\u2018CTRL\u2019: an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research

Matilda A Haas,Miranda E Vidgen,Jane Kaye,Gabi Ceregra,David Bunker,Megan Prictor,Harriet Teare,Tiffany Boughtwood

doi:10.1038/s41431-020-00782-w

Abstract

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.

Highlights

Research in genomic medicine creates new and unique challenges for the informed consent process [1, 2]
Law School, University of Melbourne, Carlton, VIC, Australia 5 Curve Tomorrow, Melbourne, VIC, Australia 6 QIMR Berghofer Medical Research Institute, Herston, QLD, Australia 7 Queensland Genomics Health Alliance, Herston, QLD, Australia must cover the potential for unexpected findings, family implications, health information privacy and data sharing for further research
Group members agreed that the website must be mobile and tablet device responsive, and that consent to future data use should be based on the GA4GH Data Use Ontology (DUO)

Summary

Introduction

Research in genomic medicine creates new and unique challenges for the informed consent process [1, 2]. Law School, University of Melbourne, Carlton, VIC, Australia 5 Curve Tomorrow, Melbourne, VIC, Australia 6 QIMR Berghofer Medical Research Institute, Herston, QLD, Australia 7 Queensland Genomics Health Alliance, Herston, QLD, Australia must cover the potential for unexpected findings, family implications, health information privacy and data sharing for further research. Given this complexity, genomic research information and consent forms can be very long. Broad consent to future use of research participant data has often been used in established genomic research programs [5]. Some participants may risk missing out on the benefits of research opportunities if they are not willing to agree to broad future use [7]

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Discussion

Conclusion