Summary

ABSTRACT

In the past 30 years, the population of prisoners in the United States has expanded more than 4.5 fold, correctional facilities are increasingly overcrowded, and more of the country’s disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, limited privacy, and often inadequate health care, they require specific protections when involved in research, particularly in today’s correctional settings. Given these issues, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) commissioned the Institute of Medicine (IOM) to review the ethical considerations regarding research involving prisoners. The resulting analysis emphasizes five broad actions to provide prisoners involved in research with critically important protections: (1) expand the definition of the term prisoner; (2) ensure universally and consistently applied standards of protection; (3) shift from a category-based to a risk-benefit approach to research review; (4) update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research involving prisoners.



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Summary ABSTRACT In the past 30 years, the population of prisoners in the United States has expanded more than 4.5 fold, correctional facilities are increasingly overcrowded, and more of the country’s disadvantaged populations—racial minorities, women, people with mental illness, and people with communi- cable diseases such as human immunodeficiency virus (HIV)/acquired im- mune deficiency syndrome (AIDS), hepatitis C, and tuberculosis—are un- der correctional supervision. Because prisoners face restrictions on liberty and autonomy, limited privacy, and often inadequate health care, they require specific protections when involved in research, particularly in today’s correctional settings. Given these issues, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) commissioned the Institute of Medicine (IOM) to review the ethi- cal considerations regarding research involving prisoners. The resulting analysis emphasizes five broad actions to provide prisoners involved in research with critically important protections: (1) expand the definition of the term prisoner; (2) ensure universally and consistently applied standards of protection; (3) shift from a category-based to a risk-benefit approach to research review; (4) update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research involving prisoners. 1

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2 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS In many important ways, the U.S. correctional system is different than it was in the 1970s, when current regulations regarding prisoners as re- search subjects were promulgated. The total correctional population (per- sons in prisons, jails, probation, and parole) increased to nearly 7 million individuals between 1978 and 2004 (Bureau of Justice Statistics [BJS], 2000a, 2005a,b,c; U.S. Census, 1994, 1998). Correctional facilities are increasingly overcrowded (BJS, 2005a), and access to programs, services, and health care has not kept pace with the rising tide of prisoners (Metzner, 2002; Sturm, 1993). More of our country’s disadvantaged populations are under correctional supervision: racial minorities, women, persons with mental illness, and persons with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis (BJS, 2005b; National Commission on Cor- rectional Health Care [NCCHC], 2002). Prisoners have been exploited in the past, carrying a heavier burden of the risks of research than the general population (Hornblum, 1998; Jones, 1993; Murphy, 2005). Although the level of severity varies depend- ing on the correctional setting, prisoners face restrictions on liberty and autonomy, limited privacy, and potentially inadequate health-care ser- vices. These factors can be barriers to the prerequisites of ethical research, namely the acquisition of voluntary informed consent, protection of pri- vacy, and access to adequate health care such that a choice between research participation and nonparticipation is not simply a desperate ac- tion to obtain treatment. However, research can impart benefits. Responsible research has the potential of improving the health and well-being of prisoners as well as improving the conditions in which they live. Adherence to the highest ethi- cal values, however, is critically important in designing and conducting human research involving prisoners. Title 45 Part 46 of the Code of Federal Regulations (45 C.F.R. Part 46) contains Subpart A, the basic DHHS regulations for the protection of hu- man research subjects, also known as the Common Rule. The Common Rule provides requirements and guidance on issues such as review by an institutional review board (IRB), informed consent by subjects, analysis of risks and benefits, protecting privacy, plus further requirements for ap- proval of proposed research. Additional subparts of 45 C.F.R. Part 46 provide more specific protections for certain particularly vulnerable popu- lations: pregnant women, fetuses, and neonates (Subpart B); prisoners (Sub- part C); and children (Subpart D). Subpart C (Additional Protections Per- taining to Biomedical and Behavioral Research Involving Prisoners as Subjects), the principal focus of this report, was first finalized in 1978 and was developed in response to the Report and Recommendations: Research Involving Prisoners by the National Commission for the Protection of Hu- man Subjects of Biomedical and Behavior Research (NCPHSBBR, 1976).

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3 SUMMARY The general stance of Subpart C is that only research that fits within four or five categories is permitted in prisoner populations. The committee’s review of current research revealed that most research involving prisoners is taking place outside the purview of Subpart C, and many prisoner studies are being conducted without IRB review. There is no ethically defensible reason to exclude certain prisoners from most, if not all, human subject protections afforded by federal regulation. All of these fac- tors point to a population that is more vulnerable and requires stronger protections than those inspired by the national commission in the 1970s. With these concerns in mind, the OHRP of the DHHS commissioned the IOM to review the ethical considerations in research involving prisoners as a basis for updating DHHS regulations to protect prisoners as research subjects. The committee was charged with the following tasks:1 • 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. • Identify considerations or safeguards necessary to ensure that re- search with prisoners is conducted ethically. • Identify issues and needs for future consideration and study. MAJOR RECOMMENDATIONS The committee developed each recommendation in this report with the interests of prisoners in mind. Throughout its deliberations, the committee was well aware of the dark history of research involving prisoners (Hornblum, 1998; Jones, 1993; Murphy, 2005) and was determined not to permit the exposure of prisoners to the kind of research abuses that oc- 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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4 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS curred before the national commission released its report (NCPHSBBR, 1976). In this report, in fact, the committee adds further protections both by expanding the population of prisoners covered by rigorous ethical rules and by recommending additional ethical safeguards. At the same time, access to research may be critical to improve the health of prisoners and the conditions in which they live, as the committee was told by prisoners during prison site visits. The task was to strike a balance between potential benefits and risks of specific research protocols. The goal is to ensure rigorous responsible research that improves the well-being of prisoners while taking great care to protect their health, well-being, and human rights. The recommendations discussed later (and presented in Box S-1) will allow research, in limited circumstances, that might benefit prisoners. These limited circumstances cannot be captured by a rigid categorical approach but need to be rooted in an ethically relevant risk-benefit analysis that grapples with the balance between a need for protection and access to potentially beneficial research protocols. During the course of the committee’s deliberations, five themes emerged as organizing categories for the committee’s recommendations: (1) expand the definition of the term prisoner; (2) ensure universal, consistent ethical protection; (3) shift from a category-based to a risk-benefit approach to research review; (4) update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research with prisoners. Expand the Definition of Prisoner Subpart C defines a prisoner as any person who is “involuntarily confined or detained in a penal institution” as a result of violating a criminal or civil statute, detained in other facilities as an alternative to criminal prosecution or incarceration, or detained pending arraignment, trial, or sentencing (45 C.F.R § 46.303[c]). The present regulation’s emphasis on custodial detention is too narrow. Of the nearly 7 million persons under adult correctional supervision in 2004, only 2.1 million were in prisons and jails. The rest—4.9 million—were on parole and probation, groups that do not clearly fit under the definition in the current regulations (BJS, 2005c). The committee, therefore, recommends an expansion of the definition of prisoner to afford protections for a larger popu- lation of prisoners involved in human subjects research. Recommendation: Redefine the term prisoner to expand the reach of human subjects protections. The Department of Health and Human Services and other relevant agencies that write, implement, or enforce regulations pertaining to research with prisoners should expand the definition of the term prisoner to include all settings, whether a correc-

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5 SUMMARY BOX S-1 Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research Recommendations Redefine the term prisoner to expand the reach of human subjects protections. (4.1) Ensure Universal, Consistent Ethical Protection • Establish uniform guidelines for all human subjects research involving prisoners. (3.1) • Maintain a public database of all research involving prisoners. (2.1) • Ensure transparency and accountability in the research enterprise. (6.7) Shift from a Category-Based to a Risk-Benefit Approach to Research Review • Apply a risk-benefit framework to research review. (5.1) Update the Ethical Framework to Include Collaborative Responsibility • Use a collaborative research approach. (5.2) • Ensure adequate standards of care. (5.3) • Support critical areas of correctional research. (5.4) Enhance Systematic Oversight of Research Involving Prisoners • Strengthen monitoring of research involving prisoners. (6.3) • Modify institutional review board considerations for independent ethical review of research protocols. (6.4) • Enhance the Office for Human Research Protections’s capacity to provide systematic oversight of research involving prisoners. (6.5) • Establish systematic oversight of all research with prisoners. (6.6) • Ensure voluntary informed consent. (6.1) • Protect the privacy of prisoners engaged in research. (6.2) tional institution or a community setting, in which a person’s liberty is restricted by the criminal justice system. (Recommendation 4.1) The goal of this recommendation is to expand the reach of the regula- tory procedures and oversight mechanisms recommended in this report to the fuller population of individuals whose liberty is restricted by the crimi- nal justice system. These individuals face greater risks than those in the general population. The freedom of a prisoner to make a choice as well as the ability to protect his or her privacy can be hampered in any of the correctional settings that restrict liberty. Throughout this report, the term prisoner is used with this expanded meaning in mind. An exclusion, how- ever, was provided by the committee so that prisoners living in a noncusto-

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6 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS dial community setting could enroll in research that is open to any citizen in the community when his or her status as a prisoner is not relevant or related to enrollment in the study. Ensure Universal, Consistent Ethical Protection The committee was asked to make recommendations regarding re- search under the oversight jurisdiction of OHRP, but currently OHRP jurisdiction is severely limited by the terms and conditions of Subpart C; its oversight extends only to research funded by 3 of 17 federal agencies. The Department of Justice’s Bureau of Prisons (BOP) has its own set of rules (BOP, 1999, 2005), and other federal agencies and nonfederal entities (e.g., state and private) that support research with prisoners are not required by statute or regulation to offer special protections for prisoner subjects. The committee recommends more uniform application of regulations and over- sight of all prisoner research regardless of the source of funding or supervis- ing agency as well as a better accounting of research involving prisoners and greater openness throughout the universe of prisoner research. Recommendation: Establish uniform guidelines for all human subjects research involving prisoners. Congress should mandate a uniform set of guidelines for human research participant protection programs2 for all research involving prisoners. (Recommendation 3.1) All human subjects research involving prisoners should be regulated by the same ethical standards irrespective of source of funding, supporting agency, or type of correctional facility (federal, state, local, or private) or program that houses the prisoner. This would mean that all 17 federal agencies that are signatories to the Common Rule, any additional federal agencies, and all nonfederal sponsors of research would be required to comply with a newly drafted Subpart C.3 All research involving prisoners, therefore, would be under OHRP oversight (see Recommendations 6.5 and 6.6). There is no justification for variability across agencies, sponsors, and 2The term human research participant protection program (HRPPP) is used throughout this report to mean the network of entities with direct responsibility for the safety of those enrolled in the studies carried out under its purview. The HRPPP most often includes the research organization, the study sponsor, investigator, IRB, and, when relevant, the data safety monitoring board (IOM, 2003). In the contexts described in this report, prison research subject advocates would be an important part of this network as well. 3Federal regulation of state and private research would be constitutionally permissible by using, for example, the federal spending power. See, e.g., South Dakota v. Dole, 483 U.S. 203, 211 (1987) (upholding the constitutionality of a federal statute conditioning states’ receipt of federal funds on adoption of a minimum drinking age of 21).

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7 SUMMARY facilities regarding their approaches to protecting the rights, health, and dignity of prisoners participating in human subjects research, individuals who are among the most vulnerable human subjects of research. Establishing uniformity within the research protections systems specific to prisoners would enable a second, important step to be realized. Cur- rently, there is no central repository of information about the amount and type of research with prisoners as subjects. For the same reasons that regis- tries of clinical research on drugs and biologics exist and have garnered strong support (DeAngelis et al., 2004; IOM, 2006), a national database would bring clarity to the currently murky landscape of research involving prisoners. Recommendation: Maintain a public database of all research involv- ing prisoners. The Department of Health and Human Services, in co- operation with the Department of Justice, should systematically and comprehensively document all human subjects research with prisoners. (Recommendation 2.1) The establishment of a publicly available, national registry of research involving prisoners should include data such as who is conducting research with what support, with what kind of research on what populations, and the nature and extent of ethical oversight provided. A national registry would shed light on the totality of research taking place on prisoners and the quality of ethical oversight provided for each protocol. To enable consideration of questions of justice, it could be used to examine the magnitude and volume of prisoners in different types of research to determine the allocation of benefits and burdens of research among prisoners. A registry would also enhance the application of research findings to prisoner populations. Recommendation: Ensure transparency and accountability in the re- search enterprise. Human research participant protections programs and prison administrations conducting human subject research should be open, transparent, and accountable. (Recommendation 6.7) A sound, ethical protection program involves an open, transparent research process. It requires that the mechanisms used to protect partici- pants from undue harm and to respect their rights and welfare must be apparent to everyone involved. This transparency requires open communi- cation and interaction with the local community, research participants, investigators, and other stakeholders in the research enterprise. Account- ability entails maintaining fidelity to the methodology stipulated in the protocol as well as accountability to ensure the quality and performance of the protection program itself.

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8 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS Shift from a Category-Based to a Risk-Benefit Approach to Research Review The current categorical approach used in Subpart C to review propos- als for research involving prisoners is dependent on narrowly defined stipu- lated research categories that are subject to various interpretations. If a protocol does not fit a category, it is not allowed. This approach does not provide sufficient or reliable protections for the human subject because it does not consider the potential benefits and risks involved in the study and might disallow research that would be quite acceptable on risk-benefit grounds. In addition, the present structure does not address the actual conditions of confinement or the restrictions on liberty experienced by the prisoner subject (whether incarcerated or subject to restraints on liberty in connection with community-based alternatives to incarceration). Recommendation: Apply a risk-benefit framework to research review. The Department of Health and Human Services should revise regula- tions regarding research with prisoners from a model based on catego- ries to a system based on weighing of risks and benefits for the indi- vidual human subject, similar to the approach currently used in Subpart D. (Recommendation 5.1) A risk-based approach is preferable because it requires human research participant protection programs (HRPPPs) and OHRP to (1) focus on the potential benefits and harms of each suggested research protocol, and (2) identify the particular ethical issues that each protocol raises in the specific context of the correctional setting. As in Subpart D (45 C.F.R. § 46.407), protections should increase as the risk-benefit scale tilts more toward risk (IOM, 2004). A risk-benefit approach should apply to all types of research: biomedi- cal, social/behavioral, and epidemiological. Ethically permissible research must offer potential benefits to prisoners that outweigh the risks. Under this framework, it is clear that studies offering no potential benefit to subjects would be precluded (i.e., testing of cosmetic products). Biomedical research in correctional settings would be severely limited. Phase 1 and 2 studies, as defined by the Food and Drug Administration (FDA), for example, would not be allowable because safety and efficacy are not yet clear in these early phases of biomedical research; therefore, risk would overshadow potential benefit. Biomedical research involving prisoners in two narrow circumstances may be ethically acceptable: 1. In normal circumstances, a biomedical research study may be ethi- cally acceptable if:

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9 SUMMARY • for research on new therapies or preventive measures, there is already some evidence of safety and efficacy, as in Phase 3 testing for new drugs, as defined by the FDA; and • the ratio of prisoner to nonprisoner subjects does not exceed 50 percent. 2. In exceptional circumstances, a biomedical research study may be ethically acceptable even if the benefit of an intervention has not been completely established, or if the research population is disproportionately comprised of prisoners. These two criteria may be waived if the research addresses a condition or behavior that is solely or almost exclusively found in incarcerated populations (e.g., repetitive sexual assaults). Studies of this nature could only proceed, however, with a federal-level review. The proto- col must be submitted to a national, specially convened panel of experts, who, in a public process, consider the ethical acceptability of a particular protocol and make recommendations to the responsible government au- thority (OHRP) regarding the special circumstances that do or do not provide a basis for research and the safeguards that must apply. This review would be very similar to the process outlined under Subpart D (45 C.F.R. § 46.407) that requires DHHS secretarial consultation for studies that are not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of prisoners (rather than children), except that the panel of experts could be convened by an entity outside DHHS if appropriate. This approach comports with the committee’s risk-benefit approach. Given the history of and continued potential for prisoner exploitation, biomedical research should be permitted only if there is a strongly favorable benefit-risk ratio for the prisoner. The distribution of burdens should also be considered, thus the requirement that at least half of the research sub- jects must come from nonprisoner populations. Research should only in- volve prisoners to provide a benefit to prisoners, not because they are a convenient source of subjects. This approach would enable fair distribution of potential benefits and burdens to prisoners. To provide extra protections in the area of biomedical intervention research, which likely carries the greatest risks for subjects, the only ben- efits that should be considered are the benefits to the subjects themselves. Benefits to prisoners as a class are not a strong enough justification for a biomedical intervention study to proceed. These biomedical inquiries may include drug studies and surgical, radiological, or any interventional study in which the outcome of the biomedical intervention is the question of interest. There may be research proposals, most likely within social/behavioral

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10 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS and epidemiological categories, that carry very low risks for the prisoner subjects but no personal benefit for the subjects. Instead, the potential benefits may be for prisoners as a class (e.g., studies to identify factors that predict recidivism or that seek to understand the effects of prior trauma on antisocial behavior). Applying a risk-benefit analysis may determine that, because the risks are very low and important knowledge or benefits may accrue for prisoners as a class, the research is ethically acceptable. The same may hold true for epidemiological studies that require analysis of biomedi- cal samples, such as tissue, blood, or urine, but are not designed to assess outcomes of an intervention. For all studies under consideration, the greater the risk and the more restrictive the correctional setting, the stronger the design and monitoring safeguards need to be. Update the Ethical Framework to Include Collaborative Responsibility In the Belmont Report (NCPHSBBR, 1979), the national commission identified respect for persons, justice, and beneficence as the fundamental ethical principles that should guide the conduct and regulation of research with prisoners. These three principles should continue to anchor discus- sions of research with prisoners. However, ideas about ethical research have evolved over the past three decades, leading the committee to suggest that collaborative responsibility be added as a derivative of the principle of justice to give attention to the needs and responsibilities of all parties who will be involved with or affected by a research endeavor. Recommendation: Use a collaborative research approach. Under an ethic of collaborative responsibility, investigators should find ways to obtain input from prisoners and other stakeholders on the design and conduct of any research protocol involving prisoners. (Recommenda- tion 5.2) Collaborative responsibility is intended to convey the idea that, to the extent feasible, all aspects of research (design, planning, and implementa- tion) should include the active participation of relevant institutional stake- holders (prisoners, correctional officers, medical staff, administrators). A focus on collaboration would help cope with the reality that each institu- tion has its own unique conditions and may facilitate openness of the research environment. The responsibility for collaboration lies with investi- gators, who need to make the effort to engage prison administration and prisoners themselves for their input, and with the other components of the HRPPP, which must determine that the effort was made.

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11 SUMMARY This report contains two additional recommendations that are part of the updated ethical framework aimed at protecting prisoners: Recommendation: Ensure adequate standards of care. Human re- search participant protection programs, together with the prison ad- ministration and prison health-care professionals, are responsible for ensuring that research with prisoners occurs in an environment that is appropriate to the health and well-being of prisoners, including access to existing medical and mental health care that is adequate, protection from inmate attempts to coerce or manipulate participation or non- participation in research, and prompt access to decent health-care services in case the research causes physical or mental harm. (Recom- mendation 5.3) Justice requires more than the protection of prisoners from harm caused by the research itself. Ethical research carries with it a responsibility to grapple with the fact that potential harm is ubiquitous in everyday prison life, creating an environment for research in which the choice to participate in a study can be inherently coercive and potentially dangerous. Thus, in order for research to be ethical, justice requires that it must be done in a setting in which there is an adequate standard of health care in place. Ethical research requires an environment that is humane and provides reasonable access to supportive care, particularly when human subjects are exposed to physical or psychological risks. Without adequate medical or psychological care, subjects may be vulnerable to undue inducements to participate in research in order to gain access to medical care or other benefits they would not normally have. Finally, researchers have an ethical obligation, if they expose subjects to risk, to rapidly and professionally remedy any harms caused by the research. Recommendation: Support critical areas of correctional research. Gov- ernment agencies should fund and researchers should conduct research to identify needed supports to facilitate prisoners’ successful reentry into society, reduce recidivism, and inform policy makers about the most humane and effective strategies for the operation of correctional systems. (Recommendation 5.4) Society creates a correctional system for clear purposes such as deter- rence to future crime and rehabilitation of those who are convicted of committing offenses. It is of utmost social importance to better understand how best to achieve the purposes of incarceration, including reduction of recidivism and successful introduction back into the community. Perhaps unavoidably, the criminal justice system inflicts some harm on those it

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12 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS punishes. As ethical people, we strive to develop and use corrective mea- sures that are effective and humane without causing unnecessary physical or mental harm to prisoners. However, prisoners are a vulnerable popula- tion subject to abuse and exploitation. Indeed, several subclasses of prison- ers are some of society’s most vulnerable populations, such as young people, persons with mental disabilities, racial minorities, women, and people with diseases (addiction, hepatitis, HIV, hypertension, diabetes) that may or may not be treated during imprisonment. It is, therefore, especially important to better understand how to protect and promote the welfare and well-being of this large and growing segment of our society. Scientific knowledge and information about best practices gained from high-quality research are critically important to understanding how best to achieve all of the legiti- mate purposes of the criminal justice system. Enhance Systematic Oversight of Research Involving Prisoners If limited opportunities for research are to be allowed, safeguards and oversight must be strengthened, made consistent, and applied in relation to the levels of study risk and liberty restrictions experienced by the prisoner population. Informed consent must be obtained and privacy protected in the context of the correctional setting. Approval of research by the IRB is a critical step, but it is not sufficient. Research involving prisoners must be monitored throughout the course of the study to verify that procedures are being conducted as approved and to detect adverse events or unanticipated problems in a timely manner. The monitoring process may need to differ depending on the setting or study type. Studies that take place in closed institutions, where liberty restrictions are the greatest, require more proactive monitoring than studies within community settings, where subjects can more easily pick up the phone to express concerns or complaints. Similarly, higher risk or more intrusive studies (e.g., research that involves medical, pharmaceutical, or biological interventions) would likely require more intrusive monitoring than social/ behavioral studies of nonsensitive issues (e.g., involving questionnaires). The committee suggests that monitoring be accomplished by a prison re- search subject advocate (PRSA), who is familiar with the local correctional setting but not an employee of the facility, to ensure credibility among the prisoner subjects and maintain independence. The IRB should have free access to the PRSA and be able to meet with the PRSA separate from the investigator and correctional staff. Recommendation: Strengthen monitoring of research involving prison- ers. Institutional review boards that review and approve research involv-

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13 SUMMARY ing prisoners should establish an onsite, ongoing monitoring function through a prison research subject advocate. (Recommendation 6.3) The activities of the PRSA go beyond the routine annual reviews that IRBs currently conduct. The PRSA’s activities are study specific (although a single person could be a PRSA for more than one study) and are “on the ground” activities, involving varying degrees of direct observation of spe- cific research activities (depending on the type and risk level of the re- search). Recommendation: Modify institutional review board considerations for independent ethical review of research protocols. Institutional re- view boards should focus on the particular ethical issues that each protocol raises in the specific context of the correctional setting. Insti- tutional review boards would no longer be required to forward re- search proposals to Office for Human Research Protections for certifi- cation, except for those rare proposals that require federal-level review. (Recommendation 6.4) IRBs should accomplish the following: • Review studies at the local level, make the initial assessments of risk and potential benefits, and approve or reject individual studies based on detailed information about the protocol and correctional setting. • Determine if a study requires federal-level review. • Evaluate investigator efforts to obtain input from prisoners and other stakeholders on the design and conduct of the protocol. • Evaluate the proposed research environment in terms of adequacy of existing health services. • Calibrate the extent of safeguards and monitoring to the level of restrictions imposed upon prisoners in the particular correctional setting and the degree of risk involved in study participation. • Receive monitoring reports directly from PRSAs and researchers, at a scope and frequency determined during study review. The committee recommends that, although IRBs should retain the bulk of the approval and monitoring functions to keep these at a local level, a national independent body is also needed as an additional safeguard. Recommendation: Enhance the Office for Human Research Protections’s capacity to provide systematic oversight of research in- volving prisoners. The Department of Health and Human Services should strengthen the capacity of the Office for Human Research Pro-

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14 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS tections to provide systematic oversight of research involving prisoners that is within its purview. (Recommendation 6.5) Four necessary functions are currently lacking in whole or in part in oversight of research involving prisoners: 1. Maintain a national registry of all prisoner research that is conducted. 2. Make determinations if a study requires federal-level review. 3. Enforce compliance with the regulations, investigate reports of pos- sible problems, intervene to curtail abuses, and impose sanctions for non- compliance. 4. Serve as a national resource for HRPPPs to promote a uniform understanding and consistent application of the regulations. OHRP is designed to perform three of the four functions above, but does not currently have the funding or personnel to adequately carry out the tasks. OHRP needs to be revitalized and refocused to carry out the three functions already within its purview. In addition, it should be charged with the task of creating and maintaining a national registry of research involv- ing prisoners. This recommendation, however, covers only research sup- ported by DHHS and two other federal agencies. The majority of research involving prisoners is being conducted in the absence of any obligation to provide safeguards or oversight. To remedy that inadequacy and ensure that these protections apply to all research involving prisoners, the en- hanced OHRP model must be replicated for all agencies and privately funded research. Recommendation: Establish systematic oversight of all research in- volving prisoners. Congress should establish a national system of over- sight that is applied uniformly to all research involving prisoners. (Rec- ommendation 6.6) To expand prisoner protections beyond the narrow jurisdiction of DHHS, Congress should establish a national system of oversight that is applied uniformly to all research involving prisoners, performing all of the functions listed in the recommendation before last. The vast majority of research involving prisoners does not fall within OHRP overview jurisdic- tion. Strengthening the safeguards provided for all prisoners involved in research, regardless of funding source, will facilitate safe and ethical re- search across the full range of research involving prisoners. These functions could be performed by the revitalized and properly funded OHRP if OHRP’s jurisdiction were extended to the entire range of research involving prisoners regardless of funding source (i.e., federal or nonfederal, public or

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15 SUMMARY private). An alternative is to compose a national entity to perform the necessary oversight functions. Placing the functions within OHRP may be more feasible and less disruptive, but it must be done with serious attention to the extra support needed within OHRP to undertake those tasks fully and much more broadly than its current limits to Common Rule agencies. The committee is calling for substantial improvements to the existing sys- tem of oversight, and if a new entity is necessary to make it happen, then it should be created. Recommendation: Ensure voluntary informed consent. Human re- search participant protection programs should ensure that voluntary informed consent is obtained from subjects in all research involving prisoners. (Recommendation 6.1) Informed consent is vital to autonomous decision making and respect for persons and is considered a bedrock of ethical research. Informed con- sent is an interactive and ongoing process to ensure that participants are voluntarily participating in research and that they understand the level and nature of the risks and the uncertainty of potential benefits. The written consent form—one part of the process—is the mechanism for documenting that communication with the participant regarding relevant considerations to enrollment in a protocol has taken place. The informed consent process must help the prisoner to exercise autonomous decision making. The pro- cess poses special challenges in the correctional setting, where autonomy is incompatible with institutional order and judicially imposed limitations on liberty. In a correctional setting, a prisoner’s capacity to exercise indepen- dent judgment may have atrophied. The consent process and discussion must focus on the risks and potential benefits of the research in the context of confinement and the nature of restrictions imposed on the prisoner’s liberty. This would include the impact of research data on a prisoner (e.g., how would testing positive for a communicable disease impact housing, work opportunities, medical treatment, family visiting). There is no ques- tion that, within correctional settings, it is more difficult to provide integ- rity to the process of informed consent, but this does not remove the obliga- tion. If it is determined that voluntary informed consent is not obtainable, then a research proposal should not go forward. Recommendation: Protect the privacy of prisoners engaged in research. Human research participant protections programs should collaborate with prison officials, probation officers, and other staff relevant to the correctional setting to protect the privacy of subjects in prisoner re- search. (Recommendation 6.2) Privacy is considered one of the necessary prerequisites for ethical re- search. In most circumstances, this means nondisclosure of the identity of

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16 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS the research subject and ensuring confidentiality of the specific data col- lected. Privacy is exceedingly difficult to attain in prison settings, however, because of the inherently coercive and institutionalized contexts and the controlled and public nature of physical movement. Maximizing privacy within a correctional setting will require collaborative planning efforts spe- cific to the particular correctional setting that involve potential subjects and staff from the correctional setting to consider the impact of participation on privacy issues. Given that it may not be possible to guarantee absolute privacy in some situations, researchers and IRBs should consider the extent to which core privacy issues can be protected from disclosure through realistic and prac- tical approaches. For instance, it may be clear to prisoners and staff that medical research is being conducted, but the specific nature of the study or the characteristics common to human subjects need not be generally known or discernible. These measures, and their limits, should be discussed in detail with prospective participants in the context of the consent process. CONCLUDING REMARKS The recommendations offered within this report are intended to en- courage the development of a uniform system that provides critically im- portant protections for prisoners involved in research. Research has the potential to help society better understand how to protect and promote the welfare and well-being of this large and growing segment of our society. For any research to go forward, however, it must offer more benefits than risks to prisoners, and the setting in which the prisoners are consigned must allow for the ethical conduct of research, including autonomous decision making, voluntary informed consent, and privacy protection. Strengthening systems of oversight and requiring collaboration at every level of the re- search process will require substantial commitments from every stakeholder (Table S-1). The committee acknowledges that the collaboration model, for example, will be new within most correctional settings and among many researchers. However, if research is to be supported to improve the welfare of prisoner populations, which the committee recommends, it must be done with rigorous safeguards and under a comprehensive HRPPP. The hallmark of a decent society is to ensure humane, respectful treatment of all prison- ers. Responsible, ethically appropriate research is one important aspect of the kind of society to which we aspire.

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TABLE S-1 Impact of Committee Recommendations on Stakeholder Responsibilities Stakeholders Current Duties Proposed Duties Based on Committee Recommendations Congress 1. Mandate uniform guidelines 2. Adequately fund OHRP to strengthen its capacity to provide uniform oversight 3. Establish national oversight entity (OHRP or other) to provide same OHRP oversight functions for the larger universe of research involving prisoners that is not within DHHS jurisdiction. DHHS/OHRP 1. DHHS agencies follow Subpart C, OHRP also has 1. Expand definition of the term prisoner. oversite for research involving prisoners for two other 2. Support critical areas of correctional research. agencies (CIA, SSA) that signed on to Subpart C. 3. Revise Subpart C regulations to reflect a risk-benefit 2. For above mentioned studies involving prisoners, approach to research review similar to Subpart D. OHRP must certify that IRB has followed Subpart C. 4. Establish a system of safeguards to be applied 3. If a protocol does not fit within one of five categories, uniformly. regardless of risk benefit, it is not approved. 5. Revitalize OHRP to enhance its capacity to provide uniform oversight. 6. Maintain a national registry of all prisoner research. 7. OHRP no longer certifies all studies, although it still oversees process of “exceptional” study review. 8. OHRP focus shifts to national oversight, data collection, compliance, enforcement, and technical assistance role. Other federal agencies Only CIA and SSA follow Subpart C. 1. All federal agencies follow Subpart C. 2. Support critical areas of correctional research. Nonfederal and private Not required to follow Subpart C. Must follow revised Subpart C. sponsors continued 17

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18 TABLE S-1 Continued Stakeholders Current Duties Proposed Duties Based on Committee Recommendations Correctional settings 1. No clear, standard expectations for providing input in 1. Be open to providing input to investigators regarding design or access for onsite monitoring. the design and conduct of research protocols involving 2. May or may not require IRB review for research at prisoners. their facility. 2. Require that research be approved by an IRB before it is conducted at their facility. 3. Assist in protection of subject privacy. 4. Provide for timely and adequate medical response to adverse events experienced by the research subjects. 5. Ensure that PSRAs have open access to monitor research activities. HRPPP/IRB 1. Protocol review is based on categories. 1. Review shifts from category-based to risk-benefit 2. For DHHS-supported research involving prisoners, approach, with focus on the particular ethical issues submit to OHRP for certification, and if necessary, that each protocol raises in the specific context of the federal-level review. correctional setting. 3. Wait for OHRP certification before study can be 2. Only “exceptional” studies are submitted to OHRP approved. for federal-level review. 4. Ensure informed consent. 3. Evaluate investigator efforts to obtain input from 5. Protect subject privacy. prisoners and other stakeholders on the design and 6. Include prisoner representative as voting member of conduct of research protocols involving prisoners. IRB. 4. Evaluate the proposed research environment in terms of adequacy of existing health services to ensure that prisoner participation is truly voluntary, and assess existing capacity to provide for timely and adequate medical response to adverse events experienced by the research subjects. 5. Ensure informed consent.

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6. Protect subject privacy. 7. Include prisoner representative as voting member of IRB. 8. Be open, transparent, and accountable. Investigators 1. Present studies to IRB and await IRB approval and 1. Present study to IRB for approval. Only requires OHRP certification. OHRP review for “exceptional” studies. 2. No standards for getting input or ensuring adequate 2. Demonstrate efforts to obtain input on study design medical response and implementation from stakeholders, including 3. Obtain informed consent. prisoners. 3. Demonstrate to the IRB that the proposed research environment provides for timely and adequate medical response to adverse events experienced by the research subjects. 4. Obtain informed consent. 5. Be open, transparent, and accountable. PRSAs Do not exist. 1. Provide assurance, via ongoing, onsite monitoring, such that research subjects within a specific facility or program are protected. 2. Multisite studies would likely have more than one PRSA. 3. Duties expand as potential risks to participants increase. Prisoners 1. Provide informed consent. 1. Provide informed consent. 2. Provide input, on request, on study design and implementation. NOTE: OHRP, Office for Human Research Protections; DHHS, Department of Health and Human Services; CIA, Central Intelligence Agency; SSA, Social Security Administration; IRB, institutional review board; PRSA, prison research subject advocate. 19

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