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From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository

Published online by Cambridge University Press:  01 January 2021

Elizabeth Bromley ,
Alexandra Mendoza-Graf ,
Sandra Berry ,
Camille Nebeker  and
Dmitry Khodyakov
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Abstract

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.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue 1: LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application , Spring 2020 , pp. 172 - 182
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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