Friday, January 23, 2015

Atran: IRBs Block Understanding of Terrorism

Interviewed by Nature, anthropologist Scott Atran reminds us that human subjects rules have impeded his efforts to understand the origins of violence like the attack on Charlie Hebdo.

[Reardon, Sara. “Looking for the Roots of Terrorism.” Nature, January 15, 2015. doi: 10.1038/nature.2015.16732. h/t Donald Pollock]

Sunday, January 18, 2015

Library Administrator Mistakes FOIA Request for Human Subjects Research

Sometime human-subjects alarmist Michael Zimmer sent requests for public documents to 30 public libraries. Though most librarians welcome requests for information, in the age of the Common Rule, you can't take anything for granted.

[Zimmer, Michael. “New Project on Privacy and Cloud Computing in Public Libraries (and Some Aftermath).” MichaelZimmer.org, January 9, 2015. h/t Rebecca Tushnet]

Zimmer reports:

One library administrator seemed to take some umbrage with my project and approach. That director emailed a larger list of library directors asking if anyone else had received my records request, noting that “There is no promise of anonymizing the data or offer to opt out of the study, which is a typically included in studies these days” and expressing surprise that my IRB would approve such a methodology. (I learned of this concern due to that director’s email being forwarded to a privacy list hosted by the ALA that I’m a subscriber to.) I’ve since replied that this methodology doesn’t involve human subjects, and follows common approaches to obtaining government information (such as the Fordham Center for Law and Information Policy’s excellent research on privacy and cloud computing in public schools). I’ll reach out to this director personally, and hopefully the concerns will be put to rest.

Sunday, January 11, 2015

Research Ethics Scales and Measures

Dr. Elizabeth Yuko kindly points me to Research Ethics Scales and Measures http://researchethicsmeasures.org/, a website run by Fordham University's Center for Ethics Education.

The website features a bibliography of publications about empirical assessments of researchers' and participants' experiences with human subjects research. Many concern medical research, particularly dealing with HIV, but they may be of interest to social researchers as well.

For additional pieces on this theme, please search this blog for the tag "empirical research."

Wednesday, December 31, 2014

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]

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.

Saturday, December 27, 2014

Canada Embraces Ethical Pluralism

The Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada have released a new version of TCPS2. Though it is not a dramatic change from the 2010 edition, it serves a reinder of how much more nimble the Canadian system is compared to the rigid U.S. regulations.

I was particularly interested in the new acknowledgement that Research Ethics Boards (REBs) do not possess a monopoly on ethical judgment:

"Activities outside the scope of research subject to REB review (see Articles 2.5 and 2.6), as defined in this Policy, may still raise ethical issues that would benefit from careful consideration by an individual or a body capable of providing some independent guidance, other than an REB. These ethics resources may be based in professional or disciplinary associations, particularly where those associations have established best practices guidelines for such activities in their discipline."

Back in 2012, I traveled to Canada to argue that "Scholarly associations know more about the ethics of particular forms of research than do national regulatory bodies," and should be more involved in articulating ethical standards and practices. Coincidence?

Friday, December 26, 2014

National Science Foundation Charged with "Non-Biomedical Science Perspective"

Rereading the e-mails mysteriously "obtained" by Public Citizen, I noticed that the White House has asked the National Science Foundation “to ensure that the ‘non-biomedical perspective is covered" in the forthcoming Notice of Proposed Rulemaking (NPRM), revising the Common Rule. Moreover, NSF "will identify places in the current regulatory text and preamble where edits are necessary to make the NPRM consistent with the January 2014 National Academy of Sciences' report that evaluated the applicability of the ideas presented in the 2011 ANPRM to the social and behavioral sciences."

[Margo Schwab to Andrea Palm, “Annotated draft reg text for Common Rule,” 29 October 2014, reproduced in Michael Carome, “Letter to Secretary Burwell Re: Common Rule NPRM,” November 20, 2014.]

This strikes me as hopeful news. The January 2014 report, though lacking in some respects, makes some sound recommendations for reform. And the NSF, which played only a minor part in writing the 1981 and 1991 regulations, is given a greater role in this round. As the sponsor of a great deal of social science research, NSF is indeed better positioned to take on this role than HHS or any other Common Rule agency.

Friday, December 12, 2014

Blog Day

Eight years of the Institutional Review Blog.

As Inside Higher Ed reported at the time

Schrag said that the problems with IRBs will probably remain for some time. “I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended,” he said. “Perhaps until then, I’m going to have to keep up the blog.”

Can't be soon enough.

Tuesday, November 25, 2014

Was OHRP Ever an Independent Watchdog?

Public Citizen is upset that NIH will get to write much of the NPRM. I don't understand why that matters.

Internal E-Mails Suggest NPRM is Coming

According to an open letter to HHS secretary Sylvia Mathews Burwell, Public Citizen obtained "very recent internal emails" among officials at the Office of Management and Budget and the Department of Health and Human Services, showing that the latter is actively working on a Notice of Proposed Rulemaking (NPRM) to revise the Common Rule.

I'll write separately about the substantive issue raised by Public Citizen. For now, the news is that as of November 13, 2014, senior officials were actively working to write an NPRM.

Well I, for one, am very interested to see what's going to happen next.