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

HFEA guidance (cont)
Mandatory requirements (cont)
Licence conditions
R20
Prior to giving consent persons providing gametes or human cells for use in research that
involves the derivation of embryonic stem cells/lines, must be provided with the following
additional information:
a. that once an embryo or human admixed embryo has been used in the project of
research they will have no control over any future use of the embryonic cells or any
stem cells derived
b. that any stem cells/lines created may continue indefinitely and be used in many
different research projects and/or clinical therapy
c. that stem cells derived in this research project will be deposited in the UK Stem Cell
Bank and the implications of this including that they may be available to other research
groups nationally or internationally
d. that the stem cells/lines may be used for commercial purposes, but that they will not
benefit financially from this, and
e. that any stem cells/lines derived or discoveries made using them, could be patented,
but that they will not benefit financially from this.
R30
Where this licence authorises the derivation of human embryonic stem cell lines:
a. a sample of all stem cell lines derived must be deposited in the UK Stem Cell Bank in
accordance with any relevant Bank guidelines, and
b. the remainder of all stem cell lines (in so far as not used or destroyed as part of or in
the course of the research project) must be deposited in the UK Stem Cell Bank or
distributed in accordance with any relevant guidelines issued by the UK Stem
Cell Bank.
R41
Centres deriving stem cells for intended human application must comply with the additional
conditions set out in Annex A to the Research Licence.
R68
The centre must record such information as is necessary to facilitate the traceability of stem cells
derived from embryos that are intended for human application and any information relating to the
quality or safety of gametes and embryos. This information must be provided to the Authority
upon request.
Centres deriving stem cells for human application should adhere to the mandatory requirements
and guidance, outlined in other guidance notes, regarding:
Traceability and coding system
(19 – Traceability)
Serious adverse events and serious adverse reactions
(27 – Adverse incidents)
Third party agreements and termination of licensed activities
(24 – Third party agreements)
Procurement of gametes and embryos
(15 – Procuring, processing and transporting gametes and embryos)
Selection criteria and laboratory tests required for donors of reproductive cells
(11 – Donor recruitment, assessment and screening)
Donation and procurement procedures and reception at the tissue establishment
(15 – Procuring, processing and transporting gametes and embryos)
Human Fertilisation and Embryology Authority
Guidance note | 22. Research and training
Version 1.0