Harvard Law Today Reports on ANPRM Conference

Harvard Law Today, published by Harvard Law School, reports on May's conference on the ANPRM, held at the school's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.

["The Future of Human Subjects Research Regulation," Harvard Law Today, July 2012.]

The article highlights the plenary address by Greg Koski, former director of OHRP.

Koski said regulation has been dominated by human-subject protectionism and an ethical-review system that has “devolved to regulatory compliance oversight.” The result, he said, is a system that is “inefficient and burdensome.” His recommendation, he said, was to replace the current system with one modeled after medical training and certification.

He said: “If we were able to develop a paradigm of professionalism in human research, it would likely be every bit as effective, less costly, less burdensome and more efficient than the protectionist, compliance-focused system that we are now seeking to reform. I would argue that reform of our current system is perhaps not the most appropriate or even adequate approach to try to achieve the goals that we seek.”

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.]

Emmerich Reviews Behind Closed Doors and Ethical Imperialism

Nathan Emmerich of Queen's University, Belfast, finds that Laura Stark's book and my own "together . . . illustrate the nature of ethics as an aspect of research governance fundamentally contributing to our understanding of the phenomena in a manner that goes beyond the relatively limited or restricted consideration offered by applied ethical analysis."

[Nathan Emmerich, Review of Behind Closed Doors: IRBs and the Making of Ethical Research and Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009, Sociological Research Online 17, Issue 2 (May 2012).]

I Hope You All Get Pox

This is a little off-topic for the blog, but to understand the IRB system, it helps to understand the history of the U.S. Public Health Service, and to understand the history of the U.S. Public Health Service, it helps to read Michael Willrich's Pox: An American History, which I just finished reading and am very glad to plug.

The history of public health is a struggle between the desire for liberty and the desire for health, since many of the most effective public health measures--quarantine, health codes, compulsory vaccination, and perhaps bans on 20-ounce soft drinks--are also infringements of liberty. Willrich's account of smallpox at the turn of the twentieth century does a marvellous job at presenting both sides of this struggle. It explains laypeople's legitimate fears about the doctors and health officers who came to snatch them and their children, but also why those health officers took pride in their snatching. We may wonder who in today's IRB debate most resembles the arrogant vaccinators of a century ago: researchers seeking scientific progress, or ethics boards seeking to restrain them?

Limited-Time Offer! Act Now!

SAGE has kindly made my article, "The Case against Ethics Review in the Social Sciences," free to access for a month. Download it while you can!

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

"Community Members" Play Murky Roles

Robert Klitzman continues to publish findings from his 2007-2009 series of interviews with 46 IRB chairs, directors, administrators, and members. In an Academic Medicine article, he finds that IRBs' "community members" struggle because their "roles can be murky."

Robert Klitzman, "Institutional Review Board Community Members," Academic Medicine 87 (July 2012), doi: 10.1097/ACM.0b013e3182578b54, post author corrections version, 22 May 2012.]

Study Finds IRBs Often Fail to Discuss Common Rule Criteria

The Common Rule [45 CFR 46.111(a)] requires IRBs to determine that each protocol they approve satisfies seven requirements: risks are minimized, risks are reasonable, selection of subject is equitable, informed consent is sought, informed consent is documented, safety is monitored when appropriate, and privacy and confidentiality are protected when appropriate. A team of researchers has found that "the IRB made clear determinations on all relevant criteria for 20 of the 104 (19%) protocols" they examined.

[Charles W. Lidz, Paul S. Appelbaum, Robert Arnold, Philip Candilis, William Gardner, Suzanne Myers, and Lorna Simon. "How Closely Do Institutional Review Boards Follow the Common Rule?" Academic Medicine 87 (July 2012), doi: 10.1097/ACM.0b013e3182575e2e, post author corrections version, 22 May 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]

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.]