In 2003, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) asked its Subpart C Subcommittee to review the text and application of Subpart C primarily to determine whether the current Department of Health and Human Services (DHHS) interpretation and application of Subpart C’s requirements should be modified.1
Among the topics the subcommittee addressed were
the definition of the term prisoner under Subpart C,
the application of research protections to those who become incarcerated after agreeing to participate in a nonprisoner study,
issues with identifying a prisoner representative for prisoner research institutional review boards (IRBs) and particularly in multisite studies,
conduct of expedited review in prisoner research,
the definition of minimal risk under Subpart C (which is different from the Subpart A definition), and
the requirement of secretarial review when prisoners in the control group are merely provided the standard of care.
These topics and the subcommittee’s recommendations for further consideration by the Institute of Medicine (IOM) are discussed in more detail below.
The full report of the subcommittee’s findings is available at http://www.hhs.gov/ohrp/sachrp/mtgings/present/SubpartC.htm.
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C Report of the SACHRP Subcommittee and Human Subjects Protections In 2003, the Secretary’s Advisory Committee on Human Research Pro- tections (SACHRP) asked its Subpart C Subcommittee to review the text and application of Subpart C primarily to determine whether the current Department of Health and Human Services (DHHS) interpretation and application of Subpart C’s requirements should be modified.1 Among the topics the subcommittee addressed were • the definition of the term prisoner under Subpart C, • the application of research protections to those who become incar- cerated after agreeing to participate in a nonprisoner study, • issues with identifying a prisoner representative for prisoner research institutional review boards (IRBs) and particularly in multisite studies, • conduct of expedited review in prisoner research, • the definition of minimal risk under Subpart C (which is different from the Subpart A definition), and • the requirement of secretarial review when prisoners in the control group are merely provided the standard of care. These topics and the subcommittee’s recommendations for further con- sideration by the Institute of Medicine (IOM) are discussed in more detail below. 1The full report of the subcommittee’s findings is available at http://www.hhs.gov/ohrp/ sachrp/mtgings/present/SubpartC.htm. 199
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200 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS DEFINITION OF PRISONER The subcommittee recommended that a modified Subpart A analysis apply when a subject who is enrolled in a study may not be fully within the definition of the term prisoner for the duration of the study. First, the subcommittee affirmed that the interpretation of prisoner should remain defined by the words of the regulation and not expanded to include other subjects whose liberty is restricted, such as those in community correctional facilities or on probation or parole. Although those subjects deserve height- ened protection, the subcommittee recommended that the DHHS rely on Subpart A’s protections for subjects “vulnerable to coercion or undue influ- ence” without including those subjects as prisoners under Subpart C. Like- wise, when a subject is incarcerated after becoming enrolled in a study, the concerns about coercion and undue influence are not as great; at the same time, it may be difficult to modify the research protocol to comply with Subpart C. Therefore, the subcommittee suggested that Subpart A’s general requirement of heightened protection apply instead. The subcommittee rec- ommended that an IRB should review a researcher’s request to continue the research when a subject subsequently becomes incarcerated, taking into account the new conditions of incarceration but without fully engaging in a new Subpart C approval process. PRISONER IRB REPRESENTATIVE The subcommittee discussed a variety of problems with identifying a representative who would be skilled and knowledgeable enough to be effec- tive but not so unlike the rest of the IRB as to be marginalized. The subcom- mittee recommended that the Office of Human Research Protections (OHRP) assist IRBs in searching for an appropriate prisoner representative, which might include family members of prisoners, former prisoners (espe- cially people in recovery from substance addiction who have also had expe- rience as prisoners), and service providers who assist in the correctional process. It was recommended that the OHRP should provide functional criteria that might help IRBs (and investigators, who are also responsible for the composition of an IRB that will properly evaluate ethical issues) identify persons who can be an effective voice for prisoners within the IRB. With respect to multisite studies, the subcommittee recommended that, although Subpart C only requires one prisoner representative on a central IRB for multisite research, the IRB must nevertheless consider the indi- vidual circumstances of each prison site, which can vary widely. In addi- tion, with respect to expedited review, the subcommittee recommended that, if expedited review of a protocol is required, a prisoner representative should be one of the reviewers.
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201 APPENDIX C DEFINING MINIMAL RISK AND BENEFIT TO PARTICIPANT The subcommittee considered two issues regarding the distinction be- tween using as the ethical baseline other healthy prisoners as opposed to other healthy persons generally. First, the subcommittee affirmed that the different definition of minimal risk in the Subpart C regulations compared with Subpart A regulations was appropriate. The Subpart C regulations specify that the determination of minimal risk must be in comparison to the ordinary experience of a healthy person, which the subcommittee inter- preted as referring to a healthy person outside the prison environment. The subcommittee cautioned that the greater situational risk in the prison set- ting should not influence the baseline for the IRB’s decision; rather, the minimal risk should be compared with the risk to a healthy person in a safe environment. The OHRP should provide guidance, using examples, of how the minimal risk might be viewed in different protocols. At the same time, the subcommittee viewed the current OHRP interpre- tation of when a protocol does not provide a benefit to the participant as overly restrictive. The OHRP’s position is that using standard of care as a control arm does not provide any benefit to the participant and thus re- quires secretarial review and expert panel consideration. The subcommittee’s view is that, because the participant receives the standard of care and does ultimately benefit from the results of the research, even if not immediately, such a control arm should not require heightened review. The subcommittee recommended that only when the control group is pla- cebo only (and thus deviating from the standard of care) should the proto- col be considered to include an arm not benefiting from the research. The subcommittee also pointed out the problems with the jurisdiction of Subpart C. Because it has been adopted by so few agencies, it has limited application to federally funded research. In addition, it does not automati- cally apply to institutions that have signed a federal-wide assurance (FWA) unless they specifically request that it be part of their obligation. Because of these two enormous gaps in coverage, most research involving prisoners does not fall under the special protections of Subpart C. RECOMMENDATIONS FOR FURTHER CONSIDERATION BY THE INSTITUTE OF MEDICINE In addition to its recommendations on the issues discussed previously, the subcommittee noted with approval that the IOM had been charged with studying the human research protections for prisoners. The subcommittee recommended the IOM committee consider the need for a requirement that research only be conducted in prisons providing standard of care to the general population (and how best to get such services in place); the interpre-
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202 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS tation of the requirement that follow-up care be provided when the pris- oner has been released from confinement; and the limited jurisdiction of Subpart C (i.e., to DHHS-supported research only). OTHER FEDERAL HUMAN SUBJECTS PROTECTIONS The full panoply of DHHS protections for prisoners in Subpart C presently only apply to research funded by DHHS, the Central Intelligence Agency, and the Social Security Administration. Some of the other 14 de- partments and agencies that have adopted the Common Rule accept the OHRP-approved FWA as assurance of compliance with ethical regulations regarding human research subjects. However, those departments and agen- cies have not adopted Subpart C, so the assurance only requires certifica- tion of compliance with the Common Rule (Subpart A).2 Although institu- tions holding an FWA and engaging in research funded by one of the other departments or agencies may voluntarily extend their protections to include those under the other subparts (including Subpart C)—the OHRP estimates that this applies to approximately 60 percent of institutions holding an FWA—they are not required to do so. Moreover, prisoner research that is funded by another department or agency (other than DHHS) falls outside of the protections of the OHRP oversight even if the institution has requested in its FWA that Subpart C apply because the OHRP does not monitor the institution’s compliance with a voluntary assurance regarding Subpart C. Additionally, an organiza- tion that does not receive its funding from any of these sources generally does not hold an FWA and is not required to comply with the Common Rule or any of the subparts (see Table C-1). At the same time, certain federal departments or agencies that have adopted a form of the Common Rule have also adopted their own addi- tional rules protecting certain categories of human research subjects other than Subpart C. Of particular interest are the Department of Justice, be- cause it includes the Bureau of Prisons, and the Food and Drug Administra- tion, because its regulations govern a majority of biomedical research (re- gardless of whether the subjects of the study are prisoners). 2One exception is the Department of Education, which has adopted Subpart D but has not adopted Subparts B or C of the DHHS regulations.
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TABLE C-1 Overview of Regulations Applicable to Research Involving Prisoners as Subjects, Independent of Funding Source Federal–Adult Federal–Juvenile State–Adult State–Juvenile Medical treatment– nontherapeutic/cosmetic Not permitted Not permitted FDA Subpart A, FDA Subpart A, state policy FDA Subpart D, state policy Pharmaceutical/medical device–therapeutic DOJ Subpart A, DOJ Subpart A, FDA Subpart A, FDA Subpart A, (for specific inmate’s condition) FDA Subpart A, FDA Subpart A, FDA Subpart D, FDA Subpart D, DHHS (Subpart C) DHHS (Subpart C), state policy state policy FDA Subpart D Non-FDA regulated medica treatment– DOJ Subpart A, DOJ Subpart A, Varies by state Varies by state therapeutic DHHS (Subpart C) DHHS (Subpart C) Nonmedical research DOJ Subpart A, DOJ Subpart A, Varies by state Varies by state BOP research policy BOP research policy xxx 203
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