Person Responsible (PR)

Regulatory principles for licensed centres (version 1.0)

The regulatory principles are a high-level statement that underpin our key regulatory priorities from the Human Fertilisation and Embryology Act 1990. They provide:

• a summary of the key behaviours and outcomes we expect licensed centres to demonstrate, and
• a means of communicating the areas of compliance we regard as key, to the Person Responsible and staff at licensed centres, patients, donors, donor-conceived people and the public.

The regulatory principles inform every part of the HFEA Code of Practice and should be read in conjunction with each of its guidance notes.

Regulatory principles

We expect the Person Responsible (PR) to ensure that their licensed centre demonstrates adherence to the following principles when carrying out activities licensed under the Human Fertilisation and Embryology Act 1990.

Licensed centres must:

1. treat prospective and current patients and donors fairly, and ensure that all licensed activities are conducted in a non-discriminatory way
2. have respect for the privacy, confidentiality, dignity, comfort and well-being of prospective and current patients and donors
3. have respect for the special status of the embryo when conducting licensed activities
4. take account of the welfare of any child who may be born as a result of the licensed treatment provided by the centre, and of any other child who may be affected by that birth
5. give prospective and current patients and donors sufficient, accessible and up-to-date information to enable them to make informed decisions
6. ensure that patients and donors have provided all relevant consents before carrying out any licensed activity
7. conduct all licensed activities with skill and care and in an appropriate environment, in line with good clinical practice, to ensure optimum outcomes and minimum risk for patients, donors and offspring
8. ensure that all premises, equipment, processes and procedures used in the conduct of licensed activities are safe, secure and suitable for the purpose
9. ensure that all staff engaged in licensed activity are competent and recruited in sufficient numbers to guarantee safe clinical and laboratory practice
10. maintain accurate records and information about all licensed activities
11. report all adverse incidents (including serious adverse events and reactions) to us, investigate all complaints properly, and share lessons learned appropriately
12. ensure that all licensed research by the centre meets ethical standards, and is done only where there is both a clear scientific justification and no viable alternative to the use of embryos, and
13. conduct all licensed activities with regard for the regulatory framework governing treatment and research involving gametes or embryos within the UK, including:
    • maintaining up-to-date awareness and understanding of legal obligations
    • responding promptly to requests for information and documents from us, and
    • cooperating fully with inspections and investigations by us or other agencies responsible for law enforcement or regulation of healthcare.

Person Responsible role description and key behaviours

There is no more important role than that of PR for the successful running of a UK fertility clinic. The HFEA Code of Practice clearly sets out the statutory requirements and responsibilities placed on all PRs. However, we know from the past 25 years working closely with PRs that there are certain behaviours and leadership qualities that successful PRs demonstrate, beyond what is set out in statute.

This document sets out the changes we expect to see of our leaders. It brings these behaviours and responsibilities together to help support future and current leaders in this pivotal role.

General Direction 0008 ‘Information to be submitted to the Human Fertilisation and Embryology Authority as part of the Licensing process’

section I - Applications to change the Person Responsible or the Licence Holder, as per General Direction 0008:

Information below (section I) available via link to GD0008

15. An application to change the Person Responsible or the Licence Holder of a licence authorising licensed activities (treatment, storage, research and non-medical fertility services) must be accompanied by the information specified below:
    1. a current CV of the proposed Person Responsible listing academic and professional qualifications; work experience and registration details with the relevant professional body;
    2. a current CV of the proposed Licence Holder listing academic and professional qualifications; work experience and registration details with the relevant professional body; and
    3. the PR Entry Programme (“PREP”) certificate number confirming satisfactory completion of the PREP (applications for a change of PR only).

Further queries about the PR Entry Programme (PREP) can be email to hfeacompliance@hfea.gov.uk.

Publication date: 1 April 2026