Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Jun;14(3):241-8.
doi: 10.1089/bio.2015.0115. Epub 2016 Apr 15.

Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?

Isabelle Budin-Ljøsne  1   2 , Deborah Mascalzoni  3   4 , Sirpa Soini  5 , Helena Machado  6 , Jane Kaye  7 , Heidi Beate Bentzen  1   2   8 , Emmanuelle Rial-Sebbag  9 , Flavio D'Abramo  10 , Michał Witt  11 , Geneviève Schamps  12 , Višnja Katić  13 , Dusanca Krajnovic  14 , Jennifer R Harris  15
Affiliations

Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?

Isabelle Budin-Ljøsne et al. Biopreserv Biobank. 2016 Jun.

Abstract

Background: There is growing consensus that individual genetic research results that are scientifically robust, analytically valid, and clinically actionable should be offered to research participants. However, the general practice in European research projects is that results are usually not provided to research participants for many reasons. This article reports on the views of European experts and scholars who are members of the European COST Action CHIP ME IS1303 (Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives) regarding challenges to the feedback of individual genetic results to research participants in Europe and potential strategies to address these challenges.

Materials and methods: A consultation of the COST Action members was conducted through an email survey and a workshop. The results from the consultation were analyzed following a conventional content analysis approach.

Results: Legal frameworks, professional guidelines, and financial, organizational, and human resources to support the feedback of results are largely missing in Europe. Necessary steps to facilitate the feedback process include clarifying legal requirements to the feedback of results, developing harmonized European best practices, promoting interdisciplinary and cross-institutional collaboration, designing educational programs and cost-efficient IT-based platforms, involving research ethics committees, and documenting the health benefits and risks of the feedback process.

Conclusions: Coordinated efforts at pan-European level are needed to enable equitable, scientifically sound, and socially robust feedback of results to research participants.

PubMed Disclaimer

References

    1. Bredenoord AL, Kroes HY, Cuppen E, et al. . Disclosure of individual genetic data to research participants: The debate reconsidered. Trends Genet 2011;27:41–47 - PubMed
    1. Wolf SM. Return of individual research results and incidental findings: Facing the challenges of translational science. Annu Rev Genomics Hum Genet 2013;14:557–577 - PMC - PubMed
    1. Knoppers BM, Zawati MH, Senecal K. Return of genetic testing results in the era of whole-genome sequencing. Nat Rev Genet 2015;16:553–559 - PubMed
    1. Shkedi-Rafid S, Dheensa S, Crawford G, et al. . Defining and managing incidental findings in genetic and genomic practice. J Med Genet 2014;51:715–723 - PubMed
    1. van El CG, Cornel MC, Borry P, et al. . Whole-genome sequencing in health care. Recommendations of the European Society of Human Genetics. Eur J Hum Genet 2013;21(Suppl 1):S1–S5 - PMC - PubMed

MeSH terms

LinkOut - more resources