Ethical Considerations for Research Involving Prisoners (2007) / Chapter Skim
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Pages 1-20
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update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research involving prisoners.
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, the principal focus of this report, was first finalized in 1978 and was developed in response to the Report and Recommendations: Research Involving Prisoners by the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (NCPHSBBR, 1976)
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With these concerns in mind, the OHRP of the DHHS commissioned the IOM to review the ethical considerations in research involving prisoners as a basis for updating DHHS regulations to protect prisoners as research subjects. The committee was charged with the following tasks:1 • Consider whether the ethical bases for research with prisoners differ from those for research with nonprisoners.
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update the ethical framework to include collaborative responsibility; and (5) enhance systematic oversight of research with prisoners.
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(4.1) Ensure Universal, Consistent Ethical Protection • Establish uniform guidelines for all human subjects research involving prisoners.
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Congress should mandate a uniform set of guidelines for human research participant protection programs2 for all research involving prisoners. (Recommendation 3.1)
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The establishment of a publicly available, national registry of research involving prisoners should include data such as who is conducting research with what support, with what kind of research on what populations, and the nature and extent of ethical oversight provided. A national registry would shed light on the totality of research taking place on prisoners and the quality of ethical oversight provided for each protocol.
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Biomedical research involving prisoners in two narrow circumstances may be ethically acceptable: 1. In normal circumstances, a biomedical research study may be ethically acceptable if:
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Given the history of and continued potential for prisoner exploitation, biomedical research should be permitted only if there is a strongly favorable benefit-risk ratio for the prisoner. The distribution of burdens should also be considered, thus the requirement that at least half of the research subjects must come from nonprisoner populations.
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Recommendation: Use a collaborative research approach. Under an ethic of collaborative responsibility, investigators should find ways to obtain input from prisoners and other stakeholders on the design and conduct of any research protocol involving prisoners.
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Ethical research requires an environment that is humane and provides reasonable access to supportive care, particularly when human subjects are exposed to physical or psychological risks. Without adequate medical or psychological care, subjects may be vulnerable to undue inducements to participate in research in order to gain access to medical care or other benefits they would not normally have.
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Scientific knowledge and information about best practices gained from high-quality research are critically important to understanding how best to achieve all of the legitimate purposes of the criminal justice system. Enhance Systematic Oversight of Research Involving Prisoners If limited opportunities for research are to be allowed, safeguards and oversight must be strengthened, made consistent, and applied in relation to the levels of study risk and liberty restrictions experienced by the prisoner population.
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Institutional re view boards should focus on the particular ethical issues that each protocol raises in the specific context of the correctional setting. Insti tutional review boards would no longer be required to forward re search proposals to Office for Human Research Protections for certifi cation, except for those rare proposals that require federal-level review.
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Recommendation: Establish systematic oversight of all research in volving prisoners. Congress should establish a national system of over sight that is applied uniformly to all research involving prisoners.
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Recommendation: Ensure voluntary informed consent. Human re search participant protection programs should ensure that voluntary informed consent is obtained from subjects in all research involving prisoners.
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Maximizing privacy within a correctional setting will require collaborative planning efforts specific to the particular correctional setting 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 and IRBs should consider the extent to which core privacy issues can be protected from disclosure through realistic and practical approaches.
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to provide same OHRP oversight functions for the larger universe of research involving prisoners that is not within DHHS jurisdiction.
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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.
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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.
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. NCPHSBBR (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research)
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