Informed consent: an international researchers' perspective

Area of Science:

• Informed Consent Process
• Clinical Research Ethics
• Global Health Research

Background:

• Identified 164 researcher recommendations for informed consent elements.
• Recommendations gathered from workshops in Africa, Europe, and the United States.
• Utilized the US Code of Federal Regulations' 8 elements of informed consent as a baseline.

Framework:

• Developed 95 distinct information points for informed consent.
• Information points primarily focused on research benefits and descriptions.
• Assessed the utility of these points across different geographic and cultural contexts.

Implementation:

• Conducted three international training workshops to gather recommendations.
• Analyzed consensus on 95 identified information points.
• Found that only 27 (28%) points were deemed useful by all workshop groups.

Implications:

• Limited consensus underscores variability in perceived essential informed consent information.
• Results indicate a need for broader stakeholder engagement in consent form development.
• Findings are crucial for adapting informed consent for international research settings.