Understanding bureaucracy in health science ethics: Toward a better institutional review board

American Journal of Public Health

Volumn 99, Issue 9, 2009, Pages 1549-1556

  Bozeman, Barry ^b   Slade, Catherine ^a   Hirsch, Paul ^b  

^a ARIZONA STATE UNIVERSITY   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

HEALTH CARE ORGANIZATION; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HUMAN; INSTITUTIONAL REVIEW; MEDICAL CARE; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; PRACTICE GUIDELINE; REVIEW;

BIOMEDICAL RESEARCH; ETHICS COMMITTEES, RESEARCH; ETHICS, INSTITUTIONAL; ETHICS, MEDICAL; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; LEAD POISONING; MODELS, ORGANIZATIONAL; RESEARCH SUBJECTS; RESEARCHER-SUBJECT RELATIONS; SYPHILIS;

EID: 69049092740     PISSN: 00900036     EISSN: 15410048     Source Type: Journal    
DOI: 10.2105/AJPH.2008.152389     Document Type: Review

References (47)

1. Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health. 1997;87:1773-1778.
2. Moore RD, Stanton D, Gopalan R, Chaisson RE. Racial differences in the use of drug therapy for HIV disease in an urban community. N Engl J Med. 1994;330:763-768.
3. Mervis J. Minority faculty. New data in chemistry show 'zero' diversity. Science. 2001;292:1291-1292.
4. Lewin ME, Rice B. Balancing the Scales of Opportunity: Ensuring Racial and Ethnic Diversity in the Health Professions. Washington, DC: National Academy Press; 1994.
5. Gray BH. Institutional review boards as an instrument of assessment: research involving human subjects in the U.S. Sci Technol Human Values. 1978; Fall(25).
6. Grimes v Kennedy Krieger Institute Inc, 782a 2d (MD 2001).
7. Bozeman B, Hirsch P. Science ethics as a bureaucratic problem: IRBs, rules, and failures of control. Policy Sci. 2006;38:269-291.
8. Lane EON. Decision-making in the Human Subjects Review System [doctoral dissertation]. Atlanta: Georgia Institute of Technology; 2005.
9. Bozeman B. Bureaucracy and Red Tape. Upper Saddle River, NJ: Prentice Hall; 2000.
10. La Porte T, Consolini P. Theoretical and operational challenges of "high-reliability organizations": air-traffic control and aircraft carriers. Int J Public Adm. 1998;21:847-852.
11. Romzek BS, Dubnick MJ. Accountability in the public sector: lessons from the Challenger tragedy. Public Adm Rev. 1987;47:227-238.
12. Perrow C. Normal Accidents: Living With High-Risk Technologies. New York, NY: Basic Books; 1984.
13. Jones JH, Tuskegee Institute. Bad Blood: The Tuskegee Syphilis Experiment. New York, NY: Free Press; 1993.
14. Timeline - The Tuskegee Syphilis Study: A Hard Lesson Learned. Atlanta, GA: Centers for Disease Control and Prevention; 2004. Available at: http://www.cdc.gov/tuskegee/timeline.htm. Accessed March 4, 2009.
15. Rosser SV. An overview of women's health in the US since the mid-1960s. Hist Technol. 2002;18:355-369.
16. Corbie-Smith G, Miller WC, Ransohoff DF. Interpretations of 'appropriate' minority inclusion in clinical research. Am J Med. 2004;116:249-252.
17. Kaiser J. Human subjects. Court rebukes Hopkins for lead paint study. Science. 2001;293:1567-1569.
18. Kaiser J. Lead paint trial castigated. Science Now. 2001;4.
19. Lewin T. U.S. investigating Johns Hopkins study of lead paint hazard. New York Times. August 24, 2001;A:11.
20. Leighton J, Klitzman S, Sedlar S, Matte T, Cohen NL. The effect of lead - based paint hazard remediation on blood lead levels of lead poisoned children in New York City. Environ Res. 2003;92:182-190.
21. Grimes v Kennedy Krieger Institute Inc and Higgins v Kennedy Krieger Institute Inc, No. 128 and 129 (MD Sept. term 2000), Appellee's motion for partial reconsideration and modification of opinion (filed September 17, 2000).
22. Farmer P. Infections and Inequalities: The Modern Plagues. Berkeley, CA: University of California Press; 1999.
23. Brown GE. The mother of necessity: technology policy and social equity. Sci Public Policy. 1993;20:411-416.
24. Johnson EB, Jackson L, Hooley D, Lee B. Dissenting opinion. In: Unlocking the Future: Toward a New National Science Policy. Washington, DC: US House of Representatives Committee on Science; 1998.
25. Ross LF. In defense of the Hopkins lead abatement studies. J Law Med Ethics. 2002;30:50-57.
26. Spriggs M. Canaries in the mines: children, risk, non-therapeutic research, and justice. J Med Ethics. 2004;30:176-181.
27. Candilis PJ, Lidz CW, Arnold RM. The need to understand IRB deliberations. IRB. 2006;28:1-5.
28. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med. 2004;141:282-291.
29. Kefalides PT. Research on humans faces scrutiny; new policies adopted. Ann Intern Med. 2000;132:513.
30. Larson E, Bratts T, Zwanziger J, Stone P. A survey of IRB process in 68 U.S. hospitals. J Nurs Scholarsh. 2004;36:260-264.
31. Shaul R. Reviewing the reviewers: the vague accountability of research ethics committees. Crit Care. 2002;6:121-122.
32. Rushing WA. Organizational rules and surveillance: propositions in comparative organizational analysis. Adm Sci Q. 1966;10:423-443.
33. Zhou X. The dynamics of organizational rules. Am J Sociol. 1993;98:1134-1166.
34. March JG, Schulz M, Zhou X. The Dynamics of Rules Change in Written Organizational Codes. Palo Alto, CA: Stanford University Press; 2000.
35. Dunn CM, Chadwick G. Protecting Study Volunteers in Research - a Manual for Investigative Sites. Boston, MA: CenterWatch Inc; 1999.
36. Pollak J. The lead-based paint abatement repair and maintenance study in Baltimore: historic framework and study design. J Health Care Law Policy. 2002;6:89-108.
37. Gunsalus CK. The nanny state meets the inner lawyer: overregulating while underprotecting human participants in research. Ethics Behav. 2004;14:369-382.
38. Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J. The limitations of "vulnerability" as a protection for human research participants. Am J Bioeth. 2004;4:44-49.
39. Putney SB, Gruskin S. Time, place, and consciousness: three dimensions of meaning for US institutional review boards. Am J Public Health. 2002;92:1067-1070.
40. Goldman J, Katz MD. Inconsistency and institutional review boards. JAMA. 1982;248:197-202.
41. Barnes M, Florencio PS. Financial conflicts of interest in human subjects research: the problem of institutional conflicts. J Law Med Ethics. 2002;30:390-402.
42. Surowiecki J. The Wisdom of Crowds: Why the Many Are Smarter Than the Few and How Collective Wisdom Shapes Business, Economies, Societies and Nations. 1st ed. New York, NY: Doubleday; 2004.
43. Kennedy M. Generalizing from single case studies. Eval Rev. 1979;3:661-678.
44. Siggelkow N. Persuasion with case studies. Acad Manage J. 2007;50:20-24.
45. White MT, Gamm JL. Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices. Account Res. 2002;9:1-16.
46. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291:476-482.
47. Bozeman B, Sarawitz D, Feeney M. Science and Inequality: Final Report to the Kellogg Foundation. Tempe, AZ: Consortium for Science, Policy and Outcomes, Arizona State University; 2007.