Ethical Considerations for Research Involving Prisoners (2007) / Chapter Skim
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Appendix C Report of the SACHRP Subcommittee and Human Subjects Protections
Appendix C Report of the SACHRP Subcommittee and Human Subjects Protections
Pages 199-204
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From page 199... ...
interpretation and application of Subpart C's requirements should be modified.1 Among the topics the subcommittee addressed were • the definition of the term prisoner under Subpart C, • 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 institutional review boards (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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assist IRBs in searching for an appropriate prisoner representative, which might include family members of prisoners, former prisoners (especially people in recovery from substance addiction who have also had experience as prisoners) , and service providers who assist in the correctional process.
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Because of these two enormous gaps in coverage, most research involving prisoners does not fall under the special protections of Subpart C RECOMMENDATIONS FOR FURTHER CONSIDERATION BY THE INSTITUTE OF MEDICINE In addition to its recommendations on the issues discussed previously, the subcommittee noted with approval that the IOM had been charged with studying the human research protections for prisoners.
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. At the same time, certain federal departments or agencies that have adopted a form of the Common Rule have also adopted their own additional rules protecting certain categories of human research subjects other than Subpart C
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TABLE C-1 Overview of Regulations Applicable to Research Involving Prisoners as Subjects, Independent of Funding Source Federal–Adult Federal–Juvenile State–Adult State–Juvenile Medical treatment– nontherapeutic/cosmetic Not permitted Not permitted FDA Subpart A, FDA Subpart A, state policy FDA Subpart D, state policy Pharmaceutical/medical device–therapeutic DOJ Subpart A, DOJ Subpart A, FDA Subpart A, FDA Subpart A, (for specific inmate's condition) FDA Subpart A, FDA Subpart A, FDA Subpart D, FDA Subpart D, DHHS (Subpart C)
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