The Authority decision

HFEA policy statement on eggs for research

February 2007

Last year the Authority decided that it was appropriate to carry out a public consultation on donation of eggs to HFEA-licensed research projects.

Following the public consultation, deliberation by the HFEA Ethics and Law Committee and consideration of other relevant information, the Authority has developed key principles on the use of donated materials in research.  A summary of the decisions made by the Authority following the consultation are below. 

These will be introduced into Guidance in the first update of the 7th Edition of the Code of Practice (October 2007) in addition to the measures that are already in place.  A report on the consultation process will be available later in the year.

Key decisions made by the Authority

1. Egg donation, either as non-patient donation or through egg-sharing arrangements, to HFEA-licensed research should be permitted, if considered to be appropriate by a Licence Committee.

2. Where it is possible to donate through egg-sharing arrangements to either research or treatment, there should be parity in the benefit-in-kind offered so that it is not advantageous to donate to either one or the other.

3. The following principles should be in place (not all of these measures will require changes to the Guidance as they are already in place) to ensure that donors are protected. These measures should, where appropriate apply to all research donors.

• a. Donors should be approached about the possibility of donation by someone not involved in the research project.
• b. Patients should be provided with detailed information relating to the research project including the likely outcomes and how any donation will impact on the work.
• c. Potential donors should have the option to discuss the project with a researcher.
• d. Before consent is given, potential donors should be given information on the personal and financial benefits that the researchers may receive as an indirect result of the donation.
• e. For egg sharing, the eggs should be divided into those for research and those for treatment by an embryologist not involved in the research project.
• f. For egg sharing, prior to collection there should be an arrangement in place detailing how the eggs are to be divided between donor and the research project.
• g. For egg sharers, the centre should ensure that the research will not affect the outcome of treatment and that donation would not impact on their treatment.
• h. There should be some temporal separation between making the decision to donate and taking consent/starting treatment.
• i. Where the donor is in a dependent relationship with the person taking consent, or with someone involved in the research project, extra caution should be taken when obtaining consent.
• j.  Formal consent to donation should be taken by someone not directly involved in the research project.
• k. The medical treatment should be overseen by someone not involved in the research project.

4. The selection and screening criteria for research donors should be considered further as current donor guidance are aimed at donation for treatment.  This work should be carried out with research groups and professional bodies.