What data can be accessed
The HFEA is committed to providing the information contained on our Register in different ways and for different audiences, depending on the aims of the research.
It is important to understand that research can only take place within the strict confines of the legislation.
The legislation still provides very strong protection of patient, donor and offspring confidentiality (stronger still than normal medical confidentiality). Any (even inadvertent or indirect) disclosure that an individual’s information is contained on our Register, constitutes a criminal offence.
Choose a Fertility Clinic
The information we hold can help patients make better choices and clinics provide better services. This is why we have improved our clinic-by-clinic publication of Register information known as Choose a Fertility Clinic.
The information contained on Choose a Fertility Clinic is primarily aimed at those who are considering treatment themselves, but it can also be used by researchers who want to explore the differences between the services clinics provide.
Because each centre represents a fairly small sample of data, the data only lends itself to limited comparative analysis of outcomes.
Fertility treatments in 2006: a statistical analysis
Outcomes of treatments, and the various factors influencing these, can be more meaningfully explored in a larger data set.
The HFEA commissioned researchers from the Oxford based National Perinatal Epidemiology Unit (NPEU) to undertake an in depth, detailed analysis of one year’s worth of register data.
Because of the time it takes to report all the outcome data and to then verify it, the data used for this analysis covers the treatments carried out between 1st April 2006 and 31 March 2007.
The report is primarily aimed at a patients and the wider public, but it will also be of use to researchers, focussing on outcomes of different types of treatment and the effects of age on the chance of having a live birth and different types of outcomes of pregnancies (multiple or singleton pregnancies, live births, miscarriages or other pregnancy losses).
Research using anonymised data
Research that aims to only interrogate the HFEA Register and not link subjects contained in our Register to other datasets (for example to explore long term health outcomes of fertility treatments for women and their children), does not need to have access to patient indentifying information
This research can still answer important questions, like which factors (patient, treatment type, technique used) influence treatment outcomes, or which indicators might suggest that a patient should have only one or two embryos transferred during treatment.
We will be publishing an anonymised version of our Register. This will contain a large proportion of all the register data going back to 1991, with the patient identifiers (for example date and place of birth, names, address, place of treatment) removed.
Research using patient-identifying information
The new statutory provisions now contained in the HFE Act 1990 (as amended), and in regulations covering the disclosure of Register data for research purposes, set out for the first time that under strict conditions identifying information about fertility patients can be made available to research.
Conditions for using patient identifying information
Research involving patient identifiers is always a last resort. It can only happen:
- if the research is of high quality and is approved by an ethics committee
- if consent to disclosure cannot effectively be obtained
- if the research cannot happen (not even in an amended form) with anonymised data.
Even if release is approved, it will only be:
- for the smallest possible number of patients
- for the smallest possible number of identifiers (date of birth or name, for example)
- for the shortest time period possible (i.e. identifiers have to be removed once data from our Register has been linked to another dataset).
The new legal provisions set out that the HFEA needs to be satisfied that the release of patient identifiers is necessary.
This will only happen if a researcher wants to link data on the HFEA Register to another dataset. For example, to find out whether IVF poses any long term health risks. Long-term health data on fertility patients is not contained in the HFEA Register, but might be contained in another dataset the researcher wants to access.
When doing this type of analysis, researchers are never interested to find out the identity of individual patients. They only ever want to know whether patients in one dataset can also be found in another dataset. This is called a linkage study.
The new legislation sets out two systems for approving linkage studies.
For data about treatments that took place after 1st October 2009
From 1 October 2009, patients and the partners who register for fertility treatments will be asked whether they consent to their information being included in studies where patient identifiers are needed to make a linkage between two datasets.
Patients are also asked to indicate whether they would be happy to take part in research that would involve contact research.
Clinics report patient’s consent or refusal to consent to the HFEA. The HFEA will approve individual research projects only where stringent criteria are met.
For data about treatments that took place before 1st October 2009
Before October 2009, patients were not asked whether they would consent to research that uses patient identifiers. Parliament has decided that, in exceptional circumstances, data should still be made available for high quality research under strict ethical oversight.
A precedence exists for health and medical data more generally, where the National Information Governance Board (NIGB), through its Ethics and Confidentiality Committee (ECC), approves high quality research on information without consents, where strict statutory requirements are met.
Opting out of research
Individuals who do not wish information about themselves or their children born as a result of treatment to be used for research purposes are not required to share personal data with researchers. There is a process in place to allow people to opt out and to exclude any information that identifies them from being used in research studies.
Page last updated: 31 March 2010