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Ethical Considerations for Research Involving Prisoners (2007)

Chapter: 6 Systems of Oversight, Safeguards, and Protections

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Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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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 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

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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 potential 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 potential risks posed by specific types of research (i.e., biomedical as distinct from social/behavioral); and (4) specific safeguards related to research design 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 researchers. To achieve the objective of adequately protecting prisoner-subjects, the system of oversight must cover all research involving this vulnerable 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 involving 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 prisoners, 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 Behavioral 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

1

Revised November 13, 2001.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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 members who have served on IRBs, the Subpart C provisions appear problematic. 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 studies can be lengthy and contentious, often resulting in (sometimes prolonged) delays, which may discourage investigators from conducting valuable research. The value added by the certification and review process, as it currently operates, is not clear. Further, the OHRP has reported receiving for review and certification studies that were designed to yield potentially important 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 framework 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 particular 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 independent 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

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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, measurable 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 purposes, especially in the context of limited financial resources and increasing demand for services (Council of State Governments, 2002). These evaluation 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 studies examine the effectiveness of the health-care delivery process.

Under the current federal regulations, only research activities that involve 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 require 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 resolved 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

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

quality care. Likewise, some activities are designed to improve the operations 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 accreditation 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 technical (e.g., scientific and nonscientific) backgrounds. In addition, the committee should include at least one prisoner representative who has experience 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 person 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 valuable 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 comments. Representatives from inside or outside the correctional setting should be given access to the prisoners so that individual concerns can be ex-

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

pressed. To ensure sufficient understanding of the risks and potential benefits of a protocol, the prisoner representatives should receive adequate training on human subjects protections to understand the risks and potential 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 convened to review studies involving prisoner-subjects. Presently, research involving 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 oversight 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 organization, 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.

2

The 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 organization, 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.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

How Reviews Are Conducted

The committee determined that the way in which IRB reviews of prisoner 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 framework, 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 representatives 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 committee 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 language 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-

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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, limitations on work opportunities and family visits, or specific medical treatments)? The consent must address the policies and practices of the correctional 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 allowed 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 particular 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-interviewing in which the respondent hears the questions through earphones and then types responses into the computer) can provide extra privacy protection for especially sensitive interview topics. Clinical studies under the purview 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

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

“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 participant is a snitch? Will it reveal HIV status or sexual preference? 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 October 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 anything substantive about the nature of the research; similarly, if the corrections agency required evidence that the prisoner consented to and/or participated 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 followup care?). The limits of confidentiality that can be ensured may also vary by

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

“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 researchers going in to [get the women to] ‘tell your story.’ This woman bears her soul, and that’s it, she goes down as another number. She’s left feeling bad, somebody else now knows her story. Now what do we do? They send these research 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 prospective 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 participation in the research leads to the need for medical or psychological services?

  • 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 research site to assure the committee that local conditions have been considered in the fashioning of responsive and appropriate study procedures. Gathering this facility-specific information and customizing the study procedures are likely to require substantial effort by the investigator, depending 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 agencies, 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

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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. Similarly, corrections staff may get a preview of the kinds of issues and proposals 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 regarding 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

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

in the correctional setting, where autonomy may be inconsistent with institutional order and judicially imposed limitations on liberty. In a correctional setting, a prisoner’s capacity to exercise independent judgment may have atrophied. The consent process and discussion must include a focus on the risks and benefits of the research in the context of confinement or the manner in which liberty has been restricted. This would include the effect of any research data on a prisoner (e.g., how would testing positive for a communicable disease effect housing, work opportunities, medical treatment, family visiting). There is no question that, within correctional settings, it is more difficult to provide integrity to the process of informed consent, but this does not remove the obligation. If it is determined that voluntary informed consent is not obtainable, then a research proposal should not go forward.

Some researchers would argue that obtaining informed consent may impede some types of research, for example, studies of social phenomena via participant observation. Informing the subjects that they are being watched would undermine the research. For nonprisoner research, studies may not require informed consent under two sections of the Common Rule:

(1) Some research can be deemed exempt from IRB review, including: “Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.”3


(2) An IRB could also waive the requirement for informed consent under 46.116: “An IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (i) The research involves no more than minimal risk to the subjects; (ii) The waiver or alteration will not adversely affect the rights and welfare of the subjects; (iii) The research could not practicably be carried out without the waiver or alteration; and (iv) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.”

However, the committee believes that neither of these justifications apply to prisoner subjects. Questions of autonomy and liberty are so different in correctional settings that the IRB should always be required to exam-

3

45 C.F.R. § 46.101(b)(2).

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

ine the ethical implications and require voluntary informed consent. In the first case, the committee feels that no research involving prisoner-subjects should be deemed exempt from IRB review because the second condition ((ii) above) cannot be met. It is conceivable that even just observation of a prisoner’s behavior, if that is disclosed to prison officials, could put the prisoner at risk. In the second case, it is not possible to say with certainty that the conditions (1) and (2) above will be met for prisoner subjects, regardless of the stated objective of the study. Even a seemingly benign study could pose more than minimal risk to the prisoner subjects. For example, prisoners might be observed selling drugs in the yard in a study whose purpose was simply to observe how different racial or ethnic groups interacted with each other in the yard. If so, a waiver of informed consent could adversely affect their rights and welfare (if the prison officials learned of this observation and took action against the prisoner). The prisoner would need to be informed of these risks before the study began.

Recommendation 6.2 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 research.

Privacy is considered one of the necessary prerequisites for ethical research. In most circumstances, this means nondisclosure of the identity of the research subject and ensuring confidentiality of the specific data collected. 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 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, IRBs, and other HRPPPs should consider the extent to which core privacy issues can be protected from disclosure through realistic and practical approaches. For instance, it may be clear to prisoners and staff that 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.

In determining whether to approve or to continue research, HRPPPs should balance the effectiveness of measures designed to protect participant privacy, the extent of confidence that human subjects understand and willingly accept the risks in view of possible benefits, and the anticipated value of the research.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

Allen Hornblum, a member of the committee’s prisoner liaison group, recalled the lack of prison privacy he witnessed as a member of the board of trustees of an 8,000-person prison system. “I would go through the rolodexes of the inmates. There were inmates who had on their cards that they were HIV positive, which absolutely was not supposed to be known to anybody in the institution except the doctor and the inmate. But on every cell block I could find it. And if the guards know it, the inmates know it.”

The committee investigated whether the Health Insurance Portability and Accountability Act (HIPAA) of 19964 afforded any special privacy protections to prisoners involved in research and found that it does not. This law protects medical information for all research participants, not just prisoner participants. In addition, not all medical information is covered; only protected health information falls under HIPAA. Protected health information includes any medical data that contain uniquely identifiable information, such as a Social Security number, address, or fingerprint and that is held by a health-care provider (or other “covered entity”).5 Thus, HIPAA applies only to information collected in the course of medical service provision. Researchers could not obtain and analyze this protected health information unless they comply with specific privacy protections that are provided under the HIPAA research provisions.6 However, researchers, assuming they are not themselves a covered entity, could collect their own data directly from prisoner research subjects without concern for these regulations.

When Reviews Are Done

As is the case for research that involves persons in the community (i.e., the free world), the review by an IRB or other ethics review committee for research involving prisoners should be conducted at the following times:

  • Initial review: This occurs before any subjects are contacted or any

4

Pub. L. No. 104-191.

5

45 C.F.R. § 160.103, 2003.

6

Otherwise protected data may be used and disclosed for research if (1) it has been deidentified; (2) the individual has given written authorization; (3) without authorization, in limited circumstances such as for activities involved in preparing for research or for research on decedents; or (4) without authorization, if a waiver has been obtained.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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information about them is accessed. The elements of this review and the types of issues to be discussed during this review were detailed previously.

  • Amendment review: This occurs any time the researcher wants to change a procedure, consent process, or data collection form.

  • Adverse events or unexpected problems: A review should be done at the time any such events or problems occur.

  • Continuing review: Such a review is done at an interval specified by the IRB at initial review and is dependent on the risk level for the study (e.g., monthly or quarterly, but no less often than once per year).

Depending on the nature of an amendment or adverse event, and at the discretion of the IRB, it may be acceptable to use an expedited IRB review procedure for these types of reviews. Expedited reviews can be done by an IRB chair or experienced IRB member (rather than by the full committee), but they must include consultation with the prisoner representative. No research involving prisoner-subjects should be deemed exempt from IRB review. Even a low-risk questionnaire involving prisoner-subjects requires an IRB review.

There are other situations for which IRB review is required. A preliminary review can be conducted before funding has been obtained for the study. During this review, the IRB can assess at the most fundamental level whether prisoners can be ethically involved in the proposed research. If so, the adequacy of the protections are assessed and suggestions offered to the researcher about how to strengthen the protections. However, the preliminary review does not substitute for the initial review. No subjects can be contacted and no information can be accessed based on a preliminary IRB review. An IRB review is also needed when an investigator wants to use data for research purposes that was collected during an activity initially classified as treatment or QI (i.e., not research).

SYSTEMATIC OVERSIGHT OF RESEARCH WITH PRISONERS

Although approval of research by the IRB or other independent review committee is a critical first step in protecting research subjects, it is not sufficient. Research involving prisoners, like other types of research, must be monitored throughout the course of the study to verify that study procedures are being conducted as approved and to detect adverse events or unexpected problems in a timely manner. Ongoing monitoring, then, is another key issue that must be considered in the new oversight requirements. The monitoring process may need to differ depending on the setting or type of study. For example, studies that take place in closed institutions that restrict subjects’ access to investigators or advocates may require more proactive (inside the institution) monitoring than those that take place in

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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the community, where subjects are more at liberty to pick up the phone and call someone. Similarly, higher-risk or more intrusive studies (e.g., research that involves medical, pharmaceutical, or biological agents or interventions) probably require more intrusive monitoring, whereas social/behavioral studies (e.g., involving questionnaires) and program evaluations may require less stringent monitoring.

Highly coercive environments, such as higher-security jails and prisons, pose well-documented challenges to conducting ethical research with prisoners. Specific threats to principles of individual autonomy (e.g., voluntary consent) and justice (e.g., not bearing disproportionate weight of research risks) are more likely to occur in such closed environments, and it is these environments to which the national commission’s recommendations and the current Subpart C regulations were most responsive.

The committee has proposed broadening the definition of the term prisoner to apply to a much larger number of individuals in a broader array of environments (see Chapter 4). This expanded definition of prisoner was developed in view of the committee’s awareness that the types of threats (i.e., coercion, undue inducement, lack of access to the outside) observed in these traditional institutional settings exist to some degree in other, less traditional settings as well. However, there are also quantitative differences in the extent to which these threats exist and in the likelihood that they will arise in less restrictive prisoner settings. There continues to be a power differential between criminal justice-involved individuals and agents of the justice system (e.g., parole or probation officers or staff in community agencies, such as residential treatment programs and halfway/transition houses where prisoners reside or receive services). Of course, the level of day-to-day control and scrutiny is likely reduced in these community settings, and there is likely a greater degree of openness in such settings. As the level of restrictiveness and external control decreases (e.g., from closed residential facility to probation or house arrest), individuals are likely to have greater opportunities for unmonitored communications with others, including telephone or visitation access to friends, family, or other third parties who may have the prisoner’s interests at heart. Depending on individual resources, increased access and individual choice in health-care services are also likely.

As a consequence of the broader proposed definition of prisoner and the expanded array of settings in which regulations governing research with prisoners as subjects may apply, it follows that IRBs responsible for reviewing and approving research with prisoners must consider the variety of settings and associated features of those settings in relation to the level of scrutiny and control, openness, and, particularly in the case of medical research protocols, quality of agency health-care services and prisoner-subjects’ access to alternatives. In this expanded definition of prisoner and

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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the broader landscape of settings in which research with prisoners may be conducted, research protections must be tailored to some degree to particular types of research (e.g., social and behavioral as compared with biomedical [broadly conceived] and the features of the particular setting).

In the context of this greater need for local identification and scrutiny of the nuances of research settings in relation to the potential for control and coercion, openness, and access, the committee considered an array of specific research design controls and research monitoring practices that IRBs should consider imposing as a function of the research setting. These controls and practices were derived from the ethical analysis described in Chapter 5. It was the committee’s view that, in most instances, such judgments and determinations could not likely be made easily or effectively by a remote, centralized review entity that had little firsthand knowledge of local circumstances. Thus, the safeguards proposed in the following section provide for federal-level administrative oversight of particular research protocols in only limited circumstances. Instead, federal-level oversight would focus on making determinations about sensitive research proposals that require federal-level review; enforcing compliance with regulations, investigating problems, intervening to curtail abuses, and applying sanctions for noncompliance; serving as a national resource for HRPPPs; and maintaining a national registry of all research involving prisoners (see later discussion). Various options for monitoring, including the use of a PRSA, the IRB itself, and a national oversight group, are discussed next.

Prison Research Subject Advocate

A PRSA would be assigned to monitor prisoner research of certain risk levels. The scope and intensity of monitoring would be determined by the IRB with input from the investigator and correctional setting staff. The PRSA concept is, in part, modeled on the research subject advocate position now in place in clinical research centers at medical research institutions around the country. However, the PRSA is distinct from a clinical research associate, who is employed by a research sponsor or contract research organization in clinical trials strictly to monitor regulatory compliance at sites participating in clinical trials. Another model for the PRSA concept comes from the European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment (Council of Europe, 1987). The intent of the convention is to strengthen the protection of persons deprived of liberty. The convention establishes a committee that visits places where persons are deprived of their liberty, including prisons and hospitals where patients are subject to detention, and writes a report of findings to the government with recommendations. The report and recommendations may be made public only at the government’s request.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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Recommendation 6.3 Strengthen monitoring of research involving prisoners. Institutional review boards that review and approve research involving prisoners should establish an onsite, ongoing monitoring function through a prison research subject advocate.

A PRSA helps provide assurance, via ongoing onsite monitoring, such that research subjects within a specific facility or program are protected. The PRSA must be local to the correctional facility in which the research is being conducted to enable frequent visits to the facility, to establish trust among the prisoners, and to respond quickly to any adverse events. The IRB should have free access to the PRSA and be able to meet with the PRSA separate from the investigator and correctional setting staff. The extent of monitoring should be calibrated to the level of restrictions imposed on prisoners in the particular correctional setting and the degree of risk involved in participation, regardless of whether this research is biomedical or social/behavioral in nature.

The PRSA’s responsibilities would include the following:

  • Monitor compliance with the protocol and full implementation of any IRB-approved research.

  • Monitor adverse events, including how these events are tracked, the submission of timely adverse event reports to the IRB and appropriate federal agencies, and IRB review of these reports.

  • Monitor compliance with all relevant regulatory requirements.

  • Determine that research is conducted only on current, approved protocols and with current, valid informed consent.

  • Monitor the consent process by investigators and study coordinators to verify that the prisoners are able to make informed—and uncoerced—decisions about participation.

  • Provide a mechanism for receiving and responding to any participant or staff-generated questions regarding participation of human subjects in the research. The PRSA should be able to receive complaints and questions from individual prisoner-subjects, so there must be mechanisms in place to ensure that prisoner-subjects have timely access to the PRSA.

  • Assess the implementation of arrangements to protect the privacy and confidentiality of research participants, particularly in connection with personal health information.

The PRSA should be an individual who has formal training in the human research participant protections system and human research ethics. Study sponsors may be required to provide all or a reasonable portion of the PRSA’s salary as an overhead expense of the study. Among various

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

candidates for the PRSA position discussed by the committee, the following were considered viable and adequate:

  • An ombudsman

  • A person employed by the IRB

  • A person affiliated with a national entity, an independent contractor hired by the study (if this is the only way to pay the PRSA using grant funding)

  • A QI director if the QI program at the facility is adequate

To help ensure the PRSA’s independence and credibility with prisoner-subjects, the PRSA should not be an employee of the correctional facility.

“I don’t think that a person who worked for the department of corrections would be the ideal person to go in and monitor. I think it would have to be somebody that has no vested interest,” said Jean Scott, at the committee’s October 2005 meeting. Ms. Scott is deputy regional director of New York City Correctional Treatment Programs, Phoenix House, and a member of the committee’s prisoner liaison panel.

The QI option proposed above is considered secondary to the other options because of concern that an individual who is an employee of the correctional setting would not be able to provide the kind of impartial monitoring that would be required to keep prisoner-subjects as the top priority. If every effort is made to identify a PRSA from outside the correctional facility and none can be found, the PRSA functions could be performed by a QI director already in place at the facility, under the following four conditions:

  1. The IRB approves the procedures that will be used by the QI director for monitoring the study.

  2. The QI process has written protocols for auditing/reviewing the responsibilities previously listed for the PRSA.

  3. The IRB receives and reviews the reports generated by the QI director relevant to the pertinent research activities and has the right to have the QI director revise/redo audits if they are not adequate for monitoring purposes.

  4. The QI director reports directly to the IRB.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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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 (depending on the type and risk level of the research) of direct observation of specific research activities. The requirement of PRSA monitoring does create an additional expense, which should be borne by the institution conducting the research as an inherent cost of ethical research.

IRB Postapproval Monitoring

Most IRBs have some mechanism for monitoring studies after they are initially approved. These vary by IRB and type of study but may include audits of study records, contact with subjects, and sometimes even direct observation of interviews. For studies involving prisoners, the type of monitoring required depends on the nature of the correctional setting, the extent of restrictions imposed on prisoners in that setting, and the degree to which the proposed research poses a risk to the health or well-being of the prisoner-subjects. At minimum, there should be some mechanism whereby prisoner-subjects can contact the IRB to report problems or ask questions. Guidance and support should be provided to IRBs to allow them to be more proactive in their approach to monitoring of research involving prisoners.

Recommendation 6.4 Modify institutional review board considerations for independent ethical review of research protocols. Institutional review boards should focus on the particular ethical issues that each protocol raises in the specific context of the correctional setting. Institutional review boards would no longer be required to forward research proposals to the Office for Human Research Protections for certification, except for those rare proposals that require federal-level review.

IRBs should:

  • 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;

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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  • 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; and

  • receive monitoring reports directly from PRSAs and researchers, at a scope and frequency determined during study review.

National Oversight

Monitoring by IRBs is not sufficient to provide the level of protection needed for research involving prisoners. It may be difficult for IRBs to engage in the kind of self-reflection necessary to rethink how a protocol, which they themselves approved, might go awry. 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 (see following discussion). Recommendation 6.5 first deals with enhancing the capacities of the oversight system under DHHS jurisdiction. A further expansion to cover all research involving prisoners follows later in this chapter.

Recommendation 6.5 Enhance the Office for Human Research Protections’ capacity to provide systematic oversight of research involving prisoners. The Department of Health and Human Services should strengthen the capacity of the Office for Human Research Protections to provide systematic oversight of research involving prisoners that is within its purview.

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 about studies that require federal-level review.

  3. Enforce compliance with the regulations, investigate reports of possible 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.

For research under DHHS jurisdiction, the OHRP is currently designed to perform three of the four functions listed in Recommendation 6.5. However, the OHRP does not have the funding or personnel to adequately carry out the tasks. The universe of research involving prisoners is larger than that covered by the current regulations. Furthermore, there are vast incon-

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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sistencies in how research is defined, who reviews it, and how it is monitored. The OHRP needs to be revitalized and refocused to carry out the three functions already within its purview. As a fourth, new function, the national registry should be housed within the OHRP as well.

IRBs or other independent review committees would still review studies at the local level, making the initial assessments of risk and approving or rejecting individual studies based on detailed information about the study. A revitalized OHRP would be more involved in investigating and intervening when problems occur and promoting consistency on a nationwide basis, thus filling critical voids in the current oversight system. To ensure that research involving prisoners is conducted in an ethically responsible way, the OHRP needs greater resources and broader powers than presently exist. The enforcement division of the OHRP, for example, presently consists of fewer than four full-time positions, and its responsibilities encompass all research (not just prisoner research) conducted under existing regulations.

Because there is no central repository for the collection of data regarding research involving prisoners, it is difficult or impossible to quantify the number of such studies underway at any given time, the number of prisoners involved, the types of studies being conducted, the subject of inquiry in this research, the incidence of protocol deviations, or the occurrence of adverse outcomes (see Chapter 2). A national registry would help the OHRP provide technical assistance and training as well. With this registry, the OHRP and others would have access to valuable information about the kinds of research being conducted, problems and adverse events that have been identified, and the types of protections appropriate for different research projects in various correctional settings. Additionally, as the national body charged with the enforcement of the governing regulations, the OHRP could provide authoritative interpretations of the regulations and their application in various circumstances. In its charge to enforce governing regulations, when less formal procedures prove inadequate, the OHRP must have the authority to initiate legal action to compel compliance, including discovery and subpoena power to uncover abuses and enforce regulations. Anyone should be able to report alleged violations of prisoner-subject rights to the OHRP without fear of retaliation (the OHRP would have to be able to invoke whistle-blower protection for people who disclose problems), substantially improving the safeguards to prisoners who agree to participate in research.

Revitalizing the OHRP to take on these four oversight functions would, however, leave a gaping hole in the national oversight structure that must be acknowledged and remedied. The OHRP’s jurisdiction regarding research involving prisoners is limited to studies funded by the DHHS, Social Security Administration (SSA), and Central Intelligence Agency (CIA). The remaining federal agencies and nonfederal and private entities are not

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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required to submit to OHRP oversight. According to the committee’s review of current research involving prisoners (see Chapter 2), only 11 percent of all of the studies reviewed were funded by the DHHS, indicating that the vast majority of research involving prisoners does not fall within the OHRP’s overview jurisdiction. Therefore, to ensure the ethical conduct of all research involving prisoners, the enhanced OHRP oversight model must be replicated for all research involving prisoners, regardless of funding source, so that research supported by any federal agency, all nonfederal agencies, and the private sector is subjected to the same systematic oversight.

Recommendation 6.6 Establish systematic oversight of all research involving prisoners. To expand prisoner protections beyond the narrow jurisdiction of the Department of Health and Human Services, Congress should establish a national system of oversight that is applied uniformly to all research involving prisoners, performing all of the functions listed in Recommendation 6.5. The vast majority of research involving prisoners does not fall within the Office for Human Research Protections’ overview jurisdiction. Strengthening the safeguards provided for all prisoners involved in research, regardless of funding source, will facilitate safe and ethical research across the full range of prisoner-involved research.

These functions could be performed by the revitalized and properly funded OHRP if its jurisdiction were extended to the entire range of research involving prisoners regardless of funding source—federal or nonfederal, public or private. An alternative is to compose a national entity to perform the necessary oversight functions. Placing the functions within the OHRP may be more feasible and less disruptive, but it must be done with serious attention to the extra support needed within the 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 system of oversight; if a new entity is necessary to make it happen, then it should be created.

Finally, for reasons similar to those underlying the committee’s recommendation for establishing systematic oversight, the research process needs to be characterized by transparency and accountability.

Recommendation 6.7 Ensure transparency and accountability in the research enterprise. Human research participant protections programs and prison administrations conducting human subject research should be open, transparent, and accountable.

A sound, ethical protection program involves an open, transparent

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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research process. It requires that the mechanisms used to protect participants from undue harm and to respect their rights and welfare must be apparent to everyone involved. This transparency requires open communication and interaction with the local community, research participants, investigators, and other stakeholders in the research enterprise. Accountability 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.

APPLYING SAFEGUARDS FOR PARTICULAR KINDS OF RESEARCH

As noted earlier, the committee recommends that the current Subpart D framework, with modifications for application with prisoner-subjects, be utilized to define permissible research. The modifications necessary for such research to be approvable include (1) a risk-benefit analysis to ascertain whether participation carries potential benefits that outweigh risks, and (2) the utilization of special design and monitoring safeguards,7 which would vary as a function of the type of research, the risks it poses, and the nature of the research setting. The greater the restrictions upon liberty in a particular correctional setting, the greater the need for safeguards and protections of prisoner-subjects.

The guidance and examples in this section are intended to be illustrative of the ethical framework presented in Chapter 5. Specifically, it demonstrates the importance and application of the risk-benefit approach with appropriate safeguards and monitoring based on the level of risk and the restrictions of the correctional setting. The framework respects the principle of justice and provides adequate protection and potential benefit for prisoners involved in research.

As stated in Chapter 5, a risk-benefit analysis would normally prohibit the following types of biomedical research involving prisoners because potential risks outweigh potential benefits:

  • phase 1 and phase 2 studies of experimental treatments, as defined by the FDA, because of insufficient evidence of prospect of direct benefit at this early stage of testing (Example 7 provides a rare, specific circumstance in which phase 1 and phase 2 studies might be permissible, and in which case, federal-level review and high-level safeguards and monitoring would be required);

7

Special safeguards mean those safeguards above and beyond the usual safeguards routinely considered necessary for the approval of research protocols.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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  • studies that involve exposing subjects to potentially noxious biological or chemical agents merely for the purpose of determining and/or evaluating human reactions to such agents; and

  • biomedical studies that would enroll more prisoners than nonprisoners, unless a federal-level review authorizes the study.

Once the IRB determines that a study involving prisoners offers more potential benefits than risks and does not fall within one of the categories of impermissible research noted above, it must determine the appropriate safeguards and monitoring. The types and levels of safeguards and monitoring required depend on the nature of the correctional setting, the extent of restrictions imposed on prisoners in that setting, and the degree to which the proposed research poses risk to the health or well-being of the prisoner-subjects.

Box 6-1 presents the kinds of special design and implementation safeguards and special monitoring safeguards that an IRB might mandate for particular research protocols. In the examples that follow, research involving low risk and conducted in less-restrictive settings may be approvable without the IRB imposing any special safeguards; however, additional special safeguards from Box 6-1 may be necessary for prisoner research that involves greater risk and is planned for more restrictive settings. Stronger safeguards would also be needed in those extremely limited circumstances when it would be ethically permissible to utilize a greater proportion of prisoners than nonprisoners.

The safeguards in Box 6-1 are designed to be responsive to specific ethical (and in some instances, practical) considerations in research with prisoners. The obvious general principle is that as the level of research risk increases and as greater restrictions on liberty appear in a particular correctional setting, additional safeguards should be used. With respect to design safeguards, D1 (federal certificates of confidentiality) is responsive to the concern that correctional settings may pose greater challenges to privacy and confidentiality. D2 (50 percent ceiling) is designed to prevent investigators from capitalizing on prisoners as a captive population and to ensure that prisoners do not bear an undue share of the burdens of research in higher risk studies. D3 (prohibiting incentives for recruitment quotas), D4 (availability of control-arm standard-of-care medications and treatments to nonresearch participants), and D6 (adequate prison health services) are viewed as protections against potentially coercive conditions. D5 (openness of the research setting) is responsive to the concern that, compared with nonprisoner research subjects, prisoners may generally be at greater risk of experiencing harmful effects of research because of limited access to researchers. D7 (30-day review presentation to IRB) provides an extra safeguard to evaluate high-risk studies once they have begun.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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BOX 6-1

Special Study Design and PRSA Monitoring Safeguards

Special Study Design Safeguards (D1–D7)

D1. Investigator should obtain a federal certificate of confidentiality to protect against the disclosure of prejudicial, confidential, or personal information.

D2. The proportion of prisoner-subjects to nonprisoner-subjects may not exceed 50 percent.

D3. Neither the PI nor any member of the research team or staff member of the institution/agency at which the study is conducted may receive financial or other incentives for meeting recruitment quotas.

D4. In clinical trials of medications in which some study arms provide for the administration of standard-of-care treatment, those same medications must be available to prisoners diagnosed with the same disease who are not recruited for, or if recruited decline to participate in, the clinical trial.

D5. The PI must demonstrate to the satisfaction of the IRB that the research setting is sufficiently open to permit regular, prompt, and proactive monitoring of prisoner-subjects’ clinical status by research staff or PRSA staff required by the research protocol.

D6. The PI must demonstrate, to the satisfaction of the IRB, that the quality of physical/mental health services in the particular correctional setting is adequate to respond in a timely and professionally responsible manner to complaints, problems, and side effects that may emerge from prisoners’ participation in a research study.a

D7. The researcher must present to the IRB how the research is proceeding after the first 30 days that subjects are enrolled.

Monitoring safeguards generally permit IRBs to obtain information about recruitment and protocol administration that is independent of the investigator or correctional setting. These safeguards are justified on the principle that research activities should be open and that investigators should be accountable for the proper administration of their protocols. M1, M2, and M3 provide independent checks on the validity of the informed consent process, which may face various threats because of the potentially coercive nature of correctional settings. M4 provides for an independent check of the protocol implementation that protects against protocol deviations that have not been approved by the IRB. M5 and M6 provide for an independent assessment of subjects’ reactions to protocol stimuli and the appropriateness and timeliness of investigators’ intervention to remedy or ameliorate untoward adverse reactions.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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Special PRSA Monitoring Safeguards (M1–M6)

M1. Periodic observation (spot-checking) of informed consent dialogues at recruitment.

M2. Soon after enrollment, test randomly selected subjects for comprehension of the consent disclosure.b

M3. Periodically debrief subjects to determine whether they experienced any pressure or coercive actions by investigators or correctional personnel regarding the prisoner-subject’s participation.

M4. Periodically observe (spot-check) protocol administrations to ensure fidelity to and compliance with the approved protocol.

M5. Periodically debrief subjects regarding personal reactions to research stimuli (e.g., interviews, questionnaires, medications, or devices).

M6. Periodically debrief subjects regarding timeliness and adequacy of investigator responses to any problems or complaints that the subjects associate with study participation (e.g., side effects or adverse reactions to medications or devices; adverse psychological reactions).


NOTE: PI, principal investigator.

  

aSee Chapter 5, page 154 for indirect measures for assessing adequacy of health-care services.

  

bThe PRSA needs to determine that the person understands, or has access to information that enables them to understand, the basic study parameters. This should not be a “memory test” of the consent disclosure. Subjects could display comprehension of the basic study parameters by retrieving their copy of the consent disclosure and “explaining” to the PRSA the information therein. A problem would exist, however, if a subject did not appear to understand the study parameters even with access to and opportunity to review the disclosure.

Sample Situations

The following vignettes are provided as exemplars of the kinds of considerations that might arise in IRB deliberations about particular types of studies. The vignettes are clearly not exhaustive, nor are the particular hypothetical “solutions” embedded in them intended to be prescriptive. IRBs encounter a wide variety of prisoner research proposals that vary in the intrusiveness of the experimental stimuli, the restrictiveness of the correctional setting, the level and extent of risks and benefits to prisoner participants as individuals or as a class, and in other study parameters. The current Subpart D framework, with modifications for application to research with prisoners, provides a better conceptual scheme for evaluating such proposals. However, IRBs should impose special study safeguards, such as those indicated in Box 6-1, when levels of restrictiveness and/or risk require them. At the highest level of risk, federal-level review becomes an added requirement, as in Subpart D of 45 C.F.R.§ 46.407).

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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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 prejudicial information;8 the questions on these measures are of the type usually encountered in routine psychological evaluations and thus meet the conventional and historical definitions of “minimal risk.” The investigator obtains a report of disciplinary infractions for each inmate in the study. Correlational analyses are conducted to determine the extent to which these general 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 particular 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 likelihood of a successful return to the community. Thus the study is considered 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

8

Prejudicial information includes the personal information that, if disclosed to or discovered 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.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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 conducts 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 dependent measure (risky behavior questionnaire) solicits information (e.g., contemporary 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 required 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 administered 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.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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 presents 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 treatment 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 comparator 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 experiences (e.g., some research questionnaires include only one or two cursory questions about whether the respondent believes that he or she has ever

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

been abused or experienced trauma, without exploring any details of such experiences). For example, M4 (PRSA monitoring, spot-checking administration 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 subjects 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 involve 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 distributed 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.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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. Extraordinary 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 interview 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 participating 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.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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 “transitional case management programs” for prisoners with HIV, diabetes, tuberculosis, 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 prisoners and starting the health education and/or behavioral intervention before 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 accomplish this goal. 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 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 prisoners.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-

9

Interesting 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 underway in Holland and Norway.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

ment and who is not. Reports of antisocial behavior (assaults and other violations) would be measured before and during the intervention. Approval 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 biomedical 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 question 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 considered 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 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 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 research involving prisoners. Those studies that are approved should incorporate 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 protections for prisoners involved in research. Strengthening the systems of oversight and requiring collaboration at every level of the research process will

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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 oversite for research involving prisoners for two other agencies (CIA, SSA) that signed on to Subpart C.

  2. For above mentioned studies involving prisoners, OHRP must certify that IRB has followed Subpart C.

  3. If a protocol does not fit within one of five categories, regardless of risk benefit, it is not approved.

  1. Expand definition of the term prisoner.

  2. Support critical areas of correctional research.

  3. Revise Subpart C regulations to reflect a risk-benefit approach toresearch review similar to Subpart D.

  4. Establish a system of safeguards to be applied uniformly.

  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.

Non federal and private sponsors

Not required to follow Subpart C.

Must follow revised Subpart C.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

Stakeholders

Current Duties

Proposed Duties Based on Committee Recommendations

Correctional settings

  1. No clear, standard expectations for providing input in design or access for onsite monitoring.

  2. May or may not require IRB review for research at their facility.

  1. Be open to providing input to investigators regarding the design and conduct of research protocols involving prisoners.

  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.

  2. For DHHS-supported research involving prisoners, submit to OHRP for certification, and if necessary, federal-level review.

  3. Wait for OHRP certification before study can be approved.

  4. Ensure informed consent.

  5. Protect subject privacy.

  6. Include prisoner representative as voting member of IRB.

  1. Review shifts from category-based to risk-benefit approach, with focus on the particular ethical issues that each protocol raises in the specific context of the correctional setting.

  2. Only “exceptional” studies are submitted to OHRP for federal-level review.

  3. Evaluate investigator efforts to obtain input from prisoners and other stakeholders on the design and conduct of research protocols involving prisoners.

  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.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

 

 

  1. Ensure informed consent.

  2. Protect subject privacy.

  3. Include prisoner representative as voting member of IRB.

  4. Be open, transparent, and accountable.

Investigators

  1. Present studies to IRB and await IRB approval and OHRP certification.

  2. No standards for getting input or ensuring adequate medical response

  3. Obtain informed consent.

  1. Present study to IRB for approval. Only requires OHRP review for “exceptional” studies.

  2. Demonstrate efforts to obtain input on study design and implementation from stakeholders, including 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.

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
×

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. However, if research is to be supported to improve the welfare of prisoner populations, it must be done with rigorous safeguards and under a comprehensive 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).

Suggested Citation:"6 Systems of Oversight, Safeguards, and Protections." Institute of Medicine. 2007. Ethical Considerations for Research Involving Prisoners. Washington, DC: The National Academies Press. doi: 10.17226/11692.
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In the past 30 years, the population of prisoners in the United States has expanded almost 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 HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision.

Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive 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' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners.

The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections:

• expand the definition of "prisoner";

• ensure universally and consistently applied standards of protection;

• shift from a category-based to a risk-benefit approach to research review;

• update the ethical framework to include collaborative responsibility; and

• enhance systematic oversight of research involving prisoners.

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