| An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. | |
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MedLine Citation:
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PMID: 21534151 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child. |
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Authors:
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Frank A Chervenak; Laurence B McCullough |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: The American journal of bioethics : AJOB Volume: 11 ISSN: 1536-0075 ISO Abbreviation: Am J Bioeth Publication Date: 2011 May |
Date Detail:
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Created Date: 2011-05-02 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100898738 Medline TA: Am J Bioeth Country: England |
Other Details:
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Languages: eng Pagination: 39-49 Citation Subset: E; IM |
Affiliation:
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Weill Medical College of Cornell University. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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