• Directions
• Chair's letters
  • 2013
  • 2012
  • 2011
  • 2007-2010
  • 2003-2006
  • 1999-2002
  • 1995-1998
  • 1991-1994
• Chief Executive's letters
• Multiple Births Minimisation Strategy: achievements and compliance
• Frequently used guidance
• Do I need to be registered by either the CQC or licensed by the HTA?
• Retrieval of storage of gametes where patients are unable to consent
• Surrogacy and legal parenthood – changes from 1 October 2013

23 April 2001

Dear Colleague,

i. New Directions on information to be provided with gametes and embryos transferred between clinics;

It has become apparent that gametes are being moved between centres without any accompanying documentation. This raises a number of concerns. One major concern is that where gametes and embryos are not accompanied by details of the relevant consents, receiving centres cannot be sure that there is valid consent for the storage and use of the material. They might also be unaware of any conditions that may have been placed on use of the samples. Without this information the recipient centre could unwittingly be using the gametes/embryos outwith the conditions of the consent that relates to it.

The new Directions therefore require an anonymised copy of the consent and HFEA registration forms (or paperwork to that effect) to accompany the gametes. A copy of the revised Directions (D.2001/1 - Information to be provided to a per son to whom another licence applies or where gametes or embryos are supplied) is attached. These Directions revoke the previous Directions D.1991/5.

The new Directions (D.2001/1) require that the records passed on by the original centre to a recipient centre must be kept in accordance with Directions (D.1992/1 Removal of information from records maintained by centres under a treatment licence, storage licence or research licence). A copy of these Directions is also attached for your information.

ii. Changes to requirements on the submission of donor information forms

It is the duty of the centre that recruits and stores the samples of a donor to register that donor with the HFEA. This enables the Authority to link any subsequent treatments using that donor, wherever they are performed, with the registered donor. However, in practice, some original centres are distributing samples of donated material to other centres (recipient centres) before the donor has been registered with the HFEA. This means the registry team is receiving treatment forms using donated gametes from unregistered donors. To address this, a further amendment has been made to the attachment for the Directions on Records (D.1999/1) requiring donors to be registered immediately upon recruitment. A copy of this attachment is attached.

If you have any queries relating to these Directions or their implementation please contact your centre's inspector co-ordinator.

Yours sincerely,

Ruth Deech
Chairman

Encl.

New Directions D.2001/1 revoking Directions D.1991/5 - Information to be provided to a person to whom another licence applies where gametes or embryos are supplied

Amended Donor Information Form attachment for Directions D.1999/1 - Directions on records

Copy of Directions D.1992/1 - Removal of information from records maintained by centres under a treatment licence, storage licence or research licence

Page last updated: 14 April 2009

• Send to a friend