04 September 2017
04 September 2017
Ref: CH(17)02
Dear Colleague
October 2017 update to the Code of Practice
On 2 October 2017, we plan to publish an update to the Code of Practice that will affect several guidance notes and General Directions 0008. I am writing to inform you about these changes, which will involve the introduction of new guidance. Details of the changes are set out in the following annexes:
- Annex I: Summary of changes included in the October 2017 update
- Annex II: Updated ‘Revision control sheet’ (lists all updated areas of the Code of Practice)
- Annex III: Changes to Code of Practice guidance notes
- Annex IV: Changes to General Directions
NOTE: all changes set out in yellow in Annexes II-IV are to be removed; changes set out in red are additions.
Treating trans patients and donors
In recent years, we have received an increasing number of enquiries from fertility clinics and the public about providing care for trans patients and donors. While the Code currently refers to gender reassignment and other protected characteristics under references to the Equality Act 2010, and we remind you of your obligation not to discriminate under equalities legislation, we realise that our guidance to you on this area could be improved. As a result, we are introducing guidance on treating trans patients and donors in this update so that you can provide better care at your clinic.
This is part of a wider piece of work that has already made some improvements to the benefit of trans patients and donors, including a suite of gender neutral consent forms that should be used when treating trans patients (released in April 2017) and patient information on our website.
The new guidance relating to treating trans patients and donors aims to address:
Gaining research ethics approval
As part of our strategy’s focus on embryo research, we have heard that it can often be difficult for clinics to submit project proposals to an ethics review process. To help improve the research application process, we will be amending General Directions 0008 to highlight that independent research conducted by research centres can seek ethics approval from an NHS Research Ethics Committee (ie, a committee that provides ethical approval to research involving NHS patients) or an independent ethics committee. The clarification will also set out our expectations on the composition of an independent ethics committee.
Other changes to guidance
We will also be introducing a link to practical information on how you can meet medicines management requirements, and correcting a line in mitochondrial donation guidance.
When will the changes come into effect?
We are previewing all upcoming changes for your information via September 2017’s edition of Clinic Focus [insert link], before they come into effect on 2 October 2017. On this date, the revised guidance and General Directions will be updated on the new Clinic Portal and website to reflect these changes.
What should you do now?
A summary of all changes in this update are listed at Annex I, while changes to the Code of Practice and General Directions are listed at Annexes III and IV, respectively. Please read the updated areas and make sure that you and your colleagues are familiar with any changes that may be relevant to your clinic. If you have any questions, please contact your inspector.
Yours sincerely
Sally Cheshire
Chair, Human Fertilisation and Embryology Authority