Evidence map›Paper›PMID 29566453›Full record

ArticleAmerican journal of medical genetics. Part C, Seminars in medical genetics2018

Analysis of state laws on informed consent for clinical genetic testing in the era of genomic sequencing.

Kayte Spector-Bagdady, Anya E R Prince, Joon-Ho Yu, Paul S Appelbaum

Abstract read
In one paragraph

Article in American journal of medical genetics. Part C, Seminars in medical genetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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

13 citing papers in PubMed.

  1. Article
  2. Review
  3. Practice Recommendations for Genetic Testing of Ataxias.Annals of clinical and translational neurology · 2025
    Review
  4. Review
  5. Article
  6. The Legal Uncertainties of Sociogenomic Polygenic Scores.Harvard journal of law & technology · 2024
    Article
  7. Review
  8. Review
  9. Informed Consent in the Genomics Era.Cold Spring Harbor perspectives in medicine · 2020
    Review
  10. Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020
    Article
  11. Article
  12. Review
  13. Genetic counselors on the frontline of precision health.American journal of medical genetics. Part C, Seminars in medical genetics · 2018
    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

4 authors.

Kayte Spector-BagdadyDepartment of Obstetrics and Gynecology, Center for Bioethics and Social Sciences in Medicine, University of Michigan Medical School, Ann Arbor, Michigan.ORCID 0000-0002-5851-6224
Anya E R PrinceUniversity of Iowa College of Law, Iowa City, Iowa.
Joon-Ho YuDepartment of Pediatrics, University of Washington School of Medicine, Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington.ORCID 0000-0002-9635-8618
Paul S AppelbaumCenter for Law, Ethics and Psychiatry, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.

Funding

Sequencing, Analysis, and Interpretation of SequencingUM1HG006508 · NHGRI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CHINNAIYAN, ARUL M, PIENTA, KENNETH J. · 2013 to 2016
$7.8M
Center for Research on the Ethical, Legal and Social Implications of Psychiatric, Neurologic and Behavioral GeneticsP50HG007257 · NHGRI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI APPELBAUM, PAUL STUART · 2013 to 2017
$5.4M
Impact of return of incidental genetic test results to research participants in tR01HG006600 · NHGRI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI CHUNG, WENDY K, PHELAN, JO C · 2011 to 2013
$2.1M
Returning Exome and Whole Genome Sequencing Results R00HG007076 · NHGRI · UNIVERSITY OF WASHINGTON · PI YU, JOON-HO · 2017 to 2019
$730k
Use of Genetic Information by Life, Long-term Care, and Disability InsurersR00HG008819 · NHGRI · UNIVERSITY OF IOWA · PI PRINCE, ANYA E.R. · 2017 to 2019
$728k
Challenges of Informed Consent in Return of Data from Genomic ResearchR21HG006596 · NHGRI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI APPELBAUM, PAUL STUART · 2011 to 2012
$400k
Use of Genetic Information by Life, Long-term Care, and Disability Insurers: Exploring International Lessons, the Domestic Legal Landscape, and Options for U.S. PolicyK99HG008819 · NHGRI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PRINCE, ANYA E.R. · 2015 to 2016
$182k
NHGRI NIH HHS K99 HG008819NHGRI NIH HHS P50 HG007257NHGRI NIH HHS R00 HG007076NHGRI NIH HHS R00 HG008819NHGRI NIH HHS R01 HG006600NHGRI NIH HHS R21 HG006596NHGRI NIH HHS UM1 HG006508
6 · The paper itself

Abstract

This article assesses the adequacy of informed consent to clinical genetic testing laws based on an examination of 15 states with institutions that had been involved in a National Institutes of Health-supported Clinical Sequencing Exploratory Research Consortium project. We identified relevant statutory provisions through a legal search engine and included statutes that describe the informed consent requirements for clinical genetic testing and/or the protections for genetic material, information, or data. We found that statutory definitions were often limited in problematic ways, such as focusing only on variants known to be associated with disease or negative health effects or associated with asymptomatic disease. Some statutes required complex levels of detail if applied to genomic technologies and set confusing disclosure standards for current use and future access. Others had exceptions from informed consent requirements for future research use, limited requirements for the destruction of specimens as opposed to derived data, or linked key definitional components to the evolving concept of "identifiability." Further reform and research are needed to ensure that state law protections advance as rapidly as the science they aspire to enable.

Indexed as

Genetic Predisposition to DiseaseGenetic TestingHuman GeneticsHumansInformed ConsentUnited Statesgenetic counselingidentifiabilityinformed consentlawpolicy

Identifiers

PMID29566453
PMCPMC5994926

What OpenQuestion holds

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Read underepoch 390

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.