title: The nanny state meets the inner lawyer: overregulating while underprotecting human participants in research.
abstract: Without any systematic data or evidence of a problem, or even a thoughtful analysis of costs and benefits, the application of the human participant review system within universities is overreaching at the same time that some risky experimentation on humans outside of universities is unregulated. This article questions the purpose, feasibility, and effectiveness of current IRB approaches to most "2 people talking" situations and proposes scaling back the regulatory system to increase respect accorded it by researchers and its ability to protect human participants of research from real versus imagined harms. In too many cases, the focus is on form over ethical substance: counting what can be counted, rather than focusing instead on what counts. Some disciplines--oral history and journalism, for example--simply do not belong within the scope of institutional review board jurisdiction. Others, such as survey research, informational interviews, and informal interactions, call for a shift from centralized review to more departmentally based (i.e., rooted in disciplinary ethics) oversight, and clearer guidelines on what requires advance review as opposed to provision of post hoc complaint systems.
authors.affiliation: Office of the University Counsel, College of Law, 342 Law Bldg., University of Illinois, 504 E. Pennsylvania Avenue, Champaign, IL 61820, USA. gunsalus@uiuc.edu
authors.forename: C K
authors.initials: CK
authors.lastname: Gunsalus
mesh_terms: D035841:Behavioral Research / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000379:methods* / Q000592:standards; D003362:Cost-Benefit Analysis; D026724:Ethical Review; D028744:Ethics Committees, Research; D033161:Government Regulation; D006801:Humans; D007407:Interviews as Topic; D020452:Journalism; D033262:Narration; D018570:Risk Assessment; D014481:United States; D014495:Universities