An Ethically Justified Framework for Clinical Investigation to Benefit Pregnant and Fetal Patients.
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...
| Publicado en: | American Journal of Bioethics Vol. 11; no. 5; pp. 39 - 50 |
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| Autores principales: | , |
| Formato: | Journal Article |
| Publicado: |
Taylor & Francis Ltd
May2011
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104887743&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104887743 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15265161 FKZ jtl: American Journal of Bioethics issn: 15265161 maglogo: N pubinfo: dt: May2011 vid: 11 iid: 5 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 104887743 2011029706 10.1080/15265161.2011.562595 NLM21534151 104887743 ppf: 39 ppct: 11 formats: fmt: @attributes: type: P tig: atl: An Ethically Justified Framework for Clinical Investigation to Benefit Pregnant and Fetal Patients. aug: au: Chervenak, Frank A. McCullough, Laurence B. affil: Weill Medical College of Cornell University, sug: subj: Research Ethics Fetal Research Ethical Issues Clinical Trials Ethical Issues Expectant Mothers Ethical Issues Fetal Research Legislation and Jurisprudence Protection of Human Subjects Ethical Issues Conceptual Framework Fetus Institutional Review United States Beneficence Patient Autonomy Consent (Research) Ethical Issues Fetus, conception to birth ab: 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. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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