Policy on Clinically Actionable Genomic Research Results

Provides guidance on establishing policies for returning genomic results to research participants

There are potential medical benefits to the millions of individuals who are participating in genomics research. If identified genetic risks can be treated in the clinic, such knowledge could be life-changing. But many research programmes lack clear guidance on if, when, and how to return clinically actionable genomic results to their participants in an ethical manner. Developed by the GA4GH Regulatory & Ethics Work Stream (REWS), the Policy on Clinically Actionable Genomic Research Results provides guidance on establishing custom return-of-results policies.

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Benefits

  • Provides actionable strategies for developing return of results policies
  • Acknowledges the differing levels of evidence behind the clinical utility of actionable genomic research results, and the complexities involved in returning such information to individuals in an ethically and legally appropriate manner

Target users

Researchers, and clinicians

Image summary: This framework helps data sharing initiatives develop ethical policies for returning genomics results to research participapnts.
THEME
CATEGORY
TYPE
STATUS
Work Stream
LATEST VERSION
v1.0
Product Leads
  • Anna Lewis
  • Robert Green
Staff Contact

Community resources

Dive deeper into this product! Responsible disclosure of clinically actionable genomic findings to research participants who have chosen to receive them can advance data sharing and benefit the research participants themselves. Achieving transparency at all stages of data sharing for all relevant parties helps motivate the move towards a clear minimum global standard with regards to the return of results. The Policy on Clinically Actionable Genomic Research Results provides guidance on establishing return of results policies that can be customised to different contexts or unique settings. The guidance emphasises the need to prepare a clear, concise protocol for returning results at the start of a project, establish funding and resources to ensure accountability, develop return of results policies with local clinical standards in mind, effectively engage participants with strategies shared in the GA4GH Engagement Framework, make tools, protocols, and resources available to other study designers to promote collaboration, and engage funders to support the return of results.


Don't see your name? Get in touch:

  • Yvonne Bombard
    University of Toronto, Unity Health Toronto
  • Subhashini Chandrasekharan
    National Institutes of Health (NIH)
  • Shu Hui Chen
    NIH National Heart, Lung, and Blood Institute (NHLBI)
  • Aida Beatriz Falcon de Vargas
    Hospital Vargas de Caracas
  • Clara Gaff
    Melbourne Genomics Health Alliance
  • Robert Green
    Broad Institute of MIT and Harvard, Harvard Medical School, Mass General Brigham
  • Shona Kerr
    MRC Human Genetics Unit
  • Anna Lewis
    Harvard University
  • Richard Milne
    Wellcome Connecting Science, Wellcome Genome Campus
  • Christine Patch
    Wellcome Connecting Science, Wellcome Genome Campus
  • Pedro Rondot Radío
    Angel H. Roffo Institute of Oncology
  • Amanda Spurdle
    QIMR Berghofer Medical Research Institute
  • Adrian Thorogood
    Terry Fox Research Institute
  • Danya Vears
    Murdoch Children's Research Institute
  • Eva Winkler
    German Cancer Research Center (DKFZ) / National Center for Tumor Diseases (NCT)

News, events, and more

Catch up with all news and articles associated with Policy on Clinically Actionable Genomic Research Results.

Doctor showing patient their returned data
23 May 2023
Public Attitudes for Genomic Policy Brief: return of research results
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11 Feb 2022
An international framework for returning clinically actionable genomic results to research participants
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8 Jul 2021
GA4GH standards in a global learning health system
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