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Institute of Medicine (US) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research; Gostin LO, Vanchieri C, Pope A, editors. Ethical Considerations for Research Involving Prisoners. Washington (DC): National Academies Press (US); 2007.

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Ethical Considerations for Research Involving Prisoners.

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BThe National Commission’s Deliberations and Findings


The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (NCPHSBBR) was created in 1973 by the National Research Act1 and charged with submitting periodic reports to the President, Congress, and Secretary of the Department of Health, Education and Welfare (DHEW) about protecting humans involved in research. The commissioners were specifically charged to look into protections for certain classes of research subjects that included children, the “institutionally mentally infirm,” and prisoners. Title II of the act, which applies to prisoners, is presented in Box B-1.

Box Icon


National Research Act Section 202(a)(2). The Commission shall identify the requirements for informed consent to participation in biomedical and behavioral research by … prisoners … The Commission shall investigate and study biomedical (more...)

The commission was further required by Section 202(a)(3) to make recommendations to Congress for developing laws that could be implemented at other agencies that would protect persons involved in biomedical and behavioral research, including research on prisoners that may have been supported by those non-DHEW agencies.

In its charge to the commission concerning research with prisoners, Congress identified informed consent as the locus of ethical concern. In particular, Congress directed the commission to attend to three components of informed consent: (1) the nature of the consent; (2) the adequacy of the information given; and (3) the competence and freedom of the prisoners or their legal representatives to make a choice.2

In carrying out this charge, the commission used elements of a principle-based ethical framework that would be more fully fleshed out in the Belmont Report (NCPHSBBR, 1976a), a response to its charge to identify the relevant ethical principles that relate to and support research with human subjects. This 20-page document discussed the line to be drawn between practice of biomedical and behavioral therapy and research in those areas. It identified three philosophical principles or general prescriptive judgments that were particularly relevant to research with human subjects: respect for persons, beneficence, and justice.

The first principle—respect for persons—“incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection” (NCPHSBBR, 1979a). The second principle—beneficence—demands that persons be “treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being” (NCPHSBBR, 1979a). The concerns of the final principle—justice—are found in the answer to the question that the report poses: “Who ought to receive the benefits of research and bear its burdens?” (NCPHSBBR, 1979a). It is clear that the concerns raised by the report remain central to the analysis of this document.


The national commission determined that research involving prisoners was so complex that a special section of regulations was needed to (1) provide severe restraints on the sorts of research that could be performed to protect the rights and interests of inmates, and (2) impose specific rules and procedures for institutional review boards reviewing protocols for correctional settings. The current inquiry, almost 30 years later, asks whether that special set of regulations is still sufficient and valid. The national commission noted that research in correctional settings presented problems largely relating to coercion and challenges to autonomous consent and refusal.

The national commission conducted a number of information-gathering activities as part of the development of its report on prisoners. Commission members made site visits to four prison facilities that conducted research with their inmate populations and two research facilities that were not penal institutions but that used prisoners as research subjects. During these visits, commission members and staff talked with inmates who did and did not participate in research projects, with prison administrators who had oversight responsibilities, and with directors of the research programs at the facilities.

When the National Commission visited the Jackson State Prison in Michigan on November 14, 1975, they met with a group of highly articulate prisoners. The leader of the group greeted them with the following opening statement: “Ladies and gentlemen: You are in a place where death at random is a way of life. We have noticed that the only place in this prison that people don’t die is in the research unit. Just what is it that you think you are protecting us from?” (Dubler and Sidel, 1989).

In addition, commission members held hearings to allow for comment by those who would be most affected by any proposed protections. Groups represented at these hearings included members of the scientific community, advocates for the rights of prisoners, attorneys who provided legal services to prisoners, representatives from the pharmaceutical industry, and members of the general public. A National Minority Conference on Human Experimentations was also held to allow for groups representing minority concerns to receive a more in-depth hearing.

In addition to these activities, members of the commission staff authored papers, completed surveys, and wrote other reports that helped to inform the commission’s deliberations. Papers were written by others as well. Topics for these papers were

  • alternatives to the use of inmates as research subjects,
  • a review of foreign practices on developing new pharmaceutical medications with prison subjects,
  • a review of philosophical, sociological, and legal views of the use of inmates in research,
  • behavioral perspectives on using inmate subjects, and
  • a survey of research review procedures, principal investigators, and inmate subjects at five facilities.

The state of the art, as reported to the commissioners, was unsettled and unsettling. The pharmaceutical industry and various stakeholders, other than prisoners, were crafting the research agenda in correctional settings. Inmates often agreed to participate, with the hope of improving their living conditions or their chances for probation or parole.

Finally, members of the national commission held a series of public hearings that began in January 1976. During these hearings, commissioners discussed findings and identified and developed recommendations that were included in the final report, which was released in October 1976 (NCPHSBBR, 1976a).


The national commission began its report by acknowledging some of the history of research with prisoners and noting that sensitivities to abuses in the United States and other countries had led to a generally growing concern about the propriety of research in prisons.

It then noted that there were two specific sets of concerns that were directly relevant to the report and recommendations: first, a set of general concerns about the “serious deficiencies in living conditions and health care that generally prevail in prisons” (NCPHSBBR, 1976b) and, second, a set of ethical concerns asking (1) do prisoners bear a fair share of the burdens and receive a fair share of the benefits of research? and (2) are prisoners, in the words of the Nuremberg Code (1949) “so situated as to be able to exercise free power of choice.” That is, can prisoners give truly voluntary consent to participate in research?

These two dilemmas relate to two of the basic ethical principles: justice, which requires that persons and groups be treated fairly, and respect for persons, which requires that the autonomy of persons be promoted and protected. In discussing these issues, the commission noted that in its judgment the “appropriate expression of respect consists in protection from exploitation” (NCPHSBBR, 1976b). On the issue of justice, it stated that the concern is:

To ensure the equitable distribution of the burdens of research no matter how large or small those burdens may be. The Commission is concerned that the status of being a prisoner makes possible the perpetration of certain systemic injustices. For example, the availability of a population living in conditions of social and economic deprivation makes it possible for researchers to bring to these populations types of research that persons better situated would ordinarily refuse. It also establishes an enterprise whose fair administration can be readily corrupted by prisoner control or arbitrarily manipulated by prison authorities. And finally, it allows an inequitable distribution of burdens and benefits, in that those social classes from which prisoners often come are seldom full beneficiaries of improvements in medical care and other benefits accruing to society from the research enterprise. (NCPHSBBR, 1976b)

Chapter 2 of this report makes clear that today’s correctional environments have the same characteristics that were of concern to the commission 30 years ago plus new, important features as well.

The commission completed its deliberations with five recommendations, which largely, although not entirely, became the guiding elements for 45 C.F.R. Part 46, Subpart C. They are listed in Box B-2.

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National Commission Recommendations. Recommended that studies of the possible causes, effects, and processes of incarceration and studies of prisons as institutional structures or of prisoners as incarcerated persons may be conducted or supported provided (more...)

The commission’s deliberations came after the late 1960s and early 1970s saw a series of exposés documenting abuses in connection with nontherapeutic research in U.S. prisons (Mitford, 1973a,b; Rugaber, 1969). Many of those who were most vocal about the plight of prisoners, journalists and the staff of prisoner advocacy and civil liberties groups, saw research with prisoners largely under the twin headings of coercion and exploitation (Mitford, 1973a,b; NCPHSBBR, 1976;3 Rugaber, 1969). For the most part, these groups pushed for restriction rather than reform of the prison research enterprise. Although the commission did not recommend a ban on all research with prisoners, its work and the aftermath have been described as tending toward that end: “The result of these regulations has been, as was their goal, the virtual elimination of biomedical research activity in prisons and jails” (Dubler and Sidel, 1989). According to one informed estimate, in the late 1990s only about 15 percent of institutions engaged in clinical research in the United States included prisoners in their research protocols (Hoffman, 20004). In 1997, New York State had the largest estimated number of HIV-infected prisoners of any prison system (9,456), but only 8 (less than 0.001 percent) were enrolled in clinical trials (Lazzarini and Altice, 2000).


  1. Dubler N, Sidel V. On research on HIV infection and AIDS. The Milbank Quarterly. 1989;67(2):171–207. [PubMed: 2630900]
  2. Hoffman S. Beneficial and unusual punishment: An argument in support of prisoner participation in clinical trials. Indiana Law Review. 2000;33:475. [PubMed: 16189915]
  3. Lazzarini Z, Altice FL. A review of the legal and ethical issues for the conduct of HIV-related research in prisons. AIDS and Public Policy Journal. 2000;15(3/4):105–135. [PubMed: 12189712]
  4. Mitford J. Experiments behind bars: Doctors, drug companies, and prisoners. Atlantic Monthly. 1973a;23:64–73. [PubMed: 11660966]
  5. Mitford J. Kind and Usual Punishment: The Prison Business. New York: Alfred A. Knopf; 1973b.
  6. NCPHSBBR (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S. Department of Health, Education, and Welfare; 1976a.
  7. NCPHSBBR. Report and Recommendations: Research Involving Prisoners. Washington, DC: U.S. Department of Health, Education, and Welfare; 1976b. DHEW Publication No. (OS) 76-131.
  8. Nuremburg Code. Trials of War Criminals Before the Nuremburg Military Tribunals Under Control Council Law No. 10. Vol. 2. Washington, DC: U.S. Government Printing Office; 1949.
  9. Rugaber W. Prison drug and plasma projects leave fatal trail. New York Times. 1969 July 29:20.



Pub. L. No. 93-348


National Research Act, § 202(a)(2).


See the summaries of presentations made to the commission (pp. 44–48) by Gabe Kaimowitz, a senior staff attorney for Michigan Legal Services; Matthew L. Myers, from the National Prison Project of the American Civil Liberties Foundation; Allan H. Lawson, executive director of the Prisoners’ Rights Council of Pennsylvania; and the Rev. Americus Roy of the Prisoners Aid Association of Maryland, at a public hearing held on January 9, 1976.


Hoffman was citing a 1998 estimate by Paula Knudson, executive coordinator of the University of Texas Health Science Center Committee for the Protection of Human Subjects. One factor to be considered may be state bans on biomedical research with prisoners; Hoffman cites a survey from the American Correctional Health Services Association finding that 22 states have such total bans.

Copyright © 2007, National Academy of Sciences.
Bookshelf ID: NBK19880
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