Skip to main content

Science ethics as a bureaucratic problem: IRBs, Rules, and Failures of control

Policy Sciences volume 38, pages 269–291 (2005)Cite this article

Abstract

“Institutionalized science ethics” refers to the statutory, professional and institution-based ethical standards that guide and constrain scientists' research work. The primary institution responsible for implementing institutionalized science ethics is the Institutional Review Board. We examine the limitations of IRBs and institutionalized science ethics, using bureaucratic theory and, especially, theory related to the development and enactment of rules. We suggest that due to the very character of rules-based systems, improvements in IRB outcomes are unlikely to be achieved through either more or better rules or even by bureaucratic reform. Instead, we suggest that improvements in human subject protection can best be advanced through increased participation. Ours is not a call for more participation by the general public but participation, via “Participant Review Boards” of persons who are eligible, by the protocols of the research in question, to serve as subjects. This provides a level of legitimacy and face validity that cannot be obtained by IRB affiliates, even by “external representatives.” In making these points, we review a recent science ethics controversy, the KKI/Johns Hopkins lead paint study. In spite of being approved by IRBs, the study resulted in a civil lawsuit that reached the Maryland Court of Appeals. The case illustrates the limits of institutionalized science ethics and the bureaucracies created for their enactment. The case also underscores the complex and equivocal nature of the ethical guidelines established under the National Research Act.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

£ 29.95

Price includes VAT (United Kingdom)

References

  • Adelman, S. A. (2001). Appellee's Motion for Partial Reconsideration and Modification of Opinion; Grimes vs. Kennedy Krieger Institute, Inc.; and Higgins vs. Kennedy Krieger Institute, Inc. September.

  • Agency for Toxic Substances and Disease Registry (ATSDR), ‘US Department of Health and Human Services’ (1988). The Nature and Extent of Lead Poisoning in Children in the United States: A Report to Congress. Washington, D.C.

  • Barber, B., J. Lally, J. Makarushka and D. Sullivan (1973). Research on Human Subjects: Problems of Social Control in Medical Experimentation. New York: Russell Sage Foundation.

    Google Scholar 

  • Bell, J., J. Whiton, and S. Connelly (1998). Final Report: Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects. Arlington, VA.

  • Bernard, S. (2004). ‘Should the centers for disease control and prevention's childhood lead poisoning intervention level be lowered,’ American Journal of Public Health 93: 1253–1260.

    Google Scholar 

  • Bozeman, B. and L. DeHart-Davis (1999). ‘Red tape and clean air: Title V air pollution permitting implementation as a test bed for theory development,’ Journal of Public Administration Research and Theory 9: 141–177.

    Google Scholar 

  • Bozeman, B. (2000). Bureaucracy and Red Tape. Upper Saddle River, New Jersey: Prentice-Hall.

    Google Scholar 

  • Brown, G. E. (1993). ‘The mother of necessity: Technology policy and social equity,’ Science and Public Policy : 411–416.

  • Campbell, G. (2000). ‘United States Demographics,’ in G. C. Jr., R. Denes and C. Morrison, eds., Access Denied: Race, Ethnicity, and the Scientific Enterprise. New York: Oxford University Press, pp. 7–41.

  • Center for Disease Control (2004a). Timeline- The Tuskegee Syphillis Study: A Hard Lesson Learned.

  • Center for Disease Control (2004b). General Lead Information: Questions and Answers.

  • Chopyak, J. and P. Levesque (2001). ‘Public participation in science and technology: Decision-making: Trends for the future,’ Technology in Society 24: 155–166.

    Article  Google Scholar 

  • Cleary, R. E. (1987). ‘The impact of IRBs on political science research,’ IRB 9: 6–10.

    Article  Google Scholar 

  • Curry, D. (2001). ‘Court condemns Hopkin-approved study that exposed children to lead dust,’ Chronicle of Higher Education 7: A32.

  • DeLeon, P. (2002). ‘Policy analysis in the good society,’ The Good Society 11: 37–41.

    Article  Google Scholar 

  • DeHart-Davis, L. and S. K. Pandey (2005). ‘Red tape and public employees: Does perceived rule dysfunction alienate managers?,’ Journal of Public Administration Research and Theory 15: 133–148.

    Article  Google Scholar 

  • Dunn, C. and G. Chadwick (1999). Protecting Study Volunteers in Research: A Manual for Investigative Sites. Boston, MA: CenterWatch, Inc.

    Google Scholar 

  • Enserink, M. (2000). ‘Helsinki's new clinical rules: Fewer placebos, more disclosure,’ Science 290: 418–419.

    Article  PubMed  Google Scholar 

  • Farmer, P. (1999). Infections and Inequalities: The Modern Plagues. Berkeley: University of California Press.

    Google Scholar 

  • Ferraro, F., E. Szigeti, K. Dawes, and S. Pan (1999). ‘A survey regarding the University of North Dakota Institutional Review Board: Data, attitudes, and perceptions,’ Journal of Psychology 133: 272–280.

    Google Scholar 

  • Fluss, S. (2000). ‘How the declaration of Helsinki developed,’ Good Clinical Practice Journal 6: 18–22.

    Google Scholar 

  • Goldman, J. and M. Katz (1982). ‘Inconsistency and Institutional review boards,’ The Journal of the American Medical Association 248: 197–202.

    Article  Google Scholar 

  • Gray, B. H. (1978). ‘Institutional review boards as an instrument of assessment: Research involving human subjects in the U.S.,’ Science, Technology, and Human Values 4: 34–46.

    Google Scholar 

  • Gray, B., R. Cooke and A. Tannenbaum (1978). ‘Research involving human subjects,’ Science 201: 1094–1101.

    Article  PubMed  Google Scholar 

  • Gross, E. (1953). ‘Some functional consequences of primary controls in formal work organizations,’ American Sociological Review 18: 368–373.

    Article  Google Scholar 

  • Howard-Jones, N. (1982). ‘Human experimentation in historical and ethical perspectives,’ Social Science and Medicine 16: 1429–1448.

    Article  PubMed  Google Scholar 

  • Human, D. and S. Fluss (2001). ‘The world medical association's declaration of Helsinki: Historical and contemporary perspectives,’ http://www.wma.net/e/ethicsunit/helsinki.htm. Accessed July 29, 2004.

  • Johnson, E. B., S. Jackson Lee, D. Hooley, and B. Lee (1998). Dissenting Views to Unlocking the Future: Report of the House Science Committee Science Policy Study. Washington, D.C.

  • Jones, J. (1993). Bad Blood: The Tuskegee Syphilis Experiment. New York: Free Press.

    Google Scholar 

  • Kaiser, J. (2001). ‘Human subjects: Court rebukes Hopkins for lead paint study,’ Science 293: 1567–1569.

    Article  Google Scholar 

  • Laird, F. (1993). ‘Participatory analysis, democracy, and technological decision making,’ Science, Technology and Human Values 18: 341–361.

    Article  Google Scholar 

  • Lamphear, B. and M. Weitzman, et al. (1996). ‘Racial differences in urban children's environmental exposure to lead,’ American Journal of Public Health 86: 1460–1463.

    Article  PubMed  Google Scholar 

  • Lane, E. (2005). Decision-Making in the Human Subjects Review System. Unpublished doctoral dissertation. Atlanta, GA: School of Public Policy, Georgia Institute of Technology.

  • Lemmons, T. and B. Freedman (2000). ‘Ethics review for sale? conflict of interest and commercial review boards,’ Milbank Quarterly 78: 547–562.

    Article  PubMed  Google Scholar 

  • Lewin, T. (2001). ‘US investigating John Hopkins study of lead paint hazard,’ The New York Times August 24.

  • Moon, M. J. and S. Bretschneider (2002). ‘Does the perception of red tape constrain IT innovativeness in organizations? Unexpected results from a simultaneous equation model and implications,’ Journal of Public Administration Research and Theory 12: 273–291.

    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. Accessible at: http://ohsr.od.nih.gov/guidelines/belmont.html.

  • National Research Council (1993). Measuring Lead Exposure in Infants, Children, and Other Sensitive Populations. Washington, D.C.: National Academy Press.

    Google Scholar 

  • National Institute of Health (2005) Title 45 CFR Part 46 Protection of Human Subjects, Office of Human Subjects Research, http://www.nihtraining.com/ohsrsite/guidelines. Accessed May 6, 2005.

  • Organ, D. and C. Greene (1981). ‘The effects of formalization on professional involvement: A compensatory process,’ Administrative Science Quarterly 26: 237–252.

    Article  Google Scholar 

  • Pandey, S. K. and P. G. Scott. (2002). ‘Red tape: A review and assessment of concepts and measures,’ Journal of Public Administration Research and Theory 12: 553–580.

    Google Scholar 

  • Rodgers, J. and G. Stephenson. (2001). Kennedy Krieger, Hopkins, UMMS and Others Ask Court of Appeals to Reconsider Issues in Lead Paint Study Decision. John Hopkins Medical Institute. Sept. 17, 2001.

  • Roig-Franzia, M. and R. Weiss (2001). ‘Md. appeals court slams researchers,’ Washington Postt. August 20, 2001. Front page.

  • Ross, L. F. (2002). ‘In defense of the Hopkins lead abatement studies,’ Journal of Law, Medicine, and Ethics 30: 50–57.

    Article  Google Scholar 

  • Rothman, D. J. (1998). ‘The nuremberg code in light of previous principles and practices in human experimentation,’ in U. Tröhler and S. Reiter-Theil, eds., Ethics Codes in Medicine: Foundations and Achievements of Codification Since 1947. Aldershot, England, and Brookfield, VT, USA: Ashgate Publishing, pp. 50–59.

    Google Scholar 

  • Scott, P. G. and S. K. Pandey (2000). ‘The influence of red tape on bureaucratic behavior: An experimental simulation,’ Journal of Policy Analysis and Management 19: 615–633.

    Article  Google Scholar 

  • Schulz, M. (1998). ‘Limits to bureaucratic growth: The density dependence of organizational rule births,’ Administrative Science Quarterly December, 1998.

  • Shaul, R. (2002). ‘Reviewing the reviewers: The vague accountability of research Ethics committees,’ Critical Care 6: 121–122.

    Article  PubMed  Google Scholar 

  • Shensul, J. J. (2002). ‘Democratizing science through social science research partnership,’ Bulletin of Science, Technology, and Society 22: 190–202.

    Article  Google Scholar 

  • Simon, H. A. (1957). Administrative Behavior. New York: Mac Millan.

    Google Scholar 

  • Spriggs, M. (2004). ‘Canaries in the mines: Children, risk, non-therapeutic research, and justice,’ Journal of Medical Ethics 30: 176–181.

    PubMed  Google Scholar 

  • Surowiecki, J. (2004). The Wisdom of Crowds: Why the Many Are Smarter Than the Few and How Collective Wisdom Shapes Business, Economies, Societies and Nations. New York: Doubleday.

    Google Scholar 

  • Thompson, J. (1967). Organizations in Action. New York: McGraw-Hill.

    Google Scholar 

  • U.S. Food and Drug Administration (2005). Guidelines for Institutional Review Boards and Clinical Investigators http://www.fda.gov/oc/ohrt/irbs/faqs.html#IRBOrg Accessed May 10, 2005.

  • Zaal, R. and L. Leydesdorff. (1987). ‘Amsterdam science shop and its influence on university research: The effects of ten years of dealing with non-academic questions,’ Science and Public Policy 14: 310–316.

    Google Scholar 

  • Zhou, X. (1993). ‘The dynamics of organizational rules,’ American Journal of Sociology 98: 1134–1166.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Research Value Mapping Program, School of Public Policy, Georgia Tech, Atlanta, Georgia, U.S.A.

    Barry Bozeman & Paul Hirsch

Authors
  1. Barry Bozeman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Paul Hirsch
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Barry Bozeman.

Additional information

We are grateful to – for providing helpful comments on an earlier draft.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Bozeman, B., Hirsch, P. Science ethics as a bureaucratic problem: IRBs, Rules, and Failures of control. Policy Sci 38, 269–291 (2005). https://doi.org/10.1007/s11077-006-9010-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11077-006-9010-y

Keywords

  • Blood Lead Level
  • Lead Poisoning
  • Science Ethic
  • Belmont Report
  • Nuremberg Code