Ethical Considerations for Research Involving Prisoners (2007) / Chapter Skim
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3 Federal Regulatory Landscape
3 Federal Regulatory Landscape
Pages 73-100
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From page 73... ...
The restrictiveness of the DHHS regulations regarding prisoners may have had the unintended effect of creating widely varying regulatory schemes applicable to research involving prisoners, because of the unwillingness of other federal agencies to adopt the same set of regulations. Under the current framework, although they can voluntarily agree to more, research institutions are only required to abide by DHHS-promulgated regulations when they conduct research funded by the DHHS (including DHHS agencies such as the National Institutes of Health [NIH]
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From page 74... ...
. In sum, regarding research involving prisoners as human research subjects, the applicable regulations are far from uniform and range from no protection at all (for research that is not funded by one of the 17 agencies that have adopted the Common Rule)
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FIGURE 3-1 Chart of applicable regulations to research involving human subjects. SOURCE: National Bioethics Advisory Commission (NBAC)
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From page 76... ...
Part 46, the basic DHHS regulations for the protection of human research subjects. The regulatory framework outlined in the Common Rule applies to 17 federal agencies that are involved in conducting or funding human subjects research.2 The Common Rule provides guidelines on conducting certain types of research with human subjects.
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Although regulations do not preclude the use of expedited review for research involving prisoners, the OHRP recommends that such research be reviewed by the full committee. Informed Consent Informed consent processes are also defined in the Common Rule.
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a statement that the individual's participation in the research must be voluntary, that refusal to participate will not result in a penalty or loss of benefits to which the individual is otherwise entitled, and that the individual may withdraw at any time.11 Additional information may also be required, depending on the specific nature of the research.12 The investigator must document that the person agreed to participate in the research project by obtaining the individual's signature or the signature of an authorized representative.13 Institutional Assurances Generally, the Common Rule requires that the departments or agencies applying the Common Rule obtain some form of written assurance from all research institutions engaging in covered research that the research complies with the regulations.14 If a research organization frequently conducts research supported by one of the signatory federal agencies, it may apply for a federal-wide assurance (FWA) , a special kind of assurance process administered by the DHHS.
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From page 79... ...
These additional protections were developed in response to the National Commission's Report and Recommendations: Research Involving Prisoners (NCPHSBBR, 1976)
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From page 80... ...
. In October 2002, the secretary of the DHHS published a notification in the Federal Register proposing to waive certain provisions of Subpart C to epidemiological research involving prisoners that involved no more than minimal risk and no more than inconvenience to potential subjects.21 The regulations, which became final in June 2003, allow for epidemiological research on specific diseases that describes the prevalence or incidence of the disease by identifying all cases, including prisoner cases, or studies of potential risk factor associations for these diseases in which prisoners were included in the population of interest but were not the sole study group.22 Implementation of an epidemiological research project involving prisoners requires that an IRB must approve the research, document that one of the two conditions described previously has been met, and determine that the research involves minimal risk and no more than inconvenience to the prisoner-subjects.23 Additional Requirements for IRBs When research is proposed that involves prisoners, IRBs must approve each individual project.
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From page 81... ...
Further, the IRB must find that the research proposal meets both the Common Rule requirements as well as additional requirements specific to the prisoner setting. These additional requirements are as follows: • the research is within one of the four permissible categories of research for prisoners; • benefits that accrue as a result of the prisoner's participation should not be so great in comparison to what is available in the correctional environment that the ability to provide informed consent is impaired; • risks are commensurate with those that would be accepted by nonprisoner volunteers; • selection procedures are fair and not subject to arbitrary intervention by either prison authorities or other prisoners; • the consent form is written in language that is easily understood by the prisoner; • the person's participation in the research project will not be a consideration in parole or probation decisions; and • adequate provisions are made for follow-up care, should it be needed, once the research study ends.24 OHRP Certification Once the IRB has found that the research meets the criteria described previously and approves the study, OHRP certification must be obtained for research in Categories i through iv and for epidemiological waivers as well (Table 3-1)
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From page 82... ...
SOURCE: Gorey, 2005. • 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 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)
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From page 83... ...
Defining Minimal Risk and Benefit to Participant The subcommittee considered two issues regarding the distinction between using other healthy prisoners as the ethical baseline 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.
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From page 84... ...
Some of the other 14 departments 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 agencies have not adopted Subpart C, so the assurance will only require certification of compliance with the Common Rule (Subpart A)
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From page 85... ...
Additionally, an organization that does not receive its funding from any of these sources generally will not hold an FWA and would not be required to comply with the Common Rule or any of the subparts.26 In evaluating the effectiveness of Subpart C, it is useful to compare other human research subjects protections to these regulations. In particular, Subpart D contains DHHS's regulations regarding children, and provides a different framework for assessing the risks and benefits (and according appropriate protections)
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From page 86... ...
Other DHHS Agencies: FDA Regulations As noted previously, the FDA has adopted a modified form of the Common Rule in 21 C.F.R. Part 50, Subpart A, as well as regulations regarding research with children as subjects in Subpart D
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Adequate provision is made for informed consent, minimizing risks, and protecting privacy and confidentiality aNote that minimal risk is defined in the same manner in Subpart D as in Subpart A (the Common Rule)
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Part 50 is simply "reserved." 31The clinical investigations regulated by the FDA are those involving drugs and medical devices approved solely for investigational use because their safety and effectiveness cannot otherwise be reasonably ensured. 32Given the different scope of the FDA regulations compared with the Common Rule, the clinical investigation covered by the FDA regulations is limited to "any experiment that involves a test article and one or more human subjects" that is either regulated by the FDA or the results of which is intended to be submitted to the FDA, and it does not apply to nonclinical laboratory studies [Electronic Records; Electronic Signatures.
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Part 46 (NIJ) .35 With respect to research involving prisoners in the custody of the BOP, however, the DOJ was concerned that Subpart C did not adequately address the level of risk in the third category of Subpart C (research on conditions particularly affecting prisoners as a class)
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policy] FDA Subpart A FDA Subpart A FDA Subpart D Non-FDA-regulated medical DOJ Subpart A DOJ Subpart A Varies by state Varies by state treatment -- therapeutic [Applicable DHHS [Applicable DHHS regulations incorporated regulations incorporated by reference in BOP by reference in BOP policy]
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First, the disclosures that are required for informed consent are modified slightly from the Common Rule requirements. In some cases, the disclosure is required to be more specific.
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, who chairs 39Because DOJ's adoption of the Common Rule renders the informed consent requirements applicable to all research conducted by, supported by, or subject to regulation by DOJ, the Common Rule's informed consent requirements should nevertheless control (28 C.F.R.
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From page 93... ...
Thus, the research program statement's description of the BRRB meets Subpart C requirements and also sets out a few additional requirements not contained in Subpart C Overall, the BOP guidelines are a useful tool for comparison with Subpart C because they govern all research involving prisoners in federal custody, whether or not it is funded by the DOJ (or DHHS)
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From page 94... ...
Under the current system of research regulation, this would mean that all 17 federal agencies that are signatories to the Common Rule, any additional federal agencies, and any nonfederal sponsors of research would be required to comply with a newly drafted subpart C.43 All research involving prisoners, therefore, would be registered with the OHRP. There is no justification for variability across agencies and facilities regarding their approaches to protecting the rights, health, and dignity of prisoners participating in human subjects research, individuals who are among the most vulnerable human subjects of research.
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From page 95... ...
However, most of the Common Rule was also drafted to apply to research not funded by the DHHS but regulated by the department.46 The catch is that the regulation defines research subject to regulation quite narrowly as "those research activities for which a federal department or agency has specific responsibility for regulating as a research activity (for example, investigational new drug requirements administered by the FDA) ."47 Regulation in such a narrow area is likewise on quite solid ground as a natural extension of its authority to regulate the research activity.
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Can the DHHS Be Granted Broader Authority? Nevertheless, for reasons similar to why the FDA is constitutionally possible, it is possible for the DHHS to be given authority to regulate research involving human subjects.
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. This case held, among other things, that universities that accept federal money could not refuse to allow the military to recruit on campus, even if military hiring and retention policy violated the university's own regulations on sexual orientation discrimination.
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to require the state agency's adoption of a regulatory scheme governing the involvement of prisoners in research as a state law because the federal statute did not reveal a congressional intent to override traditional state regulation of medical practice. See also, Gonzales v.
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Although not ideal, this framework may still reduce the amount of patchwork regulation applicable to research involving prisoners and be a step toward uniformity of ethical 5442 U.S.C.
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2004. The Ethical Conduct of Clinical Research Involving Children.
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