The Nanny State Meets the Inner Lawyer: Overregulating While Underprotecting Human Participants in Research

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. Thi...

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Bibliographic Details
Published inEthics & behavior Vol. 14; no. 4; pp. 369 - 382
Main Author Gunsalus, C. K.
Format Journal Article
LanguageEnglish
Published United States Lawrence Erlbaum Associates, Inc 01.10.2004
Taylor & Francis Ltd
Subjects
Behavioral Research - ethics
Behavioral Research - legislation & jurisprudence
Behavioral Research - methods
Behavioral Research - standards
Colleges & universities
Cost-Benefit Analysis
Ethical Review
Ethics Committees, Research
Government Regulation
Human subjects
Humans
Interviews as Topic
Journalism
Narration
Risk Assessment
United States
Universities
United States
Legal Approach
Biomedical and Behavioral Research
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Summary: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.
ISSN:1050-8422
1532-7019
DOI:10.1207/s15327019eb1404_7