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. 2006 Dec;1(4):45-60.
doi: 10.1525/jer.2006.1.4.45.

Using formative research to develop a context-specific approach to informed consent for clinical trials

Amy L Corneli  1 , Margaret E Bentley, James R Sorenson, Gail E Henderson, Charles van der Horst, Agnes Moses, Jacqueline Nkhoma, Lyson Tenthani, Yusuf Ahmed, Charles M Heilig, Denise J Jamieson
Affiliations

Using formative research to develop a context-specific approach to informed consent for clinical trials

Amy L Corneli et al. J Empir Res Hum Res Ethics. 2006 Dec.

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.

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Figures

FIG. 1
FIG. 1
BAN study design.
FIG. 2
FIG. 2
Excerpt from the vignette used in the focus group discussions.
FIG. 3
FIG. 3
An abbreviated description from the counseling cards regarding an analogy about medical research.
FIG. 4
FIG. 4
An example of how formative data informed part of the explanation of randomization.
FIG. 5
FIG. 5
Developmental process for draw ings included in the counseling cards.
See this image and copyright information in PMC

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