Qualitative Sociology Ventures Beyond the IRB

Back in December, as I was still dealing with a crush of ANPRM-related reading, I mentioned that the journal Qualitative Sociology had published a special issue on "Ethics Beyond the IRB". I have finally found some time to read the intriguing essays it contains.

Li Abandons Suit, But Brown University Still Ponders IRB Reform

Though it no longer faces a faculty lawsuit, Brown University is considering an outside review of its troubled IRB.

As readers of this blog may remember, Brown faculty have been complaining about the IRB since 2007, if not before.

In 2011, a Brown professor, Jin Li, took the highly unusual step of suing the university because of IRB interference in her work. In March, Li abandoned that effort, her attorneys agreeing to a dismissal with prejudice.

According to the Daily Herald, Brown faculty and administrators are discussing possible reforms, including an external review, broader disciplinary representation on the IRB, the creation of an additional IRB for non-biomedical human subject research, and "changing the charge of the IRB to make it not only a monitory board but also one that provides a more supportive and guiding role to research teams."

[Aparaajit Sriram, "IRB Likely to Undergo Review," Brown Daily Herald, 26 April 2012.]

The article does not mention the possibility of an appeals process, the lack of which was one of Li's complaints.

Li and Brown Continue Negotiations

A correspondent asks for an update in the case of Jin Li, the Brown professor who sued her university after its IRB restricted her research.

I checked Public Access to Court Electronic Records (PACER) and found that on January 13, the parties jointly asked for an extension of the discovery deadline, telling the court "that they continue to negotiate a settlement of the claims. Due to the efforts made negotiating a settlement, only minimal discovery has been propounded so far. As such, if the parties are unable to settle, then the parties will need time to complete formal discovery."

I have posted the motion and other key documents on my IRB Documents page.

Inside Higher Ed Reports on Li v. Brown University

Inside Higher Ed reports on the Brown University professor who is suing the university over IRB restrictions. The story quotes your humble blogger.

[Dan Berrett, "IRB Overreach?," Inside Higher Ed, 18 March 2011.]

Professor Sues Brown University Over IRB Mission Creep

Jin Li, Associate Professor of Education at Brown University, has sued the university in federal court for forbidding her from using data from a study she conducted with private funding.

[Alexandria D'Angelo, "Professor Says Brown U Has a Lot of Nerve," Courthouse News Service, 1 March 2011. Thanks to Illuminata for catching this.]

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.

Unfair IRBs Provoke Misbehavior

"Researchers who perceive that they are being unfairly treated are less likely to report engaging in 'ideal' behaviors and more likely to report misbehavior and misconduct," according to a survey of faculty at fifty top research universities in the United States.

[Brian C. Martinson, A. Lauren Crain, Raymond De Vries, Melissa S. Anderson, "The Importance of Organizational Justice in Ensuring Research Integrity," Journal of Empirical Research on Human Research Ethics 5, no. 3. (Sep 2010): 67–83.]

As the authors note, this is mostly a quantitative confirmation of earlier findings. Most relevant for this blog, they cite a 2005 article by Patricia Keith-Spiegel and Gerald P. Koocher that found that "The efforts of some institutional review boards (IRBs) to exercise what is viewed as appropriate oversight may contribute to deceit on the part of investigators who feel unjustly treated."

Like the Singer and Couper article in the same issue, this article presents a mass of quantitative data in a difficult form. Let me suggest that the Journal of Empirical Research on Human Research Ethics invest some money in decent graphs.