Applying for a research licence

Ensure your project meets the requirements of the law

We’re able to grant licences for up to three years, providing the research is being carried out to meet one of the following aims:

• increase knowledge about serious disease or other serious conditions
• develop treatments for serious diseases or other serious medical conditions
• increase knowledge about the causes of congenital diseases
• promote advances in the treatment of infertility
• increase knowledge about the causes of miscarriages
• develop more efficient techniques of contraception
• develop methods for detecting gene, chromosome or mitochondrion abnormalities in embryos before implantation
• increase knowledge about the development of embryos.

Find out what research we’ve already approved on Clinic Portal.

In addition:

• The people donating their eggs, sperm or embryos for research must provide consent to do so.
• No embryo created or used in research can be transferred to a woman.
• The embryos must not be allowed to develop in the laboratory beyond 14 days after fertilisation.

You don’t need a licence to conduct research on sperm or eggs.

Complete the initial enquiry form

Your initial enquiry should include details of your research project and will usually be followed up with a conversation with one of our team.

We’ll talk you through the application process and advise you on how you can meet our Licence Committee’s requirements before you submit your application.

Please email hfeacompliance@hfea.gov.uk for a copy of this form.

Seek research ethics approval

You’ll need to get approval from an independent research ethics committee before you apply for a licence.

Researchers from the NHS can apply to the NHS research ethics committees – find your NHS research ethics committee.

Choose a person responsible

All research projects must have an appointed person responsible (PR) who has overall responsibility for ensuring the centre and staff comply with the law.

The PR is in charge of overseeing the centre’s activities, ensuring staff have an appropriate level of training to fulfil their roles and that they comply with inspections. They’re also responsible for submitting paperwork, fees and data to us in a timely manner.

Before a PR can be formally appointed, they need to have successfully completed the person responsible entry programme (PREP), a self-assessment tool that ensures they have a good understanding of the relevant legislation they need to comply with. To undertake the PREP for prospective research PRs, download the assessment form from the Clinic Forms section on the Clinic Portal.

To find out what qualifications your PR needs, give our compliance team a call on 020 7291 8200.

Complete an application form and pay the administration fee

Once you’re confident you’ve got everything you need, you’re ready to submit your application through the secure area of Clinic Portal. Drop our compliance team a line on hfeacompliance@hfea.gov.uk or 020 7291 8200 and we’ll get you set up on this and talk you through the rest of the licensing process.

You’ll also need to submit the correct licence application fee. The fee is currently £500 to £750 depending on the project. All fees go towards the costs of being regulated and inspected.

Be aware that the licensing process can take some time. We aim to process most applications within four months if we have all the information we need. Our Licence Committee considers applications every other month so it’s worth talking to us about when’s the best time to submit your application to minimise delay.

What happens next?

Peer reviews

Once we’ve received your complete application and fee, we’ll initiate a peer review process to check that the application:

• falls within the statutory requirements of the Human Fertilisation and Embryology Act 1990 (as amended)
• requires human embryos to fulfil its aims and objectives
• requires the number and types of embryos described in the application.

Inspection

If the peer reviews are satisfactory, we’ll visit your research site to inspect your laboratories, meet the team and review your proposed project protocols.

Decision by our Licence Committee

The report from the inspection, peer reviews and your application will be presented to our Licence Committee who will decide whether or not to grant a licence.

Questions?

Contact our compliance team by emailing hfeacompliance@hfea.gov.uk.