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

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HFEA guidance (cont) Responsibilities of the person responsible Interpretation of mandatory requirements The person responsible is ultimately responsible for ensuring that all licensed activities are conducted with proper regard for the regulatory framework that governs treatment and research involving gametes or embryos. 1B 1.5 The role of the person responsible should include: (a) maintaining an up-to-date awareness and understanding of legal obligations (b) (c) responding promptly to requests for information and documents from the HFEA, and co-operating fully with inspections and investigations by the HFEA or other agencies responsible for law enforcement, regulation or healthcare. Human Fertilisation and Embryology Authority Guidance note | 1. Person responsible Version 1.0
2. Staff This guidance note contains: Mandatory requirements Extracts from the HFE Act 1990 (as amended) Extracts from licence conditions HFEA guidance Centre staff Medical staff Nursing staff Counselling staff Staff engaged in scientific services Competence and training of ICSI and embryo biopsy practitioners Staff involved in genetic testing Other legislation, professional guidelines and information Refer to principles 2, 7 and 9 Section includes interpretation of mandatory requirements Mandatory requirements Human Fertilisation and Embryology (HFE) Act 1990 (as amended) 17 The person responsible (1) It shall be the duty of the individual under whose supervision the activities authorised by a licence are carried on (referred to in this Act as the “person responsible”) to secure— (a) that the other persons to whom the licence applies are of such character, and are so qualified by training and experience, as to be suitable persons to participate in the activities authorised by the licence,… Schedule 3A Supplementary Licence Conditions: Human Application Requirements for procurement of gametes and embryos 5. Licence conditions shall require all persons to whom a licence applies who are authorised to procure gametes or embryos, or both, to comply with the requirements (including as to staff training, written agreements with staff, standard operating procedures, and appropriate facilities and equipment) laid down in Article 2 (requirements for the procurement of human tissues and cells) of the second Directive. Licence conditions T11 T12 T13 T14 The centre must have an organisational chart which clearly defines accountability and reporting relationships. Personnel in the centre must be available in sufficient number and be qualified and competent for the tasks they perform. The competency of the personnel must be evaluated at appropriate intervals. All personnel must have job descriptions that accurately reflect their tasks, and responsibilities. Personnel carrying out licensed activities or other activities carried out for the purposes of providing treatment services that do not require a licence must, where appropriate, be registered in accordance with the appropriate professional and/or statutory bodies, (eg, General Medical Council, Health Professions Council, Nursing and Midwifery Council). Human Fertilisation and Embryology Authority Guidance note | 2. Staff Version 1.0
Page 1 and 2: Code of Practice 8TH EDITION This C
Page 3 and 4: Contents User guide to the Code Reg
Page 5 and 6: Contents Facilities and administrat
Page 7 and 8: User guide to the Code Guidance not
Page 9 and 10: 1. Person responsible This guidance
Page 11: XX. Title of Guidance Note Mandator
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Page 23 and 24: 4. Information to be provided prior
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Page 35 and 36: HFEA guidance (cont) Additional con
Page 37 and 38: HFEA guidance (cont) Interpretation
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Page 45 and 46: Mandatory requirements (cont) (1) W
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Page 49 and 50: Mandatory requirements (cont) (3) S
Page 51 and 52: Mandatory requirements (cont) (2) T
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HFEA guidance (cont) 7.5 If a woman
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HFEA guidance (cont) The welfare of
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HFEA guidance (cont) Refusing treat
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Mandatory requirements (cont) T89 (
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10. Embryo testing and sex selectio
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HFEA guidance (cont) Preimplantatio
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HFEA guidance (cont) Mandatory requ
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HFEA guidance (cont) Interpretation
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11. Donor recruitment, assessment a
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Mandatory requirements (cont) (9) I
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HFEA guidance (cont) 11.3 Unless th
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HFEA Mandatory guidance requirement
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12. Egg sharing arrangements This g
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HFEA guidance (cont) Consent 12.7 T
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HFEA guidance (cont) 12.19 The agre
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HFEA guidance (cont) 12.31 If eggs
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HFEA guidance (cont) 13.1 HFEA Dire
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Mandatory requirements (cont) (b) a
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HFEA guidance (cont) See also guida
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Mandatory requirements (cont) Direc
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HFEA guidance (cont) 15.4 Sperm sho
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HFEA guidance (cont) Processing and
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HFEA guidance (cont) 15.16 (cont) (
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Mandatory requirements (cont) (4) D
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HFEA guidance (cont) General Direct
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17. Storage of gametes and embryos
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Mandatory requirements (cont) (2) N
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Mandatory requirements (cont) (3) (
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Mandatory requirements (cont) (b) e
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v HFEA guidance (cont) 17.10 In add
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v HFEA guidance (cont) Mandatory re
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18. Witnessing and assuring patient
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HFEA guidance (cont) 18.4 (cont) (j
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HFEA guidance (cont) 18.24 Centres
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HFEA guidance (cont) Risk assessmen
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20. Donor-assisted conception This
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v HFEA guidance (cont) See also gui
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HFEA guidance (cont) 20.11 (cont) (
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22. Research and training This guid
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Mandatory requirements (cont) (3) A
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Mandatory requirements (cont) (3) W
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Mandatory requirements (cont) T95 T
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HFEA guidance (cont) Information pr
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HFEA guidance (cont) Consent Interp
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HFEA guidance (cont) Interpretation
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HFEA guidance (cont) Human admixed
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XX. Title of Guidance Note Mandator
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HFEA guidance (cont) 23.10 Centre m
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XX. Title of Guidance Note HFEA gui
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24. Third party agreements This gui
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Mandatory requirements (cont) T117
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25. Premises and facilities This gu
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HFEA guidance Definition of premise
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26. Equipment and materials This gu
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HFEA guidance (cont) See also guida
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Mandatory requirements (cont) Licen
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HFEA guidance (cont) 27.4 A ‘near
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28. Complaints This guidance note c
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29. Treating people fairly This gui
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HFEA guidance (cont) 29.9 Staff at
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30. Confidentiality and privacy Thi
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Mandatory requirements (cont) (j) (
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Mandatory requirements (cont) 35 Di
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HFEA guidance (cont) 30.7 A person
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HFEA guidance (cont) Consent to dis
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31. Record keeping and document con
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Mandatory requirements (cont) T40 T
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v HFEA guidance (cont) 31.4 (cont)
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Mandatory requirements (cont) Seizu
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HFEA guidance Legal obligations tow
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Glossary D Data subject: Defined by
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Glossary N Near miss: Any occurrenc
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Glossary S Serious adverse reaction
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Index C carrier embryos, transfer o
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Index donation for research/trainin
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Index of justification for use of g
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Index charges and benefits 12.20 co
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Index embryonic stem cells/lines se
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Index preimplantation tissue typing
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Index L labelling dishes and tubes
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Index likely, information provision
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Index identification of processes n
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Index licence R25(22), 22A, 22.1 An
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Index additional requirements 5D, 5
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Index communication barrier handlin
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Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

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