期刊
KENNEDY INSTITUTE OF ETHICS JOURNAL
卷 20, 期 1, 页码 75-98出版社
JOHNS HOPKINS UNIV PRESS
DOI: 10.1353/ken.0.0307
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资金
- CIHR [/MOP 68835, 102823-1, /FRN 102823] Funding Source: Medline
Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two provisional conclusions: (1) the risks of drug administration in such trials cannot generally be justified on therapeutic grounds but by appeal to the social value of the research; and (2) a framework for adjudicating the ratio of risk/social-value must be developed.
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