Years back, conversing with a now long-retired dean, I happened to let slip the words “common sense.” He replied, “It’s been a long time since I heard that phrase uttered on this campus, much less seen it practiced.”

He had a point. Nonetheless, when in later years I was in charge of the university’s Institutional Review Board, overseeing inter alia our researchers’ ethical treatment of human subjects, I urged a light touch tempered by common sense. (I’m a management researcher who groks that subjects are unlikely to be traumatized by being asked what brand of corn flakes they like.)

This was an upstream paddle, as the IRB members gravitated toward the paternalistic and intrusive. They were buttinskys, no two ways about it. I still disagree with them, but I came to appreciate new complexities.

A New York Times article offered one such.  The piece is about former Northwestern U. psychology department chair (and our fellow Scientific Blogger) J. Michael Bailey and the nationwide academic war spurred by his 2003 book describing an alternate theory of transgender motivation.

The book presented the alternative theory “in part by telling the stories of several transgender women he met through a mutual acquaintance.”  Controversy exploded immediately (and continues here). The then-director of the Kinsey Institute said to Bailey, “Michael, I have read your book, and I do not think it is science.”

Today’s blog does not register approval or disapproval of Dr. Bailey or his scientific views. Its sole aim is to focus on the IRB-relevant “informed consent” aspect of his book as described by the Times, to wit: Four of the women whom Bailey interviewed “wrote letters to Northwestern, complaining that they had been used as research subjects without having given, or been asked to sign, written consent.”

Ethics Prof. Alice Dreger of Northwestern, now one of Bailey’s defenders, had originally thought him guilty of ethical violations.  Investigating, Dreger “found that two of the four women who complained to Northwestern of research violations were not portrayed in the book at all. The two others did know their stories would be used, as they themselves said in their letters to Northwestern.”

In her report, Dreger “argued that the book does not qualify as scientific research,” based on the federal guideline for IRBs.  As you perhaps suspect, a bizarre and troubling twist is about to round the corner: “Bailey used the people in his book as anecdotes, not as the subjects of a systematic investigation, [Dreger] reported.”

Wow. My interpretations:

  1. Though this article quotes Bailey saying “I interviewed people for a book; This is a free society, and that should be allowed,” Dreger established that Bailey did not violate informed consent rules as these would be interpreted (in spirit if not in letter) by his university’s IRB.  It was then unnecessary for Bailey’s defense for Dreger to declare, along with Bancroft of the Kinsey Institute, that Bailey’s book was not scientific research.  But she did so anyway.  

  2. A great many of my faculty  colleagues depend on qualitative methodologies such as case study, depth-interview, and so on.  If we take Dreger literally, such studies are just gussied-up anecdotes, not science.  Or at least, she has publicly opened a door to that view.  I don’t imagine university researchers will accept it, even with the silver lining (I’m being ironic now) that they wouldn’t have to submit to the IRB.

  3. I have not read Michael Bailey’s book, but I’m intrigued by “Dr. Bailey described the alternate theory, which is based on Canadian studies done in the 1980s and 1990s, in part by telling the stories of several transgender women…”  Qualitative methods are exploratory and strive toward theory, but cannot themselves produce theory, IMHO.  So the question of the book’s scientific nature (and its fit with the federal guidelines), insofar as we can answer it by reading the Times article, rests on the two words “in part.”  

  4. If one of us published less-than-rigorous work in a peer-reviewed journal article, the rest of us would be justified in jumping all over him/her.  However, academic custom gives a researcher more latitude in a book; the book author is freer to speculate and explore avenues not yet supported by strong evidence.  This is even more true in a book for popular audiences, in which the parts based on research presumably refer to stuff published earlier in journals – and which must have passed a university’s IRB muster long ago.  Viz., “Canadian studies.”

  5. If, as it indeed appears, Bailey  presented a theory based on his interpretation of the Canadian studies, and claims to have simply added color and human interest with the stories of the several women, then did the women’s stories just constitute “fill” for his text, or must they be regarded as a “hold-out sample” used by Bailey to test the theory? 

Either way, in a subject so fraught with psychological and social risk, the potential for harm to interviewees is nontrivial.

Why should a scientist be held to a standard to which journalists and novelists pay no mind? For starters, it’s part of our career commitment – if we were told about IRBs during our graduate studies. When we work on federally funded projects, or submit to a journal that wants IRB documentation, it’s a practical necessity.

But what if this was not a “systematic investigation”? That is, what if Bailey was acting in this instance not as an academic researcher but as a journalist? Cases like #5 above scream, “Borderline! Gray area!” This is where minimalism, constrained by common sense, should prevail.

My university’s IRB discussed the Bailey case and never came to agreement on it. Not being Northwestern, they didn’t have to. But someday they’ll be forced to face a like question. They’ll argue at great length, and barely achieve a majority view. There’s a lot of muddling-through involved in practical ethics.

P.S. The Scientific Blogging staff just posted an article about informed consent here.