New proposed embryonic stem cell (ES cell) research guidelines in the US are coming under fire from critics who are concerned that the rules will in fact hamper research in this area. The National Institutes of Health (NIH) has collected over 20,000 responses to its public consultation on new stem cell research guidelines, among which are many prominent scientists who are calling for it to revisit the guidelines.
The guidelines will implement an executive order (EO-13505) issued by President Obama on 9 March 2009. The NIH proposes to fund research on embryos, but only on those which have been donated following infertility treatment. Further, it is imposing a stringent consent procedure that many commentators are worried will render many of the 21 cell lines currently eligible for funding under ex-President Bush's policy out of bounds.
'We're very concerned,' said Amy Comstock Rick from the Coalition for the Advancement of Medical Research (CAMR), which has been campaigning for a more permissive federal policy on ES cell research. She added: 'If they don't change this, very little current research would be eligible. It's a huge issue.'
It appears that under the guidelines, which are currently in provisional form, donors will have to undergo formal consent procedures with strict rules on documentation. Although consent procedures were followed by researchers prior to this, there was no uniform criteria in this area and practices differed considerably. 'It's not that past practices were shoddy... but they don't necessarily meet every letter of the new guidelines,' said Lawrence Goldstein, a stem cell researcher at the University of California. 'We'd have to throw everything out and start all over again,' he added.
George Q Daley of the Harvard Stem Cell Institute agreed, saying that the NIH has moved the 'goal posts'. 'They take 2009 standards and attempt to apply them retroactively, which isn't really a standard that would allow most of the pre-existing lines to be acceptable for NIH funding,' he said. Exactly how many cell lines might be affected is not known.
Critics are calling on the NIH to reconsider the guidelines to address these issues. Raynard S Kingston, acting director of the NIH, has said the he is aware of the concerns but that will taken them into consideration with all the other responses to the consultation.
The public consultation closed on 26 May 2009. The NIH is expected to release the finalised guidelines on 7 July 2009.