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Selecting Subjects For Participation In Clinical Research: An Empirical Inquiry And Ethical Analysis, Charles Weijer

Philosophy Publications

Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.

In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the results of an examination of eligibility criteria in two sets of clinical trials, one sponsored by the NSABP, the other …