The ethical and legal framework for a Genomics England and Sano Genetics participant engagement platform
Commissioned by Genomics England, our new report examines the legal and ethical implications of an online platform for patient engagement in precision medicine research being developed by Sano Genetics
Our report, commissioned by Genomics England, examines the legal and ethical implications of an online platform for patient engagement in precision medicine research being developed by Sano Genetics.
In May 2020, Genomics England announced that it was collaborating with precision medicine research start-up Sano Genetics and data management firm Zetta Genomics to develop a platform that would allow rare disease patients and their caregivers to add vital additional information about their health and wellbeing to research databases.
The platform, which is being funded through a grant from Innovate UK, is being designed to add a vital layer of patient-derived information to the ground-breaking research being carried out through Genomics England. The platform will lay the groundwork for better capturing additional data directly from patients and their families to learn about disease progression and treatment effectiveness from their perspective. Collecting information about health and wellbeing directly from patients will help fill in the blanks between infrequent doctor visits.
In addition to a separate internal assessment being carried out by Genomics England, the PHG Foundation report has assessed the impact of the platform’s features and applications on patients. It has found that the system potentially offers opportunities to enrich existing datasets, such as those held within Genomics England’s National Genomic Research Library, and will also help enhance engagement with patients undergoing treatment.
The report recommends support for patients who may be less digitally literate and includes considerations for policymakers. It also suggests that clarity, personalisation and engagement with patients could provide a blueprint for realising the promise of the technology, while minimising potential harm.
Rakhi Rajani, Chief Digital Officer at Genomics England said: "Co-creating an innovative and intuitive platform alongside participants is crucial for engaging them in medical research. No one knows what patients and their caregivers need more than they do themselves, so we must create solutions together, using collaborative methods. Patients are at the heart of our work at Genomics England, and we are committed to ensuring our participants and their data are protected.
“The PHG Foundation’s report is an encouraging assessment that assures us the platform will help accelerate precision medicine research while ensuring that the highest levels of data security and integrity are met along the way.”
CEO and co-founder of Sano Genetics, Dr Patrick Short, comments: “In the world of precision medicine research, the participant, once they’ve contributed their data, often gets very little direct benefit. There has long been little to no incentive, and plenty of hassle, to take part in a study that might change the state of play for sufferers of a chronic or rare disease in 10 to 15 years’ time. That’s just an unacceptably long timeframe for improving lives.
“A thoughtfully designed participant engagement platform that offers users total transparency around how their data is used, coupled with a superb user experience, is long overdue but it’s critical that we get the framework right the first time so it’s right that it be subjected to rigorous external scrutiny by independent bodies, especially in the development phase. The PHG Foundation’s assessment of the legality and ethics of what we’re doing provides us with a robust blueprint that will be fundamental in our ongoing product development.”
Authors: Colin Mitchell, Tanya Brigden and Alison Hall