Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

Anya E R Prince; John M Conley; Arlene M Davis; Gabriel Lázaro-Muñoz; R Jean Cadigan

doi:10.1111/jlme.12323

Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

J Law Med Ethics. 2015 Winter;43(4):827-42. doi: 10.1111/jlme.12323.

Authors

Anya E R Prince¹, John M Conley², Arlene M Davis³, Gabriel Lázaro-Muñoz⁴, R Jean Cadigan⁵

Affiliations

¹ Postdoctoral Research Associate at the Center for Genomics and Society at the University of North Carolina at Chapel Hill School of Medicine. Ms. Prince received her Juris Doctor and Masters of Public Policy from Georgetown University in Washington, D.C.
² William Rand Kenan, Jr. Professor of Law at the University of North Carolina, and an investigator in the university's Center for Genomics and Society. He received his A.B. from Harvard University in Cambridge, MA, and J.D. and Ph.D. (Anthropology) from Duke University in Durham, NC.
³ Research Associate Professor in the Department of Social Medicine at the University of North Carolina, core faculty in its Center for Bioethics, and Adjunct Associate Professor at the University of North Carolina School of Law. She received her Juris Doctor from the University of Washington School of Law, Seattle.
⁴ Postdoctoral Research Associate at the Center for Genomics and Society at the University of North Carolina School of Medicine. Dr. Lázaro-Muñoz received his Ph.D. in Neuroscience from New York University; his J.D. from the University of Pennsylvania School of Law; his Master of Bioethics degree from the Perelman School of Medicine at the University of Pennsylvania; and his B.A. from the University of Puerto Rico, Río Piedras.
⁵ Research Assistant Professor in the Department of Social Medicine at the University of North Carolina. She received her Ph.D. in anthropology from the University of California, Los Angeles.

Abstract

In genomics research, it is becoming common practice to return individualized primary and incidental findings to participants and several ongoing major studies have begun to automatically transfer these results to a participant's clinical medical record. This paper explores who should decide whether to place genomic research findings into a clinical medical record. Should participants make this decision, or does a researcher's duty to place this information in a medical record override the participant's autonomy? We argue that there are no clear ethical, legal, professional, or regulatory duties that mandate placement without the consent of the participant. We conclude that informing participants of results, together with a clear explanation, relevant recommendations and referral sources, and the option to consent to placement in the medical records will best discharge researchers' ethical and legal duties towards participants.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Disclosure / ethics*
Disclosure / legislation & jurisprudence
Genetic Privacy
Genetic Research / ethics*
Humans
Informed Consent
Medical Records*
Patient Participation*
United States

Abstract

Publication types

MeSH terms

Grants and funding