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

Amy L. Corneli; 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

doi:10.1525/jer.2006.1.4.45

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

Journal article

Peer reviewed

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

Amy L. Corneli, Margaret E. Bentley, James R. Sorenson, Gail E. Henderson, Charles Van der Horst, Agnes Moses, Jacqueline Nkhoma, Lyson Tenthani, Yusuf Ahmed, Charles M. Heilig, …

Journal of empirical research on human research ethics, Vol.1(4), pp.45-60

12/01/2006

DOI: 10.1525/jer.2006.1.4.45

PMCID: PMC3140046

PMID: 19385837

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https://www.ncbi.nlm.nih.gov/pmc/articles/3140046View

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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.

Ethics

Life Sciences & Biomedicine

Medical Ethics

Science & Technology

Social Sciences

Social Sciences - Other Topics

Details

Title: Subtitle: Using formative research to develop a context-specific approach to informed consent for clinical trials
Creators: Amy L. Corneli - University of North Carolina at Chapel Hill
Margaret E. Bentley - University of North Carolina at Chapel Hill
James R. Sorenson - University of North Carolina at Chapel Hill
Gail E. Henderson - University of North Carolina at Chapel Hill
Charles Van der Horst - University of North Carolina at Chapel Hill
Agnes Moses - UNC Project, Lilongwe, Malawi
Jacqueline Nkhoma - UNC Project, Lilongwe, Malawi
Lyson Tenthani
Yusuf Ahmed - Ctr Dis Control & Prevent, Atlanta, GA USA
Charles M. Heilig - Ctr Dis Control & Prevent, Atlanta, GA USA
Denise J. Jamieson - Ctr Dis Control & Prevent, Atlanta, GA USA
Resource Type: Journal article
Publication Details: Journal of empirical research on human research ethics, Vol.1(4), pp.45-60
DOI: 10.1525/jer.2006.1.4.45
PMID: 19385837
PMCID: PMC3140046
NLM abbreviation: J Empir Res Hum Res Ethics
ISSN: 1556-2646
eISSN: 1556-2654
Publisher: Sage
Number of pages: 16
Language: English
Date published: 12/01/2006
Academic Unit: Obstetrics and Gynecology; VPMA - Administration
Record Identifier: 9984446721602771

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