Human Fertilisation and Embryology (HFE) Act 1990 (as amended)

12 General Conditions

• (1)

  The following shall be conditions of every licence granted under this Act -

  …(c) except in relation to the use of gametes in the course of providing basic partner treatment services, that the provisions of Schedule 3 to this Act shall be complied with..,

Schedule 3 - Consent to use or storage of gametes, embryos or human admixed embryos etc

• 1

  (1) A consent under this Schedule, and any notice under paragraph 4 varying or withdrawing a consent under this Schedule, must be in writing and, subject to sub-paragraph (2), must be signed by the person giving it.

  (2) A consent under this Schedule by a person who is unable to sign because of illness, injury or physical disability (a “person unable to sign”), and any notice under paragraph 4 by a person unable to sign varying or withdrawing a consent under this Schedule, is to be taken to comply with the requirement of sub-paragraph (1) as to signature if it is signed at the direction of the person unable to sign, in the presence of the person unable to sign and in the presence of at least one witness who attests the signature.

  (3) In this Schedule “effective consent” means a consent under this Schedule which has not been withdrawn.

• 2

  (1) A consent to the use of any embryo must specify one or more of the following purposes -

  (a) use in providing treatment services to the person giving consent, or that person and another specified person together,

  (b) use in providing treatment services to persons not including the person giving consent,

  (ba) use for the purpose of training persons in embryo biopsy, embryo storage or other embryological techniques, or

  (c) use for the purposes of any project of research,

  and may specify conditions subject to which the embryo may be so used.

  (2) A consent to the storage of any gametes, any embryo or any human admixed embryo must -

  (a) specify the maximum period of storage (if less than the statutory storage period),

  (b) except in a case falling within paragraph (c), state what is to be done with the gametes, embryo or human admixed embryo if the person who gave the consent dies or is unable, because the person lacks capacity to do so, to vary the terms of the consent or to withdraw it,and

  (c) where the consent is given by virtue of paragraph 8(2ZA) or 13(2), state what is to be done with the embryo or human admixed embryo if the person to whom the consent relates dies,

  and may (in any case) specify conditions subject to which the gametes, embryo or human admixed embryo may remain in storage.

  (2A) A consent to the use of a person’s human cells to bring about the creation in vitro of an embryo or human admixed embryo is to be taken unless otherwise stated to include consent to the use of the cells after the person’s death.

  (2B) In relation to Scotland, the reference in sub-paragraph (2)(b) to the person lacking capacity is to be read as a reference to the person -

  (a) lacking capacity within the meaning of the Age of Legal Capacity (Scotland) Act 1991, or

  (b) being incapable within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000.

  (3) A consent under this Schedule must provide for such other matters as the Authority may specify in Directions.

  (4) A consent under this Schedule may apply -

  (a) to the use or storage of a particular embryo or human admixed embryo, or

  (b) in the case of a person providing gametes or human cells, to the use or storage of –

  (i) any embryo or human admixed embryo whose creation may be brought about using those gametes or those cells, and

  (ii) any embryo or human admixed embryo whose creation may be brought about using such an embryo or human admixed embryo.

  (5) In the case of a consent falling within sub-paragraph (4)(b), the terms of the consent may be varied, or the consent may be withdrawn, in accordance with this Schedule either generally or in relation to –

  (a) a particular embryo or particular embryos, or

  (b) a particular human admixed embryo or particular human admixed embryos.

Procedure for giving consent

• 3

  (1) Before a person gives consent under this Schedule -

  (a) he must be given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and

  (b) he must be provided with such relevant information as is proper.

  (2) Before a person gives consent under this Schedule he must be informed of the effect of paragraph 4 and, if relevant, paragraph 4A below.

  
  
  

Use of gametes for treatment of others

• 5

  (1) A person's gametes must not be used for the purposes of treatment services or non-medical fertility services unless there is an effective consent by that person to their being so used and they are used in accordance with the terms of the consent.

  (2) A person's gametes must not be received for use for those purposes unless there is an effective consent by that person to their being so used.

  (3) This paragraph does not apply to the use of a person's gametes for the purpose of that person, or that person and another together, receiving treatment services.

In vitro fertilisation and subsequent use of embryo

• 6

  (1) A person's gametes or human cells must not be used to bring about the creation of any embryo in vitro unless there is an effective consent by that person to any embryo, the creation of which may be brought about with the use of those gametes or human cells, being used for one or more of the purposes mentioned in paragraph 2(1)(a), (b) and (c) above.

  (2) An embryo the creation of which was brought about in vitro must not be received by any person unless there is an effective consent by each relevant person in relation to the embryo to the use for one or more of the purposes mentioned in paragraph 2(1) (a), (b), (ba) and (c) above of the embryo.

  (3) An embryo the creation of which was brought about in vitro must not be used for any purpose unless there is an effective consent by each relevant person in relation to the embryo to the use for that purpose of the embryo and the embryo is used in accordance with those consents.

  (3E) For the purposes of sub-paragraphs (2), (3) and (3ZB) each of the following is a relevant person in relation to an embryo the creation of which was brought about in vitro (“embryo A”) -

  (a) each person whose gametes or human cells were used to bring about the creation of embryo A,

  (b) each person whose gametes or human cells were used to bring about the creation of any other embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A, and

  (c) each person whose gametes or human cells were used to bring about the creation of any human admixed embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A.

  (4) Any consent required by this paragraph is in addition to any consent that may be required by paragraph 5 above.

Embryos obtained by lavage, etc

• 7

  (1) An embryo taken from a woman must not be used for any purpose unless there is an effective consent by her to the use of the embryo for that purpose and it is used in accordance with the consent.

  (2) An embryo taken from a woman must not be received by any person for use for any purpose unless there is an effective consent by her to the use of the embryo for that purpose.

  (3) Sub-paragraphs (1) and (2) do not apply to the use, for the purpose of providing a woman with treatment services, of an embryo taken from her.

  (4) An embryo taken from a woman must not be used to bring about the creation of any embryo in vitro or any human admixed embryo in vitro.

Storage of gametes and embryos

• 8

  (1) A person's gametes must not be kept in storage unless there is an effective consent by that person to their storage and they are stored in accordance with the consent.

  (2) An embryo the creation of which was brought about in vitro must not be kept in storage unless there is an effective consent, by each relevant person in relation to the embryo, to the storage of the embryo and the embryo is stored in accordance with those consents…

  (2C) For the purposes of sub-paragraphs (2) and (2A) each of the following is a relevant person in relation to an embryo the creation of which was brought about in vitro (“embryo A”) -

  (a) each person whose gametes or human cells were used to bring about the creation of embryo A,

  (b) each person whose gametes or human cells were used to bring about the creation of any other embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A, and

  (c) each person whose gametes or human cells were used to bring about the creation of any human admixed embryo, the creation of which was brought about in vitro, which was used to bring about the creation of embryo A.

  (3) An embryo taken from a woman must not be kept in storage unless there is an effective consent by her to its storage and it is stored in accordance with the consent.

  (4) Sub-paragraph (1) has effect subject to paragraphs 9 and 10; and sub-paragraph (2) has effect subject to paragraphs 4A(4), 16 and 20.

Interpretation

• 16

  (6) References in this Schedule to capacity are, in relation to England and Wales, to be read in accordance with the Mental Capacity Act 2005.

Act guidance section

Licence conditions

• T57

  Gametes or embryos must not be used in the provision of treatment services (except in the use of gametes in the course of providing basic partner treatment services or non-medical fertility services) unless effective consent is in place from each gamete provider in accordance with Schedule 3 of the Human Fertilisation and Embryology Act 1990 (as amended).

Directions

• • 0006 - Import and export of gametes and embryos
  • 0007 - Consent

   

   

Regulations

The Human Fertilisation and Embryology (Special Exemptions) Regulations 1991
The Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009

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Consent to use and storage of gametes and embryos

• 5.1

  The centre should obtain written informed consent from a person before it carries out the following procedures:

  a) using their gametes for their own treatment or their partner’s treatment, or

  b) using their gametes for research and training.

• 5.2

  When a woman is to undergo an egg or embryo transfer, the centre should:

  a) obtain her consent to the proposed number of eggs or embryos to be transferred, and

  b) record her consent in her medical records.

• 5.3

  The centre should establish and use documented procedures to ensure that no activity involving the handling or processing of gametes or embryos is carried out without the appropriate consent having been given.

Procedure for obtaining consent

• 5.4

  Centres should ensure that, before a person gives consent, they are given the information outlined in guidance note 4 – Information to be provided prior to consent.

• 5.5

  The centre should inform anyone providing gametes that they can, if they wish, specify extra conditions for storing or using their gametes (or embryos created using them).

• 5.6

  The centre should give anyone seeking treatment or considering donation or storage enough time to reflect on their decisions before obtaining their consent. The centre should give them an opportunity to ask questions and receive further information, advice and guidance.

• 5.7

  If the possibility of donating gametes or embryos for the treatment of others, or donating embryos for research or training purposes, arises during the course of treatment, the centre should allow potential donors enough time to consider the implications and to receive counselling before giving consent.

• 5.8

  The centre should ensure that consent is:

  a) given voluntarily (without pressure to accept treatment or agree to donation)

  b) given by a person who has capacity to do so, as defined by the Mental Capacity Act 2005 (England and Wales), or the Age of Legal Capacity (Scotland) Act 1991 and the Adults with Incapacity (Scotland) Act 2000, and

  c) taken by a person authorised by the centre to do so.

• 5.9

  The centre should ensure that anyone giving consent declares that:

  a) they were given enough information to enable them to understand the nature, purpose and implications of the treatment or donation

  b) they were given a suitable opportunity to receive proper counselling about the implications of the proposed procedures

  c) they were given information about the procedure for varying or withdrawing consent, and

  d) the information they have given in writing is correct and complete.

• 5.10

  Treatment centres should take all reasonable steps to verify the identity of anyone accepted for treatment, including partners who may not visit the centre during treatment. If a patient’s identity is in doubt, the centre should verify their identity, including examining photographic evidence such as a passport or a photocard driving licence. The centre should record this evidence in the patient’s medical records.

• 5.11

  To avoid the possibility of misrepresentation or mistake, the centre should check the identities of patients (and their partners, if applicable) against identifying information in the medical records. This should be done at each consultation, examination, treatment or donation.

• 5.12

  The centre should consider the needs of people whose first language is not English and those who face other communication barriers. Where consent is obtained, the centre should record:

  a) any difficulties in communicating the implications of giving consent and providing other information to the person (eg, language barriers or hearing impairment), and

  b) an explanation of how these difficulties were overcome (eg, the use of an independent interpreter). (This guidance is based on a paragraph taken from The Human Tissue Authority's Code of Parctice on Consent (2008))

• 5.13

  The centre should establish and follow documented procedures to obtain written informed consent.

Recording consent and related information

• 5.14

  The centre should keep a copy of the signed consent forms and make a copy available to those giving consent.

• 5.15

  The centre should ensure that it documents in the medical records that relevant information, as outlined in guidance note 4, has been provided to the person giving consent.

Additional consent requirements for storing gametes and embryos

• 5.16

  The centre should normally ask patients to give consent to storage at the same time as consent to the use of gametes and embryos. However, the centre should accommodate anyone seeking long-term storage of gametes who may wish to consent to storage separately from consent to use.

• 5.17

  Before the centre obtains consent from anyone wishing to store gametes or embryos for more than 10 years, it should ensure that the conditions for extended storage in the relevant regulations are satisfied.

• 5.18

  Consent to the use of gametes or embryos for the treatment of others should state the number of families that may have children using the donated gametes or embryos.

• 5.19

  When an individual gives consent to the use of gametes for the treatment of others, the centre need not get consent from the donor’s partner or spouse. However, if the donor is married, in a civil partnership or in a long-term relationship, the centre should encourage them to seek their partner’s support for the donation of their gametes.

• 5.20

  Men who wish to donate embryos originally created for the treatment of their partner and themselves, and those people considering treatment with such embryos, should be:

  a) informed of the uncertain legal status of men donating embryos created originally for the treatment of their partner and themselves, when the embryos are used in the treatment of a single woman

  b) referred to information on the HFEA’s website on this issue, and

  c) advised to seek independent legal advice before consenting to donate their embryos or being treated with the embryos.

Additional consent requirements for those participating in a benefits in kind agreement

• 5.21

  The person obtaining consent should ensure that a gamete provider’s consent is recorded so that different conditions can be placed on:

  a) the use or storage of the gametes, and the use and storage of embryos created for the gamete provider’s own treatment, and

  b) the use of eggs or sperm, and the use and storage of embryos created for the treatment of the recipient(s)

   These conditions should be able to be varied independently of each other.

• 5.22

  The person obtaining consent should tell the gamete provider and recipient(s) that the gamete provider may withdraw or vary their consent up to when the gametes or embryo(s) are:

  a) transferred to a woman
  b) used in a research project (defined as being under the control of the researchers and being cultured for use in research)
  c) used for training, or
  d) allowed to perish.

  The possible consequences of this should:

  a) be made clear to the gamete provider and the recipient(s) before the treatment begins, and
  b) be set out in the written patient information included with the benefits in kind agreement.

Consent to examination and treatment

• 5.23

  Everyone has the right to withhold or give consent to examination and treatment. Unless there are exceptional circumstances, the centre may not examine, treat or receive gametes from people without first obtaining their consent. The only exceptional circumstance likely to arise during fertility treatment is:

  a) where the procedure is necessary to save the patient’s life, and

  b) the treatment cannot be postponed, and

  c) the patient is unconscious or mentally incapacitated so cannot indicate their wishes.

• 5.24

  The centre should comply with current professional guidelines on consent.

Consent to the presence of observers

• 5.25

  If a member of the centre’s team wishes an observer to be present when a patient is being examined, treated or counselled, they should explain why beforehand and state who the observer is. The centre should give the patient appropriate information about the proposed observation and ask them whether they consent to the observer’s presence.

Consent to disclose identifying information

• 5.26

  Before obtaining consent to disclose information, the centre should give the person enough information for them to make a properly informed decision, including:

  a) precisely what information is to be disclosed

  b) the terms on which it is to be disclosed

  c) the reasons for disclosure (eg, to keep the person’s GP informed about the fertility treatment)

  d) the implications of disclosure, in particular the fact that, once it is disclosed, the information will be subject no longer to the special provisions of the HFE Act 1990 (as amended) but only to the general law of confidentiality, and

  e) the categories of people to whom the information is to be disclosed.

• 5.27

  The centre should seek consent to disclosure to the following categories of people:

  a) the patient’s GP or the patient's partner's GP

  b) other healthcare professionals outside the centre (so they can provide the patient or the patient’s partner with the best possible medical care)

  c) auditors or administrative staff outside of the centre (so they can perform their functions in connection with the centre’s licensable activities), and

  d) medical or other researchers (so they can contact the patient about specific research projects or carry out non-contact research).

• 5.28

  The centre should renew consent to disclosure if the nature of treatment changes after initial consent has been given (eg, if during treatment, it is proposed that donor gametes are used instead of the patient’s own, or if the patient moves from unlicensed to licensed fertility treatment).

• 5.29

  The centre should ensure that people to whom they disclose identifying information know that the information remains protected by the existing common law on confidentiality. Those receiving information should also be told:

  a) the precise terms upon which it was disclosed and for which consent has been given, and

  b) that if they disclose the information they have received, a child might learn in an inappropriate way that they were born as a result of fertility treatment.

Cases where consent is not required for storage

• 5.30

  Before storing someone’s gametes without their consent, the centre should judge that the person is not competent to consent to the storage of gametes. When assessing the competence of children and adults to consent, the centre should follow current guidance produced by the Department of Health, the General Medical Council and other professional bodies.

• 5.31

  The centre should presume that it is in the child’s best interests to store gametes unless circumstances suggest otherwise. When assessing whether it is in a child’s best interests to procure and store their gametes, the centre should refer to the General Medical Council guidance ‘0-18 years: guidance for all doctors’ and consider the child’s short- and long-term best interests. Consent should be sought from the child when they reach competence.

• 5.32

  The centre should provide written information that children and young people can read and understand easily. This information should be given by a member of staff experienced in communicating with children.

Competence

• 5.33

  If the centre’s staff doubt someone’s competence to consent to a proposed procedure, or to the storage or use of gametes or embryos, they should:

  a) refer to the Mental Capacity Act 2005 (England and Wales), or the Age of Legal Capacity (Scotland) Act 1991 and the Adults with Incapacity (Scotland) Act 2000, and

  b) follow the current guidelines of professional bodies. If they remain in any doubt, the centre should seek legal advice.

Variation and withdrawal of consent

• 5.34

  The centre should check the identity of anyone withdrawing or varying consent against identifying information held in the medical records. The centre should also ensure that the person withdrawing or varying consent has been given sufficient information to enable them to make an informed decision about doing so.

• 5.35

  The centre should have procedures for dealing with disputes that may arise when one gamete provider withdraws their consent to the use or storage of gametes or embryos in treatment. In this situation the centre should stop treatment and notify all relevant parties. Centres should provide information about counselling or mediation services as appropriate.

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Consent to examination and treatment

• Reference Guide to Consent for Examination or Treatment (Department of Health, April 2001)
• Consent: patients and doctors making decisions together (General Medical Council, 2008)  
• Human Tissue Authority Code of Practice 1: Consent (Human Tissue Authority, September 2009)
• Gynaecological Examinations: Guidelines for Specialist Practice (RCOG 2002)

Competence

• Consent: patients and doctors making decisions together (General Medical Council, 2008)
• 0-18 years: guidance for all doctors (General Medical Council, 2007)
• Seeking consent: working with children (Department of Health, January 2001)
• Best Practice Guidance for Doctors and other Health Professionals on the provision of Advice and Treatment to Young People under 16 on Contraception, Sexual and Reproductive Health (Department of Health, 2004).
• Mental Capacity Act 2005
• Mental Capacity Act 2005 – Code of Practice (2007)
• Age of Legal Capacity (Scotland) Act 1991
• Adults with Incapacity (Scotland) Act 2000

Copies of the relevant legislation can be found online here.

 

 

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