Citation
Corneli, Amy L.; Bentley, Margaret E.; Sorenson, James R.; Henderson, Gail E.; van der Horst, Charles M.; Moses, Agnes; Nkhoma, Jacqueline R.; Tenthani, Lyson; Ahmed, Yusuf; & Heilig, Charles M., et al. (2006). Using Formative Research to Develop a Context-Specific Approach to Informed Consent for Clinical Trials. Journal of Empirical Research on Human Research Ethics, 1(4), 45-60. PMCID: PMC3140046Abstract
PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-tochild transmission of HIV during breastfeeding, formative research was conducted to explore the community's understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research.URL
http://dx.doi.org/10.1525/jer.2006.1.4.45Reference Type
Journal ArticleYear Published
2006Journal Title
Journal of Empirical Research on Human Research EthicsAuthor(s)
Corneli, Amy L.Bentley, Margaret E.
Sorenson, James R.
Henderson, Gail E.
van der Horst, Charles M.
Moses, Agnes
Nkhoma, Jacqueline R.
Tenthani, Lyson
Ahmed, Yusuf
Heilig, Charles M.
Jamieson, Denise J.