What is a Person Responsible?
The licensed activities must be carried out under the supervision of the Person Responsible, that is, a suitably qualified and experienced member of the team who ensures that the centre and staff comply with the HFE Act and Code of Practice.
The Person Responsible:
- may be a medical doctor, nurse or a scientist and should have sufficient insight into the scientific, medical, legal, social, ethical and other aspects of the centre’s work to be able to supervise its activities properly
- should be in possession of 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
- have at least two years’ practical experience in relevant fields
- have successfully completed the Person Responsible Entry Programme (PREP).
The Person Responsible also ensures that:
- activities are carried out on suitable premises
- centre staff comply with inspections
- application forms are submitted to the HFEA in a timely fashion
- fees are paid on time
- centre staff are appropriately trained
- data provided to the Authority is correct.
Further information on the skills and experience required for the Person Responsible role can be found in the Code of Practice.
Before a PR is appointed, they must complete the PR Entry Programme, which is a self- assessment and resource tool that helps new PRs to familiarise themselves with the Code of Practice and other legislation.
The latest PREP has been designed as an online learning resource which contains access to the Code of Practice 8, the HFE Act (1990) as amended and work based scenarios to test your knowledge in real life situations. Successful completion of the PREP is also a requirement of the Code of Practice.
- PREP for treatment and storage (doc 576kb)
- PREP for research (doc 540kb)
Preparing for PREP
In order to answer the questions you will need to have access to and have read the following reference material:
- The Human Fertilisation and Embryology Act 1990 (as amended)
- The Human Fertilisation and Embryology Act 2008
- The HFEA Code of Practice (8th edition)
- The HF&E Regulations
- HFEA Guide to Licensing
- HFEA Directions:
- 0001 Gamete and Embryo Donation
- 0002 Recording and providing information to the HFEA under a research licence
- 0003 Multiple births
- 0004 Bringing into force the Code of Practice
- 0005 Collecting and recording information to the HFEA
- 0006 Import and export of gametes and embryos
- 0007 Consent
- 0008 Information to be submitted to the Human Fertilisation and Embryology Authority as part of the licensing process
- 0009 Keeping gametes and embryos in the course of carriage between premises
- 0010 Satellite and transport IVF
- 0011 Reporting and adverse incidents and near misses
- 0012 Record retention
- HFEA Licence Conditions
Completing the programme
- Each programme consists of scenarios which have a combination of multiple choice or free text questions
- In order to answer the questions, you will need to be familiar with the relevant legislation, for example the HFE Act 1990 (as amended) and the HFEA Code of Practice, 8th edition.
- Each PREP is saved online as a protected form. Please ensure that you double click the relevant box to access the drop down menu for the multiple choice questions or enter the required number of responses if a free text box is supplied.
- It is advisable to familiarise yourself with the legislation and questions before starting the programme for the first time.
- The programme does not need to be completed in one go. However if you start the programme and decide to complete it at a later time, remember to save the document to your computer’s hard drive so that your previous answers are also saved.
- It would be useful if you could give an indication of the time spent completing the programme
- Completed forms should be emailed to hfeacompliance@hfea.gov.uk and accompanied by the appropriate application form.
Page last updated: 23 January 2013

