Qualitative Sociologists Find Standard Randomness

Sociologists Sarah Babb, Lara Birk, and Luka Carfagna surveyed qualitative sociologists about their IRB experiences and heard many of the usual horror stories, from insistence on inappropriate consent forms to the dribbling out of concerns over several rounds of comments. Few of their respondents are happy with the present system, though getting the right people in key positions can help.

[Sarah Babb, Lara Birk, and Luka Carfagna, “Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation,” American Sociologist, October 6, 2016, 1–17, doi:10.1007/s12108–016–9331-z. Note: I read a version of this article in manuscript and am so credited in the article.]

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.]

Horror Story Buffet

We end the year with two collections of IRB horror stories.

[Varma, R. “Questioning Professional Autonomy in Qualitative Inquiry.” IEEE Technology and Society Magazine 33, no. 4 (winter 2014): 57–64. doi:10.1109/MTS.2014.2363983; Glenda Droogsma Musoba, Stacy A. Jacob, and Leslie J. Robinson, The Institutional Review Board (IRB) and Faculty: Does the IRB Challenge Faculty Professionalism in the Social Sciences? Qualitative Report 19 (2014), Article 101, 1-14, http://www.nova.edu/ssss/QR/QR19/musoba101.pdf]

Report from the National Academies Workshop

Last week I attended the Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop sponsored by the National Academies.

I live-tweeted the event on my @IRBblog account, and I have collected those tweets on Storify.

What follows are what I consider some of the key messages from selected presenters. The statements following each name represent my summary of the remarks, not necessarily a quotation or paraphrase.

Is Ethics Review Like a Building Permit?

In the course of his response to Dyck and Allen, David Hunter also challenges claims by Whitney and Schneider that ethics review costs lives by delaying research for months or years. I am unpersuaded by Hunter's claims.

REB Member: Make Review Process Educative, Not Regulatory

Dominique Rivière, an education researcher at the University of Toronto, reports that REB service left her somewhat less critical of the ethics-review process, but she still calls for significant reform.

[Dominique Rivière, "Looking from the Outside/In: Re-thinking Research Ethics Review." Journal of Academic Ethics 9, no. 3 (2011): 193–204. DOI: 10.1007/s10805-011-9139-y]

Minimal Risk Approval: 27 months, $170,000

A team of health services researchers found that getting approval for a minimal risk study took 27 months and consumed $170,000 in staff time.

[Laura A. Petersen, Kate Simpson, Richard SoRelle, Tracy Urech, and Supicha Sookanan Chitwood, "How Variability in the Institutional Review Board Review Process Affects Minimal-Risk Multisite Health Services Research," Annals of Internal Medicine 156, no. 10 (May 15, 2012): 728–735. h/t Human Subject News.]

IRBs Misunderstand Researchers' Complaints

A study of IRB chairs, members, and staff finds that they understand that researchers regard them as powerful actors, "Yet IRBs may misperceive PI complaints."

[Robert Klitzman, "The Ethics Police?: IRBs’ Views Concerning Their Power," PLoS ONE 6 (2011): e28773. doi:10.1371/journal.pone.0028773. h/t Roberto Veloso]

PRIM&R: Efficiency Is Not an Ethical Value

Before moving on to other subjects, I wish to note one last passage in the PRIM&R response to the ANPRM:

The stated purpose of issuing this ANPRM is to make the process of human subjects protection more efficient. We fully recognize the potential benefits of accomplishing this goal. But we also want to note that efficiency itself is not a moral imperative or even an ethical value; human subjects protection should not be compromised by a desire for increased efficiency, a view we believe OHRP shares.

Really?

Is there no ethical problem when bright, curious undergraduates are forbidden from seeking answers to their questions? When a researcher abandons a project after months of inaction by the IRB? Or finds that by the time she gets approval, she has missed the chance to do her research? When IRB inefficiency delays medical research that can save lives?

I had thought that PRIM&R recognized justice as an ethical value. And justice delayed is justice denied.

Australian Political Scientist: "Causing Harm . . . May Be the Whole Point"

Anthony Langlois, Associate Professor in the Department of International Relations at Flinders University, Adelaide, Australia, and a former member and chair of that university's Social and Behavioural Research Ethics Committee, finds that Australia's 2007 National Statement on Ethical Conduct in Human Research is an improvement over earlier policies, but that it still leaves an "ill fit between the requirements of [the medical] model of research ethics review and the nature of humanities and social sciences research."

[Anthony J. Langlois, "Political  Research  and  Human  Research  Ethics  Committees," Australian Journal of Political Science 46 (2011): 139-154, DOI: 10.1080/10361146.2010.544287. Also available as a preliminary preprint. Thanks to Professor Langlois for mentioning the essay on socialsciencepsace.com.]

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.

Princeton IRB Delays Student Research

The Daily Princetonian reports a sociology major's difficulties getting IRB approval for her senior thesis on Brazilian immigrants' changing perceptions of gender roles.

"It's such a long process that it thwarts your field work efforts," [Christine] Vidmar said, noting that the review board does not meet to approve proposals during the summer. "I've been waiting since I got back to school. The first deadline that I could apply for was in October. It's November now, and I still can't officially go do my interviews."

. . .

Vidmar noted that a well-researched thesis may require up to a year of field work, adding that review board hurdles make it more challenging to complete sufficient research. "If you're a senior and you don't have a thesis chosen by the spring of junior year then you can't start field research until November or December of senior year, which is really late," she said. "You need to be in the field in order to know what questions you're going to ask, but in order to be in the field you need to have given the IRB your questions ahead of time."

As horror stories go, this one is mild. But consider the following:

• While details are lacking, Vidmar's proposed research sounds to be exempt under federal regulations; she's just interviewing adults about their perceptions of gender.
  
• Princeton demands full board review for "almost all proposals," offering expedited review only on "an exception basis."
  
• The IRB does not meet for three and a half months in the summer and requires proposals to be submitted two weeks in advance of the meeting. Hence, a student who misses the late-May deadline must wait almost four months until late September for review.
  

Put these together, and it seems that Princeton has built a substantial impediment to students who would like to interact with people as a capstone to their undergraduate training but are unable to write detailed research protocols six months in advance.

This is not to say that undergraduates should be sent into the field without training or supervision. But review by at the department level, as suggested by Felice Levine and Paula Skedsvold; subcommittee review, as practiced at Macquarie University; or researcher certification as permitted at the University of Pennsylvania, might well achieve the same or better levels of oversight as full-board review without delaying the work and discouraging the curiosity of a student researcher.