Fitting a Square Peg Into a Round Hole? : Imposing Informed Consent and Post-Trial Obligations on United States Sponsored Clinical Trials in Developing Countries
Southern California Interdisciplinary Law Journal 2002 Spring; 11(2): 339-360
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Reporting of Informed Consent, Standard of Care and Post-Trial Obligations in Global Randomized Intervention Trials: A Systematic Survey of Registered Trials Cohen, Emma R.M.; O'Neill, Jennifer M.; Joffres, Michel; Upshur, Ross E.G.; Mills, Edward (2009-08)OBJECTIVE: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical ...
Subjects' Views of Obligations to Ensure Post-Trial Access to Drugs, Care and Information: Qualitative Results From the Experiences of Participants in Clinical Trials (EPIC) Study Sofaer, N.; Thiessen, C.; Goold, S.D.; Ballou, J.; Getz, K.A.; Koski, G.; Krueger, R.A.; Weissman, J.S. (2009-03)OBJECTIVES: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. DESIGN: Focus groups, ...