Cancer incidence and mortality in women treated for subfertility
Research type
Research Study
Full title
Cancer incidence and mortality in a cohort of women treated for subfertility in Oxfordshire and West Berkshire
IRAS ID
313490
Contact name
Michael Francis Grant Murphy
Contact email
Sponsor organisation
University of Oxford/ Research Governance, Ethics and assurance
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This long-running study's main aim has been to examine whether some women, who had difficulty getting pregnant, were at altered risk of some cancers that may be influenced by the underlining causes of their subfertility, (particularly hormone disorders) or the medical treatments they may have received for it. It has had 2 phases.
Phase 1 was supported by 2 relevant Research Ethics Committees (RECS) and all the local Clinicians. Between 1991 and 2013. we extracted information from the hospital infertility clinic case notes and linked the individual records of about 7000 women attending there, in the 1970s/1980s, to their own national records of migration, death and cancer occurrence. There was no direct contact between the research team and the women, so we did not ask individuals if it was OK to do this. No new data have been collected since 2013, and since then the 7000 women's data have been stored securely and not examined. However, analysing those data could still be relevant to assessing some risks that might be associated with modern subfertility treatments.
In 2022, Phase 2 of the study began after a gap of 8 years. Because of changes to the Law, this has required us to seek fresh Regulatory Approval to continue the research (without collecting any new data) from a new REC and from the national Confidentiality Advisory Group (CAG) which advises the NHS Health Research Authority (for England). We are now asking REC and CAG for their permission to approach NHS Digital (NHSD) who now "own" all the data we have assembled on the women, in order to negotiate a fresh Data Sharing Agreement (DSA) between the research team and NHSD. this new DSA would ensure that we can resume further safe, legal processing, analysis and publication of the results from the data collected up to 2013.REC name
Wales REC 6
REC reference
22/WA/0136
Date of REC Opinion
8 Sep 2022
REC opinion
Further Information Favourable Opinion