Mark Kleiman takes on IRBs at The Reality-Based Community. On April 14 he asked his readers for IRB horror stories, and on May 2 he posted some of the responses.
The saddest concerns a group of law students who wished "to send testers of different races in different styles of clothing to the restaurant over some period of time to test whether they enforced their dress code in a discriminatory manner." Law school administrators told them they would have to secure IRB approval. This discouraged the students, who did not want to go through the time and effort of the approval process.
This was not the intent of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. At its 15 April 1978 meeting, the commission discussed just such a scenario (pp. II-5 to II-21 of the transcript), and all the members seemed to agree that such testing for discrimination should not require IRB review. But, as I've noted before, the commission wrote a definition of human subjects research that plausibly includes a great deal of activity the commission did not seek to regulate. Thirty years later, justice suffers as a result of the commission's sloppiness.
NOTE: In honor of Professor Kleiman's search, I have gone back through this blog to add the "horror stories" tag to some posts that should have had it to begin with. Clicking on that tag now yields more than a dozen posts, with even more documented horror stories.
Wednesday, May 13, 2009
Friday, May 8, 2009
Journal of Policy History
The Journal of Policy History has published my article, "How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991." As permitted by the transfer of copyright, I have posted a PDF on my personal website: http://www.schrag.info/research/howtalking.html.
Not much has changed since I posted a version on SSRN in April 2008. The major changes come in the "medical origins" section; the earlier draft underestimated the strength of social scientists' opposition to IRB rules in the late 1960s. Also, the new version better explains the origins of Ithiel de Sola Pool's concern about IRBs (see p. 18).
Not much has changed since I posted a version on SSRN in April 2008. The major changes come in the "medical origins" section; the earlier draft underestimated the strength of social scientists' opposition to IRB rules in the late 1960s. Also, the new version better explains the origins of Ithiel de Sola Pool's concern about IRBs (see p. 18).
Tuesday, May 5, 2009
DeGette Still Doesn't Get It
Representative Diana DeGette (D-CO) has introduced the Protection for Participants in Research Act (H.R. 1715), which would impose IRB requirements on all human subject research supported by the federal government or affecting interstate commerce.
As amp&rsand notes, this is the sixth time DeGette has introduced this bill. And I don't think that counts earlier submissions of similar bills by Senator John Glenn. None of these previous efforts went far, so there's no particular reason to fear this bill's passage.
Still, it is disappointing that DeGette has introduced this bill six times without understanding its potential consequences. Her press release states that “I think one thing we can all agree on in a bipartisan way is that we need to encourage medical experimentation but we need to do it in a way that both protects the patients and gives them informed consent about what they are getting into," as if the bill would affect only medical experimentation. It points to medical trials in 1999 and 2006 as evidence of insufficient oversight, and argues that "research is the key to innovation and discovery, including curing deadly disease." Nowhere in the press release is a hint that DeGette understands that her bill would outlaw most journalism, not to mention further inhibiting social science and humanities research.
Thirty-five years after the passage of the National Research Act, Congress still doesn't know what it has done.
Bonus question for Rebecca Tushnet's 43(B)log: Is the copyright claim on DeGette's press release--the work of a federal employee in her official capacity--illegal, or merely false?
Update 8 May 2009: A correspondent notes that the copyright statement is no longer on the site. If DeGette removed the statement in response to this blog, good for her. I have a PDF of the press release as it appeared on May 4, if anyone is interested.
As amp&rsand notes, this is the sixth time DeGette has introduced this bill. And I don't think that counts earlier submissions of similar bills by Senator John Glenn. None of these previous efforts went far, so there's no particular reason to fear this bill's passage.
Still, it is disappointing that DeGette has introduced this bill six times without understanding its potential consequences. Her press release states that “I think one thing we can all agree on in a bipartisan way is that we need to encourage medical experimentation but we need to do it in a way that both protects the patients and gives them informed consent about what they are getting into," as if the bill would affect only medical experimentation. It points to medical trials in 1999 and 2006 as evidence of insufficient oversight, and argues that "research is the key to innovation and discovery, including curing deadly disease." Nowhere in the press release is a hint that DeGette understands that her bill would outlaw most journalism, not to mention further inhibiting social science and humanities research.
Thirty-five years after the passage of the National Research Act, Congress still doesn't know what it has done.
Bonus question for Rebecca Tushnet's 43(B)log: Is the copyright claim on DeGette's press release--the work of a federal employee in her official capacity--illegal, or merely false?
Update 8 May 2009: A correspondent notes that the copyright statement is no longer on the site. If DeGette removed the statement in response to this blog, good for her. I have a PDF of the press release as it appeared on May 4, if anyone is interested.
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