Literature DB >> 16625733

The nanny state meets the inner lawyer: overregulating while underprotecting human participants in research.

C K Gunsalus1.   

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.

Entities:  

Keywords:  Biomedical and Behavioral Research; Legal Approach

Mesh:

Year:  2004        PMID: 16625733     DOI: 10.1207/s15327019eb1404_7

Source DB:  PubMed          Journal:  Ethics Behav        ISSN: 1050-8422


  6 in total

1.  Education Research and Human Subject Protection: Crossing the IRB Quagmire.

Authors:  Gail M Sullivan
Journal:  J Grad Med Educ       Date:  2011-03

2.  Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.

Authors:  Hanna Ezzat; Sue Ross; Peter von Dadelszen; Tara Morris; Robert Liston; Laura A Magee
Journal:  BMC Health Serv Res       Date:  2010-07-30       Impact factor: 2.655

3.  Understanding bureaucracy in health science ethics: toward a better institutional review board.

Authors:  Barry Bozeman; Catherine Slade; Paul Hirsch
Journal:  Am J Public Health       Date:  2009-07-16       Impact factor: 9.308

4.  Restoring balance: a consensus statement on the protection of vulnerable research participants.

Authors:  James M DuBois; Laura Beskow; Jean Campbell; Karen Dugosh; David Festinger; Sarah Hartz; Rosalina James; Charles Lidz
Journal:  Am J Public Health       Date:  2012-10-18       Impact factor: 9.308

5.  Survey of U.S. Boards that Review Mental Health-related Research.

Authors:  Joseph A Catania; Bernard Lo; Leslie E Wolf; M Margaret Dolcini; Lance M Pollack; Judith C Barker; Stacey Wertlieb; Jeff Henne
Journal:  J Empir Res Hum Res Ethics       Date:  2008-12       Impact factor: 1.742

6.  Reporting ethics committee approval in public administration research.

Authors:  Sara R Jordan; Phillip W Gray
Journal:  Sci Eng Ethics       Date:  2013-04-12       Impact factor: 3.525

  6 in total

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