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Informed consent for clinical trials: a review
V M Lema1, M Mbondo, E M Kamau
1Family Health International, Africa Regional Office, P.O. Box 38835-00623, Nairobi, Kenya.
East African Medical Journal
|August 26, 2009
Summary
Informed consent for clinical trials in sub-Saharan Africa faces challenges due to literacy, cultural factors, and weak ethics committees. True understanding and voluntary participation are often compromised, necessitating improved guidelines and local capacity building.
Area of Science:
- Global Health
- Bioethics
- Clinical Research
Background:
- Informed consent is a cornerstone of ethical clinical research.
- Sub-Saharan Africa presents unique challenges in implementing informed consent processes.
Purpose of the Study:
- To identify and highlight challenges related to the informed consent process for clinical trials in sub-Saharan Africa.
Main Methods:
- Review of published original research findings and reviews in English literature.
- Inclusion of anecdotal information from professional experiences.
- Online searches and requests for reprints.
Main Results:
- Informed consent in sub-Saharan Africa is often not truly informed or voluntary.
- Low literacy, socio-economic, and cultural factors impede guideline implementation.
- Weak or non-existent local ethics committees, language barriers, and perceived benefits affect participant understanding and enrollment.
Conclusions:
- Need for national guidelines addressing local circumstances and international standards for clinical research ethics.
- Development and strengthening of local bioethics and research capacity are crucial.
- Research sponsors should contribute to capacity building; local research on informed consent validity is needed.
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