Problems with minimal-risk research oversight: A threat to academic freedom?

IRB Ethics and Human Research

Volumn 31, Issue 3, 2009, Pages 11-16

  Rasmussen, Lisa M ^a  

^a UNIVERSITY OF NORTH CAROLINA AT CHARLOTTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HUMAN; PROFESSIONAL PRACTICE; PROFESSIONAL STANDARD; RESEARCH ETHICS; RISK ASSESSMENT; UNITED STATES;

ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; PROFESSIONAL AUTONOMY; RISK ASSESSMENT; UNITED STATES;

EID: 67649958112     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants research: Identifying problems to evaluate reform proposals. Annals of Internal Medicine 2004:141 (4) :282-291.
2. American Association of University Professors, Committee A. Research on human subjects: Academic freedom and the institutional review board, 2006, http://www.aaup.org/AAUP/comm/rep/A/humansubs.htm.
3. See ref. 2, American Association of University Professors 2006.
4. Russell C. Academic Freedom. London, U. K.: Routledge, 1993, p. 5.
5. See ref. 4, Russell 1993, p. 4.
6. See Streiffer R, Academic freedom and academic-industry relationships in biotechnology. Kennedy Institute of Ethics Journal 2006;16 (2) :129-149.
7. American Association of University Professors. 1940 statement of principles on academic freedom and tenure, http://www.aaup.org /AAUP/pubsres/policydocs/contents/194ostatement.htm.
8. See ref. 6, Streiffer 2006, for discussion of academic freedom in a related context.
9. See ref. 2, American Association of University Professors 2006.
10. Emanuel et al., for example, cite a long list of structural, procedural, and assessment problems with IRBs, none of which are alleged to be a threat to academic freedom. See ref. 1, Emanuel et al. 2004.
11. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46.102 (i).
12. Examples given in contrast with this claim that also meet the description of research advanced by the report, include Humphreys L. Tearoom Trade: Impersonal Sex in Public Places. Chicago, IL: Aldine Publishing Company, 1970;
13. and Thomas J, When cyber-research goes awry: The ethics of the Rimm "cyberporn" study. The Information Society I996:12 (2) :189-197, http://venus.soci.niu.edu/~cudigest/rimm /go.jt2.
14. It is worth noting the many levels of oversight that journalists nevertheless experience from their editors, publishers, and risk management departments.
15. See ref. 2, American Association of University Professors 2006.
16. American Association of University Professors. Institutional review boards and social science research, 2000, http://www.aaup.org /AAUP/comm/rep/A/protecting.htm.
17. American Association of University Professors. Protecting human beings: Institutional review boards and social science research. Academe 2001;87:3, http://findarticles.com/p/articles/mi-qa3860/is-200105/ai-n893977o/ pg-1.
18. See ref. 16, American Association of University Professors 2001.
19. See Department of Health and Human Services. Protection of Human Subjects 45 CFR 46, subpart D, for the exception in federal regulations that would allow direct federal review of protocols for some research involving children. This seems to be a fairly rare occurrence; Wendler and Varma point out that as of 2005, only 17 protocols have ever been recommended for such reviews. See Wendler D, Varma S. Minimal risk in pediatric research. Journal of Pediatrics 2006;149:855-861.
20. One ought to bear in mind here other possible instances of selfcensorship, such as the reluctance to publish criticisms of one's department colleagues. These are probably not best construed as academic freedom issues but rather, for example, choices to weigh collegial relations more heavily than the need to publish a particular argument.
21. See ref. 2, American Association of University Professors 2006, section 2.
22. This point is made by Bruce Bridgeman, IRB chair at the University of California, Santa Cruz, in a response letter to the report (Bridgeman B. Letter to the editor. Academe 2006;92 (1) :6.) The AAUP report's authors responded in the same column. The possibility of legal appropriation of research records is also discussed in reference to the Brajuha case. See ref. 12, Thomas 1996;
23. Thomas J. "Big brother" or allies? In defense of IRBs and RCR. SSSI Notes 2001, http://venus.soci. niu.edu/~jthomas/ethics/sssieth.html. It is not clear how strong a point this is. Perhaps a university could choose to offer legal representation to researchers in alternative models as well, but it may not be obliged to do so.
24. See ref. 21, Thomas 2001.
25. Grady C. Quality improvement and ethical oversight. Annals of Internal Medicine 2007;146 (9) :677-678, at 678.