02 February 2017
Dear Colleague
April 2017 update to the Code of Practice
On 3 April 2017, we will publish an update to the Code of Practice. I am writing to inform you about these changes, which will affect a number of guidance notes, General Directions, consent forms and best practice guidance on obtaining consent. The majority of these changes reflect guidance previously issued via Chair’s and Chief Executive’s letters and provide clarification on existing guidance. Details of the changes are set out in the following annexes:
- Annex I: Summary of changes included in the April 2017 update
- Annex II: Revision control sheet
- Annex III: Changes to Code of Practice guidance notes
- Annex IV: Changes to General Directions
- Annex V: Changes to consent forms
- Annex VI: Changes to best practice guidance on consent
Note: all changes set out in yellow in Annexes II-VI are to be removed; all changes set out in red are additions.
Legal parenthood and recording consent
In recent years there have been a series of anomalies in the recording of consent to legal parenthood. This led to a number of recommendations from the High Court to ensure consent is accurately recorded. While we took action on these recommendations and advised you of the steps to take via Chair’s and Chief Executive’s letters, we have used this update to incorporate those recommendations into Code of Practice guidance. This is to ensure you are able to uphold your statutory responsibility to ensure that you obtain properly informed consent from your patients, and as informed consent is one of the most important principles in healthcare and a fundamental feature of the Human Fertilisation and Embryology Act 1990 (as amended).
The main updates relating to legal parenthood and consent focus on what you should do if you discover an error(s) in the way legal parenthood has been recorded at your clinic, and when to ensure a patient’s marital status is noted. As well as updating Code of Practice guidance on these matters, we have also introduced a new consent form to record consent to posthumous birth registration and made changes to best practice guidance (ie, the ‘Guide to consent’) to reflect this.
Other clarifications to guidance
We have also made changes to clarify or update existing guidance following Chief Executive’s letters, the mitochondrial scientific review and enquiries we have received from colleagues across centres. These changes relate to mitochondrial donation, egg sharing arrangements, cases where consent to storage is not required, and storage periods for eggs, sperm and embryos. Minor amendments will also be made to guidance that involve the addition of external links and corrections.
Changes to consent forms relating to treating transgender patients
This update will see the introduction of a suite of gender neutral consent forms that should be used when treating transgender patients. This follows feedback we have received from the sector that transgender patients often find it difficult to complete the Authority’s consent forms due to the male and female references within them. The new forms see all references to ‘males’ or ‘females’ removed, and have been tested by transgender patients to ensure that they meet patient needs.
We have also updated several existing consent forms to ensure that they are also gender neutral. This enables you to use these particular forms for all patients that you treat, and avoids the need to have a separate set of these forms specifically for transgender patients.
Other changes to consent forms
We have also made a number of minor practical changes to consent forms following your feedback.
When the changes will come into effect
All changes are currently available for your information via the February 2017 Clinic Focus article, before they come into effect on 3 April 2017. On this date, the revised guidance, General Directions and consent forms will be updated on the new Clinic Portal and website to reflect these changes.
What you should do now
A summary of changes in this update are listed at Annex I, changes to the Code of Practice are listed at Annex II, and actual amendments are highlighted at Annexes III-VI. Please read the updated areas and make sure that you and your colleagues are familiar with any changes that may be relevant to them and your clinic. If you have any questions, please contact your inspector.
Yours sincerely
Sally Cheshire
Chair, Human Fertilisation and Embryology Authority