Code of Practice

292 Pages·2017·4.11 MB·English

Edition 8.0 Human Fertilisation and
First published October 2009 Embryology Authority
Revised April 2010, April 2011, 10 Spring Gardens
October 2011, April 2012, London
October 2013, October 2014, SW1A 2BU
April 2015, October 2015, July
t 020 7291 8200
2016, May 2017
e [email protected]
w www.hfea.gov.uk

Presented to Parliament pursuant to section 26(4) of the
Human Fertilisation and Embryology Act 1990
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Where third party material has
Revised April 2010, April 2011,
been identified, permission from
October 2011, April 2012,
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October 2013, October 2014,
must be sought.
April 2015, October 2015,
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Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority

Version 10.0

This table provides a record of revisions made to the 8th edition of the Code of Practice since it was
published in October 2009. The table shows which sections have been revised and the date that they
were implemented.
Section Content change Date last revised
Copyright page Revision May 2017
Removed reference to index Oct 2013
Contents Title of guidance note 25 Oct 2014
Added guidance note 33 Oct 2015
Removed reference to index Oct 2013
User guide to the Code
Removed reference to regulatory
Jul 2016
principles
Regulatory principles for licensed
Withdrawn Jul 2016
centres
Mandatory requirements
1. Person responsible T7 Oct 2011
1.1-1.2, 1.5
T14, 2.15, 2.16, 2.18, 2.24c Oct 2014
2.14, 2.20, 2.22, 2.23, 2.24, 2.25,
Oct 2015
2. Staff 2.26, 2.27, 2.28
2.25, 2.26, 2.27, 2.28 (renumbering)
Jul 2016
Other legislation/information
Mandatory requirements
Oct 2011
T60, T61
3. Counselling Other legislation/information Oct 2013
3.13 Oct 2014
3A, 3.3, 3.5, 3.7a, 3.10 Oct 2015
4. Information to be provided prior 4.5
Oct 2014
to consent Other legislation/information
Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority

4A, 4.4 Oct 2015
Other legislation/information Jul 2016
5A Apr 2010
5A, 5D, 5.21-5.22 Apr 2012
5A, 5H Oct 2013
5.4, 5.16 Oct 2014
5. Consent to treatment, storage, 5.6, 5.16, 5.19, 5.20 Apr 2015
donation, and disclosure of
Mandatory requirements
information Oct 2015
5A, 5H, 5.9, 2.25
Other legislation/information Jul 2016
Mandatory requirements
5A, 5.1, 5.3-5.40, 5D, 5G May 2017
Other legislation/information
6G Apr 2010
Mandatory requirements
Oct 2011
T60, T61
6.1-6.6, 6.8, 6.9, 6.11, 6A, 6C, 6D,
Oct 2013
6G, 6.12, Decision tree
6. Legal parenthood
Mandatory requirements
Oct 2015
6H
Mandatory requirements
6.4-6.30, 6A, 6B, 6C, 6D, 6E, 6F, May 2017
6G, 6H, 6I, 6J, 6K, 6L
7A Apr 2010
7.1 Apr 2011
Mandatory requirements
T123 Oct 2011
7. Multiple births
7.1-7.2
7.2
Oct 2013
Other legislation/information
T123 Oct 2014
8.5
8. Welfare of the child Oct 2013
Other legislation/information
Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority

8.5 Oct 2015
Mandatory requirements
Oct 2011
T88, T89, T90

9. Preimplantation genetic
9.1-9.3, 9B
screening (PGS)
9A, 9.1-9.8
Jul 2016
Other legislation/information
Mandatory requirements Apr 2010
10.7-10.9
Mandatory requirements
T88, T89 Oct 2011
10. Embryo testing and sex
selection 10.4
Mandatory requirements Oct 2013
10A, 10.7-10.8, 10.10, 10.13, 10.15
Jul 2016
Other legislation/information
Mandatory requirements Oct 2011
T52, T53
11.40-11.42, 11.50-11.52 Apr 2012
11.2-11.6, 11.15-16, 11.18-11.20 Oct 2013
Mandatory requirements
T52b
11. Donor recruitment, assessment Oct 2014
11.14b, 11.15, 11.22
and screening
Other legislation/information
Mandatory requirements
Apr 2015
T52
Mandatory requirements
Oct 2015
11.48
Other legislation/information July 2016
Mandatory requirements Apr 2012
12.1-12.27, 12.29-12.32
General Direction 0001
12. Egg sharing arrangements
12.1, 12.4, 12.5, 12.8, 12.19c, Oct 2015
12.27, 12.32
Other legislation/information Jul 2016
Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority

Mandatory requirements
May 2017
12.5
13. Payments for donors 13A, 13.1-13.7, 13B Apr 2012
Mandatory requirements
Apr 2010
14.1
14. Surrogacy 14A, 14.1-14.3, 14.5-14.8 Oct 2013
Mandatory requirements
Oct 2015
14.3
15A Apr 2010
Mandatory requirements
Oct 2011
T66, T67
15D
15. Procuring, processing and Oct 2013
Other legislation/information
transporting gametes and embryos
T50, T51; 15D
Oct 2014
Other legislation/information
Mandatory requirements
Apr 2015
T50
16.4-16.6 Apr 2010
16B Oct 2015
16. Import and exports
Other legislation/information Jul 2016
16C May 2017
Mandatory requirements
T84 Oct 2011
17.15
17B Apr 2012
Mandatory requirements
17. Storage of gametes and T51 Oct 2013
embryos 17A
T50
17A, 17B Oct 2014
Other legislation/information
T50
Apr 2015
17.11, 17.12, 17D, 17.15-17.18,
Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority

17.20- 17.22
17.10 Oct 2015
Mandatory requirements
May 2017
17C, 17D
Mandatory requirements
Oct 2011
T71

18.21
18.2-18.8, 18.10, 18.12, 18.21-
18. Witnessing and assuring patient
18.23, 18.26-18.29, 18.31, 18.32,
and donor identification Oct 2013
18.35,
18.37, 18.38, 18.42
18.4m Oct 2015
Other legislation/information Jul 2016
19. Traceability T101 Oct 2014
Mandatory requirements
Oct 2011
T54
20.1 Apr 2012
20. Donor assisted conception 20.1
Oct 2013
Other legislation/information
Mandatory requirements
Oct 2015
20.6, 20.10
21.4 Oct 2011
21. Intracytoplasmic sperm injection
(ICSI)
Other legislation/information Oct 2014
T96, T95 Oct 2011
Mandatory requirements
Oct 2013
Other legislation/information
22. Research and training 22B
Oct 2014
Other legislation/information
Mandatory requirements Oct 2015
Other legislation/information Jul 2016
23. The quality management Mandatory requirements
Oct 2011
system T36
24. Third party agreements Mandatory requirements Oct 2011
Revision control sheet (Version 10.0) Human Fertilisation and Embryology Authority

T115, T116
T124, T125
Oct 2015
24.1
Mandatory requirements
Oct 2011
T5, 25.9
T2
25. Premises, practices and
25.3, 25.4, 25.19-25.36 Oct 2014
facilities
Other legislation/information
T124, T125 Oct 2015
Other legislation/information Jul 2016
26.3-26.5 Oct 2014
26. Equipment and materials Other legislation/information
Other legislation/information Jul 2016
27.1, 27.9 Oct 2011
27.9 Oct 2015
27. Adverse incidents Other legislation/information Jul 2016
27.1, 27A
May 2017
Other legislation/information
28. Complaints Other legislation/information Jul 2016
New guidance note Apr 2011
29.8
Oct 2014
29. Treating people fairly Other legislation/information
29.3 Oct 2015
Other legislation/information Jul 2016
Mandatory requirements Oct 2011
T43
30.6-30.8 Oct 2014
30. Confidentiality and privacy
30A, 30B, 30.16 Oct 2015
Mandatory requirements
May 2017
30B
31. Record keeping and document Mandatory requirements
Oct 2013
control T39, T41