Luke Gelinas, PhD; Joel S. Weissman, MD; Holly Fernandez Lynch, JD; Avni Gupta, BDS, MPH; Ronen Rozenblum, PhD; Emily A. Largent, JD, PhD, RN; I. Glenn Cohen, JD; for the Delphi Working Group Participants *
Disclaimer: The views presented in this article are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its board of governors, or its methodology committee.
Acknowledgment: The authors thank the following persons for their contributions to this manuscript: Laura Beskow, Martha Carnie, Maureen Fagan, Amy Lynn McGuire, and 2 anonymous reviewers for this journal.
Grant Support: Research reported in this article was funded through a PCORI award (ME-1409-21701).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-1334.
Corresponding Author: Luke Gelinas, PhD, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, 23 Everett Street, 3rd Floor, Cambridge, MA 02138; e-mail, Luke.Gelinas@advarra.com.
Current Author Addresses: Dr. Gelinas: Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, 23 Everett Street, 3rd Floor, Cambridge, MA 02138.
Dr. Weissman and Ms. Gupta: Center for Surgery and Public Health, Brigham and Women's Hospital, 1620 Tremont Street, One Brigham Circle, 4-020, Boston, MA 02120.
Prof. Lynch: Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, 1426 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104.
Dr. Rozenblum: Unit for Innovative Healthcare Practice & Technology, Brigham and Women's Hospital, 1620 Tremont Street, Suite OBC-03-002, Boston, MA 02120.
Dr. Largent: Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, 423 Guardian Drive, Blockley Hall, 14th Floor, Philadelphia, PA 19104.
Prof. Cohen: Harvard Law School, 1525 Massachusetts Avenue, Griswold 503, Cambridge, MA 02138.
Author Contributions: Conception and design: L. Gelinas, J.S. Weissman, H.F. Lynch, A. Gupta, R. Rozenblum, E.A. Largent, I.G. Cohen.
Analysis and interpretation of the data: L. Gelinas, J.S. Weissman, H.F. Lynch, A. Gupta, R. Rozenblum, E.A. Largent, I.G. Cohen.
Drafting of the article: L. Gelinas, J.S. Weissman, R. Rozenblum, E.A. Largent, I.G. Cohen.
Critical revision of the article for important intellectual content: L. Gelinas, J.S. Weissman, H.F. Lynch, A. Gupta, R. Rozenblum, E.A. Largent, I.G. Cohen.
Final approval of the article: L. Gelinas, J.S. Weissman, H.F. Lynch, A. Gupta, R. Rozenblum, E.A. Largent, I.G. Cohen.
Provision of study materials or patients: L. Gelinas.
Statistical expertise: A. Gupta.
Obtaining of funding: J.S. Weissman.
Administrative, technical, or logistic support: L. Gelinas, J.S. Weissman, A. Gupta, I.G. Cohen.
Collection and assembly of data: L. Gelinas, J.S. Weissman, A. Gupta, R. Rozenblum, E.A. Largent, I.G. Cohen.
A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research, from design to dissemination. However, certain elements of PCOR raise challenging and potentially novel ethical and regulatory issues for institutional review boards and oversight bodies. These challenges stem primarily from the engagement of patients in roles other than research subject, such as advisors, study personnel, and co-investigators, which gives rise to questions about appropriate levels of protection, training, and education, as well as identifying and managing conflicts of interest. This article presents and discusses recommendations from a Delphi expert panel that was convened to address these and other PCOR-related oversight challenges.
Table. Consensus Recommendations
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Gelinas L, Weissman JS, Lynch HF, Gupta A, Rozenblum R, Largent EA, et al. Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel. Ann Intern Med. ;169:559–563. doi: 10.7326/M18-1334
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Published: Ann Intern Med. 2018;169(8):559-563.
Published at www.annals.org on 25 September 2018
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