CE(00)08

To:  Persons Responsible

Date:  29th August 2000

Dear Colleague,

Long Term Storage of Sperm HFEA(00)9 Consent Forms and Guidance Notes

I am writing to inform you that the HFEA has introduced a new statutory consent form HFEA (00)9. This form has been designed for the long term storage of sperm for men who are eligible to store their sperm beyond the statutory ten years in accordance with the criteria set out in Regulations. A copy of the Regulations are attached to this letter for your reference.

The Human Fertilisation and Embryology Act 1990 requires that a consent to the storage of any gametes must specify the maximum period of storage and state what is to be done with the gametes if the person who gave the consent dies or is unable because of incapacity to vary the terms of the consent or to revoke it.

You will find enclosed with this letter an orange folder containing copies of the new consent form HFEA (00)9. In addition, comprehensive guidance notes on the completion of the new form have been produced and are attached to the folder. The guidance notes also outline the conditions contained in the Regulations allowing the extended storage of sperm beyond ten years.

The new form HFEA (00)9 is designed to be used for two categories of men:

a) those who need to store sperm because they are about to embark on treatment that may impair their fertility e.g. certain types of chemotherapy. Providing that a registered medical practitioner is satisfied that the requirements of the Regulations have been fulfilled and completes the relevant parts of the form (or a letter from a registered medical practitioner may be attached), the sperm may be stored up until the man's 55th birthday.

It is essential that any man providing consent using this new form understands that completion of this form alone only provides consent for storage of sperm, but makes no provision for the use of the sperm. It should also be understood that the only consent they can give on this form is for the sample, in the event of their death or mental incapacity, to be allowed to perish.

Before the stored sperm could be used in treatment services, consent for use must be obtained. This would also include any wishes for posthumous use. Consent to use would be given by completing a HFEA (00)6 statutory consent form. HFEA (00)6 also provides consent for the creation and storage of embryos. This form should be attached to the completed HFEA (00)9.

b) those who already have sperm in storage and are eligible to extend storage beyond the statutory ten years. This group will already have completed a standard HFEA consent form for the storage and use of sperm and embryos, which provides consent for their sperm to be stored for ten years. These men may use the new HFEA (00)9 to extend their consent for a longer period, up to their 55th birthday. These men should complete the HFEA (00)9 giving their consent for the extended period of storage and then get the form signed by a registered medical practitioner to verify that they are eligible for storage beyond the statutory ten years. This new form is designed to operate in the same way that the HFEA (96)8 is currently used to extend the storage period for embryos beyond the statutory storage period.

Centres should continue to order new batches of consent forms through the HFEA's Data Administrator, Sally Payne (020 7539 3332). However, if any questions relating to either the use of the new forms or the guidance notes arise, these should be directed to Ginny Shires (020 7539 3311) at the HFEA.

Yours faithfully,

Suzanne McCarthy
Chief Executive

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GUIDANCE  NOTES  FOR THE  COMPLETION  OF  HFEA  (00)9  CONSENT TO  THE  LONG  TERM STORAGE OF SPERM

INTRODUCTION

The Human Fertilisation and Embryology Act 1990 requires the effective consent of individuals for the storage and use of their gametes or embryos. This form has been designed for patients who satisfy the conditions for the long-term storage of gametes. These conditions are that the gametes must have been provided by a person:

a)  whose fertility since providing them has or is likely to become, in the written opinion of a registered medical practitioner, significantly impaired;

b)  who was aged under 45 on the date on which the gametes were provided; and

c)  who intends the gametes for his own use.

This is, therefore, a form for storage and not for the subsequent use of sperm in treatment services. It is expected that the appropriate forms for the use of sperm will be completed if the patient subsequently wishes to undergo fertility treatment (HFEA (00)6). The attached consent form may be used to ensure that legal obligations are fulfilled with respect to the long term storage of sperm.

The patient may withdraw or vary a consent that they have given by notice given to the person keeping the sperm or embryos. In this case it is advisable that a new consent form is completed. Patients should be asked to inform the centre of any changes that may affect the consent they have given. This may include a change of address or partner.

Before completing the consent form, the patient must be given suitable opportunity to receive proper counselling about the implications of the proposed steps and must be provided with all the relevant information. It is, however, appreciated that time may be very limited where the commencement of treatment is paramount.

GUIDANCE NOTES

The sections below relate to the corresponding sections of the consent form for the long term storage of sperm.

NAME

The full name of the patient should be entered in this section together with any other name by which he has been known to the centre.

CONSENT FOR STORAGE OF SPERM

a)  Patients who, since placing their sperm in storage, have, or are likely to develop significantly impaired fertility may indicate how many years they wish to keep their sperm in storage. This time period must not exceed their 55th birthday (see chart at the end of these guidelines). The other conditions of the regulations must also be fulfilled (see above).

b)  The patient must note the date of his 55th birthday to comply with the regulations for the extension of the statutory storage period, even if he does not wish to store the sperm for that long.

c)  A registered medical practitioner must verify that the fertility of the patient has, or is likely to become, significantly impaired since the sperm was placed in storage.

The registered medical practitioner may complete this section on the form or, alternatively, a letter to the same effect may be attached. This letter must state that, since providing the sperm, the fertility of the patient has, or is likely to become, significantly impaired.

d)  It is a statutory requirement that the patient specifies what should be done with his sperm should he die or become mentally incapacitated. This section of the form must be completed in all circumstances.

If the patient wishes his partner to have treatment with his sperm in the event of his death, or to donate his sperm to a project of research, he must complete a form for consent to storage and use of sperm and embryos (HFEA (00)6). Sperm held in storage for more than ten years cannot be donated for use in the treatment services of other people.

Any subsequent use of sperm in storage is not provided for by this consent form. An HFEA (00)6 form must be completed in this instance.

e)  The patient should indicate whether he has also completed an HFEA (00)6 form.

This form should be signed and dated by the patient.

CALCULATING THE MAXIMUM PERIOD OF STORAGE
Current Age    Possible Storage        Year of        Year of
  in years           Period in years             Birth      55th birthday
                          (not exceeding
                           55th Birthday)

   15                          40                            1960           2015
   16                          39                            1965           2020
   17                          38                            1970           2025
   18                          37                            1975           2030
   19                          36                            1980           2035
   20                          35                            1985           2040 etc
   21                          34
   22                          33
   23                          32
   24                          31
   25                          30
   26                          29
   27                          28
   28                          27
   29                          26
   30                          25
   31                          24
   32                          23
   33                          22
   34                          21
   35                          20
   36                          19
   37                          18
   38                          17
   39                          16
   40                          15
   41                          14
   42                          13
   43                          12
   44                          11

For example a man born on 1 January 1971 storing his sperm in the year 2000 would be eligible to store his sperm for a maximum of 26 years, not exceeding his 55th birthday which would be 1 January 2026.