Exploring informed consent in HIV clinical trials: A case study in Uganda

Area of Science:

• Clinical Research Ethics
• Informed Consent Process
• Public Health

Background:

• Low literacy levels pose challenges to informed consent in clinical trials.
• Exploration of experiences and concerns of key actors in HIV clinical trial informed consent.

Purpose of the Study:

• To investigate the experiences and concerns of stakeholders in the informed consent process for HIV clinical trials.
• To identify challenges and best practices for ensuring informed consent in diverse literacy settings.

Main Methods:

• Semi-structured interviews with 46 participants (trial participants, study team, ethics committee members).
• Focus group discussions with 14 Community Advisory Board (CAB) members and 17 trial participants.
• Thematic analysis of qualitative data to identify key themes in the informed consent process.

Main Results:

• All stakeholders emphasized the importance of the consent process, with differing areas of focus.
• Research teams and ethics committees prioritized signed consent forms as documented evidence.
• Participants questioned the necessity of witnesses for non-literate individuals, emphasizing understanding over literacy.

Conclusions:

• A signature or thumbprint on a consent form does not equate to full participant understanding.
• Effective informed consent requires adequate time, well-trained staff, and a supportive, dynamic process.
• Ensuring informed consent is a relation-centered process that extends throughout the research study duration.