SACHRP recommends prisoner regulations changes
SACHRP recommends prisoner regulations changes
CR path will be paved more smoothly
The Secretary's Advisory Committee on Human Research Protections (SACHRP) for the U.S. Department of Health and Human Services (DHHS) has endorsed recommendations that might make it a little less burdensome for clinical trial sites to conduct research involving prisoners.
The Subpart C Subcommittee of SACHRP has met for more than a year, looking at the additional protections for prisoners that have been in place for nearly 30 years, says Ernest Prentice, PhD, SACHRP chair and an associate vice chancellor for academic affairs at Nebraska Medical Center in Omaha, NE.
The additional protections for prisoners were issued in an era of protectionism," Prentice notes.
"Clearly the entire penal system in the United States has changed dramatically since 1977, so quite frankly we felt at the end of our deliberations that what needed to be done was a complete rewrite of protections for prisoners," Prentice says. "And we felt that before that could be accomplished there should be a study of what should be the ethical basis for providing additional protections for prisoners involved in research."
The Office for Human Research Protections (OHRP) contracted with the Institute of Medicine (IOM), who in turn, produced a report issued this summer, Prentice says.
"That report is very lengthy, and it presents a series of recommendations," he adds.
"The idea is to recommend specific changes in the way we provide protections for prisoners, which in turn may allow more research to be conducted that may provide benefits for prisoners in general," he says. "But we're a long ways off before that's going to happen; anytime you try to change a federal regulation, it's a very lengthy process."
The IOM prisoner research recommendations are as follows:
1. Expand the definition of "prisoner."
• Recommendation: Redefine "prisoners" to expand the research of human subjects protections. DHHS and other relevant agencies that write, implement, or enforce regulations pertaining to research with prisoners should expand the definition of prisoner to include all settings, whether a correctional institution or a community setting, in which a person is held under conditions that restrict liberty as a result of the operation of the criminal justice system.
2. Ensure universal, consistent ethical protection.
• Recommendation: Establish uniform guidelines for all human subjects research involving prisoners. Congress should mandate a uniform set of guidelines for human research participant protection programs for all research involving prisoners.
• Recommendation: Maintain a public database of all research involving prisoners. DHHS, in cooperation with the Department of Justice, should systematically and comprehensively document all human subjects research with prisoners.
• Recommendation: Ensure transparency and accountability in the research enterprise. Human research participant protections programs and prison administrations conducting human subject research should be open, transparent, and accountable.
3. Shift from a category-based to a risk-benefit approach to research review.
• Recommendation: Apply a risk-benefit framework to research review.
DHHS should revise regulations regarding research with prisoners from a model based on categories to a system based on weighing risks and benefits for the individual human subject, similar to the approach currently used in Subpart D.
4. Update the ethical framework to include collaborative responsibility.
• Recommendation: Use a collaborative research approach. Under an ethic of collaborative responsibility, investigators should find a ways to obtain input from prisoners and other stakeholders on the design and conduct of any research protocol involving prisoners.
• Recommendation: Ensure adequate standards of care. Human research participant protection programs, together with the prison administration and prison health care professionals, are responsible for ensuring that research with prisoners occurs in an environment that is appropriate to the health and well-being of prisoners, including access to existing medical and mental health care that is adequate, protection from inmate attempts to coerce or manipulate participation or nonparticipation in research, and prompt access to decent health care services in case the research causes physical or mental harm.
• Recommendation: Support critical areas of correctional research. Government agencies should fund, and researchers should conduct, research to identify needed supports to facilitate prisoners' successful re-entry into society, reduce recidivism, and inform policy makers about the most humane and effective strategies for the operation of correctional systems.
5. Enhance systematic oversight of research with prisoners.
• Recommendation: Strengthen monitoring of research involving prisoners.
Institutional Review Boards that review and approve research involving prisoners should establish an on-site, ongoing monitoring function through a prison research subject advocate.
• Recommendation: Modify IRB considerations for independent, ethical review of research protocols. Institutional review boards should focus on the particular ethical issues that each protocol raises in the specific context of the correctional setting. IRBs would no longer be required to forward research proposals to OHRP for certification, except for those rare proposals that require federal-level review.
• Recommendation: Enhance OHRP's capacity to provide systematic oversight of research involving prisoners. DHHS should strengthen the capacity of OHRP to provide systematic oversight of research involving prisoners that is within its purview.
• Recommendation: Establish systematic oversight of all research involving prisoners. Congress should establish a national system of oversight that is applied uniformly to all research involving prisoners.
• Recommendation: Ensure voluntary informed consent. Human research participant protections programs should ensure that voluntary informed consent is obtained from subjects in all research involving prisoners.
• Recommendation: Protect the privacy of prisoners engaged in research.
Human research participant protection programs should collaborate with prison officials, probation officers, and other staff relevant to the correctional setting to protect the privacy of subjects in prisoner research.
Conclusions: The IOM committee offers these recommendations to encourage the development of a uniform system for protecting all prisoners who are involved in research. Ethical research has the potential to help us understand and promote the welfare of this large and growing segment of our society.
For more information, see: www.iom.edu/prisonerresearchethics.
The Secretary's Advisory Committee on Human Research Protections (SACHRP) for the U.S. Department of Health and Human Services (DHHS) has endorsed recommendations that might make it a little less burdensome for clinical trial sites to conduct research involving prisoners.Subscribe Now for Access
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