Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

HFEA guidance
Consent to use and storage of gametes and embryos
Interpretation of mandatory requirements
The law requires the centre to obtain written informed consent from a person before it performs the
following procedures:
5A
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
storing their gametes (exemptions are outlined in the HFE (Special Exemptions)
Regulations 1991)
using their gametes for the treatment of others or for non-medical fertility services
creating embryos in vitro with their gametes
storing embryos created with their gametes
using embryos created with their gametes for their own treatment, treatment of a
partner or treatment of others
using embryos created with their gametes for training people in embryo biopsy,
embryo storage or other embryological techniques
using embryos created with their gametes for any research project
using their cells to create embryos for research, or
creating human admixed embryos with their gametes or cells.
The centre must ensure it obtains written informed consent from a person before procuring their
gametes. If gametes are collected without proper consent, it may be considered assault. Gametes
should not be taken from a person if written, informed consent to storage has not been obtained.
If no consent is in place, because the person is unable in law to provide it, or is deceased, then the
gametes must not be procured, stored or used. The provisions in the Human Tissue Act 2004 which
allow next of kin to provide consent to harvesting of other body tissues do not apply to gametes.
The law allows gametes to be stored without consent if the conditions met in paragraph 9 or 10, and
11 of Schedule 3 of the HFE Act 1990 (as amended) are met.
The law requires that gametes stored without consent cannot be used, unless the gamete provider
becomes competent and consents to such use.
If gametes or embryos are to be transferred to a centre outside the UK, the UK centre must obtain
the consent of the gamete provider(s) to their export to the country in which the receiving centre is
situated. Such consent must then be provided to the centre receiving the gametes or embryos.
If gametes or embryos are to be transferred into the UK from a centre outside the UK, the person
responsible for the UK centre must be satisfied that the provider has given written consent to the
transfer of the gametes or embryos to the UK, and has not withdrawn that consent.
Further requirements and the exemptions regarding obtaining consent to the use of gametes, cells and
embryos for research (including for the creation of admixed embryos), and the exemptions, are outlined
in guidance note 22 – Research and training.
Requirements regarding consent to parenthood are outlined in guidance note 6 – Legal parenthood.
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.
Human Fertilisation and Embryology Authority
Guidance note | 5. Consent to treatment, storage, donation and disclosure of information
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