Listing of Comments on Draft NIH Human Stem Cell Guidelines
Entire Comment Period: 04/23/2009-05/26/2009

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On April 23, 2009, the National Institutes of Health (NIH) published draft stem cell guidelines for public comment in the Federal Register. The purpose of these guidelines are to implement President Barack Obama’s Executive Order 13505 “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells,” which was issued on March 9, 2009.

NIH received 49,015 comments by May 26, 2009, the closing date of the comment period, and have compiled these comments on this website. Any comments received via email or mail after the May 26 deadline are not included on this website. In reviewing the comments, NIH determined that 60 comments were inappropriate (i.e., contained SPAM responses or offensive language), and these comments have been excluded from this website. In addition, to protect the identities and personal information of individuals who submitted comments, NIH has removed personally identifiable information from the comments on this website even though individuals consented that the information provided could be made available for public review and posting.



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ID Entry Date Affiliation Organization
Name
Organization
Address
Comments Attachment
46817 05/26/2009 at 01:47:25 PM Self     I completely support federal funding for stem cell research.

 
46818 05/26/2009 at 01:47:36 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46819 05/26/2009 at 01:48:09 PM Self     As an MD and a parent, I object to embryonic stem cell research (ESCR) on several levels: one, scientific evidence of success, two, moral responsibility to hardworking families to use tax dollars responsibly, and three, value and contribution of adopted human life. In light of the overwhelming success of new developments in adult stem cell use every year, including over 70 current safe and effective treatments, it is hard to justify tax dollars pouring down the drain of theoretical ESCR which continues to show zero successes, and still faces the mountain range of obstacles known as understanding and controlling cell growth regulation processes, in other words how to prevent tumor formation, a field of inquiry which compared to adult stem cell research is still in the Stone Age. Other mountain ranges to follow include immune system rejection of the the foreign embryonic tissue. How can a scientist with integrity choose otherwise when section II Guidelines for Eligibility specifically uses the language "responsible, scientifically worthy human stem cell research"?

Prime example of adult stem cell success: February 2009: The Bentham Open Stem Cell Journal documents the first successful adult neural stem cell transplant, reversing the effects of Parkinson's disease for at least 36 months, and demonstrated the long term safety and therapeutic effects of the approach over a five year period (Dr. Michel Levesque is the lead author and principal investigator for NeuroGeneration, a biotechnology company, and is affiliated with the UCLA School of Medicine and the Brain Research Institute.) Let us be extremely careful with what we allow federal tax dollars to support, because people are working very hard to feed their families and deserve to know that they are on a winning team, and that there is hard scientific evidence supporting the kind of research their government is promoting and spending their tax dollars to support. On another level, we are on a slippery moral slope to assume that it is the best that embryos who began life in infertility treatment be destroyed in research, and not live to run, play, grow, mature and add to our society. It was not the original intent of the infertility treatment and parents to provide sacrificial embryos. I believe the potential good of the adopted child far outweighs the hundreds and thousands of embryos that would need to be destroyed in the process of 'inquiry.'

What evidence do I have for this? My neighbor adopted two "leftover" embryos who are now strong and healthy American children, a sister and brother. We are abandoning the value of human life to relegate these embryos to the level of laboratory tissue, an issue faced by medical professionals in many historical contexts, such as under Adolph Hitler in World War II. I believe we need to facilitate and promote the adoption of these embryos, not facilitate and promote their complete destruction for potential financial benefit. In summary, I object to embryonic stem cell research on three levels: one, scientific evidence of success, two, moral responsibility to hard working families to use tax dollars very responsibly, and three, the incredible value and contribution of adopted human life.

Thank you for your time, Sincerely,

 
46820 05/26/2009 at 01:48:25 PM Self     If this can assist us witth tthis muttiple scerosisis let them move forwward MS is very debiliitatating and any answers tahat can assist us let them continue with there help

 
46821 05/26/2009 at 01:48:47 PM Self     Today is the last day to comment on NIH’s draft stem cell guidelines. Your support for human embryonic stem cell research is needed -- each comment is recorded and counted! Although the vast majority of Americans support stem cell research, as of last week, most of the comments NIH has received are in opposition to stem cell research. We must do everything we can to shift that balance. Please submit comments if you have not done so already. Once you have submitted your comments, encourage your friends and family to voice their support for stem cell research as well. PAN has also submitted organizational comments on the NIH draft guidelines. Generally, PAN is pleased that the draft guidelines greatly expand the availability of federal funds for stem cell research. PAN’s detailed comments also identify regulatory adjustments and clarifications that are needed in the final guidelines, which is far more detail than what individuals need to submit. The comment period closes at the end of the day today. Please take five minutes to express your support for this important research now! How to Submit Your Comments: • To access the NIH comment form, visit: http://nihoerextra.nih.gov/stem_cells/add.htm • Provide your name, and select ‘self’ for Affiliation; and • Copy and paste the text below into the comment box, edit as appropriate, provide the security check ID on the form, and click ‘submit comments.’ Suggested Comment Text: Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46822 05/26/2009 at 01:50:36 PM Self     The current NIH draft guidelines are a dramatic improvement over the restrictive 2001 funding policy for embryonic stem cell (hESC) research, but they could be even better. The draft guidelines will expand hESC research by increasing the range of available cell lines for NIH-funded research. The issue is which lines can be used in NIH research. That, in turn, depends on whether they were derived from embryos that were donated in an acceptable manner. First, the draft guidelines are redundant. The federal “Common Rule” regulations for the protection of tissue donors apply to all federally funded research and have been voluntarily adopted by most institutions for all research under their auspices. These regulations include a comprehensive system of independent oversight by Institutional Review Boards (IRBs), and documentation of proper standards and procedures for informed, voluntary consent free of any undue inducements. The draft guidelines set out a parallel set of requirements, but with terminology and procedures that require new interpretations and possibly new forms of oversight and documentation. Many existing hESC lines – whether approved or not by the Bush Administration -- were derived from embryos donated by couples who were fully informed of their options and of the purposes of the research, and whose donations were overseen by an IRB. Despite this, if their consent forms do not have the precise words listed in the draft guidelines, there is a risk these lines will be ruled ineligible for use in NIH-funded research. The same risk attaches to lines developed pursuant to the laws and regulations of various states and foreign countries, even if their requirements are substantially equivalent to those in the U.S. It is my belief that the following points conform to President Obama’s goal of expanding research on human embryonic stem cell research with an ethical process mandated by the Federal government that has demonstrated effectiveness for years.

1. The informed consent process for deriving the lines as described in the guidelines is basically the same that is already used for the donation of human tissue under the Common Rule, which requires voluntary informed consent, an appreciation of alternatives, and information about any risks or benefits. The draft guidelines, however, risk creating confusion because they use slightly different words and procedures. I recommend that any line derived from materials originally donated in accordance with the Common Rule be acceptable for use in NIH-funded research. The same standard should be applied to existing lines and to lines that are derived in the future. Similarly, the same standard should apply to lines derived here and abroad.

2. As a practical matter, the vast majority of lines already in existence were originally derived from embryos donated in accordance with the Common Rule. As is done for other tissue-research, IRBs can provide the necessary assurance that this occurred. And again, as is done for other tissue-research, IRBs can provide the necessary assurance that lines derived abroad come from materials originally donated in an acceptable manner.

3. The same considerations should apply to embryos already donated but from lines have not yet been derived, that is, the lines that are derived from them in the future should be usable in NIH-funded work provided the original donation was done in accordance with the Common Rule.

4. ESCROs and SCROs will be optional, with some institutions choosing to eliminate them entirely, and others maintaining them as a source of advice.

5. This proposal takes advantage of the fact that IRBs are already required to assure that cell lines and tissues have been obtained in an appropriate manner. This proposal avoids the redundancy and confusion inherent in the draft guidelines' approach.

In sum, the NIH should abandon the effort to create what is, essentially, a new, parallel system of governance for hES cell research alone. Instead, it should insist that hES cell work comply with the same regulatory standards and procedures that apply to donations from human research subjects. Treating embryonic stem cell research rules as a subset of human tissue research rules (including those for non-embryonic sources of stem cells) makes it more likely that they will be understood and properly implemented. And this approach will relieve barriers to responsible hES cell research while better respecting those who donated sensitive biological materials in order to advance this promising field of research.

 
46823 05/26/2009 at 01:50:39 PM Self     I want you to stop doing research with embryonic stem cells. I do not believe that you should use embryos from in vitro fertilization. Adult stem cells should be used for research.

It is murder to use embryos from in vitro fertilization for medical research.

Tax dollars should not be used for research with embryohic stem cells or for cloning research.

 
46824 05/26/2009 at 01:51:10 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46825 05/26/2009 at 01:51:14 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46826 05/26/2009 at 01:51:38 PM Self     The use of embryonic stem cells involves the taking of one Human life. In what role is conception in distinguishing one life from another? All Human life should be protected and the idea of sacrificing one Human life for the sake of another Human life's extension is not in keeping with our basic life values. Many constituents of our great country view the concept of taking a embryonic stem cell as the taking of a Human life and as sacred. Why would our government disregard the will of a vast number its constituents in such a sensitive position and ask them to further pay for such a grotesque concept? Where does the idea of sacrificial taking of the un-conceived to cover the ills of others gain credibility? Please let the voice of the good people who believe contrary the deliberations of this body, be rightfully represented. This body is aware of this controversy and should be respectful and honorable to the people of whom they are sworn to serve and receive compensation.

 
46827 05/26/2009 at 01:51:51 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46828 05/26/2009 at 01:52:09 PM Self     My husband has PD and is one of the folks who could benefit from a successful stem cell solution. Please give him the opportunity to live a long and productive life by supporting stem cell research and providing the funds for those programs.

 
46829 05/26/2009 at 01:52:16 PM       From a simple legal standpoint, the drafted NIH Human Stem Cell Guidelines are unacceptable. The application of retroactive regulation in any area of law has long been considered unethical in our society and legal system. Though the proposed guidelines for the generation of new stem cell lines in the future are both ethical and reasonable, the idea of applying these guidelines to previously established stem cell lines is an abomination. Though it is also true that such retroactive application will greatly hinder current research, and unjustly negate grants currently "guaranteed" to investigators, it is even more important to consider the implications on future science policy. Were guidelines such as these retroactively enforce present-day policy on past actions and research, it would set a precedent for similar future action. It does not take a student of law or a scientist to recognize how dangerous such a precedent will be. In essence, the philosophy behind these guidelines suggest that any current legal action can be prosecuted anytime in the future, were the laws to change to make that action illegal. Such a philosophy is completely unacceptable in our society. Although I commend these guidelines for the NEW regulations on stem cell research - which will make it both more accessible to investigators and more ethically conducted - it is immoral and flat-out dangerous to apply the NEW regulations to previously-established research. These guidelines should NOT be passed in their current form.

 
46830 05/26/2009 at 01:52:30 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46831 05/26/2009 at 01:52:33 PM Self     1. I believe that a 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.

2. 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.

 
46832 05/26/2009 at 01:52:35 PM Self     The current NIH draft guidelines are a dramatic improvement over the restrictive 2001 funding policy for embryonic stem cell (hESC) research, but they could be even better. The draft guidelines will expand hESC research by increasing the range of available cell lines for NIH-funded research. The issue is which lines can be used in NIH research. That, in turn, depends on whether they were derived from embryos that were donated in an acceptable manner.

First, the draft guidelines are redundant. The federal “Common Rule” regulations for the protection of tissue donors apply to all federally funded research and have been voluntarily adopted by most institutions for all research under their auspices. These regulations include a comprehensive system of independent oversight by Institutional Review Boards (IRBs), and documentation of proper standards and procedures for informed, voluntary consent free of any undue inducements. The draft guidelines set out a parallel set of requirements, but with terminology and procedures that require new interpretations and possibly new forms of oversight and documentation.

Many existing hESC lines – whether approved or not by the Bush Administration -- were derived from embryos donated by couples who were fully informed of their options and of the purposes of the research, and whose donations were overseen by an IRB. Despite this, if their consent forms do not have the precise words listed in the draft guidelines, there is a risk these lines will be ruled ineligible for use in NIH-funded research. The same risk attaches to lines developed pursuant to the laws and regulations of various states and foreign countries, even if their requirements are substantially equivalent to those in the U.S.

It is my belief that the following points conform to President Obama’s goal of expanding research on human embryonic stem cell research with an ethical process mandated by the Federal government that has demonstrated effectiveness for years.

1. The informed consent process for deriving the lines as described in the guidelines is basically the same that is already used for the donation of human tissue under the Common Rule, which requires voluntary informed consent, an appreciation of alternatives, and information about any risks or benefits. The draft guidelines, however, risk creating confusion because they use slightly different words and procedures. I recommend that any line derived from materials originally donated in accordance with the Common Rule be acceptable for use in NIH-funded research. The same standard should be applied to existing lines and to lines that are derived in the future. Similarly, the same standard should apply to lines derived here and abroad. 2. As a practical matter, the vast majority of lines already in existence were originally derived from embryos donated in accordance with the Common Rule. As is done for other tissue-research, IRBs can provide the necessary assurance that this occurred. And again, as is done for other tissue-research, IRBs can provide the necessary assurance that lines derived abroad come from materials originally donated in an acceptable manner. 3. The same considerations should apply to embryos already donated but from lines have not yet been derived, that is, the lines that are derived from them in the future should be usable in NIH-funded work provided the original donation was done in accordance with the Common Rule. 4. ESCROs and SCROs will be optional, with some institutions choosing to eliminate them entirely, and others maintaining them as a source of advice. 5. This proposal takes advantage of the fact that IRBs are already required to assure that cell lines and tissues have been obtained in an appropriate manner. This proposal avoids the redundancy and confusion inherent in the draft guidelines' approach.

In sum, the NIH should abandon the effort to create what is, essentially, a new, parallel system of governance for hES cell research alone. Instead, it should insist that hES cell work comply with the same regulatory standards and procedures that apply to donations from human research subjects. Treating embryonic stem cell research rules as a subset of human tissue research rules (including those for non-embryonic sources of stem cells) makes it more likely that they will be understood and properly implemented. And this approach will relieve barriers to responsible hES cell research while better respecting those who donated sensitive biological materials in order to advance this promising field of research.

 
46833 05/26/2009 at 01:52:44 PM Self     I strongly support the draft guidelines on embryonic stem cell research. They demonstrate the ability of NIH to create a research framework that will allow for the potential of embryonic stem cell research while maintaining the highest safety and ethical standards. As this process moves forward, however, I hope that NIH will consider adapting the guidelines to ensure they include funding not only new stem cell lines, but current stem cell lines that have been developed using prevailing ethical practices. Research on these current stem cell lines should be eligible for federal funding as part of the final rule.

 
46834 05/26/2009 at 01:52:50 PM Self     I support funding of hESC research and incorporate by reference the comments lodged by the California Inst. for Regenerative Medicine.

 
46835 05/26/2009 at 01:53:28 PM Self     I am writing this in response to the draft guidelines regarding embronic stem cell research. I am opposed to this research since I believe it is taking the life of one person for the hope of saving another even though I find no research that proves this procedure has been of merit. I do support the use of stem cell research which has proved to be of help and takes no one elses life in doing so. Please do not go forward with the plan and do not use my tax money in this research. Thank you.

 
46836 05/26/2009 at 01:54:06 PM Self     Dear Mr. President:

I strongly oppose embryonic stem cell research. Please reconsider signing ANY bill allowing this type research to advance, no matter how great the social pressure. We as human beings must respect ALL human life form, no matter how small. The day we as a nation begin to look at embryonic human cells as hope for those who are afflicted physically is a day that is disturbing to me and anyone who knows what God's Word, The Bible, says about the shedding of innocent blood. Yes, they are embryos. But I dare to suggest that we were ALL embryos at one point and thank God that the adult population didn't look at us and think of the benefits to aborting us and using our stem cells for research to "help" others. When research is done on a willing adult participant that is good science but when we experiment with the smallest, most innocent forms of human life, we are a nation on the brink of extreme social decay. Please, Mr. President, consider my request with the weight that it carries. Lives, small, tiny lives, hang in the balance. I know I personally don't want to answer to God one day for why I allowed this to happen in our nation without me voicing this to you. Do you really want to stand before him one day and explain this to Him? Consider. Sincerely, Registered voter,

 
46837 05/26/2009 at 01:54:15 PM Organization BioTime, Inc.   To Whom It May Concern:

I am the ***** of BioTime, Inc. and Embryome Sciences, Inc. of *****. I was the ***** of Geron Corporation and while there, organized the effort to isolate human embryonic stem cells and embryonic germ cells in collaboration with Drs. ***** and *****. My CV can be found at *****

I would like to comment on the proposed future guidelines for human stem cell research. In my opinion the currently-proposed guidelines are an unnecessary and illogical restriction of the potentially valuable research that could be conducted using pluripotent stem cells derived from parthenogenesis. For example, parthenogenetic stem cells provide a unique model for the study of the potential immunological advantages of HLA-matching of differentiated cells to patient recipients and for the study of epigenetic factors involved with differentiation. The method of parthenote derivation can be conducted in ethically compliant manners and the derivation itself could be funded with private funds. In any event, parthenogenesis would almost certainly not result in a viable human embryo and the oocytes could be obtained in IVF clinics in manners that have been approved by at least four ESCRO committees at major research institutions in California. In the public debate over the ethics of embryonic stem cell research there has been little concern voiced over the use of parthenotes, and it seems ill-advised that the NIH would have a more restrictive position on the use of parthenote-derived lines than even the conservative critics of embryonic stem cell research.

In addition, I would urge the NIH to allow federal funding of any lines regardless of how they were produced as long as the embryo utilized was not allowed to develop past 13 days. So, for instance, if an embryonic stem cell line was created using SCNT utilizing private funding, the cell line itself should be allowed to be freely distributed and studied using federal funds as long as it can be documented that the SCNT embryo was not allowed to develop past 13 days in vitro. The British Human Fertilisation and Embryology Authority provides well thought out guidelines in this regard that could be a pattern for US policy.

Lastly, in regard to existing hES cell lines previously approved by President Bush, many researchers have invested years of effort in good faith engineering genetic modifications such as reporter constructs and genetic selection vectors into the current registered lines and deriving derivative lines that are valuable resources to the scientific community. It seems certainly to be wrong to punish members of the scientific community that have complied with President Bush’s restrictions and invested many hours of labor by now making those lines ineligible for use with federal funding. We therefore request that all of the lines previously recognized by President Bush be grandfathered in.

Thank You,

 
46838 05/26/2009 at 01:55:05 PM Organization Thomas More Society   The comments are set forth in the document attached to this submission.

 
46839 05/26/2009 at 01:55:07 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46840 05/26/2009 at 01:55:14 PM Self     Vital for Parkinson's research.

 
46841 05/26/2009 at 01:55:23 PM Self     I am opposed to your draft guidelines for embryonic stem cell research, which force me as a taxpayer to subsidize research requiring the destruction of innocent human life. Support should be directed to stem cell research and treatments that harm no one and are already producing good results.

 
46842 05/26/2009 at 01:55:48 PM Self    

Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46843 05/26/2009 at 01:57:19 PM Self     I dissagree with creating embroyo's for stem cell research.

 
46844 05/26/2009 at 01:57:37 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46845 05/26/2009 at 01:58:03 PM Self     MESSAGE TO NIH: “I am opposed to your draft guidelines for embryonic stem cell research, which force me as a taxpayer to subsidize research requiring the destruction of innocent human life. Support should be directed to stem cell research and treatments that harm no one and are already producing good results. In no case should government support be extended to human cloning or other morally reprehensible creation of human embryos for research purposes.”

 
46846 05/26/2009 at 01:58:19 PM       I fully support stem cell research--embryonic, adult, somatic cell nuclear transfer, or induced pluripotentiary. I believe that each avenue of research deserves careful investigation.

 
46847 05/26/2009 at 01:58:37 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46848 05/26/2009 at 01:58:41 PM Self     NIH Stem Cell Guidelines, MSC 7997 9000 Rockville Pike Bethesda, MD 20892

Dear Dr. Kington and Stem Cell Guidelines Committee:

I urge the NIH to adopt alternative criteria that will allow federal money to be used with stem cell lines currently approved for NIH-funding. Eliminating federal support for use of these lines would seriously undermine current research programs. I recommend that the criterion for acceptable derivation be oversight of embryo and oocyte donation by an Institutional Review Board (IRB) or its equivalent. The IRB should ensure that the informed consent process conformed to accepted regulations and guidelines at the time and place of donation. This alternative IRB criterion for informed consent continues support for current research programs and supports use of an expanded set of valuable stem cell lines.

I also urge the NIH to develop a registry or data-base of NIH-approved stem cell lines. This registry would save tax payer dollars by eliminating the need for each research institution to conduct its own reviews of stem cell lines.

Finally, I support the use of NIH-funds with stem cell lines derived through parthenogenesis and nuclear transfer as long as they meet standards for ethical derivation.

Yours truly,

 
46849 05/26/2009 at 01:58:43 PM Self     Adult stem cell are working and showing results in many ways, the money should be put in to what works.

 
46850 05/26/2009 at 01:58:52 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46851 05/26/2009 at 01:59:15 PM Self     Harvesting human embryos in the first place is profoundly wrong, and so is the use and/or destruction of harvested embryos for scientific experimentation. We must respect human life. Funds should be directed to ethical forms of stem cell research.

 
46852 05/26/2009 at 01:59:38 PM Self     Stem cell research is the best hope to cure Diabetes. I have Type 2, the negative effects of this disease has been a part of my life for over 15 years. Please give us a chance to live a long normal life. Thank you.

 
46853 05/26/2009 at 01:59:51 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46854 05/26/2009 at 01:59:58 PM Self     I do NOT agree with using tax-dollars to fund embryonic stem cell research. Just because President Obama changed the regulations, you don’t have to fund it in the federal budget.

These new rules would also divert funding away from the much more promising (and ethical) area of adult stem cell research.

PLEASE DO NOT use hard-working tax dollars to support embryonic stem cell research.

 
46855 05/26/2009 at 02:00:19 PM Self     As a tax payer, I want to express my opposition to the funding of the type of the stemcell research which is the subject of the Federal Notice. The use of embryonic stemcells is not as effective as using adult stemcells. The research and practice in this area has demonstrated good reults in the treatment and cure of many deseases. I also object because research in the use of embryonic stemcells necessitates the destrucion of human embryos.

 
46856 05/26/2009 at 02:00:27 PM Self     I have had Parkinson's for over 20 years. Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders.  I am not a scientist, but as a member of the Parkinson’s community and I have been following progress in this field with great interest.  Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible.  The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.   I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding.  It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived.  This will ensure that the final guidelines build on progress that has already been made.   I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT).  Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways.  If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46857 05/26/2009 at 02:00:52 PM Self     Dear NIH:

President Obama’s Executive Order 13505 represents a tremendous opportunity for the NIH to support ethically responsible and scientifically worthy stem cell research. The NIH deserves credit for producing draft Guidelines quickly to provide time for public comment. However, I am worried that the NIH proposal will exclude funding for many existing stem cell lines ethically created over the last eight years. I appreciate the opportunity to comment on the Draft National Institutes of Health Guidelines for Human Stem Cell Research and urge you to take the following into consideration:

[1] Develop final Guidelines that allow the NIH to fund research utilizing established hESC lines derived in accordance with the core principles in the ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research. These guidelines recommend independent oversight, voluntary and informed donor consent and no undue inducements. Most established hESC lines that are widely used in research today have been obtained in accordance with these principles. To ensure continued international collaboration, these principles should be applied to the evaluation of existing lines.

[2] Most existing U.S. lines have been derived in accordance with the core principles in the ISSCR’s guidelines and consistent with the established federal regulatory framework involving IRB oversight and approval. In some instances, additional specialized embryonic stem cell research oversight committees (ESCROs), and other oversight methods in other countries (referred to as SCROs in ISSCR Guidelines), have also provided oversight. Established policy has demonstrated that this self-regulatory structure has provided a sound ethical foundation for stem cell research. In developing the final Guidelines the NIH should consider this well-established framework of independent oversight and give weight to its determinations.

[3] Specifically, for funding eligibility purposes, the ethical provenance of existing U.S. cell lines should be judged based on the standards that prevailed at the time they were derived, provided the protocol under which donations were accepted, and any amendments, were approved by an IRB operating under federal regulations. Non-US lines should be eligible for funding within the US if the IRB and/or SCRO for the US institution receiving NIH funding determines that the protocol under which the underlying donation occurred met operative standards of the time and core ethical principles. In addition, new requirements that go beyond established U.S. and international practice should be applied prospectively only, and after a time period for affected parties, including IVF clinics, to adapt. We specifically ask the NIH to reconsider those aspects that go beyond existing ISSCR standards, including, for example, the proposed mandatory dual IVF consent the proposed guidelines would require, and the proposed requirement that the informed consent form is the sole source for ethical validation.

[4] It will be essential that investigators know with some certainty what lines are eligible for funding. I therefore urge the NIH to work with organizations such as the ISSCR to develop a list or registry of hESC lines available for NIH-funding or resources to support the oversight process. The ISSCR has in development a registry to document that hESC derivation was performed in accordance with ethical requirements, and make associated documentation available to reviewing IRBs and stem cell oversight bodies. Such a registry would reduce uncertainty and improve research efficiency. While that registry is being finalized, a useful and easy place to start in the meantime would be for the NIH to publish, on a Web site, the lines that are determined to be fundable based on IRB and SCRO determinations.

Thank you for the opportunity to comment on the draft Guidelines.

 
46858 05/26/2009 at 02:00:58 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46859 05/26/2009 at 02:01:19 PM Self     Not only is embryonic-destructive stem cell research reprehensible, it is totally unnecessary! Please consider all of these other forms, especially those that do not take a life, the embryo, for research purposes!

 
46860 05/26/2009 at 02:01:33 PM Self     Embryonic stem cell research holds great promise for millions of Americans facing the challenges of living with many diseases and disorders. I have been following progress in this field with great interest and understand the importance that it holds for people living with chronic diseases like multiple sclerosis. I am encouraged to see the field of human embryonic stem cell research expanded through the issuance of these guidelines and the change in federal policy around funding for this important scientific field. Much progress has been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

 
46861 05/26/2009 at 02:01:41 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses

 
46862 05/26/2009 at 02:01:43 PM Self     I am a Parkinwon's Diseasse patient and am strongly in favor of the of the guidelines

 
46863 05/26/2009 at 02:01:54 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46864 05/26/2009 at 02:02:01 PM Organization National Council of Jewish Women   May 26, 2009

National Institutes of Health Acting Director Raynard Kington MSC 7997 9000 Rockville Pike Bethesda, Maryland 20892 Re: NIH Stem Cell Guidelines

Dear Acting Director Kington:

On behalf of the 90,000 members and supporters of the National Council of Jewish Women (NCJW), I am writing regarding the NIH draft guidelines entitled “National Institutes of Health Guidelines for Human Stem Cell Research.”

NCJW was pleased when President Obama issued the executive order lifting the restrictions on federal funding of stem cell research put in place by the Bush administration. Embryonic stem cell research offers the hope of treating deadly and disabling diseases and conditions that affect more than 100 million Americans. Limiting research has stymied progress, increased costs, and made the US a follower instead of a leader in the field.

NCJW is supportive of the fact that these draft guidelines -- in Section II B -- appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. We believe that final guidelines should allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. Inspired by Jewish values, NCJW strives for social justice by improving the quality of life for women, children, and families and by safeguarding individual rights and freedoms. For this reason and those detailed above, on behalf of NCJW, I urge you to implement stem cell research guidelines that provide scientists with access to the resources they need to conduct this critical research.

Sincerely,

 
46865 05/26/2009 at 02:02:09 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46866 05/26/2009 at 02:02:12 PM Organization Center for Stem Cell and Regenerative Medicine   Center for Stem Cell and Reg enerative Medicine (CSCRM) Response to NIH Draft Guidelines May 26, 2009 Submitted by *****

The recent enactment of Executive Order 13505 by President Obama represents a major step forward in the ability of scientists to harness the power and potential of human embryonic stem (ES) cells in a safe and ethically-regulated manner. The President’s Executive Order effectively overturned the previous policy enacted by the Bush Administration and opened the door to Federal funding for additional cell lines, but Executive Order 13505 did not detail the exact nature of new Federal funding requirements. The President asked the NIH to establish these guidelines. To this end, we are grateful that the NIH is allowing, and seriously taking into consideration, input from scientists. Representing our institutional affiliates, Case Western Reserve University, Cleveland Clinic, and University Hospitals Case Medical Center, the Center for Stem Cell and Regenerative Medicine (CSCRM, www.thestemcellcenter.org) is a multi-institutional center with 95 investigators, over $80M in federal research funding and 48 cell therapy clinical trials in multiple therapeutic indications.. The National Center for Regenerative Medicine serves as a coordinating entity for regenerative medicine technology and is comprised of the stemcell , CSCRM, and tissue engineering, Clinical Tissue Engineering Center (www. ctecohio.org) centers in Ohio.

Although we strongly support the ethically responsible expansion of human ES cell Federal funding, we feel 4 specific areas in the draft guidelines need to be addressed further: 1. Creation and maintenance of an inclusive registry of lines eligible for Federal funding To avoid potential confusion regarding the eligibility criteria set forth in the draft guidelines, we encourage the NIH to maintain a list of lines eligible for Federal funding.

2. Continued eligibility for lines derived prior to the enactment of these guidelines We support the intent to mandate that all cell lines studied using Federal funding were derived under the highest of ethical and informed consent standards. We feel, however, that the detailed informed consent criteria put forth in the draft guidelines will have the unintended consequence of excluding most cell lines currently used by Federally-funded investigators if applied retroactively. These pre-existing lines were derived with the core principles of 1) voluntary informed consent, 2) no undue inducement, and 3) independent review and oversight and were thus deemed suitable by the NIH and local IRBs. Elimination of Federal funding for these pre-existing lines would have detrimental consequences on the field by nullifying all studies that currently utilize these lines. Furthermore, all data would have to be repeated on new cell lines causing an unnecessary increase in the spending of valuable NIH resources. Within CSCRM, we study over 7 pre-existing human ES cell lines including WA01, WA07, WA09, WA14, TE03, ES01, UC06, and BG03 and we urge the NIH to allow the continued study of these pre-existing lines.

3. Removal of wording that bars funding for lines derived from embryos created for research CSCRM believes it is important for the NIH to fund all areas of pluripotent stem cell research, including funding of research on pluripotent stem cell lines derived from in vitro fertilization (IVF) blastocysts, from IVF blastocysts created specifically for research purposes, from somatic cell nuclear transfer (SCNT), and from induced pluripotent stem cells. Although, at present, no pluripotent stem cell lines have been derived from SCNT or other embryos created for research, in the interests of pursuing all areas of stem cell science that may help the health of the world population, we urge the NIH to remove wording from the draft guidelines that specifically bars Federal funding for research on stem cell lines derived from SCNT and other research embryos. There is no scientific rationale to provide Federal funding for lines derived from embryos created for IVF but not from embryos created for research. We are aware that the annual renewal of the Dickey-Wicker Amendment as part of the appropriations bill for the Department of Health and Human Services prevents any funding of the derivation of pluripotent stem cell lines from IVF blastocysts, or from blastocysts derived from SCNT or other methods. However, if and when pluripotent stem cell lines are derived through alternative funding from embryos created specifically for research and available via rigorous guidelines already outlined by the National Academy of Sciences and the International Society for Stem Cell Research, the NIH ought to draft specific Federal funding guidelines as necessary at that time. Removal now of specific wording that bars funding for lines derived from research embryos will avoid the awkwardness of having to retract this element of the NIH guidelines at a future time.

4. Details pertaining to future amendments to the guidelines The field of human pluripotent stem cell biology is rapidly progressing. In anticipation of advances we encourage the NIH to include provisions for scientifically-guided amendments to the guidelines.

Writing group:

File Link (.txt)
CSCRM Comments on NIH proposed guidelines
46867 05/26/2009 at 02:02:14 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses

 
46868 05/26/2009 at 02:02:34 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46869 05/26/2009 at 02:02:37 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses

 
46870 05/26/2009 at 02:02:55 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses

 
46871 05/26/2009 at 02:03:01 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

This research will allow scientists an opportunity to better explore how to control and direct stem cells so they can grow insulin-producing beta cells found in the pancreas. Creating new beta cells could mean a cure for type 1 diabetes – something my family and I desperately want for my young daughter who was diagnosed over 6 years ago! And this research could also provide a powerful tool for controlling type 2 diabetes.

I strongly support the draft guidelines on embryonic stem cell research. They demonstrate the ability of NIH to create a research framework that will allow for the potential of embryonic stem cell research while maintaining the highest safety and ethical standards.

As this process moves forward, however, I hope that NIH will consider adapting the guidelines to ensure they include funding not only new stem cell lines, but current stem cell lines that have been developed using prevailing ethical practices.

Research on these current stem cell lines should be eligible for federal funding as part of the final rule.

Given the enormous promise of stem cells for diseases such as diabetes, it is important to allow federal funding for all forms of stem cell research, including research on embryonic stem cells, and that NIH continue to adapt as our scientists learn more about the promise of stem cell research.

I commend NIH for taking this important action to support research that provides the potential for new treatments, and ultimately a cure, for diabetes.

 
46872 05/26/2009 at 02:03:10 PM Self     Comment Text (please copy and paste into Comments section)

For many Americans with a personal connection to type 1 diabetes, the Administration’s expansion of the federal policy on embryonic stem cell research has renewed our hope for a cure. I am writing today to support the National Institutes of Health’s (NIH) draft guidelines and suggest a change to ensure promising, ethically conducted research currently underway will be eligible for federal funding in the future.

The Administration’s Executive Order on stem cell research restored scientific decision-making to its rightful place at the NIH. In these guidelines, the NIH has demonstrated its capacity to formulate a research framework that will unleash the potential of embryonic stem cell research while maintaining the highest safety and ethical standards. I would encourage the NIH, however, to grandfather into this policy stem cell lines that have received federal funding, as well as existing lines that were derived in an ethically-responsible manner according to the best practices at the time. Research on these stem cell lines should be eligible for federal funding so that scientists can maximize the scientific advancements already achieved through research on these lines.

Research should be vigorously pursued on all promising stem cell sources that could potentially lead to a cure for type 1 diabetes. While embryonic stem cell research is still in its early stages, this research has already yielded impressive results in our continuing effort to find a cure for type 1 diabetes. Recent research suggests that embryonic stem cells can be differentiated to produce the insulin-producing beta cells that could reverse the course of type 1 diabetes.

We do not yet know which stem cell sources may ultimately lead to a cure or be the most clinically useful or practical for patients with type 1 diabetes. It is clear, however, that the more knowledge we gain about embryonic stem cells, the better we can assess the full therapeutic potential of all stem cell sources. These draft guidelines allowing federal funding for embryonic stem cell research using excess embryos from fertility clinics will ensure that this research matures and its potential is more fully realized. I commend the NIH for allowing this important research to expand in a scientifically and ethically appropriate manner.

 
46873 05/26/2009 at 02:03:10 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses

 
46874 05/26/2009 at 02:03:29 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses

 
46875 05/26/2009 at 02:03:44 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses

 
46876 05/26/2009 at 02:04:15 PM Self     For many Americans with a personal connection to type 1 diabetes, the Administration’s expansion of the federal policy on embryonic stem cell research has renewed our hope for a cure. I am writing today to support the National Institutes of Health’s (NIH) draft guidelines and suggest a change to ensure promising, ethically conducted research currently underway will be eligible for federal funding in the future.

The Administration’s Executive Order on stem cell research restored scientific decision-making to its rightful place at the NIH. In these guidelines, the NIH has demonstrated its capacity to formulate a research framework that will unleash the potential of embryonic stem cell research while maintaining the highest safety and ethical standards. I would encourage the NIH, however, to grandfather into this policy stem cell lines that have received federal funding, as well as existing lines that were derived in an ethically-responsible manner according to the best practices at the time. Research on these stem cell lines should be eligible for federal funding so that scientists can maximize the scientific advancements already achieved through research on these lines.

Research should be vigorously pursued on all promising stem cell sources that could potentially lead to a cure for type 1 diabetes. While embryonic stem cell research is still in its early stages, this research has already yielded impressive results in our continuing effort to find a cure for type 1 diabetes. Recent research suggests that embryonic stem cells can be differentiated to produce the insulin-producing beta cells that could reverse the course of type 1 diabetes.

We do not yet know which stem cell sources may ultimately lead to a cure or be the most clinically useful or practical for patients with type 1 diabetes. It is clear, however, that the more knowledge we gain about embryonic stem cells, the better we can assess the full therapeutic potential of all stem cell sources. These draft guidelines allowing federal funding for embryonic stem cell research using excess embryos from fertility clinics will ensure that this research matures and its potential is more fully realized. I commend the NIH for allowing this important research to expand in a scientifically and ethically appropriate manner.

 
46877 05/26/2009 at 02:04:23 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46878 05/26/2009 at 02:04:33 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46879 05/26/2009 at 02:04:59 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am a physician and I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46880 05/26/2009 at 02:05:29 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

This research will allow scientists an opportunity to better explore how to control and direct stem cells so they can grow insulin-producing beta cells found in the pancreas. Creating new beta cells could mean a cure for type 1 diabetes and could provide a powerful tool for controlling type 2 diabetes. I strongly support the draft guidelines on embryonic stem cell research. They demonstrate the ability of NIH to create a research framework that will allow for the potential of embryonic stem cell research while maintaining the highest safety and ethical standards.

As this process moves forward, however, I hope that NIH will consider adapting the guidelines to ensure they include funding not only new stem cell lines, but current stem cell lines that have been developed using prevailing ethical practices. Research on these current stem cell lines should be eligible for federal funding as part of the final rule. Given the enormous promise of stem cells for diseases such as diabetes, it is important to allow federal funding for all forms of stem cell research, including research on embryonic stem cells, and that NIH continue to adapt as our scientists learn more about the promise of stem cell research. I commend NIH for taking this important action to support research that provides the potential for new treatments, and ultimately a cure, for diabetes.

 
46881 05/26/2009 at 02:06:05 PM Self     For many Americans with a personal connection to type 1 diabetes, the Administration’s expansion of the federal policy on embryonic stem cell research has renewed our hope for a cure. I am writing today to support the National Institutes of Health’s (NIH) draft guidelines and suggest a change to ensure promising, ethically conducted research currently underway will be eligible for federal funding in the future.

The Administration’s Executive Order on stem cell research restored scientific decision-making to its rightful place at the NIH. In these guidelines, the NIH has demonstrated its capacity to formulate a research framework that will unleash the potential of embryonic stem cell research while maintaining the highest safety and ethical standards. I would encourage the NIH, however, to grandfather into this policy stem cell lines that have received federal funding, as well as existing lines that were derived in an ethically-responsible manner according to the best practices at the time. Research on these stem cell lines should be eligible for federal funding so that scientists can maximize the scientific advancements already achieved through research on these lines.

Research should be vigorously pursued on all promising stem cell sources that could potentially lead to a cure for type 1 diabetes. While embryonic stem cell research is still in its early stages, this research has already yielded impressive results in our continuing effort to find a cure for type 1 diabetes. Recent research suggests that embryonic stem cells can be differentiated to produce the insulin-producing beta cells that could reverse the course of type 1 diabetes.

We do not yet know which stem cell sources may ultimately lead to a cure or be the most clinically useful or practical for patients with type 1 diabetes. It is clear, however, that the more knowledge we gain about embryonic stem cells, the better we can assess the full therapeutic potential of all stem cell sources. These draft guidelines allowing federal funding for embryonic stem cell research using excess embryos from fertility clinics will ensure that this research matures and its potential is more fully realized. I commend the NIH for allowing this important research to expand in a scientifically and ethically appropriate manner.

 
46882 05/26/2009 at 02:06:23 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46883 05/26/2009 at 02:06:25 PM Self     I oppose all research involving the manipulation and/or destruction of human embryos outside of the wombs of their mothers, and my tax money should not be used for such purposes.

 
46884 05/26/2009 at 02:06:32 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am a member of the Parkinson’s community and am also a scientist, I've been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46885 05/26/2009 at 02:06:51 PM Self     I fully support federal funding for stem cell research.

I would like to see the guidelines expanded to provide funding for all existing stem cell lines, grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease.

I also support such groundbreaking technologies as somatic cell nuclear transfer. This needs to be supported.

Further, I support the comments made by The Brooke Ellison Project on this matter.

Thank you,

 
46886 05/26/2009 at 02:07:25 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46887 05/26/2009 at 02:07:29 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46888 05/26/2009 at 02:07:39 PM Self     It is unfortunate that I am writing this note in support of stem cell research. I say that because a dear friend of mine was just recently diagnosed with parkinsons' disease at the young age of 37. When a friend/loved one has an illness that can possibly be cured, of course you want to do everything for them. That is why I am writing this note. Through further research, if anything can be done to help millions of people (one of them a dear person to me), then please do it!

 
46889 05/26/2009 at 02:07:41 PM Self     This comment came from an online source called: About.com:Catholicism and it expresses my feelings and thoughts exactly

Reconciling Science and Faith:

Ironically, despite all of the media attention that has been devoted to ESCR, not a single therapeutic use has been developed with embryonic stem cells. In fact, every use of embryonic stem cells in other tissue has led to the creation of tumors.

The greatest advances in stem-cell research so far have come through adult stem-cell research: Dozens of therapeutic uses have been developed and are currently in use. And the recent discovery of amniotic stem cells may well provide scientists with all the advantages that they had hoped to derive from ESCR, but without any of the moral objections.

It seems to me that the onus on the Medical community (NIH) is to protect human life in every way and not to pick and choose forfeiting one life to save another. They should try with every means to save and protect both lives and it is possible without ESCR as tne statement above emphasizes. The Greeks of a pagan civilization acted more civilized than do we as a nation in upholding and creating the Hippocratic oath which stated that doctors promised to harm no life.

 
46890 05/26/2009 at 02:07:42 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46891 05/26/2009 at 02:08:01 PM Organization St Gall Parish   The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46892 05/26/2009 at 02:08:11 PM Self     Please do not use human embryonic stem cells for research without getting the permission of the embryo (not its legal representative) personally.

To be clear, I do NOT support embryonic stem cell research.

 
46893 05/26/2009 at 02:08:19 PM Self     It is my hope that no research would be conducted on human embryos no matter how they originated. This type of experimentation upon the smallest of human beings has moved us to devalue life to an even greater extent and under the guise of providing cures at the expense of another human being.

 
46894 05/26/2009 at 02:08:20 PM Self     Embryonic stem cell research holds great promise for millions of Americans facing the challenges of living with many diseases and disorders. I have been following progress in this field with great interest and understand the importance that it holds for people living with chronic diseases like multiple sclerosis. I am encouraged to see the field of human embryonic stem cell research expanded through the issuance of these guidelines and the change in federal policy around funding for this important scientific field. Much progress has been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines — in Section II B — would appear to permit federal funding of studies using stem cell lines previously not eligible for federal funding and using new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos. Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses. Thank you.

 
46895 05/26/2009 at 02:08:21 PM Self     The current NIH draft guidelines are a dramatic improvement over the restrictive 2001 funding policy for embryonic stem cell (hESC) research, but they could be even better. The draft guidelines will expand hESC research by increasing the range of available cell lines for NIH-funded research. The issue is which lines can be used in NIH research. That, in turn, depends on whether they were derived from embryos that were donated in an acceptable manner. The draft guidelines are redundant, since Federal regulations already in place protect tissue donors by law or by voluntary adoption in the majority of embryo donations. Those regulations include a comprehensive system of independent oversight by Institutional Review Boards (IRBs) and documentation of proper standards and procedures for informed, voluntary consent free of any undue inducements. The draft guidelines set out a parallel set of requirements, but with terminology and procedures that require new interpretations and possibly new forms of oversight and documentation. Many existing hESC lines – whether approved or not by the Bush Administration -- were derived from embryos donated by couples who were fully informed of their options and of the research purposes, and whose donations were overseen by an IRB. Despite this, because their consent forms will not have the precise words listed in the draft guidelines, these lines are at risk of being ruled ineligible for use in NIH-funded research. The same risk attaches to lines developed pursuant to the laws and regulations of various states and foreign countries. It is my belief that the following points conform to President Obama’s goal of expanding research on human embryonic stem cell research with an ethical process mandated by the Federal government that has demonstrated effectiveness for years.

1. The informed consent process for deriving the lines as described in the guidelines is basically the same that is already used for the donation of human tissue under the Common Rule, which requires voluntary informed consent, an appreciation of alternatives, and information about any risks or benefits. The draft guidelines, however, risk creating confusion because they use slightly different words and procedures. I recommend that any line derived from materials originally donated in accordance with the Common Rule be acceptable for use in NIH-funded research. The same standard should be applied to existing lines and to lines that are derived in the future. Similarly, the same standard should apply to lines derived here and abroad.

2. As a practical matter, the vast majority of lines already in existence were originally derived from embryos donated in accordance with the Common Rule. As is done for other tissue-research, IRBs can provide the necessary assurance that this occurred. And again, as is done for other tissue-research, IRBs can provide the necessary assurance that lines derived abroad come from materials originally donated in an acceptable manner.

3. The same considerations should apply to embryos already donated but from lines have not yet been derived, that is, the lines that are derived from them in the future should be usable in NIH-funded work provided the original donation was done in accordance with the Common Rule.

4. ESCROs and SCROs will be optional, with some institutions choosing to eliminate them entirely, and others maintaining them as a source of advice.

5. This proposal takes advantage of the fact that IRBs are already required to assure that cell lines and tissues have been obtained in an appropriate manner. This proposal avoids the redundancy and confusion inherent in the draft guidelines' approach.

 
46896 05/26/2009 at 02:08:22 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

--------------------------------------------------------------------------------

 
46897 05/26/2009 at 02:08:25 PM Self     Memorial Day reminded me that people willingly sacrifice--even their lives--for their fellow Americans. I hope that those who have suffered and died for us were compensated by their strong sense of purpose. Now, an embryo in a laboratory cannot feel a sense of purpose, but if it could, I would think that it would not want to sit on a shelf in perpetuity. What kind of purpose is that? The language of the proposed guidelines includes allowing "funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose." Let's give these embryos a purpose they could be proud of. Let researchers discover ways to help people like my fiance who has Huntington's Disease (HD). Stem cell research can at least give hope to children who are gene positive for HD that they will be the first generation to overcome the disease.

 
46898 05/26/2009 at 02:10:17 PM Self     On behalf of family and patients I treat with Parkinsons Disease that I treat, I urge you to give them a chance by endorsing stem cell research.

 
46899 05/26/2009 at 02:10:19 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46900 05/26/2009 at 02:10:33 PM Self     I support embryonic stem cell research, and am glad some of the restrictions are being loosened.

 
46901 05/26/2009 at 02:10:50 PM Self     I am in favor of the Draft NIH Human Stem Cell Guidelines. It is of the utmost importance that embryonic stem cell research proceed. My husband, who suffers from and with Parkinson's disease, and countless others with similar debilitating diseases are waiting for advances in this area.

Please do whatever is humanly possible to enable such research to find a way to alleviate the suffering of millions.

Thank you.

 
46902 05/26/2009 at 02:11:01 PM Self     Dear Sir/Madam:

The following comments suggest clarifications, revisions or deletions.

The NIH draft guidelines for embryonic stem cell research appear to force taxpayers to subsidize research destroying innocent human life and for that reason fail the test of acceptability.

Support should be directed to stem cell research and treatments that harm no one and are already producing good results.

The proposed guidelines separate biomedical research from its ethical foundation, respect for human life at all stages. That appears to be inconsistent with President Obama's standards for integrity and ethics at all stages of scientific research.

The proposed guidelines for embryonic stem cell research, to the extent that they allow/treat innocent human beings as mere sources of body parts or commodities for our use, fail to maintain the standard of respect and dignity we accord all humans in the United States.

 
46903 05/26/2009 at 02:11:16 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46904 05/26/2009 at 02:11:27 PM Self     To Whom It May Concern:

I support the initiatives from the Obama Administration and Coalition of Life Sciences to establish a framework of guidelines for federal funding of embryonic stem cell research to ensure that the science is done in an efficient and ethical manner that retains high quality science and is not overly bureaucratic. I am not an expert in the field of stem cell research. However, I have confidence in those experts in the field such as Dr George Daley who will help establish this framework. I paste below a letter of correspondence from Dr George Daley together with a letter from the CLS that outlines key issues that need to be addressed.

*****

***** ***** ***** ***** ***** *****

Of course, thanks

________________________________ **** **** **** ****

Dear George, Thank you for such a rapid response. Can I circulate our correspondence back to CLS for them to use and disseminate as a quote and also to nonscientists so that I am not the only one whose letter benefits? *****

From: ***** To:***** Date: Fri, 22 May 2009 14:36:54 -0400 Subject: Re: Comments Needed on Stem Cell Guidelines Thread-Topic: Comments Needed on Stem Cell Guidelines Thread-Index: AcnbCTqCteEWnNkCRi23+q3ULNL3vQAAwzYw Accept-Language: en-US acceptlanguage: en-US x-ironport-anti-spam-filtered: true x-ironport-anti-spam-result:

*****,

Thanks for taking the time to respond:

Here's my version of below--

Two critical changes need to be made to the current draft guidelines, especially 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 which were derived according to the most ethical standards recognized at the time of derivation. To prohibit their eligibility for federal funds under this new policy would do great harm to the field of stem cell research. Therefore, I urge the NIH to include a provision within Section II to allow federal funding of human embryonic stem cell lines as long as they were derived according to the following core principles: 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.

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Sample text from Coalition of Life Sciences:

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.

 
46905 05/26/2009 at 02:11:37 PM       I strongly oppose the new NIH guidelines for taxpayer- funded human embryonic stem cell research. Science tells us that these embryos are living human beings. This research is a new form of barbarism. No government had the authority over another human being's life. Yours and mine could be next. If you love America, work to restore respect for human life.

 
46906 05/26/2009 at 02:11:49 PM Self     I already submitted a comment on behalf of the American Society for Cell Biology as Chair of its public policy committee. I would like to make some of the same points as a citizen scientist.

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.

 
46907 05/26/2009 at 02:11:49 PM Self     I am just submitting my remarks in favor of Stem Cell Research. I am in favor of the research as well as funding existing stem cell lines. I have a son with a new spinal cord injury. Not only will stem cell research benefit him but millions of others living with SCI and others facing other medical issues. This will enable my son to have a life out of a wheelchair.

Thank you.

 
46908 05/26/2009 at 02:11:54 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46909 05/26/2009 at 02:12:23 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

My tax dollars should not be used to promote destructive embryonic stem cell research or any form of human cloning. Instead support should be directed to adult stem cell research, which is ethically sound, harms no one, and is already helping suffering patients with dozens of conditions.

 
46910 05/26/2009 at 02:12:38 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

This research will allow scientists an opportunity to better explore how to control and direct stem cells so they can grow insulin-producing beta cells found in the pancreas. Creating new beta cells could mean a cure for type 1 diabetes and could provide a powerful tool for controlling type 2 diabetes.

I strongly support the draft guidelines on embryonic stem cell research. They demonstrate the ability of NIH to create a research framework that will allow for the potential of embryonic stem cell research while maintaining the highest safety and ethical standards.

As this process moves forward, however, I hope that NIH will consider adapting the guidelines to ensure they include funding not only new stem cell lines, but current stem cell lines that have been developed using prevailing ethical practices. Research on these current stem cell lines should be eligible for federal funding as part of the final rule.

Given the enormous promise of stem cells for diseases such as diabetes, it is important to allow federal funding for all forms of stem cell research, including research on embryonic stem cells, and that NIH continue to adapt as our scientists learn more about the promise of stem cell research.

I commend NIH for taking this important action to support research that provides the potential for new treatments, and ultimately a cure, for diabetes.

 
46911 05/26/2009 at 02:12:41 PM Self     I support federal funding stem cell research. I also support expanding the guidelines to provide funding for all existing stem cell lines.

 
46912 05/26/2009 at 02:12:56 PM Self     Please do not create incentives for the killing of human embryos created in fertility clinics.

 
46913 05/26/2009 at 02:13:27 PM Organization Division of Acquisition Policy and Evaluation, OAMP/OALM/NIH   Comments on the Draft Guidelines for Human Stem Cell Research Notice

1. The comments do not take into account the contract process. For example, the Human subject regulations referenced in the Supplementary Information and in the Guidelines themselves are not the regulations used by Contract staff. For example, 45 CFR 74.53 is grants-related, and is not the language used by contract staff (45 CFR 74.48).

2. The guidance should be rewritten to encompass both the grant and the contract process, since they are different, and the language should be rewritten to include both grants and contracts.

3. Page 2 of the Notice states that Human embryonic stem cells (HESCs) are cells are cells that are derived from human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Page 3 of the Notice states that the guidelines would allow funding for research using only those human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose. Page 5, Item IV, states that NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding of human embryo research.

Don’t these two statements conflict with one another? If they don’t because the law does not address the specific circumstances laid out in page 3 as above, then the guidance should clearly so state.

 
46914 05/26/2009 at 02:13:30 PM Self     For many Americans with a personal connection to type 1 diabetes, the Administration’s expansion of the federal policy on embryonic stem cell research has renewed our hope for a cure. I am writing today to support the National Institutes of Health’s (NIH) draft guidelines and suggest a change to ensure promising, ethically conducted research currently underway will be eligible for federal funding in the future.

The Administration’s Executive Order on stem cell research restored scientific decision-making to its rightful place at the NIH. In these guidelines, the NIH has demonstrated its capacity to formulate a research framework that will unleash the potential of embryonic stem cell research while maintaining the highest safety and ethical standards. I would encourage the NIH, however, to grandfather into this policy stem cell lines that have received federal funding, as well as existing lines that were derived in an ethically-responsible manner according to the best practices at the time. Research on these stem cell lines should be eligible for federal funding so that scientists can maximize the scientific advancements already achieved through research on these lines.

Research should be vigorously pursued on all promising stem cell sources that could potentially lead to a cure for type 1 diabetes. While embryonic stem cell research is still in its early stages, this research has already yielded impressive results in our continuing effort to find a cure for type 1 diabetes. Recent research suggests that embryonic stem cells can be differentiated to produce the insulin-producing beta cells that could reverse the course of type 1 diabetes.

We do not yet know which stem cell sources may ultimately lead to a cure or be the most clinically useful or practical for patients with type 1 diabetes. It is clear, however, that the more knowledge we gain about embryonic stem cells, the better we can assess the full therapeutic potential of all stem cell sources. These draft guidelines allowing federal funding for embryonic stem cell research using excess embryos from fertility clinics will ensure that this research matures and its potential is more fully realized. I commend the NIH for allowing this important research to expand in a scientifically and ethically appropriate manner. (I support the above).

 
46915 05/26/2009 at 02:13:38 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46916 05/26/2009 at 02:13:48 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made.

I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 



Go to NIH Stem Cell Information Page