Wednesday, November 30, 2011

Claude Fischer: Zealous IRBs Can Derail Social Studies

Claude Fischer, professor of sociology at UC Berkeley, links IRB restrictions with the death of The Statistical Abstract of the United States and fears that they and other trends "combine to increasingly blind policymakers and the public to what is going on in America."

[Claude Fischer, "Stumbling in the Dark," Made in America (blog), 22 November 2011,]

Saturday, November 26, 2011

Health Researcher Complains of "Social Science Types" and HIPAA

Since I have frequently documented the complaints of social scientists who suffer from inappopriate conditions imposed by medically oriented IRBs, it seems fair to report a story going the other way, related on a Scientific American blog by Judy Stone, MD:

This past summer, I went to India to volunteer at a hospital and to try and help them with their self-identified problem with tuberculosis. There was considerable debate as to whether or not IRB approval was necessary—my infectious disease colleagues felt it was not, as it was part of a public health initiative and the "research" was no different than that conducted every day in public health departments. The social science types at the U.S. university I was working with all insisted we obtain IRB approval, a time-consuming and, in some settings, expensive process. (Many IRBs levy an administrative charge of $1-2,000 per study). And the folks in India could have cared less, nor did they understand the fuss, as there is next to no patient privacy in their crowded facility, nor was it culturally relevant. All they wanted was help caring for their patients.

Stone does not relate what happened next: whether she did, in fact, seek IRB approval, and--if so--what level review she received or what kinds of restrictions she faced.

Ultimately, Stone blames not the social science types but flaws in the regulations and laws, especially HIPAA, which she blames for "failing to provide any protection for clinical research subjects [while] increasing research costs and probably reducing participation . . ." She hopes "that reason will prevail, and the HIPAA rules will be eliminated for clinical research."

Friday, November 25, 2011

Stark Reviews Ethical Imperialism

Laura Stark, assistant professor of sociology at Wesleyan University, reviews Ethical Imperialism for the American Journal of Sociology. She finds that the occasional "keen observation . . . is not harnessed to a broader analytic framework or explanatory apparatus."

[Laura Stark, Review of Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009 by Zachary Schrag, American Journal of Sociology 117 (November 2011): 1019-1021.]

Wednesday, November 23, 2011

Criminologists: IRB Demands Threatened Confidentiality

Two professors of criminal justice--Mitch Librett of Bridgewater State College and Dina Perrone of California State University at Long Beach--describe IRB demands that endangered research participants. They suggest that "the oversight element and informed consent requirement of IRBs may in fact represent the greatest threat to the well-being of participants, which is contrary to the mission, purpose and objective of IRBs."

[Mitch Librett and Dina Perrone, "Apples and Oranges: Ethnography and the IRB," Qualitative Research 10 (2010): 729-747, DOI: 10.1177/1468794110380548.]

Tuesday, November 22, 2011

Kojo Nnamdi Show on Common Rule Now Online

Yesterday I had the pleasure of joining Jerry Menikoff of OHRP and Kathy Hudson of NIH on an episode of the Kojo Nnamdi Show entitled, "Rethinking the "Common Rule": The Ethics of Research with Human Subjects." We received many thoughtful, informed comments and questions.

I don't think any of us said anything that will surprise those who have followed the ANPRM debate closely, but I was pleased to hear Dr. Hudson concede that "The level to which current IRB protections actually protect participants is a somewhat understudied area. And I would hope that as we put these new rules in place that we can actually try to measure how effective they are in protecting participants in research."

In other words, after 45 years of imposing IRB review on researchers, we might begin asking if it does any good.

The audio recording and a transcript are now online at the link above.

Thursday, November 17, 2011

Radio Show to Feature Menikoff, Hudson, and Me

On Monday (November 21) at 1pm, WAMU's Kojo Nnamdi Show will air "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects." Jerry Menikoff of OHRP, Kathy Hudson of NIH, and I will discuss the ANPRM.

The show airs in Washington on 88.5 FM and is streamed online.

Sunday, November 13, 2011

AAUP and Me

I earlier mentioned that I helped draft the AAUP comments in response to the ANPRM. I am pleased to report that I have since joined the AAUP's Subcommittee on Academic Freedom and the Institutional Review Board, which since 1981 has sought to keep IRB oversight within reasonable bounds.

Tuesday, November 8, 2011

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.


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.

Friday, November 4, 2011

Harvard Law School to Sponsor ANPRM Conference

Michelle Meyer of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School kindly alerted me to a conference on the ANPRM planned for May 18 and 19, 2012. The following comes from the official announcement.

Thursday, November 3, 2011

PRIM&R: IRBs Don't Write Consent Forms

PRIM&R's ANPRM comments make the helpful concession that "consent forms have become longer, more complicated, more 'legalistic,' and less useful as sources of information to potential subjects." But PRIM&R does not wish its members blamed for this trend, and claims that IRBs do not write consent forms. While this may be true in a technical sense, I believe it fails to acknowledge IRBs' share of responsibility for the problem.