Biomedical Ethics Research Group, Murdoch Children's Research Institute, Parkville, VIC, 3052, Australia.
University of Melbourne, Parkville, VIC, 3052, Australia.
Eur J Hum Genet. 2023 Jun;31(6):687-695. doi: 10.1038/s41431-023-01328-6. Epub 2023 Mar 22.
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.
越来越多的欧洲研究项目正在或计划向参与者返还个体基因组研究结果 (IRR)。虽然根据《通用数据保护条例》(GDPR)，数据访问是数据主体的权利，并且许多法律和伦理准则允许或要求参与者接收在研究中生成的个人数据，但返还结果的实践并不简单，并且引发了一些实际和伦理问题。现有的重点关注返还 IRR 的准则大多是针对特定项目的，仅讨论了要返还哪些结果，或者是在欧洲以外制定的。为了解决这一差距，我们使用归纳内容分析法在线分析了现有的规范性文件。我们使用此分析结果制定了一份检查表，以协助考虑是否向参与者返还 IRR 的欧洲研究人员。然后，我们向一组来自欧洲的跨学科专家（临床医生、临床研究人员、基于人群的研究人员、生物库管理人员、伦理学家、律师和政策制定者）征求了对检查表的反馈意见，以完善检查表。该检查表概述了研究人员在确定是否以及如何向成年研究参与者返还结果时应考虑的七个主要部分：1) 决定返还哪些结果；2) 制定返还结果的计划；3) 获得参与者的知情同意；4) 收集和分析数据；5) 确认结果；6) 披露研究结果；7) 随访和监测。我们的检查表为欧洲研究人员提供了一个清晰的框架，用于在其自己的研究项目中制定符合伦理和可持续性的结果返还途径。需要进一步的法律分析以确保此检查表符合相关国内法律。
