STAGE 1

1
DECISION TREE FOR USE BY LICENCE COMMITTEE AND
EXECUTIVE LICENSING PANEL CONSIDERATION OF
APPLICATIONS TO GRANT OR RENEW A LICENCE
NO
STAGE 1 Is the application submitted in the form
required, and does it contain the supporting
information, required by General Direction 0008?
STAGE 14 If the application involves the use of
embryos for training purposes, are the
requirements of paragraph 1(3) and (4A) of
Schedule 2 to the Act satisfied? Refer to
decision tree on embryo for training purposes
STAGE 15 Does the application involve the testing
of embryos?
NO
YES
YES
NO
YES
NO
NO
STAGE 16 If the application involves the testing
of embryos are the requirements of paragraph 1ZA
of Schedule 2 to the Act satisfied? Refer to
decision tree on PGD.
STAGE 2 Has the appropriate fee been paid?
STAGE 13 Does the application involve the use of
embryos for training purposes?
NO
YES
NO
ISSUE A NOTICE OF PROPOSAL TO REFUSE APPLICATION
WITH REASONS. IF UNSURE, ADJOURN AND SEEK FURTHER
INFORMATION
YES
YES
STAGE 3 Does the application designate an
individual to act as the Person Responsible
(PR)?
YES
STAGE 12 Are you satisfied that the premises to
be licensed (and any relevant 3rd party premises)
are suitable for the conduct of licensed
activities there? This decision must be evidence
based. Relevant considerations include findings
in inspection report and criteria in Code of
Practice.
STAGE 17 Is the application to authorise
activities for the purpose of research?
YES
NO
STAGE 4 If the applicant is not the designated
PR, has the proposed PR consented to act as such?
YES
NO
NO
YES
NO
STAGE 18 Go to Research Licence Decision Tree
YES
STAGE 11 Are you satisfied that the character of
the PR is such as is required for supervision of
the licensed activities and that the PR will
discharge the duties under section 17 of the Act?
This decision must be evidence based. Relevant
considerations may include completion of PREP
previous history of compliance with Act/ licence
conditions/Directions issued by HFEA/Code of
Practice/Professional Body Guidelines any
findings of other bodies concerned with the
regulation of health care criminal convictions
etc
STAGE 5 If the applicant is not the designated
PR, is s/he a suitable person to hold a Licence?
This decision must be evidence based. Relevant
considerations include previous compliance
history.
Research Licence Up to 3 Years
NO
ISSUE A NOTICE OF PROPOSAL TO REFUSE APPLICATION
WITH REASONS. IF UNSURE, ADJOURN AND SEEK FURTHER
INFORMATION
NO
STAGE 19 How long should the licence be granted
for? (Refer to Indicative Applications Criteria.)
Other Licences Up to 5 Years
YES
STAGE 6 Does the Licence application concern
treatment, storage or non-medical fertility
services which relate to gametes or embryos
intended for human application? Or does the
Licence application concern research in
connection with the derivation of stem cells
intended for human application?
YES
NO
STAGE 20 Should additional conditions be attached
to the licence to be granted, in addition to the
standard conditions which must be imposed by
section 12-15 of the Act or which are imposed by
the Authority on all centres on a standard basis?
What is the risk identified? Is imposition of
further conditions a proportionate response to
any risk identified?
STAGE 10 Does the PR possess satisfactory
qualifications and experience?
NO
YES
NO
YES
NO
STAGE 9 Does the licence application concern
storage of gametes and embryos not intended for
human application? Or does the licence
application concern research other than the
derivation of stem cells not intended for human
application?
STAGE 7 Does the PR possess the formal academic
qualifications set out in S16(2)(c) (i)?
STAGE 21 GIVE REASONS FOR -decision to grant
licence -period of length of licence -any
decision to impose further conditions -not
agreeing with any executive recommendation
NO
YES
STAGE 8 Does the PR have at least 2 years
practical experience which is directly relevant
to the licensed activity to be carried out?
YES
2
EMBRYOS FOR TRAINING DECISION TREE (Stage 14)
STAGE 14a Is the activity necessary or desirable
for the purpose of providing treatment services?
Paragraph 1(3) of Schedule 2 to the Act
NO
YES
STAGE 14b Is the Authority satisfied that any
proposed use of embryos for training purposes is
necessary for that purpose? Paragraph 1(4A) of
of Schedule 2 to the Act
ISSUE A NOTICE OF PROPOSAL TO REFUSE APPLICATION
WITH REASONS. IF UNSURE, ADJOURN AND SEEK FURTHER
INFORMATION
NO
YES
Return To Stage 19 Of Main Decision Tree
3
PGD DECISION TREE (Stage 16)
STAGE 16a Establish the purpose(s) of the testing

• STAGE 16c(i)
• Is the purpose of testing the embryo to establish
  the sex of
• the embryo in case where there is a particular
  risk that
• any resulting child will have or develop
• a gender-related serious physical or mental
  disability,
• a gender-related serious illness,
• any other gender-related serious medical
  condition?

STAGE 16d(i) Is the purpose of testing the
embryos to establish whether the tissue of the
resulting child is compatible with that of a
sibling?
STAGE 16e Is the purpose of testing the embryos
one of those set out in paragraph 1ZA(1) (a) or
(e) of schedule 2 of the Act?
STAGE 16b(i) Is the purpose of testing the embryo
to establish whether it has a particular
abnormality or any other gene, chromosome or
mitochondrial abnormality?
STAGE 16f Any other purpose of testing
YES
YES
YES
YES
STAGE 16d(ii) Is this sibling the child of the
person whose gametes were used to bring about the
creation of the embryo?
STAGE 16c(ii) Give reasons why there is a
particular risk that the child will have or
develop a serious disability/illness/condition.
STAGE 16b(ii) Give reasons why there is a
particular risk that the embryo may have any
abnormality.
YES
YES
ISSUE A NOTICE OF PROPOSAL TO REFUSE APPLICATION
WITH REASONS. IF UNSURE, ADJOURN AND SEEK FURTHER
INFORMATION
ISSUE A NOTICE OF PROPOSAL TO REFUSE APPLICATION
WITH REASONS. IF UNSURE, ADJOURN AND SEEK FURTHER
INFORMATION
STAGE 16d(iii) Does the sibling suffer from a
serious medical condition?
STAGE 16c(iii) Does the physical or mental
disability, illness or other medical condition
affect only one sex, or it affects one sex
significantly more than the other?
STAGE 16b(iii) Is there a significant risk that a
person with the abnormality will have or develop
a serious physical or mental disability, a
serious illness or any other serious medical
condition?
NO
NO
YES Give reasons why the condition is
considered to be serious
YES
STAGE 16d(iv) Can the medical condition be
treated by umbilical cord blood/stem cells/bone
marrow or other tissue from the child resulting
from the embryo?
YES
YES

• STAGE 16b(iv)
• Give reasons why-
• The risk is considered to be significant
• The disability, illness or condition is
  considered to be serious.

STAGE 16g Should any conditions be put on the
licence?

• FACTORS TO TAKE INTO CONSIDERATION FOR JUDGING
  SERIOUSNESS
• Age of onset
• Symptoms of the disease
• Viability of Phenotype (i.e. mild to severe
  symptoms)
• Whether the condition is treatable
• Type of treatment (if any, then the likely extent
  of treatment and its potential invasiveness)
• Effect of the disease on quality of life
  (including speed of degeneration in progressive
  disorders ad the extent of any physical and/or
  intellectual impairment)

YES
NO - Conditions
Specify Conditions
Return To Stage 19 Of Main Decision Tree
4
APPLICATIONS FOR RESEARCH DECISION TREE (Stage 18)
STAGE 18e Is the activity to be licensed
necessary or desirable for the purposes specified
in paragraph 3A(2) of Schedule 2 to the Act or
in regulations? Or is it necessary or desirable
for the purpose of providing knowledge that in
the view of the Authority may be capable of being
applied for increasing knowledge about or
developing treatments for serious disease or
other serious medical conditions? must be
necessary or desirable by paragraph 3A(1) of
Scheduled 2 of the Act
STAGE 18d Does the project of research involve
mixing sperm with the egg of an animal AND
creating, using and keeping human admixed
embryos? these two research activities cannot be
the subject of the same licence-paragraph 3(4) of
Schedule 2 to the Act
NO
YES
NO
YES
YES Reasons why necessary or desirable
STAGE 18c Is the activity to be licensed
permitted under the Act?
STAGE 18f Are you satisfied that the proposed use
of embryos/human admixed embryos is necessary for
the purpose of the research? must be
necessary-paragraph 3(5) Scheduled 2 of the Act
NO
ISSUE A NOTICE OF PROPOSAL TO REFUSE APPLICATION
WITH REASONS. IF UNSURE, ADJOURN AND SEEK FURTHER
INFORMATION
NO
STAGE 18b Identify the proposed activities to be
authorised by the licence
YES Reasons why you are satisfied
STAGE 18g(ii) Are you satisfied with Patient
Information and Consent Forms?
YES
STAGE 18g(i) Has the applicant provided evidence
of Ethics approval?
YES
NO
STAGE 18a Does the proposed licence apply to more
than one project of research? a licence can only
apply to one project of research paragraph
4(2)(a) of Schedule 2 of the Act
NO
NO
YES
Consider Adjourning Or Formulating An Additional
Licence Condition
Return To Stage 19 Of Main Decision Tree
5
APPLICATIONS FOR RESEARCH DECISION TREE (Stage
18) KEY

• Prohibited activities include
• Placing in a woman any non permitted embryos or
  non permitted eggs or sperm (as defined in
  Section 3ZA of the Act) (section 3 (2))
• Keeping or using an embryo after the appearance
  of the primitive streak (section 3(3)(a))
• Placing an embryo in an animal (section 3(3)(b))
• Keeping or using any embryo in any circumstances
  prohibited by regulations (section 3(3)(c))
• Storing or using gametes in any circumstances
  prohibited by regulations (section 4(2))
• Placing in a woman a human admixed embryo or non
  human embryos or gametes (section 4A(1))
• Keeping or using a human admixed embryo after the
  appearance of the primitive streak or after 14
  days from creation (whichever is earlier)
  (section 4A(3))
• Placing a human admixed embryo in an animal
  (section 4A(4))
• Keeping or using a human admixed embryo in any
  circumstances prohibited by regulations (section
  4A(5))

• Purposes specified in paragraph 3A(2)
• Increasing knowledge about serious disease or
  other serious medical conditions
• Developing treatments for serious disease or
  other serious medical conditions
• Increasing knowledge about the causes of any
  other congenital disease or congenital condition
• Promoting advances in the treatment of
  infertility
• Increasing knowledge about the causes of
  miscarriage
• Developing more effective techniques of
  contraception
• Developing methods for detecting the presence of
  gene, chromosome or mitochondrion abnormalities
  in embryos before implantation
• Increasing knowledge about the development of
  embryos