"Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform

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"Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Quittel, Robin M. en_US
dc.date.accessioned 2012-06-07T03:19:47Z
dc.date.issued 2001 en_US
dc.identifier.citation "Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform (2001 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8846772
dc.description.abstract To demonstrate the inadequacies of informed consent in the contemporary context and the need for better subject protection, this paper begins by scrutinizing the rise of modern informed consent doctrine in international legal documents as well as in the United States arena. After examining the federal regulatory framework governing experimentation with human subjects, considerable attention is given to the doctrine of informed consent and its shortcomings in the research setting, including lack of competence to grant consent, misunderstandings and conflicts of interest between researcher and subject, and the doctrine's incompatibility with several dynamics of the patient-physician encounter. Flaws pertaining to both the research and therapeutic settings are also noted. IRBs' responsibilities for protecting subjects are then explored, along with the numerous factors preventing these bodies from providing adequate safeguards. The paper then discusses current regulations regarding various groups- the terminally ill, women, children, prisoners, and the decisionally/cognitively impaired, including psychiatric patients and the elderly- as well as considerations unique to each. This uncovers shortcomings of current informed consent doctrine and illustrates that meaningful consent can only be achieved by crafting procedures and policies specifically tailored to the needs of each particular population. Next, problems that modern medical research in the gene therapy area raises are probed, and numerous proposals to ameliorate the informed consent process as well as IRB efficacy are offered. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject informed consent en
dc.subject human experimentation en
dc.subject gene therapy en
dc.title "Informed" Consent and Human Experimentation: Present Status, Pitfalls, and the Need for Reform en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T03:19:47Z

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