Evidence map›Paper›PMID 23448723›Full record

ArticleGenetics in medicine : official journal of the American College of Medical Genetics2013

Managing incidental genomic findings: legal obligations of clinicians.

Ellen Wright Clayton, Susanne Haga, Patricia Kuszler, Emily Bane, Krysta Shutske, Wylie Burke

Abstract read
In one paragraph

Article in Genetics in medicine : official journal of the American College of Medical Genetics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Is there a duty to recontact in light of new genetic technologies? A systematic review of the literature.Genetics in medicine : official journal of the American College of Medical Genetics · 2015
    Pooled it
  2. Article
  3. GENETIC DUTIES.William and Mary law review · 2020
    Article
  4. Article
  5. Return of Results in Participant-Driven Research: Learning from Transformative Research Models.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020
    Article
  6. From Genetics to Genomics: Facing the Liability Implications in Clinical Care.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020
    Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Research participant interest in primary, secondary, and incidental genomic findings.Genetics in medicine : official journal of the American College of Medical Genetics · 2016
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Patient decisions for disclosure of secondary findings among the first 200 individuals undergoing clinical diagnostic exome sequencing.Genetics in medicine : official journal of the American College of Medical Genetics · 2014
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ellen Wright ClaytonCenter for Biomedical Ethics and Society, Vanderbilt University, Nashville, Tennessee, USA.
Susanne Haga
Patricia Kuszler
Emily Bane
Krysta Shutske
Wylie Burke

Funding

Genomic Health Care and the Medically UnderservedP50HG003374 · NHGRI · UNIVERSITY OF WASHINGTON · PI BURKE, WYLIE G. · 2004 to 2014
$9.8M
Pharmacogenetic Testing: Challenges of Clinical IntegrationR01GM081416 · NIGMS · DUKE UNIVERSITY · PI HAGA, SUSANNE · 2008 to 2018
$4.6M
Vanderbilt Genome Electronic Records ProjectU01HG006378 · NHGRI · VANDERBILT UNIVERSITY · PI RODEN, DAN M · 2011 to 2014
$4.0M
NHGRI NIH HHS 1R21HG00612-01NHGRI NIH HHS P50 HG003374NHGRI NIH HHS U01 HG006378NHGRI NIH HHS U01-HG HG006378NIGMS NIH HHS R01 GM081416NIGMS NIH HHS R01-GM081416-01A1
6 · The paper itself

Abstract

purposeClinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but clinicians' obligations to identify and disclose such findings are a matter of debate. We sought legal cases that could offer insights into clinicians' legal liability.

methodsWe searched for cases in which incidental findings were related to the cause of action, using the search engines WestLaw, WestLaw Next, Lexis, and Lexis Advance.

resultsWe found no case law related to incidental findings from genetic testing but identified eight cases involving incidental findings in medical imaging. These cases suggest that clinicians may face liability for failing to disclose incidental findings that would have offered an opportunity for interventions to improve health outcome, if under the applicable standard of care, they fail to identify or appreciate the significance of the incidental finding or they negligently fail to notify other clinicians and/or the patient of the identified incidental finding. Other cases support liability for failure to refer appropriately to a clinician with greater expertise.

conclusionsClinicians may face liability if they fail to disclose incidental information that could inform interventions to improve health outcome; information lacking clinical actionability is likely to have less import.

Indexed as

DisclosureIncidental FindingsLiability, LegalDiagnostic ImagingExomeGenetic TestingGenomicsHumansPhysiciansStandard of CareUnited States

Identifiers

PMID23448723
PMCPMC3805501

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.