CH(10)04

Dear Colleague,

New Regulations and update to consent form

This month Parliament debated and approved new regulations on the disclosure of HFEA Register data for research purposes and on parental orders. These regulations will come into force on 6 April 2010.

Disclosure of information for research purposes & consent changes

As you know, it has been possible since 1 October 2009 for patients starting licensed fertility treatment to consent to their disclosure of their information from the HFEA Register for use in medical research.

With the passing of the Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010, we now have a clear understanding of how Parliament would like the HFEA to handle data entered on the HFEA Register before October 2009. With the exception of information relating to donor conception and to patients who have opted out, the HFEA can disclose such data for research purposes, with the following safeguards:

  • Only recognised research institutions may apply for access to Register data.
  • Applicants must demonstrate how their research will be in the public interest, and why it cannot be carried out on non-identifying information
  • Applicants must have research ethics committee approval for their proposed projects prior to submission to the HFEA
  • Researchers will be bound by the same confidentiality restrictions as the HFEA and licensed clinics.

All medical research projects will be considered by the Ethics and Confidentiality Committee of the National Information Governance Board. The NIGB’s recommendation will be passed to a new Register Research Panel at the HFEA, where the final decision will be made. The Authority will have oversight of the entire application and disclosure process.

We believe that this access to the Register, with the appropriate restrictions and safeguards, will enable valuable research to be carried out using HFEA Register data, and from linking this to other datasets.

Although the Regulations apply to data about patients and their partners entered on the Register before October 2009, they relate to information about any children born as a result of treatment occurring both before and after that time. However, rather than disclosing all data relating to children in the same way as pre-2009 data, we will disclose it according to the consent that the prospective parents gave at the time of their treatment. A revised CD form, explaining the handling of children-related data, will be available from 6 April at http://www.hfea.gov.uk/2504.html

Later in the year we will be introducing a consent variation form. This can be used to notify the HFEA about changes to consent by patients and partners about their own data or that of their children.

Parental orders

As previously advised in our Chair's Letter of 26 February 2010 (CH[10]03), the remaining parts of the 2008 Act and new regulations relating to parental orders will come into force on 6 April 2010. The regulations are:

  • Parental Orders (Human Fertilisation and Embryology) Regulations 2010
  • Parental Orders (Human Fertilisation and Embryology)(Scotland) Regulations 2010

As set out in the February letter and the accompanying update to the Code of Practice, these provisions allow unmarried and same-sex couples, as well as married couples, to apply for a parental order. Besides using the updated Code of Practice from 6 April, no further action on your part is needed.

 

Applications and warrants

Another new set of regulations, the Human Fertilisation and Embryology (Procedure on Applications and Execution of Warrants) Regulations 2010, also come into force on 6 April 2010.

The Regulations empower the HFEA's Licence Committee, in certain limited circumstances, to require a person to attend the proceedings and to give evidence or produce documents. They also set out the information that must be provided to the occupier of licensed premises if the HFEA were to enter those premises under a warrant.

This information includes confirmation that the person entering is authorised to do so by the Authority, as well as details of relevant legislation and the powers available to the individual in possession of the warrant.

If you have any questions about the new regulations or the changes to the CD form, please contact your inspector in the first instance or email code8@hfea.gov.uk

Yours faithfully,

Professor Lisa Jardine CBE
Chair – Human Fertilisation and Embryology Authority


 

Annex A – Revised introduction to section 4 of CD form

Please do not fill in this section if you are donating your eggs, sperm or embryos for the treatment of others or you are a patient using donor eggs, sperm or embryos in your treatment.

During the course of your or your partner's treatment, information about yourself (including your health and other issues relevant to your treatment) is collected. If you are receiving treatment, then information about any child born as a result of this will also be collected. Some of this information is sent to the HFEA and recorded on the HFEA Register.

This information can be of great use to researchers investigating, for example, how treatment can be improved. The law allows for information that identifies you (e.g. your name and date of birth) to be disclosed to researchers, although this may only happen if you give your consent.

The HFEA will use any consent you give in this section to inform how, in future, information on the HFEA Register is processed about any child born as a result of your treatment, until they reach the age of 16. For example, if you consent in this section to your identifying information held on the HFEA Register being disclosed for medical and non-medical research purposes, then the HFEA may also release that of any child born as a result of your treatment. Equally, if you do not consent in this section to your identifying information being disclosed for research purposes, then the HFEA will not release that of any child born as a result of your treatment.

You should notify your centre if you do not wish the consent you give in this section about the use of your own data to inform how data about children is processed. Notification, if necessary, should be given after the child's birth It is your right to change the consent you give here at any time.

 

Page last updated: 17 August 2012