Prisoners as Human Subjects

Prisoners are considered especially vulnerable as human research subjects. With support from the National Institute on Drug Abuse of the National Institutes of Health (DA0000459), we developed a special reference guide for researchers on the subject, titled "Prisoners as Human Subjects: Clinical Researcher Reference Guide." The guide provides background information, references, and practice pointers. The appendices include original source documents that are not readily accessible elsewhere. To view these materials, click a link below.

>> Access the Clinical Researcher Reference Guide

>> Access the Guide’s Appendices

>> Access Suggested Readings related to the guide

Below are related additional resources and an updated bibliography pertaining to prisoners as human subjects

Additional resources

• 43 Federal Register 53652 (U.S. Department of Health, Education and Welfare, 1978) (original final rule on federal regulations pertaining to research involving prisoners as subjects)
• The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) (refer to section B-1 under "Respect for Persons," section B-3 under "Justice" and section C-3 under "Selection of Subjects" discussing involvement of prisoners as subjects of research)
• Subpart C of Title 45 Code of Federal Regulations Part 46, (U.S. Department of Health and Human Services, 2008) (federal HHS regulations pertaining to research involving prisoners as subjects)
• Check out U.S. Department of Health and Human Services’ Office for Human Research Protection’s FAQs about research involving prisoners and investigators’ as well as IRB responsibilities
• Access the HHS Secretary’s Advisory Committee on Human Research Protections’ proceedings and reports related to prisoner research (scroll down to Subcommittee on Research Involving Prisoners)
• Check out the Institute of Medicine’s advance Report Brief on ethical considerations for research involving prisoners (2006)
• Link for publication information about the National Academy of Sciences Institute of Medicine report on recommendations regarding prisoner research in its 2007 report, "Ethical Considerations for Research Involving Prisoners"

Bibliography (select readings on prisoners as human subjects)

1. Advisory Commission on Human Radiation Experiments. Final Report of the Advisory Committee on Human Radiation Experiments. 1995. U.S. Government Printing Office: Washington, D.C. (Chapter 9: Prisoners: A Captive Research Population).
2. Barton, P.E., and Coley, R.J. Captive Students: Education and Training in America’s Prisons. 1996. Educational Testing Service: Princeton, New Jersey.
3. Dubler, N.N., and Sidel, V.W. On Research on HIV Infection and AIDS in Correctional Institutions. The Milbank Quarterly vol. 67, no. 2: 171-207, 1989. PMID: 2630900.
4. Faden, R.R., Lederer, S.E., Moreno, J.D. U.S. Medical Researchers, the Nuremberg Doctors Trial, and the Nuremberg Code: A Review of Findings of the Advisory Committee on Human Radiation Experiments. Journal of the American Medical Association, vol. 276, no. 20: 1667-1671, 1996. PMID: 8922454.
5. Fisher, C.B. Ethics in Drug Abuse and Related HIV Risk Research. Applied Developmental Science 8(2): 91-103, 2004.
6. Geller, A.L. Regulations Limiting Medical Research in Prisons Remains Necessary. Journal of Biolaw and Business, vol. 8, no. 4: 72-73, 2005. PMID: 16619451.
7. Gostin, L.O. Biomedical Research Involving Prisoners: Ethical Values and Legal Regulation. Journal of the American Medical Association, vol. 297, no. 7: 737-740, 2007. PMID: 17312293.
8. Hornblum, A.M. Acres of Skin: Human Experiments at Holmesburg Prison. 1998. Routledge: New York, New York.
9. Lerner, B.H. Subjects or Objects? Prisoners and Human Experimentation. New England Journal of Medicine, vol. 356, no. 18: 1806-1807, 2007. PMID: 17476006.
10. Moser, D.J., Arndt, S., Kanz, J.E., Benjamin, M.L., Bayless, J.D., Reese, R.L., Paulsen, J.S., and Flaum, M.A. Coercion and Informed Consent in Research Involving Prisoners. Comprehensive Psychiatry, vol. 45, no. 1: 1-9, 2004. PMID: 14671730.
11. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Prisoners. 1976. U.S. Government Printing Office: Washington, D.C.
12. Nelson, R.M., and Merz, J.F. Voluntariness of Consent for Research: An Empirical and Conceptual Review. Medical Care, vol. 40, no. 9: V-69-V80, 2002. PMID: 12226588.
13. Novick, A. Clinical Trials with Vulnerable or Disrespected Subjects. AIDS & Public Policy Journal, vol. 4, no. 2: 125-130, 1989. PMID: 11651960.
14. Schüklenk, U. Protecting the Vulnerable: Testing Times for Clinical Research Ethics. Social Science & Medicine, vol. 51, no. 6: 969-977, 2000. PMID: 10972439.
15. Stone, T.H. Federal Regulations and the Protection of Prisoners from Research Risks. Medical Research Law & Policy Report, vol. 1, no. 9: 270-274, 2002.
16. Stone, T.H. Currents in Contemporary Ethics: Discerning Minimal Risk in Research Involving Prisoners as Human Subjects. Journal of Law, Medicine & Ethics, vol. 32, no. 3: 535-537, 2004. PMID 15490602.
17. Stone, T.H. Legalities: Take Care When Using Prisoners as Research Subjects. Correctcare, vol. 16, no. 1: 8, 2002. PMID: 12374161.
18. Wiegand, T.J. Captive Subjects: Pharmaceutical Testing and Prisoners. Journal of Medical Toxicology, vol. 3, no. 1, 2007. PMID: 18072157.
19. Wyman, B.P. Biomedical and Behavioral Research on Juvenile Inmates: Uninformed Choices and Coerced Participation. Journal of Law & Health, vol. 15, no. 1: 77-104, 2000. PMID: 11930505.

New resources will be added as they become available