Saturday, March 30, 2013

Rivera: Faculty Researchers Are Notoriously Poor Judges of Risks

Suzanne Rivera, Associate Vice President for Research at Case Western Reserve University and member of the Secretary's Advisory Committee on Human Research Protections, responds to the AAUP's IRB report by asserting that faculty are inept at making determinations of exemption. I question this claim.

[Rivera, Suzanne A. “Academic Freedom and Responsibility |.” Bill of Health. Accessed March 28, 2013. h/t Michelle Meyer]

Monday, March 25, 2013

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.

Wednesday, March 20, 2013

National Academies Post Workshop Agenda

The National Academies has posted the agenda for their Workshop on Proposed Revisions to the Common Rule in Relation to Behavioral and Social Sciences, to be held tomorrow and Friday in Washington, D.C.

I plan to attend and to post comments to this blog. If I can establish WiFi, I may also live tweet at @IRBblog.

Sunday, March 17, 2013

On Signing the Markingson Petition

By April 1942, the Pentagon was 40 percent over budget, partly because it had been enlarged since first approved, but mostly because the original estimate of $35 million had never been realistic. Lieutenant General Brehon Somervell delayed telling Congress, but in June he finally sent Colonel Leslie Groves to appear before a House Apppropriations subcommittee.

Thursday, March 14, 2013

Tolich and Tumilty Explain TEAR

Martin Tolich and Emma Tumilty explain the origins and aims of The Ethics Application Repository (TEAR)

[Tolich, Martin, and Emma Tumilty. “Making Ethics Review a Learning Institution: The Ethics Application Repository Proof of Concept.” Qualitative Research (January 3, 2013). doi:10.1177/1468794112468476.]

Wednesday, March 13, 2013

Thursday, March 7, 2013

ANPRM Is Mostly Dead

The Chronicle of Higher Education reports that the regulatory reform process that began with the 2011 ANPRM "appears to be stuck, with little optimism for a way forward."

[Basken, Paul. “Federal Overhaul of Rules for Human Research Hits Impasse.” Chronicle of Higher Education, March 7, 2013, sec. Government. (paywall)]

Wednesday, March 6, 2013

Inside Higher Ed Reports on AAUP Recommendations

Inside Higher Ed presents the key points of the newly finalized AAUP report.

[Carl Straumsheim, “AAUP Recommends More Researcher Autonomy in IRB Reform," Inside Higher Ed, March 6, 2013.

Tuesday, March 5, 2013

AAUP Publishes Final Report, Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board

The American Association of University Professors has published the final version of Regulation of Research on Human Subjects: Academic Freedom and the Institutional Review Board, prepared by a subcommittee (of which I am a member) of the Association’s Committee A on Academic Freedom and Tenure.

The report explains,

As things now stand, the IRB system assembles local committees whose members have no special competence in assessing research projects in the wide range of disciplines they are called on to assess, whose approval is required for an only minimally restricted range of research projects and who are invited to bring to bear in assessing them an only minimally restricted body of what they take to be information, who are only minimally restricted in the demands they may make on the researchers, and whose judgments about whether to permit the research to be carried out at all are, in most institutions, final. When one steps back from it, one can find oneself amazed that such an institution has developed on university campuses across the country.

Monday, March 4, 2013

A Credible Social Assurance

I am reading Alex John London's claims that IRBs help to "provide a 'credible social assurance' to the American people that social institutions, funded by their tax dollars and empowered to advance their health and well-being, work to: respect and affirm the moral equality of all community members; prevent the arbitrary exercise of social authority; and help create a 'market' in which the diverse stakeholders, often working to advance diverse ends, collaborate in a way that advances the common good."

I am reading Carl Elliott's accounts of the difficulties he has faced trying to use the IRB system at a public university to achieve any accountability for the burying of a drug study after it did not deliver the results a drug company wanted.

And I am re-reading Allan Brandt's Cigarette Century, which explains how tobacco companies reacted to early findings that cigarette smoking causes lung cancer. They promoted the use of filter tips, which didn't trap carcinogens but did turn brown as the cigarette burned. In 1966, Philip Morris executives noted that "the illusion of filtration is as important as the fact of filtration."