Improving the Proficiency of Research Consent Administrators

Area of Science:

• Bioethics
• Health Literacy
• Informed Consent

Background:

• Obtaining informed consent from diverse populations, including those with limited literacy, presents unique challenges.
• Existing training for consent administrators may not adequately address these specific needs.
• Effective consent processes are crucial for ethical research conduct and participant protection.

Purpose of the Study:

• To develop and evaluate a training module designed to improve consent administrators' skills.
• To enhance the ability to obtain research consent from culturally and linguistically diverse and low literacy populations.
• To provide a resource for institutional review boards, researchers, and educators.

Main Methods:

• A video-based training module incorporating community vignettes was developed.
• Content, face, and construct validity were assessed by experts.
• A field trial involved 112 consent administrators completing pre- and post-knowledge tests and satisfaction surveys.

Main Results:

• Post-test scores showed a statistically significant improvement compared to pre-test scores (p = 0.003).
• Years of experience in obtaining consent did not correlate with test scores.
• User evaluations were generally positive, with constructive feedback for further refinement.

Conclusions:

• Despite relatively high pre-test scores, training needs for consenting diverse and low-literacy populations may persist.
• This training module can serve as a valuable resource to supplement existing training.
• Stakeholders including institutional review boards, researchers, and policymakers should prioritize addressing these training gaps.