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How we regulate (treatment and research)

Human embryo research

A fertility clinician using a microscopeWe have the power by law to grant licences for research projects involving human embryos. Under the Human Fertilisation and Embryology (HF&E) Act 1990, research projects can be carried out under the following conditions:

  • Each research project must be carried out under a licence granted by the HFEA in suitable premises.
  • The HFEA, before granting a licence, must be satisfied that the research fulfils at least one of the purposes set out in the Act (see below) and that the use of human embryos is necessary.
  • 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.

Research purposes

Research can only be carried out for one of the following purposes:

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

Where do the embryos used in research come from?

The majority of embryos used in research projects are donated by patients undergoing fertility treatment. Patients may choose to donate their embryos to research because:

  • the embryos are unsuitable for use in treatment
  • the patients do not want to have any embryos frozen; or
  • the patients have finished having treatment and would like and leftover frozen embryos to be used to help other patients.

Sometimes, where the research involves the creation of embryos as part of the study, sperm and eggs are donated either by people undergoing fertility treatment or non-patient donors who wish to support the research in question.

How does the HFEA decide what research can go ahead?

The HFEA must not grant a research licence unless it is satisfied that the research meets the requirements of the HF&E Act (outlined above).

Our role is to ensure that the application is lawful, that patients or donors have given properly informed consent and that the use of embryos is justified.

For these reasons, the scientists applying for a research licence are asked to provide a lot of information about the research they wish to carry out and why the research could not be done using animal embryos or other types of cells.

The scientists also have to submit the information which will be given to patients or donors to explain their research before they ask them to consent to the use of their gametes sperm, eggs or embryos. To help us make our decision, we take independent advice on each application from peer reviewers. All research applications are then considered by the HFEA’s Licence Committee, which is chaired by a lay member.

Decisions on the suitability of research projects, particular those creating embryonic stem cell lines, are continually informed by progress in scientific research worldwide. Our expert Scientific and Clinical Advances Advisory Committee monitors research developments and informs the Licence Committee if other areas of research have become sufficiently developed to make the use of human embryos unnecessary.

To try to maximise the benefit of embryonic stem cell research all licensed research projects which use embryos to derive embryonic stem cell lines must deposit a sample of these lines in the UK Stem Cell Bank. The UK Stem Cell Bank was established in 2002 to provide a repository for human stem cell lines of all types. The Bank ensures that there is a single national independent institute responsible for supplying ethically approved, quality controlled stem cell lines both for basic research and for the development of clinical applications. The existence of this central resource means that, once enough stem cell lines of suitable quality have been deposited in the UK Stem Cell Bank, fewer embryos will be needed to generate new lines.

Researchers can find out more about the licensing process in the clinic area of our website. Broadly it consists five steps:

1. Contacting the HFEA

The procedure for contacting the HFEA depends on whether researchers are applying for a new licence or renewing an existing one.

  • New licences: Most researchers contact the HFEA to discuss their proposed research before they submit their application for a licence. The research centre also must also obtain approval from their local research ethics committee.
  • Existing licence holders: Existing licence holders liaise directly with the HFEA compliance cepartment on renewals and evaluations.

2. Applying for a licence (initial/renewal)

The centre sends its completed application to the HFEA compliance department, together with an administration fee, which varies depending on the nature of the research.

3. Undergoing peer reviews

The HFEA compliance department initiates peer reviews to consider the following specific questions:

  • whether the research fulfils the purposes for which embryo research is permitted;
  • the importance of the research in the field;
  • whether the research has been done before; and
  • whether the use of human embryos is justified

4. Being inspected

If the peer reviews are satisfactory, the HFEA initiates visits to proposed research sites. These visits are conducted by HFEA Compliance staff. The primary focus of these visits is to:

  • review proposed project protocols
  • inspect research laboratories; and
  • meet research teams.

Following these visits, the inspectors produce an inspection report which is published on the Choose a Fertility Clinic of the HFEA website alongside the corresponding clinic listing.

5. Presentation to the Licence Committee

The inspectors’ report, together with the application and the peer reviews are presented to the HFEA’s Licence Committee, who decide whether to grant a research licence.

Find out more about research we have approved. A lay summary of each research project can be viewed by clicking on the link to the research project in our 'choose a fertility clinic' tool.

Further information:

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Looking for inspection reports and Licence Committee minutes?

Thank you for your interest in our clinic inspection reports and Licence Committee minutes.

For ease of use, the reports and Licence Committee minutes can be found in our Choose a Fertility Clinic search - alongside their corresponding clinic listing.


Page last updated: 09 July 2012

Policy review: Hybrids and Chimeras

Dictionary entry of the word policyThe creation human/animal embryos for research comes with many ethical and social implications.

The HFEA held a public consultation on the matter. Find out the results.

...more about Hybrids and Chimeras

Genetic testing

Photo of an embryo

Learn about pre-implantation genetic diagnosis (PGD).

Discover how this technique could help to avoid passing on inherited conditions to any potential child.

...more about genetic testing