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

HFEA guidance (cont)
Interpretation of mandatory requirements (cont)
22D
(b)
If the person is an adult
(i)
The Authority must be satisfied that specified conditions relating to adults and
consent have been met.
(ii)
An appropriate person must have been consulted by the person responsible, and
given suitable information and an opportunity to state what the adult’s wishes and
feelings would have been about the proposed use of their cells for that purpose.
(iii) The person consulted must not have stated that the adult would have been likely
to refuse to consent.
(iv) Consent must not have been validly withdrawn by the person providing the cells
before the use of the cells or any resulting embryo or human admixed embryo.
For both a) and b), the cells or embryos (or cells derived from these) must have been lawfully stored for
research purposes before 1 October 2009, and certain conditions must have been met.
Human admixed embryos: general requirements
Mandatory requirements
Human Fertilisation and Embryology (HFE) Act 1990 (as amended)
4A Prohibitions in connection with genetic material not of human origin
(1) No person shall place in a woman–
(a) a human admixed embryo,
(b)
(c)
any other embryo that is not a human embryo, or
any gametes other than human gametes.
(2) No person shall–
(a) mix human gametes with animal gametes,
(b)
(c)
bring about the creation of a human admixed embryo, or
keep or use a human admixed embryo,
except in pursuance of a licence.
(3) A licence cannot authorise the keeping or using of a human admixed embryo after the earliest
of the following–
(a) the appearance of the primitive streak, or
(b) the end of the period of 14 days beginning with the day on which the process of
creating the human admixed embryo began, but not counting any time during which
the human admixed embryo is stored.
(4) A licence cannot authorise placing a human admixed embryo in an animal.
(5) A licence cannot authorise keeping or using a human admixed embryo in any circumstances in
which regulations prohibit its keeping or use.
Human Fertilisation and Embryology Authority
Guidance note | 22. Research and training
Version 1.0