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‘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
  1. Claire Carson1,
  2. Lisa Hinton2,
  3. Jenny Kurinczuk1,
  4. Maria Quigley1
  1. 1 National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK
  2. 2 Health Experiences Research Group, Department of Primary Health Care Sciences, Oxford University, Oxford, UK
  1. Correspondence to Dr Claire Carson; claire.carson{at}npeu.ox.ac.uk

Abstract

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.

  • data sharing
  • record linkage
  • consent
  • fertility
  • assisted reproductive technologies

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Contributors The ‘Taking pART’ study was conceived and designed by CC (Principal Investigator), with input from JK, LH and MQ. CC and LH developed the interview strategy, CC conducted all interviews, CC and LH reviewed transcripts, and analysed the findings. CC drafted the manuscript with inputs from all authors.

  • Funding This study was funded by the Medical Research Council (UK) as part of a Career Development Award to CC (ref: MR/L019671/1). CC (as lead author) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

  • Competing interests None declared.

  • Ethics approval Ethical approval for the study was granted by London City & East Research Ethics Committee (15/LO/1305) and local site R&D with oversight for the NHS clinics.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The signed consent allows the use of interview transcripts for this study, but not for further sharing. As such transcripts are not currently available for secondary use.

  • Patient consent for publication Not required.

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