6
Systems of Oversight, Safeguards, and Protections

Participation in human subjects research has often been thought of as a burden, which suggests that the barriers to participation were significant. Although it is important to be vigilant to avoid unwarranted burdens, there is also an increasing awareness that research participation can sometimes afford benefits. Thus, when thinking about research involving prisoners, potential benefits and risks must be carefully considered. This chapter focuses on the systems of oversight, safeguards, and protections that would enable human research participant protections programs to weigh the potential benefits and risks and then apply important safeguards and monitoring processes, based on level of risk, to approved research. It includes a discussion of how prisoner research should be defined and how it should be reviewed (when, what, and by whom). Recommendations regarding the use of a prison research subject advocate (PRSA) and stronger national oversight of prisoner research are also discussed. The chapter ends with the committee’s suggestions to modify the risk-benefit approach used in Subpart D of 45 C.F.R. Part 46 for application to apply it to research involving prisoners. Relevant examples are provided.

OVERARCHING PRINCIPLE

In considering a system of oversight, safeguards, and protections under the broader proposed definition of the term prisoner, the committee weighed the current system in view of the locus of specific threats to ethical research with prisoners and perceived need for concrete responses to those specific



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6 Systems of Oversight, Safeguards, and Protections Participation in human subjects research has often been thought of as a burden, which suggests that the barriers to participation were significant. Although it is important to be vigilant to avoid unwarranted burdens, there is also an increasing awareness that research participation can sometimes afford benefits. Thus, when thinking about research involving prisoners, potential benefits and risks must be carefully considered. This chapter fo- cuses on the systems of oversight, safeguards, and protections that would enable human research participant protections programs to weigh the po- tential benefits and risks and then apply important safeguards and monitor- ing processes, based on level of risk, to approved research. It includes a discussion of how prisoner research should be defined and how it should be reviewed (when, what, and by whom). Recommendations regarding the use of a prison research subject advocate (PRSA) and stronger national over- sight of prisoner research are also discussed. The chapter ends with the committee’s suggestions to modify the risk-benefit approach used in Sub- part D of 45 C.F.R. Part 46 for application to apply it to research involving prisoners. Relevant examples are provided. OVERARCHING PRINCIPLE In considering a system of oversight, safeguards, and protections under the broader proposed definition of the term prisoner, the committee weighed the current system in view of the locus of specific threats to ethical research with prisoners and perceived need for concrete responses to those specific 137

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138 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS threats. In doing so, the committee considered (1) alternative conceptual frameworks for defining and reviewing permissible research with prisoners; (2) the substantial variability in threats to ethical research (e.g., the poten- tial and likelihood for coerced participation; the degree of openness to outside review, and remediation of emergent research-related problems) across the expanded array of research settings (i.e., community settings as well as traditional institutions); (3) differing types and magnitudes of po- tential risks posed by specific types of research (i.e., biomedical as distinct from social/behavioral); and (4) specific safeguards related to research de- sign and implementation monitoring that might facilitate safe and ethical research across these diverse settings. To correct the inadequacies and lack of complete coverage of current regulations, as described in Chapter 3, the systems recommended by the committee are meant to apply to all research with prisoners to ensure that the same protections are afforded to every prisoner-subject. Prisoner- subjects are currently being enrolled in a broad spectrum of research on various topics at many different institutions and by many different re- searchers. To achieve the objective of adequately protecting prisoner-sub- jects, the system of oversight must cover all research involving this vulner- able population regardless of the funding source, the federal-wide assurance (FWA) status of the institution conducting the research, the correctional setting in which the research will take place, or the type of research being conducted. Additionally, the oversight system should cover research involv- ing individuals meeting the definition of prisoner set forth in Chapter 4, which includes persons at all custody levels, from those who reside in prisons or jails to those who are under supervision in detention centers or other types of community placements. DEFINING AND REVIEWING PRISONER RESEARCH For the tasks of defining and reviewing permissible research with prison- ers, the committee considered the current framework of the U.S. Department of Health and Human Services (DHHS) regulations at 45 C.F.R. Part 46 Subpart C (Additional DHHS Protections Pertaining to Biomedical and Be- havioral Research Involving Prisoners as Subjects).1 This regulation requires that a duly constituted institutional review board (IRB), with at least one prisoner representative as a voting member, review and approve the study, with consideration of the special circumstances inherent in conducting the research with prisoner-subjects. Subpart C defines permitted research using a combination of substantive research categories and risk levels and for certain 1Revised November 13, 2001.

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139 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS types of research. All studies involving prisoners within this framework are subject to certification by the DHHS Office for Human Research Protections (OHRP), which verifies that (1) the IRB has appropriately reviewed the study, and (2) the study falls into one of the categories of permissible research (see Chapter 3 for details). This subpart also requires federal-level review (in consultation with a panel of experts) and published notice in the Federal Register for certain categories of research. On close inspection and in light of the experiences of committee mem- bers who have served on IRBs, the Subpart C provisions appear problem- atic. The substantive categories are not mutually exclusive, and a study that might be permitted without secretarial review in one category (e.g., a study of drug addiction as a cause of criminal behavior) might require secretarial review in another (e.g., drug addiction as a condition particularly affecting prisoners). The classification and OHRP certification process for such stud- ies can be lengthy and contentious, often resulting in (sometimes prolonged) delays, which may discourage investigators from conducting valuable re- search. The value added by the certification and review process, as it cur- rently operates, is not clear. Further, the OHRP has reported receiving for review and certification studies that were designed to yield potentially im- portant and useful information but could not be approved because they did not fall into one of the approvable substantive categories. The committee considered whether a modified version of the frame- work provided under 45 C.F.R. Part 46 Subpart D might be preferable for the review of research involving prisoners. The Subpart D framework is structured primarily in terms of level of risk posed to the subject (minimal or greater than minimal) and whether the research presents the prospect of direct benefit to individual subjects (for a more detailed description, see IOM, 2004, pp. 100–103). With modifications that either (1) specify par- ticular research categories that would be impermissible with prisoners, or (2) delineate specific kinds of design and monitoring safeguards necessary for IRB approval of permissible research, the committee judged that greater protections could be afforded prisoner-subjects by the use of a modified Subpart D framework (see page 160, “Applying Safeguards for Particular Kinds of Research”). What Is Reviewed All research that involves prisoners must be reviewed by an indepen- dent body before it begins. Under 45 C.F.R. Part 46, the term research is defined as “a systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This definition is subject to varying interpretations both inside and outside the prisoner research context. The main distinction between a

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140 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS research activity and a nonresearch activity is the primary intent of the activity: Research aims to test hypotheses and/or generate new knowledge, whereas nonresearch aims to control a disease or other condition or to improve a program or service. Clinical or epidemiological studies that are intended to reveal new information about a disease, behavior, or treatment are clearly research. In contrast, data collection efforts that are intended solely to aid in evaluating an internal system or in quality improvement (QI) initiatives may not be research. There is little dispute that correctional health-care systems should have an ongoing system in place to monitor and evaluate health-care services from quality assurance and improvement perspectives. In general, measur- able components of care include accessibility, appropriateness, continuity, effectiveness, efficacy, efficiency, patient perspective issues, safety of the care environment, and timeliness (Joint Commission on Accreditation of Healthcare Organizations, 1992). Such internal program assessments are central to policy makers and organization executives for management pur- poses, especially in the context of limited financial resources and increasing demand for services (Council of State Governments, 2002). These evalua- tion systems have a variety of different labels, including QI, comprehensive QI, total QI, and quality assurance (QA). In more mature systems, QA is an element of a more comprehensive QI process. Outcome QI studies examine whether expected outcomes of patient care were achieved. Process QI stud- ies examine the effectiveness of the health-care delivery process. Under the current federal regulations, only research activities that in- volve human subjects (or data from or about human subjects) require IRB review and approval. However, state-level departments of corrections (DOCs) have different rules and are not consistent in what they consider to be research and nonresearch (see Chapter 2). For example, (1) in some states internal evaluations are not considered research, whereas similar activities undertaken by outside researchers are, (2) in-house activities re- quire fewer approvals or reviews than external activities, and (3) unless results are to be published, IRB review may not be required. Because either type of activity (research or nonresearch, in-house or external) may involve the collection of private or sensitive information, there is a chance that prisoners who participate may be put at risk. Thus, to afford the greatest protection to prisoners, both activities may need outside scrutiny, especially in view of the heightened vulnerability of prisoners. If there is doubt about whether an activity requires review, it should be re- solved in favor of providing additional protection to the human subjects through independent review and oversight. However, some activities (e.g., review of information from medical records to determine what therapies are most effective in a given correctional facility) are clearly designed to give clinicians and prison administrators information needed to provide

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141 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS quality care. Likewise, some activities are designed to improve the opera- tions of the facility (i.e., QI processes) and are not intended to be disclosed outside that facility. These activities, as well as external surveys for accredi- tation purposes, would not require review by an IRB because they do not constitute research. Who Reviews Current regulations state that research involving prisoners must be reviewed by an independent review committee, such as an IRB, before any prisoner-subjects are contacted or any information about prisoner-subjects is accessed by the researcher. This independent committee should include members with diverse demographic (e.g., gender, race, ethnicity) and tech- nical (e.g., scientific and nonscientific) backgrounds. In addition, the com- mittee should include at least one prisoner representative who has experi- ence with the prison setting, but is not an employee of the setting. This person should have particular knowledge of the correctional setting and should be able to represent the interests of the prisoners. The prisoner representative, who is a voting member on the committee, could be a per- son who works with prisoners (e.g., an attorney, a service provider, or a chaplain who is not an employee of the correctional institution or agency), a family member of an inmate, or an ex-offender. The committee should not include any individuals who have a conflict of interest in reviewing the study, such as the researchers themselves, representatives from a sponsor, or the prison staff. In the case of multisite studies, it may be necessary to obtain input from more than one prisoner representative, because local conditions are likely to vary from site to site. Two implementation issues require specific discussion. First, it is vital that the prisoner representatives on the IRB have sufficient opportunity to be heard, independent from the people who work in prisons (correction officers, medical staff, and administrators). Prison staff can provide valu- able input concerning the institutional needs and capacities. However, their institutional perspective may make it difficult for them to appreciate or articulate an accurate or sensitive assessment of the actual risk to prisoner subjects. As such, the prisoner representative must have the independence to freely express prisoner concerns, even when they may come in conflict with the institutional issues. Second, it will be important to diligently seek out and train prisoner representatives. If a representative is an ex-offender or prisoner advocate from outside of the institution, he or she must be familiar enough with the characteristics of the particular setting in question to provide relevant com- ments. Representatives from inside or outside the correctional setting should be given access to the prisoners so that individual concerns can be ex-

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142 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS pressed. To ensure sufficient understanding of the risks and potential ben- efits of a protocol, the prisoner representatives should receive adequate training on human subjects protections to understand the risks and poten- tial benefits of protocols. Currently, prisoner research that falls under 45 C.F.R. § 46 Subpart C must be reviewed by a properly constituted IRB that is registered with the OHRP and operates under an FWA. This IRB may be the same committee that reviews nonprisoner research, or it may be a distinct committee con- vened to review studies involving prisoner-subjects. Presently, research in- volving prisoners that is not governed by 45 C.F.R. § 46 Subpart C may or may not be reviewed by an IRB. Instead, it may be reviewed by another, independent prison review committee, such as a research committee that reviews research conducted at a specific prison. Although a prison review committee may review a study, theirs should not be the only review because of their close ties to the prison. According to the committee’s survey of DOC representatives (Chapter 2), IRB review is not consistent, and DOC IRBs do not universally include prisoner representatives. Other DOC IRBs may include people designated as prisoner representatives who may lack sufficient detachment and objectivity to perform that function (e.g., health- care professionals employed by the prison). Under the recommended over- sight paradigm, review by an IRB (or other independent review committee) would be required for all research involving prisoners regardless of whether review by a prison review committee is also done. For studies conducted at more than one facility, reviews may be required by a local IRB or review committee for each facility. It should be noted that the IRB is only one component of an institution’s human research participants protection program (HRPPP).2 The HRPPP is a broader organizational structure in which the responsibility for protecting research participants is shared among the sponsor, the larger research orga- nization, the investigators, and the IRB (IOM, 2003). Components of the HRPPP, in addition to the IRB, may entail additional levels of review and monitoring for prisoner studies, depending on the type and the risk level of the research. 2The term human research participant protection program 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 organiza- tion, the study sponsor, investigator, IRB, and, when relevant, the data safety monitoring board (IOM, 2003). In the contexts described in this report, prison subject research advocates would be an important part of this network as well.

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143 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS How Reviews Are Conducted The committee determined that the way in which IRB reviews of pris- oner studies are conducted need not vary substantially from how these reviews are done currently, except for an increased emphasis on assessing risks and benefits. (Biomedical research, compared with other types of research, remains a critically important area of concern.) This accounts for the committee’s recommendation to replace the current Subpart C frame- work, which requires categorization of the research study, with a modified Subpart D framework, which focuses on risks and individual benefits, to guide the IRB in reviewing research involving prisoners. Prisoner studies should be reviewed by a fully convened (and properly constituted) IRB or other independent review committee, as is presently done and recommended by the OHRP. One or more prisoner representa- tives must be in attendance at this review. The committee reviews the study protocol and all associated study materials (e.g., letters, consent forms, questionnaires, experimental protocols, drug information, and monitoring procedures). Committee members discuss the procedures in detail, with particular emphasis on potential risks to the prisoner-subjects and whether proper protections are proposed to mitigate these risks. They also evaluate other issues that are unique to performing the research with prisoners in a correctional setting, such as the following: • Is it necessary to involve prisoners in the study? This first question addresses the concerns expressed by several prisoner liaison panel members (Chapter 5). There are many more nonprisoners than prisoners in this country. Why are prisoners an appropriate source of subjects for the study? • Will prisoners constitute a majority of the study subjects? The com- mittee determined that, for most biomedical research, no more than 50 percent of the subjects may be prisoners. • How will the prisoners be recruited for the study, and how will prison staff be involved in this process? • How will informed consent be obtained from the prisoner-subjects? Voluntary informed consent is difficult to ensure in prison settings because of the inherently coercive environment. Thus, this evaluation by the IRB will include a full review of the consent process. With regard to the consent form itself, are all elements of consent included and explained in lay lan- guage and translated into a language the prisoner can understand if he or she does not speak English? For prisoners with poor reading skills, is the informed consent process modified to accommodate their needs, perhaps including a test of comprehension? Just as critical is the IRB’s review of the procedures that will be followed to obtain consent: Who will obtain con-

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144 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS sent? How will the information be presented to the potential subject to ensure full comprehension? How will the prisoner’s questions be answered? • Will the prisoner be informed of any special implications related to participation in the research study in a given facility (e.g., in some facilities, testing positive for HIV may lead to transfer to a different facility, limita- tions on work opportunities and family visits, or specific medical treat- ments)? The consent must address the policies and practices of the correc- tional setting in which the study is conducted; it is the investigator’s responsibility to become informed about these issues before presenting the study procedures to the IRB. • Will the prisoner-subject be paid for participation in the study? If so, how will this payment be made (e.g., into a spending account, as a noncash item)? What assurances have been given that such payments are both al- lowed by the facility and appropriate? • Will the prisoner-subject feel that participation is truly voluntary and feel free from coercion (either to participate or not)? Is it possible to hold in confidence the prisoner’s decision whether or not to participate? The IRB must also be assured, and the prisoner-subject informed, that neither parole nor the confinement situation will be affected by the decision to participate or not in the research. • How will privacy be maximized? The interview setting is of particu- lar concern, including the physical location of the room and the location of officers while the interview is underway. Officers need to be out of earshot, but it may also be important to make provisions to conduct the interview out of sight or with the prisoner facing away from officers and passersby. Computerized data collection methods (e.g., audio-assisted self-interview- ing in which the respondent hears the questions through earphones and then types responses into the computer) can provide extra privacy protec- tion for especially sensitive interview topics. Clinical studies under the pur- view of the Food and Drug Administration (FDA) require that a copy of the written informed consent, which contains details on the protocol, be placed in the participant’s medical record. However, for other studies, such as those of a social or behavioral nature, unless the correctional setting has a policy that requires the same, a copy of the consent form need not be entered into the file, and perhaps need not be left with the prisoner-subject. (There are circumstances under which possession of the consent form itself could compromise privacy.) The IRB could waive that requirement, while ensuring informed consent occurs. The IRB could also assign a unique study number to a research protocol (e.g., USF#12.344). Because IRBs (and correctional agencies) may both require evidence that the prisoner gave written informed consent, it could be arranged that the final/signature page of the consent form include only the following language, plus signature blocks: “I have had an opportunity to read and discuss the consent form

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145 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS “You have to know what the perception is going to be, not just the exact design, but how it is going to be perceived in the populace and by staff. Does involvement say the partici- pant is a snitch? Will it reveal HIV status or sexual prefer- ence? That is a precursor to doing the risk-benefit analysis,” said Jack Beck, director of the Prison Visiting Project at the Correctional Association of New York, and a member of the committee’s prisoner liaison panel, at the committee’s Octo- ber 2005 meeting. that explains research study Number USF12.344. I have had ample time to discuss this study with a member of the research staff and have received satisfactory information to allow me to decide about taking part in the study. By my signature below, I do voluntarily consent to participate in this study.” The prisoner could keep a copy of this consent form which, if discovered by corrections staff or other prisoners, would not disclose any- thing substantive about the nature of the research; similarly, if the correc- tions agency required evidence that the prisoner consented to and/or par- ticipated in the study, a copy of this in the file also would not violate confidentiality concerns beyond the fact of participation (which the agency almost inevitably and unavoidably knows because of movement control). • Will a prisoner’s status as a research subject have social or other consequences (either positive or negative) for the prisoner? • What arrangements will be made for prisoners to voice complaints about the study or concerns about their rights as subjects, and how will these communications be facilitated in the correctional setting? (Access to telephones is commonly restricted in correctional facilities, so this too must be considered.) • How will the confidentiality of the study data be maintained? The IRB will assess whether adequate plans are in place to prevent breaches of confidentiality, including how hard copy forms are handled by the study staff within the correctional setting and how electronic data are protected. Unless names of prisoners are critical to the study (i.e., the study involves continuing treatment, future follow-up, or linkage to other records), the link between names and study data should be destroyed at the earliest possible time. Different types of confidentiality provisions will be required for different types of data (e.g., How are HIV results or other lab results protected? What happens when a prisoner reports an illegal behavior or a parole violation? Who is informed when a prisoner-subject requires follow- up care?). The limits of confidentiality that can be ensured may also vary by

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146 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS “The research on women in the prison is very touchy for me,” explained Jean Scott, deputy regional director of New York City Correctional Treatment Programs, Phoenix House, and a prisoner liaison panel member. “I see a lot of research- ers going in to [get the women to] ‘tell your story.’ This woman bears her soul, and that’s it, she goes down as an- other number. She’s left feeling bad, somebody else now knows her story. Now what do we do? They send these re- search teams in to start opening up all these wounds with these women, and it is not a good thing. [We need] to have a program that is going to spend the time that is needed for the women.” location (i.e., related to individual state laws or facility rules), and prospec- tive prisoner-subjects must be informed of these limits during the consent process (e.g., some jurisdictions require reporting of child abuse or threats to harm oneself or others). • How will the research subjects access adequate health care if partici- pation in the research leads to the need for medical or psychological ser- vices? • How will follow-up care be provided to prisoners who may need it? Will it be possible for prison health-care providers to be informed of a person’s participation without informing other prison authorities? • How will study procedures be adapted to fit different settings in multisite studies? The researcher must present information about each re- search site to assure the committee that local conditions have been consid- ered in the fashioning of responsive and appropriate study procedures. Gathering this facility-specific information and customizing the study pro- cedures are likely to require substantial effort by the investigator, depend- ing on the number of participating study sites, as well as approval by a local IRB that had the benefit of participation by a prisoner advocate familiar with the particular facility. The IRB needs as much insight into the correctional setting as possible. To optimize a collaborative research relationship between correctional agen- cies, investigators, and prisoners to answer the questions listed above, some institutional initiative will be required. In addition to including a prisoner representative on the IRB and consulting with prison staff at each study site, it may be desirable for researchers to convene a prison advisory group to assist them in developing appropriate and feasible procedures for each study site. This group should be composed of current prisoners who can

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147 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS inform the researchers about unique factors to consider at their particular institution. For example, they could provide suggestions about how to publicize the study, the best times and locations for recruitment, and how to minimize outside influences on a prisoner’s participation decision. This information will also be critical to the IRB as it decides whether adequate protections are in place to allow the study to go forward. It may also be advisable for an individual who is monitoring related or other studies within the same setting (the PRSA) and/or prison staff to attend IRB meetings relevant to research within their institutions. Investigators could consider scheduling periodic (e.g., annual or semiannual) meetings with correctional agencies. With such exchange, investigators may be able to broaden their research protocols to address issues of concern in the correctional setting that would “host” their study, even if the original or primary focus of the investigation is derived from the investigators’ own research program. Simi- larly, corrections staff may get a preview of the kinds of issues and propos- als that the investigators intend to pursue and be able to contribute at the early (and later) stages of study design and implementation. During the deliberation phase of the review, the IRB will decide whether prisoners can be involved in the research study at all in view of the risks and benefits affecting this special population. The IRB may vote to approve the study, approve with modifications, defer, disapprove the study, or it may determine that the study requires a federal-level review. Two elements of research discussed previously—informed consent and privacy—are so integral to high-quality, ethical research that they require special attention. As such, the committee formulated recommendations re- garding both issues. Recommendation 6.1 Ensure voluntary informed consent. Human research participant protection programs should ensure voluntary informed consent is obtained from subjects in all research involving prisoners. Informed consent is vital to autonomous decision making and respect for persons and is considered a bedrock of ethical research—whether it involves prisoners or nonprisoners. Informed consent 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 process poses special challenges

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164 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS It is beyond the scope of this committee’s charge to prescribe extensive and highly detailed requirements that would accommodate any foreseeable study design; the judgment of the IRB will be required to implement special safeguards in any given case. However, this discussion of IRBs imposing special safeguards should not be read as a mere suggestion; the committee is unanimous in asserting the need for regulations that expressly require IRBs to proactively impose special safeguards when needed to adequately protect prisoner-subjects. Moreover, it is anticipated that regulations based on the committee’s deliberations will ensure adequate protection for prisoner- subjects in all research settings. Example 1: A psychologist administers a measure of general personality traits, such as impulsivity, extraversion, and anxiety sensitivity, to prisoners as they prepare for discharge from prison to a community halfway house. This is a noninterventional study that does not elicit any sensitive or preju- dicial information;8 the questions on these measures are of the type usually encountered in routine psychological evaluations and thus meet the conven- tional and historical definitions of “minimal risk.” The investigator obtains a report of disciplinary infractions for each inmate in the study. Correla- tional analyses are conducted to determine the extent to which these gen- eral personality traits predict the subsequent disciplinary problems. Based on these analyses, suggestions are made to the prison staff responsible for discharge planning about the potential utility of these kinds of measures for identifying prisoners more or less likely to adjust successfully in this par- ticular type of placement. The study has the potential to benefit prisoners as a class by informing the placement decisions that DOC officials make when prisoners are transitioned to the community, potentially increasing the like- lihood of a successful return to the community. Thus the study is consid- ered low enough risk that the IRB might opt not to impose any special safeguards. Informed consent can be obtained in the usual way without requiring PRSA monitoring or spot-checking, and there is no apparent 8Prejudicial information includes the personal information that, if disclosed to or discov- ered by certain third parties, might result in formal consequences for the individual. Examples include self-reporting of (1) having previously abused children or the elderly (potentially subject to state mandatory reporting laws), (2) medical conditions or vulnerabilities that might be stigmatizing or adversely affect ability to obtain or retain medical insurance, (3) prior criminal activity (only if described in sufficient detail to render the subject a suspect in a particular crime), or (4) conduct that violates institutional or program rules or conditions of probation or parole, the revelation of which could result in the imposition of punitive or disciplinary measures (e.g., drug use). Sensitive information is that which might be potentially embarrassing if revealed to third parties (e.g., sexual habits) even if such disclosure might not put the person at risk for formal sanctions.

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165 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS reason to require the investigator to seek a certificate of confidentiality. At minimum, there should be some mechanism whereby prisoner-subjects can contact the IRB to report problems or ask questions. Example 2: An investigator is interested in the personality correlates of risky behavior. With the cooperation of a probation services office, she recruits voluntary participants from individuals living in the community who come in for monthly probation supervision. Her protocol includes self- report questionnaires that assess general personality features; she also con- ducts a semistructured interview that queries the individual about risky behaviors, such as participating in unprotected sex, illicit drug use, reckless or fast driving, and other kinds of risky behaviors. Although the protocol may meet traditional and historical criteria for “minimal risk,” the depen- dent measure (risky behavior questionnaire) solicits information (e.g., con- temporary drug use or law violations) that, if revealed to the probation officer, could result in violation of probation; the questionnaire also solicits information (e.g., sexual activity) that might be potentially embarrassing under some circumstances. The study does have the potential to benefit prisoners as a class by identifying personality features that may lead to a risky lifestyle, and this information could potentially form the basis for interventions that target the reduction of such behaviors in other prisoners in the future. When a protocol will solicit sensitive or prejudicial information, the IRB should consider requiring safeguards and monitoring procedures of the type indicated in Box 6-1. For research in a relatively lower security setting (e.g., a probational services office), the investigator might be re- quired to obtain a federal certificate of confidentiality; a PRSA might also be assigned to periodically debrief randomly selected subjects to determine whether they had experienced any untoward actions by investigators or their probation officers, such as coercion. In higher-security settings (e.g., a jail or prison), additional and stronger safeguards and monitoring might be deemed necessary. For example, the PRSA might be assigned to spot- check protocol administration to ensure that the protocol was adminis- tered within the institution in a way that protected the prisoner’s privacy. And of course, in any study that elicits sensitive or prejudicial information, the potential prisoner-subject must be advised in clear terms of the risks associated with disclosure of such information. The potential participant must also be advised that he or she may refuse to answer any questions, and that he or she may discontinue his participation in the study at any time without adverse consequence to his personal circumstances or the conditions of his confinement.

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166 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS Example 3: A phase 3 study plans to enroll more prisoners than non- prisoners comparing an experimental treatment for hepatitis C with an existing therapy. This research involves greater than minimal risk, but pre- sents the prospect of direct benefit to the individual participants (currently § 46.405 Subpart D). The study is not approvable, however, unless it reduces the percentage of prisoner-subjects to no more than 50 percent. If prisoner enrollment is reduced, safeguards and monitoring should still be extensive. They might include all of the safeguards listed in Box 6-1, plus M3-6 of the PRSA monitoring safeguards. Example 4: A phase 3 study is planned to compare an experimental treat- ment to placebo for a condition for which no standard therapy exists. Placebo-controlled studies are not allowable if there is a standard therapy for the condition. Current standard therapy would have to be the compara- tor to the experimental therapy in order for the study to provide potential benefits to the individual prisoner-subjects. If there is no standard therapy and placebo control is proposed, concerns regarding use of placebo are sufficient for the committee to determine that federal-level review would be necessary. Exceptional safeguards would need to be put in place as well. The PRSA should attend informed consent dialogues to ensure prisoners understand that they may be receiving a placebo. Also appropriate are M5 and M6 from Box 6-1, which provide for reactions to study medications and subjects’ experiences with the responsiveness of the prison staff and investigators to adverse events that they may have experienced. In addition, M7 should be used, requiring researchers to present the study’s status to the IRB after the first 30 days the subjects are enrolled. Example 5: In a study of post-traumatic stress disorder, participants will be queried in depth about prior traumas and associated reactions, but the study does not involve investigation of treatments for such conditions. In- depth explorations of traumatic events and the deliberate uncovering of associated feelings and emotions might result in a degree of psychological discomfort that increases potential risk to some participants. In addition, this study provides no potential benefit for the individual, but may benefit prisoners as a class if the investigation aims to understand the impact of trauma on crime or recidivism after release from prison, or serves as a potential basis for developing therapeutic interventions. The research may be approvable if benefits to prisoners as a class can be ascertained. However, level of risk is greater than minimal; therefore, the IRB may deem necessary a type of PRSA monitoring that has a higher frequency and a greater extent (as described in Box 6-1) than would be needed for a study that delved only superficially into past traumatic experi- ences (e.g., some research questionnaires include only one or two cursory questions about whether the respondent believes that he or she has ever

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167 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS been abused or experienced trauma, without exploring any details of such experiences). For example, M4 (PRSA monitoring, spot-checking adminis- tration of the protocol) might reveal the extent to which the investigator evaluated the immediate impact of the protocol on the subject and took appropriate action (e.g., crisis intervention, referral to services) when sub- jects became upset as a consequence of participation. Example 6: A study will utilize functional magnetic resonance imaging to study brain activity during subjects’ responses to visual or verbal stimuli that invoke feelings of anger and aggression. This study is an example of a behavioral study in that the outcomes involve monitoring of brain activity (behavior). It does not provide direct benefit to prisoner-subjects, but it might benefit prisoners as a class if methods to reduce anger could be developed based on the magnetic resonance imaging (MRI) results. Because MRI is considered an invasive monitoring procedure, the study would in- volve somewhat greater than minimal risk. Safeguards and monitoring must be correspondingly more stringent. In addition, safeguards and monitoring would need to be more stringent if the study were taking place in a high- security correctional setting than if it were in a less-restrictive setting. Example 7: A phase 1 study of a medication may reduce repetitive sexual assaults. Research that presents an opportunity to understand, prevent, or alleviate a serious problem that solely or almost exclusively affects the health or welfare of prisoners is a narrow category that the committee expects will be used in only rare cases. The committee recommends that proposals for this type of research be permissible only under the added scrutiny of federal-level review and approval. Such studies may not proceed until after the secretary has consulted with the appropriate experts, such as an ad hoc committee as used for Subpart D of § 46.407, and published notice in the Federal Register of the intent to approve such research. It includes studies seeking to develop medications for the treatment or management of certain behaviors that are unique to, or almost exclusively found in, prisoner populations. For example, repetitive violence or repetitive sexual assault are behaviors not widely dis- tributed in the general population. Individuals who exhibit these behaviors are confined for long periods of time with little prospect for release unless methods are developed to manage their deviant behavior. Insofar as the committee has recommended against permitting prisoners to participate as research subjects in phase 1 and phase 2 clinical trials of medications, in the case of such conditions an exception is necessary as there are no alternative candidate research populations to draw from. Due to the potential risks (prisoners make up more than 50 percent of the study population and phase 1 testing is early testing with little data on benefit), this study would require the most stringent design safeguards and PRSA monitoring , some of which is described in the Box 6-1.

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168 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS Example 8: Research will study segregation or other isolated settings and its effects. There would be significant problems gaining reliable voluntary consent from individuals within the isolated confines of segregation or who face the bleak future of death row. Approval of any studies within these settings would require a federal-level review process, including consultation with the appropriate experts, such as an ad hoc committee as used for Subpart D of § 46.407, and published notice in the Federal Register of the intent to approve such research. Studies proposed within these settings would have to establish a clear potential benefit to the prisoner-subjects and would likely be limited to studies designed to measure the adverse effects of segregation on mental or physical health or well-being. Extraordi- nary safeguards must be in place to minimize coercive forces and maximize the likelihood that prisoner participation is voluntary. Monitoring should be extensive as well, including PRSA attendance at every enrollment inter- view to ensure and reinforce disclosure that participating (or not) in the research does not affect how long the person may remain in his or her current special status or setting. Example 9: A study is proposed to compare drug X with drug Y to treat impulse control disorders. Clinicians currently use drug Y to treat such disorders; however, it is not on the prison’s formulary due to its cost. Available instead is the lower-cost generic form, which is more likely to cause gastric side effects than drug Y. The study would not be approvable because of standard-of-care and consent issues. Some prisoners may be willing to expose themselves to unknown risks of taking drug X in the hope of receiving drug Y, which is considered a useful drug for impulse control disorders, but is not available, except through this research project. Example 10: A person sentenced to probation is released from jail and resumes living at home and makes monthly visits for probation supervision. This prisoner reads in the newspaper that the local university medical school is conducting a phase 2 study of a drug to treat adult attention deficit disorder (ADHD). Having previously been diagnosed with ADHD, he calls the university and makes an appointment to meet with the study coordinator and eventually enrolls in the study. This is an example of the situation described in Chapter 4, in which the prisoner is voluntarily par- ticipating in a study that has no necessary connection to his status as a prisoner; no criminal justice agent (e.g., his probation officer) is involved in the identification or recruitment process, and his status as a “prisoner” is of no interest or consequence to the investigators—they are simply interested in adults with ADHD. The proposed regulations and guidelines in this report pertaining to “prisoner research” would not apply to this individual because there is no criminal justice nexus to his study participation.

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169 SYSTEMS OF OVERSIGHT, SAFEGUARDS, AND PROTECTIONS Example 11: A study compares the effectiveness of two in-prison education programs for prisoners with HIV. The study would assess prisoner actions after release from prison. Many DOCs have recently instituted “transi- tional case management programs” for prisoners with HIV, diabetes, tuber- culosis, or mental health issues as a standard of care when prisoners are released from custody. Researchers are trying to better understand the impact of this new case management model and how to improve it and compare it with other models. This research would involve recruiting pris- oners and starting the health education and/or behavioral intervention be- fore their release, then following prisoners after their release to determine if they follow up with their treatment, for example, or if they are using condoms. The risks are low, and potential benefits exist for prisoners as individuals and as a class. Regarding important safeguards, the researchers would need to (1) obtain a federal certificate of confidentiality to protect the confidentiality of the information the prisoner provides for the study, (2) convince the IRB that financial or other incentives are not provided for meeting recruitment quotas, and (3) find that the setting is sufficiently open to conduct the research (D1, D3, and D5). Although risks are considered low, the IRB will still want to be convinced that participants know what they are getting into and that the researchers are adhering to the protocol. Periodic monitoring (spot-checking), as described in Box 6-1 should accom- plish this goal. And of course, in any study that elicits sensitive or prejudi- cial information, the potential prisoner-subject must be advised in clear terms of the risks associated with disclosure of such information. The po- tential participant must also be advised that he may refuse to answer any questions, and that he may discontinue his participation in the study at any time without adverse consequence to his personal circumstances or the conditions of his parole. Example 12: A study will compare the effect of standard diet plus a dietary supplement versus standard diet alone on violent behavior among prison- ers.9 Nonprisoner research has shown a correlation between high intake of omega-3 fatty acids (fish) and lower murder rates. A researcher proposes to enroll 231 volunteers in a prison. Half would receive omega-3 fatty acids and other supplements; half would receive a placebo. A placebo is used so that the study subjects and others do not know who is receiving the supple- 9Interesting note: This study was actually published in 2002 in the United Kingdom (Mihm, 2006). Antisocial behavior (assaults and other violations) dropped by a third (relative to previous records) in the group that received the supplements. There was no behavior change in the control group. The investigator is planning a larger study and similar trials are under- way in Holland and Norway.

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170 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS ment and who is not. Reports of antisocial behavior (assaults and other violations) would be measured before and during the intervention. Ap- proval or disapproval of this study would depend on whether the IRB views it as behavioral or biomedical. The researchers are measuring behavior, but what is the supplement considered—a behavioral intervention or a bio- medical intervention? No diagnosed condition is being “treated” and the supplement is not a drug controlled by the FDA. This may be a case in which fitting a study into a clear category is less helpful than doing a straightforward risk-benefit analysis. If viewed as biomedical, the study would be unapprovable because of the 50 percent rule. The placebo ques- tion is tricky as well. If a standard of care exists, it should be provided as the comparator arm. There is no standard of care in terms of dietary supplements, but both groups are getting the same standard diet. If consid- ered a behavioral study, it would likely be approvable. What safeguards and monitoring would be necessary? If the study is approvable, as prisoners will be ingesting a substance, it is worth putting special safeguards in place, including D1, D3, D5, and D6. The PRSA should periodically attend in- formed consent dialogues to ensure prisoners understand that they may be receiving a placebo. Also appropriate are M5 and M6 from Box 6-1, which provide for reactions to study medications and subjects’ experiences with the responsiveness of the prison staff and investigators to adverse events that participants may have experienced. OTHER CATEGORIES AND TYPES OF RESEARCH INVOLVING PRISONERS PROHIBITED Because of the history of abuse in prisoner research and the continuing existence of powerful incentives to exploit this vulnerable population, the committee encourages a conservative approach to the approval of any re- search involving prisoners. Those studies that are approved should incorpo- rate safeguards necessary and appropriate to ensure the safety of prisoner- subjects in view of the correctional setting in which the study will be conducted. The committee unanimously recommends against the conduct of any research involving prisoners that is not specifically permitted under this report. IMPACT OF COMMITTEE RECOMMENDATIONS ON STAKEHOLDER RESPONSIBILITIES The recommendations offered in this report are intended to support the development of a uniform system that provides critically important protec- tions for prisoners involved in research. Strengthening the systems of over- sight and requiring collaboration at every level of the research process will

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TABLE 6-1 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 171

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172 TABLE 6-1 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.

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5. Ensure informed consent. 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. 173

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174 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS require substantial commitments from every stakeholder (Table 6-1). The committee acknowledges, for example, that the collaboration model will be new within most correctional settings and among many researchers. How- ever, if research is to be supported to improve the welfare of prisoner populations, it must be done with rigorous safeguards and under a compre- hensive HRPPP. REFERENCES Council of Europe. 1987. European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment. [Online]. Available: http://conventions.coe.int/ Treaty/EN/Reports/HTML/126.htm [accessed December 26, 2005]. Council of State Governments. 2002. Criminal Justice/Mental Health Consensus Project. New York: Council of State Governments. IOM (Institute of Medicine). 2003. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press. IOM. 2004. The Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. Joint Commission on Accreditation of Healthcare Organizations. 1992. The Transition from QA to QI: Performance-Based Evaluation of Mental Health Organizations. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations. Mihm, S. 2006, April 16. Does eating salmon lower the murder rate? New York Times Magazine. [Online]. Available: http://www.nytimes.com/2006/04/16/magazine/16wwln_ idealab.html?ex=1146110400&en=2528d21f31d15f30&e=5070 (accessed April 25, 2006).