A practical checklist for return of results from genomic research in the European context

European Journal of Human Genetics 1:1-9 (2023)
  Copy   BIBTEX

Abstract

An increasing number of European research projects return, or plan to return, individual genomic research results (IRR) to participants. While data access is a data subject’s right under the General Data Protection Regulation (GDPR), and many legal and ethical guidelines allow or require participants to receive personal data generated in research, the practice of returning results is not straightforward and raises several practical and ethical issues. Existing guidelines focusing on return of IRR are mostly project-specific, only discuss which results to return, or were developed outside Europe. To address this gap, we analysed existing normative documents identified online using inductive content analysis. We used this analysis to develop a checklist of steps to assist European researchers considering whether to return IRR to participants. We then sought feedback on the checklist from an interdisciplinary panel of European experts (clinicians, clinical researchers, population-based researchers, biobank managers, ethicists, lawyers and policy makers) to refine the checklist. The checklist outlines seven major components researchers should consider when determining whether, and how, to return results to adult research participants: 1) Decide which results to return; 2) Develop a plan for return of results; 3) Obtain participant informed consent; 4) Collect and analyse data; 5) Confirm results; 6) Disclose research results; 7) Follow-up and monitor. Our checklist provides a clear outline of the steps European researchers can follow to develop ethical and sustainable result return pathways within their own research projects. Further legal analysis is required to ensure this checklist complies with relevant domestic laws.

Links

PhilArchive

External links

  • This entry has no external links. Add one.
Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

The Return of Results of Deceased Research Participants.Anne Marie Tassé - 2011 - Journal of Law, Medicine and Ethics 39 (4):621-630.
Understanding Incidental Findings in the Context of Genetics and Genomics.Mildred K. Cho - 2008 - Journal of Law, Medicine and Ethics 36 (2):280-285.
The Return of Results of Deceased Research Participants.Anne Marie Tassé - 2011 - Journal of Law, Medicine and Ethics 39 (4):621-630.

Analytics

Added to PP
2023-03-27

Downloads
135 (#132,116)

6 months
73 (#58,210)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Signe Mezinska
University of Latvia

Citations of this work

No citations found.

Add more citations

References found in this work

No references found.

Add more references