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

HFEA guidance (cont)
See also guidance note:
3 – Counselling
5 – Consent to treatment, storage, donation, and
disclosure of information
12 – Egg sharing arrangements
See also:
HFEA consent forms available at www.hfea.gov.uk
Additional requirements for stem cell research
Mandatory requirements
The Human Fertilisation and Embryology Act 1990 (as amended):
Licence conditions
12 General conditions
(2) Subsection (3) applies to–
... (c) every licence under paragraph 3 of that Schedule, so far as authorising activities in
connection with the derivation from embryos of stem cells that are intended for
human application.
(3) It shall be a condition of every licence to which this subsection applies that–
(a) such information as is necessary to facilitate the traceability of gametes and
embryos, and
(b)
any information relating to the quality or safety of gametes or embryos,
Shall be recorded and provided to the Authority upon request.
14A
Conditions of licences: human application
(1) This section applies to–
(c) every licence under paragraph 3 of that Schedule [Schedule 2], so far as authorising
activities in connection with the derivation from embryos of stem cells that are intended
for human application.
(2) A licence to which this section applies may not authorise the storage, procurement, testing,
processing or distribution of gametes or embryos unless it contains the conditions required by
Schedule 3A.
(3) In relation to any gametes or embryos imported into the United Kingdom from an EEA state other
than the United Kingdom or from Gibraltar, compliance with the requirements of the laws or other
measures adopted in the relevant state or territory for the purpose of implementing the first, second
and third Directives shall be taken to be compliance with the conditions required by Schedule 3A.
(4) Subsection (3) shall not apply to any licence conditions imposed by the Authority which amount to
more stringent protective measures for the purposes of Article 4(2) of the first Directive.
Human Fertilisation and Embryology Authority
Guidance note | 22. Research and training
Version 1.0