From "Informed" to "Engaged" Consent
Risks and Obligations in Consent for Participation in a Health Data Repository
Published in: Journal of Law, Medicine & Ethics, Volume 48, Issue 1, pages 172–182 (Spring 2020). doi: 10.1177/1073110520917007
Posted on RAND.org on January 07, 2021
The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing (n=44) to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes.