Hostname: page-component-f554764f5-qhdkw Total loading time: 0 Render date: 2025-04-15T08:36:26.702Z Has data issue: false hasContentIssue false
  • English
  • Français

Human Subjects Protection and Large-N Research: When Exemptis Non-Exempt and Research is Non-Research

Published online by Cambridge University Press:  18 June 2008

Mitchell A. Seligson
Mitchell A. Seligson
Affiliation:
Vanderbilt University
Get access Rights & Permissions [Opens in a new window]

Extract

Social scientists are well aware of the unintended consequences of public policies. Theprotection of human subjects regulations, which emerged in response to a serious problem inthe medical community, provides an ideal example of such unintended consequences; toparaphrase an old aphorism, “the road to bureaucratic hell is paved with well-intentionedpublic policies.” In this essay I will seek to make three points. First, the protection ofhuman subjects by federal regulation was long overdue. Second, this benefit to society has,in its application, ignored another widely accepted regulatory principle, namely that thecosts of regulation should not outweigh its benefits; a combination of “bureaucratic creep”and litigation phobia has resulted in intrusive and counterproductive regulation of socialscience research, such that the cure has become worse than the disease. Third, ironically,because of institutional review boards' definition of what is and what is not research, theprotection of human subjects is denied to subjects who actually could be at risk.

Type
Symposium—Protecting Human Research Participants, IRBs, and Political Science Redux
Information
PS: Political Science & Politics , Volume 41 , Issue 3 , July 2008 , pp. 477 - 482
Copyright
Copyright © The American Political Science Association 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Article purchase

Temporarily unavailable

References

American Association of University Professors. 2006. “Research on Human Subjects: Academic Freedom and the Institutional Review Board.” Washington, D.C.Google Scholar
Fenno, Richard F. 1996. Senators on the Campaign Trail: The Politics of Representation. Norman: University of Oklahoma Press.Google Scholar
HHS. 1981. Federal Policy for the Protection of Human Subjects (45 CFR 46): Subpart A (Common Rule). Code of Federal Regulations. Office for Human Research Protections.Google Scholar
Katz, Jack. 2007. “Toward a Natural History of Ethical Censorship.” Law and Society Review 41 (4): 797–810.CrossRefGoogle Scholar
Miller, Arthur G. 1986. The Obedience Experiments: A Case Study of Controversy in Social Science. New York: Praeger.Google Scholar
National Commission for the Protection of Human Subjects of Biomedical, and Behavioral Research. 1979. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education, and Welfare. Washington, D.C.: U.S. Government Printing Office.Google Scholar
Townsend, Robert B. 2004. AHA Council Reaffirms Position on Oral History and Institutional Review Boards. Press Release. American Historical Association. http://www.historians.org/press/2004_06_08_Council_IRBs.htm (March 23, 2008).Google Scholar