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

Published online by Cambridge University Press:  01 January 2021

Anya E.R. Prince ,
John M. Conley ,
Arlene M. Davis ,
Gabriel Lázaro-Muñoz  and
R. Jean Cadigan
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Extract

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 43 , Issue 4 , Winter 2015 , pp. 827 - 842
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

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