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Abstract
Improving informed consent in HIV/AIDS research: a conceptual framework and supportive materials
C Woodsong1, Q Abdool Karim2, A Coletti1
1Family Health International, North Carolina, United States; 2University of Natal, Durban, South Africa
Issues:
Achieving truly informed and voluntary consent is difficult, especially in culturally diverse settings. Despite widespread agreement that informed consent is a process, rather than a one-time event culminating in a participant's signature, there is a lack of clarity about what this larger process includes, and how best to accomplish high quality, reliable, informed consent.
Description: This paper presents a conceptual framework to guide the development of an informed consent process to help ensure initial and continued comprehension of research participation through the life of a study, and strengthen HIV prevention research. The framework has a multi-level and multi-phased approach to consent, with attention placed at individual and community levels, and at three study phases: pre-enrollment, enrollment and study continuation. This approach is being used in a microbicide clinical trial conducted by the HIV Prevention Trials Network in 7 countries.
Lessons learned: The paper will present examples of the following materials and how they are being used. 1.Supportive materials: Materials, including booklets, flip charts and fact sheets, benefited from community consultation on format and content. 2.Training materials for staff and community advisory boards: Ethics training for staff and community advisory boards was expanded to include the conceptual framework. 3.Comprehension assurances: Initial and periodic monitoring of informed consent comprehension uses a simple tool designed to assess comprehension, and study procedures also monitor community-level perceptions of the study.
Recommendations: The framework can aid in the creation of an informed consent form that is comprehensible to potential participants, and an informed consent process that remains active throughout the study. It can also strengthen the research effort, through recruitment and retention of participants who better understand their roles and responsibilities in a study.
The XV International AIDS Conference
Abstract no.
ThPeC7583
Suggested Citation
" C Woodsong , , et al.
Improving informed consent in HIV/AIDS research: a conceptual framework and supportive materials.
Poster Exhibition:
The XV International AIDS Conference:
Abstract no.
ThPeC7583"
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