Practical experiences in obtaining informed consent for a vaccine trial in rural Africa.
نویسندگان
چکیده
منابع مشابه
Informed consent and participant perceptions of influenza vaccine trials in South Africa.
BACKGROUND AND OBJECTIVES There are few insights from sub-Saharan Africa on research participants' experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among in...
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In this review we describe the ethical issues central to local and international debates about HIV vaccine trials. These issues include the physiological and psycho-social risks of trial participation, the preventative interventions to be provided to participants, access to treatment for participants who seroconvert, access to an effective vaccine after the trial, the role of placebo-controlled...
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BACKGROUND There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical resear...
متن کاملFitting a routine health-care activity into a randomized trial: an experiment possible without informed consent?
Due to possible methodological and practical problems, many researchers refrain from using a randomized controlled trial design to evaluate procedures already embedded in routine health care. We performed a randomized controlled trial on the effects of routine individual feedback on test ordering behavior of family physicians. The trial started after 4 years of feedback and lasted for 2.5 years...
متن کاملEthical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial
BACKGROUND Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes ...
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عنوان ژورنال:
- The New England journal of medicine
دوره 336 5 شماره
صفحات -
تاریخ انتشار 1997