Confessions of an Undocumented Human Subjects Researcher

I confess.  Like Jimmy Carter, I have lusted in my heart, and like most law professors, I have engaged in unprotected human subjects research (HSR).  Just last week, for instance, I called a lawyer and an insurance executive to get their views on a legal issue I was researching, and I might cite them in the article I’m writing.  Later, I wondered whether I should have had IRB permission first to do that. 

I expect that a good portion of this forum on IRBs will address overregulation, but I doubt we’ll be able to do much about that in the short term, so I would like to kick off a second line of discussion this week: practical tips for coping with IRB oversight.  To focus discussion, note that there are two regulatory thresholds: 1) is an activity non-exempt human subjects research (HSR) to begin with; and 2) if so, does it pose more than minimal risk?  This post focuses on the first of these two thresholds. 

As summarized in the IRB FAQs that Ron Wright and I posted several weeks ago, there are several bases to claim that interaction with, or data about, living humans in the course of legal scholarship is not a covered activity (not identifiable, not systematic, not private, etc.).  Naturally, those concepts have room for interpretation.  The hitch is that institutions expect researchers to notify the IRB so it can have the final say on whether the exclusionary concepts apply. But, that quickly leads to innumerable absurdities.  Every hour of every working day, I do things that are not HSR.  Which of those things do I need to tell the IRB about, simply to confirm they aren’t non-exempt HSR?  Do we also need to define a grey zone threshold for when an activity MIGHT be interpreted as covered HSR by an IRB?

Not necessarily.  I believe this threshold decision is one that researchers should be able to make on their own in good faith, albeit at their own risk of being wrong.  If I’m not seeking external funding, and I’m not publishing the research in journals that routinely deal with HSR, then it’s not likely that anyone will require me to verify the absence of HSR.  And, if in fact I haven’t done any HSR, then have I done anything wrong by not clearing the activity first with the IRB?   If not, then maybe I only need to seek IRB approval if I’m not sure about the activity being HSR, OR if I anticipate having to verify to an outsider (journal or funding agency) that it isn’t covered HSR.  Am I wrong about this?  How much trouble could I or the institution get into for doing things that aren’t covered HSR without seeking IRB approval first?

Addendum:  Jack Katz’s related post refers to an excellent paper of his (available soon here, and in press at the American Ethnologist), that develops two key points in detail:  1) IRBs are not required to review research that is not federally funded.  Although most Universities require this, some prominent ones are starting to step back from that.  2) Some types of research involving humans are not sufficiently “systematic” to meet the Common Rule’s threshold definition.  It’s a really good paper; you should read it. 

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