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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47617 05/26/2009 at 06:01:59 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.

 
47618 05/26/2009 at 06:02:37 PM Self     To whom it may concern,

I am writing to let you know that I am very much opposed to using tax dollars to support embryonic stem cell research.

Thank you for your time.

 
47619 05/26/2009 at 06:03:38 PM Self     To whom it may concern,

I am writing to let you know that I am very much opposed to using tax dollars to support embryonic stem cell research.

Thank you for your time, and take care.

 
47620 05/26/2009 at 06:04:05 PM Self     I oppose the emphasis given to embryonic stemm cell research as stated in the Draft NIH Human Stem Cell Guidelines. It is not in the best interest of true scientific solutions to the valued use of stem cells. Adult stem cells are currently being harvested and used successfully in many applications while embryonic stem cells have not proven any better in such applications. This approach merely clouds the truth and diverts dollars to unproved theory.

 
47621 05/26/2009 at 06:04:29 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.

 
47622 05/26/2009 at 06:04:47 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.

I support these guideines and urge passage of the draft.

 
47623 05/26/2009 at 06:05:37 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 do not destroy human life and are already proven successful. There is no case under which government support should be extended to human cloning or the creation of human embryos for research purposes.

-Embryo-destructive stem cell research has shown to be ineffective and even dangerous, forming uncontrollable tumors and causing rejection problems. Adult stem cells are non-controversial, ethical, and most importantly, effective in treating patients. We should not fund controversial research that destroys human life when we have other options that do not destroy human life.

-The proposed regulations do not prevent future funding for embryonic stem cell research that could lead to the creation of clones and human-animal hybrids. This loophole must be closed immediately.

I will not allow more of my tax dollars to be spent on the destruction of human life.

 
47624 05/26/2009 at 06:06:01 PM Self     May 26, 2009

Dr. Raynard S. Kington Acting Director National Institutes of Health

Kathleen Sebelius Secretary U.S. Dept. of Health & Human Services

Dear Dr. Kington & Secretary Sebelius:

We are encouraged that expanded stem cell research efforts will soon commence thanks to Executive Order 13505, signed by President Barack Obama on March 9, 2009, and the National Institutes of Health’s (NIH) upcoming final guidelines on human stem cell research. By establishing a predictable framework to guide stem cell research, scientists can confidently pursue the promise of treatments and cures for the most debilitating diseases. We support the strong informed consent criteria listed in the draft guidelines, which establishes a solid ethical framework for moving forward with stem cell research. The importance of these guidelines must not be diminished, as it is our hope that they would be adopted as the gold standard across the federal government and around the world.

We hope you will consider the following comments as you prepare to finalize the guidelines:

Eligibility of Existing Lines We believe that any responsibly derived stem cell lines should be eligible for federal funding, regardless of the date on which they were derived. Specifically, we are concerned that the draft guidelines set a precedent that stem cell lines must retroactively meet new guidelines each time the NIH decides to publish updates. If stem cell lines meet the prevailing ethical standards at the time of derivation, such lines should be recognized as eligible for research using federal funding. In order to maximize the scientific research already underway, the NIH must adopt an inclusive policy that would expand and not limit stem cell research. NIH must develop criteria for determining if lines that are currently in use, including lines approved by President George W. Bush that may not meet all of the requirements set out in section II B, should continue to be eligible for federal funding. Just like with other human tissue research, these stem cell lines should be evaluated on a case-by-case basis.

Information Repository—Coordinating Assurance Requirements Once stem cell lines have been confirmed to meet the eligibility requirements set by the NIH guidelines, we believe a repository or registry for this information must be established. This would protect scientists and research institutions from having to duplicate time consuming efforts already undertaken in order to confirm eligibility requirements were met, per the assurance requirements laid out in section II C of the guidelines. Such a repository or registry could be managed by the NIH, by another entity designated by the NIH, or by a consortium of universities and research institutions. Requiring each institution to start from scratch in reviewing a line’s eligibility would create a significant burden on the scientific community and drastically slow the pace of research moving forward. We believe that the NIH must work with the research community to identify and implement a feasible solution to this potential problem.

Periodic Updates & Scientific Advancements As specified in President Barack Obama’s Executive Order, the guidelines must be reviewed and updated periodically. We encourage the NIH to include in section IV of the guidelines specific language stating that the guidelines will be updated periodically. This will signal to the scientific community that ethically responsible and scientifically worthy advances in stem cell research will be considered in future updates to the guidelines. Further, if the purpose of the guidelines is to specify the parameters for stem cell research that is eligible to receive federal funding, we do not believe it is necessary to list activities that are ineligible for funding in section IV.

We appreciate your hard work and dedication to the field of stem cell research. We are hopeful for scientific advancements that will support research into a variety of genetic diseases and are excited that as stem cell research goes forward, we will be able to conduct research on stem cell lines with genetic diversity that represents the entire population. Thank you for your consideration of our comments as you work to complete and implement the final guidelines on human stem cell research.

Sincerely,

Diana DeGette Michael N. Castle Gene Green Charles W. Dent Tammy Baldwin Russ Carnahan Lois Capps Mark Steven Kirk James R. Langevin Ed Perlmutter Henry A. Waxman

 
47625 05/26/2009 at 06:06:03 PM Self     Protect human embryos from destruction. They are utterly innocent human lives. Please focus instead on adult stem-cell research, which already has provided dozens of therapies and treatments for humans.

 
47626 05/26/2009 at 06:06:28 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.

 
47627 05/26/2009 at 06:06:29 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.

 
47628 05/26/2009 at 06:06:31 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.

 
47629 05/26/2009 at 06:06:34 PM Self     It's time for us to take a scientific approach to the embryonic stem cell (ESC) issue.

Science demonstrates that faith healing is ineffective, and, consequently, we don't let people use faith healing instead of science-based medicine when lives are at stake. Why should ESC objectors be taken more seriously than faith healers. Ethics requires that we be well-informed, and ESC opponents are not well-informed. Science clearly demonstrates that we are material beings, and that we are no more made of spirits than the ocean is made of sea sprites. And it is this spirit-world mentality that informs the ESC objector position.

Beyond the normal ethical consent safeguards provided to embryo donors, there should be no additional burden imposed on ESC research. The objections to ESC research are based on non-scientific and pseudoscientific worldviews, and too many lives are at stake to play their childish games.

 
47630 05/26/2009 at 06:06:45 PM Self     I support the advancing stem cell research to improve treatments and find a cure for multiple sclerosis. As a person who suffers from Multiple Sclerosis (MS) who watched her mother die a slow death from complications due to MS I feel this is a worthy cause that can not be ignored. There is no cure for MS and curent drug therapy can slow the progression of the disease but does nothing to cure the disease. I understand that stem cell research shows significant promise in finding a cure for MS and to not use stem cells already procured is unconscionable to say the least and at most willfully prescribing a death sentence for every person suffering from MS. Please allow this breakthough of modern medicine to help find a cure for MS and end a lifetime of not knowing what the next day will bring.

 
47631 05/26/2009 at 06:06:48 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.

 
47632 05/26/2009 at 06:07:01 PM Self     Basic to the Unied State of America, is the idea that a persn can follow ther conscience and not be made to do anything they believe is morally abhorrent. This is why we need a conscience clause to protect those in a sticky situation. Doctors, nurses, healthcare personnel, pharmacists, even teachers, should NOT be forced by the government to do things that are against thir conscience.

 
47633 05/26/2009 at 06:08:16 PM Self     This is just a money pit. . .or money grab. It is a proven fact that embryonic stem cells are worthless. What next? Alaskan Huskey stem cells? It doesn't matter what the money is designated for as it is ALL headed for Washington, D.C. and the tax and spend critters up in those upholstered chairs in the House and Senate. The Rise and Fall of the Holy Roman Empire revisited!!! Dear Gussey!!!!!

 
47634 05/26/2009 at 06:08:49 PM Self     As a former biomedical researcher, I applaud the proposed expansion of the NIH Human Stem Cell Guidelines to permit federal funding of some existing stem cell lines previously not eligible for federal funding and for new lines that will be created from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that all current stem cell lines will be eligible for federal funding. I believe the final guidelines should permit federal funds to support research using any existing stem cell lines that were created under ethical guidelines. This will allow research to 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. Since new breakthroughs to create stem cell lines occur regularly, it is crucial that the final guidelines provide federal funding using stem cell lines derived in other ethical ways.

I believe that sufficient safeguards are in place with rigorous peer review of federally funded grants that stem cell research will be conducted responsibly within these modified guidelines.

 
47635 05/26/2009 at 06:08:55 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.

Research of this type has not produced a single treatment or cure, while research using stem cells taken from non-embryonic sources ahs already been used to help numerous patients with many different conditions.

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.

 
47636 05/26/2009 at 06:09:30 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.

 
47637 05/26/2009 at 06:09:56 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. In no case should government support be extended to human cloning or the human embryos for research purposes.

 
47638 05/26/2009 at 06:10:35 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.

 
47639 05/26/2009 at 06:10:54 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.

 
47640 05/26/2009 at 06:13:09 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.

 
47641 05/26/2009 at 06:14:17 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.

 
47642 05/26/2009 at 06:14:29 PM Self     "Ethically responsible"

Destruction of human life for research purposes is not ethical, no matter what the perceived benefit may be. The basic tenets of ethical principles state that "One must never do evil so that good may come from it." Destroying one human being to benefit another violates every moral principle known outside the third world and violates the moral and religious sensibilities of millions of taxpayers. How can one consider any research to be ethical if it only benefits those who are not morally offended? Hundreds of thousands of Americans are refusing to use vaccines produced from aborted fetal cell lines. Shouldn't public tax dollars be used in a manner that benefits ALL Americans?

"Scientifically worthy"

Despite years of research and billions of dollars poured into embryonic stem cell research using private funds, to date, there has not been one single cure for any human illness using embryonic stem cells, while adult stem cells continue to provide cures for thousands of patients with over 70 diseases. For a list of some of these treatments, see: http://www.sciencemag.org/cgi/data/315/5810/328b/DC1/1

In addition, embryonic stem cells have consistently proved that fatal tumors form whenever they are manipulated for use in treatments and because they are not patient-specific, like most adult stem cell treatments, patients will have severe immune rejection problems.

"In Accordance with Existing Law"

Research which involves the deliberate destruction of human life violates every principle found in existing law, including the Code of Federal Regulations 45 CFR 46, (See http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm ) and the Dickey Wicker Amendment, which was signed into law under President Clinton and states:

SEC. 509. (a) None of the funds made available in this Act may be used for-- (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Ac (42 U.S.C. 289g(b)) (Title 42, Section 289g(b), United States Code). (b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 (the Human Subject Protection regulations) . . . that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes (sperm or egg) or human diploid cells (cells that have two sets of chromosomes, such as somatic cells). In addition, US Constitution guarantees the right to life for every human being. Embryos ARE human beings - and this is not an ideological fact - it is a scientific fact. Embryos do not start out as some other sort of life form - they are not carrots or puppies that evolve somehow through the development process. From the first moment of the union of the egg and sperm, the embryo has all DNA necessary to become a unique individual, including hair color, eye color, personality traits, etc. Thus, as a human individual, they are entitled to the same protection under Federal Law as other human beings.

 
47643 05/26/2009 at 06:14:40 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.

 
47644 05/26/2009 at 06:14:58 PM Self     I applaud President Obama's and the NIH's efforts to loosen the restrictions on stem cell research. This is a much needed step that will immediately help to hasten the process of scientific discovery in this important area of research which has the potential to lead to better treatments and/or cures for diseases which afflict so many people. However, the current guidelines could be significantly improved by adopting the additional steps outlined in the ISSCR's position statement. I hope these additional concerns raised by the ISSCR will be seriously considered and ultimately implemented so that this promising line of research can move forward in an appropriately regulated manner.

 
47645 05/26/2009 at 06:15:04 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.

 
47646 05/26/2009 at 06:15:32 PM Self     Don't even think about "using" embryonic stem cells, or destroying REAL life, in order to experiment which would be just like the Nazi/Hitler experiments! Have you ever heard of Dr. Josef Mengele, Auschwitz in 1943? Don't go there! Even on an embryonic level, it is still the same killing! Were you ever an embryo? What are you blind?

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.

 
47647 05/26/2009 at 06:16:03 PM Self     Dear Sir or Madam,

I have read and fully support the letter submitted to you by Msgr. David J. Malloy on May 22, 2009 in behalf of the United States Conference of Catholic Bishops regarding 74 Fed. Reg. 18578-80 which was published on their website at www.usccb.org/prolife/NIHcomments.pdf.

The funding of the destruction IVF human embryos is an immoral and unethical practice -- at any time -- but especially when so much progress has been realized through adult stem cell research, which will not benefit from funds and energy allocated instead to embryonic stem cell research! Section I. Scope of the Guidelines states "Although human embryonic stem cells are derived from embryos, such cells are not themselves embryos." If the honest purpose of such a statement is to edify the reader, why would the phrase "which are destroyed in the process" be omitted from the end of the sentence? Section II.B.7.d. also neglected to address the destruction of the living human embryo by simply stating "what would happen to the embryo in the derivation of human stem cells for research". Why would NIH neglect to mention the honest presentation of the death of the embryo while posting their guidelines for public review, which we know includes uneducated readers? This is in itself unethical and begs examination!

It is very disturbing that such commentary even needs to be made. How is it that human beings who have themselves been so blessed with life, education, and the means to conduct research for the improvement of human health and well-being cannot for a moment "remove" the most important person in their life and all the good they have done -- and fathom the vacuum that is left behind? Does it even need to be said that each human embryo that is destroyed leaves this same vacuum, magnified by all the other people he or she is forbidden to touch -- in the pretense of alleviating another human being's suffering, who themselves have excellent promise of achieving the same goal through other means such as adult stem cell research has been able to achieve? What if YOU are that embryo which is to be destroyed? Who would be able to fill the unique void which you would leave in the lives of your loved ones -- and in the world which we all hope you will effect for the good? Please stop, please re-think, please act in behalf of the innocent human beings who are as of yet powerless to help themselves -- you know, given only the same chance you had to grow, that they are as human as you are! How is it possible to enable this destruction of human life in a world where even human slavery, human trafficing (Section II.B.7.i. "...may have commercial potential...."; Section II.B.6. "Wherever it was practicable...."), human experimentation, and human drug testing ("Supplementary Information" Section, paragraph 5, "test new drugs...new medications could be tested....") are deplored by civilized cultures?

I sincerely hope the NIH will rise to the occasion to stand up now against the international disedification and destruction which it’s stature will only promote by funding the destruction of any human embryo for “research” purposes. The "left-over" IVF embryos are unwanted because they should not have been created in a laboratory the first place -- not because they can still be destroyed for "research"! Enabling more of them will never justify the wrong done to them in the first place, nor will destructive embryonic stem cell research made redundant by already successful adult stem cell therapies ever justify the wrong done to them. Please be humane for your own sake and for the good of the watching world -- which we know in many places has woefully less potential for oversight than we hope to exemplify in the United States!

 
47648 05/26/2009 at 06:16:36 PM Self     I believe that if a potential cure for Parkinson's Disease can be found, then all efforts should be made to advance research. A cure for PD will free up millions of money for other causes.

 
47649 05/26/2009 at 06:17:43 PM Self     To whom it may concern:

President Obama’s Executive Order 13505 represents a tremendous opportunity for the NIH to support ethically responsible and scientifically worthy stem cell research. However, I am worried that the NIH proposal will exclude funding for many existing ethically created stem cell lines, create systemic redundancies that will waste scarce resources without added value, and unduly delay important scientific research. I appreciate the opportunity to comment on the Draft Guidelines for Human Stem Cell Research and urge you to take the following into consideration before finalizing federal rules:

1. HONOR EXISTING REGULATIONS AND GUIDELINES Informed consent and independent regulatory oversight by an Institutional Review Board (IRB) represent the international standard used to measure the protection of tissue donors and research subjects. The NIH Guidelines should use the same standards when judging the acceptability of funding work on human embryonic stem cell (hESC) lines derived from donated embryos rather than retroactively imposing new requirements based on ethical principles that are fully encompassed by existing federal regulations.

The federal regulations for the protection of human subjects at 45 CFR 46 are the gold standard for the protection of human research subjects, specifically, the informed consent and independent regulatory oversight of research tissue donors. The same standards should be used to judge the acceptability of funding research with cell lines derived from donated embryos, including the required elements of informed consent at 45 CFR 46.116 and 117. Most established hESC lines widely used in research today were created from embryos that were obtained in accordance with existing federal regulations and are consistent with the core principles outlined by The Belmont Report, the California Institute for Regenerative Medicine (CIRM) regulations and the International Society for Stem Cell Research (ISSCR) Guidelines for the Conduct of Human Embryonic Stem Cell Research. Additionally, many of the hESC lines have to date been eligible for federal support and under the new rules such support will cease, making the proposed Guidelines more restrictive than those of the previous administration.

The established hESC lines serve as the scientific standard and were created in compliance with the existing regulations and guidelines requiring independent oversight, voluntary and informed donor consent and no undue inducements. To ensure continued scientific success and international collaborations, the principles and regulations used to ensure the ethical donation of human tissue should be applied to the evaluation of existing lines rather than creating new requirements that would be applied retroactively. 2. EXISTING SELF-REGULATORY PROCESS The NIH guidelines should support the strong existing federal regulatory framework provided by 45 CFR 46, rather than setting new and unique requirements for hESC research. The new guidelines should acknowledge that most existing domestic lines were derived in accordance with the core principles in the CIRM regulations and the ISSCR guidelines, and are consistent with the established federal regulatory framework involving the protection of human subjects (donors) through IRB oversight and approval. The federal human research regulations support ethically responsible and scientifically worthy research by: o Requiring independent oversight by IRBs and the international equivalent that have extensive experience reviewing informed consent in the context of human tissue research; o Ensuring a process for voluntary informed consent including the review of consent procedures performed domestically and internationally; o Requiring no undue inducements to donors.

In some instances, oversight bodies called Embryonic Stem Cell Research Oversight (ESCRO) committee, as recommended by the National Academy of Science (NAS) and required by CIRM, as well as other oversight methods in other countries, provide oversight of human pluripotent stem cell research. Established policies demonstrate that the self-regulatory structure provides 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. PROVENANCE BASED ON PREVAILING STANDARDS OF THE TIME The determination of the ethical and legal provenance of hESC lines should be based on the investigator’s documentation of IRB approval for the obtaining of the original tissue used for the derivation of the line. The IRB approval would be based on the usual determination that the embryos were collected in an ethically appropriate manner consistent with existing federal standards for informed consent.

For the purpose of determining eligibility for federal funding, the ethical provenance of existing domestic 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 applicable federal regulations. Many existing hESC lines, whether ineligible or eligible for federal funding during 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. Nevertheless, many of those very same hESC lines will not be eligible for federal research support solely because the IRB approved consent forms donors signed do not comply with the specific new requirements promulgated in the draft Guidelines. As a result, there is serious risk that these lines, some of which are currently the gold standard for hESC research and that receive federal support, will be ruled ineligible for use in NIH-funded research under the proposed Guidelines.

The same risk applies 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 US. Non-US lines should be eligible for federal funding if the IRB and/or ESCRO 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 US and international practice should only be applied prospectively and after a period for affected parties, including IVF clinics, to adapt. The NIH should reconsider those aspects of the proposed guidelines that go beyond existing IRB, CIRM, NAS, and ISSCR standards, including, for example, the proposed mandatory dual IVF consent the proposed guidelines would require, and the establishment of the informed consent document as the sole source for ethical validation of the informed consent process. Such a standard is a new requirement not previously contemplated by CIRM rules, NAS or ISSCR guidelines and is not required by the federal regulations for the protection of human subjects in domestic or international research.

4. FEDERAL hESC REGISTRY A central NIH registry should serve as a single point for verification of hESC lines eligible for federal funding. Such a registry will provide certainty to all parties that the identified lines were derived according to ethical and legal standards. The evaluation of hESC provenance represents a major resource commitment for oversight committees. It is common for multiple institutions to evaluate the provenance of the same lines resulting in the use of scarce resources in a duplication of a labor intensive effort. The NIH should support a more efficient use of scarce resources, reduction in errors, and ensure consistency and certainty of investigators and compliance committees, by supporting initiatives designed to establish and share the provenance of existing and to be created hESC lines. I, therefore, urge the NIH to work with organizations such as the CIRM and ISSCR to develop a list or registry of hESC lines available for NIH-funding or resources to support the oversight process. The CIRM, for example, has a registry mechanism 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. Ultimately, such a registry will reduce uncertainty, redundancy of review, and improve research efficiency. While that registry is being established, it would be useful for the NIH to publish, on a Web site, the lines that are determined to be eligible for federal funding based on IRB and ESCRO determinations.

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

 
47650 05/26/2009 at 06:18:13 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.

 
47651 05/26/2009 at 06:18:16 PM Self     Embryonic stem cell research degrades human life. As an attorney I can find no reason for the government to justify spending tax money on such debated and unethical research. The nation was once divided over treating all humans as equals (i.e. the slavery issue that divided this nation) I thought we solved that issue-ALL HUMANS ARE EQUAL- and therefore should be protected not mutilated through research. Do not divide this nation again!

 
47652 05/26/2009 at 06:18:29 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.

 
47653 05/26/2009 at 06:19:14 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.

 
47654 05/26/2009 at 06:19:17 PM Self     Please take note that my husband and I are strongly against the use of living, underdeveloped human beings (i.e.embryos)in stem-cell research and we are equally opposed to our tax dollars being used to support such research. Taking the unborn because their potential use hasn't been discovered yet is like taking the extremely elderly whose "use" has long-since passed. Please stick to the more moral and ethical ways of obtaining stem-cells that are currently in use!

 
47655 05/26/2009 at 06:19:34 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.

 
47656 05/26/2009 at 06:20:06 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.

 
47657 05/26/2009 at 06:20:34 PM Self    

I am a scientist, trained in science with advanced degrees. Unfortunately Congress is being sold a bill of goods by scientists who want money for funding. Some scientists can be very impartial and weigh evidence fairly, even regarding the merit of their own research. But other scientists can be very effective at persuading people that their research is critical and is much more promising than it really is.

There is no doubt that stem cells in our bodies work wonders. They repair damaged organs. They rebuild vital tissues and muscles. And they have already changed people?s lives. They?ve helped people with severe spinal cord injuries to walk again. They?ve helped children avoid a life of pain from sickle-cell anemia. And stem cells are showing further promise in treating a host of diseases like Parkinson?s, diabetes and heart disease. But these are not embryonic stem sells. They are adult stem cells (obtained without any controversial ethical issues). Some insist miracle cures will come only from embryonic stem cells. Yet two decades of embryonic stem cell research have not produced a single cure in any animal or helped a single person. Embryonic stem cells tend to be genetically unstable and can form lethal tumors. And they come with the hefty price tag of ethical questions that some are deeply opposed to. Embryonic stem cells have been hyped. But it?s the adult stem cells that are showing hope. So where is the future? Please look deep inside; the answer can be clear. But perhaps only if some of the bias from the misinformation can be removed or at least reduced.

Briefly, the main issue is simple. When there is a medical issue that divides our country so strongly (even if not equally) such as embryonic stem cell research, why should the government not be sensitive to those with strong moral objections when they are so many who are concerned and the following situation exists? After decades of research, embryonic stem cell therapy has been notably ineffective, has not helped a single person or cured a single animal. When embryonic stem cell therapy has been used, tumors or other unwanted effects have killed the patient. Adult stem cell therapies have found significant success for multiple diseases. Why should those who are strongly opposed have to pay for what they think is immoral if there is an alternative that works so much better? Clearly a society must (or at least should) find a way to compromise when there is disagreement about significant moral issues. Why can?t the compromise position be that the alleged immoral action is legal, but not funded by taxpayer money? If embryonic stem cell research has been so ineffective, then why should our government spend its money (our money) on research that is so much less promising in the light of decades of research as recognized by the majority in the scientific community (and is morally offensive to many Christians and other religious citizens)? If the private sector wishes to spend/waste its money in this direction, then it can be allowed, if it so desires (although this is morally offensive to many Christians). But let our public money not be spent on such highly speculative endeavors that are extremely controversial. Let it be spent in a way that weighs the likelihood of success (which is so strongly in the direction of using adult stem cells).

If this argument is not convincing enough, then please consider the following.

The Guidelines state that their purpose is: to establish policy and procedures under which NIH will fund research, in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. (Summary, Paragraph 2) These Guidelines do not accomplish these purposes. Specifically, they do not promote ethically responsible and scientifically worthy research.

Scientifically worthy? Embryonic stem cell therapy is known to cause tumors and tissue rejection. Recent advances have obviated the need for destroying human embryos in order to obtain pluripotent stem cells. Scientists have demonstrated that they can reprogram ordinary human skin cells into pluripotent stems cells which have the same properties as the embryonic. These cells have the added advantage that they can be obtained from the patient himself, obviating the immune rejection that occurs with human embryonic stem cells.

Ethically responsible? Who determines what is ethically responsible? Are there ethical principles or definitions that most people can agree to? Is truth determined by a vote? Although truth is not determined by a vote, we may have no other method to proceed in a democracy. But ethically, even if there is a slight majority opinion that a particular action is OK, should it be done if there is another action that accomplishes the same purpose much better and is not ethically questioned by a vast number in our society? This is the situation with the issue of the use of embryonic stem cells in research. The issue is not just the killing of embryos that is morally offensive to many Christians; it is the use of embryonic stem cells, since they can only come from the killing of embryos. On these grounds it is unethical to force a large portion of our society to pay for something that is morally offensive to their beliefs (the use of embryonic stem cells) when a better method could be funded with great medical benefit to all in our society. Thus, the Guidelines are not ethically responsible and scientifically worthwhile.

Additional concerns: There are elements of the guidelines that try (and fail) to address the moral concerns of the controversy that surround these issues. Some examples: The Guidelines state that they will limit funding for research using ?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.? (Supplementary Information, Paragraph 2, under page 18579) The Guidelines are written to appear to outline ethically responsible research, but to those who are ethically opposed to using embryonic stem cells for research, this is only an appearance of a compromise. The authors of the guidelines do not seem to comprehend the objections to this research. Specifically, the Guidelines state: ?Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos.? (I. Scope of Guidelines, Paragraph 2) Once the stem cells are extracted from the embryo?s inner cell mass, each one of these cells is not the whole embryo; however, the human embryo must be destroyed to obtain these stem cells. I recognize that taxpayer dollars will not be used to destroy the embryo, but to do research on the cells obtained from that destruction. But this distinction in the Guidelines does not address the ethical issues to which many Christians are greatly opposed. Even though the proposal in the Guidelines may not represent the worst possible scenario, it is still highly objectionable and highly offensive because the use of embryonic stem cells for research is held to be morally wrong by many Christians and others who value the dignity of human life in all its stages.

The Guidelines also provide criteria for the donation of the embryos destroyed to obtain embryonic stems cells, e.g.: ?II. B. 2. No inducements were offered for the donation.? However, II B. 6. of the Guidelines do not definitively prohibit the researcher from being the same person as the reproductive-care physician thus creating the likelihood of subtle inducements: ?Decisions related to the creation of human embryos for reproductive purposes were made free from the influence of researchers proposing to derive or utilize human embryonic stem cells in research. Whenever it was practicable [emphasis added], the attending physician responsible for reproductive clinical care and the researcher deriving and/or proposing to utilize human embryonic stem cells should not have been the same person.? The potential for subtle inducements is great and necessitates a complete separation of the roles of researcher and reproductive-care provider. The Guidelines actually could establish incentives for the engendering of an untold number of new human embryos for the sole purpose of destroying them, due to the lack of a strict and enforceable mandate concerning the separation between the roles of the researcher and the reproductive-care provider.

The Guidelines - on the positive side:

I support the prohibitions in the Guidelines against: III.A. Research in which human embryonic stem cells (even if derived according to these Guidelines) or human induced pluripotent stem cells are introduced into non-human primate blastocysts. III.B. Research involving the breeding of animals where the introduction of human embryonic stem cells (even if derived according to these Guidelines) or human induced pluripotent stem cells may have contributed to the germ line.

However, additional prohibitions need to be provided against the development of stem cell lines from animal/human hybrids.

Conclusion

The Guidelines are inherently unethical because they attempt to implement an executive order that is inherently unethical. This executive order lifts restrictions on federal funding of human embryonic stem cell [pluripotent] research when it has been announced in the press that scientists can now make induced pluripotent [flexible] stem cells without destroying embryos. It is unethical to violate the consciences of so many Americans when it is not necessary since the order to spend public monies to fund research that ultimately will destroy embryos is less promising and diverts funds that could be used for adult stem cell research that is proving to be much more successful and ethical.

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.

 
47659 05/26/2009 at 06:21:50 PM Self     We are opposed to your draft guidelines for embryonic stem cell research, which forces us as taxpayers to subsidized research requiring the destructin of innocent human life. Support should be directed to adult stem cell research and treatments that do not destroy innocent humman life and are already proven effective. Government support should not be extended to human cloning or the creation of human embryos for research purposes.

Embryo destructive research has shown to be ineffective. Adult stem cells are effective in treating patients and do not destroy innocent human life. We should not fund research that destroys innocent human life when we have other effective options.

The guidelines that are proposed do not prohibit funds for embryonic stem cell research that could lead to human cloning or the production of animal-human hybrids. These loopholes must be closed.

Thank you for the opportunity to comment on these draft guidelines and for considering our comments.

 
47660 05/26/2009 at 06:22:03 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.

 
47661 05/26/2009 at 06:22:12 PM Self     I oppose all funding of embryonic stem cell research. I oppose having my tax dollars used on human experiments where the subjects have no voice regarding their participation. Put the funding towards iPS cell research--that is where the major breakthroughs are anyway. I greatly appreciate your attention in this important matter.

 
47662 05/26/2009 at 06:22:12 PM Self     stem cells can be derived from adult skin cells as well as from umbilical cord blood and cells.ALL umbilical cords are saved and sent to lab in all births occurring in hospitals and could and SHOULD be used as an unending supply of stem cells.The killing of fetuses is unneccessary and it is academically dishonest to say abortion is needed for stem cell research.

 
47663 05/26/2009 at 06:22:25 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.

 
47664 05/26/2009 at 06:22:34 PM Self     NIH comment period closes at 11pm tonight! More Info

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.

 
47665 05/26/2009 at 06:23:39 PM Self     Please do not allow this to happen.

 
47666 05/26/2009 at 06:23:53 PM Self     We are writing to ask that our tax dollars not be used for embryonic stem cell research, stem cells collected from invitro fertilization so called "left-overs". This is unethical and horrific. Are parents even given their consent to kill these little humans, are those childless couples in our country able to adopt these "left-overs". Research using adult stem cells has made great headways. Please use the tax dollars to improve and to encourage this research before using helpless human life. No one can argue that human life is in that petri dish!! Our country must not allow such inhumane action toward other human life! The Draft for the NIH Stem Cell Guidlines must not include the use of embryonic stem cells. Tax dollars from people who oppose such actions must not be used for embryonic stem cell research. Thank you.

 
47667 05/26/2009 at 06:24:24 PM Self     We support federal funding for stem ell research. We think the guidelines should be expanded to provide funding for all existing stem cell lines. We also support the groundbreaking technologies as somatic cell nuclear transfer.

 
47668 05/26/2009 at 06:25:20 PM Organization Cure Michigan P.O. Box 20216, Lansing, MI 48901 On behalf of CureMichigan, Michigan’s leading organization supporting embryonic stem cell research, I provide the following comments and recommendations on the draft Guidelines for Human Stem Cell Research. Below, please find support for the safeguards established in the draft, a recommendation for clarification of existing stem cell line use, and a suggestion for eligibility of existing lines derived from somatic cell nuclear transfer.

Applaud Strong Safeguards I applaud the draft NIH Guidelines’ inclusion of safeguards similar to those which are now a part of Michigan's Constitution. Since Missouri is the only other state with safeguards of this magnitude, Michigan is certainly a leader in recognizing the importance of advancing important medical research while prioritizing patient safety and ethics.

Current Lines Should Be Eligible The Guidelines are not clear as to whether current lines, derived before the final regulations are in place, are eligible for funding. I contend that as long as lines were created under strict ethical practices at the time of derivation, they should be eligible for federal funding, to build on existing progress in research and the development of much-needed therapies and cures.

SCNT Eligibility Recommendation The NIH Guidelines currently prohibit funding eligibility of lines created from sources other than excess IVF embryos (i.e. somatic cell nuclear transfer, or SCNT.)

While Michigan struggled with the politics behind removing SCNT from Proposal 2, other states, such as Missouri, did not. The NIH should not adopt a hard-line rule against SCNT, when other states have specifically included SCNT in their state's Constitution. As an alternative, the NIH could make an exception for those lines created in states where SCNT is specifically provided for by law.

Thank you,

***** CureMichigan *****

 
47669 05/26/2009 at 06:25:26 PM Self     These guidelines seem to be stating;

1. That the biomolecular makeup and unique genetic character of a human is the legal property of that human for his/her lifetime. 2. That the biomolecular makeup and unique genetic character of a human's offspring are the legal property of the parent until an age of independent determination is reached by the offspring.

This raises a series of difficult and complex questions concerning a number of other issues such as genetic fingerprinting, co-ownership of offspring between parents, transplantation and abortion.

At present the guidelines of the US government do not seem to be based on any single philosophy of the determination of ownership of genetic characters, but rather on a series of populist campaigns raised by religious pressure groups.

Research and therapies based on the study of existing pluripotent cell germ lines has a high likelyhood of leading to massive general utility for the entire human race. It is the duty of the US government not to stand in the way of this research without being able to provide a sensible and structured argument against such research based on a single underlying philosophy which should be applied across the legislation covering the human genomen and it's ownership.

 
47670 05/26/2009 at 06:25:29 PM Self     The ethical value of these guidelines is mixed. They provide typical safeguards against conflicts of interest and coercion, and they require researchers to document what they do.

As the Obama Administration asked, the guidelines do expand the practice of embryonic stem cell research. They enable research on human embryos created in IVF clinics for reproductive purposes. Noticeably absent is any discussion of the main ethical issue: the destruction of those human embryos. The guidelines envision a couple’s deciding to create embryos to have children and then deciding to donate some to research. Thus, the guidelines promote ESCR, but they also show its injustice: They permit the destruction of embryos who—as everyone recognizes—could equally well be sustained, nurtured in the womb, born and raised.

These guidelines clearly do not resolve the ethical issues regarding ESCR. In fact, they will do more harm than good. They give the appearance of legitimacy to scientific practices that destroy human embryos.

In conclusion, the Obama Administration has done fine work to solicit public commentary on some of its policies. I encourage the HHS to think through the ethics of stem cell research and promote policies that respect each human life.

 
47671 05/26/2009 at 06:26:36 PM Self     Human embryonic stem cells should not be used!

 
47672 05/26/2009 at 06:26:57 PM Self     The new NIH guidelines are poor science and poor health care policy, and would divert dollars away from real treatments. Any federal dollar used for embryonic stem cell experimentation is a dollar not used for adult stem cells. This will delay adult stem cell treatments and cures. This new policy puts the health of Americans in danger. We need to put the patients first, and put federal funds toward the real treatments and real promise of adult stem cells.

 
47673 05/26/2009 at 06:26:58 PM       I my self suffer from Juvenile Type one diabetes and it runs my wole life everything I do. I hope there is a cure one day soon but if not at least hope for our children.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.

 
47674 05/26/2009 at 06:27:07 PM Self     I oppose the funding of destructive stem cell research. It's wrong.

 
47675 05/26/2009 at 06:27:10 PM Self     Please honor the wishes of the people you serve, by protecting human embryos from destruction. All embryos are sacred, but humans even more so. This is heavy responsibility you possess. I pray you do the right thing.

 
47676 05/26/2009 at 06:27:29 PM Self     I am a United States citizen and a registered voter. And I am totally against these new rules. They will encourage "create & kill" behavior. These new rules would also divert funding away from the much more promising, as well as ethical, adult stem cell research.

 
47677 05/26/2009 at 06:27:39 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. In no case should government support be extended to human cloning or the human embryos for research purposes.

 
47678 05/26/2009 at 06:27:42 PM Self     I believe in stem cell research but you will be better off staying in the adult stem cell research program. It is unethical to create embryo's for research purposes...this essentially is murder. You need to stop this!

 
47679 05/26/2009 at 06:28:39 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.

 
47680 05/26/2009 at 06:29:22 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.

 
47681 05/26/2009 at 06:29:35 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.

 
47682 05/26/2009 at 06:29:36 PM Self     I forcefully oppose any use of embryonic stem cells. It is not necessary to sacrifice human life to the god of science.

 
47683 05/26/2009 at 06:29:38 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am a scientist, 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.

 
47684 05/26/2009 at 06:29:40 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.

 
47685 05/26/2009 at 06:30:27 PM Self     Adult stem cells seem to be working. We don’t need to kill babies to save lives.

 
47686 05/26/2009 at 06:31:12 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. In no case should government support be extended to human cloning or the human embryos for research purposes.

 
47687 05/26/2009 at 06:31:21 PM Self     Quite frankly, embryonic stem cell research is immoral and counterproductive. It is immoral in the fact that it is a proven fact that human life begins at the moment of conception. It is counterproductive and less cost effective due to the fact that we have created stem cells from hair and other body cells. Please, seeing as other alternatives can be used (and even if they weren't it would still be wrong) stop this monstrous wanton destruction of human lives.

 
47688 05/26/2009 at 06:31:22 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.

 
47689 05/26/2009 at 06:31:27 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.

 
47690 05/26/2009 at 06:31:27 PM Self     I do not approve embryonic stem cell research, but I do approve adult stem cell [research].

 
47691 05/26/2009 at 06:32:19 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.

 
47692 05/26/2009 at 06:32:26 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.

 
47693 05/26/2009 at 06:32:32 PM Self     Opposes human embryonic stem cell research but supports adult stem cell research.

 
47694 05/26/2009 at 06:32:52 PM Self     Please protect human embryos. As scientists are learning, there is a high success rate with using adult human stem cells. There has not been any proof that embryo stem cell is useful.... added with using adult stem cell, you are not destroying embryos, which is human life.

 
47695 05/26/2009 at 06:33:00 PM Self     IT IS COMPLETELY OUTRAGEOUS THAT MY TAX DOLLARS ARE GOING TOWARDS FUNDING OF THE UNETHICAL AND IMMORAL PROCESS OF EMBRYONIC STEM CELL RESEARCH. STOP FUNDING IT ONCE AND FOR ALL. THANK YOU.

 
47696 05/26/2009 at 06:33:33 PM Self     I think we should stick with [adult] stem cells that have proved to be successful.

 
47697 05/26/2009 at 06:33:37 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.

 
47698 05/26/2009 at 06:33:45 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.

 
47699 05/26/2009 at 06:33:58 PM Self     It's been proven that stem cells are not even the best option for therapy's benefiting from this type of research. And to create life of any kind just to distroy is unethical in any civilized socitey.

 
47700 05/26/2009 at 06:34:05 PM Self     To whom it may concern:

On April 17, the National Institutes of Health (NIH), USA, issued draft guidelines for the federal funding of human embryonic stem cell research and requested feedback. View the ISSCR response below.

Your comments are critical! The ISSCR urges you to respond as individuals, as well as at an institutional and organizational level, providing your comment on the guidelines and reiterating the need for expanded federal support of human embryonic stem cell research. In turn, encourage friends and family to express their support.

SUBMIT YOUR COMMENTS TO THE NIH BY THE MAY 26, 11:00 p.m. ET DEADLINE

Click here: http://nihoerextra.nih.gov/stem_cells/add.htm

A template response letter is also available. For recent publications, visit www.cellstemcell.com.

To view the NIH draft guidelines, click here.

___________________________________________________________

The official response from the International Society for Stem Cell Research (ISSCR):

May 22, 2009

Dear NIH,

Re: Draft “National Institutes of Health Guidelines for Human Stem Cell Research”

We welcome and applaud the leadership that the NIH proposes to assume for the oversight of human embryonic stem cell research in the United States. The draft guidelines represent an important step towards accelerating critical medical research by giving scientists access to more embryonic stem cell lines that better reflect the diversity in our society, make it possible to model inherited human diseases, and have favorable properties such as reduced contamination with animal products. Given the importance of human embryonic stem cell research to future medical progress, access to an increased range of lines will accelerate efforts to understand and treat major public health problems.

President Obama’s Executive Order 13505 represents a tremendous opportunity for the NIH to support ethically responsible and scientifically worthy stem cell research. However, I am worried that the NIH proposal will exclude funding for many existing ethically created stem cell lines, create systemic redundancies that will waste scarce resources without added value, and unduly delay important scientific research. I appreciate the opportunity to comment on the Draft Guidelines for Human Stem Cell Research and urge you to take the following into consideration before finalizing federal rules:

1. HONOR EXISTING REGULATIONS AND GUIDELINES Informed consent and independent regulatory oversight by an Institutional Review Board (IRB) represent the international standard used to measure the protection of tissue donors and research subjects. The NIH Guidelines should use the same standards when judging the acceptability of funding work on human embryonic stem cell (hESC) lines derived from donated embryos rather than retroactively imposing new requirements based on ethical principles that are fully encompassed by existing federal regulations.

The federal regulations for the protection of human subjects at 45 CFR 46 are the gold standard for the protection of human research subjects, specifically, the informed consent and independent regulatory oversight of research tissue donors. The same standards should be used to judge the acceptability of funding research with cell lines derived from donated embryos, including the required elements of informed consent at 45 CFR 46.116 and 117. Most established hESC lines widely used in research today were created from embryos that were obtained in accordance with existing federal regulations and are consistent with the core principles outlined by The Belmont Report, the California Institute for Regenerative Medicine (CIRM) regulations and the International Society for Stem Cell Research (ISSCR) Guidelines for the Conduct of Human Embryonic Stem Cell Research. Additionally, many of the hESC lines have to date been eligible for federal support and under the new rules such support will cease, making the proposed Guidelines more restrictive than those of the previous administration.

The established hESC lines serve as the scientific standard and were created in compliance with the existing regulations and guidelines requiring independent oversight, voluntary and informed donor consent and no undue inducements. To ensure continued scientific success and international collaborations, the principles and regulations used to ensure the ethical donation of human tissue should be applied to the evaluation of existing lines rather than creating new requirements that would be applied retroactively. 2. EXISTING SELF-REGULATORY PROCESS The NIH guidelines should support the strong existing federal regulatory framework provided by 45 CFR 46, rather than setting new and unique requirements for hESC research. The new guidelines should acknowledge that most existing domestic lines were derived in accordance with the core principles in the CIRM regulations and the ISSCR guidelines, and are consistent with the established federal regulatory framework involving the protection of human subjects (donors) through IRB oversight and approval. The federal human research regulations support ethically responsible and scientifically worthy research by: o Requiring independent oversight by IRBs and the international equivalent that have extensive experience reviewing informed consent in the context of human tissue research; o Ensuring a process for voluntary informed consent including the review of consent procedures performed domestically and internationally; o Requiring no undue inducements to donors.

In some instances, oversight bodies called Embryonic Stem Cell Research Oversight (ESCRO) committee, as recommended by the National Academy of Science (NAS) and required by CIRM, as well as other oversight methods in other countries, provide oversight of human pluripotent stem cell research. Established policies demonstrate that the self-regulatory structure provides 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. PROVENANCE BASED ON PREVAILING STANDARDS OF THE TIME The determination of the ethical and legal provenance of hESC lines should be based on the investigator’s documentation of IRB approval for the obtaining of the original tissue used for the derivation of the line. The IRB approval would be based on the usual determination that the embryos were collected in an ethically appropriate manner consistent with existing federal standards for informed consent.

For the purpose of determining eligibility for federal funding, the ethical provenance of existing domestic 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 applicable federal regulations. Many existing hESC lines, whether ineligible or eligible for federal funding during 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. Nevertheless, many of those very same hESC lines will not be eligible for federal research support solely because the IRB approved consent forms donors signed do not comply with the specific new requirements promulgated in the draft Guidelines. As a result, there is serious risk that these lines, some of which are currently the gold standard for hESC research and that receive federal support, will be ruled ineligible for use in NIH-funded research under the proposed Guidelines.

The same risk applies 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 US. Non-US lines should be eligible for federal funding if the IRB and/or ESCRO 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 US and international practice should only be applied prospectively and after a period for affected parties, including IVF clinics, to adapt. The NIH should reconsider those aspects of the proposed guidelines that go beyond existing IRB, CIRM, NAS, and ISSCR standards, including, for example, the proposed mandatory dual IVF consent the proposed guidelines would require, and the establishment of the informed consent document as the sole source for ethical validation of the informed consent process. Such a standard is a new requirement not previously contemplated by CIRM rules, NAS or ISSCR guidelines and is not required by the federal regulations for the protection of human subjects in domestic or international research.

4. FEDERAL hESC REGISTRY A central NIH registry should serve as a single point for verification of hESC lines eligible for federal funding. Such a registry will provide certainty to all parties that the identified lines were derived according to ethical and legal standards. The evaluation of hESC provenance represents a major resource commitment for oversight committees. It is common for multiple institutions to evaluate the provenance of the same lines resulting in the use of scarce resources in a duplication of a labor intensive effort. The NIH should support a more efficient use of scarce resources, reduction in errors, and ensure consistency and certainty of investigators and compliance committees, by supporting initiatives designed to establish and share the provenance of existing and to be created hESC lines. I, therefore, urge the NIH to work with organizations such as the CIRM and ISSCR to develop a list or registry of hESC lines available for NIH-funding or resources to support the oversight process. The CIRM, for example, has a registry mechanism 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. Ultimately, such a registry will reduce uncertainty, redundancy of review, and improve research efficiency. While that registry is being established, it would be useful for the NIH to publish, on a Web site, the lines that are determined to be eligible for federal funding based on IRB and ESCRO determinations.

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

 
47701 05/26/2009 at 06:34:17 PM Self     We in no way support embryonic stem cell research. Adult stem cells have proved effective.

 
47702 05/26/2009 at 06:34:20 PM Self     I encourage NIH to support and provide federal funding for all forms of stem cell research including but not limited to SCNT. Please do not limit this extremely valuable research. There are 128 million people in this country who have a disease's who could benefit from this incredible stem cell research.

When you limit research you are not truly performing research. Research is to include but not limit to:

My mother ***** has Alzheimer's. This is a wicked disease that destroys the brain. I have seen my mother lose her mind and become a vegetable.

Please, Please provide federal funding for all forms of stem cell research.

 
47703 05/26/2009 at 06:36:04 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.

 
47704 05/26/2009 at 06:36:26 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.

 
47705 05/26/2009 at 06:37:05 PM Self     I am the wife of a Stage IV Parkinson's victim and I have been following the progress of stem cell research for many years; particularly as it has been advanced in other countries.

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. However, it is important for the final guidelines to allow federal funding for research using ALL stem cell lines created by following ethical practices at the time they were derived, in additionto those derived from excess IVF embryos, including somatic cell nuclear transfer. This will ensure that the final guidelines build on progress that has already been made.

Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines be amended, as described above.

If not, it is essential that the NIH, at the least, continue to monitor developments in this area and to update the subject guidelines as the research progresses.

 
47706 05/26/2009 at 06:37:24 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.

 
47707 05/26/2009 at 06:37:42 PM Self     I oppose the use of embryonic stem cells for science because doing so destroys an early stage human. I do want tax money generated by me being used for such unethical practices. There is plenty of progress being made with adult stem cells lines, so there is absolutely no need to destroy humans and/or divert funds from ethical methods to embryonic research. Let's focus our attention and funds on the stem cell research that not only shows the most promise, but also generates the least controversy: adult stem cell research.

 
47708 05/26/2009 at 06:38:10 PM Self     I, like so many others, have lost friends and family to diseases that can be cured or better treated through stem cell research.

It would be criminal not to allow as much progress as possible to be made with stem cell research, which could help millions of Americans and their families. Using stem cells for this research is the only moral and ethical course of conduct.

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. My concern is that 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.

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.

 
47709 05/26/2009 at 06:38:26 PM Self     The experimentation with embryos is a highly inmoral and unethical issue which only promots the lowering of the value and dignity of each human being. My husband and I oppose this bill.

 
47710 05/26/2009 at 06:40:33 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. In no case should government support be extended to HUMAN CLONING or the HUMAN (babies) embryos for research purposes. Get the lobbyist out of Washington. It is well known that embryonic stem cells have not produced any considerable results.

 
47711 05/26/2009 at 06:40:42 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from devastating diseases and conditions. As someone who sees the great potential of stem cell research, I strongly support all forms of stem cell research. I am pleased to see that NIH has been directed to create the guidelines for federal funding of stem cell research. I am confident that the NIH is most able to draft effective guidelines that will build on the progress in this field over the past decades so that cures and new therapies can get to patients as quickly as possible. While ensuring ethical standards, the final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

I am pleased with the intent of the NIH’s draft guidelines to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from excess embryos at fertility clinics.

I do encourage that the guidelines cover all basis by including a “grandfather” clause to allow federal funding for existing stem cell lines that were created using the best ethical practices at the time of derivation. At present draft, there is uncertainty if current lines meet all the guidelines set forth in the current draft and thus might be excluded from federal funding.

While recent scientific advances have been truly remarkable, such as the generation of induced pluripotent stem cells, I still believe that somatic cell nuclear transfer (SCNT) is meritous and ethical research. Thus, SCNT should be supported by the NIH and have the benefit of the institution’s oversight.

Finally, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses. With the proper support and resources, I believe stem cell research will help my generation meet the medical challenges of the 21st century.

Thank you for reviewing my comments.

 
47712 05/26/2009 at 06:40:54 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.

 
47713 05/26/2009 at 06:41:32 PM Self     To Whom It May Concern, I am writing to let you know that I strongly oppose using tax dollars to support embryonic stem cell research. Thank you for your time.

 
47714 05/26/2009 at 06:42:29 PM Self     To Whom It May Concern, I am writing to let you know that I strongly oppose using tax dollars to support embryonic stem cell research. Thank you for your time.

 
47715 05/26/2009 at 06:42:55 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.

 
47716 05/26/2009 at 06:44:56 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.

 



Go to NIH Stem Cell Information Page