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

Mandatory requirements (cont)
(3) (cont)
(b)
P lacks capacity to consent to the storage of the gametes,
(c)
(d)
P is likely at some time to have that capacity, and
the storage of the gametes is in P’s best interests.
(4) Condition C is that, at the time when the gametes are first stored, P lacks capacity to consent
to their storage.
(5) Condition D is that P has not subsequently, at a time when P has capacity to give a consent
under this Schedule–
(a)
given consent to the storage of the gametes, or
(b)
given written notice to the person keeping the gametes that P does not wish them to continue
to be stored.
(6) In relation to Scotland–
(a) references in sub-paragraphs (3) and (4) to P lacking capacity to consent are to be read
as references to P being incapable, within the meaning of section 1(6) of the Adults with
Incapacity (Scotland) Act 2000, of giving such consent,
(b)
(c)
the references in sub-paragraphs (3) and (5) to P having capacity are to be read as references
to P not being so incapable, and
that Act applies to the storage of gametes under this paragraph to the extent specified in
section 84A of that Act.
11 A person’s gametes must not be kept in storage by virtue of paragraph 9 or 10 after the person’s death.
Licence conditions
T50
Prior to the storage of patient gametes or embryos the centre must:
a. Carry out the following biological tests to assess the risk of cross contamination
HIV 1 and 2: Anti-HIV – 1, 2
Hepatitis B: HBsAg/Anti-HBc
Hepatitis C: Anti-HCV-Ab
b. Devise a system of storage which clearly separates:
quarantined/unscreened gametes and embryos,
gametes and embryos which have tested negative, and
gametes and embryos which have tested positive.
c. Perform HTLV- 1 antibody testing for patients living in or originating from high incidence areas
or with sexual partners originating from those areas or where the donor’s parents originate
from those areas
d. In certain circumstances, carry out additional testing depending on the patient’s travel
and exposure history and the characteristics of the tissue or cells donated
(eg, Rh D, Malaria, CMV, T.cruzi)
Positive results will not necessarily prevent the use of the partners’ gametes.
Human Fertilisation and Embryology Authority
Guidance note | 17. Storage of gametes and embryos
Version 1.0