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Using Formative Research to Develop a Context-Specific Approach to Informed Consent for Clinical Trials

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: PMC3140046

Abstract

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.2006.1.4.45

Reference Type

Journal Article

Year Published

2006

Journal Title

Journal of Empirical Research on Human Research Ethics

Author(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.

PMCID

PMC3140046