How should we address the inevitable harms from non-negligent variant reclassification in predictive genetic testing?

Misha Rashkin; Kerry Kingham; Karlena Lara-Otero; Meghan Mckenna; Janelle Villiers; Monty Mykolas Worthington; Anya Prince

doi:10.1002/jgc4.1638

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How should we address the inevitable harms from non-negligent variant reclassification in predictive genetic testing?

Journal article

Open access

Peer reviewed

How should we address the inevitable harms from non-negligent variant reclassification in predictive genetic testing?

Misha Rashkin, Kerry Kingham, Karlena Lara-Otero, Meghan Mckenna, Janelle Villiers, Monty Mykolas Worthington and Anya Prince

Journal of genetic counseling, Vol.32(1), pp.18-30

02/2023

DOI: 10.1002/jgc4.1638

PMCID: PMC10092710

PMID: 36260514

Appears in UI Libraries Support Open Access

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Published (Version of record)CC BY-NC V4.0, Open Access

Abstract

The process of interpreting genetic variants, in which experts use all available evidence to determine whether an identified variant is associated with a current or future disease, is both scientific and nevertheless subjective. In this paper, we summarize the existing evidence that any given variant could be reclassified and that such a reclassification could lead to harm. Furthermore, the racial gap in genetic databases could lead to a higher likelihood of harm for non-white patients. We also review recent legal analyses indicating it is unlikely that an individual who sues for restitution would be successful, especially in the absence of evidence of lab negligence. We then propose a compensation program for medical genetic tests to ensure that individuals who experience demonstrable harm due to a variant reclassification can be made whole financially. We conclude by discussing outstanding questions that must be answered for such a program to be feasible.

Social Sciences

Biomedical Social Sciences

Genetics & Heredity

Health Care Sciences & Services

Health Policy & Services

Life Sciences & Biomedicine

Science & Technology

Social Sciences, Biomedical

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Details

Title: Subtitle: How should we address the inevitable harms from non-negligent variant reclassification in predictive genetic testing?
Creators: Misha Rashkin - Stanford Health Care
Kerry Kingham - Stanford Health Care
Karlena Lara-Otero - Stanford Hlth Care, 900 Blake Wilbur Dr,4 Floor, Palo Alto, CA 94304 USA
Meghan Mckenna - Stanford Health Care
Janelle Villiers - Sarah Lawrence College
Monty Mykolas Worthington - Stanford University
Anya Prince - University of Iowa
Resource Type: Journal article
Publication Details: Journal of genetic counseling, Vol.32(1), pp.18-30
Publisher: Wiley
DOI: 10.1002/jgc4.1638
PMID: 36260514
PMCID: PMC10092710
ISSN: 1059-7700
eISSN: 1573-3599
Number of pages: 13
Language: English
Electronic publication date: 10/19/2022
Date published: 02/2023
Academic Unit: Law Faculty
Record Identifier: 9984323232002771

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