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1 Introduction
Pages 21-28

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From page 21...
... Certain unique circumstances faced by prisoners,1 however, require particular attention. Numerous ethical problems surrounding research with prisoners grow out of the complexity of the correctional settings and the disempowered status of the potential research participants.
From page 22...
... or hepatitis C makes quite clear what the inmate's visit portends. Third, ethical research involves ensuring, as a prerequisite for research, that the standard of medical health care available in the correctional setting permits the inmate to have a meaningful choice between the existing care that is available and the experimental intervention.
From page 23...
... . • Inadequate health-care services is a reality of some correctional settings, notwithstanding Eighth Amendment proscriptions against "deliberate indifference to the serious medical needs" of prisoners (Braithwaite et al., 2005; HRW, 2003; Metzner, 2002; Restum, 2005; Sturm, 1993)
From page 24...
... OHRP has oversight and educational responsibilities wherever DHHS funds are used to conduct research involving human participants. The Secretary's Advisory Committee for Human Research Protections(SACHRP)
From page 25...
... The committee was asked to address the following three questions: 1. What are the unique features of the prison setting as an environment for research with respect to the general characteristics of the prison population, its specific and general health-care needs, the adequacy of existing health-care services, and the legal constraints placed on prisoners and the institutions that house them?
From page 26...
... • How should the standard of existing medical care be valued when reviewing research protocols involving control or placebo-control arms? • Should there be a risk threshold for allowing research with pris oners?
From page 27...
... Finally, Chapter 6 contains the committee's recommendations for a new, more comprehensive system of oversight, safeguards, and protections for research involving prisoners, with more intrusive monitoring for higher risk studies. Appendix A contains a thorough description of the committee's methods and data sources; Appendix B, the national commission's deliberations and findings; Appendix C, the report of the SACHRP Subcommittee and Human Subjects Protections; Appendix D, the Code of Federal Regulations 45 Part 46 (Protection of Human Subjects)
From page 28...
... New York: Vintage. NCCHC (National Commission on Correctional Health Care)


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