From Return of Information to Return of Value: Ethical Considerations when Sharing Individual-Level Research Data

Article type: Review Article

Authors: Nebeker, Camille^{a; b; c} | Leow, Alex D.^d | Moore, Raeanne C.^{a; e; f; *}

Affiliations: [a] Center for Wireless and Population Health Systems, UC San Diego, La Jolla, CA, USA | [b] Department of Family Medicine and Public Health, School of Medicine, UC San Diego, La Jolla, CA, USA | [c] Research Center for Optimal Digital Ethics, Qualcomm Institute and School of Medicine, UC San Diego, La Jolla, CA, USA | [d] Departments of Psychiatry and BioEngineering, University of Illinois College of Medicine, Chicago, IL, USA | [e] Department of Psychiatry, School of Medicine, UC San Diego, La Jolla, CA, USA | [f] Mental Health Technology Center, UC San Diego, La Jolla, CA, USA

Correspondence: [*] Correspondence to: Raeanne C. Moore, PhD, 220 Dickinson Street, Suite B (8231), San Diego, CA 92103, USA. Tel.: +1 619 543 5378; Fax: +1 619 543 1235; E-mail: [email protected].

Abstract: The implementation of digital health technologies into research studies for Alzheimer’s disease and other clinical populations is on the rise. Digital tools and strategies create opportunities to further expand the framework for conducting research beyond the traditional medical research model. The combination of participatory and community-based research methods, electronic health records, and the creation of multi-dimensional, large-scale research platforms to support precision medicine, along with the Internet of Things era, have led to more engaged and informed research participants. Research participants increasingly possess an expectation they will play a critical role as partners in the design and conduct of research. Moreover, there is growing interest among research participants to have access to individual-level research data in real-time and/or at study completion. The traditional medical research model is largely one-directional where participants contribute data that is analyzed by researchers to yield generalizable knowledge. In this Ethics Review, we discuss a framework for a more nuanced intermediate research model, which is largely bidirectional and individually customized. Based on the seven ethical guidelines adopted by the National Institutes of Health, we speak to the ethical challenges of this intermediate type research. We also introduce a concept we are calling “MyTerms,” in which prospective participants tailor the terms and conditions of informed consent to their personalized preferences for receiving information, including research results. Digital health technologies offer a convenient and flexible approach for researchers to develop protocols that make it possible for participants to obtain access to their study data in a personalized and meaningful way.

Keywords: Cognitive dysfunction, digital medicine, disclosure, information dissemination, informed consent, mobile health, patient rights, privacy, research ethics, return of results

DOI: 10.3233/JAD-190589

Journal: Journal of Alzheimer's Disease, vol. 71, no. 4, pp. 1081-1088, 2019