On April 19, the National Institutes of Health unveiled its draft guidelines for federal funding eligibility in the field of stem cell research. The NIH was given the charge of developing these guidelines by President Obama, as part of his executive order to relax restrictions theretofore imposed upon federal funding. In what was seen by countless stem cell researchers, activists, and organizations as the start of a new era in U.S. scientific history, President Obama was making a bold step to rectify eight years of science based on ideology rather than science based on science. However, in the NIH draft guidelines, it appears that an opportunity has been missed to make this bold step more than just rhetoric.

There are several components of the NIH draft stem cell guidelines that are particularly troubling for the future of this research and, as a result, the future of the quest for cures. Most notably among these is the limitation of funding to stem cell lines derived only from excess IVF embryos. This overly-onerous restriction eliminates the availability for funding for stem cell lines that are crucial to scientific understanding, including those stem cell lines that have already been created privately from non-IVF embryos since the 2001 federal limitations were put into place, are already in use by the scientific community, and are more representative of the genetic variation of the population, at large. These existing stem cell lines, many created at such progressive institutions as Harvard University and University of Wisconsin at Madison and have been derived using private or state funds, have helped to bridge much of the gap that was created as result of President Bush’s restrictions. A lack of federal support for these lines would be a disservice to scientific inquiry.

In addition to the lost opportunity borne out through a lack of federal funding for non-IVF stem cell lines, the restrictions imposed by the NIH draft guidelines would prohibit any opportunity for federally-funded somatic cell nuclear transfer (SCNT). SCNT has shown itself to be an extremely valuable area of stem cell research, allowing for the possibility of embryonic stem cell lines that both disease-specific and patient-specific. If we are to hope for the development of actual treatments that can be used in vivo, SCNT must be pursued. If we are to hope for full appreciation of science within the United States, SCNT needs to be federally funded.

As the president and founder of THE BROOKE ELLISON PROJECT, a nonprofit organization dedicated to providing public education and advocacy for stem cell research, I offer the following policy recommendations for the NIH’s draft guidelines:

1. Allow federal funding for ALL existing stem cell lines, regardless of their origin, thereby grandfathering in lines that were created via non-IVF embryos
2. Allow federal funding for research on privately-derived stem cell lined moving forward, pursuant to the Dickey-Wicker Amendment as interpreted by the Clinton Administration.
3. Create a registry to catalog all federally approved stem cell lines.
4. Establish that donor consent need only be obtained once, and that consent need not be reobtained in cases where it is unreasonably difficult to do so.  Issues of consent should be in compliance with either ISSCR or NAS guidelines

Under the Obama administration, with strong democratic control of both houses of Congress, now is an opportunity of nearly unprecedented proportions to make great strides in this field. Similarly, as the NIH guidelines, once they have been solidified, will likely be the standing policy for quite some time, it behooves all of us to make them as comprehensive as possible. Under the current draft guidelines, that does not happen. These recommendations take us a bit farther, though not all the way, to reaching the goal we all hope to reach, funding cures for disease.

Thank you for your consideration of these comments.