The Department of Health and Human Services has announced the appointment of Dr. Jerry Menikoff as the director of the Office for Human Research Protections (OHRP). Menikoff holds degrees in medicine, law, and public policy, and has served as a law professor and public official.
A quick glance at Dr. Menikoff's CV suggests that while he has published extensively on the ethics of medical experimentation, he is written little on questions of the regulation of social science. The exception is his article, "Where’s the Law? Uncovering The Truth About IRBs and Censorship," Northwestern University Law Review 101 (2007): 791-799, which I described in a January 2007 blog entry. In that article, Menikoff suggested that the 46.101 exemptions were sufficient to avoid any conflict with the First Amendment.
Menikoff does understand that many IRBs have abused social researchers. "There are surely too many instances in which IRBs and others fail to understand, and properly administer, the regulations," he writes. (793, n. 9) Later, in a response to an Inside Higher Ed article about this blog, he wrote, "As to social science and behavioral studies, I do support reforms to relax the rules somewhat, though the claims that the system constitutes censorship under the U.S. Constitution are overkill."
It is not clear, however, that Menikoff understands how rarely the 46.101 exemptions are applied, and how much responsibility OHRP bears in their disappearance. And in his Northwestern piece, Menikoff praises OHRP for "concluding . . . that much of the work performed by oral historians, in sitting down with people and getting information from them, does not fall within the category of doing 'research.'" (798) He seems not to know that OHRP so contradicted itself that its pronouncement had no effect on most universities.
If Menikoff uses his position to revive 45 CFR 46.101, to restore the agreement with oral historians, and to correct other lapses between the regulations as written and as enforced by OHRP, his accession to the OHRP directorship will be great news not only for scholars in the social sciences and humanities, but also to participants in medical research, since resources can be reprogrammed for their protection. Under the leadership of a lawyer, perhaps OHRP will begin to obey the law.