CH(11)01
28 January 2011
Dear Colleague,
Update to General Directions, Code of Practice and consent forms
We have made changes to the 8th edition of the Code of Practice to reflect the new multiple births target for year three, and to reflect the introduction of the Equality Act 2010. We have also updated the Multiple Births General Directions (0003) and revised the ‘Consent to the disclosure of information’ form (the ‘CD’ form). These changes will come into effect on 6 April 2011.
Multiple births: Guidance note 7 and General Directions 0003
After carefully reviewing the progress of centres so far, the Authority has set a year three maximum multiple birth rate of 15%. The target rate was recommended by professional bodies and patient groups as a stretching but realistic target for centres.
This means no more than 15% of a centre’s annual birth events, from treatment started between 6 April 2011 and 5 April 2012, should be multiple births. Births from IVF, ICSI and GIFT treatments using fresh and frozen embryos/eggs, from patients’ own eggs and donor eggs are included in the calculation of the multiple birth rate. Births from IUI or DI are excluded from the calculation.
We appreciate that the 15% target is a challenging one for centres, although several centres achieve this rate now. Your multiple births minimisation strategy is critically important, including your arrangements in place for review and audit. At inspection we will look at evidence that your strategy and outcomes are reviewed in light of your performance with regard to the target.
From April this year, centres’ clinical pregnancy rates will be monitored using the latest available performance information. Where analysis of clinical pregnancy rates indicates that the resulting live birth rate is likely to be in excess of the target your inspector will explore your performance with you.
We have revised paragraph 5 (b) of the Multiple Births General Directions 0003 and paragraph 7.1 of the Code of Practice to reflect the new target.
We know that many centres have tackled this major issue with determination. We will be looking at ways of sharing good practice and HFEA staff are willing to support centres who wish to redesign their approach in the light of lessons learned elsewhere.
Guidance note 29 – Treating people fairly
Code of Practice Guidance Note 29, ‘Treating People Fairly’, has been updated to reflect the Equality Act 2010.
The Equality Act 2010 provides a new legislative framework to protect the rights of individuals and advance equality of opportunity for all. It updates, simplifies and strengthens previous legislation. The main provisions of the Act came into force in October 2010. Guidance Note 29 has been updated with the key principles of the Equality Act 2010 to ensure the Code reflects current law.
Consent to the disclosure of identifying information
The consent form ‘Consent to the disclosure of information’ (the ‘CD’ form) collects two types of consent. Section 3 collects consent to the disclosure of identifying information by clinic staff to GPs, healthcare professionals, administrative staff and auditors. Section 4 collects consent to the disclosure of identifying information by the HFEA to researchers.
Feedback from centres was clear that it would be more practical to have the two consents on separate forms. This is because it is useful to obtain the consent in section 3 at the start of a patient’s treatment (for example, to enable contact with the patient’s GP), whereas it is more suitable to obtain consent to disclosure of identifying information for research purposes later in a patient’s treatment, when patients have a better understanding of the consent implications.
The CD form will therefore be available as two separate forms. We will also continue to make the whole CD form available for clinics which prefer to use a single form.
The updates will come into force on 6 April. The General Directions and consent forms will be available on the HFEA website shortly, so that you can familiarise yourself with them before the 6 April. Hard copies of updated sections of the Code of Practice are enclosed and should be used to replace current guidance as instructed in the accompanying leaflet.
If you have questions about the new Code of Practice, consent forms or Directions, 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
Page last updated: 17 August 2012