Institutional Review Board Mission Creep: The Common Rule, Social Science, and the Nanny State

In: The independent review: journal of political economy, Band 11, Heft 4, S. 547-564

Abstract

Though it is agreed that some biomedical scientific research on human subjects must be externally monitored, the degree to which the government should be involved in this process is an open question. Evaluated here is the monitoring of such research by Institutional Review Boards (IRBs), arguing that the protection afforded research subjects by IRB regulation is far outweighed by the costs of implementing the program. The devolutionary process by which public institutions co-opt & "mindlessly expand" successful programs such that they can no longer perform their original functions -- mission drift -- is expanded here to include a deliberate, "nefarious" motive in co-opting such programs -- "mission creep." The history of mission creep over the past 30 years of government-sponsored IRB programs is chronicled & conceptual problems with IRBs are identified. The concepts of biomedical & behavior risk are explicated, & IRB interpretations of such risks are critiqued. Alternatives to the bureaucratic control exercised by IRBs that could truly protect research subjects -- particularly those in vulnerable populations -- are explored. References. K. Hyatt Stewart