Implementing a Universal Informed Consent Process for the All of Us Research Program

Forthcoming, Pacific Symposium on Biocomputing, (Author Preprint)

12 Pages Posted: 27 Nov 2018

See all articles by Megan Doerr

Megan Doerr

Sage Bionetworks

Shira Grayson

Sage Bionetworks

Christine Suver

Sage Bionetworks

John Wilbanks

Sage Bionetworks

Jennifer Wagner

Geisinger Health System Inc. - Bioethics Research

Date Written: July 27, 2018

Abstract

The United States’ All of Us Research Program is a longitudinal research initiative with ambitious national recruitment goals, including of populations traditionally underrepresented in biomedical research, many of whom have high geographic mobility. The program has a distributed infrastructure, with key programmatic resources spread across the US. Given its planned duration and geographic reach both in terms of recruitment and programmatic resources, a diversity of state and territory laws might apply to the program over time as well as to the determination of participants’ rights. Here we present a listing and discussion of state and territory guidance and regulation of specific relevance to the program, and our approach to their incorporation within the program’s informed consent processes.

Keywords: informed consent, conflicts of law, choice of law, ELSI, bioethics

Suggested Citation

Doerr, Megan and Grayson, Shira and Suver, Christine and Wilbanks, John and Wagner, Jennifer, Implementing a Universal Informed Consent Process for the All of Us Research Program (July 27, 2018). Forthcoming, Pacific Symposium on Biocomputing, (Author Preprint). Available at SSRN: https://ssrn.com/abstract=3277573 or http://dx.doi.org/10.2139/ssrn.3277573

Megan Doerr (Contact Author)

Sage Bionetworks ( email )

1100 Fairview Ave. N.
Mailstop M1-C108
Seattle, WA 98109
United States

Shira Grayson

Sage Bionetworks ( email )

1100 Fairview Ave. N.
Mailstop M1-C108
Seattle, WA 98109
United States

Christine Suver

Sage Bionetworks ( email )

1100 Fairview Ave. N.
Mailstop M1-C108
Seattle, WA 98109
United States

John Wilbanks

Sage Bionetworks ( email )

1100 Fairview Ave. N.
Mailstop M1-C108
Seattle, WA 98109
United States

Jennifer Wagner

Geisinger Health System Inc. - Bioethics Research ( email )

100 North Academy Ave.
Danville, PA 17822-4910
United States

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