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.]

AAHRPP Claims IRBs Rarely Disapprove Research

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) notes that of the organizations it surveyed (it doesn't report how many or how they were selected) 63 percent "did not disapprove any protocols in the past year" and only "13.2 percent disapproved two or more percent." The AAHRPP uses these figures to argue that the "perception that IRBs disapprove a significant portion of research protocols submitted is not true."

I wonder whom they are accusing of holding this perception. Serious observers of IRBs know that a board need not formally reject a proposal to make it impossible for the researcher to proceed. Look at what happened at Linda Thornton. Look at what happened to Kathryn Edgerton-Tarpley's student. Or the anonymous researcher who wanted to study how parents discipline their children. In these cases, researchers abandoned projects in the face of IRB intransigence, allowing the IRB to claim it had not disapproved the project.

I am therefore unsurprised by AAHRPP's figures. I am surprised that AAHRPP thinks that formal disapproval is a meaningful measure of the IRB suppression of research, and by its stooping to this straw man argument.

Against Armchair Ethics: Some Reflections from Petrie-Flom

As followers of my Twitter feed will know, I spent Friday and the first half of the Saturday at The Future of Human Subjects Research Regulation, a conference sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

The conference organizers, led by Professor Glenn Cohen, did a magnifent job bringing together participants with varied views and backgrounds, and as a group we discussed ideas ranging from treating research subjects as workers to including adolescents on IRBs. Those who want the full story should be able to watch videos of the presentations before too long.

I was struck, however, by one recurring theme: the distinction between evidence-based approaches and armchair ethics.

The Case against Ethics Review in the Social Sciences

Research Ethics has published my article, "The Case against Ethics Review in the Social Sciences." The article appeared in print in December 2011, but it has only recently appeared online.

[Zachary M. Schrag, "The Case against Ethics Review in the Social Sciences," Research Ethics 7 (December 2011): 120-131, doi:10.1177/174701611100700402]

(As of 17 May 2012, the DOI is working, but one can find the article at http://rea.sagepub.com/content/7/4/120.abstract.)

The article gathers many of the arguments made in the first five years of this blog.

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).]

Research Participants Find REB Assumptions "Stereotypical, Simplistic, and Discriminatory"

While I'm catching up on my JERHRE reading, here's an important article from the December 2011 issue. An anthropologist and a public health researcher at the University of British Columbia have found that women who use drugs resent assumptions that they are unable to consent to participating in research, and they consider participation in such research to be an absolute right.

[Kirsten Bell and Amy Salmon, "What Women Who Use Drugs Have to Say About Ethical Research: Findings of an Exploratory Qualitative Study." Journal of Empirical Research on Human Research Ethics 6, no. 4 (December 1, 2011): 84-98, DOI: 10.1525/jer.2011.6.4.84.]

Sieber and Tolich Lament "Medical Model"

The editors of the Journal of Empirical Research on Human Research Ethics call for researchers to stand up to their IRBs.

[Joan E. Sieber and Martin Tolich. "Research Ethics and Research Governance." Journal of Empirical Research on Human Research Ethics 7, no. 2 (April 2012): 1-2, DOI: 10.1525/jer.2012.7.2.1].

Community Researchers Flee the CITI

An article in the latest issue of the Journal of Empirical Research on Human Research Ethics finds that standard research ethics training programs--specifically the mortifyingly stupid CITI Program--are inappropriate for Community-Engaged Research (CEnR).

[Anderson, E., S. Solomon, E. Heitman, J. Dubois, C. Fisher, R. Kost, M. Lawless, et al. "Research Ethics Education for Community-Engaged Research: A Review and Research Agenda." Journal of Empirical Research on Human Research Ethics 7, no. 2 (April 2012): 3, DOI: 10.1525/jer.2012.7.2.3]

Philosopher and IRB Chair Call for Repeal of IRB Exemptions

Writing in IRB: Ethics & Human Research, Mahesh Ananth and Michael Scheessele, both of Indiana University South Bend, argue against exempting all minimal-risk research from IRB review. They do so in terms that would require the repeal of the 45 CFR 46.101 exemptions, though it is not clear they understand the implications of their own argument.

[Mahesh Ananth and Michael R. Scheessele, "Exempting All Minimal-Risk Research from IRB Review: Pruning or Poisoning the Regulatory Tree?" IRB: Ethics & Human Research 34, no. 2 (April 2012): 9–14.]

Dingwall: UK May Enact Research Integrity Rules With Little Scholarly Input

Writing on social science space, Robert Dingwall warns that the United Kingdom's Economic and Social Research Council seems to be crafting burdensome regulations on research integrity without defining the problem to be solved, considering the costs of regulation, or consulting scholarly associations:

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.