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.
Conference Announcement and Call for Proposals: The Future of Human Subjects Research Regulation
The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School is pleased to announce plans for our annual conference, this year entitled: “The Future of Human Subjects Research Regulation” The one and a half day event will take place Friday, May 18 and Saturday May 19, 2012 at Harvard Law School in Cambridge, Massachusetts.
Conference Description
The U.S. Department of Health and Human Services recently released an Advanced Notice of Proposed Rulemaking (ANPRM), titled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” which proposes to substantially amend the Common Rule for the first time in twenty years. This development, as well as attention by the Presidential Commission for the Study of Bioethical Issues, suggests we are at a moment when the regulation of human subjects research is ripe for re-thinking. This conference is meant to gather leading experts from the U.S. and across the globe to assist in that rethinking.
For further information on the call and for application requirements and deadlines, please see http://www.law.harvard.edu/programs/petrie-flom/events/conferences/humansubjects/hsrconfcall.pdf
Proposals are due November 25.
Friday, November 4, 2011
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The time is now to press for a proposed rule that eliminates totally and completely regulation of the social sciences and humanities. The Obama Administration is trying to show its bona fides in deregulation. Eliminating current censorship and torture by IRBs could save tens of millions of hours and billions of dollars a year in wasted "paperwork" and "information collection" costs that are currently illegally imposed in violation of the Paperwork Reduction Act and the First Amendment. The man in charge is Cass Sunstein, head of the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget, and a former University of Chicago professor. It is time for him to earn his pay. The woman in charge is Kathleen Sibelius, Secretary of HHS. We do NOT want to wait until next spring for a conference on the ANPRM, we want a proposed rule (NPRM) this winter, aimed at eliminating IRB review of riskless social and humanities research and at preventing IRBs from even reviewing whether such research is exempt or "excluded." Send Sunstein and Sibelius a message, and enlist thinktank and other external support. Remember that the current rule actually says that 99 percent of all social science is excluded, and doesn't even bother to discuss history and the humanities, which were not ever regarded as human experimentation that even needed to be excluded. The current rule does not give IRBs any authority to review exempt research, let alone to decide whether or not it is exempt. This is a problem that can easily be solved, if only the Administration will face it frontally. The time for academic discussion is over. The time for action is now.
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