Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives

• Published in: Journal of empirical research on human research ethics Vol. 19; no. 4-5; pp. 175 - 185
• Main Authors: McInnis, Brian J., Pindus, Ramona, Kareem, Daniah, Nebeker, Camille
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.10.2024; Sage Publications Ltd
• Subjects: Adult; Aged; Digital Health; Digital Technology; Female; Focus Groups; Humans; Informed Consent; Male; Middle Aged; Qualitative Research; Research Design; Research Subjects; research ethics committee/IRB review; digital health; informed consent; participant perspectives; research ethics; human centered design
• ISSN: 1556-2646; 1556-2654; 1556-2654
• DOI: 10.1177/15562646241290078

The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.