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Appendix B The National Commission's Deliberations and Findings
Pages 191-198

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From page 191...
... In its charge to the commission concerning research with prisoners, Congress identified informed consent as the locus of ethical concern. In particular, Congress directed the commission to attend to three components of informed consent: (1)
From page 192...
... and involving prisoners…to determine the nature of the consent obtained from such persons or their legal representatives before such persons were involved in such research; the adequacy of the information given them respecting the nature and purpose of the research, procedures to be used, risks and discomforts, anticipated benefits from their research, and other matters necessary for informed consent; and the competence and the freedom of the persons to make a choice for or against in volvement in such research. On the basis of such investigation and study the Com mission shall make such recommendations to the Secretary as it determines ap propriate to assure that biomedical and behavioral research conducted or supported under programs administered by him meets the requirements respect ing informed consent identified by the Commission.
From page 193...
... impose specific rules and procedures for institutional review boards reviewing protocols for correctional settings. The current inquiry, almost 30 years later, asks whether that special set of regulations is still sufficient and valid.
From page 194...
... The pharmaceutical industry and various stakeholders, other than prisoners, were crafting the research agenda in correctional settings. Inmates often agreed to participate, with the hope of improving their living conditions or their chances for probation or parole.
From page 195...
... 195 APPENDIX B that the status of being a prisoner makes possible the perpetration of certain systemic injustices. For example, the availability of a population living in conditions of social and economic deprivation makes it possible for researchers to bring to these populations types of research that per sons better situated would ordinarily refuse.
From page 196...
... 2000. Beneficial and unusual punishment: An argument in support of prisoner participation in clinical trials.
From page 197...
... 1976b. Report and Recommendations: Research Involving Prisoners.


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