Dreger's article, the commentaries, and Dreger's response focus on big questions about the nature of transsexuality, the definitions of science, power relationships in research, and the ground rules of scholarly debates. Only a handful take up the smaller question of whether—as a matter of law and as a matter of ethics--Bailey should have sought IRB approval prior to writing his book. But that's the question that falls within the scope of this blog.
Bailey's book is based, in part, on his knowledge of the life stories of several transsexual women. In July 2003, four of those women filed formal complaints with Northwestern University's' Office of the Vice President for Research. They were Anjelica Kieltyka, a transsexual activist who had introduced Bailey to transsexual women seeking sex reassignment surgery, and three anonymous complainants who had sought Bailey's endorsement of the surgery. Also in July 2003, two prominent scholars, Deirdre McCloskey and Lynn Conway (both transsexuals) filed their own complaint in support of the four women, alleging "misuse of human subjects" among other charges.
In their complaints, the women note two sets of interactions with Bailey. First, Bailey had interviewed the three anonymous women prior to writing letters of support for their requests for sexual reassignment surgery (SRS). According to Dreger, the interviews allowed Bailey to write letters "reporting simply what he observed in terms of a pre-op transsexual woman’s gender identity presentation, her apparent understanding of the surgery, and her likelihood of adjusting well after SRS." (372) It's not clear from any of the documents what questions he asked or what answers he got, and the book itself does not mention the interviews.
The second set of interactions came as a result of Bailey's invitation to Kieltyka and at least two other complainants to act as guest lecturers in his classes on human sexuality. As Dreger notes, these were "heavily attended," and "between 1994 and 2003, a total of several thousand Northwestern University students saw Kieltyka’s annual appearances." (373) The complainants, including McCloskey and Conway, suggest that these lectures were themselves abusive. As McCloskey and Conway put it, "The women [who] have come forward . . . fear that the hundreds of Northwestern undergraduates before whom they were paraded in the on-going freak shows in Professor Bailey's classes might recognize them."
These latter are unusual charges for an IRB complaint. Does anyone familiar with IRB regulations argue that inviting someone to lecture to one's course constitutes human subjects research?
More plausible is the charge that the pre-surgery interviews should have triggered IRB review. While Bailey likely began writing reference letters in 1996, prior to beginning his work on the book in 1997, at least two interviews took place in 1998 and 2000. Chronologically, it's possible that he interviewed these women knowing he might use their stories in his book, but not telling them.
But did he? On page 177, Bailey writes, "most of the homosexual transsexuals I have met, I met through Cher", his pseudonym for Kieltyka. The complainants take this as a reference to them, and as evidence that he used material from the pre-surgery interviews in his book. But there is another explanation of that line. Dreger notes that Kieltyka also "encouraged Bailey to accompany her to the local bars frequented by pre- and post-op transsexual women and drag queens where Kieltyka was familiar with many of the regulars." (372) And on page 181 of his book, Bailey makes it clear that these bars were the sites of his first encounters with at least some of the women on whom he based his writings--women whom he interviewed in IRB-approved, laboratory settings. Thus, the reference on page 177 could well be to Kieltyka's help in recruiting subjects for Bailey's IRB-approved studies. (Dreger, 377) There's no reason to think that Bailey used any information from the pre-surgery interviews in his writings, making it hard to label them as unauthorized research.
Dreger notes another set of interactions, not mentioned in the complaints:
The information about individuals that Bailey gathered for the book from Kieltyka, Juanita, Braverman, and others he obtained haphazardly—without any developed plan of research—from their occasional presentations to his classes, from their joint social outings, and from one-on-one discussions that occurred on an irregular basis. Bailey did conduct a few fill-in-the-blank discussions with Kieltyka, Juanita, and others (Bailey to Dreger, p.e.c., August 22, 2006)—discussions during which, as I show below, they knew he was writing about them in his book, and with which they cooperated. But these fill-in-the-blank discussions can again hardly be called systematic or productive of generalizable knowledge. When I pressed him to consult or perhaps even turn over to me the notes he took from these conversations, Bailey admitted he had no organized notes that he had bothered to keep. Obviously, he never really thought of these discussions as research—systematic work meant to be productive of generalizable knowledge—any more than he ever imagined that the women who seemed eager to tell their stories and have him write about them might later charge him with abuse. Otherwise, he surely would have protected himself and his work by being significantly more organized.
Dreger agrees with Bailey that his work was neither systematic nor generalizable, and therefore not subject to IRB review.
Of the commentators in the journal who take on the human-subjects angle, most recognize the flimsiness of the human-subjects case against Bailey. Brian A. Gladue, of the University of North Texas Health Science Center's Office for the Protection of Human Subjects, writes:
the Northwestern IRB would have determined that Bailey’s book project did not need IRB review, and Bailey was correct, both ethically and by regulations, in not seeking or obtaining IRB review. Simply stated, he did not need it—any more than journalism students need IRB review for class projects, or history faculty need IRB review to ask people questions about growing up in their hometowns, or interviewing war veterans about their experiences, etc. Frankly, IRBs generally are busy enough and do not need the extra business and burden of evaluating minimal risk human interactions that are not in and of themselves scientific research.
He goes on to warn about the continued expansion of IRB jurisdiction.
(Gladue also claims that "it is hugely ironic that social activists and social scientists/life historians would even argue that Bailey should have obtained IRB review for his book. For years, these groups of scholars and academics have chafed under the regulatory burden of IRB reviews." (448) As Dreger notes in her response, two of Bailey's three main antagonists are not social scientists/life historians of any stripe. (507) Gladue has a better case against McCloskey, whom I doubt got IRB approval for her memoir--based in part on conversations with other people, and published by a university press.)
Elroi Windsor concurs with Dreger's conclusion that "as an unscientific work that lacked systematic inquiry, [Bailey's book] did not qualify as human subjects research and therefore Bailey did not violate research standards." (495) Likewise, Seth Roberts refers to the McCloskey-Conway effort as "an absurd human-subjects complaint." (485) He elaborates (quoting his correspondence with McCloskey):
Never before in the history of science had the subject of a story told to illustrate a point been thereby considered a research subject. Bailey’s book is not a scientific monograph. It is not a piece of science. It is a trade book about science. When I or anyone else gives a lecture about a scientific subject, and tell a story from everyday life to make the conclusions come alive, do we need informed consent from everyone mentioned in the story? Of course not. No one has ever been required to do this. No one has ever done this. No one has ever even conceived of such a thing.
Marta Meana's commentary faults McCloskey and Conway for trying to use Northwestern's IRB as a makeshift censorship board. She describes the ethical complaints as "completely off-topic and simply an attempt to inflict as much damage as possible." (471) Indeed, Bailey's critics accused him of everything from practicing clinical psychology without a license to "plagiarism and identity theft."
Of all the commentaries, only two argue that Bailey's work should have been subject to IRB review. Richard Green writes,
I take exception to the Dreger article characterization of research as the systematic investigation, including research development, testing, and evaluation, designed to contribute to generalizable knowledge, and only then subject to protection of human subjects. A scholarly studymay differ from a scientific one welded to that definition but still impact its subjects. Stoller’s (1973) epic ‘‘Splitting: A Case of Female Masculinity’’ was a 395 page case study of a woman convinced that she had a penis. It was seven years of interview transcripts. It was not generalizable. There was no hypothesis testing. But his subject required (and received) protection. (452)
While I don't know the details of Stoller's work, I do know that the current definition of human subjects research was adopted in 1981, so the treatment of a 1970s project is quite irrelevant to the interpretation of current rules. Green's essay may be an unintentional plea for a return to the pre-1981 regulations.
The other case for inclusion comes from sociologist John H. Gagnon:
Bailey’s usual scientific work has been with subjects in experiments or in surveys and in these studies he has (here I am supposing, I have not asked) submitted his research plans to his IRB on the main campus at Northwestern and provided consent forms to his (and his colleagues’) subjects. His contacts with transgendered persons were (if I may infer), to his mind, more casual and less scientific than his other work. (447)
This passage shows that Gagnon did not read Dreger's article very carefully. Dreger makes clear (377) that Bailey did get IRB approval for his more systematic studies, and that those IRB-approved studies included transsexuals. Maybe Gagnon's claim of un-reviewed "field work" refers to the "fill-in-the-blank discussions" mentioned by Dreger. But that's just a guess.
For good measure, Gagnon argues that Dreger herself should have faced IRB review for the interviews and correspondence she used in writing her article. Dreger did, in fact, consult the Northwestern University Office for the Protection of Research Subjects, which assured her that her work was "not IRB-qualified." (401) Gagnon tries to explain this away by claiming Dreger "was exempted from human subjects review by the IRB at Northwestern University’s medical school despite the fact that she was interviewing people whom I would treat as 'human subjects.' I am not sure how the IRB on the main campus of Northwestern, which is far more familiar with social science research, would have dealt with Dreger’s submission." (447) Again, Gagnon is a sloppy reader. Dreger consulted not with a medical-school IRB, but with Eileen Yates, an official with the university office that oversees both medical and non-medical research.
Gagnon writes that IRBs "are often (perhaps more often than not) excessively intrusive, legalistic, and ignorant of the methods and traditions of the disciplines which they review. However, they are part of the apparatus of managing ethical dilemmas in human science in the current political and economic atmosphere that surrounds the production of knowledge by academic researchers. The decision to define either Bailey’s or Dreger’s works as nonscience may be tactically useful in this case, but in my view, neither choice is the correct one." (447)
I don't know what Gagnon means by the "current political and economic atmosphere." Does he mean that we depend on federal money, so we'd better shut up? Is there a difference between a "political atmosphere" and federal law as enacted by Congress? In a different political and economic atmosphere, would Bailey's actions be ethical?
I do know that his essay makes no distinctions between what is and is not within IRB purview, and he offers no counterexamples of scholarly works that might not require review. As best I can tell, he thinks that any published writing by a scholar who has talked with other people requires IRB review. That's a pretty extreme position.
Significantly, Gagnon makes the case for IRB review only on procedural grounds: "both [Bailey's book] and Dreger’s comment are works which fall into recognizable genres of scientific writing and both are dressed in scientific costume,." he writes. "Both employ methods that bring them under the rules and regulations of the appropriate Institutional Review Boards about informing human subjects that they have become ‘'data.'" (447) He does not claim that IRB review would have prevented or resolved the conflict between Bailey and his critics. Would it?
Certainly, an IRB might have insisted on written consent from some of Dreger's sources, notably Kieltyka and the pseudonymous "Juanita," whose stories each take up several pages in the book. As Dreger notes in her article, both women seem to have been aware that Bailey was writing about them and gave oral consent, but later claimed that they had not known of the book. A paper trail would have been good for all concerned.
But it's clear from the complaints that Bailey's failure to secure written consent was hardly the issue that sparked real anger. The damage they allege is not to the individual participants, but to the transsexual community as a whole. They specifically complain that Bailey’s students may get the wrong idea about transsexuals. This is a harm, but IRBs are not designed to protect communities against this kind of damage. As the National Commission put it in its Institutional Review Board; Report and Recommendations of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research:
In evaluating risks and benefits to subjects, an IRB should consider only those risks and benefits that may result from the conduct of the research. . . . The possible longrange effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy affecting a segment of the population) should not be considered as among those research risks falling within the purview of the IRB . . . .
Bailey's critics, including some women whose experiences he drew on for his work, think he wrote a stupid, offensive book that will poison readers' ideas about transsexuals. They may be right. But IRBs cannot protect people from every kind of harm without stifling legitimate research, and universities accept that some of the ideas put forth by their researchers will hurt people.