Dr Michael Murphy- Requirement to publicise a study
This study may be of interest to YOU (or people you know).This is a Privacy Notice about the ways in which clinical data from the 1970s/1980s may have been used, without explicit consent of the women involved, in a specific University of Oxford study: “Cancer incidence and mortality in a cohort of women treated for subfertility in Oxfordshire and West Berkshire”.
SUMMARY
This long running study has had 2 Phases. The main question has always been : “Are women who had drug treatment to help them get pregnant, because of underlying medical conditions, at higher risk of developing some cancers that may be linked to lower fertility”. Some of the drugs used in the 1970s/1980s to assist with getting pregnant are still used today, though treatment for subfertility is now dominated by use of Assisted Reproductive Technology (ART). Women living with reduced fertility often take longer to become pregnant than others. Some of the medical causes of this may also affect the balance of female hormones, such as Oestrogen and Progesterone. So these medical conditions, that affect the speed of getting pregnant, may also affect a woman’s risk of some cancers.
Phase 1 of the study ran from 1991 to 2013. We collected data from hospital infertility clinic notes of about 7000 women who had problems getting pregnant in the 1970s/1980s in Oxfordshire and West Berkshire (Ox/WB). We linked these data to their national records of migration, death and cancer in the 7000 women. The research team did not have any contact with the women and we did not ask individual women if it was OK with them to store their data and study it. The Research Ethics Committees (RECs) of Ox/WB and a Clinical Advisory Group made sure that we protected patient privacy and that the data we collected were stored safely. We now need to look at this information because it may still be helpful in understanding present-day disease risks.
Phase 2 started in 2022, at the Nuffield Department of Women’s and Reproductive Health (NDWRH). We have had to seek new approvals to continue our research from another REC, and the national Confidentiality Advisory Group (CAG). These committees advised us on our use of confidential patient information in research. The data we collected to 2013 are now owned by NHS Digital (NHSD). They collect, store and analyse national health data for England. We have been working with NHSD to reach a new legal agreement so that we can continue in the coming months to safely process and analyse the data we collected up to 2013. We will not be collecting any new data about the 7000 women.
THANKYOU FOR READING THIS SUMMARY. More information about the study is available below, or from Dr Michael Murphy (Chief Investigator):
Email: Michael.murphy@retired.ox.ac.uk or Telephone 01865 872984. You can also read this full document at: https://www.wrh.ox.ac.uk/ABOUT/DATA-PRIVACY-NOTICE.
BACKGROUND.
Exposure to hormones during a woman’s life may be linked to risk of some female cancers, such as breast, ovarian, womb, and cervix. This exposure can be measured by the age when periods start, pregnancy history and age when menopause begins. The use of oral contraceptives and hormone replacement therapy may be also important. We would like to find out if medical conditions linked to lower fertility, and/or the drugs used to help women get pregnant, change the risk of a woman developing some cancers later in life. The drugs used to help women release eggs for fertilisation have been in use since the late 1960s. Other treatments for infertility, including in vitro fertilisation, and sperm injections into the egg, now known collectively as “Assisted Reproductive Technology” (ART), became more common from the 1980s onwards. But some of the same drugs used 50 years ago are still used today to help women get pregnant. We still don’t know how these drugs, or the medical conditions which can reduce a woman’s fertility, affect subsequent cancer risk
HISTORY.
Phase 1 of the present study began in 1992 with a grant from the Medical Research Council. The Oxfordshire/West Berkshire Research Ethics Committees (RECs) agreed that the study team could look at patient data from women who were having drug treatment to help them get pregnant. The team included specialist doctors who helped women who were having problems having a baby. Data about fertility problems, drug treatment, pregnancy and general health was collected from 7000 women in their care from 1970-1989. Most of these women became pregnant after taking drugs which helped them release eggs, and many healthy babies were subsequently born. The ART records of a few hundred women enrolled in the cohort and treated at the John Radcliffe from about 1985 were not accessed for this study. However, there was no direct contact with the women by the research team and no individual consent from the 7000 women was sought at the time about the use of their records.
From 1992 we were allowed to follow the long term health of the women. This included information on cancer diagnosis, mortality, and whether still under NHS care. We did this using information obtained from the hospital records about the women’s forenames and initials, surnames at birth and thereafter, and date-of-birth. These long term follow-up events were recorded for the 7000 women in the study until April 2013 when the study closed. The data have been held securely, unprocessed and unanalysed since then, until 2022.
Phase 2 of this research began in 2022. We are in the process of asking NHS digital if we can again access and analyse the data collected up to 2013. The main aim remains to find out if the risk of some cancers is altered by the causes of the woman’s subfertility and/or the types of drug treatment she was given for it. We are particularly interested in those cancers linked to hormones, such as breast, ovarian and cancer of the womb lining. The data may show that a full term pregnancy and birth of a baby lowers the risk of some cancers. We don’t know if drug treatment for reduced fertility will change this. We will also examine if any of the causes of death in those of the 7000 women who died is different to that of the general population of women. The data collected on the babies born to those women following subfertility treatment will also be used to find out: why twins were more common than singletons; is the ratio of male to females at birth different from expected; and are the babies of generally slightly lower birthweight. We were going to look at childhood cancer risks in the children that were born to the 7000 women, because there is a lot of interest in this topic, but we are not seeking permission to do this any longer.
Our new study is only the third in the UK since the 1990s to use data copied from the hospital records of women treated for subfertility with drugs that help egg production or increase the number of healthy eggs that a woman makes. The amount of follow-up data for adult female cancer risks is larger in our study than in two similar London-based clinical studies. The Chief Investigator of the present study is Dr MFG Murphy. Since 2013, when the present study closed, he has been involved in other studies with the UK Human Fertilisation and Embryology Authority (HFEA) which looked at cancer risks in women who had help getting pregnant with IVF or injection of sperm into their eggs, and in the babies they delivered. References for these studies are shown at the end of this document.
REGULATORY PROCEDURES FOR THIS STUDY.
This study was reviewed and given a final Favourable Opinion on 08/09/2022 by the REC: Wales.REC6@wales.nhs.uk (REF 22/WA/0136).
Research is a task that we perform in the public interest. The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible.
The legal basis for the processing and storage of personal data for this study is that it is ‘a task in the public interest’, (article 6(1)(e)) and ‘that sensitive personal data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes’, (article 9 (2) (j), based on Article 89(1)).
The data that we have received up to 2013, and would now like to analyse, will have all identifying information about the 7000 individual women removed. No new data has been collected since then, and will not be. We will remove all the identifiers that we used to link the 7000 womens’ individual hospital clinical record data, extracted onto case record forms (CRFs), to their subsequent vital event data (owned now by NHSD) before analysis and eventual anonymised publication. The information we received until 2013 from NHSD was imported into a database held securely by the University of Oxford. It will be used solely for academic research purposes. Importantly, whilst the information received is specific to each woman in the study, no individual will be identifiable in any publication arising from this work. No woman’s personal data will be shared with any 3rd parties and will not be used for any automated decision making or profiling. If you would like to have this data withdrawn, please contact the study team using the details given below.
Under Section 251 of the NHS Act 2006, we have permission to conduct this study without consent. We have special permission to conduct this study without study-specific consent (ie to link, transfer, process and analyse the data) from the Confidentiality Advisory Group (CAG). This permission is given under Section 251 of the National Health Service Act 2006 and its current regulations, the Health Service (Control of Patient Information Regulations 2002): CAG Fully Supported Outcome, dated 09/09/2022, Reference number: 22/CAG/0080.
What to do next?
If you decide you do not want your data to be retained in this way you can withdraw it from this follow-up study, without affecting your current medical care, by contacting the study team, who would require your identifiers to delete it and to inform NHSD that you do not wish to be part of this cohort study. NHSD will not allow us to use data for anyone who has expressed the wish for their data to be withdrawn.
Data protection regulation provides you with control over your personal data and how it is used. Further information about your rights with respect to your personal data is available at https://compliance.admin.ox.ac.uk/individual-rights or by contacting the study team using the details below. The University’s data protection officer can be reached at data.protection@admin.ox.ac.uk. If you have further questions or are not happy with the way your data has been handled, please contact the study team using the contact details below. Alternatively, you can contact the study sponsor on 01865 616480 or ctrg@admin.ox.ac.uk. You have the right to lodge a complaint with the Information Commissioner’s Office (0303 123 1113 or www.ico.org.uk).
The Chief Investigator for this study is: Dr Michael Francis Grant Murphy. He is now a retired Consultant Epidemiologist, but since 2014 has worked as an Honorary Research Worker in NDWRH. His telephone number is 01865 872984. His email is Michael.murphy@retired.ox.ac.uk.
This document is also available to read at: https://www.wrh.ox.ac.uk/about/data-privacy-notice.
REFERENCES TO RESEARCH MENTIONED IN THE TEXT.
Williams CL et al. BMJ 2018: volume 362, k2644;
Williams CL et al. Human Reproduction 2018: volume 33, pages 140-146;
Williams CL et al. New England Journal of Medicine. 2013; volume 369, pages 1819-1827)
Doyle P et al. Human Reproduction 2002: volume 17(8), pages 2209-2213;
dos Santos Silva I et al. Br J Cancer 2009: volume 100(11), pages 1824-1831).
Thankyou for reading through all this detail (!).