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

Authors:
  • MBMargaret E. Bentley
    Margaret E. Bentley
  • JSJames R. Sorenson
    James R. Sorenson
  • GHGail E. Henderson
    Gail E. Henderson
  • CHCharles van der Horst
    Charles van der Horst
  • AMAgnes Moses
    Agnes Moses
  • JNJacqueline Nkhoma
    Jacqueline Nkhoma
  • YAYusuf Ahmed
    Yusuf Ahmed
  • DJDenise J. Jamieson
    Denise J. Jamieson
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Abstract
Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally-appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child 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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