Public Comments Open on Draft NIH Guidelines for Human Stem Cell Research

About a week ago, the NIH announced its draft guidelines covering the funding of human embryonic stem cell research. You can read the draft guidelines here and my post on the topic here. As these are draft guidelines, they are open to a month-long period of public comment before the final guidelines are released, and an online system for accepting comments has just been opened up. Comments must be received by 11:00 pm EST on May 26, 2009, and you can enter your comments here.

Below, I have pasted the comments I submitted:

To Whom It May Concern:

These comments are in response to the Draft National Institutes of Health (NIH) Guidelines for Human Stem Cell Research (Federal Register April 23, 2009, Volume 74, Number 77, pages 18578-18580). In summary, I argue that the new guidelines mark a significant step forward for United States science, but they remain unnecessarily restrictive.

On March 9, 2009, President Barack H. Obama lifted the restrictions placed on federal funding of human embryonic stem cell (hESC) research by President George W. Bush in August 2001. President Bush's rules on this area greatly reduced the scope of research conducted by federally-funded researchers in the United States by limiting such research to just a few preexisting lines of hESCs that were not representative of the significant genetic diversity that exists in our population and would have not been suitable for therapeutic work due to the means by which they had been extracted. These rules limited the research activities of many scientists and caused great hardship for investigators who chose to pursue research on hESC lines not covered by federal funds. These restrictions had a measurable impact on the quantity of hESC research produced in the United States, thus limiting the contribution of America to this exciting and important burgeoning scientific field (Levine, 2008).

Recently, the NIH announced its new draft guidelines for hESC research. The new guidelines will greatly expand the scope of federally-funded research by allowing funds to be used for work on stem cell lines derived from excess fertility clinic embryos (Section II.B). The scientific community, with the support of much of the public, has long argued in favor of such a measure. This marks a significant step forward, and it will increase the potential of research in the United States. For this reason, the NIH and the administration of President Obama should be applauded.

However, under the draft guidelines, unnecessary restrictions on hESC research remain in place. In particular, federal funds will not be available for work on hESC lines derived from embryos that have been generated specifically for the purpose of stem cell work (Section IV.B). This is a severe limitation that basically ensures that if a cell line was derived from an embryo that was not left over from a fertility clinic, work on that cell line can never be funded by federal dollars. This is unfortunate, as the ability to generate specific hESC lines will be very important--and likely essential--for therapeutic cloning to be possible and even just for scientists to be able to use hESCs for the study of a wide variety of diseases. Considering that national hESC policy is so closely correlated with research performance in this area, I would ask that the NIH consider easing this particularly harsh restriction.

Sincerely,

Nicholas J. Anthis

D.Phil Candidate, Department of Biochemistry, University of Oxford

Science Blogger, The Scientific Activist, http://scienceblogs.com/scientificactivist/

References:

Levine, A.D. (2008). Identifying Under- and Overperforming Countries in Research Related to Human Embryonic Stem Cells. Cell Stem Cell, 2, 521-4.