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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
Author(s) -
COHEN EMMA R.M.,
O'NEILL JENNIFER M.,
JOFFRES MICHEL,
UPSHUR ROSS E.G.,
MILLS EDWARD
Publication year - 2009
Publication title -
developing world bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.398
H-Index - 27
eISSN - 1471-8847
pISSN - 1471-8731
DOI - 10.1111/j.1471-8847.2008.00233.x
Subject(s) - medicine , clinical trial , informed consent , randomized controlled trial , declaration of helsinki , odds ratio , research ethics , family medicine , alternative medicine , psychiatry , pathology
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 considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting.