Theoretical model of critical issues in informed consent in HIV vaccine trials

Abstract

The informed consent process (ICP) for HIV vaccine trials poses unique challenges and would benefit from improvements to its historically based structure and format. Here, we propose a theoretical framework that provides a basis for systematically evaluating and addressing these challenges. The proposed framework follows a linear pathway, starting with the precondition of voluntariness, three main variables of valid decision-making (competency, provision of information and understanding) and then the consequential outcome of either refusal or consent to participate. The existing literature reveals that culturally appropriate provision of information and resultant understanding by the vaccine trial participant are among the most significant factors influencing the authenticity of valid decision-making, though they may be overridden by other considerations, such as individual altruism, mistrust, and HIV-related stigma. Community collaborations to foster bidirectional transmission of information and more culturally tailored consenting materials, therefore, represent a key opportunity to enhance the ICP. By providing a visual synopsis of the issues most critical to IC effectiveness in a categorical and relational manner, the framework provided here presents HIV vaccine researchers a tool by which the ICP can be more systematically evaluated and consequently improved.

Keywords:

• HIV vaccine trials
• informed consent
• theoretical models
• HIV vaccine
• HIV

Funding

This work was supported by the Division of AIDS, National Institutes of Allergy and Infectious Diseases, Developmental Center for AIDS Research [grant P30 AI078498] (NIH/NIAID) and the University of Rochester School of Medicine and Dentistry. The work was also partly supported by the University of Rochester CTSA [award number TL1 TR000096] from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Additional information

Funding

Funding: This work was supported by the Division of AIDS, National Institutes of Allergy and Infectious Diseases, Developmental Center for AIDS Research [grant P30 AI078498] (NIH/NIAID) and the University of Rochester School of Medicine and Dentistry. The work was also partly supported by the University of Rochester CTSA [award number TL1 TR000096] from the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.