Edward Abbey quipped that “No tyranny is so irksome as petty tyranny.” But, rather than fighting or railing against the system, my final post this week invites discussion on coping with IRBs. My prior post, and Jack Katz’s, talked about claiming exemption and when it’s safe to not even file. This post focuses on the “minimal risk” threshold. Below it, protocols may qualify for expedited review and waiver of formal consent, but beware ye who pass above it.
Richard Campbell, member of a now-defunct advisory committee, offers this excellent analysis: the Common Rule defines minimal risk as “not greater than those ordinarily encountered in daily life.” This should mean the sort and magnitude one encounters working, shopping, driving, or having a doctor’s check-up, which includes temporary or low-grade harms such as stress, anger, embarrassment, stubbed toes, paper cuts, etc. Campbell notes that risk of even disastrous harm meets the “everyday” standard if it’s fairly rare, such as an auto accident.
Building on the transportation example, Bill Ford articulated the absurdities of regulating car driving risks as we do research risks. It’s easy enough to point out differences between the two that justify regulating one but not the other. But the key point is to match the type of regulation with the degree of risk. Ford’s absurd example of filing route plans before driving is in fact how general aviation is regulated by the FAA (more or less) - which makes sense for its degree of risk. Similarly, the Common Rule, as written, could limit and modulate IRB oversight appropriately - if only IRB administrators could be convinced. In response to Ron Wright, perhaps that’s what law professors should be trying to do.