One recurring discussion that occurs at our full IRB board meetings is what is “more than minimal risk”. According to 45 C.F.R 46.102(i), aka “The Common Rule”, minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” Those of us who work at smaller institutions with protocols of a social-behavioral nature rarely see a study that may need to go to the full board (more than minimal risk). But, when we do it can be challenging for us to define the level of risk. For other institutions, every submission might go to the full board; which makes everything they see more than minimal risk. With the wide range of experiences, research compliance rules regarding levels of risk can at the same time seem very confining and subjective.
It helps to consider the federal definitions above, but it is also important to think “outside the box” to better determine what in a particular study may expose a participant to a risk that might not be apparent. It can be hard to glean in social behavioral research.
Any good IRB reviewer thinks broadly about the stated risks and any possibly hidden risks within the protocol (this thought process should flow to the consent form document and recruitment materials). For research administration professionals, it can be difficult train new IRB reviewers in this kind of vigilance. At the other end of the spectrum, some new reviewers can be hyper-vigilant, afraid to approve anything even within the lowest risk categories. I have encountered IRB reviewers that are paralyzed between Exempt research and Not Human Subjects Research.
In Social-Behavioral, minimal risk research, the risks could be related to:
- where documents are stored
- how much information is revealed during a routine survey or interview
- whether asking a question about how someone is feeling may need a referral for mental health services
- whether a student’s grade will be affected by a decision not be part of their professor’s study
Sometimes open-ended questions are even harder to allow. I once had to review a series of studies where the principal investigator asked one question, “Tell me the story of your life”. In this case, those were always reviewed as expedited, since we never knew what could be revealed.
I find that I tend to review IRB submissions with a “worst case scenario” logic when thinking through the study’s subject population and procedures. Sometimes just asking the PI to explain what they would do if a situation came along they weren’t prepared for and having them write it in the protocol is way of avoiding unforeseen challenges. Sometimes you just have to think of it for them. That is the hardest part.
The questions related to the definition above that are more important are what is “daily life” and what is “routine” to any given participant in this kind of risk level research. As an IRB reviewer goes through their career, they will meet a varying number of novel risks and this will help them compare between their reviews, and make it easier to discern the potential risks. Although most IRB submissions are fairly routine, every once in a while, a brand new challenge will arise. Only after these challenges and their resolutions, will we be able to fully understand levels of risk.