B
The National Commission’s Deliberations and Findings

NATIONAL RESEARCH ACT

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.

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

1

Pub. L. No. 93-348

2

National Research Act, § 202(a)(2).



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B The National Commission’s Deliberations and Findings NATIONAL RESEARCH ACT 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, Educa- tion 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 “institution- ally mentally infirm,” and prisoners. Title II of the act, which applies to prisoners, is presented in Box B-1. The commission was further required by Section 202(a)(3) to make recommendations to Congress for developing laws that could be imple- mented 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 compo- nents 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 1Pub. L. No. 93-348 2National Research Act, § 202(a)(2). 191

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192 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS BOX B-1 National Research Act Section 202(a)(2) The Commission shall identify the requirements for informed consent to partic- ipation in biomedical and behavioral research by . . . prisoners . . . The Commis- sion shall investigate and study biomedical and behavioral research conducted or supported under programs administered by the Secretary [DHEW] and involving prisoners…to determine the nature of the consent obtained from such persons or their legal representatives before such persons were involved in such research; the adequacy of the information given them respecting the nature and purpose of the research, procedures to be used, risks and discomforts, anticipated benefits from their research, and other matters necessary for informed consent; and the competence and the freedom of the persons to make a choice for or against in- volvement in such research. On the basis of such investigation and study the Com- mission shall make such recommendations to the Secretary as it determines ap- propriate to assure that biomedical and behavioral research conducted or supported under programs administered by him meets the requirements respect- ing informed consent identified by the Commission. In carrying out this charge, the commission used elements of a prin- ciple-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 prescrip- tive judgments that were particularly relevant to research with human sub- jects: 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—de- mands 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 bur- dens?” (NCPHSBBR, 1979a). It is clear that the concerns raised by the report remain central to the analysis of this document.

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193 APPENDIX B NATIONAL COMMISSION METHODOLOGY 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 correc- tional settings. The current inquiry, almost 30 years later, asks whether that special set of regulations is still sufficient and valid. The national commis- sion 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-gather- ing activities as part of the development of its report on prisoners. Commis- sion members made site visits to four prison facilities that conducted re- search 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 articu- late 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 commu- nity, 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,

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194 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS • 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). NATIONAL COMMISSION DELIBERATIONS, FINDINGS, AND CONCLUSIONS 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 judg- ment 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

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195 APPENDIX B 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 per- sons better situated would ordinarily refuse. It also establishes an enter- prise whose fair administration can be readily corrupted by prisoner con- trol 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 environ- ments 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 recommenda- tions, 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. 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, journal- ists and the staff of prisoner advocacy and civil liberties groups, saw re- search 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 activ- ity in prisons and jails” (Dubler and Sidel, 1989). According to one in- formed 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 3See 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, execu- tive 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. 4Hoffman 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.

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196 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS BOX B-2 National Commission Recommendations 1. 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 that (a) they present minimal or no risk and no more than mere inconvenience to the subjects, and (b) the requirements under Recommendation 4 are fulfilled. 2. Research on practices both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the individual prisoner, may be conducted or supported provided the requirements under Rec- ommendation 4 are fulfilled. 3. Discussed the need for a national ethical review body to determine that the research fulfills an important social and scientific need, that the involvement of the prisoners satisfies conditions of equity, and that a high degree of voluntariness is required. This recommendation led to requirements for certain sorts of secretarial review in the actual regulations but did not mirror the commission’s list of manda- tory characteristics of the prison, which included many requirements for conditions of confinement, such as adequate living space, existence of single occupancy cells, operable toilets, access to clean and working showers, existence of good- quality medical facilities in the prison that are adequately staffed and equipped and approved by an outside medical accrediting organization, among others. This re- quirement for the specifics of prison existence did not become part of the regula- tions. 4. This recommendation had two parts: • The head of the responsible federal department or agency should deter- mine that the competence of the investigators and the adequacy of the research facilities involved are sufficient for the conduct of any research project in which prisoners are to be involved. • All research involving prisoners should be reviewed by at least one hu- man subjects review committee. 5. A grandfathering provision that permitted research in existence to continue for at least 1 year. 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). REFERENCES Dubler N, Sidel V. 1989. On research on HIV infection and AIDS. The Milbank Quarterly 67(2):171–207. Hoffman S. 2000. Beneficial and unusual punishment: An argument in support of prisoner participation in clinical trials. Indiana Law Review 33:475. Lazzarini Z, Altice FL. 2000. A review of the legal and ethical issues for the conduct of HIV- related research in prisons. AIDS and Public Policy Journal 15(3/4):105–135.

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197 APPENDIX B Mitford J. 1973a. Experiments behind bars: Doctors, drug companies, and prisoners. Atlantic Monthly 23:64–73. Mitford J. 1973b. Kind and Usual Punishment: The Prison Business. New York: Alfred A. Knopf. NCPHSBBR (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). 1976a. 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. NCPHSBBR. 1976b. Report and Recommendations: Research Involving Prisoners. DHEW Publication No. (OS) 76-131. Washington, DC: U.S. Department of Health, Education, and Welfare. Nuremburg Code. 1949. Trials of War Criminals Before the Nuremburg Military Tribunals Under Control Council Law No. 10, Vol. 2. Washington, DC: U.S. Government Print- ing Office. Rugaber W. 1969, July 29. Prison drug and plasma projects leave fatal trail. New York Times, p. 20.

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