CH(10)03

26 February 2010

Dear Colleague

Update to General Directions, Code of Practice and consent forms

In October 2009, we sent you a new edition of the Code of Practice, revised consent forms and General Directions, bringing mandatory requirements and guidance in line with the new legislation. However, as Alan Doran recently outlined, some parts of the 2008 Act will not be brought into force until 6 April 2010. In the period since October, we have also reviewed some of our policy and received ideas from centres about minor improvements which could be made.

As a result, we have made a number of changes which will come into force on 6 April 2010 and which are set out in the following annexes:

The updated General Directions and consent forms are now available to download.

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.

Please note that changes to guidance notes 6 and 14 have been included on the assumption that the Parental Orders (Human Fertilisation and Embryology) Regulations 2010 and the Parental Orders (Human Fertilisation and Embryology) (Scotland) Regulations 2010 are passed in Parliament in late March. We will contact you with further instructions if this does not occur.

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


Annex A - General Directions

0001 Gamete and embryo donation
Paragraphs 3 to 7 and 10 have been updated to ensure the HFEA’s policies on donor reimbursement for expenses, loss of earnings and benefits in kind (outlined in guidance note 11 of the Code of Practice) are clearly represented.

0002 Recording and providing information to the Human Fertilisation and Embryology Authority under a research licence
New requirements have been added at paragraphs 4 and 5 instructing Persons Responsible for research centres to complete and submit the Research Information and Data Sheet, set out in the Schedule to the General Directions. Where the HFEA request further research activity data, Persons Responsible must submit this within 14 days of the request.

0006 Import and export of gametes and embryos
Minor typographical errors have been corrected and clarifications made to Schedule 1, paragraph 2 and Schedule 3, paragraph 2.

0007 Consent
The titles of four consent forms, listed in the Schedule to the General Directions, have been updated. For further details see Annex C of this Chair’s letter.

0008 Information to be submitted to the Human Fertilisation and Embryology Authority as part of the licensing process
Paragraphs 1 to 13 have been updated reflecting the HFEA’s new online licence application system which will be in place on 1 April 2010. The General Directions instruct Persons Responsible to submit the appropriate licence application via the new HFEA portal.

A new requirement of centres applying for Special Directions to export gametes or embryos has been added at paragraph 26. Centres must confirm that the intended export destination centre/clinic are willing to accept the gametes or embryos for the purpose specified in the application.

The reference to “case by case licensing” in paragraph 24 has been removed to reflect the HFEA’s decision to bring the licensing of later onset, lower penetrance conditions into line with the main preimplantation genetic diagnosis (PGD) licensing regime. Such conditions will now be licensed on a condition by condition basis.

0012 Retention of records
A new requirement of centres undertaking preimplantation genetic diagnosis (PGD) has been added at paragraph 6. Stemming from the HFEA’s recent decision to licence PGD on a condition by condition, rather than a case by case basis, centres must, in respect of each case, retain information in the patient records which fully details the reasons why the Person Responsible considered PGD to be appropriate in that case.

Annex B - Code of Practice

Guidance note 5 - Consent to treatment, storage, donation, training and disclosure of information
The “Interpretation of mandatory requirements” box 5A has been updated following legal developments.

Box 5A has now clarifies that gametes should only be taken from a person if written, informed consent to storage has been obtained. Legal developments have clarified that it is important for centres to consider, in all cases, consent to storage at the time of gamete procurement. In the situation where a gamete provider dies before or during treatment, the gametes cannot not be procured or used posthumously without their consent to storage being in place.

Box 5A now also clarifies that the provisions in the Human Tissue Act 2004 which allow next of kin to provide consent to harvesting of other body tissues do not apply to gametes.

Guidance note 6 - Legal parenthood
The “Interpretation of mandatory requirements” box 6G has been updated in anticipation of the commencement on 6 April 2010 of the Parental Orders (Human Fertilisation and Embryology) Regulations 2010, the Parental Orders (Human Fertilisation and Embryology) (Scotland) Regulations 2010 and sections of the Human Fertilisation and Embryology 2008 Act relating to parental orders (Part 2, sections 54 and 58).

The new provisions will enable same sex couples and unmarried couples, as well as married couples, to apply for a Parental Order.

Guidance note 7 - Multiple births
New guidance has been added at paragraph 7.1 to reflect the requirement that clinics should not exceed the new year 2 maximum multiple birth rate of 20%. The reference to a calendar year in the “Interpretation of mandatory requirements” box (7A) has also been removed to reflect the new starting date of 6 April 2010.

Guidance note 10 - Embryo testing
A new reference to General Direction 0012 – “Retention of records” has been added to guidance note 10 to reflect the HFEA’s new process for licensing preimplantation genetic diagnosis (PGD). This process includes an additional requirement for PGD centres to record information about the offer of PGD in particular circumstances, which is detailed in General Direction 0012.

New guidance has been added at paragraphs 10.7-10.9 about two types of embryo testing which allow people who are at risk of a late onset condition (such as Huntington’s disease) to have children free from the condition, without finding out their own carrier status: exclusion testing and non-disclosure testing.

At its January 2010 meeting, the Authority decided that PGD with exclusion testing is an acceptable method of testing and that current regulatory safeguards were sufficient. However, the Authority also decided that new guidance on the non-disclosure of genetic test results should be adopted, because of the additional ethical issues relating to this type of test.

Guidance note 14 – Surrogacy
The “Mandatory requirements” section and a reference to the HFE Act 2008 under paragraph 14.1 have been updated in anticipation of the commencement of the Parental Orders (Human Fertilisation and Embryology) Regulations 2010, the Parental Orders (Human Fertilisation and Embryology) (Scotland) Regulations 2010 and sections of the Human Fertilisation and Embryology 2008 Act relating to parental orders (Part 2, sections 54 and 58).

The new provisions will enable same sex couples and unmarried couples, as well as married couples, to apply for a Parental Order.

Guidance note 15 - Procuring, processing and transporting gametes and embryos
A new “Interpretation of mandatory requirements” box (15A) has been added following legal developments, stating the requirement of the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 section 9(3) that the procurement of gametes must be undertaken at licensed premises or in accordance with a third party agreement.

This update does not affect the HFEA's guidance on home production of sperm provided in paragraphs 15.6-15.9 of the Code of Practice. Centres may continue to use sperm produced by a man at home (or other unlicensed site).

Guidance note 16 - Imports and exports
The references to HFEA application forms for Special Directions to export or import gametes and embryos and notification forms for transfer of gametes or embryos between UK centres have been updated.

Application forms for Special Directions to export or import gametes and embryos are now online at www.hfea.gov.uk and gamete and embryo transfer notification forms can be found on the Electronic Data and Interchange (EDI) system.

 

Annex C - Consent forms

Consent to the use and storage of gametes and embryos after death or mental incapacity
A note has been added to a number of consent forms to remind patients, partners and donors that if they wish to consent to their gametes or embryos being used in the event of their death or mental incapacity, their consent to storage of these may also be required.

Forms affected:

  • MT Consent to the use and storage of your sperm and embryos for your partner’s treatment
  • WT Consent to the use and storage of your eggs and embryos for your treatment
  • MGI Consent to the use and storage of your sperm in IUI or GIFT
  • WGI Consent to the use and storage of your eggs in GIFT
  • MSG Consent to the use and storage of your sperm or embryos for surrogacy
  • WSG Consent to the use and storage of your eggs or embryos for surrogacy
  • MD Consent to the use and storage of your donated sperm
  • WD Consent to the use and storage of your donated eggs
  • ED Consent to the use and storage of your donated embryos.

Consent to the storage of gametes during IVF treatment
The reference to consent to the storage of gametes has been removed from the titles of the two main IVF treatment forms, ensuring the title accurately reflects the consent collected on the forms.

Forms affected:

  • MT Consent to the use and storage of your sperm and embryos for your partner’s treatment
  • WT Consent to the use and storage of your eggs and embryos for your treatment
  • GS Consent to the storage of your eggs or sperm
  • MGI Consent to the use and storage of your sperm in IUI or GIFT
  • MSG Consent to the use and storage of your sperm or embryos for surrogacy
  • WSG Consent to the use and storage of your eggs or embryos for surrogacy
  • WD Consent to the use and storage of your donated eggs

Consent to the use of gametes and embryos in training
In response to requests from centres, a new section has been added to the consent form guidance document about consent to the use of gametes and embryos in training.

Consent to the use of gametes in research after death or mental incapacity
The consent question in section 3.3 of the Gamete Storage form has been updated to clarify that consent to the use of the patient’s gametes in research must be obtained before the patient’s death or mental incapacity.

Form affected:

  • GS Consent to the storage of your eggs or sperm
    Consent to the use and storage of your sperm or eggs in IUI or GIFT
    Where consent to the use of sperm in treatment, without the creation of embryos in vitro, is mentioned in the consent forms, the references to intra-uterine insemination (IUI) and gamete intra-fallopian transfer (GIFT) have been replaced with artificial insemination.

Feedback from the sector was that the previous terminology excluded those undergoing variations of IUI and GIFT, such as Intra-cervical insemination, from using the consent forms.

Also, consent to the storage of sperm and eggs has been removed from the MGI and WGI forms following feedback that this is not a treatment pathway the majority of patients undergoing IUI or GIFT follow.

Forms affected:

  • MGI Consent to the use and storage of your sperm in IUI or GIFT
  • WGI Consent to the use and storage of your eggs in GIFT
  • MD Consent to the use and storage of your donated sperm
  • MSG Consent to the use and storage of your sperm or embryos for surrogacy

Minor corrections
Typographical and formatting errors have been corrected in sections 3.1 and 3.2 of the consent form covering storage of eggs or sperm.

Form affected:

  • GS Consent to the storage of your eggs or sperm

Page last updated: 17 August 2012