Designing a Solution to Manage Electronic Consent for Children

Area of Science:

• Clinical research informatics
• Bioethics and research integrity
• Longitudinal cohort studies

Background:

• Existing electronic consent systems primarily capture direct subject consent.
• Integrating research consent into electronic patient record systems is often difficult.
• The Born In Bradford study requires parental consent for infant participation from birth, traditionally managed via paper.

Purpose of the Study:

• To address the complexities of managing parental consent for a large, from-birth cohort study.
• To develop an electronic consent system compatible with existing maternity workflows.
• To translate nuanced consent regulations for children into a transparent electronic process.

Main Methods:

• User-centered design approach to address specific consent management challenges.
• Development of a technical solution for electronic consent capture.
• Integration strategy with existing maternity and electronic patient record systems.

Main Results:

• A novel electronic system for managing parental consent for infant research participation.
• The system facilitates transparent consent processes, fostering trust among families and clinical teams.
• The solution is designed to accommodate the expansion of the Born In Bradford study.

Conclusions:

• Electronic systems can effectively manage complex consent requirements for large cohort studies.
• User-centered design and technical integration are crucial for successful implementation.
• This approach enhances trust and streamlines research participation for families and healthcare providers.