent with sound research design, and risks to participants are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result. (Criteria for approval, 45 CFR 46.111)
How should the board go about determining a project’s risk level? We recommend starting by reading UAMS IRB Policy 16.1, which discusses some considerations related to risks.
The definition of “minimal risk” merits some special attention and discussion. A risk is minimal where the probability and magnitude of harm or discomfort in the proposed research are not greater than those ordinarily encountered in daily life, or in the performance of routine physical or psychological exams or tests. Federal regulations define minimal risk at 45 CFR 46.102; they do not, however, provide a definition for “greater than minimal risk.”
The probability and magnitude of harm or discomfort in daily life can vary depending on a person’s perceptions. For example, the drive along I-40 between Little Rock and Memphis can be considered daily life. For some people, that drive is the equivalent of taking your life in your hands. For others, it’s old hat. It’s a daily life risk — but do we want to put research subjects in the path of that magnitude and probability of risk? Do the potential benefits equal or outweigh those risks? That is the sort of discussion that benefits from the diversity of experiences and opinions among IRB members.
Remember that IRB votes do not have to be unanimous. Reasonable people can disagree on the degrees of risk associated with research. But the risk level of research merits careful consideration and discussion, so the IRB can assure the requirements for approval are met and that the study materials adequately describe potential risks.
Children are considered a vulnerable population, and the regulations address risk levels and determinations differently for research involving minors. We’ll discuss those determinations in a future blog item.