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1 Introduction Prisoners are an especially vulnerable class of potential research partici- pants who historically have been exploited by physicians and researchers seeking expedient solutions to complex research problems (Hornblum, 1997, 1998; Mitford, 1974). They are the classic “captive population.” The ethical issues surrounding research on any human population re- quire serious consideration. Certain unique circumstances faced by prison- ers,1 however, require particular attention. Numerous ethical problems surrounding research with prisoners grow out of the complexity of the correctional settings and the disempowered status of the potential research participants. Although the limitations on personal choice and control are perhaps most evident and oppressive in locked detention facilities (e.g., jails, prisons), the power differential between criminal justice agents and prisoners exists in many other contexts as well (e.g., probation, parole); the differences are a matter of degree. First among the problems are those related to informed consent, ensur- ing that the setting permits the processes of informed consent and refusal. Second, privacy is much more difficult to ensure within a correctional setting. In a prison or jail, everyone sees who moves where and can specu- 1The term prisoner is defined by the Committee in Chapter 4 and used throughout this report to mean all persons whose liberty has been restricted by decisions of the criminal justice system. The setting is not limited to prisons and jails but can include community settings, such as work release programs, probation, parole, and so on. 21

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22 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS late on what that movement means. For example, an inmate’s trip to a medical clinic that is investigating acquired immune deficiency syndrome (AIDS) or hepatitis C makes quite clear what the inmate’s visit portends. Third, ethical research involves ensuring, as a prerequisite for research, that the standard of medical health care available in the correctional setting permits the inmate to have a meaningful choice between the existing care that is available and the experimental intervention. In addition, other mat- ters that generally are not complex issues in research outside of correctional settings appear as ethical dilemmas in the prison or jail. For example, in a correctional setting it may be difficult to distinguish between a refusal of care and a denial of care. Likewise, there can be difficulties in distinguishing between compliance and noncompliance in the research protocol. For ex- ample, if an inmate does not appear for a scheduled research meeting, which may also provide access to health care, it may not be clear whether the inmate has (1) decided not to come, (2) been barred or precluded from coming, (3) been taken to court for an unanticipated appearance, or (4) been presented with an unscheduled family visit. These concerns are readily apparent in the context of research involv- ing prisoners. However, what about questions of justice and fairness? How much of the burden of research should prisoners be asked to bear? How many of the potential benefits of research will be directed toward the prisoners? The acne medication Retin-A was basically developed in the Philadelphia prison system, with serious harms and few benefits afforded the prisoners who were involved in the research (Hornblum, 1998). Alter- natively, many inmates would choose to live and work in a research unit if they could, regardless of the risks and benefits associated with research participation. Should that be encouraged, permitted, or, as it is now, barred from the prison setting? What if the burdens of research are actually expe- rienced by inmates as benefits to be coveted in the deprived and stark setting of the prison? Should that overcome the current stance of the regu- lations in the U.S. Department of Health and Human Services (DHHS, 2005a) 45 C.F.R. Part 46 (see Appendix D)? WHY NOW? In response to a request from the Office for Human Research Protec- tions (OHRP), the Institute of Medicine (IOM) formed the Committee on Ethical Considerations for Protection of Prisoners Involved in Research to address ethical considerations for protecting prisoners involved in research. The broad purpose was to examine whether the conclusions reached in 1976 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (see Appendix B) remain appropriate today. The national commission’s report (NCPHSBBR, 1976) was the basis

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23 INTRODUCTION for 45 C.F.R. Part 46, which contains four subparts. Subpart A, also known as the Common Rule, is “Basic U.S. DHHS Policy for Protection of Human Research Subjects” (DHHS, 2005a). Subparts B, C, and D of 45 C.F.R. Part 46 provide further and more specific protection for certain particularly vulnerable populations: pregnant women, fetuses, and neonates; prisoners; and children, respectively (DHHS, 2005a). Subpart C, “Additional Protec- tions Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects,” the focus of this project, was first finalized in 1978 (DHHS, 2005a). This examination will consider the impact of developments in correc- tional systems since that time (1976) as well as societal perceptions of the balance between burdens and potential benefits of research. Many changes have occurred within the U.S. correctional system since the late 1970s, and these changes have important ramifications for research involving prisoners. They include the following: • An escalating prisoner population. For example, persons under prison supervision grew from 216,000 in 1974 to 1.4 million in 2004, largely as a result of the war on drugs, harsher sentencing laws, and high recidivism rates (Bureau of Justice Statistics [BJS], 2003, 2005a; Human Rights Watch [HRW], 2003; Jacobson, 2005). The overall correctional population, including persons in prison, jail, and on parole and probation, has jumped from 1.5 million in 1978 to nearly 7 million in 2004 (BJS, 2005a,b,c,d). • The overrepresentation of men and women of color in prisoner popu- lations (BJS, 2003). One out of eight black men in their late 20s is under the jurisdiction of the criminal justice system, including, jail, prison, probation, and parole (Lotke, 1997; Mauer and King, 2004). • Increased overcrowding in correctional facilities, resulting in dimin- ished availability of and access to programs and services. Construction has not kept pace with the increasing number of inmates (Jacobson, 2005). • Inadequate health-care services is a reality of some correctional set- tings, notwithstanding Eighth Amendment proscriptions against “deliber- ate indifference to the serious medical needs” of prisoners (Braithwaite et al., 2005; HRW, 2003; Metzner, 2002; Restum, 2005; Sturm, 1993). • Increasing population of female inmates—growing at a faster rate than that of male inmates—who face unique challenges (BJS, 1999). As with male prisoners, female inmates are more likely to be a minority, poor, and undereducated, but as women they are more likely to be the primary caregiver for children, and they suffer disproportionate victimization from sexual and physical abuse (BJS, 1999). • Increased number of prisoners serving their sentences in alternative programs, outside the traditional “bricks and mortar” prisons and jails

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24 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS (BJS, 2004). The environments to which prisoners are consigned have ex- panded to include work-release programs, halfway houses, electronic moni- toring programs, and other alternatives to incarceration (BJS, 2004). • Overrepresentation of communicable diseases, such as HIV/AIDS, hepatitis B and C, and tuberculosis, in prisons (Hammett et al., 2002; Khan et al., 2005; MacNeil et al., 2005; National Commission on Correctional Health Care [NCCHC], 2002). In addition, among an aging prison popula- tion, chronic diseases such as diabetes and hypertension are critical man- agement issues (NCCHC, 2002). • Increasing admissions of mentally ill prisoners with the closing of the large state mental institutions (HRW, 2003). Mental illness and vio- lence take a heavy toll on the prisoner population (BJS, 1999; New Free- dom Commission on Mental Health [NFCMH], 2004). At the same time that prison populations have been expanding, there has been a considerable amount of confusion and disagreement in the research community regarding the interpretation and application of Sub- part C of 45 C.F.R. Part 46 (“Additional Protections Pertaining to Biomedi- cal and Behavioral Research Involving Prisoners as Subjects” [DHHS, 2005a]) to current issues of research involving prisoners. The OHRP’s responsibilities include implementation of the DHHS Regulations for the Protection of Human Subjects (DHHS, 2005a) and the provision of guid- ance on ethical issues in biomedical and behavioral research. OHRP has oversight and educational responsibilities wherever DHHS funds are used to conduct research involving human participants. The Secretary’s Advi- sory Committee for Human Research Protections(SACHRP), the advisory committee to OHRP, has asked OHRP to rewrite Subpart C, taking into consideration the current prison environment (see Appendix C). OHRP recommended that, before such an effort is undertaken, there should be a thorough review of the ethical considerations in research in- volving prisoners, which could serve as the basis for developing new regula- tions. Beyond its importance regarding revisions to Subpart C, such a re- view would be instructive for developing ethical bases for making future changes to the DHHS Regulations for the Protection of Human Subjects and the Common Rule. COMMITTEE’S TASK AND APPROACH This report addresses ethical considerations for the protection of pris- oners involved in research. The overall purpose of the committee was to examine whether the conclusions reached by the national commission in 1976 remain appropriate today. This examination considered the impact of developments in correctional systems since that time and societal percep-

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25 INTRODUCTION tions of the balance between research burdens and potential benefits of research. The committee was asked to • consider whether the ethical bases for research with prisoners differ from those for research with nonprisoners; • develop an ethical framework for the conduct of research with prisoners; • based on the ethical framework developed, identify considerations or safeguards necessary to ensure that research with prisoners is conducted ethically; and • identify issues and needs for future consideration and study. The committee was asked to address the following three questions: 1. What are the unique features of the prison setting as an environment for research with respect to the general characteristics of the prison popula- tion, its specific and general health-care needs, the adequacy of existing health-care services, and the legal constraints placed on prisoners and the institutions that house them? Considerations include the following: • How should the term prisoner be defined? • What features of the current system of incarceration must be considered in conducting and reviewing research? • What constitutes voluntariness in the prison setting? Are special measures needed to ensure informed consent in this setting? • Must there be a finding that no alternative population is available in order for ethical research involving prisoners to occur? • What safeguards are necessary to ensure that research proceeds ethically? For example, how can privacy and confidentiality be pro- tected in a setting in which individuals are institutionalized? 2. What criteria or factors are relevant to determining whether research with prisoners can be conducted ethically? Specifically: • Does the national commission’s conclusion that research involv- ing prisoners should only be conducted if it benefits prisoners indi- vidually or as a group merit continued support? • What should constitute minimal risk in the context of research with prisoners? • Should prisoner research be limited to “not greater than minimal risk?” • What are the priorities for research involving prisoners?

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26 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS 3. What is an appropriate ethical framework for the conduct of such research? How should the concepts of minimal risk, voluntary informed consent, privacy and confidentiality, and distributive justice be incorpo- rated into such a framework? Specifically:1 • Are the criteria for allowing prisoner research expressed by the national commission regarding voluntariness and openness (e.g., public scrutiny, grievance procedures) still appropriate? • What measures beyond exclusion from research are appropriate for protecting the rights and welfare of prisoners? • How should the standard of existing medical care be valued when reviewing research protocols involving control or placebo-control arms? • Should there be a risk threshold for allowing research with pris- oners? If so, how should the prospect of benefit affect that thresh- old? Methods and Approach In conducting its work, the committee cast a broad net for the collec- tion of information. In addition to the traditional sources of information (e.g., literature, workshops, commissioned papers [see Box A-1 in Appen- dix A]), the committee also had a liaison group (see Box A-2) and visited two correctional facilities. Appendix A provides a detailed summary of the committee’s methods and data sources. ORGANIZATION OF THIS REPORT This report is organized into six chapters. This introduction is followed by a thorough discussion of the demographics of today’s correctional sys- tem in Chapter 2, which also details the committee’s efforts to determine 1The committee decided to exclude children (unless treated as adults), military personnel, persons under restricted liberty due to mental illness, and persons outside the criminal justice system, such as those detained under the U.S. Patriot Act. By excluding these groups, the committee emphasizes that these groups face very similar circumstances and that very strong ethical safeguards are required. However, the committee lacks the expertise to address the needs of these special populations and such an inquiry exceeds the committee’s charge. Paral- lel studies, such as the one undertaken by this committee, may be needed to explore ethical issues of research involving these groups. If, however, juveniles are transferred from the original jurisdiction of the family court (or the equivalent, such as a juvenile court) to the jurisdiction of a state or federal criminal court, then they would fall under the provisions of this report.

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27 INTRODUCTION the type and scope of research involving prisoners within the past two years. Chapter 3 provides a description of the current federal regulatory landscape, with a discussion of its limitations. Chapter 4 introduces the committee’s broadened definition of prisoner aimed at expanding protec- tions to a wider group of people who have restricted liberties because of decisions of criminal courts. Chapter 5 describes a new framework for research involving prisoners, based on the ethical principles of respect for persons and justice, and introduces the derivative concept of collaborative responsibility as being particularly important for planning and implement- ing research involving this vulnerable population. Finally, Chapter 6 con- tains the committee’s recommendations for a new, more comprehensive system of oversight, safeguards, and protections for research involving pris- oners, with more intrusive monitoring for higher risk studies. Appendix A contains a thorough description of the committee’s methods and data sources; Appendix B, the national commission’s deliberations and findings; Appendix C, the report of the SACHRP Subcommittee and Human Subjects Protections; Appendix D, the Code of Federal Regulations 45 Part 46 (Pro- tection of Human Subjects); and Appendix E, brief biographies of the com- mittee members, liaison group, and IOM staff. REFERENCES BJS (Bureau of Justice Statistics). 1999. Mental Health and Treatment of Inmates and Proba- tioners. [Online]. Available: http://www.ojp.usdoj.gov/bjs/pub/pdf/mhtip.pdf [accessed December 23, 2005]. BJS. 2003. Prevalence of Imprisonment in the U.S. Population, 1974–2001. [Online]. Avail- able: http://www.ojp.usdoj.gov/bjs/pub/pdf/piusp01.pdf [accessed December 30, 2005]. BJS. 2004. Probation and Parole in the United States, 2003. [Online]. Available: http:// www.ojp.usdoj.gov/bjs/pub/pdf/ppus03.pdf [accessed January 20, 2005]. BJS. 2005a. Prison and Jail Inmates at Midyear 2004. [Online]. Available: http:// www.ojp.usdoj.gov/bjs/pub/pdf/pjim04.pdf [accessed January 20, 2006]. BJS. 2005b. Prisoners in Custody, 1977-98. [Online]. Available: http://www.ojp.usdoj.gov/ bjs/prisons.htm#selected [accessed April 4, 2006]. BJS. 2005c. Adults on Probation, Federal and State by State, 1977–2004. [Online]. Available: http://www.ojp.usdoj.gov/bjs/pandp.htm#selected [accessed April 4, 2006]. BJS. 2005d. Adults on Parole, Federal and State by State, 1977–2004. [Online]. Available: http://www.ojp.usdoj.gov/bjs/pandp.htm#selected [accessed April 4, 2006]. Braithwaite RI, Treadwell HM, Arriola KRJ. 2005. Health disparities and incarcerated women: A population ignored. American Journal of Public Health 95(10):1679–1680. DHHS (Department of Health and Human Services). 2005a. Code of Federal Regulations: Title 45. Public Welfare. Part 46: Protection of Human Subjects. Washington, DC: DHHS. Hammett TM, Harmon MP, Rhodes W. 2002. The burden of infectious disease among in- mates of and releasees from US correctional facilities, 1997. American Journal of Public Health 92:1789–1794. Hornblum AM. 1997. They were cheap and available: Prisoners as research subjects in twen- tieth century America. British Medical Journal 315:1437–1441.

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28 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS Hornblum AM. 1998. Acres of Skin: Human Experiments at Holmesburg Prison. New York: Routledge. HRW (Human Rights Watch). 2003. Ill-Equipped: U.S. Prisons and Offenders with Mental Illness. [Online]. Available: http://www.hrw.org/reports/2003/usa1003/index.htm [ac- cessed October 13, 2005]. Jacobson, M. 2005. Downsizing Prisons: How to Reduce Crime and End Mass Incarceration. New York: New York University Press. Khan AJ, Simard EP, Bower WA, Wurtzel HL, Khristova M, Wagner KD, Arnold KE, Nainan OV, LaMarre M, Bell BP. 2005. Ongoing transmission of hepatitis B virus infection among inmates at a state correctional facility. American Journal of Public Health 95(10): 1793–1799. Lotke E. 1997 Hobbling a Generation: Young African American Men in D.C.’s Criminal Justice System Five Years Later. National Center on Institutions and Alternatives. [Online]. Available: http://66.165.94.98/stories/hobblgen0897.html [accessed April 6, 2006]. MacNeil JR, Lobato MN, Moore M. 2005. An unanswered health disparity: Tuberculosis among correctional inmates, 1993 through 2003. American Journal of Public Health 95(10):1800–1805. Mauer M, King RS. 2004. Schools and Prisons: Fifty Years After Brown V. Board of Educa- tion. [Online]. Available: http://sentencingproject.org/pdfs/brownvboard.pdf [accessed January 2, 2006]. Metzner JL. 2002. Class action litigation in correctional psychiatry. Journal of the American Academy of Psychiatry and the Law 30:19–29. Mitford J. 1974. Kind and Usual Punishment. New York: Vintage. NCCHC (National Commission on Correctional Health Care). 2002. The Health Status of Soon-to-Be-Released Inmates: Executive Summary. [Online]. Available: http://www. ncchc.org/stbr/Volume2/ExecutiveSummary.pdf [accessed October 10, 2005]. NCPHSBBR (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). 1976. Report and Recommendations: Research Involving Prison- ers. Washington, DC: NCPHSBBR. NFCMH (New Freedom Commission on Mental Health). 2004. Subcommittee on Criminal Justice Background Paper. DHHS Pub. No. SMA-04-3880, Rockville, MD. Available: http://www.mentalhealthcommission.gov/papers/CJ_ADACompliant.pdf [accessed March 20, 2006]. Restum ZG. 2005. Public health implications of substandard correctional health care. Ameri- can Journal of Public Health 95(10):1689–1691. Sturm SP. 1993. The legacy and future of corrections litigation. University of Pennsylvania Law Review 142:638–738.