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6 Systems of Oversight, Safeguards, and Protections
Pages 137-174

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From page 137...
... 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.
From page 138...
... 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)
From page 139...
... 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)
From page 140...
... Under the current federal regulations, only research activities that involve human subjects (or data from or about human subjects) require IRB review and approval.
From page 141...
... 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)
From page 142...
... 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.
From page 143...
... 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)
From page 144...
... 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
From page 145...
... 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)
From page 146...
... 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.
From page 147...
... 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.
From page 148...
... . 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.
From page 149...
... Recommendation 6.2 Protect the privacy of prisoners engaged in re search. Human research participant protections programs should col laborate with prison officials, probation officers, and other staff rel evant to the correctional setting to protect the privacy of subjects in prisoner research.
From page 150...
... , 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 4Pub.
From page 151...
... 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.
From page 152...
... 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 prisonersubjects' access to alternatives.
From page 153...
... 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)
From page 154...
... 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.
From page 155...
... 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.
From page 156...
... 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 wellbeing of the prisoner-subjects.
From page 157...
... 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.
From page 158...
... 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)
From page 159...
... The vast majority of research involving prisoners does not fall within the Office for Human Research Protections' overview jurisdiction. Strengthening the safeguards pro vided for all prisoners involved in research, regardless of funding source, will facilitate safe and ethical research across the full range of prisoner involved research.
From page 160...
... 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) ; 7Special safeguards mean those safeguards above and beyond the usual safeguards routinely considered necessary for the approval of research protocols.
From page 161...
... 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 prisonersubjects. 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.
From page 162...
... 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.
From page 163...
... 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.
From page 164...
... 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 8Prejudicial information includes the personal information that, if disclosed to or discovered by certain third parties, might result in formal consequences for the individual.
From page 165...
... Her protocol includes selfreport 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)
From page 166...
... 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.
From page 167...
... 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.
From page 168...
... 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.
From page 169...
... 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.
From page 170...
... 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 prisonersubjects in view of the correctional setting in which the study will be conducted.
From page 171...
... For above mentioned studies involving prisoners, approach to research review similar to Subpart D OHRP must certify that IRB has followed Subpart C
From page 172...
... For DHHS-supported research involving prisoners, approach, with focus on the particular ethical issues submit to OHRP for certification, and if necessary, that each protocol raises in the specific context of the federal-level review. correctional setting.
From page 173...
... 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.
From page 174...
... . The committee acknowledges, for example, that the collaboration model will be new within most correctional settings and among many researchers.


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