Ethical Considerations for Research Involving Prisoners (2007) / Chapter Skim
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5 The Ethical Framework for Research Involving Prisoners
5 The Ethical Framework for Research Involving Prisoners
Pages 113-136
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From page 113... ...
The commission focused on respect for persons and justice as the two key ethical considerations guiding their recommendations. The intervening decades have offered few reasons to quarrel with the commission's identification of these two factors as fundamental ethical principles guiding the conduct and regulation of research with prisoners.
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From page 114... ...
Only through close cooperation and communication with all relevant parties, in every implicated setting, can researchers ensure that they are creating ethical conditions that are favorable for respect and unfavorable for exploitation in any research context. THE 1976 COMMISSION'S ETHICAL FRAMEWORK Historical Context The commission's deliberations took place against a background that included the Nazi experiments with concentration camp prisoners followed by the adoption of a stringent standard of voluntary consent in the Nuremburg Code.
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From page 115... ...
The commission identified two basic ethical dilemmas arising in connection with the use of prisoners as research subjects and linked these dilemmas to two basic ethical principles (NCPHSBBR, 1976)
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From page 116... ...
The perception that all forms of research involving prisoners are equally ethically problematic, or subject to blanket prohibition or to conditions so onerous that the research is not worth doing, may be responsible for the dwindling of prisoner research participation to the point that justice concerns have been expressed about the exclusion of prisoners from clinical trials. AN UPDATED ETHICAL FRAMEWORK The committee developed a new ethical framework that utilizes the ethical principles applied by the national commission in the 1976 report, with several new, important components.
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From page 117... ...
Prisoners, as a vulnerable population, are in jeopardy of receiving a disproportionate share of the risk associated with human subjects research. As stated by the National Bioethics Advisory Commission (NBAC)
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From page 118... ...
More attention needs to be paid to risks and riskbenefit analysis rather than the formalities of an informed consent document. The ethical risks associated with research involving prisoners cannot be solved by focusing only on the informed consent document.
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From page 119... ...
For example, an emphasis on external assurances may weaken the sense of personal moral responsibility on the part of investigators. Similarly, rigid external assurances, like those seen in the current regulations, can direct attention away from an analysis of risks and benefits, where the key ethical issues can be found.
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From page 120... ...
One can simultaneously believe that the piling on of more rules and oversight bodies at some point becomes counterproductive and that human subjects are presently inadequately protected. Indeed, many modern ethicists seem to hope for a reawakening of scientific conscience rather than additional fortifications to the citadel of regulations.
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From page 121... ...
Justice and respect for persons are as vital today as they were three decades ago; research still must be constrained by these ethical principles. The prison continues to be a setting in which it may be difficult to avoid contamination through contact with what will often be a culture of, at best, deprivation and dysfunction and, at worst, corruption, brutality, and degradation (Hornblum, 1997, 1998; Murphy, 2005; Rhodes, 2005)
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From page 122... ...
The following recommendations strive to acknowledge that, in limited circumstances, the potential benefit of a research protocol can justify research involving prisoners. These limited circumstances cannot be captured by a rigid categorical approach but need to be 4Of course, this survey only represents the views of a limited sample of prisoners.
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From page 123... ...
The U.S. Department of Health and Human Services should revise regulations regarding research with prisoners from a model based on categories to a system based on weighing of risks and benefits for the individual human subject, similar to the approach currently used in Subpart D.5 The risks and benefits of human subjects research are the ethically relevant issues, not the category of the research.
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From page 124... ...
In the absence of benefit, either to the prisoner-subject or to prisoners as a class, the research should be conducted in other settings This balancing framework represents a departure from the way that decisions are currently made for approving research protocols. The present system utilizes the idea of "minimal risk" to evaluate the dangers associated with a protocol; studies are often characterized as presenting either minimal risk or more than minimal risk.
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From page 125... ...
125 THE ETHICAL FRAMEWORK FOR RESEARCH INVOLVING PRISONERS ently in Subpart C should be replaced by a slightly modified version of the definition, as follows: The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons living outside the correc tional setting. This definition reflects the fact that prisoners are faced with a high baseline level of daily risk, thus making prison life an inappropriate reference point for determining whether a research protocol presents more than minimal risk.
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From page 126... ...
126 ETHICAL CONSIDERATIONS FOR RESEARCH INVOLVING PRISONERS Rationale This approach starts with the presumption that biomedical research should be severely restricted and is allowable only in limited circumstances. Biomedical research involving prisoners as subjects is only permitted when the potential benefit to the prisoner-participants outweighs the risk to which the subjects are exposed.
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From page 127... ...
. Due to the inherent risks associated with research involving prisoners, increased oversight is needed when a biomedical study enrolls a high proportion of prisoners or when the potential benefits are expected but not yet established.
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From page 128... ...
The ethical problems associated with research involving prisoners will manifest themselves differently in each correctional setting. The one-size-fitsall approach characterized by a focus on informed consent cannot adequately address the unique concerns presented by each setting.
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From page 129... ...
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. To satisfy the spirit of the Belmont Report principles in modern correctional settings requires recognition of an additional ethical imperative.
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From page 130... ...
Recruitment and enrollment make up a third area of potential collaboration. Involving prisoners in the recruitment process can go a long way toward minimizing potential coercion or undue inducement.
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From page 131... ...
The commission thought of distributive justice as requiring the fair distribution of research risks and burdens. However, much of the recent philosophical work argues that although justice requires the protection of vulnerable subjects from exploitative research, sometimes it also mandates that research be done to improve
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From page 132... ...
argues that justice should take us beyond purely distributive concerns to the evaluation and modification of "institutional arrangements" and structures of "decision making and other procedural aspects of research." Another chapter, "Convenient and Captive Populations," provides a history of the regulation of research with prisoners, institutionalized persons, military personnel, and students in the United States. It concludes by endorsing a protectionist stance toward these populations, based on histories of abuse, while noting that "there are circumstances in which justice may permit, or even require, access to research" for these populations, such as "the prevalence of a disease that poses a particular threat" to its members and "cannot be studied as effectively with other subjects" (Moreno, 1998)
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From page 133... ...
Other factors, which would be useful though not definitive, include: • Is the system accredited by a third party, such as National Commission on Correctional Health Care (NCCHC) , American Correctional Association (ACA)
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From page 134... ...
Lastly, if research is to be done in prisons, there is an ethical responsibility to devote much of this research effort to determine how best to achieve all of the legitimate purposes of the criminal justice system. Recommendation 5.4 Support critical areas of correctional research.
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From page 135... ...
It is, therefore, especially important to better understand how to protect and promote the welfare and well-being of this large and growing segment of our society. Scientific knowledge and information about "best practices" gained from high-quality research is critically important to understanding how best to achieve all of the legitimate purposes of the criminal justice system.
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