The Niche

NIH issues draft guidelines for funding human embryonic stem cell research

I just got off a teleconference discussing draft guidelines about what kinds of human embryonic stem cell lines the NIH will fund. Research advocates still have some work to do for final guidelines due out just after the 4th of July. Here’s a link to the NIH draft guidelines.

Right now, here’s what’s not fundable: lines created from parthenotes (made by stimulating an unfertilized egg to divide; these have been created), lines created from cloned human embryo (made by taking an unfertilized egg and replacing its nucleus with that of another person, then using that to make a genetically matched line of embryo; these have not been created), also any embryos made for the purposes of research (i.e. fertilizing eggs with sperm with the intention of using the resultant embryo for deriving stem cell lines; these have not been created as far as I know, and doing so is prohibited in widely accepted scientific guidelines). The embryos used for deriving lines are typically blastocysts (hollow balls of cells, about 5 days old). Much more rarely, younger embryos (solid balls of cells) are used.

Here is what’s fundable : all of those lines that have been made from embryos that would otherwise have been discarded by fertility clinic including those diagnosed with certain genetic diseases, provided researchers can document certain conditions: That the embryo donors knew what would happen to the embryos when the lines are made (the balls of cells are typically destroyed), that donors knew the lines would be maintained for years and that if any commercial benefits developed from the lines, the donors would not get them. Interestingly, the NIH did not talk about grandfathering in any of the hES cell lines that were fundable under the Bush administration, and consent issues have been raised surrounding some of those lines. (See When the past catches up with the present)

This is a big expansion of the lines available, though researchers very much want to compare lines between embryos produced from cloning and left-over embryos to try to figure out what controls the machinery that maintains cells in an embryonic state. Interestingly, when Bill Clinton had the NIH issue guidelines during his presidency, the draft forms did allow funding of embryonic stem cell lines created for research purposes, but, after public comment, the final guidelines restricted funding to left-over embryos from IVF. The Bush Administration withdrew these guidelines when it issued its more-restrictive policy. These guidelines wre based on the kinds of research that enjoyed broad public support.

The proposed new NIH policy is both more and less restrictive than policies in the UK and Australia. The UK does not allow research on embryos unless researchers obtain a license from the government, of which very few have been granted. However, these licenses do allow researchers to transfer nuclei into eggs for the purposes of creating embryonic stem cells. In the US, anyone can try such procedures, but they can’t get federal money to do so.

I’ll post more in a few days as there is more information. A few months ago, Bryn Nelson compared how policy on hES research evolved in the UK, US, and Germany. That seems particularly relevant now. (Persistence pays off)

Also, here’s reporting from Reuters.

PS: This came through from the Harvard Stem Cell Institute as I was typing this up.

“The draft guidelines released today clearly reflect a great deal of careful consideration of the scientific and ethical issues involved. We strongly support the development of unambiguous, ethically sound regulation of the field of embryonic stem cell research, and will carefully consider these proposed guidelines and offer detailed response during the public comment period.”


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