‘I haven’t met them, I don’t have any trust in them. It just feels like a big unknown’: a qualitative study exploring the determinants of consent to use Human Fertilisation and Embryology Authority registry data in research

OBJECTIVES: To explore why and how fertility patients decide to allow (or deny) the use of personal data held in the Human Fertilisation and Embryology Authority registry for linkage and research. DESIGN: A qualitative study was conducted using in-depth face-to-face interviews and an online survey to garner information on experience and opinions from fertility clinic patients and staff. Verbatim transcripts were analysed using the ‘one sheet of paper’ method to identify themes. SETTING: Women and men were recruited between September 2015 and December 2017, via fertility clinics across England and online advertising, then interviewed at a location convenient to them. PARTICIPANTS: 20 patients and 9 staff were interviewed, 40 patients completed the online survey. RESULTS: Consent for disclosure (CD) forms are completed at a stressful time, when patients often feel overwhelmed; these forms were considered a low priority. Perceptions of benefit (to individuals, to wider society) and harm (misuse of data, impact of disclosure on child) influenced consent. Important themes included: understanding of the forms; trust in those asking, in researchers, in the Human Fertilisation and Embryology Authority (HFEA); and wider attitudes to data use. Issues influencing response, and thus the representativeness of the HFEA data set, were highlighted. CONCLUSIONS: Understanding what is being asked, and trust in those organisations keeping and using personal data, affects individual decisions to consent to disclosure. Patients were influenced by the wider context of infertility, as well as general concerns about data sharing and security. Low consent rates, which vary by clinic and likely also by patients’ characteristics, have adverse implications for research conducted using HFEA data collected after 2008. Public understanding of data use and security is relatively poor; increased public trust in, and awareness of, research based on routine data could improve consent to data use and reduce the risk of bias.