Ethics group adopts opinion on human embryonic stem cell use in FP7 projects

The European Group on Ethics (EGE) in Science and New Technologies has issued an opinion setting out guidelines for use during the ethics review of EU-funded research projects involving human embryonic stem cells (hESC). The report was drawn up following a request in November ...

The European Group on Ethics (EGE) in Science and New Technologies has issued an opinion setting out guidelines for use during the ethics review of EU-funded research projects involving human embryonic stem cells (hESC). The report was drawn up following a request in November 2006 from European Commission President José Manuel Barroso.

The final agreement setting up the Seventh Framework Programme (FP7) subjects research involving hESC to the same requirements as the Sixth Framework Programme. Under these rules, applicants must prove that regulatory criteria are met and that hESCs come from non-implanted in vitro fertilisation (IVF) embryos. They must also set out how personal data will be protected along with information on the conditions of donation of the embryos.

In their report, the EGE experts recommend that in addition to the ethics rules already adopted by the European Parliament and Council, certain extra considerations be taken into account.

The first of these concerns the development of alternatives to hESCs. 'If alternatives to hESCs with the same scientific potential as embryo-derived stem cells will be found in the future, their use should be maximised,' the Opinion reads.

The rights of donors also receive attention from the group. For example, funding applicants should be able to confirm that no pressure has been put on donors at any stage; that the donor's health has not been put at risk by excessive ovarian stimulation; that donors are aware that consent can be withdrawn up to the stage of stem cell creation; and that no financial incentives were offered to donate embryos for research. Ideally, hESC lines banked in the new European stem cell registry should be used.

In addition to the ethical review, hESC-related project proposals also have to undergo a scientific review. Here the EGE states that the scientific review should address issues such as whether the research objectives could be achieved with alternatives to hESC and whether the applicants can demonstrate that their research is aimed at improving human health or boosting biomedical knowledge.

Furthermore, the scientific panel should 'ensure that researchers of hESC FP7 projects collaborate nationally and internationally in order to minimise the use of hESCs within FP7 funded projects and to achieve complementary synergy rather than competition'.

Finally, the experts address the wider ethical aspects of research using human embryonic stem cells. 'As the ethical conflicts concerning hESCs have not been resolved either academically or politically, the EGE recommends that, under the FP7, funding should be provided in order to foster further collaborative and multidisciplinary international research on the ethical implications of hESC research and the pertinent surrounding issues, as well as to encourage informed public debate,' they write. Researchers who receive funding for hESC research under FP7 should also be encouraged to engage with social, political and ethical debates, the EGE states.

Other issues requiring further attention, according to the group, are the patenting of hESC derived materials and the tension induced by a policy that encourages both free donation and commercial use of derivates from human substances.