Erdos: U.K. Data Protection Act May Stifle Research

David Erdos of the University of Oxford kindly alerted me to two recent publications in which he warns that the United Kingdom's Data Protection Act 1998, which implements European Union requirements, could inhibit social research in much the same way human subjects laws and regulations have done in the United Kingdom, Canada, and the United States.

David Erdos, "Systematically Handicapped? Social Research in the Data Protection Framework, Information & Communications Technology Law 20, no. 2 (2011): 83-101,
doi: 10.1080/13600834.2011.578925
David Erdos, "Stuck in the Thicket? Social Research under the First Data Protection Principle," International Journal of Law and Information Technology 19, No. 2 (2011), doi:10.1093/ijlit/ear001.]

Ohio State Restricts LGBTQ Research, Ponders Reforms

Two Ohio State University professors, James Sanders and Christine Ballengee-Morris, complain about IRBs' impacts on research and teaching in their fields and report on efforts at reform.

[James H. Sanders III and Christine Ballengee-Morris, "Troubling the IRB: Institutional Review Boards' Impact on Art Educators Conducting Social Science Research Involving Human Subjects," Studies in Art Education: A Journal of Issues and Research in Art Education 49 (2008): 311-327. Yes, it's two years old, but I just found out about it recently.]

Many of the complaints are familiar enough. The authors--one in arts policy, the other in art education--lament biomedical models, delays in approvals, and "lengthy boiler-plate consent forms." Yet the article advances the conversation about IRBs in two interesting ways.

First, the article highlights the difficulty of getting IRB approval to study lesbian, gay, bisexual, transgender, and queer self-identified youth. The authors would like to know "how LGBTQ students experience the World Wide Web, art and culture, and their self-image, or how they establish resilient behaviors." But, they find, "Conservative IRB interpretations of federal regulations requiring parental consent of all human subjects under 18, may have failed to protect the rights and welfare of LGBTQ adolescent research participants, and further dissuade researchers from studying all but (safe) consenting adult heterosexual subjects."

Second, the article describes reform efforts at Ohio State. Advised by colleagues to "be intentionally vague . . . speak in generalities, or simply not tell what we were actually doing," the authors did consider "lying to a repressive and controlling body that claims to care about human subjects' protections and then denies autonomy or voice to those living with repression." Instead, they joined 160 faculty members to petition their Office of Research to reconsider its policies.

The result was the issuance in 2007 of the Report of the IRB Working Group for Research in the Social and Behavioral Sciences." That report offers a number of constructive suggestions. For example,

• Relaxing the requirement that all changes to a protocol be reported to the IRB, even if they "have absolutely no material impact on a human subject's participation in a study."
  
• Accepting that interviewers cannot foresee in advance all the topics they may raise in a conversation.
  
• Informing investigators about their right to appeal decisions to the IRB chair, the full board, or the institutional official.
  
• Listing approved protocols, so researchers do not have to reinvent the wheel when submitting their own projects.
  

The 2007 report ends with a strong call for IRB policy to be shaped by the faculty. It specifically recommends the active participation of the University Research Committee, which is comprised mostly of regular facutly:

It is also important that there be continuing transparency and communication of IRB policy and procedure development among the faculty, the Office of Research, the IRB Policy Committee, and ORRP [Office of Responsible Research Practices]. To ensure that such consideration and implementation occurs, we recommend that an ad-hoc subcommittee of the University Research Committee be appointed for this purpose. This subcommittee should receive regular reports from the IRB Policy Committee regarding the development of new policies related to the Working Group's recommendations and suggestions, and from the ORRP staff regarding progress in staffing, website development, and electronic submission procedures.

In the longer term, it is important for the University Research Committee to participate actively in the human subject protection program at Ohio State, and to assess and suggest additional improvements to the operations of ORRP and the IRB. We strongly encourage the University Research Committee to set up a means to do so.

As of their writing, however, Sanders and Ballengee-Morris had yet to see improvement:

In short, one is required to think through every possible contingency and clearly communicate how such contingencies would be addressed. While the process itself strengthens the research design, the unreasonableness of some alternative scenarios posed by those unfamiliar with the researchers' field of study have been stifling. In response, many students and colleagues have chosen to change methods or abandon their research problems, rather than be subjected to this arduous, frustrating, and at times, humiliating process.

Can Satire Match IRB Reality? Comment on Lederman's "Modest Proposal"

The last entry in the PoLAR symposium for which I will offer comments is Rena Lederman's "Comparative 'Research': A Modest Proposal concerning the Object of Ethics Regulation."

Lederman, an anthropologist and sometime member of the Princeton University IRB, challenges the regulatory defintion of research: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." She correctly notes that the definition was crafted to distinguish the practice of medicine from biomedical research. As she puts it,

U.S. human subjects research regulations (known since 1991 as the “Common Rule” but formally set in place in the early 1970s) derive from earlier National Institutes of Health guidelines based on specifically biomedical experience and ethical problematics. Their logic goes something like this: First, medical therapy is appropriately evaluated in terms of individual patient interests, because its central concern is the direct improvement of individual patient well-being. Second, medical research is appropriately evaluated in terms of society’s and science’s interests, because its central concern is the production of knowledge “generalizable” beyond individual cases. And third, although physical risks to persons are inherent in both medical research and therapy, the risks to individuals are qualitatively greater in research (where individual persons are not the central concern) than in therapy (where they are). Consequently, research needs special oversight. (312)

[It's worth noting that the research definition entered the regulations as a result of congressional mandate; the National Research Act of 1974 instructed the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to consider "the boundaries between biomedical or behavioral research involving human subjects and the accepted and routine practice of medicine." The result was the defintion of research now encoded in regulations.]

Lederman then explains that the boundaries between research and therapy remain fuzzy even for biomedical topics. A case study of an individual patient offers some contribution beyond therapy, but is it generalizable? What about quality improvement, like the Johns Hopkins checklist?

Finally, Lederman produces her "modest proposal":

If there are indeed other ways of knowing the world that are similarly entangled in the everyday but not yet benefiting from IRB oversight, doesn’t fairness dictate that all of these modes be surveilled in the same manner? What would happen if ethnographers made common cause—all in (or all out)—not just with ethnographically inclined sociologists, political scientists, religion scholars, and folklorists but also with urban planners, architects, engineers, literary and cultural studies scholars, and colleagues in college and university writing programs—all of whom are engaged in varieties of research-with-human-participants? (320)

She then goes on to note similarities between the methods of ethnographers and novelists, asking why the latter have not been swept into the IRB dragnet.

The problem with Lederman's self-described "parodic" comparison is that some regulators and IRBs are already enacting parody as policy. As Lederman notes, "IRBs are already involving themselves in the lives of writing teachers, journalists, and others who had not heard of “human subjects research” until their own work came under scrutiny." (324, n. 10)

Other countries have taken this further. The Australian National Statement on Ethical Conduct in Human Research (2007) observes that the British definition of human subjects research "could count poetry, painting and performing arts as research," then fails to offer a defintion of human subjects research that clearly excludes those endeavors. It then goes on to state that "the conduct of human research often has an impact on the lives of others who are not participants," raising the possibility that a novelist might violate Australia's ethical standards without even talking to anyone. (p. 8) More recently, in February 2008, a Canadian committee proposed adding a chapter on Research Involving Creative Practices to Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. The draft chapter suggests that some creative processes are outside the purview of ethics boards, but it does not make a good case for any review of creative work, except that "researchers from a wide range of disciplines" would feel cheated if artists got special treatment.

It's too late for reductio ad ridiculum; the ridiculous is at the gates.

Like Bosk's essay, Lederman's expresses frustration with IRB oversight of ethnography without clearly calling for an end to such oversight, much less offering a strategy to achieve that goal. She reports, offhand, that when oral historians seemed to have escaped IRB jurisdiction, the anthropologists she knew "were briefly thrilled, but there was no notable effort to follow suit." (318) Why this passivity? I am less interested in why ethnographers have not made common cause with novelists than in why they have not made common cause with themselves.