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

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.

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“…10 Additionally, there are important ethico-legal considerations, which include the participant's right of access to their personal data, the participant's right to know and right not to know, and the researchers' duty of care. 23 The challenge of disclosing individual genetic findings to research participants presents both opportunities and risks, necessitating thoughtful consideration. Disclosing individual genetic research results can have direct benefits to participants, such as modifying medical management and providing more information regarding diagnosis and prognosis as well as opportunities for participation in clinical trials.…”

Assessment of the Needs of Nephrology Divisions to Implement Return of Clinically Significant Research Genetic Results: A Survey of Nephrotic Syndrome Study Network (NEPTUNE) Investigators

“…The need for return of research genetic results, as well as its challenges, have been similarly addressed globally. A panel of European experts in genetics and public health recently outlined the steps required for effective return of results, including determining which results to return and making a plan for how to disclose results [ 10 ]. They also acknowledge the challenges of accessing the extensive resources required for return of results and finding genetics-trained providers [ 10 ].…”

“…A panel of European experts in genetics and public health recently outlined the steps required for effective return of results, including determining which results to return and making a plan for how to disclose results [ 10 ]. They also acknowledge the challenges of accessing the extensive resources required for return of results and finding genetics-trained providers [ 10 ]. These findings are supported by a survey of psychiatrists worldwide about return of results, in which only 14% felt there are adequate guidelines for return of results and 59% felt their own knowledge about how to manage return of results was poor [ 11 ].…”