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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46917 05/26/2009 at 02:14:08 PM Self     I am a quadriplegic and I support federal funding for stem cell research and I would like to see the guidelines expanded to provide funding for all existing stem cell lines, grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease. And, I also support such groundbreaking technologies as somatic cell nuclear transfer, and it too needs to be supported by the government, not only for people like myself, but for ALL the people who supported the people who were voted into office to support those who cannot help themselves

 
46918 05/26/2009 at 02:14:40 PM Self     Several members of my maternal family have Parkinsons...We desparately need funding for all research in combatting this dread.....Thank you …

 
46919 05/26/2009 at 02:14:47 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.

 
46920 05/26/2009 at 02:14:54 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.

 
46921 05/26/2009 at 02:14:59 PM Self     I support federal funding for stem cell research. I would like to see the guidelines expanded to provide funding for all existing stem cell lines, including in the grandfathering of those lines that have been derived since 1998. I also support new technologies as they may arise, e.g., somatic cell nuclear transfer.

The United State needs to lead the world in research to improve the human condition and save lives. But even more importantly, we need to support any scientific research that will provide lower cost and more effective care and potential cures for our citizens. To do less would put us back into the Dark Ages.

 
46922 05/26/2009 at 02:15:11 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.

 
46923 05/26/2009 at 02:15:33 PM Self     I am opposed to the use of my tax dollars for abortion, embryonic stem cell research, cloning, or any other use that either destroys live, or creates it outside of the marital sexual act.

 
46924 05/26/2009 at 02:15:34 PM Self     I want to express my opinion on the more unrestricted federal funding of embryonic stem cell research listed in the National Institutes of Health Guidelines for Human Stem Cell Research. I want to strongly add my belief with others that this only leads to more senseless killing of unborn children. I find it inconceivable that no one promoting such things ever uses their human intellect to come to the conclusion that it must be true human life from the beginning of cenception considering that all of us began that way and are, hopefully, thankful that we exist because we were allowed to survive.

 
46925 05/26/2009 at 02:15:43 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. Of which I am one.

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.

 
46926 05/26/2009 at 02:16:05 PM Organization Washington University in St. Louis   May 26, 2009

Raynard S. Kington National Institutes of Health NIH Stem Cell Guidelines MSC 7997 9000 Rockville Pike Bethesda, MD 20892-7997

Dear Dr. Kington:

***** has a long-standing commitment to research initiatives. This strong and vibrant research enterprise brings in more than $500 million in sponsored funds annually for a wide-range of projects. We promote and encourage faculty in their research while taking steps to assure that our research is conducted ethically and responsibly. We welcome President Obama’s Executive Order 13505 Removing the Barriers to Responsible Scientific Research Involving Human Stem Cells and are pleased to provide our support to the comment letters written by our colleagues at the Association of American Medical Colleges (AAMC) and the Council on Governmental Relations (COGR). Washington University has an established Embryonic Stem Cell Committee (ESCRO) that is committed to providing appropriate oversight of human embryonic stem cell research. The ESCRO is responsible for providing scientific and ethical review of all Washington University research projects involving human embryonic stem cells. Additionally, the ESCRO works closely with the Washington University Institutional Review Board to assure the protection of human subjects research. We appreciate the fact that the proposed Guidelines recognize the need for institutions to establish processes and procedures that best address the needs of our research programs. I encourage the NIH to carefully consider all of the points raised in the AAMC and COGR letters in order to best support this area of research. Thank you for the opportunity to comment. Sincerely,

 
46927 05/26/2009 at 02:17:11 PM Self     As a scientist who has been actively involved in adult stem cell research for over 40 years, I believe that embryonic stem cell research offers an unprecedented opportunity to expand our understanding of human biology and to develop new treatments for diseases where none now exist. I am grateful that President Obama has issued an Executive Order lifting the ban on federal funding of this crucial scientific work. However, I believe that the draft guidelines, as they stand, would still place unnecessary impediments in the path of science and retard the pace of medical discovery. I believe that we cannot let a loud minority stand in the way of the will of the American people, who want to bring an end to the suffering of millions of their fellow citizens who are afflicted with disease.

These are my chief concerns: 1. NIH must address the status of currently available human embryonic stem cell lines with regard to eligibility for Federal funding. The Guideline’s eligibility and documentation requirements including written consent for the donation of human embryos for research provide a strong ethical framework consistent with but inevitably different from current community-based standards. I believe that stem cell lines that have been responsibly derived prior to April 23, 2009 and in a manner consistent with the proposed Guidelines should be eligible for Federal funding.

I recommend that for human embryonic stem cell lines created before April 23, 2009 to be eligible for Federal funding, institutions be required to assure that the derivation process met the standards set on August 9, 2001. Specifically, the institution would assure that:

• The stem cells were derived from an embryo that was created for reproductive purposes; • The embryo was no longer needed for those purposes; • Consent was obtain for the donation of the embryo for research purposes; and • No financial inducements were provided for the donation of the embryo.

The method the institution uses to provide such an assurance should not be limited by NIH nor should the newly defined informed consent requirements be applied to these lines de novo.

I am concerned that without a process for “grandfathering” in existing lines, stem cell lines currently in use in research that were responsibly derived may not meet and/or cell line owners may not have documentation that meets the written informed consent criteria outlined in the proposed Guidelines. This may be true of cell lines currently on NIH’s Human Embryonic Stem Cell Registry being used in NIH-supported research.

2. The guidelines should call for the establishment of a registry of stem cell lines that are eligible for NIH funding. In that way, individual research institutions would not have to undertake needless work to prove the eligibility of stem cell lines that have already been approved for funding.

3. Institutions conducting stem cell research should not be responsible for the practices of the institutions providing them with embryos or stem cell lines. Although a “Certificate of Compliance,” or similar mechanism, from the provider seems a reasonable precaution, the institution receiving the embryos or stem cell lines should not have the burden of “assuring” that compliance. That would be an impossible standard to meet.

4.As with the eligibility of cell lines, current grantees conducting NIH-supported research using human embryonic stem cell lines identified in the NIH Registry need approval to continue their research. We urge NIH to consider how it will manage on-going NIH-supported research. The Guidelines could provide a general or blanket removal of the restrictions in lieu of the time-consuming issuing of individual amendments to each grantee.

5. I believe the section of the Guidelines that describe Other Non-Allowable Research (Section IV) is unnecessary and can be deleted from the Guidelines. Current non-allowable research may become allowable and, as a consequence, require modifications of the Guidelines as proposed. I believe these are sound, reasonable modifications in the provisions of the draft guidelines. I believe that they will ensure that stem cell science in this country proceeds in a responsible, ethical manner, without needless red tape and delay.

 
46928 05/26/2009 at 02:18:04 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.

 
46929 05/26/2009 at 02:18:15 PM Self     I am AGAINST ANY human stem cell testing on unborn babies! There are promising results from existing adult stem cell testing, please protect our unborn babies.

 
46930 05/26/2009 at 02:18:40 PM Self     Living with Parkinson's through both my mother and husband has made me aware of how critical stem cell research is for this and many other diseases.

Please vote in favor of funding and all possible research to help find a cure for us.

Thank you.

 
46931 05/26/2009 at 02:18:43 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.

 
46932 05/26/2009 at 02:18:55 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.

 
46933 05/26/2009 at 02:19:17 PM Organization Associazione Luca Coscioni   In accordance with the enclosed DECLARATION OF THE SECOND MEETING OF THE WORLD CONGRESS FOR FREEDOM OF SCIENTIFIC RESEARCH, endorsed by five Nobel Prize Laureates, together with patient advocates and academicians from all over the world, we the undersigned hereby reaffirm freedom of research on stem cells as an overall objective to be pursued at transnational, national and local level.

Referring to the guidelines under reference, we suggest that:

- the NIH extend the eligibility to research using human embryonic stem cells derived from somatic cell nuclear transfer;

- the applicability of NIH guidelines is not extended to existing lines, since the retroactivity of NIH procedure would exclude from funding many ongoing projects formerly judged as appropriate, thus causing an additional hindrance to the advancement of research and cures.

Finally, with reference to the nine levels of consent, the former practice including A. Voluntary informed consent, B. No undue inducement, and C. Independent review and oversight will probably be more desirable and practical, also according to the International Society for Stem Cell Research.

We wish that the NIH will take into account this commentary and the needs of thousands of patients and their relatives.

File Link (.txt)
Declaration of the Second Meeting of the World Congress for Freedom of Scientific Research
46934 05/26/2009 at 02:19:53 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.

 
46935 05/26/2009 at 02:20:30 PM Self     This research destroys human life. It is for immoral purposes and could lead to a new from of slavery. Adult stem cells are were the real possiblies are.

 
46936 05/26/2009 at 02:20:41 PM Self     I oppose your proposition on the Human Stem Cell Guidelines because it is not morally and ethically correct. It is totally against life.

 
46937 05/26/2009 at 02:20:43 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.

 
46938 05/26/2009 at 02:20:52 PM Self     Stem cell research will help improve the lives of many people and really does not hurt anyone.

 
46939 05/26/2009 at 02:21:01 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 other morally reprehensible creation of human embryos for research purposes.

Thanks,

 
46940 05/26/2009 at 02:21:08 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

 
46941 05/26/2009 at 02:21:14 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
46942 05/26/2009 at 02:21:19 PM Self     I am opposed to tax monies being spent to support embryonic stem cell research.....Why is it that embryonic stem cell research is the research being considered, when embryonic stem cell research escr has been known to be unsuccessfully tried and that adult stem cell research has been successful in more than 70 cases....why are we not trying to support the efforts on adult cells which are effective???????

I am opposed to your draft guidelines for embryonic stem cell research, which force taxpayers 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 also no case under which government support should be extended to humnan 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.

 
46943 05/26/2009 at 02:21:22 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.

 
46944 05/26/2009 at 02:21:40 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. Please take this opportunity to stand up to President Obama's order that allows more of your tax dollars to be spent on the destruction of human life.

 
46945 05/26/2009 at 02:21:43 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.

 
46946 05/26/2009 at 02:21:51 PM Self     We strongly oppose the use of tax money for research on embryonic stem cells. This desdtroys human life is murder in our eyesd. We strongly agree with tx money sprent on research on the use of adult stem cells . The benefits of the use of adult stem cells has been proven and no human life is destroyed.

 
46947 05/26/2009 at 02:21:52 PM Self     The draft guidelines set out a parallel set of requirements, but with terminology and procedures that require new interpretations and possibly new forms of oversight and documentation. Many existing hESC lines – whether approved or not by the Bush Administration -- were derived from embryos donated by couples who were fully informed of their options and of the purposes of the research, and whose donations were overseen by an IRB. Despite this, if their consent forms do not have the precise words listed in the draft guidelines, there is a risk these lines will be ruled ineligible for use in NIH-funded research. The same risk attaches to lines developed pursuant to the laws and regulations of various states and foreign countries, even if their requirements are substantially equivalent to those in the U.S. I recommend that any line derived from materials originally donated in accordance with the Common Rule be acceptable for use in NIH-funded research. The same standard should be applied to existing lines and to lines that are derived in the future. Similarly, the same standard should apply to lines derived here and abroad.

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

 
46948 05/26/2009 at 02:21:59 PM Self    

NIH Stem Cell Guidelines, MSC 7997 9000 Rockville Pike Bethesda, Maryland 20892-7997 May 26, 2009

SUBJECT: Submission of Comments and Recommendations on the “National Institutes of Health Guidelines for Human Stem Cell Research” (Guidelines)

Dear people,

The following comments and recommendations are submitted by me in opposition to the “National Institutes of Health Guidelines for Human Stem Cell Research” (hereinafter “Guidelines”). This submission is based on the request by the National Institutes of Health (hereinafter “NIH”) for public comment to the Guidelines which were drafted pursuant to Executive Order 13505 issued on March 9, 2009. Although I am opposed to the Guidelines, I do thank the NIH for this opportunity to comment. Also I urge NIH to adopt the Recommendations which I have provided in these Comments. Finally, several people have signed on to these comments showing their support for what I am filing. I have included these names at the end of these Comments.

I. GENERAL POSITION

Based upon science itself, I am opposed to any scientific research and experimentation which use human embryonic stem cells. These embryonic stem cells are derived through a process which necessarily causes the death of these human embryos. This process has nothing to do with protecting the health and lives of these human embryos. Such human embryos, according to science, are tiny developing human beings. Causing the death of these human beings for such experimentation and research is unethical, illegal, and contrary to our system of medical morality dating back thousands of years. There are also other important grounds for why this human embryonic stem cell research and experimentation should not be conducted. These include concerns over the use of our scarce tax dollars; the goal of achieving the maximum medical advances using our limited resources; the need for more funding of stem cell research using adult stem cells as well as cells from human placentas and other products related to human birth, and the advantages of using a patient’s own stem cells rather than cells from other human beings. Furthermore, I am quite concerned that this whole NIH proposal and Guidelines as well as the President’s Executive order are illegal. This is based upon the seeming conflict of this NIH proposal with the requirements of the Federal Dickey-Wicker Amendment now in force. I spell these out in more detail later. I admit that I am fully aware of the ongoing debate about the use of human embryonic stem cells. There are those who are not happy with these Guidelines which they had hoped would be “more loose” because of their sincere desires to help suffering and ill human beings. I too share their humanitarian goals (both on personal grounds and on more general grounds), but based on science and ethics I must oppose the means they are urging of using human embryonic stem cells to the detriment and destruction of these newly developing human beings. I am also aware of some who thought the Guidelines would be “worse,” and thus in their relief that the Guidelines are not “worse,” they show a willingness to accept the guidelines and even praise the Administration. Pardon my sarcasm, but I view this latter position as akin to those who would have praised King Solomon because he only proposed to cut the baby in half, rather than in quarters. We cannot support human research which is “partly ethical and partly unethical.” History shows us how small ethical deviations lead to larger ones, and soon we are all sliding headlong down the slippery slope. We who consider ourselves “pro-life” are extremely willing to work with others--who may hold different views on such issues as free choice and abortion--in maximizing medical gains so long as we do not cross ethical guidelines of misusing and abusing any human lives including those of newly developing human embryos. At this juncture where science and morality intersect, the German medical experiences as well as the German virtue of clarity are all important. I will also explain this later. Finally, even though I oppose the Guidelines, I do offer Recommendations for many of the individual paragraphs and sections of the Guidelines. I would not want these Recommendations to be considered as a general approval of the Guidelines. These are simply ideas for improving the Guidelines, should the Guidelines be adopted—which adoption I of course oppose.

II. SCIENCE AND HUMAN EMBRYONIC STEM CELL RESEARCH

Before considering the Guidelines, it is first necessary to look at what Science tells us about the human embryo, including at the very earliest stages of human development and conception. The following is a sample from various medical and medical experts. (I collected these from a website which can be reached at Abort73 – Medical Testimony.) Let us begin with several quotations from Modern Teaching texts on Embryology and Prenatal Development. "Human development begins at fertilization, the process during which a male gamete or sperm (spermatozoo development) unites with a female gamete or oocyte (ovum) to form a single cell called a zygote. This highly specialized, totipotent cell marked the beginning of each of us as a unique individual." "A zygote is the beginning of a new human being (i.e., an embryo)." Keith L. Moore, The Developing Human: Clinically Oriented Embryology, 7th edition. Philadelphia, PA: Saunders, 2003. pp. 16, 2.

"Development begins with fertilization, the process by which the male gamete, the sperm, and the female gamete, the oocyte, unite to give rise to a zygote." T.W. Sadler, Langman's Medical Embryology, 10th edition. Philadelphia, PA: Lippincott Williams & Wilkins, 2006. p. 11.

"[The zygote], formed by the union of an oocyte and a sperm, is the beginning of a new human being." Keith L. Moore, Before We Are Born: Essentials of Embryology, 7th edition. Philadelphia, PA: Saunders, 2008. p. 2.

"Although life is a continuous process, fertilization (which, incidentally, is not a 'moment') is a critical landmark because, under ordinary circumstances, a new genetically distinct human organism is formed when the chromosomes of the male and female pronuclei blend in the oocyte." Ronan O'Rahilly and Fabiola Müller, Human Embryology and Teratology, 3rd edition. New York: Wiley-Liss, 2001. p. 8. Human embryos begin development following the fusion of definitive male and female gametes during fertilization… This moment of zygote formation may be taken as the beginning or zero time point of embryonic development." William J. Larsen, Essentials of Human Embryology. New York: Churchill Livingstone, 1998. pp. 1, 14.

These statements support the scientific conclusion that each of us human beings began our individual lives at conception when the human sperm and human egg joined together to form a new human being. These medical statements in modern textbooks are echoed by statements from older teaching texts on these subjects:

"It is the penetration of the ovum by a spermatozoan and resultant mingling of the nuclear material each brings to the union that constitutes the culmination of the process of fertilization and marks the initiation of the life of a new individual." Clark Edward Corliss, Patten's Human Embryology: Elements of Clinical Development. New York: McGraw Hill, 1976. p. 30. "The term conception refers to the union of the male and female pronuclear elements of procreation from which a new living being develops." "The zygote thus formed represents the beginning of a new life." J.P. Greenhill and E.A. Friedman, Biological Principles and Modern Practice of Obstetrics. Philadelphia: W.B. Saunders, 1974. pp. 17, 23.

"Every time a sperm cell and ovum unite a new being is created which is alive and will continue to live unless its death is brought about by some specific condition." E.L. Potter and J.M. Craig, Pathology of the Fetus and the Infant, 3rd edition. Chicago: Year Book Medical Publishers, 1975. p. vii.

Author Geraldine Lux Flanagan, in her book, Beginning Life. New York: DK, 1996. p. 13, provides this very beautiful poetic and scientific summary of the information presented in the rather dry medical statements submitted above: "Every baby begins life within the tiny globe of the mother's egg… It is beautifully translucent and fragile and it encompasses the vital links in which life is carried from one generation to the next. Within this tiny sphere great events take place. When one of the father's sperm cells, like the ones gathered here around the egg, succeeds in penetrating the egg and becomes united with it, a new life can begin." - 13 Individual doctors and medical experts have also provided their expert testimony on this issue of the beginning of human life:: "When fertilization is complete, a unique genetic human entity exists." Christopher Hook, M.D. Oncologist, Mayo Clinic, Director of Ethics Education, Mayo Graduate School of Medicine "Science has a very simple conception of man; as soon as he has been conceived, a man is a man." Jerome Lejeune, M.D., Ph.D.

Our own United States Congress in its Judiciary Subcommittee has received testimony on this issue. (See Subcommittee on Separation of Powers to Senate Judiciary Committee S-158, Report, 97th Congress, 1st Session, 1981): The NIH must consider such testimony from our best medical experts. Even President Barack Obama who signed Executive Order 13505 has stated that the issue of when human life begins is “above my pay grade.” In order to make proper scientifically-based judgments and policies in this area, our President Barack Obama and this Administration should carefully consider all of the expert evidence presented here as well as the following relevant testimony presented to Congress: “It is incorrect to say that biological data cannot be decisive…It is scientifically correct to say that an individual human life begins at conception." Professor Micheline Matthews-Roth, Harvard University Medical School "I have learned from my earliest medical education that human life begins at the time of conception." Dr. Alfred M. Bongioanni, Professor of Pediatrics and Obstetrics, University of Pennsylvania "After fertilization has taken place a new human being has come into being. [It] is no longer a matter of taste or opinion…it is plain experimental evidence. Each individual has a very neat beginning, at conception." Dr. Jerome LeJeune. Professor of Genetics, University of Descartes "By all the criteria of modern molecular biology, life is present from the moment of conception." Professor Hymie Gordon, Mayo Clinic "The beginning of a single human life is from a biological point of view a simple and straightforward matter – the beginning is conception." Dr. Watson A. Bowes, University of Colorado Medical School

The official Senate Report of these proceedings provides a judgment which the NIH should not and must not overlook. Here is the succinct but powerful conclusion: "Physicians, biologists, and other scientists agree that conception marks the beginning of the life of a human being - a being that is alive and is a member of the human species. There is overwhelming agreement on this point in countless medical, biological, and scientific writings."

In summary, the overwhelming scientific and medical conclusion is that each human life begins at conception when the sperm fertilizes the egg. Sex, hair and eye coloring, and many other human attributes are already determined at conception. Hopefully, NIH and its proposed Guidelines as well as the Obama Administration will not overlook this scientific evidence and testimony.

III. GENERAL COMMENTS

These are general comments about Human Embryonic Stem Cell research coupled with Recommendations for actions by NIH. First, from the expert evidence presented in SECTION II above, it is obvious that the current experimentation and research using human embryonic stem cells results in the destruction of a newly developing human being. The research and experimentation necessarily and in premeditated fashion causes the death of a new human life. What is the justification at law for taking human life? Usually, a human life can only be taken when done in self-defense and when there is no other reasonable option. Taking the lives of these new embryonic human lives can hardly be justified as a self-defense measure. At the very least, this is an unethical and immoral killing, which is illegal under some circumstances and should be generally illegal. NIH and its Acting Director Raynard Kington, M.D., Ph.D., may try to justify such killings as simply implementing an Executive Order 13505, but this defense of “I was only following orders” has been legally unacceptable since at least the Nuremberg Trials. My understanding is that thousands and thousands of human lives of these human embryos could be endangered and destroyed by the new Guidelines. Such a taking of human life in terms of numbers of human beings recalls all of the human lives lost in the various crimes against humanity throughout history. To the extent that NIH, its Acting Director, and its staff are aware that newly developing human lives are destroyed in the research and experimentation allowed by the proposed Guidelines, they should take steps to protest this Executive Order 13505 which they are being compelled to implement. This leads to my FIRST RECOMMENDATION: FIRST RECOMMENDATION: NIH, its Acting Director Dr. Raynard Kingston, and the NIH staff should protest the efforts by the Administration to fund Human Embryonic Stem Cell research and experimentation which will result in the direct and premeditated destruction and killing of newly developing human lives. Instead, they should advocate for human stem cell research which will lead to health advances without requiring the destruction of newly developing human embryonic lives.

Second, NIH gets its funds from the taxpayers. This should make the NIH all the more careful in funding any proposals for human embryonic stem cell research when so many taxpayers question the morality of this research. At the very least, all proposals seeking such funding should be available for public inspection, especially by any taxpayers. Furthermore, any proposals that are funded along with any conditions attached to such proposals should be available for public inspection. Also any periodic reports and final reports of such research and experimentation should be available for public inspection. This includes any documentation about such proposals contained in the records at NIH. Lastly, if and when there are any funds generated from any commercial use of any successful proposal, these funds should be shared with NIH and thus with the taxpayers who provided the original funding.

SECOND RECOMMENDATION: Since taxpayer funds are involved in NIH funding of any embryonic stem cell research, all records about such funding and the involved proposals and reports should be open to public inspection. Also any commercial profits made as a result of the research and experimentation should be shared with NIH and thus the taxpayers. The specifics of this Recommendation should be included as conditions which must be accepted by the proposal grantee(s) before receiving funding.

Third, much work has already been conducted in human stem cell research. So far, it seems that vastly more beneficial results have been achieved through adult stem cell research and other non-embryonic stem cell research, rather than through embryonic stem cell research. Given that NIH funding is limited and given that taxpayer funds should be protected, any grantee seeking NIH funding for human embryonic stem cell research should be required as a condition of funding to demonstrate that the only way to carry out the proposed research and experimentation is through using human embryonic stem cells, rather than using human non-embryonic stem cells.

THIRD RECOMMENDATION: in order to insure the wise use of NIH funds which are also taxpayer funds, any proposal seeking funding for human embryonic stem cell research and experimentation must demonstrate that there is no other feasible method for carrying out the research and experimentation, including through using adult human stem cells and other non-embryonic stem cells, except by resorting to stem cells obtained from the destruction of human embryos. Fourth, I am rather puzzled at the Guidelines in general because of the empowerment of the donors of the egg and sperm as the ones who can give permission for the use and destruction of the embryo in order to obtain embryonic stem cells. These donors are actually the “parents” of this new human life. Can parents ordinarily “sacrifice” their children for research and experimentation which is not intended for the benefit of the children? Could parents, for example, agree to give up both kidneys of their child to help another human being, knowing this double-kidney donation will cause their child’s death? I assume the answers to these questions are obvious. Furthermore, the Guidelines seem to turn the new human life of the embryo into some kind of property or chattel. The Guidelines then allow the donors to dispose of the embryo as though the human embryo was “abandoned property.” This is all very puzzling and very troubling. I can understand how using only embryos from efforts of earnest donors seeking to conceive a child and become parents may be a worthwhile limitation on human embryonic stem cell research, but it seems like an approach which can lead to further problems about the legal role of parents in safeguarding their children and always satisfying the legal obligation of looking out for the “best interests” of their children. Using their offspring, even when they are at the very earliest stages of development as embryos, hardly seems to satisfy the legal ideal of protecting the “best interests” of children. The fact that certain reproductive activities may lead to “left over” human embryos should never justify misusing these human lives. No one would justify research and experimentation on other “abandoned” human beings such as the homeless or elderly unvisited patients in nursing homes. All of these “left over” human beings deserve much more respect and protection than simply being turned into “research fodder.” Fifth, Executive Order 13505 specifically states in Section 2: “Research. The Secretary of Health and Human Services (Secretary), through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” [Emphasis supplied]. Any NIH funding for human embryonic stem cell research would have to be provided within the law which brings up consideration of the Dickey-Wicker language that appears in Section 509 of the Omnibus Budget Bill. This was signed into law by President Obama on March 11, 2009. This Dickey-Wicker language specifically forbids Federal funding for any “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death." This language has been a part of the annual appropriations bill for the Department of Health and Human Services for each fiscal year since 1996. Listen to this explicit Dickey-Wicker Amendment wording: "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. How does NIH propose to meet this legal requirement while providing funds for research in which human embryos have to be destroyed in order to acquire the embryonic stem cells? Hopefully, nobody at NIH intends to allow someone else to “do the dirty deeds” of destroying the human embryos, derive the cells from these new human lives, and then make these available for the research while pretending that Federal funds are not involved for this but are only funding the aftermath of the research and experimentation. Since the Dickey-Wicker wording and Section 509 have been signed into law by the President, it is hard to see how any funding can be made available under the proposed Guidelines….unless some kind of word trickery are employed by NIH and grant applicants. Nobody, hopefully, is contemplating any such evasive and shifty tactics. In conclusion, these proposed Guidelines appear ineffective, unnecessary, and impracticable. On these legal grounds alone, NIH should withdraw these Guidelines. FOURTH RECOMMENDATION: Because it would be illegal under the Dickey-Wicker legal requirements in the Federal Budget Omnibus Law to use Federal funds to conduct research and experimentation using embryonic stem cells obtained through the willful destruction of human embryos, NIH should and must withdraw these proposed Guidelines which seemingly would allow such research and experimentation. Sixth, although I oppose research which results in the destruction of newly developing embryonic human lives, I urge that there be transparency and openness in the proposed Guidelines and notices presented to prospective embryonic donors. Given how science was perverted in Germany in the 1930’s and early 1940’s during which human subjects were used for experimentation that hurt or even killed these subjects, it is important that clarity and transparency be followed in these Guidelines. Therefore I have made various recommendations below for individual items in the Guidelines.

IV. SPECIFIC COMMENTS AND RECOMMENDATIONS The National Institutes of Health has issued a set of specific Guidelines for Human Stem Cell research pertaining to embryonic stem cells. These are cells obtained from a human embryo at a very early stage of human development. In the process of obtaining these cells, the embryo is destroyed and cannot be revived or rehabilitated. These Guidelines are set forth below. I have provided my comments and recommendations for each of the sections and paragraphs. I am providing my comments beginning with the word “COMMENT:” and my recommendations with the wording “RECOMMENDATION:” NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR HUMAN STEM CELL RESEARCH COMMENT: The full title for these Guidelines should include the word “Embryonic” both to insure there is no misunderstanding as well as to provide clarity. FIFTH RECOMMENDATION: The Title should read: “NATIONAL INSTITUTES OF HEALTH GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH.”

I. SCOPE OF GUIDELINES These Guidelines describe the circumstances under which human embryonic stem cells are eligible for use in extramural NIH-funded research, and they also include a section on uses of human embryonic stem cells or human induced pluripotent stem cells that are ineligible for NIH funding. For the purpose of these Guidelines, “human embryonic stem cells” are cells that are derived from human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos. COMMENT: While the stem cells are not themselves human embryos, they are derived from human embryos and in this process the human embryos are completely destroyed. Language should be added which provides for this information. SIXTH RECOMMENDATION: Language should be added which explicitly states the following: “The human embryos are destroyed in this process of obtaining the stem cells.”

II. GUIDELINES FOR ELIGIBILITY OF HUMAN EMBRYONIC STEM CELLS FOR USE IN RESEARCH A. The Executive Order: Executive Order 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, states that the Secretary of the Department of Health and Human Services (DHHS), through the Director of the NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law. COMMENT: I already have provided Recommendations to insure that “responsible, scientifically worthy human stem cell research, including human embryonic stem cell research” is supported and conducted. See FIRST, SECOND, and THIRD RECOMMENDATIONS above. Such research should only be allowed when it does not result in either harm to or the destruction of the human embryos from whom these embryonic stem cells are derived.

B. Eligibility of Human Embryonic Stem Cells Derived from Human Embryos: Human embryonic stem cells may be used in research using NIH funds, if the cells were derived from human embryos that were created for reproductive purposes, were no longer needed for this purpose, were donated for research purposes, and for which documentation for all of the following can be assured: 1. All options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donor(s). COMMENT: What are “all options”? These should be spelled out in these Guidelines in order to promote clarity and openness. SEVENTH RECOMMENDATION: “All options” should be spelled out in the Guidelines. These would include the following: One option is that the unneeded embryos could be placed for “adoption” by other couples. This has already happened and children have been born and are now alive through such adoptions of embryos “no longer needed” by the donors. A second option is to preserve these embryos for future needs in case of tragedies. For example, a couple may use some of the embryos and a child (children) is born. Later that child may encounter a tragedy and be lost. The couple would then have the option of using other embryos which had been preserved. A third option is that embryos might be needed for future use in terms of helping a needy child of the donors resulting from reproduction who encounters various medical conditions. These and other options should be clearly spelled out in the Guidelines and in the Consent Form signed by the donors..

2. No inducements were offered for the donation. 3. A policy was in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s). COMMENT: Why is the word “donor(s)” used with an “(s)”? I assume that sperm are used from a male and the eggs from a female in order to produce the embryo. Both donors should be advised of what may happen to their embryos donated for research. EIGHTH RECOMMENDATION: Both the donor of the sperm and the donor of the eggs should be provided adequate notice about the use of the embryos for research. This recommendation applies to all of the paragraphs of the Guidelines. Where ever the term “donor(s)” is used as well as “individual(s).”

4. There was a clear separation between the prospective donor(s)'s decision to create human embryos for reproductive purposes and the prospective donor(s)'s decision to donate human embryos for research purposes. 5. At the time of donation, consent for that donation was obtained from the individual(s) who had sought reproductive services. That is, even if potential donor(s) had given prior indication of their intent to donate to research any embryos that remained after reproductive treatment, consent for the donation should have been given at the time of the donation. Donor(s) were informed that they retained the right to withdraw consent until the embryos were actually used for research. COMMENT: Will donors be advised of the time when their embryos will be used for research? This would seem proper and appropriate, especially because the donors have until that time “to withdraw consent.” NINTH RECOMMENDATION: The donors should be advised of the time when their embryos will be used for research. 6. 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, 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. COMMENT: What does the terminology “Whenever it was practicable” mean? The “attending physician responsible for reproductive clinical care” and “the researcher deriving and/or proposing to utilize embryonic stem cells” must be separate individuals. Also they should be from separate agencies and/or institutions. This will reduce the possibility of improper inducements and/or persuasion. TENTH RECOMMENDATION: The Physician “for the reproductive clinical care” and the researcher seeking “the embryonic stem cells” must be separate individuals and from separate agencies.

7. Written informed consent was obtained from individual(s) who sought reproductive services and who elected to donate human embryos for research purposes. The following information, which is pertinent to making the decision of whether or not to donate human embryos for research purposes, was in the written consent form for donation and discussed with potential donor(s) in the informed consent process: a. A statement that donation of the embryos for research was voluntary; b. A statement that donor(s) understood alternative options pertaining to use of the embryos; COMMENT: These “Alternative options” must be spelled out in the Consent Form. See SEVENTH RECOMMENDATION above. Furthermore, the actual “Consent Form” should be published by NIH for comment. C. A statement that the embryos would be used to derive human embryonic stem cells for research; COMMENT: It must be clearly stated in the Consent Form that the process used to obtain the embryonic stem cells results in the destruction of the human embryos. See SIXTH RECOMMENDATION above.

D. Information about what would happen to the embryos in the derivation of human embryonic stem cells for research; COMMENT: Again it must be clearly stated that the human embryos are destroyed. ELEVENTH RECOMMENDATION: Add this language: “The human embryos are destroyed in the derivation of the human embryonic stem cells for research.” e. A statement that human embryonic stem cells derived from the embryos might be maintained for many years; f. A statement that the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefit from the use of the stem cells; g. A statement that the research was not intended to provide direct medical benefit to the donor(s); h. A statement as to whether or not information that could identify the donor(s) would be retained prior to the derivation or the use of the human embryonic stem cells (relevant guidance from the DHHS Office for Human Research Protections (OHRP) should be followed, as applicable; see OHRP's Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles (37.8 KB PDF; get Adobe Reader) and Guidance on Research Involving Code

 
46949 05/26/2009 at 02:22:55 PM Self     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.

 
46950 05/26/2009 at 02:23:46 PM Self     I oppose embryonic stem cell research.

 
46951 05/26/2009 at 02:23:46 PM Self     If our nation loses all respect for life, there will no longer be any distinction between our nation and others that disregard life.

 
46952 05/26/2009 at 02:24:17 PM Self     There need to be strict limits on human stem cell research. This is years behind all the studies done on stem cells from adults or umbilical cords. I fear the scientist going too far this is I believe a human person.

 
46953 05/26/2009 at 02:24:44 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. The 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. 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.

 
46954 05/26/2009 at 02:24:56 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 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.

Please take this opportunity to stand up to President Obama's order that allows more of your tax dollars to be spent on the destruction of human life

 
46955 05/26/2009 at 02:25:41 PM Organization The Burnham Institute for Medical Research   Dear NIH: President Obama’s Executive Order 13505 represents a tremendous opportunity for the NIH to support ethically responsible and scientifically worthy stem cell research. The NIH deserves credit for producing draft Guidelines quickly to provide time for public comment. However, I am worried that that the NIH proposal will exclude funding for many existing stem cell lines ethically created over the last eight years. I appreciate the opportunity to comment on the Draft National Institutes of Health Guidelines for Human Stem Cell Research and urge you to take the following into consideration: [1] Develop final Guidelines that allow the NIH to fund research utilizing established hESC lines derived in accordance with the core principles in the ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research. These guidelines recommend independent oversight, voluntary and informed donor consent and no undue inducements. Most established hESC lines that are widely used in research today have been obtained in accordance with these principles. To ensure continued international collaboration, these principles should be applied to the evaluation of existing lines. [2] Most existing U.S. lines have been derived in accordance with the core principles in the ISSCR’s guidelines and consistent with the established federal regulatory framework involving IRB oversight and approval. In some instances, additional specialized embryonic stem cell research oversight committees (ESCROs), and other oversight methods in other countries (referred to as SCROs in ISSCR Guidelines), have also provided oversight. Established policy has demonstrated that this self-regulatory structure has provided a sound ethical foundation for stem cell research. In developing the final Guidelines the NIH should consider this well-established framework of independent oversight and give weight to its determinations. [3] Specifically, for funding eligibility purposes, the ethical provenance of existing U.S. cell lines should be judged based on the standards that prevailed at the time they were derived, provided the protocol under which donations were accepted, and any amendments, were approved by an IRB operating under federal regulations. Non-US lines should be eligible for funding within the US if the IRB and/or SCRO for the US institution receiving NIH funding determines that the protocol under which the underlying donation occurred met operative standards of the time and core ethical principles. In addition, new requirements that go beyond established U.S. and international practice should be applied prospectively only, and after a time period for affected parties, including IVF clinics, to adapt. We specifically ask the NIH to reconsider those aspects that go beyond existing ISSCR standards, including, for example, the proposed mandatory dual IVF consent the proposed guidelines would require, and the proposed requirement that the informed consent form is the sole source for ethical validation. [4] It will be essential that investigators know with some certainty what lines are eligible for funding. I therefore urge the NIH to work with organizations such as the ISSCR to develop a list or registry of hESC lines available for NIH-funding or resources to support the oversight process. The ISSCR has in development a registry to document that hESC derivation was performed in accordance with ethical requirements, and make associated documentation available to reviewing IRBs and stem cell oversight bodies. Such a registry would reduce uncertainty and improve research efficiency. While that registry is being finalized, a useful and easy place to start in the meantime would be for the NIH to publish, on a Web site, the lines that are determined to be fundable based on IRB and SCRO determinations. Thank you for the opportunity to comment on the draft Guidelines.

 
46956 05/26/2009 at 02:26:49 PM Self     I do not want my tax dollars to fund research that uses stem cells derived from human embryos resulting in their death. The killing of one class of humans to benefit another class of humans is profoundly immoral. Instead, direct research toward adult and cord blood stem cells, which is ethical and has proven to be successful.

 
46957 05/26/2009 at 02:27:08 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.

 
46958 05/26/2009 at 02:27:18 PM Self     PLEASE VOTE " NO !" ON ANY STEM CELL REREARCH.

 
46959 05/26/2009 at 02:27:29 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.

 
46960 05/26/2009 at 02:27:30 PM       I strongly oppose the new NIH guidelines for federally funded human ESCr. Science tells us that these embryos are living human beings. No government has the authority to destroy another human being's life. Our country will be strong if its values are strong. Science exists for the good of human beings, not vice-versa. No person's life should be sacrificed to science.

 
46961 05/26/2009 at 02:27:35 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.

 
46962 05/26/2009 at 02:27:41 PM Self     Adult Stem Cells have proven valuable, and are given freely, there is NO reason to kill embryos, to accomplish something, that has proven to actually NOT accomplish anything productive. WE MUST ALWAYS ASK OURSELVES WHAT WOULD JESUS THINK? If we actually did this, and act according to how he would want us to, what a beautiful world we would live in.

 
46963 05/26/2009 at 02:28:23 PM Self     I oppose fast tract science, and as President Carter coined the term, scientific adventurism. I believe human experimentation has gone down the wrong road for too many years and it needs to be more closely monitored and regulated. Even with informed consent we are on a slippery slope where one terrible experiment leads to another and then another and then another with no end in sight. People are being used and exploited and lives are being destroyed. Even with Behavioral Research, many medical personnel tell themselves it is harmless, simple mind games and yet lives and families and even communities are paying a heavy price to test brain research medications.

 
46964 05/26/2009 at 02:28:24 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.

 
46965 05/26/2009 at 02:28:30 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.

 
46966 05/26/2009 at 02:28:35 PM Organization National Alliance for Eye and Vision Research (NAEVR)   The National Alliance for Eye and Vision Research (NAEVR), a 501c4 non-profit advocacy coalition comprised of 55 professional, consumer, and industry organizations involved in eye and vision research, is pleased to submit these comments on the National Institutes of Health's (NIH) Human Stem Cell Research Guidelines.

NAEVR supports technological developments and policies that enable and encourage all facets of stem cell research and would like to thank the NIH leadership for action taken to draft Human Stem Cell Research Guidelines. Per the request for public comment on these guidelines, NAEVR has worked with the vision research community through the Association for Research in Vision and Ophthalmology (ARVO) to develop recommendations for revision of the Draft Guidelines. The recommendations were compiled from an electronic survey distributed to ARVO members and represent the majority opinion of comments provided by 72 members.

Based on that ARVO survey of vision researchers, NAEVR has the following recommendations for revision of the Draft Guidelines: 1) That the NIH Draft Guidelines on Human Stem Cell Research permit federal funding for research using human stem cell lines derived prior to July 2009 if they were created in a manner consistent with ethical guidelines at the time of derivation. Guidelines stated in IIA/B should apply to cell lines derived after July 2009; 2) That IIB/4 of the draft guidelines be clearly defined, specifying whether “clear separation” between the donor’s decision to create human embryos and their decision to donate human embryos for research purpose means a separate location on the form or a separation by time; 3) That provision should be provided for retroactive consent to donate embryos for research purposes; 4) That the NIH Draft Guidelines include the future possibility of federal funding for human stem cells derived from sources other than excess embryos from in vitro fertilization (such as SCNT) if and when the scientific and ethical challenges can be fully addressed; 5) That the NIH Draft Guidelines specify that verification of human stem cell lines after July 2009 be performed according to a standard procedure. Examples include the WARF (Wisconsin Alumni Research Foundation) method or an NIH standard on the verification/purity of cell lines. Within one year after derivation, the cell line should be assigned a unique identifier and submitted to a public database via a standard electronic form with available data about karyotyping and protein expression. Submission to an NCBI database would allow the data to be annotated, linked to publications, and whether the data has been verified by more than one group could be indicated similar to how it is done in GenBank. Other databases models suggested included cancer registry, GEO, and clinical trials databases. Verification of existing cell lines should be eligible for federal funding, and the data should be submitted to a public database within one year after completion of verification. The actual cell lines could be maintained by ATCC, National Stem Cell Bank, or another third party. 6) That institutions provide internal oversight of the derivation and use of human stem cell studies by developing an oversight committee, similar to what is currently done for animal care and human subject experimentation, and file compliance assurances for human stem cell research by a standard form, similar to how things are done for IRB and [I]ACUC. This oversight could come under the IRB, or there could be a separate stem cell research oversight process.

 
46967 05/26/2009 at 02:28:44 PM Self     It is a fact that adult stem cells have been more beneficial than embryonic stem cells. Please do not destroy life when so much can be done with adult stem cells.

 
46968 05/26/2009 at 02:29:22 PM Self     Breakthroughs in adult stem cell research now allows adult stem cells to be used successfully in place of embryonic stem cells, making human cloning unnesscary so human life will not need to be harmed or destroyed. Embryonic stem cells should be a thing of the past.

 
46969 05/26/2009 at 02:30:46 PM Self     I believe that stem cells can be obtained form cord blood and should not be retrieved from fetal tissue. I believe that this research can improve the quality of life for many people, but oppose ending a life to allow this opportunity.

 
46970 05/26/2009 at 02:30:53 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.

 
46971 05/26/2009 at 02:30:55 PM Self     1. The draft Guidelines in Section II(b.) reflect important safeguards which have been a part of the public debate for the past decade. Voters in both Missouri (2006) and Michigan (2008) approved similar safeguards which are now in their state constitutions. Clearly, those two states believe the safeguards appropriately balance the need to pursue the medical research while preserving patient safety and ethics.

2. In that same vein, however, the Guidelines are not clear as to whether current lines, derived before the final regulations are in place, are eligible for federal funding. I believe the NIH should clarify whether, and to what extent, they apply to research that is already underway in state's who have independently pursued such research while President Bush's Executive Order was in force.

I would argue that as long as lines were created under strict ethical practices at the time of derivation, for example (a) approval by an ethics oversight board, (b) the National Academy of Sciences (NAS), or (c) the International Society for Stem Cell Research (ISSCR), and they are willing to conform to the adopted Guidelines prospectively, then those projects should be eligible. Important progress made thus far in those state's are too important to remain excluded from federal funding.

2a. The draft Guidelines also currently prohibit funding eligibility if the lines were created from sources other than excess IVF embryos (i.e. somatic cell nuclear transfer). I believe it's unwise to adopt a bright-line rule against alternative source lines when there are states (e.g. California (2004) and Missouri (2006)) which specifically permit somatic cell nuclear transfer in their state constitutions.

Perhaps a better approach would be to set a defined time-table for those projects to demonstrate to the NIH the following: (a) the project was legal in the jurisdiction when launched and (b) it was approved by an ethics oversight board, NAS, or the ISSCR (see 2 above). Those projects which meet those additional criteria should be eligible for federal funding, and should be held to conform to the adopted Guidelines prospectively.

I appreciate very much the opportunity to comment on something so historic and meaningful.

Thank you,

 
46972 05/26/2009 at 02:30:58 PM Self     Adult stem cells have PROVEN to help, while embryonic stem cells have yet to have one success. Funds diverted from the effective and successful research and development of adult stem cells will only harm our future. Diversion to embryonic stem cell research will continue to show no fruit and this diversion will continue to cause division.

 
46973 05/26/2009 at 02:31:04 PM Self     Am concerned that Adult Stem Cells are being neglected, and that focus is being placed improperly. There should be no need for harvesting cells from aborted fetus tissue, nor should there be an effort made to create embryos for similar purposes, as it appears aldult stem cells, harvested properly, can do as good or better job since they CAN come from the patient.

 
46974 05/26/2009 at 02:31:11 PM Self     The Draft NIH Human Stem Cell Guidelines are way too limiting. It is wrong to restrict funding to stem cells derived from blastocysts created by in vitro fertilization (IVF) for reproductive purposes and slated for destruction. It is critical to support research on all hESCs, including cells derived through SCNT.

In addition, it is misguided to disqualify currently approved stem cell lines by retroactively applying requirements that will be difficult or impossible to meet at this time.

I concur with the comments issued by the California Institute for Regenerative Medicine (CIRM).

 
46975 05/26/2009 at 02:31:19 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.

 
46976 05/26/2009 at 02:31:19 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.

 
46977 05/26/2009 at 02:31:35 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.

 
46978 05/26/2009 at 02:31:52 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.

 
46979 05/26/2009 at 02:31:55 PM Self     There must not be a renewal of embryonic stem cell research, and especially not at taxpayer expense.

To begin with, I do not know when, precisely, life begins. Neither does the President, nor do you. We do know that at that moment, the gentic material is in place to determine all the inherited aspects of that eventual new person. Its sex, the color of its hair and eyes, its talents, its sexuality, its height, even its health issues, all and more are determined.That is why we must for now presume that life begins when a sperm and an egg unite. "Destroying embryos" is just another way of saying they'll be killed.

Secondarily, from the reading I've done, other forms of stem cell research are holding out very much more promise than the embryonic sort.

Gentlemen, I have multiple sclerosis. My dad died with the chronic/progressive sort of MS. I have been blessed with medications he never had the chance to take that have improved my outlook. But I swear on my dad's ashes that even if a cure for MS wee to be presented to me, I would not accept it if it resulted from embryonic research. How arrogant of me to think that my life, that the quality of any one person's life, should be improved at the cost of another's, especially one that hasn't even been born yet.

Shame on anyone who thinks so.

Thank you.

 
46980 05/26/2009 at 02:31:55 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

 
46981 05/26/2009 at 02:31:59 PM Self     I oppose your draft guidelines for embryonic stem cell research which force me as a taxpayer to subsidize research requiring the destruction of innocent human life. Efforts and support should be directed to stem cell research and treatments that harm no one and are also producing good results. In no case should government support be extended to human cloning or the morally reprehensible creation of human embryos for reserach purposes.

 
46982 05/26/2009 at 02:32:13 PM Self     Please fund this research!! My daughter receives 4 shots everyday and has to be pricked 4 times as well to test for glucose numbers!

 
46983 05/26/2009 at 02:32:51 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.

 
46984 05/26/2009 at 02:32:56 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.

 
46985 05/26/2009 at 02:33:03 PM Self     I fully support federal funding for stem cell research. I would like to see the guidelines expanded to provide funding for all existing stem cell lines, grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease.

I also support such groundbreaking technologies as somatic cell nuclear transfer.

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

 
46986 05/26/2009 at 02:33:13 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.

 
46987 05/26/2009 at 02:33:14 PM Self     I feel that you should never attempt to alter the sactity of life for any reason. Life begains at conception. Just leave this alone Gods plan is a mystery and you just have to have faith. If you don't respect life how can you respect anything of value. What is more valuble than life. And should you be Pro Choice, why not choose life......

 
46988 05/26/2009 at 02:33:32 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.

 
46989 05/26/2009 at 02:33:52 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.

 
46990 05/26/2009 at 02:34:02 PM Self     My wife has Muliple System Atrophy diagnosed by the NIH in 2004. 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.

 
46991 05/26/2009 at 02:34:16 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.

 
46992 05/26/2009 at 02:34:20 PM Organization Consumer Watchdog   Your ethical guidelines for stem cell research make sense going forward with one exception. There should be provisions to fund research on parthenogentic stem cell lines.

NIH guidelines should not be applied retrospectively to ethically derived hESC lines. Cell lines that were ethically derived under IRB or ESCRO supervision, meeting standards of such organizations as the National Academy of Science, the International Society for Stem Cell Research or the California Institute for Regenerative Medicine should explicitly be allowed for funding. In addition, research on the previously NIH approved lines should be eligible for funding.

 
46993 05/26/2009 at 02:34:22 PM Self     Dear Ma’am/Sir,

Currently Federal Law prohibits the use of tax money for research that destroys human embryos. The NIH's proposed guidelines appear to take advantage of the compromised exception to utilize embryonic stem cells that were the result of in-vitro fertilization that were no longer needed and created prior to Aug 9 2001. I find Executive Order 13505 morally offensive and the decision to proceed with public comment over these guidelines particularly unsettling.

As a government employee I understand the necessity of your department’s decision to go forward to implement EO 13505 by asking for public comment. I understand who our boss is, and understand I am expected to carry out the lawful policies of our elected representatives. But I also believe anyone who closely examines the moral and ethical ramifications of the compromised exception quickly discovers the sham that this restriction is. Quite similar in reasoning that considers a “partial Birth abortion” anything other than what it really is; infanticide. The real crime here is all the activity that will be wasted by this effort and that will divert resources away from truly outstanding and needed advances currently being made with adult stem cells. I will do everything in my power to ensure my elected representatives object to these morally reprehensible, and exceptionally non-effective forms of research and am concerned that these actions will impact the other desperately needed and clearly ethical forms of research your department funds. The non-effectiveness of current embryonic stem cell research clearly belies the motivation to utilize government resources for funding, but it also makes the citizenry of this great country accomplices in this great evil. I speak not only for myself, but for Knights of Columbus Council 13091.

Very sincerely and respectfully

 
46994 05/26/2009 at 02:34:33 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.

 
46995 05/26/2009 at 02:34:36 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I 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.

 
46996 05/26/2009 at 02:34:41 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

 
46997 05/26/2009 at 02:34:46 PM Self     With TWO DAUGHTERS with 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. 2598 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.

 
46998 05/26/2009 at 02:34:52 PM Self     I strongly support human stem cell research. I know there are usually two sides to every story but I really don't see any substance to the objections raised by opponents. Embryos are created and discarded by IVF clinics all the time. Why not use the embryos for research that likely will result in relieving the suffering of real living and breathing human beings.

 
46999 05/26/2009 at 02:34:52 PM Self     Have you seen this report? Please use this in your final decision on the proposed Guidelines for Human Embryonic Stem Cell Research and Experimentation:

www.catholicnewsagency.com

Obama embryo research policy ‘a step backward,’ bioethics council members say

President Barack ObamaWashington D.C., Mar 30, 2009 / 06:30 am (CNA).- Ten members of the President’s Council on Bioethics have issued a statement seeking to “clarify” President Barack Obama’s comments on human embryonic stem cell research. The council members said Obama’s policy is “a step backward” because it fails to reconcile the needs of research and moral concerns.

Noting that new forms of stem cell research do not involve killing human embryos, the council members also warned that the president’s policy could permit funding for human cloning while requiring that clones be killed.

The ten members who signed the March 25 statement were Gilbert Meilaender, Paul McHugh, Benjamin Carson, Nicholas Eberstadt, Jean Bethke Elshtain, Alfonso Gómez-Lobo, William Hurlbut, Donald Landry, Peter Lawler, and Diana Schaub.

The members said that President Obama made an inaccurate characterization when he said his executive order lifted the ban on federal funding for embryonic stem cell research (ESCR).

“The policy announced by President Bush on August 9, 2001, did not ban federal funding of embryonic stem cell research; rather, for the first time, it provided and endorsed such funding (as long as the stem cell lines had been derived prior to that date),” the statement said.

Some pro-lifers had criticized Bush’s decision as an unacceptable compromise that would lead to further destruction of human embryos if the research progressed.

The council members said Bush’s policy was an attempt “to seek a way for science to proceed without violating the deep moral convictions of many of our fellow citizens.”

“Attention to the ethical principles that ought to guide and limit scientific research has been constant since the end of World War II. Different kinds of research have been limited, and sometimes prohibited, not in order to suppress science but in order to free it as a genuinely human and moral activity,” the group said.

Citing the President’s Council on Bioethics 2005 document “Alternative Sources of Human Pluripotent Stem Cells,” the council members’ statement said researchers had advanced in other alternative methods. They also noted that The New York Times said in March that the embryonic stem cell research promoted by President Obama “has been somewhat eclipsed by new advances.”

The National Bioethics Advisory Commission, active under the Clinton administration, itself held that embryo-destructive research is justifiable “only if no less morally problematic alternatives are available for advancing the research.”

“Such alternatives are now available, and research on them is advancing,” the council members’ March 25 statement said. “With respect to the progress that had been made in reconciling the needs of research and the moral concerns of many Americans, we can only judge, therefore, that the president’s action has taken a step backward, and we regret that.”

Turning to President Obama’s March 9 remarks on cloning, the statement said that the president’s new policy would permit federal funding of research on stem cells from “spare” IVF embryos but also on lines derived from created or cloned embryos.

“In the latter two cases, we would be producing embryos simply in order to use them for our purposes,” the statement said, warning that the President’s opposition to cloning for human reproduction could require the destruction of existing human embryos.

An earlier bioethics council document, “Human Cloning and Human Dignity,” warned that preventing cloning for reproductive purposes would require a law prohibiting the implantation of cloned embryos for the purpose of producing children.

“‘To do so, however, the government would find itself in the unsavory position of designating a class of embryos that it would be a felony not to destroy,’” the document notes.

“We cannot believe that this would advance our society’s commitment to equal human dignity,” the council members’ March 25 statement said.

In a separate personal statement, President’s Council on Bioethics member Edmund D. Pellegrino voiced his individual support for “the substance of the objections of some council members to recent relaxation of existing policies regarding human embryonic stem cell research.”

“Ethically, I cannot support any policy permitting deliberate production and/or destruction of a human fetus or embryo for any purpose, scientific or therapeutic.”

Copyright @ CNA (http://www.catholicnewsagency.com)

 
47000 05/26/2009 at 02:34:56 PM Self     Please recommend funding for adult stem cell research and not embryonic stem cell research.

 
47001 05/26/2009 at 02:35:01 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

 
47002 05/26/2009 at 02:35:05 PM Self     Dear NIH:

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

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

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

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

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

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

 
47003 05/26/2009 at 02:35:18 PM Organization California Research Universities Network   NIH Stem Cell Guidelines MSC 7997 9000 Rockville Pike Bethesda, Maryland, 20892-7997

May 26, 2009

On behalf of California’s research universities, we thank you for the opportunity to comment on the Draft National Institutes of Health (NIH) Guidelines for Human Stem Cell Research published in the Federal Register on April 23, 2009. President Obama’s March 9, 2009, Executive Order was an important first step in allowing promising stem cell research to move forward with much-needed federal funds, and we applaud NIH’s swift publication of draft guidelines to implement this Order.

While the draft guidelines raise a number of issues that merit comment, we highlight two issues that are of particular importance to our institutions: Prohibition on Sources of Stem Cells The draft guidelines preclude federal funding of research using human embryonic stem cells derived from sources other than from embryos created for reproductive purposes and no longer needed, such as somatic cell nuclear transfer (SCNT), parthenogenesis, and IVF embryos created for research purposes. These lines represent an important resource for disease-specific investigations because of their unique genetic composition. We believe that many of these techniques hold remarkable scientific promise that, without the potential for federal support, may go unrealized.

We strongly urge the NIH to remove from its funding prohibitions research using human embryonic stem cells derived from sources other than discarded IVF embryos created for reproductive purposes, while still requiring appropriate ethical oversight and responsible derivation. Grandfathering Research Using Current Lines A great deal of promising, ongoing research involves stem cell lines that were responsibly and ethically derived but that may not meet each of the specific technical informed consent requirements detailed in the draft guidelines. Many of the lines currently in use represent important “building blocks” for research in certain fields, and several states and private entities have made significant investments into projects that involve lines that were responsibly derived at the time. These include many lines created in compliance with the National Academy of Sciences (NAS) Guidelines for Human Embryonic Stem Cell Research, lines created prior to 2001 (and eligible for federal funding before President Obama’s executive order), and lines created overseas in compliance with the laws and guidelines of other nations. Lines created in compliance with standards that ensured voluntary and informed donor consent and no undue inducements should not be precluded from federal funding. As written, because they retroactively apply specific technical requirements for procurement and consent, the guidelines may have the unintended consequence of precluding the use of federal funds for these lines.

We therefore urge the NIH to incorporate flexibility into the guidelines by including language that states that stem cell lines derived under the prevailing ethical standards at the time they were derived are eligible for federal funding.

We thank you for your consideration of our comments, which we hope will contribute to final guidelines that are clear and effective. Some of our institutions (as well as individual researchers within our institutions) may also be submitting individual comments, as this is a matter of great interest and importance to our research programs. Please do not hesitate to contact us if we can provide you with further information.

Sincerely,

 
47004 05/26/2009 at 02:35:20 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.

 
47005 05/26/2009 at 02:35:32 PM Organization FasterCures   Human embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. Thanks to substantial private and State investment in this area of research over the past decade, significant strides have been made. Expanded investment by the Federal Government will rapidly accelerate progress, however, the final guidelines issued by NIH to govern federally funded research 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.

We are pleased that these draft guidelines, specifically in section IIB, would appear to permit federal funding of research using stem cell lines previously not eligible for federal funding and for new lines created in the future from embryos donated by patients no longer needing them for infertility treatments. However, as drafted, Section IIB does not ensure that some currently existing stem cell lines will meet the new criteria and thus research using them would be ineligible for federal funding. It is important that the final guidelines allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived – essentially “grandfathering in” many existing stem cell lines. If cell lines were derived in accordance with the existing guidelines at the time – those of either the National Academy of Sciences or the International Society for Stem Cell Research, which were quite stringent – and their derivation was approved by either an Embryonic Stem Cell Oversight Committee or an Institutional Review Board, then research on those lines should be eligible for federal funding. Otherwise, we will have negated six years’ worth of progress in stem cell research.

We also note with concern that the draft guidelines do not permit federal funding of research using stem cell lines derived from sources other than excess IVF embryos, specifically through somatic cell nuclear transfer (SCNT), also known as “therapeutic cloning.” We understand that no human stem cell lines have yet been successfully derived and maintained through SCNT, and therefore it may not yet be considered necessary to grapple with this issue. But it must be recognized that the scientific community widely believes that the potential use of genetically customized or characterized stem cells will be of the greatest value in research to more effectively treat and even cure diseases such as Parkinson’s, Alzheimer’s, and multiple sclerosis. In addition, it will be critical to use SCNT in treating patients with their stem cell lines to minimize immune rejection. It is therefore essential that NIH not hamstring its ability to continue to monitor developments in this field and to update these guidelines as the research progresses.

In addition, we strongly recommend that the final guidelines include the continuation of an NIH-funded registry that will list lines that are eligible for research using NIH funds. Without a registry, each institution will be required to review each stem cell line’s derivation process and informed consent compliance, regardless of how widely that line is used elsewhere for NIH-funded research. This will create a significant burden on institutions and researchers and slow the pace of their work.

FasterCures is dedicated to saving lives by saving time. Our mission is to identify ways to accelerate the discovery and development of new therapies for the treatment of deadly and debilitating diseases both in the United States and around the globe. The organization was founded in 2003 under the auspices of the Milken Institute to aggressively catalyze systemic change in cure research and to make the complex machinery that drives breakthroughs in medicine work for all of us faster and more efficiently. FasterCures is independent and non-partisan. We do not accept funding from companies that develop pharmaceuticals, biotechnology drugs, or therapeutic medical devices. Our primary mission is to improve the lives of patients by improving the research environment, research resources, and research organizations.

Thank you for the opportunity to present these comments.

 
47006 05/26/2009 at 02:36:41 PM Self     I have been suffering the effects of MS since 1992 and I welcome the research that might help reduce my suffering and that of so many others with MS or other diseases or conditions that steal our joy of life. Stem cell research promises to be an answer to our prayers. I hate the idea of abortion, but I know that it is a decision that the woman and her doctor must make with the advice of her clergyman. Embryonic stem cells come from medical waste. I believe that if we can recycle that waste and save lives with it, we should do it. God gives us intellect to unlock the secrets of science. Who are we to tie the hands of those scientists who are working to help the sick and injured of the world?

 
47007 05/26/2009 at 02:37:19 PM Organization American Nurses Association   Please see attached comments of the American Nurses Association.

File Link (.txt)
ANA Comments, Stem Cell Research, May 2009
47008 05/26/2009 at 02:37:20 PM Organization American Thoracic Society   May 26, 2009

Raynard Kington, MD Acting Director National Institutes of Health 9000 Rockville Pike Bethesda, MD 20892

Dear Dr. Kington:

The American Thoracic Society (ATS) is pleased to have this opportunity to provide input on the draft National Institutes of Health Guidelines for Human Stem Cell Research. The American Thoracic Society is a medical professional society of over 15,000 physicians, nurses, respiratory therapists and researchers dedicated to the prevention, treatment, cure and research of respiratory disease, critical care illness and sleep medicine.

Respiratory diseases are leading causes of morbidity and mortality both in the US and internationally, and curative therapy of many end-stage lung diseases is limited to lung transplantation. The field of human stem cell research offers opportunities for replacement or repair of lung tissues damaged by these diseases, as well as for novel investigations into developmental and pathogenetic pathways in the respiratory system. Although important advances already have been made (Proc. Am. Thor. Soc. 5:637-6678, 2008), application of stem cell research to the respiratory system has been difficult because of the lung’s structural complexity and cellular heterogeneity.

In 2006, the ATS Statement on Human Embryonic Stem Cell Research proposed that the ban on the use of federal funds for human embryonic stem cells generated after August 9, 2001 be lifted (Am. J. Respir. Crit. Care Med. 173:1043 -1045, 2006). The ATS applauds President Obama for eliminating this impediment to embryonic stem cell research, which we hope will yield important benefits for patients with lung disease.

In general, the draft guidelines are clear and reasonably broaden the criteria to advance the science in this area. The ATS recommends the following additions to the final guidelines:

1. Section II.B.5 “Donors were informed that they retained the right to withdraw consent until embryos were actually used for research.” The ATS recommends that more detail be provided about the precise time point that constitutes the “beginning of research” after which consent may no longer be withdrawn.

2. The ATS recommends that the final guidelines articulate a process between IVF facilities and potential investigators for communication on when appropriate embryos become available. This is especially important in view of planned dissociation of those obtaining consent from investigators that will use the embryos for research.

3. The draft guidelines do not address the process by which embryos will be allocated among investigators. The ATS recommends that the final guidelines should, in particular, clarify how allocation decisions will be made when two investigators seek the same “rare” embryo, such as an embryo that is homozygous for the CFTR gene for cystic fibrosis.

4. II.B.7.c. “A statement that the embryos would be used to derive human embryonic stem cells for research.” The ATS recommends that the final guidelines include the following addition to this section: “Potential uses of the human embryonic stem cells are to generate cell and tissue models for studies of disease mechanisms, to test drug effectiveness, and for transplantation.”

5. The ATS recommends that consideration be given to addressing the situation in which embryos derived from a couple at an IVF facility and tested by pre-implantation genetic screening are found to contain disease-causing genes (e.g. for alpha-1-antitrypsin deficiency). The final guidelines should describe how such a couple potentially could make a targeted donation of these embryos to produce disease-associated human embryonic stem cells for use in research. 6. The current draft guidelines do not address directly issues of protecting donor confidentiality regarding already known or newly discovered disease genes or genetic risk factors/disease modifiers. The ATS recommends that the final guidelines ensure full donor confidentiality.

The ATS believes that these the final NIH guidelines will establish a coherent and consistent national policy for the responsible regulation and practice of human stem cell research. We appreciate the opportunity to provide input.

Sincerely,

 
47009 05/26/2009 at 02:37:40 PM Self     As it pertains to Executive Order 13505, it "would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose."

Who decides whether these human beings (embryos) are "no longer needed?" How is it ethical for someone, anyone, to arbitrarily decide that a life is no longer "needed?"

With obvious disregard for ethics, past research using embryonic stem cells has shown no promise. However, research using adult stem cells has demonstrated great strides. Please stop the abuse of our most vulnerable, and those who cannot speak for themselves. IVF, and technologies that tamper unethically with human life need to end. We do a better job protecting endangered wildlife than we do humans!

 
47010 05/26/2009 at 02:38:59 PM Self     I support stem cell research.

 
47011 05/26/2009 at 02:39:58 PM Self     I 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.

 
47012 05/26/2009 at 02:40:28 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.

 
47013 05/26/2009 at 02:41:02 PM Self     Stop killing people for "research"!!!!!!!!!!!!!!!!!!!!!!

 
47014 05/26/2009 at 02:42:06 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.

 
47015 05/26/2009 at 02:42:17 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 am a member of the Parkinson's community and have been following programs in this field with interest. Significant studies have been made over the past decade and the final guidelines issued by NIH must build on the progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new beuracratic hurdles that will slow the pace of progress.

 
47016 05/26/2009 at 02:43:56 PM Self     I oppose the funding of the stemcell research as it described in the Federal Notice. This type of research includes the destruction of human embryos. I believe that human life must be respected from the moment of conception. It is possible and feasible to conduct research using adult stem cells- in fact much research has been done. These adult cells have been used successfully in the treatment of many types of desease.

 



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