The Cost of Ethical Review, Part III: Hindering HIV Prevention

Risk-averse IRBs are hindering potentially life-saving research, write Brian Mustanski and Celia Fisher. “Critical advances in HIV prevention among AMSM [adolescent men who have sex with men],” they note, “have been impeded by the failure of IRBs to apply federal regulations permitting adolescents to self-consent to research without parental involvement.”

[Mustanski, B., & Fisher, C. B. (2016). HIV Rates Are Increasing in Gay/Bisexual Teens: IRB Barriers to Research Must Be Resolved to Bend the Curve. American Journal of Preventive Medicine, In Press. doi:10.1016/j.amepre.2016.02.026.]

British Universities See Ethics Committees as "Easy and Convenient" Censors

Adam Hedgecoe reports on two cases in which British university administrators turned to their university research ethics committees (URECs) not to protect the subjects of research, but to block controversial research they feared would tarnish the universities’ reputations.

[Adam Hedgecoe, “Reputational Risk, Academic Freedom and Research Ethics Review,” Sociology, June 25, 2015, doi:10.1177/0038038515590756.]

Quebec Court Shields Confidential Interview from Police

A Quebec court has quashed a search warrant for an interview given in confidence by accused killer Luka Magnotta to University of Ottawa researchers. The court agrees with the professors that "the public interest in protecting researcher-participant confidentiality in general, and in the specific circumstances of this case, clearly outweighs what minimal contribution, if any, the release of the seized items will make to the prosecution of the accused in the criminal proceeding." (2)

[Parent c. R., 2014 QCCS 132. h/t Will C. van den Hoonaard]

CU-Boulder Retracts IRB Claim

The Chronicle of Higher Education reports that Mark Miller, the University of Colorado at Boulder spokesman who had earlier suggested that professors should consult the IRB before teaching controversial subjects, has retracted that suggestion.

[Peter Schmidt, “U. of Colorado’s Response to a Gritty Lecture Worries Sociologists,” Chronicle of Higher Education, December 17, 2013. http://chronicle.com/article/U-of-Colorados-Response-to-a/143653/. (gated)]

CU-Boulder Tells Faculty to Consult IRB Before Teaching

A spokesman for the University of Colorado at Boulder has recommended that university faculty consult the IRB before teaching.

The comment concerns sociology professor Patti Adler's announcement that she plans to retire early rather than risk being fired for classroom teaching that might make students uncomfortable.

[Scott Jaschik, “Tenured Professor at Boulder Says She Is Being Forced out over Lecture on Prostitution," Inside Higher Ed, December 16, 2013. http://www.insidehighered.com/news/2013/12/16/tenured-professor-boulder-says-she-being-forced-out-over-lecture-prostitution.]

Interview by Washington Monthly - Ten Miles Square

Rachel Cohen interviewed me for Ten Miles Square, a Washington Monthly blog.

I guess in this case the ten miles square still includes Arlington.

Cohen, Rachel. “What Are Institutional Review Boards and Why Should We Care? An Interview with Zach Schrag.” The Washington Monthly - Ten Miles Square, November 1, 2013. http://www.washingtonmonthly.com/ten-miles-square/2013/11/what_are_institutional_review047608.php?

REB Members Beg U of Ottawa to Defend Confidentiality

IRB apologists sometimes argue that IRB review is necessary to ensure that universities will defend researchers and their participants from litigation. Boston College Subpoena News reminds us that ethics approval is no guarantee of such support.

[“News of Interest: Canadian Academics Strongly Defend Research Confidentiality, Call for University Support of Researchers.” Boston College Subpoena News, April 9, 2013. http://bostoncollegesubpoena.wordpress.com/2013/04/09/news-of-interest-canadian-academics-strongly-defend-research-confidentiality-call-for-university-support-of-researchers/.]

Northeastern U. IRB Makes Sex Research Untenable

Carey Noland, associate professor of communcation studies at Northeastern University, complains that "many IRBs . . . seem to have difficulty accurately assessing the potential harm involved with qualitative research on sex."

[Carey M. Noland, “Institutional Barriers to Research on Sensitive Topics: Case of Sex Communication Research Among University Students.” Journal of Research Practice 8, no. 1 (November 24, 2012): Article M2, http://jrp.icaap.org/index.php/jrp/article/view/332/262]

Autoethnographer Finds REB Review Intimidating

Lee Murray describes getting REB approval for her doctoral research at the University of Saskatchewan. Though she was able to devise a proposal that passed the committee "without taking away from what I want to accomplish," she was left feeling she "would not want to make the journey again."

[Lee Murray, Debbie Pushor, and Pat Renihan. “Reflections on the Ethics-Approval Process.” Qualitative Inquiry 18, no. 1 (January 2012): 43–54. doi:10.1177/1077800411427845.]

Sociologists of Sexuality Voice IRB Complaints

Sociologist Janice Irvine finds that IRBs "play a significant but largely unnoticed role in the marginalization of sexuality research," and that "the IRB closet obstructs a broad production of sexual knowledge—not simply about identities and communities, but also about a range of sexual acts, desires, and attitudes."

[Janice M. Irvine, "Can't Ask, Can't Tell : How Insitutional Review Boards Keep Sex In The Closet," Contexts 2012 11: 28, DOI: 10.1177/1536504212446457. The story has been picked up by the Chronicle of Higher Education: Dan Berrett, "Review Boards Force Sex Research Into the Closet, Survey Suggests," Chronicle of Higher Education, 28 June 2012.]

Sex and Trauma Surveys No Riskier Than Cognitive Tests

A team of psychologists has found that responding to survey questions about trauma and sex is no more stressful than completing "well-established cognitive tests."

[Elizabeth Yeater, Geoffrey Miller, Jenny Rinehart, and Erica Nason. "Trauma and Sex Surveys Meet Minimal Risk Standards Implications for Institutional Review Boards." Psychological Science (Published online before print May 22, 2012), doi: 10.1177/0956797611435131. h/t Michelle Meyer.]

Ethics Committees as Foucauldian Shepherds

Three Norwegian researchers using a "Foucault-inspired analysis" charge that "ethics monitoring bodies can be conceived as executing a type of paternalistic power over vulnerable and marginalized groups, a practice which is virtually identical to the exercise of power that, according to their mandate, they should be protecting these groups against."

[Truls I Juritzen, Harald Grimen, and Kristin Heggen. “Protecting Vulnerable Research Participants: A Foucault-Inspired Analysis of Ethics Committees.” Nursing Ethics 18, no. 5 (September 2011): 640–650, doi: 10.1177/0969733011403807]

REC Forbids Dissertations on Lap Dancing

Robert Dingwall fears that "research ethics is co-opted to infantilize students who are legally adults but treated as if they should never be allowed to risk a bad experience."

[Robert Dingwall, "Better Drowned than Duffers…?," social science space, 19 February 2012.]

Boellstorff Warns of ANPRM Ethics Creep

Occupational Health & Safety alerts me to a comment on the ANPRM posted on September 1 by Tom Boellstorff, Professor of Anthropology, University of California, Irvine, and Editor-in-Chief, American Anthropologist.

Sociologist: IRBs Have Almost Killed Fieldwork

Laurie Essig, Assistant Professor of Sociology and Women's & Gender Studies at Middlebury College and a contributor to the Chronicle of Higher Education's Brainstorm blog, complains that "IRBs have effectively shut down our ability to actually find out about people’s lived experiences. IRBs have treated speaking with someone as equivalent to experimenting on them and have almost killed fieldwork in the process."

[Laurie Essig, "The IRB and the Future of Fieldwork," Brainstorm: Ideas and Culture, 12 August 2011.]

Sex Researcher Calls for "An Evidence-Informed Process"

Brian Mustanski, Associate Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, calls for "moving the IRB process of risk/benefit assessment from being entirely subjective to being evidence-based."

[Brian Mustanski, "Ethical and Regulatory Issues with Conducting Sexuality Research with LGBT Adolescents: A Call to Action for a Scientifically Informed Approach," Archives of Sexual Behavior, published online 29 April 2011.]

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.

IRB Says Women Can't Be Photographed

The New York Times reports IRB interference with a study that combines medical and social research. (Gina Kolata, "Fitness Isn’t an Overnight Sensation," 21 January 2009).

Carl Foster, an exercise physiologist at the University of Wisconsin, La Crosse, was amused by ads for a popular piece of exercise equipment. Before-and-after photos showed pudgy men and women turned into athletes with ripped bodies of steel . . .

“We said: ‘Wait a minute. You can’t change yourself that much,’ ” Dr. Foster said. So he and his colleagues decided to experiment. Suppose they recruited sedentary people for a six-week exercise program. Would objective observers notice any changes in their bodies?

The plan was to photograph volunteers wearing skimpy bathing suits and then randomly assign them to one of three groups: cardiovascular exercise, weight lifting or control. Six weeks later, they would be photographed again.

Their heads would be blocked out of the photos, which would be shuffled. Then the subjects and judges would rate the body in each photo on a scale of 1 to 10, with 10 being spectacular.

The volunteers were men, age 18 to 40 (the university’s human-subjects review board looked askance at having women photographed and rated like that).

This is another case where Canada's TCPS (even the existing version) shows a more sophisticated undertsanding of research ethics than does the Belmont Report or the U.S. regulations. Whereas the Belmont authors were concerned about vulnerable populations being inappropriately targeted for medical studies, they did not think about the arbitrary exclusion of populations, or the stigmatization of competent adults as incompetent. By contrast, Article 5.2 of the 2005 version of the TCPS states that "women shall not automatically be excluded from research solely on the basis of sex or reproductive capacity."

I am unaware of any U.S. regulation or guidance that so specifically forbids the kind of sexism displayed by the La Crosse IRB. Still, it's disappointing that that IRB thinks adult women incapable deciding for themselves whether to participate in a study open to men.

For this study's implications for advertising law, see Rebecca Tushnet's 43(B)log.

The Psychologist Who Would Be Journalist

Back in August 2007, I mentioned the controversy surrounding the book The Man Who Would be Queen (Washington: Joseph Henry Press, 2003) by J. Michael Bailey, Professor of Psychology, Northwestern University. At the time, Professor Alice Domurat Dreger, also of Northwestern, had just posted a draft article on the controversy. Now that article, along with twenty-three commentaries and a reply from Dreger, has appeared in the June 2008 issue of the Archives of Sexual Behavior.

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.