Taking pART: How people decide to consent for fertility research
Research type
Research Study
Full title
Taking pART: Understanding how patients decide whether to consent to the use of fertility data for research - A qualitative study of patients undergoing treatment and the staff who explain consent procedures
IRAS ID
173379
Contact name
C Carson
Contact email
Duration of Study in the UK
1 years, 0 months, 29 days
Research summary
The UK has compulsory reporting of all fertility treatment, and of all infants born after Assisted Reproductive Technologies (ART) such as IVF. Since 1991 the Human Fertility and Embryology Authority (HFEA) has regulated ART in the UK, and maintains a central register. This is a rich, though under-exploited, resource for research into the safety and consequences for the health of women and their children born through ART. However, although data on all ART cycles are collected by the HFEA, a more limited dataset is available for research. Since 1st October 2009, patients have been asked for consent for data about their treatment to be used for research, whether use of patient identifiers for linkage to other datasets is permissible, and whether they agree to be contacted for future research projects (potentially requiring face-to-face contact). Where applicable, both partners must complete the consent forms although they can agree to different things. Consent rates remain below 50% despite efforts to improve participation. The impact on the validity of research conducted using HFEA data collected after 2009 is unknown, but there are concerns that research using the data may produce biased (misleading) findings.
This qualitative study will gather, explore and compare the experiences of people who have received fertility treatment in England and who had to make the decision to allow, or not, their data to be used in research. Clinic staff who discuss consent with patients will also be included. Approximately 40 participants will be recruited from a number of sources including fertility clinics, online fora and support groups. They will each be interviwed in person, and interviews will be audio-recorded. We will focus on what underpins the decision making around consent for research in infertility, to better understand how patients make this choice.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1305
Date of REC Opinion
20 Jul 2015
REC opinion
Favourable Opinion