In March, President Obama issued an Executive Order instructing the National Institutes of Health (NIH) to develop guidelines to establish a framework for federal funding of embryonic stem cell research. NIH released its draft guidelines, and the public now has a short opportunity to comment on them.
NIH will review the content, as well as the volume/number, of the comments it receives as it drafts the final guidelines. It is critical that the NIH hear from more proponents of stem cell research before the deadline, because the opponents of stem cell research have submitted tens of thousands of negative comments. Please follow the instructions below to submit your comments to ensure that the final guidelines are crafted in a way that allows federally funded scientific research to proceed without undue impediments.
How to submit your comments:
Click http://nihoerextra.nih.gov/stem_cells/add.htm to access the NIH comment form.
Provide your name and select "self" for "Affiliation." Insert comments into the comment box, provide the security check ID on the form, and click "submit comments."
You may wish to consider the following sample comments as you compose your remarks. This is very similar to the letter that Sharon Paige, an active King County Democrat and medical student/stem cell researcher, submitted to the NIH. If your time is limited so that you cannot write original comments, please submit this material rather than no comments at all.
President Obama's executive order was intended to ease restrictions on federal funding for embryonic stem cell research. Thus, I believe that two critical changes need to be made to the current draft guidelines.
First, I believe that a major flaw exists in section II. B, "Eligibility of Human Embryonic Stem cells for Use in Research". While this section provides a reasonable standard for the eligibility of human embryonic stem cell lines derived in the future, it does not recognize the existence of hundreds of stem cell lines currently in use in research labs across the United States. While these existing lines were derived according to the most ethical standards recognized at the time of derivation, they may not meet in every detail the new, more rigorous standards set forth in the NIH draft guidelines. To prohibit their eligibility for federal funds under this new policy would do great harm to the field of stem cell research. Federally funded researchers would be forced to stop their work and wait for a yet unknown number of new embryonic stem cells that comply with the new NIH guidelines to be derived. Such a halt to research would be detrimental to the scientific community's progress and devastating to patients around the world who might benefit from this important research.
Therefore, I urge the NIH to include a provision within Section II to allow human embryonic stem cell lines previously and ethically derived to be eligible for use in federally funded research under these guidelines. Instead of requiring previously derived cell lines to comply with either the National Academy of Sciences (NAS) guidelines or the guidelines by the International Society of Stem Cell Research (ISSCR), I ask the NIH to consider a different standard. I recommend that the final guidelines allow NIH funding for any lines derived prior to the implementation of the new policy that had been derived: a) with informed consent, b) without undue inducement, and c) with oversight by an ethics advisory committee, such as an Institutional Review Board.
Second, I also urge the replacement of section II C, "Prior to the Use of NIH Funds". The requirement that each recipient of federal funds ensure the compliance of the cell lines to be used would be administratively burdensome and unnecessarily restrict research. Under the draft guidelines, each investigator who wishes to use a cell line in his or her research must provide assurances that the cell line complies with the NIH Guidelines. This repeated reauthorization of the same cell lines seems unnecessary. It is also possible that different institutions might judge the eligibility of the same cell line differently. This lack of uniformity threatens the free flow of scientific investigation.
To avoid bureaucratic and legal confusion, I ask the NIH to establish an NIH registry of human embryonic stem cell lines available for federally funded research. When a cell line is first used in federally funded research, assurance documentation should be submitted to an NIH-run registry. The registry would allow researchers to review the cell lines that meet the NIH guidelines and then apply to use those stem cells lines.