How Informed Is Consent in Vulnerable Populations? Experience Using a Continuous Consent Process During the MDP301 Vaginal Microbicide Trial in Mwanza, Tanzania
Hayes, Richard J
BMC medical ethics 2010 June 13; 11: 10
HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania.
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Conducting Research Using the Emergency Exception From Informed Consent: The Public Access Defibrillation (PAD) Trial Experience Mosesso, Vincent N., Jr.; Brown, Lawrence H.; Greene, H. Leon; Schmidt, Terri A.; Aufderheide, Tom P.; Sayre, Michael R.; Stephens, Shannon W.; Travers, Andrew; Craven, Richard A.; Weisfeldt, Myron L. (Public Access Defibrillation [PAD] Trial Investigators, 2004-04)
Improving the Quality of Consent to Randomised Controlled Trials by Using Continuous Consent and Clinician Training in the Consent Process Allmark, P.; Mason, S. (2006-08)OBJECTIVE: To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians ...