Main Article Content
Therapeutic misconception and clinical trials in sub-saharan Africa: A review
Abstract
Objectives: To identify possible existence of therapeutic misconception and its effects on clinical trials in sub-Saharan Africa.
Data source: Original research findings and reviews published in the English literature and author’s professional experience with clinical trials in some East, Central and West African countries.
Design: Review of peer-reviewed articles.
Data extraction: Online searches and requests for reprints from corresponding authors and institutional subscription.
Data Synthesis: Information categorised accordingly.
Results: Therapeutic misconception, defined as a conflation by research subjects of research goals and those of routine health care is considered widely prevalent globally. The subjects misunderstand the disclosures during consenting process and enroll hoping to derive personal benefits from the study. Though no study has looked at therapeutic misconception specifically in sub-Saharan Africa, available evidence suggests that it is prevalent. Therapeutic misconception is incompatible with informed voluntary consent. It may affect participation in clinical trials, subjects’ safety and well-being and possibly the research findings.
Conclusions: There is need for studies to identify the prevalence and effects of therapeutic misconception in the region. Researchers in sub-Saharan Africa should be aware of its existence, thus design trials in which it will not have significant effects and strengthen the consent process to reduce it.
Data source: Original research findings and reviews published in the English literature and author’s professional experience with clinical trials in some East, Central and West African countries.
Design: Review of peer-reviewed articles.
Data extraction: Online searches and requests for reprints from corresponding authors and institutional subscription.
Data Synthesis: Information categorised accordingly.
Results: Therapeutic misconception, defined as a conflation by research subjects of research goals and those of routine health care is considered widely prevalent globally. The subjects misunderstand the disclosures during consenting process and enroll hoping to derive personal benefits from the study. Though no study has looked at therapeutic misconception specifically in sub-Saharan Africa, available evidence suggests that it is prevalent. Therapeutic misconception is incompatible with informed voluntary consent. It may affect participation in clinical trials, subjects’ safety and well-being and possibly the research findings.
Conclusions: There is need for studies to identify the prevalence and effects of therapeutic misconception in the region. Researchers in sub-Saharan Africa should be aware of its existence, thus design trials in which it will not have significant effects and strengthen the consent process to reduce it.
