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30 May 2000

Dear Colleague,

Patient Consent to Research on Human Embryos

The HFEA has recently carried out a review of the giving of patient consent to allow embryos to be used in research. This letter explains the HFEA's advice to centres on this subject. An HFEA patient information leaflet on this subject is enclosed which centres may wish to give to patients. A copy of the leaflet can also be found on the HFEA's web-site, www.hfea.gov.uk.

As you may be aware, Schedule 3 paragraph 3(1) of the Human Fertilisation and Embryology Act 1990 provides that, before a person gives their consent, they:-

• must be given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and
• must be provided with such relevant information as is proper.

In addition, paragraph 2(1) provides that consent to the use of an embryo for the purpose of any research project may specify conditions for which the embryo may be used.

While part 4 of the Code of Practice gives guidance on the type of information that should be given to people consenting to the storage of their gametes and embryo, the Code does not give any guidance about information that should be given to those thinking of donating embryos for research. The HFEA intends to rectify this omission in the Code's next edition.

The HFEA recognises that general consent for use in research is considered to be sufficient under the 1990 Act and that it is for the individual providing embryos to stipulate conditions on use. However, there is some concern about secondary research, i.e. research on fixed and non-viable embryos. In particular, the HFEA has recently noted that patients have a duty to disclose the results of genetic tests to insurance companies if asked. The HFEA is concerned that this may have implications for patients who donate surplus embryos to research following IVF treatment. While, the majority of licensed research undertaken is carried out on embryos that will be discarded when the project is complete, there are instances where embryos or embryo cell samples may be preserved or fixed for secondary research, which could include genetic research. The HFEA has no remit over the regulation of secondary research. However, recent guidance suggests that centres should inform patients that secondary research might be carried out on their embryos and the implications of this.

As part of their discussions the HFEA considered the following three reports:

• 'Seeking patients' consent: the ethical considerations', GMC, February 1999
• 'Operational and ethical guidelines for collections of human tissues and biological samples for use in research' interim guidelines, MRC, November 1999
• 'Advice to research ethics committees', ACGT, October 1998

In light of these reports, it was agreed that, while the HFEA has no remit over secondary research it has an obligation to make certain that centres ensure that patients are given the opportunity to make informed decisions as to the type(s) of research for which they wish to donate their embryos. As a means of protecting patient confidentiality it has been suggested that embryos for secondary research, which could include genetic research should be anonymised. Clinics and patients should be aware of the potential implications of agreeing to donate embryos to either reversibly or irreversibly anonymised research.

The HFEA is aware that there may be embryos currently stored for which only general consent to research has been given. The HFEA has agreed that it would be impractical to prohibit the use of such embryos simply because more specific consent was not sought. Nevertheless, the HFEA advises that these embryos should be irreversibly anonymised now prior to research to avoid the problems of alerting 'donors' to the research findings that may have implications for their own health and that of family members and the need to obtain further consent before allowing additional unrelated genetic research. If secondary research has already been undertaken on non-anonymised samples, reference should be made to the MRC guidelines. These advise that information on genetic risk obtained as a result of research studies should not be fed-back in most cases, especially where the participant did not know that the specific test was being done and where there is no clear course of action or treatment that can be done.

The HFEA strongly advises that, from now on, centres planning to carry out secondary research sometime in the future should ensure that donors are fully informed of the distinction between reversible and irreversible anonymisation and be required to give separate and specific consent for this. Those patients consenting to reversible anonymisation should be given the opportunity to consent to being informed of the results of genetic research, if it is meaningful to do so. Consent to reversible anonymisation in studies that could yield genetic information should only be given following appropriate counselling. The ACGT guidelines suggest that consent should be obtained for such research. It might therefore be necessary to establish whether individuals consenting to the use of their material in reversibly anonymised studies would be willing to be contacted in the future to give their consent for unrelated genetic tests.

If embryos may be transferred to another centre for research purposes, then patients should be provided with comprehensive literature regarding the various types of research that might be undertaken using their donated material. This will enable them to indicate their consents to certain types of research before their embryos are included in research projects involving genetic or other forms of secondary research.

You are also reminded that you are required to record details of the consent procedures used, and that copies of all consent forms, information leaflets and other material given to participants must be kept on file.

If you have any queries regarding the above, please do not hesitate to contact Jo Rippington on 0207-539-3328.

Yours sincerely,

Ruth Deech
Chairman

Page last updated: 14 April 2009

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