I am beginning a new thread here to avoid threadjacking the other conversation going on about the relationship between COI and IRBs.
How far do we let IRBs go before we actively resist? If the IRB decided they needed to see my medical records, should I just give it to them?
IRBs were initially designed to manage risk related medical research. Now they try to govern social science research as well (which is ok in my view). But they also find it fit to judge whether something is real science, whether people can be paid by researchers, and all sorts of other activities. …. The institution of the IRB has grown enormously in ways that were not anticipated by anyone.
Here’s my view: the IRB system has grown way beyond its proper role, to the point that it routinely and actively exercises prior restraint over appropriate, legitimate research for which responsibility should be borne and accepted by the investigator. This is largely because IRB members and administrators tend to think extremely expansively about the concepts of “risk” and “harm.” I have faced major delays with the IRB here at UNC over the years because they thought that people who wrote letters to the editor with the intent to publish could face embarrassment if their words were disclosed; and, more recently, because survey respondents might be embarrassed if their opinions about sensitive topics (e.g., abstinence-only sex education and same-sex marriage) were to get out. My response on the latter: if they’re embarrassed about their opinions they should consider adopting new ones! I do not think that making people feel sad or uncomfortable ought to constitute a risk of harm.
Analytically, I think the likely explanation for this expansion is institutional isomorphism: generations of academics are trained to think about harm to subjects as the third rail of scientific work. Universities engage a CYA strategy to manage perceived legal risks, which gives rise to a growing bureaucracy and field of IRBs. I think it’s extremely likely that the COI process will expand similarly.
AAUP’s position on this is, in my view, appropriate:
we recommend that research whose methodology consists entirely of collecting data by surveys, conducting interviews, or observing behavior in public places be exempt from the requirement of IRB review.
Note that this means excused from review, not just covered under an exemption that the IRB or its staff must grant!
It’s important to recognize that excusing research from IRB oversight would not imply that human subjects may be harmed. Rather, low-risk research should be conducted ethically on the part of the investigator, and investigators should be liable for unethical behavior and subject to sanctions when they commit it. But as in the regulation of speech, prior restraint should be reserved for those cases where the potential harm would be grave and irreversible.