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Designing a Solution to Manage Electronic Consent for Children.

Gary Leeming1, Sarah Thew1,2, John Ainsworth1

  • 1Centre for Health Informatics, Division of Informatics, Imaging and Data Science, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.

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|June 24, 2020
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Summary

Managing research consent for a large birth cohort study, like Born In Bradford, presents unique challenges. This paper details an electronic system designed to capture parental consent for child participation from birth, improving upon paper-based methods.

Keywords:
Digital consentElectronic Patient RecordsUCDUser centred design

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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.