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

More documents

Recommendations

Info

XX. Title of Guidance Note Mandatory requirements (cont) 16 Grant of licence (1) The Authority may on application grant a licence to any person if the requirements of subsection (2) below are met. (2) The requirements mentioned in subsection (1) above are — (a) that the application is for a licence designating an individual as the person under whose supervision the activities to be authorised by the licence are to be carried on, (b) that either that individual is the applicant or— (i) (ii) the application is made with the consent of that individual, and the Authority is satisfied that the applicant is a suitable person to hold a licence, (c) in relation to a licence under paragraph 1 or 1A of Schedule 2 or a licence under paragraph 2 of that Schedule authorising the storage of gametes or embryos intended for human application, that the individual— (i) (ii) possesses a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences, awarded on completion of a university course of study, or other course of study recognised in the United Kingdom as equivalent, or is otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications in the field of nursing, and has at least two years’ practical experience which is directly relevant to the activity to be authorised by the licence, (ca) in relation to a licence under paragraph 2 of Schedule 2 authorising storage of gametes, embryos or human admixed embryos not intended for human application or a licence under paragraph 3 of that Schedule, that the Authority is satisfied that the qualifications and experience of that individual are such as are required for the supervision of the activities, (cb) that the Authority is satisfied that the character of that individual is such as is required for the supervision of the activities and that the individual will discharge the duty under section 17 of this Act, (d) (e) that the Authority is satisfied that the premises in respect of which the licence is to be granted and any premises which will be relevant third party premises are suitable for the activities, and that all the other requirements of this Act in relation to the granting of the licence are satisfied. Licence conditions T7 T8 T9 Where the person responsible is unable to carry out their duties, whether permanently or temporarily, (eg, where the PR is suspended pending investigation or is on extended sick leave) the holder of the licence must inform the Authority immediately and apply to the Authority for a licence variation to nominate a substitute PR. This nominated substitute PR must not commence their post unless and until the Authority decides that they are suitable. The PR must have successfully completed the Authority’s PR Entry Programme. The PR must have responsibility for: a. ensuring the requirements imposed by section 31ZD of the Human Fertilisation and Embryology Act 1990 (as amended), in relation to the provision of information to donors about resulting children, are complied with b. ensuring that the activities are carried out on suitable premises c. ensuring the centre’s staff co-operate fully with inspections and investigations by the Authority or other agencies responsible for law enforcement or regulation of healthcare d. ensuring fees are paid to the Authority within the timescale specified in Directions or in writing Human Fertilisation and Embryology Authority Guidance note Note | 1. Person responsible Version 1.0 1.0
XX. Title of Guidance Note Mandatory requirements (cont) T9 (cont) e. ensuring data provided to the Authority about activities and data, which the Authority is required to hold on its Register of Information, is accurate and provided by dates specified in Directions or in writing f. ensuring requests for information and/or documents from the Authority are responded to promptly, and g. notifying the Authority immediately if s/he becomes aware of any decision or proposal to close their centre. T10 In the event of termination of activities, for whatever reason, the PR must ensure that all stored gametes, embryos or admixed embryos are transferred to another licensed centre or centres. The PR must ensure that all relevant information including traceability data and information concerning the quality and safety of gametes and embryos, is transferred with any stored gametes, embryos or admixed embryos, or that records containing this information are made accessible as required. HFEA guidance Appointing the person responsible Interpretation of mandatory requirements 1A The law requires licensable activity take place only under the supervision of the ‘person responsible’, as named on the centre’s licence. An individual can be appointed as the person responsible only with the approval of the HFEA. That person must complete the Persons Responsible Entry Programme (PREP) assessment before the HFEA can consider whether or not to approve them. The licence holder and the person responsible 1.1 It is currently the case in many centres that the individual who is the licence holder is also the person responsible. Either the person responsible or the licence holder may apply for a licence or for its variation or revocation. However, only the licence holder may apply to a licence committee to vary a licence in order to designate another individual to be the person responsible. 1.2 If a separate person is not designated as the licence holder and the person responsible becomes temporarily or permanently unable to carry out their duties, the only course of action available is the revocation of that centre’s licence. A new licence would then be applied for by naming an alternative person responsible. Centres will therefore find it advantageous for a senior staff member to be the licence holder on an HFEA licence. Centres operating within a hospital or other healthcare organisation may find it advisable to nominate a senior hospital management representative to be the licence holder on an HFEA licence. Qualifications for the role of the person responsible 1.3 The person responsible should have enough understanding of the scientific, medical, legal, social, ethical and other aspects of the centre’s work to be able to supervise its activities properly. It is also important that the person responsible possesses integrity, and managerial authority and capability. 1.4 The HFEA expects the person responsible to take any necessary specialist advice to allow them to run the centre professionally. Human Fertilisation and Embryology Authority Guidance note Note | 1. Person responsible Version 1.0 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: 1. Person responsible This guidance
Page 13 and 14: 2. Staff This guidance note contain
Page 15 and 16: v HFEA guidance (cont) 2.3 All staf
Page 17 and 18: v HFEA guidance (cont) 2.19 The ind
Page 19 and 20: 3. Counselling This guidance note c
Page 21 and 22: = HFEA guidance (cont) Interpretati
Page 23 and 24: 4. Information to be provided prior
Page 25 and 26: HFEA guidance (cont) Interpretation
Page 27 and 28: 5. Consent to treatment, storage, d
Page 29 and 30: Mandatory requirements (cont) Proce
Page 31 and 32: HFEA guidance Consent to use and st
Page 33 and 34: HFEA guidance (cont) (c) (d) they w
Page 35 and 36: HFEA guidance (cont) Additional con
Page 37 and 38: HFEA guidance (cont) Interpretation
Page 39 and 40: HFEA guidance (cont) Mandatory requ
Page 41 and 42: HFEA guidance (cont) Mandatory requ
Page 43 and 44: 6. Legal parenthood This guidance n
Page 45 and 46: Mandatory requirements (cont) (1) W
Page 47 and 48: Mandatory requirements (cont) 42 Wo
Page 49 and 50: Mandatory requirements (cont) (3) S
Page 51 and 52: Mandatory requirements (cont) (2) T
Page 53 and 54: v HFEA guidance (cont) See also: H
Page 55 and 56: HFEA guidance (cont) Parenthood aft
Page 57 and 58: HFEA guidance (cont) People not to
Page 59 and 60: HFEA guidance (cont) Information pr
Page 61 and 62:
7. Multiple births This guidance no
Page 63:
HFEA guidance (cont) 7.5 If a woman
Page 66 and 67:
HFEA guidance (cont) The welfare of
Page 68 and 69:
HFEA guidance (cont) Refusing treat
Page 70 and 71:
Mandatory requirements (cont) T89 (
Page 73 and 74:
10. Embryo testing and sex selectio
Page 75 and 76:
Page 77 and 78:
HFEA guidance (cont) Preimplantatio
Page 79 and 80:
HFEA guidance (cont) Mandatory requ
Page 81 and 82:
HFEA guidance (cont) Interpretation
Page 83 and 84:
11. Donor recruitment, assessment a
Page 85 and 86:
Mandatory requirements (cont) (9) I
Page 87 and 88:
HFEA guidance (cont) 11.3 Unless th
Page 89 and 90:
HFEA Mandatory guidance requirement
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
12. Egg sharing arrangements This g
Page 97 and 98:
HFEA guidance (cont) Consent 12.7 T
Page 99 and 100:
HFEA guidance (cont) 12.19 The agre
Page 101:
HFEA guidance (cont) 12.31 If eggs
Page 104 and 105:
HFEA guidance (cont) 13.1 HFEA Dire
Page 106 and 107:
Mandatory requirements (cont) (b) a
Page 108 and 109:
HFEA guidance (cont) See also guida
Page 110 and 111:
Mandatory requirements (cont) Direc
Page 112 and 113:
HFEA guidance (cont) 15.4 Sperm sho
Page 114 and 115:
HFEA guidance (cont) Processing and
Page 116 and 117:
HFEA guidance (cont) 15.16 (cont) (
Page 118 and 119:
Mandatory requirements (cont) (4) D
Page 120 and 121:
HFEA guidance (cont) General Direct
Page 123 and 124:
17. Storage of gametes and embryos
Page 125 and 126:
Mandatory requirements (cont) (2) N
Page 127 and 128:
Mandatory requirements (cont) (3) (
Page 129 and 130:
Mandatory requirements (cont) (b) e
Page 131 and 132:
v HFEA guidance (cont) 17.10 In add
Page 133 and 134:
v HFEA guidance (cont) Mandatory re
Page 135 and 136:
18. Witnessing and assuring patient
Page 137 and 138:
HFEA guidance (cont) 18.4 (cont) (j
Page 139 and 140:
HFEA guidance (cont) 18.24 Centres
Page 141:
HFEA guidance (cont) Risk assessmen
Page 144 and 145:
Page 147 and 148:
20. Donor-assisted conception This
Page 149 and 150:
Page 151 and 152:
v HFEA guidance (cont) See also gui
Page 153:
HFEA guidance (cont) 20.11 (cont) (
Page 157 and 158:
22. Research and training This guid
Page 159 and 160:
Mandatory requirements (cont) (3) A
Page 161 and 162:
Mandatory requirements (cont) (3) W
Page 163 and 164:
Mandatory requirements (cont) T95 T
Page 165 and 166:
HFEA guidance (cont) Information pr
Page 167 and 168:
HFEA guidance (cont) Consent Interp
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175 and 176:
Page 177 and 178:
HFEA guidance (cont) Interpretation
Page 179 and 180:
Page 181 and 182:
Page 183:
HFEA guidance (cont) Human admixed
Page 186 and 187:
XX. Title of Guidance Note Mandator
Page 188 and 189:
HFEA guidance (cont) 23.10 Centre m
Page 190 and 191:
XX. Title of Guidance Note HFEA gui
Page 193 and 194:
24. Third party agreements This gui
Page 195 and 196:
Mandatory requirements (cont) T117
Page 197 and 198:
25. Premises and facilities This gu
Page 199 and 200:
HFEA guidance Definition of premise
Page 201 and 202:
26. Equipment and materials This gu
Page 203:
HFEA guidance (cont) See also guida
Page 206 and 207:
Mandatory requirements (cont) Licen
Page 208 and 209:
HFEA guidance (cont) 27.4 A ‘near
Page 211 and 212:
28. Complaints This guidance note c
Page 213 and 214:
29. Treating people fairly This gui
Page 215 and 216:
HFEA guidance (cont) 29.9 Staff at
Page 217 and 218:
30. Confidentiality and privacy Thi
Page 219 and 220:
Mandatory requirements (cont) (j) (
Page 221 and 222:
Mandatory requirements (cont) 35 Di
Page 223 and 224:
HFEA guidance (cont) 30.7 A person
Page 225 and 226:
HFEA guidance (cont) Consent to dis
Page 227 and 228:
31. Record keeping and document con
Page 229 and 230:
Mandatory requirements (cont) T40 T
Page 231:
v HFEA guidance (cont) 31.4 (cont)
Page 234 and 235:
Page 236 and 237:
Mandatory requirements (cont) Seizu
Page 238 and 239:
HFEA guidance Legal obligations tow
Page 240 and 241:
Glossary D Data subject: Defined by
Page 242 and 243:
Glossary N Near miss: Any occurrenc
Page 244 and 245:
Glossary S Serious adverse reaction
Page 246 and 247:
Index C carrier embryos, transfer o
Page 248 and 249:
Index donation for research/trainin
Page 250 and 251:
Index of justification for use of g
Page 252 and 253:
Index charges and benefits 12.20 co
Page 254 and 255:
Index embryonic stem cells/lines se
Page 256 and 257:
Index preimplantation tissue typing
Page 258 and 259:
Index L labelling dishes and tubes
Page 260 and 261:
Index likely, information provision
Page 262 and 263:
Index identification of processes n
Page 264 and 265:
Index licence R25(22), 22A, 22.1 An
Page 266 and 267:
Index additional requirements 5D, 5
Page 268 and 269:
Index communication barrier handlin
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?