Table 1 Recommendations to optimize trial recruitment and consent

1. Reduce variability across investigators and sites

 a. Communication skills training and education of investigators

 b. Involvement of the clinical team in the consent process

 c. Incorporation of study-specific scripts, visual aids, checklists, talking points

2. Incorporate technology

 a. Use of interactive electronic-based technology (e.g., diagrams, images, graphics, videos, narration)

 b. Video teleconferencing to include both parents during consent discussions

 c. Use of electronic informed consent (eIC)

3. Address barriers/disparities

 a. Recognize disparities (racial, ethnic, socioeconomic) in research participation

 b. Address language barriers via in person or tele-interpreters

 c. Address limited medical literacy during the design of the consent process and development of informed consent documents

 d. Incorporate assessment tools to test and ensure comprehension and voluntariness

 e. Foster awareness about research and potential benefits of participation through community-based education and outreach