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HFEA decision on altruistic egg donation for research

The Science Media Centre asked scientists to comment on the ruling by the Human Fertilisation and Embryology Authority that women can donate their eggs for altruistic reasons to aid research using stem cells.

Professor Ian Wilmut, Joint head of the Dept of Gene Expression and Development, Centre For Reproductive Biology, University of Edinburgh, said:

“Research with stem cells from cloned human embryos will help us to understand and then treat unpleasant inherited diseases such as Motor Neurone Disease and Parkinson’s disease. I welcome the announcement from the HFEA as this recognises the importance of altruistic egg donation for this and other research. Ideally research with human eggs should be supported by studies using animal eggs as this will help us to make the best possible use of scarce human eggs.”

A spokesperson for the Royal College of Obstetricians and Gynaecologists said, said:

“Women have been involved in egg donation for more than 20 years and research papers have been published since the 1980s on the use of donor eggs to investigate early embryo development.

“Women are asked to be volunteers where their ovaries would be stimulated to develop eggs specifically and solely for research.

“The Royal College of Obstetricians and Gynaecologists believes that women involved in egg donation need to be made aware of the procedures they will put themselves through when harvesting their eggs. They should be informed about existing research, their role in the advancement of human science and how their eggs may be used, but more importantly, they also need to know about the risks involved and the complications that could develop. There should be checks in place to ensure that they are not coerced into donating their eggs and a system whereby an arms-length research nurse receives the formal consent from the women and not the doctors and scientists carrying out the research.

“In order for egg collection to be safe for the women involved, a good research oversight committee should be in place to monitor the woman’s reaction to the drugs received and the settling of over-response. Women should also be screened for Ovarian Hyperstimulation Syndrome before they undergo treatment to detect if they have a predisposition to the condition.

“The issue of payment is an important matter for further consideration for the Ethics and Law Committee (ELC) since the number of women who will be drawn to altruistic donation are few. In order to encourage participation, women should be financially reimbursed for donating their eggs since the procedures are inconvenient and invasive. They should be compensated for their troubles.

“However, the level of payment and number of times a women is allowed to donate her eggs should be capped to prevent this from being a lucrative means of making money. To this effect, the RCOG is in favour of a regulatory body, such as the HFEA, to monitor and evaluate female participation in egg donation in the UK. “

Professor Ian Craft, London Fertility Centre, said:

“London Fertility Centre (LFC) does not support infertile couples being tempted to give half of their eggs away for research in order to receive subsidised IVF treatment since this will compromise their total fertility potential. The indirect financial benefit of $2,000 is far in excess of the present maximum allowance of £250 for altruistic egg and sperm donors.

“LFC supports donors being able to donate for research but not the infertile and considers that the present priority is the recruitment of more fertile donors for the infertile which the current £250 limit appears to be a disincentive. Regulators need to reconsider this disparity if the profound delay to treatment is to be overcome, or realistic numbers of donors who have had children are prepared to donate specifically for research.”

Dr Allan Pacey, Senior Lecturer at the University of Sheffield and Secretary of the British Fertility Society, said:

“The British Fertility Society recognised the importance of undertaking basic research on human eggs in order to understand the causes of infertility and also to facilitate research in regenerative medicine. Because of this, we consulted our membership at the time of the consultation and fed our response back to the HFEA.

“The response of our members was that women should have the right as autonomous individuals to give informed consent for procedures which may yield great benefit to society. However, many members are concerned about eggs obtained during a woman’s IVF treatment being donated to projects of research as part of an egg sharing arrangement for which they receive Benefits in Kind.

“Whilst members feel more comfortable with such donations being made to another infertile woman, they see a distinction between this and donating to projects of research. The BFS therefore supports the concept of non-patient donors being able to make donations to research, but our members have mixed views on this being done by women who are patients themselves.”

Dr Kieran Breen, Director of Research and Development for the Parkinson’s Disease Society, said:

“Stem cell research is an important area of study for people with a range of conditions, including Parkinson’s. Because stem cells are so versatile they could possibly be used to repair and renew cells in the body and brain, and therefore, potentially lead to a cure for conditions such as Parkinson’s.

“The Parkinson’s Disease Society firmly supports stem cell research, provided it is carried out within the UK’s strict ethical and regulatory framework.

“The Society is keen that all potential avenues for stem cell research, within the UK’s ethical and regulatory framework, are properly explored. The use of human eggs is one of many approaches for stem cell research being currently pursued. Consent to egg donation for medical research should be decided through individual and fully informed choice, with no coercion and within a rigorously regulated environment.

“Stem cell research offers the 120,000 people with Parkinson’s in the UK significant – but as yet not fully explored – hope for the future.”

Anna Smajdor, Researcher in Medical Ethics, Imperial College, said:

“Eggs are already a highly prized commodity, and the notion of ‘altruistic donation’ is an ethical whitewash. It perpetuates a skewed market in gametes. The advantage is all on the side of those who already stand to gain, while altruistic donors assume all the risks and receive none of the benefits. Women should be offered fair payment for their eggs, otherwise they are the sole losers in this burgeoning marketplace. £250 fails on all counts: it is enough to entice women from poorer countries, while failing to represent the market value of eggs, or compensate women adequately for the burdens of donation in the UK economy.””

Professor Peter Braude, Director of the Centre for Preimplantation Genetic Diagnosis, Guy’s and St Thomas’ Foundation Trust, said:

“DONATING eggs is not new. Women have been donating eggs for more than 20 years, usually those undergoing sterilization where the eggs would be used to study early embryonic development.

“The difference now is that women are being asked as volunteers where their ovaries would be stimulated to develop eggs specifically and solely for research. I do not see a problem with that. Women are intelligent enough to make decisions for themselves about whether or not they want to take part in research. I cannot see why they should not be allowed to do so if they wish, so long as they are fully informed about the research and have been told about the risks.

“Although a lot has been written about women over-responding to the drugs (OHSS), in the research setting this should not really occur – the drugs are simply stopped before the final hCG injection which is usually given about 36 hours before intended egg collection, and the over-response settles without ill effect. What is needed is a good research oversight committee that ensures that this happens.

“Payment is a more difficult issue. It is unreasonable to expect women to go through all of this altruistically. With any sort of procedure, even research, nurses and doctors are paid, so why not the women involved themselves? It is the right balance that is needed. It need not be different from contract research where volunteers receive a fee, there should be a payment for the inconvenience involved – compensation for the trips to the hospital, the scans, the drugs received, the procedure itself which is invasive and requires sedation or anaesthesia. There is quite a lot of “time out” involved here that requires some recognition and reimbursement. It should be a reasonable amount – the difficulty is to ensure that it is not so attractive, that women see it as a means to earning. Even if it were a significant amount it could be restricted to a once only participation anywhere in the country which could easily be monitored by the HFEA.”

Dr Jacky Boivin, School of Psychology, Cardiff University, said:

“1) Research in Belgium (Guido Pennings, summer 2006) shows that the number of women willing to donate their eggs in egg share programs drops by 70% when the government fully funds the cost of IVF showing that donation is mainly due to reduced costs of treatment rather than altruism.

“2) There could be a potential conflict of interest if the researcher is also clinically involved as he/she administers the fertility drugs that determine the number of eggs the women produces.”

Professor Chris Higgins, Director, MRC Clinical Sciences Centre, Imperial College, said:

“I am sure the HFEA will, as usual, make a wise decision to ensure that informed volunteers can participate in medical research which will benefit all of us. After all, an egg is just another cell.”

Professor Guido Pennings (University of Ghent, Belgium), co-ordinator of the European Society of Human Reproduction and Embryology’s Task Force on Ethics and Law, said:

“The ESHRE Task Force has recently undertaken a study on this subject and come down on the side of reasonable compensation, based on the premise that a woman who donates eggs for research should be considered as a research subject in the same way as a woman who takes part in a clinical trial would be. However, it is extremely important to stress the precautionary measures that should be taken to reduce the risks for the donor and to fit this practice into the general ethical framework for scientific research. For example, we believe that counselling for potential donors by an independent person should be mandatory, and that the centre that uses the eggs in research should verify whether they have been obtained according to ethical standards. Measures should be taken to prevent undue inducement and disproportionate recruitment among vulnerable groups, and no imported eggs or candidate donors coming from abroad should be accepted.”

Professor Chris Shaw, Neurologist, Institute of Psychiatry, King’s College London, said:

“This is good news as it will advance stem cell research. Most people who contribute to research do so on an altruistic basis and many medical research studies contain an element of risk. I support any study where volunteers have been properly consented, the risk is small and the process is tightly regulated.”

Dr Marita Pohlschmidt, Director of Research, Muscular Dystrophy Campaign, said:

“Embryonic stem cell research has the potential to develop into an efficient and powerful therapeutic technique to improve chronic and disabling conditions like muscular dystrophy and allied diseases. However, the current shortage of eggs for research slows and delays efficient progress. We welcome the donation of donor eggs for research as long as women and their families have freedom of choice and are not placed under any kind of pressure. We also believe that this process should undergo tight regulation by an independent body such as the HFEA.”

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