29 April 2010
New consent arrangements for disclosure of information for research purposes
As you know, it has been possible since 1 October 2009 for patients starting treatment at a licensed centre to consent to the disclosure of their personal identifying information from the HFEA Register for use in research.
I understand that the introduction of this new consent has not been easy, and I appreciate the efforts that clinic staff have made so far in explaining to patients the purpose of disclosure.
With the Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010 coming into force on 6 April this year, it is now possible for personal identifying information that was entered onto the HFEA Register before 1 October 2009 to be disclosed for use in research. Such disclosure will usually be used to link the HFEA Register to other, separate datasets. This can make possible high quality research projects into outcomes of fertility treatments under the strict ethical oversight of both the HFEA and the National Information Governance Board, a body specifically created to govern the use of patient information for research.
This Chair’s letter sets out how clinics are expected to handle patient information that spans the 1 October 2009 date. I appreciate that this is not a straightforward issue and the Authority has sought to keep any additional burden for clinic staff and patients to a minimum.
The Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010 distinguishes between two categories of data held on the HFEA Register. The first applies to patients treated before 1 October 2009, while the second applies to patients treated on or since 1 October 2009.
Registration and treatment before October 2009
The new Regulations establish an authorisation process whereby the HFEA can permit researchers to access personal identifying data held on the HFEA Register as part of formally approved research projects. Disclosure can take place without an individual's explicit consent. However, certain caveats apply. For example, information that identifies a donor is excluded, as is information where patients, partners or people born as a consequence of treatment have explicitly dissented from the disclosure of personal identifying data.
The HFEA is operating an opt-out service via its public website for patients, partners and children who wish to dissent from disclosure.
Registration and treatment since 1 October 2009
Patients registering for treatment with a licensed centre since 1 October 2009 have been required to fill in the ‘Consent to the disclosure of identifying information form' (CD form). See HFEA General Directions 0007 – Consent. The HFEA is committed to rewriting its information leaflet for patients about this consent, following on from feedback we are gathering at a number of workshops for centre staff.
Registration before 1 October 2009 and treatment between 1 October 2009 and 30 April 2010
The distinction made by the new Regulations between two categories of data (pre- and post-October 2009) has created an anomalous situation. This applies to people who registered with a licensed clinic before 1 October 2009 and received treatment at any time before 1 May 2010.
The Authority has considered two options. The first would have required the retrospective completion of CD forms by patients and their partners treated in this period. This was considered too burdensome both for patients and for clinic staff. The second option, which has been adopted by the Authority, is to exclude all personal identifying data relating to this group of individuals from being disclosed for research purposes. The Authority recognises that this exclusion will reduce the size of the dataset available to researchers, but believes that this is preferable to the burden of the first option. The Authority is also confident that the data gap will reduce as patients returning for treatment after 1 May 2010 will be given the opportunity to consent to disclosure.
Treatment on or after 1 May 2010
All patients and partners who receive treatment from 1 May 2010, regardless of the date when they first registered with a licensed centre, will be required to complete a CD form, unless they have previously completed one. The consent on the CD form will apply to all data held in the HFEA Register about that individual, regardless of when the patient first started treatment.
This requirement of clinics will be implemented by amended HFEA General Directions 0007 – Consent, which will come into force on 1 May 2010
|1 August 1991 - 30 September 2009||Since 1 October 2009|
|Treatment date||1 August 1991 - 30 September 2009||Data available for disclosure to researchers unless dissent expressed.||N/A|
|1 October 2009 - 30 April 2010||Data not available for disclosure unless a CD form subsequently filled in expressing consent to disclosure.||CD form must be completed.|
|Since 1 May 2010||CD form must be completed. Preferences (consent or dissent) will be applied to all data relating to the individual completing the form.||CD form must be completed.|
Patients and their partners have the right to vary their consent given on the CD form at any time.
The HFEA will be introducing an EDI-based Consent Variation form for clinics to record a patient's or partner’s consent variation. Form completion guidance will be made available on the 'For Clinic Staff' of the HFEA website. Requirements for submission are set out in amended Directions 0005 - Collecting and recording information for the HFEA, which will come into force on 1 May 2010.
Generally, parental consent recorded on a CD form will also apply to data about a child born as a consequence of this treatment. With respect to treatment undertaken since 1 October 2009, data about children will automatically be excluded from disclosure for research purposes once that child reaches the age of 16. Anyone born as a consequence of treatment undertaken since 1 October 2009 who is 16 years or older will be able to consent to disclosure of their personal identifying data for research purposes. It is expected that in such cases the relevant individual will contact the HFEA and will be required to verify their identity.
With respect to individuals born as a consequence of treatment undertaken between 1 August 1991 and 30 September 2009, parents and guardians can dissent to the disclosure of information until children reach the age of 16. Relevant individuals can then dissent to disclosure themselves. Again, in such circumstances, they would be required to contact the HFEA and verify their identity.
If you have any questions about this letter, please contact Emer O'Toole, Information Manager, at email@example.com or call 020 7291 8275.
Professor Lisa Jardine CBE
Chair – Human Fertilisation and Embryology Authority
Page last updated: 17 August 2012