Coping with the “Petty Tyranny” of IRBs

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. 

Comments

[Work From Home]

Coping with the “Petty Tyranny” of IRBs-Nice post.Good job done.

[Acai Optimum]

very informational... educative as well, i read and felt like reading over and over again....good job!

[Acai Berry Optimum]

I enjoyed reading this post. Thanks for a wonderful job!

[Acai Optimum]

Wonderful post. Please continue your good work!

[William Ford]

As a clarification, like the regulation of air travel and flight plans by the FAA, the example I used of regulating the transportation of certain hazardous materials over public roads is real. The Federal Motor Carrier Safety Administration actually does this. Route plans are even required, though I don’t know if you actually need to file these plans with the FMCSA. I was not suggesting this regulatory activity is absurd. I don’t know much about the details, but it makes intuitive sense to closely regulate shipments of highly toxic materials because the risks are so great.

See, e.g., 49 C.F.R. 397.101(d) (2006) (“A carrier . . . who operates a motor vehicle which contains a package of highway route controlled quantity of Class 7 (radioactive) materials . . . shall prepared [sic] a written route plan and supply a copy before departure to the motor vehicle driver and a copy to the shipper . . . . Any variation between the route plan and routes actually used, and the reason for it, shall be reported in an amendment to the route plan delivered to the shipper as soon as practicable but within 30 days following the deviation.”).

My tongue-in-cheek example is simply meant to suggest we reach the point of absurdity when, as Mark suggests, we stop sensibly “match[ing] the type of regulation with the degree of risk.” The FMCSA would be more IRB-like if we needed to file paperwork with it before driving home from the store with a bottle of drano. Driving with a bottle or two of drano would of course be “exempt,” but you would still need to fill out some forms.