Regulatory Paradox in the Protection of Human Research Subjects: A Review of Ohrp Enforcement Letters
Temple University - James E. Beasley School of Law
Conrad O'Brien Gellman & Rohn, P.C.
Northwestern University Law Review, Vol. 101, No. 2, 2007
Temple University Legal Studies Research Paper No. 25
Institutional Review Boards (IRBs) are required, on behalf of universities and other research institutions, to ensure that research on human subjects comports with indeterminate standards of beneficence, justice and autonomy. Writing in 2001, the National Bioethics Advisory Commission (NBAC) complained that IRBs were overwhelmed not only by high workloads and limited resources but also a regulatory system that often distracts from rather than focuses on key ethical issues. Because the quality of an IRBs deliberations, let alone the accuracy of its ethical decisions, cannot readily be verified, institutional compliance with federal regulations is measured almost entirely by review of records and consent forms. NBAC concluded that this emphasis by regulators on procedure is frustrating to IRBs and investigators and also contributes to an atmosphere in which review of research becomes an exercise in avoiding sanctions and liability rather than in maintaining appropriate ethical standards and protecting human participants.
The federal Office for Human Research Protection (OHRP) is the primary government agency responsible for enforcing the federal human subject protection regulations, known as the Common Rule, overseeing research at the more than 10,000 federally funded institutions in the country. The OHRP was created in 2000 in response to alleged failures by IRBs and calls for a stronger regulatory oversight role for federal government. Reflecting a trend toward strong protectionism in human subject research, the oversight budget and staff have grown significantly.
In this article, we examine OHRP's enforcement letters between January 1, 2002 and June 30, 2004. We find no improvement since NBAC's report, but also that blaming the agency is too simple. The heart of the problem is the paradoxical scheme of embedding virtue in federal regulations, and then constructing an enforcement system that purports to encourage deliberation but in fact enforces procedural diligence and paperwork through top-down command and control methods. This is not to say that the Common Rule is a complete failure; on the contrary, we think IRBs regularly improve the ethicality of studies and help promote ethical consciousness in researchers. It does suggest that fundamental changes in the system will be required to solve the problems identified by NBAC and other critics.
Number of Pages in PDF File: 45
Keywords: Institutional Review Boards, Research, ImplementationAccepted Paper Series
Date posted: September 27, 2006 ; Last revised: December 9, 2012
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