1 July 2009
Certain areas of stem cell research are dependent on a sufficient supply of human oocytes, for example for somatic cell nuclear transfer (SCNT). SCNT involves removal of DNA from the nucleus of an unfertilised egg and replacement with DNA from an adult cell and may aid in the generation of patient-specific stem cells to create replacement tissue, also known as therapeutic cloning (see previous news). Currently the main source of human oocytes for stem cell research is eggs left-over from in vitro fertilisation procedures but the number and quality of available oocytes is a limiting factor. Another source of oocytes is through the recruitment of women willing to donate their eggs for research; however, such endeavours have largely been unsuccessful. Earlier this month members of the Empire State Stem Cell Board (ESSCB), which advises the New York State Stem Cell program on matters of funding and ethics, adopted a resolution in favour of compensating women who donate their eggs solely for the purpose of stem cell research. They hoped this move would overcome the shortages of human eggs for research purposes.
The resolution allows reimbursements of up to $10,000 for “out-of-pocket expenses, including payments for travel, housing, medical care, child care and similar expenses incurred as a result of the donation of the oocytes for research purposes and compensated for the time, inconvenience and burden associated with the donation”. All reimbursements will have to be reviewed by the Embryonic Stem Cell Research Oversight (ESCRO) committee and the Institutional Review Board. The US National Institute of Health (NIH) in its guidelines recommends against reimbursing egg donors except for direct expenses incurred for the process. However, in the US women are compensated when they donate eggs for reproductive purposes, which have led the ESSCB to argue that “There is no principled reason to distinguish between donation of oocytes for reproductive purposes and research purposes when determining the ethicality of reimbursement”. Furthermore, they state “that a policy prohibiting reasonable payments because they may interfere with a woman’s ability to weigh the risks and benefits of donation is unnecessarily paternalistic”.
Comment: Harvesting human eggs for any purpose is an uncomfortable and potentially risky procedure; for example, ovarian hyperstimulation syndrome is a rare but potentially fatal complication. In countries such as in the UK, women who donate eggs solely for research are not paid, but may receive financial compensation for expenses incurred during the donation process (as well as loss of earnings - the latter being subject to a maximum of £250, around US $400 per cycle; see previous news). The situation is different in most US states, where women who donate eggs for research purposes are not compensated, whilst those who donate eggs for reproductive purposes are routinely paid, sometimes very substantial sums.
The statutory basis for reimbursement being limited in this way in the UK is Article 12(1) of the EU Tissue and Cells Directive (2004) which provides that Member States should endeavour to ensure that donations of tissues and cells are voluntary and unpaid but in default that "Donors may receive compensation which is strictly limited to making good the expenses and inconveniences related to the donation. In that case, Member States define the conditions under which compensation is paid". The question of reimbursement was discussed in the HFEA SEED report which was followed by public consultation and debate. Within the UK, there is no distinction made between those women who donate eggs for stem cell research and other types of research.
Some argue that it is unethical to compensate those who donate eggs solely for research, as it may encourage women to put themselves at risk with no immediate benefit. However, others argue that such a view is overly paternalistic and women can understand the risks associated with egg donation and make an appropriate decision. Altruistic egg donation for stem cell research is more of a contentious issue than for reproductive purposes (the intended result of which is the birth of a child), especially in countries where such research is still controversial. It is possible that ambivalent attitudes to stem cell research in the US accounts in part for the more generous level of reimbursement (compared with the UK) that is now available.