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The Human Fertilisation and Embryology Act 2008 will allow the HFEA to disclose identifiable data (either about the patient or any children born as a result of treatment) held on the HFEA register to medical and non-medical researchers.

Data collected after 1 October 2009 can only be disclosed with the patient's consent. Patients could also later choose to withdraw or vary their consent. Finally, the HFEA would need to be satisfied that the research was worthwhile.

 

What data does the HFEA hold?

The HFEA holds data such as the patient’s name and date of birth. It also holds basic details about patients’ obstetric history and the clinical cause of their fertility problems.

The data held by the HFEA also includes very basic information about the outcome of treatment, including whether the patient carried a pregnancy to term, whether or not it was a multiple birth, and the sex of the baby.

Clinics themselves hold more detailed information about patient details, which are not held on the HFEA register. For example, the HFEA Register does not include a lot of the information from patients’ health records.

At present, patients can consent to such data being disclosed to researchers, although this would be done via the clinic (not via the HFEA).

 

Using the data: ‘contact’ and ‘non-contact’ research

The types of research that the data outlined above might be used for can broadly be divided into ‘contact’ and ‘non-contact’ research:

Contact research

For contact research, the researchers are looking for a particular type/grouping of patients for a specific study (eg. a study might only require patients who received a particular form of treatment, such as ICSI) who they will invite to participate directly in the study.

The patient would need to provide consent for researchers to look at data about themselves (or data about their child) in order to enable them  to identify people who fall into a particular target group, and therefore find suitable participants for their study.

If the patient is a suitable candidate for the study and provided they have given consent, they would be contacted and invited to participate in the research. 

Non-contact research

Research may involve much larger numbers of patients than contact research.

The research may involve, for example, linking data from the HFEA register to another database, such as a cancer registry or the congenital abnormalities register. This would help researchers explore any patterns (and therefore any possible links between the two areas). This could, for example, provide important information about any health risks associated with IVF treatment.

Patients would be asked for consent for their data (or data about their children) to be used for ‘non-contact research’. Provided they agree to this, patients would not be contacted for specific consent for each and every study using their data (or data about their children).

Patients can withdraw their consent to their data being used in any further studies if they wish.

 

When will these changes come into force?

Changes will come into effect on 1 October 2009. The changes will enable the HFEA (with patient consent) to disclose patient identifiable data to researchers.

In order to implement these changes, the HFEA is developing new 'Consent to Disclosure forms' which patients will be asked to consider at an initial stage of treatment (and probably before any pregnancy).

Download drafts of these forms: 

• Draft consent to disclosure form

Inital consultations have taken place regarding these forms, and along with other stakeholder input, the HFEA anticipates making a number of changes to the consent forms.

Page last updated: 19 August 2009

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