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dc.creatorVollmer, Sara Hen
dc.creatorHoward, Georgeen
dc.date.accessioned2016-03-18T17:40:29Zen
dc.date.available2016-03-18T17:40:29Zen
dc.date.created2010-12en
dc.date.issued2010-12en
dc.identifierdoi:10.1007/s11948-010-9244-0en
dc.identifier.bibliographicCitationScience and engineering ethics 2010 Dec; 16(4): 675-91en
dc.identifier.urihttp://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=Statistical+power,+the+Belmont+report,+and+the+ethics+of+clinical+trials.&title=Science+and+engineering+ethics+&volume=16&issue=4&date=2010-12&au=Vollmer,+Sara+H;+Howard,+Georgeen
dc.identifier.urihttp://dx.doi.org/10.1007/s11948-010-9244-0en
dc.identifier.urihttp://hdl.handle.net/10822/1040431en
dc.description.abstractAchieving a good clinical trial design increases the likelihood that a trial will take place as planned, including that data will be obtained from a sufficient number of participants, and the total number of participants will be the minimal required to gain the knowledge sought. A good trial design also increases the likelihood that the knowledge sought by the experiment will be forthcoming. Achieving such a design is more than good sense-it is ethically required in experiments when participants are at risk of harm. This paper argues that doing a power analysis effectively contributes to ensuring that a trial design is good. The ethical importance of good trial design has long been recognized for trials in which there is risk of serious harm to participants. However, whether the quality of a trial design, when the risk to participants is only minimal, is an ethical issue is rarely discussed. This paper argues that even in cases when the risk is minimal, the quality of the trial design is an ethical issue, and that this is reflected in the emphasis the Belmont Report places on the importance of the benefit of knowledge gained by society. The paper also argues that good trial design is required for true informed consent.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:336066en
dc.subjectClinical Trialsen
dc.subjectConsenten
dc.subjectEthicsen
dc.subjectHarmen
dc.subjectInformed Consenten
dc.subjectKnowledgeen
dc.subjectPoweren
dc.subjectRisken
dc.subject.classificationHistory of Health Ethics / Bioethicsen
dc.subject.classificationHuman Experimentation Policy Guidelines / Institutional Review Boardsen
dc.subject.classificationInformed Consent or Human Experimentationen
dc.titleStatistical Power, the Belmont Report, and the Ethics of Clinical Trialsen
dc.provenanceCitation prepared by the Library and Information Services group of the Kennedy Institute of Ethics, Georgetown University for the ETHXWeb database.en
dc.provenanceCitation migrated from OpenText LiveLink Discovery Server database named EWEB hosted by the Bioethics Research Library to the DSpace collection EthxWeb hosted by DigitalGeorgetown.en


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