Prisoners are an especially vulnerable class of potential research participants 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 require serious consideration. Certain unique circumstances faced by prisoners,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, ensuring 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-
The 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.
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 matters 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 example, 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 involving 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). Alternatively, 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 experienced by inmates as benefits to be coveted in the deprived and stark setting of the prison? Should that overcome the current stance of the regulations in the U.S. Department of Health and Human Services (DHHS, 2005a) 45 C.F.R. Part 46 (see Appendix D)?
In response to a request from the Office for Human Research Protections (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
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 Protections 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 correctional 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 populations (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 diminished 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 settings, notwithstanding Eighth Amendment proscriptions against “deliberate 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
(BJS, 2004). The environments to which prisoners are consigned have expanded to include work-release programs, halfway houses, electronic monitoring 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 population, chronic diseases such as diabetes and hypertension are critical management issues (NCCHC, 2002).
Increasing admissions of mentally ill prisoners with the closing of the large state mental institutions (HRW, 2003). Mental illness and violence take a heavy toll on the prisoner population (BJS, 1999; New Freedom 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 Subpart C of 45 C.F.R. Part 46 (“Additional Protections Pertaining to Biomedical 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 guidance 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 Advisory 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 involving prisoners, which could serve as the basis for developing new regulations. Beyond its importance regarding revisions to Subpart C, such a review 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 prisoners 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-
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:
What are the unique features of the prison setting as an environment for research with respect to the general characteristics of the prison population, 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 protected in a setting in which individuals are institutionalized?
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 involving prisoners should only be conducted if it benefits prisoners individually 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?
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 incorporated 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 prisoners? If so, how should the prospect of benefit affect that threshold?
Methods and Approach
In conducting its work, the committee cast a broad net for the collection of information. In addition to the traditional sources of information (e.g., literature, workshops, commissioned papers [see Box A-1 in Appendix 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 system in Chapter 2, which also details the committee’s efforts to determine
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 protections 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 implementing research involving this vulnerable population. Finally, Chapter 6 contains the committee’s recommendations for a new, more comprehensive system of oversight, safeguards, and protections for research involving prisoners, 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 (Protection of Human Subjects); and Appendix E, brief biographies of the committee members, liaison group, and IOM staff.
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