title: Using formative research to develop a context-specific approach to informed consent for clinical trials.
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.
authors.affiliation: University of North Carolina at Chapel Hill.
authors.forename: Amy L
authors.initials: AL
authors.lastname: Corneli
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Bentley
authors.forename: James R
authors.initials: JR
authors.lastname: Sorenson
authors.forename: Gail E
authors.initials: GE
authors.lastname: Henderson
authors.forename: Charles
authors.initials: C
authors.lastname: van der Horst
authors.forename: Agnes
authors.initials: A
authors.lastname: Moses
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Nkhoma
authors.forename: Lyson
authors.initials: L
authors.lastname: Tenthani
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Ahmed
authors.forename: Charles M
authors.initials: CM
authors.lastname: Heilig
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Jamieson