Authors
Emma RM Cohen, Jennifer M O'neill, Michel Joffres, Ross EG Upshur, Edward Mills
Publication date
2009/8/1
Journal
Developing world bioethics
Volume
9
Issue
2
Pages
74-80
Publisher
Blackwell Publishing Ltd
Description
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 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.
Methods:  We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled‐trials.com. We searched for intervention trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007.
Results:  We collected data from 312 trials. Fifty‐eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty‐eight percent (58 …
Total citations
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