A satisfied customer at American University

Patricia Aufderheide, University Professor of Communication Studies at American University, reports her satisfaction with the IRB at that institution. It’s great to hear some good news, and Aufderheide’s essay points to the importance of having the right people in positions of power. But it also raises questions about how good and how replicable AU’s experience is.

[Patricia Aufderheide, “Does This Have to Go Through the IRB?,” Chronicle of Higher Education, August 17, 2016.]

IRB Chair: "Nobody Really Knows" If IRBs Do Any Good

A former chair of the University of Wisconsin-Madison Education and Social/Behavioral Science IRB guesses that IRB review “most likely” protects subjects from harm, but concedes that “nobody really knows.” He also notes that it consumes tens of thousands of hours of work, mostly by researchers, at his university each year.

[Kenneth R. Mayer, “Working through the Unworkable? The View from Inside an Institutional Review Board,” PS: Political Science & Politics 49, no. 02 (April 2016): 289–93, doi:10.1017/S1049096516000226.]

Nursing Professors Want IRB Oversight of Interviews with Bereaved

Two professors of nursing warn that "Psychological harm is indeed a risk when interviewing individuals who may be in a fragile state and researchers should not have unfettered access to them." But they offer no evidence that IRBs offer appropriate protection without restricting legitimate research that may directly benefit the people being interviewed.

[Florczak, Kristine L., and Nancy M. Lockie. “IRB Reformation Is Unfettered Access the Answer?” Nursing Science Quarterly 28, no. 1 (January 2015): 13–17. doi:10.1177/0894318414558621.]

Florczak and Lockie rely on the story of "Katie," as in this passage:

Katie knew from conducting numerous interviews that they were not innocuous. Her participants frequently broke down and expressed myriad emotions from anger to fear but most often a profound overwhelming sadness. Dyregrov and colleagues (2011) added credence to Katie’s assumption that interviews are other than insipid conversations. They said that bereavement interviews can unearth painful memories resulting in the participants becoming emotionally exhausted and distressed.

It is not clear from the essay if "Katie" is a pseudonym, a composite, or an entirely fictional creation.

Florczak and Lockie do cite Kari Madeleine Dyregrov, Gudrun Dieserud, Heidi Marie Hjelmeland, Melanie Straiton, Mette Lyberg Rasmussen, Birthe Loa Knizek, and Antoon Adrian Leenaars. “Meaning-Making Through Psychological Autopsy Interviews: The Value of Participating in Qualitative Research for Those Bereaved by Suicide,” Death Studies 35, no. 8 (September 2011): 685–710. doi:10.1080/07481187.2011.553310. And that study did indeed report that "Some bereaved cried or were upset when talking about their loss."

But Florczak and Lockie do not report Dyregrov et al.'s equally important findings that "very few people felt distressed when discussing the suicide and almost all of the participants felt no different or better than usual at the 4-week follow-up" and that "The majority of informants (62%) responded with unambiguous, highly positive statements that were numerous, varied, and spontaneous." This led Dyregrov et al. to warn that "Too often ethical boards delay or stop research projects with vulnerable populations, influenced by presumed rather than empirically documented vulnerability."

Dyregrov et al. attribute the positive results to "the value of talking about the circumstances with a professional who has insight into the reasons and processes around suicides." This suggests that a credentialling system, rather than review of individual protocols, might better serve research participants.

A Reply to Maxine Robertson

In an essay in Research Ethics, Maxine Robertson, Professor of Innovation and Organisation at Queen Mary University of London (QMUL), responds to my essay, "The case against ethics review in the social sciences," published in the same journal in 2011. I wish she had responded to more of the broader ethics-review critique and offered more details about ethics review at her own institution.

[Robertson, Maxine. “The Case for Ethics Review in the Social Sciences: Drawing from Practice at Queen Mary University of London.” Research Ethics 10, no. 2 (June 2014): 69–76. doi:10.1177/1747016113511177]

NIH Policy Makes Interviewing Children Easier

Susan Ridgely, assistant professor of religious studies at the University of Wisconsin at Oshkosh, finds that IRBs can cause trouble for qualitative researchers who want to talk with children, but that IRB review has some benefits. Moreover, since the NIH started calling for children to be included in medical studies, she is finding it easier to get IRB permission to speak to children.

[Susan B. Ridgely, “Doing Ethnography with Child Consultants: Making the IRB Process Work.” Journal of American Folklore 125, no. 3 (2012): 474–485.]

Schrag Responds to Responses to Schrag

The June 2012 issue of Research Ethics features four responses to my December 2011 essay, "The Case Against Ethics Review in the Social Sciences." Three scholars based in Canada wrote a joint response, while three in Britain wrote individual replies. I am grateful to all of the respondents for their attention, kind words, and challenging critiques.

• Nicholls, Stuart G., Jamie Brehaut, and Raphae Saginur. “Social Science and Ethics Review: A Question of Practice Not Principle.” Research Ethics 8, no. 2 (June 2012): 71–78. doi:10.1177/1747016112445435
• Hedgecoe, Adam. “The Problems of Presumed Isomorphism and the Ethics Review of Social Science: A Response to Schrag.” Research Ethics 8, no. 2 (June 2012): 79–86. doi:10.1177/1747016112445437
• Jennings, Sean. “Response to Schrag: What Are Ethics Committees for Anyway? A Defence of Social Science Research Ethics Review.” Research Ethics 8, no. 2 (June 2012): 87–96. doi:10.1177/1747016112445423
• Bond, Tim. “Ethical Imperialism or Ethical Mindfulness? Rethinking Ethical Review for Social Sciences.” Research Ethics 8, no. 2 (June 2012): 97–112. doi:10.1177/1747016112445423

Since the responses overlap somewhat in their themes, I think it best for me to respond to them collectively.

Geographer: Unnecessary IRB Delay Threatens NSF Grants

In the fifth and final Professional Geographer essay, Scott M. Freundschuh, Professor of Geography at the University of New Mexico, notes that many IRBs "unnecessarily require research protocols to be reviewed by the full IRB, therefore impeding the progress of research projects." Rather than suggesting structural changes to the IRB system, he counsels geographers to work within existing rules.

[Scott M. Freundschuh, "Institutional Review for Research in the Social Sciences from the Federal Perspective," Professional Geographer 64, no. 1 (2012): 43-48, DOI:10.1080/00330124.2011.596791]

Can Macalester's Divisional Review Work Elsewhere?

In his contribution to the Professional Geographer special issue, Dan Trudeau of Macalester College writes that "IRBs can be a pedagogical asset, particularly if institutional review practices cultivate the habits of mind and strategies necessary for engaged and reflexive research." The key, his article suggests, may be the devolution of review to specialized committees rather than the general-purpose IRBs that are the norm. But Trudeau does not stress the degree to which Macalester's sucess depends on its departure from federal standards.

[Dan Trudeau, "IRBs as Asset for Ethics Education in Geography," Professional Geographer 64, no. 1 (2012): 25-33, DOI: 10.1080/00330124.2011.596786.]

Berkeley Historian Defends IRB Review of Oral History

Martin Meeker, a historian with the Regional Oral History Office (ROHO) at the University of California, Berkeley, argues that "Historians of the recent past, many of whom use interviews as a source, need to be more systematic about doing oral histories as a form of research [and] that cooperation with IRBs offers one way to do that." What he really means, I think, is that cooperation with IRBs may help historians get legal help from their universities.

[Martin Meeker, "The Berkeley Compromise: Oral History, Human Subjects, and the Meaning of 'Research,'" in Doing Recent History: On Privacy, Copyright, Video Games, Institutional Review Boards, Activist Scholarship, and History That Talks Back, edited by Claire Bond Potter and Renee C. Romano (Athens: University of Georgia Press, 2012).]

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.

After Lawsuit, Arizona State IRB Hindered Native American Interviews

Kimberly TallBear, assistant professor of science, technology, and environmental policy at Berkeley, describes her encounters with IRBs there and at Arizona State University. At the latter, the IRB imposed conditions that made her abandon plans to interview Native Americans.

["Interview with Kimberly TallBear," GeneWatch, May/June 2010.]

As she puts it:

IRBs vary from university to university, and some are much stricter than others. For example, the Arizona State University IRB is, after the Havasupai lawsuit, incredibly strict where tribes are concerned. If you're going to do research with native populations, whether it's biological research or even social science research, you have to get approval from the tribal council before the university will even look at your protocol. On the other hand, I'm doing a project at Berkeley where I'm interviewing both genetic scientists and tribal government people, and Berkeley didn't look twice at my interview with indigenous people. I asked if they require some sort of documentation that I got approval from the tribe, and they said, "No, no, no, that's not a problem." So there are differences between IRBs as well as between disciplines . . .

I'm not an expert on IRBs, but I can speak from personal experience—I have worked at both Arizona State and Berkeley, so I have seen the huge differences in IRBs. In short, the difference is that ASU has been sued. Before the Havasupai suit, ASU was lax as well.

I was at ASU in 2006 and 2007. As a social scientist, I was interviewing a range of people—native people, scientists, regulators—and the IRB was very strict about allowing me to talk to tribes. I had interviewees at five or six tribes, which meant I would have had to go through each one of those tribes to get approval for those interview questions. So, in order to get approval for my science piece, I backed out of the Native American community member questions.

This was also really interesting: I study the culture and politics of genetic science, and I think they should have been more strict and careful about my research questions for scientists. In my work, scientists are potentially vulnerable subjects. Now, I don't actually think they are very vulnerable—I think they actually have a lot more cultural authority than I do in the broader world—but I'm a potential critic. While the native populations were seen as potentially vulnerable subjects, it didn't seem to have crossed the IRB's minds that scientists could be potentially vulnerable subjects, too.

It was the opposite at Berkeley, actually: they were much, much more concerned about my questions for scientists and protecting their confidentiality, and they seemed not at all concerned about my questions for indigenous people, at least from my perspective.

TallBear does not appear angry that the the ASU IRB's strictness forced her to "back out" of planned interviews. Rather, she seems to wish that IRBs were even stricter: "What IRBs require is a bare minimum of the standards that you have to meet to conduct ethical research. IRB approval doesn't constitute a thorough process." And, later, "you see people who have just decided they don't want to work with tribes, because they don't want to have to go through a tribal research review board, they don't want to let a tribal council or a tribal IRB have a say over whether they can publish something or not. I think that's a good thing . . . Go do something else!"

It is not clear from the published interview whether she believes that such discouragement is appropriate only for geneticists and other biomedical researchers, or if she is happy to let tribal governments control the writings of social scientists and journalists as well.

Librarian Urges Cooperation with IRBs

Maura Smale, information literacy librarian at the New York City College of Technology, suggests that librarians "embrace research involving human subjects" and seek IRB approval to do so.

[Maura A. Smale, "Demystifying the IRB: Human Subjects Research in Academic Libraries," portal: Libraries and the Academy 10 (July 2010): 309-321, DOI: 10.1353/pla.0.0114]

Smale notes that librarians can interact with IRBs in two ways. First, they can serve as IRB members or consultants, helping researchers and reviewers inform themselves about a proposal. Better library research, she suggests, could have prevented the 2001 death of Ellen Roche, a volunteer in a Johns Hopkins University asthma study. Smale could also have mentioned that better library research might prevent unreasonable IRB demands.

Second, librarians can act as researchers. Smale offers as examples two of her own studies of student and faculty users of her library. She found value in the approval process:

While it was a lengthy and labor-intensive process, obtaining IRB approval was an experience with real value, not simply a bureaucratic hurdle to overcome. Applying to the IRB required us to think deeply and critically about the goals for our research project while still in the early planning stages of the study; navigating the IRB approval process helped us make our research project both stronger and more relevant. Additionally, because we created all of our materials for the IRB application, we were ready to get started on our project as soon as the IRB approval came through, which saved us time at the beginning of our study. (317)

Smale does note that approval took five months, leading the skeptic to ask whether the same deep thinking could have been achieved in less time by another form of review.

Most of Smale's article is less of an argument than an introduction to IRBs for librarians new to the concept. (309). While it serves reasonably well for this purpose, the article unfortunately includes some factual errors that deserve correction:

• "Any study involving human subjects that meets the definition of research in the Belmont Report requires review by the IRB." (312) In fact, the Belmont Report has no legal force, and it is the definition of research in 45 CFR 46 that determines the need for IRB review. That this definition does not match the definition in the Belmont Report suggests the imprecision of the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (More on this in Ethical Imperialism.)



• "There are three levels of IRB review—exempt, expedited, and full. The IRB evaluates each research project and determines the level of review required; researchers may not make this determination on their own." (312) Exempt means exempt; it is not a level of IRB review. The regulations do not forbid researchers from making the exempt determination. And not even OHRP's recommendations insist that an IRB be involved in that determination.



• "Certain types of studies automatically meet the criteria for exemption set forth in the Common Rule, including research on 'normal educational practices' such as curriculum design, instruction, and assessment. Research involving use of previously collected data is also usually exempt. In both cases the subjects' anonymity must be preserved." (313) The "normal educational practices" exemption, 45 CFR 46.101(b)(1), imposes no requirement of anonymity. The existing data exemption, 45 CFR 46.101(b)(4), does not require anonymity if the data are publicly available.



• "Library research projects that include procedures in which the researcher is in direct contact with the subject will usually be required to undergo expedited review by the IRB." (315) Perhaps this is the practice at Smale's institution, but the regulations exempt this kind of research unless "any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation." [45 CFR 46.101(b)(2)]. This would not seem the case in the kind of research Smale proposes concerning "the use of space in the library" or "collaboration between the library and the campus writing center." (318)



• "It is worth noting that the underlying principles used by the IRB to evaluate projects involve ethical treatment of subjects and preservation of privacy and are similar to the recommendations of many discipline-specific professional organizations, including the Oral History Association and the American Anthropological Association." (316). For over a decade, the Oral History Association has been fighting IRB requirements and insisting on the differences between the ethics of medical research and the ethics of oral history. Smale does cite the CITI Program in support of this assertion, but she fails to notice that the CITI Program offers no support for its statement.
{See comments for a correction.]

I am grateful to Smale for sharing her experience and for her kind citations to this blog and to my scholarship. But I fear that she has too readily accepted the claims of IRB administrators and training programs, leading her to advise librarians to tolerate months of delay when they should be demanding swift exemption.