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

HFEA guidance (cont)
Interpretation of mandatory requirements (cont)
(k) research activities being carried out under the supervision of anyone other than the
specific person designated in the licence
22A
(l)
a treatment licence authorising the activities of a research project, and
(m) a research licence applying to more than one research project.
The HFE (Special Exemptions) Regulations 2009 allow gametes to be stored without a licence for
research on gametes, for developing pharmaceutical or contraceptive products, or for teaching,
provided that the gametes are not used for treatment purposes or for other prohibited purposes set out
in the Regulations.
22.1 The person named as the person responsible on a research licence should not also be named as the
person responsible on a treatment licence.
22.2 The centre should have documented procedures for:
(a)
obtaining embryos to be used for research or training purposes, and
(b)
obtaining written informed consent from donors for research and training purposes, and
ensuring that embryos are used only in line with this consent.
22.3 If embryos or human admixed embryos will be used for research or training purposes, the research centre
should record, before the project starts:
(a)
the proposed duration of the culture period
(b)
(c)
the procedure that will be used to ensure that embryos do not develop after 14 days or the
primitive streak has appeared (if earlier), and
the method that will be used to terminate development.
See also guidance note:
17 – Storage of gametes and embryos
22.4 The centre should have documented procedures for ensuring that embryos and human admixed embryos
are used within the maximum period of storage permitted by law or within any period of storage specified
in the donor’s consent (if shorter).
Disclosure of interests
22.5 Staff involved in research should follow relevant guidelines produced by the respective professional bodies
(eg, the General Medical Council, or the Nursing and Midwifery Council). The centre should ensure that:
(a) all financial interests and sums of money known or estimated to be paid for the research are
disclosed to a research ethics committee, and
(b) all members of the research team, including nurses and non-medical staff, are informed about
how the research is being financed and managed.
Human Fertilisation and Embryology Authority
Guidance note | 22. Research and training
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