Evidence map›Paper›PMID 28858330›Full record

ArticleGenetics in medicine : official journal of the American College of Medical Genetics2018

Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.

Susan M Wolf, Laura M Amendola, Jonathan S Berg, Wendy K Chung, Ellen Wright Clayton, Robert C Green, Julie Harris-Wai, Gail E Henderson, Gail P Jarvik, Barbara A Koenig and 6 more

Abstract read
In one paragraph

Article in Genetics in medicine : official journal of the American College of Medical Genetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing 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

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

  1. Pooled it
  2. Trial
  3. Covering medical care costs for participants in the eMERGE Network: Challenges for equity and implementation.Genetics in medicine : official journal of the American College of Medical Genetics · 2025
    Article
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  5. Far from Home: Managing Incidental Findings in Field Research with Portable MRI.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2024
    Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Participant choices for return of genomic results in the eMERGE Network.Genetics in medicine : official journal of the American College of Medical Genetics · 2020
    Article
  16. Article
  17. 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
  18. 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
  19. Review
  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

16 authors.

Susan M WolfLaw School; Medical School; Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota, Minneapolis, Minnesota, USA.
Laura M AmendolaMedical Genetics, Department of Medicine, University of Washington, Seattle, Washington, USA.
Jonathan S BergDepartments of Genetics and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Wendy K ChungDepartments of Pediatrics and Medicine, Columbia University, New York, New York, USA.
Ellen Wright ClaytonCenter for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Robert C GreenGenetics, Department of Medicine, Brigham and Women's Hospital, Broad Institute and Harvard Medical School, Boston, Massachusetts, USA.
Julie Harris-WaiInstitute for Health and Aging, University of California-San Francisco; Division of Research, Kaiser Permanente Northern California, San Francisco, California, USA.
Gail E HendersonDepartment of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Gail P JarvikMedical Genetics, Department of Medicine, University of Washington, Seattle, Washington, USA.
Barbara A KoenigProgram in Bioethics, Institute for Health and Aging, University of California-San Francisco, San Francisco, California, USA.
Lisa Soleymani LehmannVeterans Administration National Center for Ethics in Health Care, Washington, DC, USA.
Amy L McGuireCenter for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.
Pearl O'RourkeHuman Research Affairs, Partners HealthCare, Boston, Massachusetts, USA.
Carol SomkinDivision of Research, Kaiser Permanente Northern California, Oakland, California, USA.
Benjamin S WilfondTreuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital, Department of Pediatrics, University of Washington, Seattle, Washington, USA.
Wylie BurkeMedical Genetics, Department of Medicine, University of Washington, Seattle, Washington, USA.

Funding

North Carolina Clinical Genomic Evaluation by Next-gen Exome Sequencing 2U01HG006487 · NHGRI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BERG, JONATHAN S, POWELL, BRADFORD C. · 2012 to 2021
$22.7M
Measuring Perceptions of Utility of Clinical Genome Sequencing: Instrument Testing and ValidationU01HG006485 · NHGRI · BAYLOR COLLEGE OF MEDICINE · PI MCGUIRE, AMY L, PARSONS, DONALD W. · 2012 to 2021
$22.1M
University of Washington Biomedical Informatics and Data Science Research Training ProgramT15LM007442 · NLM · UNIVERSITY OF WASHINGTON · PI JOHN H. GENNARI, Andrea L. Hartzler · 2002 to 2026
$19.6M
Exome sequencing in Diverse Populations in Colorado & OregonU01HG007292 · NHGRI · KAISER FOUNDATION RESEARCH INSTITUTE · PI LEO, MICHAEL C, WILFOND, BENJAMIN SIMON · 2017 to 2021
$15.7M
Integration of Whole Genome Sequencing into Clinical MedicineU01HG006500 · NHGRI · BRIGHAM AND WOMEN'S HOSPITAL · PI GREEN, ROBERT C. · 2012 to 2016
$11.5M
Clinical sequencing in cancer: Clinical ethical and technological studiesU01HG006507 · NHGRI · UNIVERSITY OF WASHINGTON · PI JARVIK, GAIL PAIRITZ · 2012 to 2016
$10.6M
Clinical Implementation of Carrier Testing using NGSUM1HG007292 · NHGRI · KAISER FOUNDATION RESEARCH INSTITUTE · PI GODDARD, KATRINA A., WILFOND, BENJAMIN SIMON · 2013 to 2016
$8.2M
Evolving Our Partnership: The CSER2 Centralized Support Coordinating CenterU24HG007307 · NHGRI · UNIVERSITY OF WASHINGTON · PI FULLERTON, STEPHANIE MALIA, JARVIK, GAIL PAIRITZ · 2017 to 2021
$5.8M
CSER RoRC Centralized Support Coordinating CenterU01HG007307 · NHGRI · UNIVERSITY OF WASHINGTON · PI BURKE, WYLIE G., JARVIK, GAIL PAIRITZ · 2013 to 2016
$3.6M
Disclosing Genomic Incidental Findings in a Cancer Biobank: An ELSI ExperimentR01CA154517 · NCI · MAYO CLINIC ROCHESTER · PI KOENIG, BARBARA A., PETERSEN, GLORIA M. · 2011 to 2015
$2.7M
LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical ApplicationR01HG008605 · NHGRI · UNIVERSITY OF MINNESOTA · PI CLAYTON, ELLEN WRIGHT, LAWRENZ, FRANCES PATRICIA · 2016 to 2018
$2.2M
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
NCI NIH HHS R01 CA154517NHGRI NIH HHS P20 HG007243NHGRI NIH HHS R01 HG006600NHGRI NIH HHS R01 HG008605NHGRI NIH HHS U01 HG006485NHGRI NIH HHS U01 HG006487NHGRI NIH HHS U01 HG006500NHGRI NIH HHS U01 HG006507NHGRI NIH HHS U01 HG007292NHGRI NIH HHS U01 HG007307NHGRI NIH HHS U24 HG007307NHGRI NIH HHS UM1 HG007292NLM NIH HHS T15 LM007442
6 · The paper itself

Abstract

PurposeThe Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health-funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research-clinical interface.MethodsA CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research-clinical interface.ResultsSurvey responses described how studies approached the research-clinical interface, including in consent practices, recording results, and using a research versus clinical laboratory. Responses revealed four characterizations of the interface: clear separation between research and clinical care, interdigitation of the two with steps to maintain separation, a dynamic interface, and merging of the two. All survey respondents utilized at least two different characterizations. Although research has traditionally been differentiated from clinical care, respondents pointed to factors blurring the distinction and strategies to differentiate the domains.ConclusionThese results illustrate the difficulty in applying the traditional bifurcation of research versus clinical care to translational models of clinical research, including in genomics. Our results suggest new directions for ethics and oversight.

Indexed as

Biomedical ResearchGenomicsTranslational Research, BiomedicalDisclosureElectronic Health RecordsHealth PersonnelHumansInformed ConsentNational Institutes of Health (U.S.)Surveys and QuestionnairesUnited States

Identifiers

PMID28858330
PMCPMC5832495

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.