Sharing data for future research'engaging participants' views about data governance beyond the original project: a DIRECT Study

Abstract

Biomedical data governance strategies should ensure that data are collected, stored, and used ethically and lawfully. However, research participants' preferences for how data should be governed is least studied. The DIRECT project collected substantial amounts of health and genetic information from patients at risk of, and with Type II Diabetes. We conducted a survey to understand participants' future data governance preferences. Results will inform the post-project data governance strategy. Methods A survey was distributed in Denmark, Sweden, The Netherlands, and UK. Results In total 855 surveys were returned. Ninety-seven percent were supportive of sharing data post-project, and 90% were happy to share data with universities, and 56% with commercial companies. The top 3 priorities for data sharing were: highly secure database, DIRECT researchers to monitor data used by other researchers, and researchers cannot identify participants. Respondents frequently suggested that a post-project Data Access Committee should involve: a DIRECT researcher, Diabetes clinician, patient representative, and a DIRECT participant. Conclusion Preferences of how data should be governed, and what data could be shared and with whom varied between countries. Researchers are considered as key custodians of 2 participant data. Engaging participants aids in designing governance to support their choices.

Patients’ and public views and attitudes towards the sharing of health data for research: a narrative review of the empirical evidence

“…Re-use of data for purposes that participants do not agree on 30 Distrust of the government as an oversight body for genetic research data 35 Risks are mitigated 15 90% were supportive to share data with universities postproject 36 Maximising the value of resources 14…”

“…Highly secure database 30 36 56% were supportive to share data with commercial companies postproject 36 Reducing waste in research 30 Stigmatisation or repercussions 15…”

“…Postproject Data Access Committee should involve a researcher from the original research project, a clinician, patient representative, and a participant in the original study 36 Fear of exploitation 15 Reputation of and trust in research organisation 35 Data access agreements 30 Willingness lower when pharmaceutical companies had access to data 11…”

Towards a Paradigm Shift in Governing Data Access and Related Intellectual Property Rights in Big Data and Health-Related Research

“…49 40 46 Vayena and Blasimme (2017), p. 504. 47 Merson et al (2015), p. 256; see also study by Shah et al (2018), which established that for unknown reasons European research participants prefer to share data with universities and are least happy to share with commercial companies. 48 Denny et al (2015), p. 297.…”

"Who is Watching the Watchdog?": Ethical Perspectives of Sharing Health-related Data for Precision Medicine in Singapore

“…24 Second, much of the existing literature investigates patient and public preferences about data sharing and patient control of data access and use. 25,26,27,28,29,30 This focus on preferences is arguably misdirected. Taylor and Taylor found that people under some circumstances were still willing to accept "non-preferred" data sharing models.…”