E-Book, Englisch, 186 Seiten, eBook
ISBN: 978-1-59745-295-3
Verlag: Humana Press
Format: PDF
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Weitere Infos & Material
How Does Bioethics Help Judicial Reasoning?.- Health Care Ethics Committee Determinations.- Institutional Review Board Determinations.- Bioethics Commission Reports.- Bioethics Scholarship.- Reliability of Bioethics Testimony.- Reliability of Bioethics Testimony.- Reliability of Bioethics Testimony.- Conclusion.
3 ,Institutional Review Board Determinations (p. 56-57)
Institutional review boards (IRBs) were created pursuant to the 1974 National Research Act1 to ensure that the rights and welfare of human subjects would be protected. The Act and implementing regulations were a response to research scandals, such as the Tuskegee Syphilis study, in which black men with syphilis were left untreated for more than three decades by the US Public Health Service, and the Jewish Chronic Disease Hospital study, in which live cancer cells were injected into hospital patients without consent. The regulations delegated to IRBs the responsibility to review and oversee research on human subjects. Although they would be highly regulated, law would rely on them in an ongoing manner. Susan Wolf describes IRBs as a "perfect example of a body conceived to do both law and ethics. They are required to apply the federal regulations, which are law, but those regulations are so open-textured and the overriding mission of IRBs is so clearly to protect human subjects, that IRBs must do ethics too."
IRB recommendations are developed for a particular study and a particular set of researchers—not for litigation purposes. Those recommendations may include whether a study involving human subjects could ethically proceed, whether potential research subjects are "at risk," and if so, whether the risks outweigh the potential benefits to the research subjects and the importance of the knowledge that might be gained from the research, what information should be disclosed in the informed consent process, whether the selection of subjects is equitable, what methods should be used for protecting confidentiality, whether disclosures to subjects regarding confidentiality are adequate, how the data will be monitored to ensure the safety of subjects, and whether incentives to participate can be offered, and, if so, the conditions under which the offer may be made.3 Today, any of these bioethics recommendations, as well as communications regarding the processes by which they were reached, may interact with law.