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15 September 1994

Dear Director/Inspector

This is the second of a regular series of letters to keep licensed centres in touch with the Authority's views on licensing and policy issues. This letter covers several consent issues and a licensing issue which have come to the attention of the Authority in recent months. A note on information to be provided for patients about embryo freezing is also included.

1. Consent forms HFEA (91)6 and (91)7 - must be used and a copy given to the patient/donor
The Authority has been surprised to discover recently that some centres still seem to be unaware that they must use HFEA forms to obtain consent from people providing gametes to the storage of the gametes or their use in treatment or research. It is a condition of a licence that centres obtain consent on forms HFEA(9116 and (91)7 which are supplied by the Authority in self-copying duplicate pads.

The Authority has also become aware that a number of centres keep both copies of the consent forms HFEA(91)6 and (91)7 in their patient records. The Authority would like to remind centres that the Manual for Centres makes it clear that one copy of this legal consent form should be given to the man or woman who has signed it. The purpose of this is to minimise the risk of misunderstanding between all the parties about the exact nature of the legal consent given.
 
2. Consent forms HFEA(91)6 and HFEA(91)7 - posthumous storage & use

I would also draw your attention to a further point relating to these consent forms.  That is, that centres should not seek to limit the scope of the consent to use and storage that people providing gametes are required to give.

Some centres have been requiring men storing their sperm to say on the HFEA form that they wish their sperm, or embryos produced using their sperm, to be allowed to perish if they should die. The centres concerned have insisted on this because they have a policy of refusing to use in treatment the gametes of people who have died.
However, this is to misunderstand the nature of the consent being given on the HFEA forms. These forms when completed contain the various consents required to make storage and use of gametes and embryos legal. The options which the law allows to the person providing gametes cannot be limited by the centre that is initially undertaking storage. If, for example, the centre concerned will not give artificial insemination to a woman using her dead partner's sperm, but the man has given legal consent to this procedure, then the stored gametes will need to be moved elsewhere following his death.

3. Consent to use spare eggs and dead embryos in research

You will be aware that the use of eggs and dead embryos for research is not regulated under the Human Fertilisation & Embryology Act 1990. It has recently come to the notice of the Authority that some centres therefore consider that spare eggs from IVF or GIFT treatment and dead embryos are waste material, and that research using this material may be carried out without the consent of the people who provided the gametes.
The Authority wishes to make it clear that the consent of the people providing the gametes should always be obtained before eggs or dead embryos are used in research.
 
From the legal standpoint, it is arguable that without this consent doubt may be cast on the validity of the original consent which the people providing the gametes gave to the use or storage of their embryos, or to treatment using their eggs. This is because the centre could be said to have failed to give complete relevant information to the persons whose consent was required in order to obtain the eggs and embryos. However, above all, the Authority regards it as unethical to use in research the gametes or embryos of individuals who may be completely opposed to research without their consent.

4. Observation of embryos in vitro under a treatment licence
I will take this opportunity to remind centres about the limits of a treatment licence. The Authority is aware that some centres have in the past cultured spare embryos and observed them for a number of days as a quality control check on their culturing systems. This practice is not allowed under an HFEA treatment licence.

An embryo may not be kept under a treatment licence if it is no longer to be used in the treatment of a woman, or if any information that may be obtained from keeping it will not be of specific use in the treatment or diagnosis of the individuals whose gametes were used to produce it. If there is some specific value for a couple in continuing to culture spare embryos from a particular treatment cycle, this should be done with the knowledge and agreement of the couple concerned.

5. Embryo Freezing - information for patients
First of all, I would like to thank centres for their co-operation in providing information to the Working Group on Embryo Freezing. A summary of the outcome of the Group's investigations was published in the recent HFEA Annual Report (page 14). Following from this, I would draw your attention to the Authority's concern about the uneven provision of information for patients about embryo freezing.

The Working Group carried out a survey of patients7 views. This clearly showed that many patients would have found it helpful to have more information and discussion before they made the decision to go ahead with embryo freezing. Some, for example, said they had been unprepared for the distress of learning that their embryos were not viable on thawing. Others reported having been given widely differing average success rates for frozen embryo transfer. Many were concerned that they had not considered at the outset the implications of keeping embryos in storage for up to five years.

The Authority intends to produce a leaflet for patients about embryo freezing next year. Until that becomes available, the Authority will expect centres to give particular attention to the need to provide patients with full information about the implications of embryo freezing, so that they can make properly informed decisions.

I will be writing to you again in about six months to let you know of further developments in policy or licensing issues.

Yours faithfully

SIR COLIN CAMPBELL

Page last updated: 15 August 2012

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