CE(00)07
20 July 2000
To: Persons Responsible
Dear Colleague,
Guidance for the Completion of HFEA Statutory Consent Forms
As many of you are aware, the HFEA has updated its statutory consent forms for the storage and use of gametes and embryos. In addition, new comprehensive guidance notes on the completion of both consent forms have been produced.
It has also been agreed that, in future, HFEA consent forms will no longer be provided in pads. They will now be distributed loose leafed with refillable folders. These folders have the new guidance notes attached for reference purposes.
You will find enclosed with this letter two orange folders containing the new consent forms. Many centres will have received copies of these new forms already, but for those that have not, a brief explanation of the changes is given in the following paragraphs.
Centres, if they wish, may continue using their remaining pads of HFEA (96)6 and (96)7 until these stocks are exhausted. The only exception to this is for women who are freezing their eggs for whom the new HFEA (00)7 consent form must be used.
HFEA (00)6 Consent to the Storage and Use of Sperm and Embryos
(Previously HFEA (96)6)
This form is very similar to the previous form HFEA (96)6, except that a space has been provided for a partner's name in Part I USE a.i. as well as PART I USE b.i..
The completion of this space with a partner's name should remove any ambiguity that may exist over who the sperm provider wishes to be inseminated with his stored sperm. This has caused problems in the past when consent has been given for the sperm to be used posthumously and the identity of the intended recipient is unclear.
Additionally, the guidance puts added emphasis on the importance of patients informing centres of any changes, such as a change of partner, which may require them to complete a new consent form.
HFEA (00)7 Consent to the Storage and Use of Eggs and Embryos
(Previously HFEA (97)6)
The new consent form HFEA (00)7 was developed to accommodate the consent requirements of women who wish to freeze their eggs. The forms can be used in the same way as the HFEA (97)6 for women wishing to create embryos and/or donate their eggs.
Please note it is only patients who are contemplating the freezing of their eggs that need to be given the HFEA's information leaflet on egg freezing that is mentioned at the top of the consent form.
Centres should continue to order new batches of consent forms through the 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 Danielle Marx (020 7539 3308) or 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)6 CONSENT TO STORAGE AND USE OF SPERM AND EMBRYOS
INTRODUCTION
The Human Fertilisation and Embryology Act 1990 requires the effective consent of individuals for the storage and use of their gametes or embryos. These consents must, by law, specify the purpose for which the patient's genetic material is intended.
Completion of this HFEA consent form will ensure that men providing or donating sperm have given the necessary consents. Any man producing sperm which is to be stored, used for the treatment of a woman, used to fertilise eggs in vitro or used in research must complete and sign the consent form.
A man providing sperm should be informed that one consent will be assumed to cover all the sperm he provides on successive occasions at that centre unless he specifies otherwise on the consent form. In the exceptional case of a man providing sperm at more than one centre, each centre must obtain a separate consent.
A man 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.
The terms of any consent to the use of any embryo cannot be varied, and such consent cannot be withdrawn, once the embryo has been used in providing treatment services or for the purposes of a project of research.
Couples undertaking treatment together should be reminded that their consents to the storage and use of embryos developed in vitro using their gametes must be compatible, otherwise their consents will be invalid and the future use of their embryos will be affected.
Before completing the consent form, the man must be given a suitable opportunity to receive proper counselling about the implications of the proposed steps and must be provided with all the relevant information. Centres may wish to make reference to the Code of Practice where this requirement is explained.
No carbon is required to make a duplicate copy. Centres must retain the top copy for their own records and give a duplicate to the man providing the sperm. Guidance notes are provided here. The forms should be completed in ball point pen, or typed.
GUIDANCE NOTES
The sections below relate to the corresponding sections of the consent form for the storage of sperm and embryos.
NAME
The full name of the man concerned should be entered in this section together with any other name by which he has been known.
PART I - CONSENT FOR USE OF SPERM AND EMBRYOS
Ia This section enables the man to consent to the use of his sperm for a specific purpose.
i The man may consent to the use of his sperm in the treatment of his partner. The partner with whom the man is having treatment must be named in full. This is only consent to treatment that does not involve the creation of an embryo in vitro and the man concerned must be aware that this clause is insufficient for treatment using IVF and ICSI. In order to have treatment that involves the creation of an embryo section Ib must be completed.
ii The man may indicate that he wishes to donate sperm for the treatment of others. In this case, he must be screened in accordance with BAS guidelines. This section only provides for donation and not the creation of an embryo in vitro. If the man concerned wishes to allow the creation of embryos from his sperm for the treatment of others, he must give his consent in section Ib.
iii The man may indicate that he wishes to donate his sperm to a project of research. He must have received all relevant information pertaining to the nature of the research that might be carried out. This section only provides for the donation of sperm and not the creation of embryos from this sperm for the purpose of research. If the man concerned wishes to allow the creation of embryos from his sperm to be used in research, he must give his consent in section Ib.
The man concerned may indicate any particular conditions that he wishes to place on the use of his sperm.
Ib This section enables the man to consent to the use of his sperm for the creation of an embryo in vitro.
i This section must be completed in order for any treatment involving the creation of an embryo in vitro to take place, including ICSI. The partner with whom the man is having treatment must be named in full.
ii The man may consent here to the use of his sperm for the creation of an embryo in vitro for the treatment of others. In this case, he must be screened in accordance with BAS guidelines,
iii The man may consent here to the use of his sperm for the creation of an embryo in vitro for a project of research. He must have received all relevant information pertaining to the nature of the research that might be carried out.
The man concerned may indicate any particular conditions that he wishes to place on the use of his sperm. This section of the form must be signed and dated.
PART II - CONSENT FOR THE STORAGE OF SPERM AND EMBRYOS
IIa This section enables the man to specify a length of time for which his sperm is to remain in storage. In the event that he is eligible to store his sperm for longer than ten years, a form for the consent to the long-term storage of sperm should be completed.
IIb The man may specify here the length of time that embryos created with his sperm may be kept in storage. For the embryos to be kept in storage for longer than five years, the woman with whom he is being treated must be eligible for long-term storage. If this is the case, this form should be accompanied by a completed HFEA (96)8 for the extension of the statutory storage period of embryos.
In order for the recipient of donor sperm or embryos to extend the storage period of her embryos, the consent of the man who has provided the sperm must be given. For this reason, centres may wish to advise men who donate their sperm to indicate a storage period for embryos of longer than ten years to prevent subsequent complications.
IIc This section provides for what should happen to the sperm and embryos in the event of the death or mental incapacity of the person concerned. It must be completed in all circumstances.
i This option indicates that the genetic material of the man be allowed to perish in the event of his death or mental incapacity.
ii The man may indicate that, in the event of his death or mental incapacity, his sperm or embryos may continue in storage for the purposes to which he consented in section I. The man must be aware that a consent given under section la will only enable his sperm to be used for insemination after his death. If he wishes his partner, or those to whom he has donated, to have IVF or ICSI treatment, this must have been indicated in Section Ib.
If the man wishes that his sperm, or embryos created using his sperm be donated for the treatment of others after his death, or if he wishes to allow the creation of embryos after his death for the treatment of others, he must have been screened at the time of storage and preferably have been tested again after six months storage. Even if donation is not the primary intention, therefore, the man can only donate samples posthumously if such screening has been carried out.
iii The man concerned may indicate other purposes for which his sperm, or embryos created using his sperm, may be used in the event of his death or mental incapacity. This may include donating them to projects of research.
If a man wishes his partner to use his sperm or embryos in the event of his death or incapacity he is advised to indicate this clearly in the space provided.
IId The man concerned may indicate here any other conditions of storage. He may, for example, choose to distinguish between sperm or embryos intended for the treatment of his partner and those intended for donation
IIe The man concerned must be reminded of the statutory storage period of embryos and the centre's obligation to allow those embryos to perish once they reach the end of their storage period.
This form must be signed and dated by the man concerned.
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GUIDANCE NOTES FOR THE COMPLETION OF HFEA
(00)7 CONSENT TO THE STORAGE AND USE OF EGGS AND EMBRYOS
INTRODUCTION
The Human Fertilisation and Embryology Act 1990 requires the effective consent of individuals for the storage and use of their gametes or embryos. These consents must, by law, specify the purpose for which the patient's genetic material is intended.
Completion of this HFEA consent form will ensure that women providing eggs have given the necessary consents. Any women producing eggs to be stored, used in the treatment of another woman, used in research or to be fertilised in vitro to produce embryos which may be stored and subsequently used in treatment or research, must complete and sign the consent form.
A woman providing eggs(s) should be informed that one consent will be assumed to cover all the egg(s) she provides at that centre unless she specifies otherwise on the form. In the exceptional case of a woman providing egg(s) at more than one centre, each centre must obtain a separate consent.
A woman may withdraw or vary a consent that she has given by notice given to the person keeping the egg(s) or embryo(s). In this case, it is advisable that a new consent form is completed. Patients should be asked to inform the clinic of any changes that may affect the consent that they have given. This may include a change of address or partner.
The terms of any consent to the use of any egg or embryo cannot be varied, and such consent cannot be withdrawn once the genetic material has been used in providing treatment services or for the purposes of a project of research.
Couples undertaking treatment together should be reminded that their consents to the storage and use of embryos developed in vitro using their gametes must be compatible, otherwise their consents will be invalid and the future use of their embryos will be affected.
Before completing the consent form, the woman must be given a suitable opportunity to receive proper counselling about the implications of the proposed steps and must be provided with all the relevant information. Centres may wish to make reference to the Code of Practice where this requirement is explained.
No carbon is required to make a duplicate copy. Centres must retain the top copy for their own records and give a duplicate to the woman providing the egg(s). Guidance notes are provided here. The form should be completed in ball point pen, or typed.
GUIDANCE NOTES
The sections below relate to the corresponding sections of the consent form for the storage of eggs and embryos.
NAME
The full name of the woman concerned should be entered in this section together with any other name by which she has been known.
PART I - CONSENT FOR USE OF EGGS AND EMBRYOS
Ia This section enables the woman concerned to consent to the use of her eggs for a specific purpose.
i The woman concerned may consent to the use of her eggs in her own treatment. This is only consent to treatment that does not involve the creation of an embryo in vitro and the woman must be aware that this clause is insufficient for treatment using IVF and ICSI. In order to have treatment that involves the creation of an embryo section Ib must be completed.
ii The woman concerned may indicate that she wishes to donate eggs for the treatment of others. In this case, she must be screened accordingly. This section only provides for donation and not the creation of an embryo in vitro. If the woman concerned wishes to allow the creation of embryos from her eggs for the treatment of others, she must give her consent in section Ib.
iii The woman may indicate that she wishes to donate her eggs to a project of research. She must have received all relevant information pertaining to the nature of the research that might be carried out. This section only provides for the donation of eggs for the purpose of research. If the woman concerned wishes to allow the creation of embryos from her eggs to be used in research, she must give her consent in section Ib.
The woman concerned may indicate any particular conditions that she wishes to place on the use of her eggs.
Ib This section enables the woman to the consent to the use of her eggs for the creation of an embryo in vitro.
i This section must be completed in order for any treatment involving the creation of the embryo in vitro to take place, including ICSI. If the woman is having treatment together with a partner, he must be named in full on the consent form.
ii The woman may consent here to the use of her eggs for the creation of an embryo in vitro for the treatment of others. In this case, she must be screened accordingly.
iii The woman may consent here to the use of her eggs for the creation of an embryo in vitro for a project of research. She must have received all relevant information pertaining to the nature of the research that might be carried out.
The woman concerned may indicate any particular conditions that she wishes to place on the use of her eggs. This section of the form must be signed and dated.
PART II - CONSENT FOR THE STORAGE OF EGGS AND EMBRYOS
IIa This section enables the woman concerned to specify a length of time for which her eggs are to remain in storage. In the event that she is eligible to store her eggs for longer than ten years, a form for consent to the long term storage of eggs should be completed.
IIb This section enables the woman concerned to specify a length of time for which embryos created using her eggs may remain in storage. If she is eligible to store her embryos for longer than five years, this form should be accompanied by a completed HFEA (96)8 for the extension of the statutory storage period of embryos.
In order for the recipient of donor eggs or embryos to extend the storage period of her embryos, the consent of the woman who has provided the eggs must be given. For this reason, centres may wish to advise women who donate their eggs to indicate a storage period for embryos of longer than ten years to prevent subsequent complications.
IIc This section provides for what should happen to the eggs and embryos in the event of death or mental incapacity of the person concerned. It must be completed in all circumstances.
i This option indicates that the eggs and/or embryos of the patient be allowed to perish in the event of her death or mental incapacity.
ii The woman may indicate that, in the event of her death or mental incapacity, her eggs and/or embryos may continue in storage for the purposes to which she consented in sections Ia and Ib, however it is important to note this is only valid for Ia ii and iii and Ib ii and iii, i.e. for donation to others or research.
If a woman wishes for her eggs and/or embryos to be donated for the treatment of others after her death, she must have been screened at the time of storage and preferably have been tested again after six months storage. Therefore, even if donation is not the primary intention a woman can only donate posthumously if such screening has been carried out.
iii The woman concerned may indicate here any other conditions of storage. She may, for example, choose to distinguish between eggs or embryos intended for her own treatment and those intended for donation.
If the woman wishes for her eggs and/or embryos to be carried by another woman (a surrogate for example) for her partner she should specify this clearly in the space provided. Again the woman will need to have been screened at the time of storage and preferably have been tested again after six months storage. Eggs or embryos can only be used posthumously if such screening has been carried out.
IId The woman concerned may indicate any particular conditions that she wishes to place on the use of her eggs. This section of the form must be signed and dated.
IIe The woman concerned must be reminded of the statutory storage period of embryos and the centre's obligation to allow these embryos to perish once they reach the end of their storage period.
This form must be signed and dated by the woman concerned.
Page last updated: 24 August 2012