Australian Genomics Health Alliance, Parkville, VIC, Australia.
Murdoch Children's Research Institute, Parkville, VIC, Australia.
Eur J Hum Genet. 2021 Apr;29(4):687-698. doi: 10.1038/s41431-020-00782-w. Epub 2021 Jan 6.
The complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.
参与基因组医学研究的知情同意过程的复杂性是有据可查的。受动态同意增加参与者在决策中的选择和自主权的潜力以及它提供的持续参与机会的启发，我们希望试用动态同意，并为此开发了自己的基于网络的应用程序（网络应用程序），称为 CTRL（控制）。本文介绍了 CTRL 的设计和开发，用于澳大利亚基因组学研究：一个构建证据的卫生服务研究项目，为将基因组医学纳入主流医疗保健提供信息。澳大利亚基因组学汇集了一个多学科团队来开发 CTRL。设计和开发过程考虑了用户体验；安全性和隐私；数据共享方面的国际标准的应用；IT、运营和道德问题。该 CTRL 工具现在提供给研究中的参与者，他们可以使用 CTRL 来更新个人和联系信息；做出同意选择（包括表示对结果的返回和对生物样本、基因组和健康数据的未来研究使用的偏好）；跟踪他们在研究中的进展；完成调查、联系研究人员并访问研究新闻和信息。虽然在基因组研究中实施动态同意仍然存在挑战，但本研究证明了构建此类工具的可行性，并且其持续使用将提供关于动态同意在大规模基因组研究计划中的价值的证据。
