TY - JOUR
T1 - Implementing a universal informed consent process for the All of Us Research Program
AU - Doerr, Megan
AU - Grayson, Shira
AU - Moore, Sarah
AU - Suver, Christine
AU - Wilbanks, John
AU - Wagner, Jennifer
N1 - Funding Information:
The research reported in this publication was supported by the Department of Health and Human Services of the National Institutes of Health under award number U24OD023176, by the National Human Genome Research Institute (NHGRI) Grant No. 5R00HG006446-05, and by the National Institutes of Health, Office of the Director via 1OT2OD024609-01. Approval for the release of this research was granted by the All of Us Research Program Publication Board (Approval date: July 3, 2018). The authors take full responsibility for any errors or omissions within this manuscript; the content does not necessarily represent the official views of the National Institutes of Health. The authors acknowledge with gratitude: Eva Yin, Patrick Kayne, and Farrah Gerdes, attorneys at Wilson Sonsini Goodrich & Rosati, P.C.; Katherine Blizinsky, Policy Director, All of Us Research Program, National Institutes of Health; Stephanie Devaney, Deputy Director, All of Us Research Program, National Institutes of Health; the Consent Work Group of the All of Us Research Program; All of Us Research Program Consortium members, especially Laura Beskow, Louise Bier, Robert C. Green, Mitch Dean, Joyce Ho, Rosario Isasi, Shenela Lakhani, and Matthew Lebo; Erin C. Fuse Brown, Professor of Law, Georgia State University College of Law; and Leslie E. Wolf, Professor of Law and Director for the Center for Law, Health & Society, Georgia State University College of Law.
Publisher Copyright:
© 2018 The Authors.
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85062764734&partnerID=8YFLogxK
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M3 - Conference article
C2 - 30963079
AN - SCOPUS:85062764734
SN - 2335-6928
VL - 24
SP - 427
EP - 438
JO - Pacific Symposium on Biocomputing
JF - Pacific Symposium on Biocomputing
IS - 2019
T2 - 24th Pacific Symposium on Biocomputing, PSB 2019
Y2 - 3 January 2019 through 7 January 2019
ER -