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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47017 05/26/2009 at 02:44:08 PM Self     To whom it may concern,

Thank you for the opportunity to give feedback on the NIH’s proposed guidelines. I fully support the comments submitted by the New York Stem Cell Foundation. Their comments are as follows: 1. The current title “Guidelines for Human Stem Cell Research” should be revised as follows: “National Institutes of Health Guidelines for the Federal Funding of Human [Embryonic] Stem Cell Research.” This would more accurately reflect the purpose of the guidelines, which is to identify the kinds of research eligible for federal funding. 2. [Refers to Section IIB] There are fundamental problems with the structure proposed by the NIH to manage informed consent that would qualify or disqualify stem cell lines for federal funding. If these regulations go forward unmodified, it would dramatically and needlessly limit the number of stem cell lines that could be used in Federally funded research. The regulations also need to have provisions that would allow the use of cell lines that are derived in other jurisdictions under ethical guidelines that have been carefully and responsibly considered, but that may not be exactly the same as those of the NIH. These structural issues with respect to informed consent must be resolved to allow maximum progress toward understanding stem cell biology and the development of therapies. We strongly recommend that the NIH consult with institutions and organizations that have previously considered these issues and consider leveraging existing protocols to ensure that scientifically significant work can proceed in an ethically responsible way. The New York Stem Cell Foundation, which has been deeply involved with these issues, fully endorses the well-developed comments and approaches recommended to the NIH by our colleagues at the ISSCR, the Harvard Stem Cell Institute, CAMR and NYAMR (the New York Academy of Medical Research), among others.

3. [Refers to Section IIC of the guidelines] Establishment of a Federal Registry of Stem Cell Lines. At the same time as increasing numbers of stem cell lines are being generated, the rules governing their use are becoming ever more complex as different state and national jurisdictions establish their own particular guidelines that qualify the lines for research support. The federal government could provide an important service by establishing a comprehensive registry for stem cells that would give their provenance, including the method of derivation, the conditions of derivation (use of animal cells and products), consent and payment status, if relevant, degree of characterization, availability and eligibility for federal support. To be most useful, the federal registry should be as comprehensive as possible and not be limited to lines that are eligible for Federal support. With such a registry, investigators will be able to determine unambiguously which cell lines meet the requirements of which funding sources. An authoritative registry would save repetitive documentation by research institutions and funding agencies and would facilitate progress.

4. [Refers to Section IV of the guidelines] The proposed guidelines would limit some very promising avenues of current research, including the creation of disease and patient specific human embryonic stem cell lines, by specifically excluding funding for stem cell lines derived by somatic cell nuclear transfer (“SCNT”), or from parthenotes or IVF embryos created for research. The guidelines also, albeit inadvertently, limit the genetic diversity of the human embryonic stem cell lines that will be eligible for federal funding because of the socio-economic demographics of those who currently pursue IVF treatment. The guidelines are inconsistent with President Obama’s Executive Order 13505, March 9, 2009, seemingly putting politics ahead of scientific advancement. It is extremely important that scientists be allowed to use existing and new human embryonic stem cell lines in Federally sponsored research, as long as the lines are made by methods that are consistent with best ethical and medical practices. Although Federal funds cannot be used to make the lines because of the Dickey-Wicker amendment, research on such lines should not be deprived of Federal support. This would amplify the utility of these stem cell lines and accelerate the rate of progress derived from them.

 
47018 05/26/2009 at 02:44:14 PM       No! to the NIH draft guidelines for human embryonic stem cell research. Our country's moral values would be even further eroded. We need to preserve respect for every human being, even the littlest.

 
47019 05/26/2009 at 02:44:16 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47020 05/26/2009 at 02:44:30 PM Self Multiple Sclerosis   If you have Multiple Sclerosis (MS), you know what challenges and hardships are faced with this unpredictable disease every day. And if you love a person with MS, you understand what it means to support that person. That person in my life is my husband, Ronald Clark, who has been battling MS for over two decades; he is a strong and stubborn fighter who is remarkably optimistic! My mother-in-law also struggled through her life with this same devasting disease and passed away several years ago. She will always live in us through our memories. Please help us to help others so they don't have to live in pain every day for the rest of their lives. Thank you.

 
47021 05/26/2009 at 02:45:25 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47022 05/26/2009 at 02:45:28 PM Self     This is in response to the request by NIH for public comment on its Draft Guidelines on Embryonic Stem Cell Research. Destruction of human life for research purposes is not ethical, regardless of what the perceived benefits may be. The basic tenets of ethical principles state that; "One must never do evil so that good may come from it." The destruction of human life is evil. 1 strongly urge that the National Institutes of Health rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is extremely disturbing that some supporters of this research are urging NIH to endorse a policy encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. The creation of new life for the sole purpose of destroying it would mark the final reduction of human beings to mere objects or commodities. 1 further protest the use of my tax dollars to fund such monstrous activities.

 
47023 05/26/2009 at 02:45:46 PM Self     There is no proof that embryonic stem cell research works. I am not in favor of this research. Please stop funding this with my tax dollars. There are other avenues that are successful that do not require the murder of embryos.

 
47024 05/26/2009 at 02:45:57 PM Self     I feel the necessity to voice my opinion on "Embryonic Destructive Stem Cell Research." The word today is science over God but even here when science shouts out that Adult Stem Cells are proving to be beneficial over Embryonic Stem Cells the President chooses to close his eyes to the evidence. It appears our nation wants to be a nation of death. Abortion, stem cell research and what's next euthanasia for the nonessentials. If our nation continues on this path of murder then we will become a nation of darkness and greed. Please Bless America by Blessing God.

 
47025 05/26/2009 at 02:46:09 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47026 05/26/2009 at 02:46:36 PM Self     Response to Invitation for Public Comment on the NIH Human Stem Cell Guidelines Draft This refers to the proposed policy and procedures for Executive Order 13505r providing taxpayer funding for research using embryos produced in vitro fertilization clinics, that are not used for reproductive purposes. In particular, it addresses the stated NIH goals fhat the research will be "ethicafly responsible, scientifically worthy, and conducted in accordance with applicable Saw." (1) Ethically Responsible: We held that it is scientificaiSy proven that the htinan organism is genetically determined and complete at conception and that destruction of human life for research purposes is not ethical, no matter what the perceived benefit may be. Therefore, the use od our tax money for such purposes fundamentally violates our conscience and our rights as dfeens, not to speak of the graduate students who will be obliged to work on the projects funded by NIH grants in order to obtain thetr degrees, irrespective of their moral principles or religious faith. (2) Scientifically worthy: There has been already research with private funds on this topic. No succcessful treatment and several adverse effects of the attempted treatment have been reported. In contrast, adult stem cells continue to provide cures for thousands of patients with over 70 diseases, including those that the NIH draft indicates as goals of the research to be funded. (See a list at: http://www.sciencemag.Org/cgi/data/315/5810/328b/DC1/1). It makes every sense to give grants for research that has been shown to work. (3) In Accordance with Existing Law: Deliberate destruction of human life violates every principle found in existing law, as for example the Code of Federal Regulations 45 CFR 46, (http://www.dhhs.gov/ohrpAiumansubjects/guidance/45ctT46.htm) and the Dickey Wicker Amendment, signed into law by President Clinton, which states: SEC. 509. (a) None of the funds made available in this Act may be used for- (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or koowmgty subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a}{2) and Section 498(b) of the Public Health Service Ac (42 U.S.C. 289g(b)) (Title 42r SecSram :289g(b). United States Code).. . and: (b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 (the Human Subject Protection regulations}... that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes (sperm or egg) or human diploid cells (cells that have two sets of chromosomes, such as somatic cells). In addition, the U.S. constitution guarantees the rights of every human being The scientific data noted under (1) above extend the guarantee to the embryos.

 
47027 05/26/2009 at 02:46:40 PM Self     I am opposed to using American taxpayer dollars to further fund embryonic stem cell research which has yielded NO valid treatments for patients suffering terrible diseases.

I am completely supportive of spending these dollars for ADULT STEM CELL RESEARCH ONLY, if indeed federal tax dollars should be spent for these purposes at all.

ADULT STEM CELL RESEARCH has yielded treatment for over 70 diseases currently and patients have been helped.

Every dollar spent on embryonic stem cell research is a dollar that is diverted from ADULT STEM CELL successes that already have proven track records and deserve further research.

 
47028 05/26/2009 at 02:46:54 PM Self     Last March, President Barack Obama issued an executive order that will allow virtually unrestricted federal funding of embryonic stem cell research. Funding that will create incentives for scientists to create new human embryos specifically to destroy them for research.

Former President Bush set a policy in place in 2001 that restricted federal funding only to stem cell lines that existed as of that date - thus discouraging "create and kill" behavior. This policy should be maintained.

There are ways to research that don't involve killing pre-born humans.

 
47029 05/26/2009 at 02:46:58 PM Self     Response to Invitation for Public Comment on the NIH Human Stem Cell Guidelines Draft This refers to the proposed policy and procedures for Executive Order 13505r providing taxpayer funding for research using embryos produced in vitro fertilization clinics, that are not used for reproductive purposes. In particular, it addresses the stated NIH goals fhat the research will be "ethicafly responsible, scientifically worthy, and conducted in accordance with applicable Saw." (1) Ethically Responsible: We held that it is scientificaiSy proven that the htinan organism is genetically determined and complete at conception and that destruction of human life for research purposes is not ethical, no matter what the perceived benefit may be. Therefore, the use od our tax money for such purposes fundamentally violates our conscience and our rights as dfeens, not to speak of the graduate students who will be obliged to work on the projects funded by NIH grants in order to obtain thetr degrees, irrespective of their moral principles or religious faith. (2) Scientifically worthy: There has been already research with private funds on this topic. No succcessful treatment and several adverse effects of the attempted treatment have been reported. In contrast, adult stem cells continue to provide cures for thousands of patients with over 70 diseases, including those that the NIH draft indicates as goals of the research to be funded. (See a list at: http://www.sciencemag.Org/cgi/data/315/5810/328b/DC1/1). It makes every sense to give grants for research that has been shown to work. (3) In Accordance with Existing Law: Deliberate destruction of human life violates every principle found in existing law, as for example the Code of Federal Regulations 45 CFR 46, (http://www.dhhs.gov/ohrpAiumansubjects/guidance/45ctT46.htm) and the Dickey Wicker Amendment, signed into law by President Clinton, which states: SEC. 509. (a) None of the funds made available in this Act may be used for- (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or koowmgty subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a}{2) and Section 498(b) of the Public Health Service Ac (42 U.S.C. 289g(b)) (Title 42r SecSram :289g(b). United States Code).. . and: (b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 (the Human Subject Protection regulations}... that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes (sperm or egg) or human diploid cells (cells that have two sets of chromosomes, such as somatic cells). In addition, the U.S. constitution guarantees the rights of every human being The scientific data noted under (1) above extend the guarantee to the embryos.

 
47030 05/26/2009 at 02:47:24 PM Self     It has been proven that adult stem cells and stem cells from the umbilical cords are just as effective at embryonic stem cells, even more so.

In addition, it has been found in research that the embryonic stem cells are too radical and cannot be prevented from becoming cancers in the body. Stem cells from other sources are much more stable and reliable.

Stem cells from embryos are not necessary, or even desirable. Please do not fund embryonic stem cell research. Please review the following article form the Scientific American. http://www.scientificamerican.com/blog/60-second-science/post.cfm?id=embryonic-stem-cells-cause-cancer-i-2009-02-19

 
47031 05/26/2009 at 02:47:47 PM Self     I support federal funding for stem cell research and 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 groundbreaking technologies such as somatic cell nuclear transfer and it needs to be supported.

 
47032 05/26/2009 at 02:48:05 PM Self     Dear Decision Makers, As a long time administrator in a national health sciences center, I am well aware of the importance of stem cell research and I am hopeful that some of our scientists will be funded. I am taking the time to write for a more personal reason. My best friend from childhood and the mother of two young teenagers is watching her brilliant, athletic, funny, generous husband struggle with losing his speech, motor abilities, and emotional equilibrium to the dreadful progression of Parkinson's Disease. As I work to be supportive and positive, inside I am heartbroken by their struggle and inspired by their unselfishness. We are all hoping and praying that research will continue that may help my friend regain some of what he has lost. If that is not possible, that he may not lose any more. And, of course, we all hope that promising research into the causes of PD will continue that help us prevent this devastating illness from stricking down future generations. Please know that there are many, many people who support stem cell research even if they don't know about writing to you. Thank you for your time in reading this.

 
47033 05/26/2009 at 02:48:13 PM Self     Please do not use tax dollars to fund stem cell research on umbilical cords.

Tax dollars for researching adult stem cell would be good.

 
47034 05/26/2009 at 02:48:27 PM Self     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.

 
47035 05/26/2009 at 02:48:27 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 memmber 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 progress.

I believe that final guidelines should allow federal funds to be used for research using all stem cell lines created by following ethical practices at the time they were derived and that 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).

 
47036 05/26/2009 at 02:48:28 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. We cope with the devastating effects of both Type I and Type II Diabetes every day--in both a battle with the disease itself, and in in our efforts to support family members effected by these terrible diseases. Nonetheless, we remain convinced that the ethical problems associated with research involving EMBRYONIC stem cells are too great to justify their continued use. Though our suffering at the hands of this disease is great, it does not legitimize in any way the violation of basic human dignity that results from the use of embryonic stem cells in medical research.

As this process moves forward, however, I hope that NIH will consider adapting the guidelines to ensure they DO NOT include funding for either new stem cell lines or current stem cell lines that have been developed using prevailing practices. THESE PRACTICES ARE INCREDIBLY UNETHICAL. Research on these current stem cell lines should NOT be eligible for federal funding as part of the final rule.

Given the overwhelming moral concerns raised by the use of embryonic stem cells, it is important to prevent federal funding for stem cell research involving embryonic stem cells. \

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

 
47037 05/26/2009 at 02:48:42 PM Self     I am against embryonic stem cell research. Please do not allow federal funding for such research. There are several other types that should be funded instead, including adult stem cell research.

 
47038 05/26/2009 at 02:48:46 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. Thank you,

 
47039 05/26/2009 at 02:48:56 PM Self     We are disappointed at the continuing movement towards further funding of embryonic stem cell research when the evidence is clear that the best outcomes have been achieved using ADULT stem cells. This makes neither scientific nor moral sense to continue a practice that is ineffective and wastes the taxpayers dollars. Our country is in an embarrassing amout of debt, so to throw money at this research that does not deliver what is promised is at the very least foolish.

 
47040 05/26/2009 at 02:49:10 PM Self     As one of Concerned Women for America's over 500,000 members, I am writing today to oppose the draft guidelines proposed by the National Institutes of Health in response to President Obama's Executive Order issued on March 9, 2009. The proposed regulations will force taxpayers like me to subsidize unethical research that destroys human embryos. Despite the millions of dollars spent on destructive embryonic stem cell research in California and elsewhere, the results have been an abject failure because embryonic stem cells tend to become deadly tumors. Science has surpassed this unethical research, producing astonishing advances with adult stem cells and discovering ways to make embryonic-like stem cells without killing anyone. Funding should be directed to alternatives to embryonic stem cells which are ethical and more efficient, effective, and are actually treating patients. The proposed regulations create a financial incentive for the creation of more human embryos to be destroyed to obtain their embryonic stem cells. These regulations also open the door to cloning and human/animal hybrids. Embryonic stem cell research is destructive and outdated, and taxpayer monies should be used for ethical research that can actually treat patients.

 
47041 05/26/2009 at 02:49:42 PM Self     This is in response to the request by NIH for public comment on its Draft Guidelines on Embryonic Stem Cell Research. Destruction of human life for research purposes is not ethical, regardless of what the perceived benefits may be. The basic tenets of ethical principles state that; "One must never do evil so that good may come from it." The destruction of human life is evil. I strongly urge that the National Institutes of Health rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is extremely disturbing that some supporters of this research are urging NIH to endorse a policy encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stern cell research. The creation of new life for the sole purpose of destroying it would mark the final reduction of human beings to mere objects or commodities. 1 further protest the use of my tax dollars to fund such monstrous activities.

 
47042 05/26/2009 at 02:49:46 PM Organization University of Wisconsin, Madison Stem Cell Research Oversight Committee   University of Wisconsin, Madison Stem Cell Research Oversight Committee Comments on the 2009 Draft National Institutes of Health Guidelines for Human Stem Cell Research

In November of 2005, the University of Wisconsin, Madison, established a Stem Cell Research Oversight (SCRO) Committee in accordance with the 2005 recommendations of the National Academies. The SCRO Committee has discussed the 2009 Draft National Institutes of Health Guidelines for Human Stem Cell Research. We applaud the removal of former President Bush’s restriction of federal funding to human embryonic stem cell (hESC) research only using lines derived before August 9, 2001, and offer the following additional comments for the NIH’s consideration.

The Committee has significant concerns that the draft guidelines’ detailed requirements for specific wording in the embryo donor consent forms could result in the disqualification of hESC lines that were ethically derived. Although the end being sought--restricting funding to lines derived from embryos donated with the voluntary and informed consent from embryo donors--is ethically essential, no particular set of words or phrases is necessary for attaining that end. We therefore recommend replacing the detailed requirements for specific wording with a general requirement that a qualified IRB approve the consent processes used during embryo procurement. The IRB would be responsible for reviewing the consent process to determine that the following conditions were met:

1. The embryo from which the line was derived was donated voluntarily and without any financial inducements.

2. The embryo from which the line was derived was donated with informed consent for hESC research.

This general requirement for IRB approval could be applied to lines derived prior to the promulgation of the guidelines, to lines derived after the promulgation of the guidelines, and to lines derived in foreign jurisdictions not subject to U.S. law.

There are several advantages to this approach.

It capitalizes on the decades of experience that IRBs and OHRP have in terms of overseeing and reviewing consent processes and subsequent research. Especially relevant is the extensive experience that local IRBs have in determining whether new research with already existing cell lines falls within the scope of research about which the donors were adequately informed. To disqualify lines that were derived ethically but with consent forms that differed from the prescribed language would be unfair to the scientists who derived them, to the researchers who want to use them, and to the embryo donors who wanted to further scientific research in this area. It is estimated that there are approximately 900 such embryos at the University of Wisconsin, Madison, donated using a consent form that was reviewed by UW’s Health Sciences IRB and UW’s Biotechnology Advisory Committee. Out of respect for the commitments made to the donors of those embryos, and in light of the fact that the consent forms satisfy any reasonable substantive and procedural ethical requirements, lines derived from these embryos should be eligible for NIH funding.

Many of the existing hESC lines were derived from embryos donated before much information was available about hESC research, and local IRBs should have the flexibility to determine whether the procurement processes for those embryos satisfied the requirement for voluntary and informed consent, whatever language was used in the consent form. Moreover, detailed requirements for specific wording discourages consent forms from improving over time and, in unanticipated circumstances, can even require the provision of inappropriate or false information to donors. By allowing IRBs to focus on whether the line was ethically derived, the suggested approach allows for flexibility and improvement over time of the particular instruments used to achieve the ethical ends.

While the IRB would draw on a wide array of relevant evidence about the embryo procurement process, including the consent forms, written policies, standard operating procedures, and certifications from responsible parties at the facility in question, the IRB’s review would culminate in a simple IRB approval letter, which could be filed with the principal investigator and submitted to the NIH as assurance of compliance, as is already the case for other federally funded research.

There would be profound scientific costs to invalidating research that has been conducted with appropriate review and consent. Forgoing the use of lines that were ethically derived but which did not contain the precise language now required by the NIH could make it impossible to compare new results to previous results and may require using or creating new lines that are less well-characterized when better lines are available. Many of the benefits of a decade of extraordinary scientific accomplishment would be lost.

For these reasons, we encourage the NIH to move hESC research squarely within the framework provided by the existing IRB review system.

If the NIH decides nonetheless to provide a detailed set of wording requirements, we suggest the following improvements for II. B. 1-7:

II.B.1. “all options” is too broad, as options may become available in the future which were unforeseeable at the time of donation. We suggest: “Relevant alternatives for disposition of the embryos no longer needed for reproductive purposes were explained to the potential donor(s).”

II.B.2. “No inducements” is too broad, as it could be construed to include even the provision of innocuous information about the possible scientific benefits of hESC research. Also, the guidelines should be specific as to which donation is at issue. We suggest: “No financial inducements were offered for the donation of the embryos.”

II.B.7.b. Some facilities separate the consent process for discarding an embryo from the consent process for donating that embryo to research. Given that it is preferable that alternatives pertaining to the use of the embryos be discussed in the consent form for discarding, it should not be required to also be in the consent form for donating to research.

II.B.7.d. Researchers’ understanding of what will happen to embryos used in the derivation of hESCs for research may change between the time an embryo is collected and the time at which it is used in research. We suggest: “Information about what is expected to happen to the embryos in the derivation of human embryonic stem cells for research.”

II.b.7.f. As stated, this would prohibit even an innocuous statement such as “The research may provide benefits in the future to individuals with Parkinson’s disease.” “Medical benefit” should therefore be replaced with “direct medical benefit.” We suggest: “A statement that the donation was made without any restriction or direction regarding the individual(s) who may receive direct medical benefit from the use of the stem cells”.

II.B.7.h. It should be explicit that “information that could identify the donor(s)” will be understood the same way here as it is understood in the federal human subjects regulations.

II.B.7.i. OHRP previously issued guidelines regarding consent form language indicating that research participants will not receive any financial or other benefits from commercial development, which contradicts the language here. The draft guidance should be consistent with OHRP guidance, which utilizes the phrase “no plans to provide financial compensation.”

 
47043 05/26/2009 at 02:49:53 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.

 
47044 05/26/2009 at 02:49:54 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.

 
47045 05/26/2009 at 02:50:16 PM Self     As a parent, I oppose all research involving the manipulation and/or destruction of human embryos. I am pleased that the proposed guidelines prohibit somatic cell nuclear transfer, parthenogenesis, and the creation of embryos for research purposes. However, informed consent for the donation of "leftover" IVF embryos does not make the destruction of those embryos ethical. We would never allow parents to consent to "donate" a 6-month-old child for a research experiment that would not benefit the child in any way and that would assuredly lead to his or her death. Likewise, we should only be horrified that parents could be permitted to consent to their embryonic children being dissociated and used as mere biological matter. First and foremost, sound morals and ethics prohibit the proposed practices, but I will also point out, that if this research were so valuable, there would be adequate private funds supporting it and federal funds would not be needed. Please stop using my taxes to support this research.

 
47046 05/26/2009 at 02:50:31 PM Self     Ultrasounds have given us a clear image of the babies that are not "merely blobs" nor "masses of cell tissue" as I was taught by my culture and those responsible for educating me. Not knowing President Obama personally, I felt I must take him at face value. When he looks to the Lincoln Memorial and declares the words of our Constitution that "all men are created equal" I would expect him to carry that reasoning to all peoples. It is a sad and dying society that does not value the life of all it's people. We have history to echo that back from the ages. It is unfathomable to think that this would be done with money that is given to run our government, protect the citizens, support the states. Has anyone looked at the Constitution? Does anyone remember it's role as prescribed by our Founding Fathers? As for me, I have been again taught by my culture that I cannot trust the words of man. They are not lasting, they are not true, they will not be honored by generations to come. God's Word says that children are a heritage from the Lord. What man has the right or presumed power to remove generations of God's heritage? God help us and may God save you Mr. President and our Congress.

 
47047 05/26/2009 at 02:50:47 PM Self     As a parent, I oppose all research involving the manipulation and/or destruction of human embryos. I am pleased that the proposed guidelines prohibit somatic cell nuclear transfer, parthenogenesis, and the creation of embryos for research purposes. However, informed consent for the donation of "leftover" IVF embryos does not make the destruction of those embryos ethical. We would never allow parents to consent to "donate" a 6-month-old child for a research experiment that would not benefit the child in any way and that would assuredly lead to his or her death. Likewise, we should only be horrified that parents could be permitted to consent to their embryonic children being dissociated and used as mere biological matter. First and foremost, sound morals and ethics prohibit the proposed practices, but I will also point out, that if this research were so valuable, there would be adequate private funds supporting it and federal funds would not be needed. Please stop using my taxes to support this research.

 
47048 05/26/2009 at 02:51:56 PM Organization United Spinal Association   Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. United Spinal Association serves consumers including veterans across the country who are likely to benefit from embryonic stem cell research. 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.

United Spinal Association is 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.

United Spinal Association strongly supports the guidelines in that they provide for ethical and responsible research with embryonic stem cell research, that is: they do not allow remuneration for donors of embryos and they only allow research on embryos that would otherwise be discarded by in vitro fertilization clinics.

It is essential that NIH continue to follow the research progress of embryonic stem cell research and revisit the guidelines as there are new developments in this changing and evolving area of research.

 
47049 05/26/2009 at 02:52:05 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--the very treatments that were denied further federal funding by President Obama. In no case should government support be extended to human cloning or the human embryos for research purposes.

 
47050 05/26/2009 at 02:52:06 PM Self     I am against killing human embryos. The proposed regulations will forces taxpayers (like me) to fund research I am inequitably against because it is unethical because it requires the destruction of human embryos.

 
47051 05/26/2009 at 02:52:49 PM Self     I am writing to oppose the draft Guidelines proposed by the National Institutes of Health (NIH) as they seriously contradict the ‘Right to Life' of the unborn HUMAN members of our society. Also, the draft Guidelines contradict existing law, namely the Dickey/Wicker amendment to the annual Labor/HHS appropriations bills. In addition to being morally unacceptable and legally flawed, the Guidelines are also medically unnecessary, as advances using adult and cord blood stem cells have ALREADY treated dozens of ailments and disabling conditions. How can these words from the man who first isolated and cultured human embryonic stem cells be ignored: “If human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough.” This man, Dr. Thompson, admittedly struggled with his conscience over destroying human embryos, and finds induced pluripotent stem cell research both more promising AND morally acceptable. The act of protecting human life, at any age and any condition, WILL NEVER compromise a civilized society. On the other hand, these Guidelines, will serve to compromise our society in many unconscionable ways. Respectfully submitted,

 
47052 05/26/2009 at 02:53:19 PM Organization UMASS Medical School   Dear NIH:

We appreciate the efforts of the Administration and the NIH to create a less restrictive environment for embryonic stem cell research in the U.S. It is our belief that this research has enormous promise for the development of new strategies for drug discovery and development as well as potential therapies for a range of diseases. The March 9, 2009 Executive Order and these draft guidelines seem to be positive steps towards expanding NIH funding of embryonic stem cell research. However, there are aspects of the draft guidelines that are of concern.

Restrictive guidelines for informed consent: The guidelines state that NIH funding requires the ES lines used for research to be derived with written informed consent as detiled in Section B7 (a-i). A document published last year (Streiffer, Hastings Center Report, 2008) studied the informed consent process for the cell lines available for NIH funding prior to March 9, 2009. These lines are the most heavily used and studied hESC lines, including the Wisconsin lines H1 and H9, are found in almost every hESC laboratory and stem cell core facility in the U.S., and are the basis for over half of the publications in the hESC field. According to this study, few, if any, of the old “NIH approved” hESC lines would meet all of the informed consent criteria outlined in the current draft guidelines.

So, based on these issues: 1. It is possible that few currently existing lines would meet all criteria in the guidelines. 2. The most commonly lines may not meet the criteria, limiting their continued use though they have been studied in the U.S. and worldwide for many years. 3. The ban on creation of new lines would not allow development of cell lines using the required informed consent.

Given these issues, hESC researchers may be in a more restrictive environment than they were before March 9, 2009.

It would seem that some of these potential problems could be avoided if the old “NIH approved” lines could be grandfathered in so that research using these lines could continue. We strongly support an exemption for as many existing lines as possible even in cases where there is insufficient documentation of the conditions under which they were derived

Embryos created for reproductive purposes: In the draft guidelines, Section II.B. “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,…”

This statement is a bit ambiguous. For instance, some valuable disease-specific hESC lines have been derived from embryos that went through preimplantation genetic diagnosis (PGD) testing and were found to carry specific disease mutations. Would these still fall under the concept of “no longer needed for this purpose”? Other lines have been developed form poor quality embryos. At a minimum, maybe the guidelines should state “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 or were found to be unsuitable for this purpose,…”

The draft guidelines also state that research using stem cells derived from sources other than from embryos created for reproductive purposes, such as somatic cell nuclear transfer, parthenogenesis, and IVF embryos created for research purposes, is not allowed under these guidelines. We believe that these techniques have potential to develop cell lines that may not be possible using “standard” embryonic stem cell derivation for embryos created for reproductive purposes and should be allowed.

Safe Harbor – Registry: The NIH will need to develop a registry or use an existing registry to provide guidance for researchers as to which lines are available for funding under the new guidelines. It would be very burdensome for each individual research institution to individually ascertain which lines meet the eligibility requirements especially since comprehensive documentation of informed consent is often difficult to obtain. We suggest that the NIH create and advisory panel and request provenance information for lines that developers would like to submit for NIH approval.

Financial Inducements: Guidelines section B.2. No inducements were offered for the donation.

Very specific language may be needed regarding financial inducements. For instance, was there reimbursement for expenses, payments to gamete donors, etc. Should “no inducements” be clarified?

Guidelines for other federally funded research: The draft guidelines state that these guidelines will pertain only to extramural NIH-funded research, while noting that intramural research will be subject to corresponding policies. We suggest that there should be a statement that other federal agencies, such as the FDA that may fund or oversee this type of research are expected to adopt the same parameters.

We hope that the NIH will move quickly to adopt the recommended changes to the draft guidelines in order to expand funding for this important field of research.

Sincerely,

Center for Stem Cell Biology and Regenerative Medicine University of Massachusetts Medical School

 
47053 05/26/2009 at 02:53:55 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.

 
47054 05/26/2009 at 02:54:13 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.

 
47055 05/26/2009 at 02:54:26 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 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.

 
47056 05/26/2009 at 02:54:51 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47057 05/26/2009 at 02:54:53 PM Organization Duke University Medical School, Stem Cell Research Oversight Committee   Duke University Medical School in Durham, NC, appreciates the opportunity to review and comment on the guidelines proposed by the National Institutes of Health to qualify human embryonic (hES) and induced pluripotent cells (iPS) for federally funded research. We support the careful and ethically responsible review of both obtaining of these cells and their experimental uses. These principles are supported in the proposed Guidelines.

This comment is offered in the revival of a carefully considered continuation of public debate. The proposed Guidelines do allow donation of embryos generated for the treatment of fertility, Section II. Guidelines for Eligibility of Human Embryonic Stem Cells for Use in Research. No mention is made of who may donate embryos where the identity of only one of the parents is known. Sperm donors may donate on a condition of anonymity. We would recommend that such embryos not be used unless the consent of both donors can be obtained.

 
47058 05/26/2009 at 02:55:29 PM Self     Dear NIH:

I appreciate the efforts of the Administration and the NIH to create a less restrictive environment for embryonic stem cell research in the U.S. It is our belief that this research has enormous promise for the development of new strategies for drug discovery and development as well as potential therapies for a range of diseases. The March 9, 2009 Executive Order and these draft guidelines seem to be positive steps towards expanding NIH funding of embryonic stem cell research. However, there are aspects of the draft guidelines that are of concern.

Restrictive guidelines for informed consent: The guidelines state that NIH funding requires the ES lines used for research to be derived with written informed consent as detiled in Section B7 (a-i). A document published last year (Streiffer, Hastings Center Report, 2008) studied the informed consent process for the cell lines available for NIH funding prior to March 9, 2009. These lines are the most heavily used and studied hESC lines, including the Wisconsin lines H1 and H9, are found in almost every hESC laboratory and stem cell core facility in the U.S., and are the basis for over half of the publications in the hESC field. According to this study, few, if any, of the old “NIH approved” hESC lines would meet all of the informed consent criteria outlined in the current draft guidelines.

So, based on these issues: 1. It is possible that few currently existing lines would meet all criteria in the guidelines. 2. The most commonly lines may not meet the criteria, limiting their continued use though they have been studied in the U.S. and worldwide for many years. 3. The ban on creation of new lines would not allow development of cell lines using the required informed consent.

Given these issues, hESC researchers may be in a more restrictive environment than they were before March 9, 2009.

It would seem that some of these potential problems could be avoided if the old “NIH approved” lines could be grandfathered in so that research using these lines could continue. I strongly support an exemption for as many existing lines as possible even in cases where there is insufficient documentation of the conditions under which they were derived

Embryos created for reproductive purposes: In the draft guidelines, Section II.B. “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,…”

This statement is a bit ambiguous. For instance, some valuable disease-specific hESC lines have been derived from embryos that went through preimplantation genetic diagnosis (PGD) testing and were found to carry specific disease mutations. Would these still fall under the concept of “no longer needed for this purpose”? Other lines have been developed form poor quality embryos. At a minimum, maybe the guidelines should state “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 or were found to be unsuitable for this purpose,…”

The draft guidelines also state that research using stem cells derived from sources other than from embryos created for reproductive purposes, such as somatic cell nuclear transfer, parthenogenesis, and IVF embryos created for research purposes, is not allowed under these guidelines. We believe that these techniques have potential to develop cell lines that may not be possible using “standard” embryonic stem cell derivation for embryos created for reproductive purposes and should be allowed.

Safe Harbor – Registry: The NIH will need to develop a registry or use an existing registry to provide guidance for researchers as to which lines are available for funding under the new guidelines. It would be very burdensome for each individual research institution to individually ascertain which lines meet the eligibility requirements especially since comprehensive documentation of informed consent is often difficult to obtain. We suggest that the NIH create and advisory panel and request provenance information for lines that developers would like to submit for NIH approval.

Financial Inducements Guidelines section B.2. No inducements were offered for the donation.

Very specific language may be needed regarding financial inducements. For instance, was there reimbursement for expenses, payments to gamete donors, etc. Should “no inducements” be clarified?

Guidelines for other federally funded research: The draft guidelines state that these guidelines will pertain only to extramural NIH-funded research, while noting that intramural research will be subject to corresponding policies. I suggest that there should be a statement that other federal agencies, such as the FDA that may fund or oversee this type of research are expected to adopt the same parameters.

I hope that the NIH will move quickly to adopt the recommended changes to the draft guidelines in order to expand funding for this important field of research.

Sincerely,

 
47059 05/26/2009 at 02:55:37 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47060 05/26/2009 at 02:55:45 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47061 05/26/2009 at 02:56:56 PM Self     I support the overall thrust of these guidelines. However, it will be crucial for continued progress that scientists be allowed to use NIH funding for continuing research with existing human embryonic stem (hES) cell lines. Therefore, I would strongly advocate for a formal exemption to allow such funding for as many existing lines as possible, even in cases where there is insufficient documentation of the conditions under which they were derived. Of greatest priority will be the exemption of all of the currently approved hES lines.

 
47062 05/26/2009 at 02:57:00 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.

 
47063 05/26/2009 at 02:57:15 PM Organization New Jersey Catholic Conference   May 26, 2009

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

Subject: Draft Guidelines on Human Embryonic Stem Cell Research

To Whom It May Concern: The New Jersey Catholic Conference (NJCC) offers the following comments on draft guidelines proposed by the National Institutes of Health (NIH) to authorize federally funded human embryonic stem cell research, published at 74 Fed. Reg. 18578-80 (April 23, 2009) (Guidelines).

Founded in 1949, NJCC represents the Catholic Bishops of New Jersey on matters of public policy. There are more than 600 parishes and more than 3.5 million Catholics registered in seven dioceses throughout New Jersey.

Monsignor David J. Malloy, S.T.D., General Secretary of the United States Conference of Catholic Bishops (USCCB) provided comprehensive comments on May 22, 2009. The NJCC supports and endorses Monsignor Malloy’s comments without reservation or qualification.

We add our voice to that of the USCCB to emphasize that the dignity and inviolability of human life at every stage of development is a foundational principle of a civilized society.

Subsequent to President Obama’s March 9, 2009 executive order, the NIH has proposed guidelines for federally funded embryonic stem cell research. If these Guidelines are approved, it would be the first time ever that federal regulation would allow the use of taxpayer funds to encourage the killing of embryonic human beings to obtain their stem cells.

Through the support of embryonic stem cell research, we treat innocent human beings as mere sources of body parts, as commodities for our use.

Rather than destroying human embryos, alternative methods of stem cell research are available and have been shown to be beneficial and effective. Adult stem cell and cord blood research are now showing great promise to treat ailments and disabling conditions without harming human life.

Peer-reviewed studies have shown that reprogramming ordinary adult cells into “induced pluripotent stem cells” has provided significant advances in treating cancer, juvenile diabetes, Parkinson’s disease, spinal cord injury, and heart disease.

We would hope that the NIH will recognize that science is moving away from embryonic stem cell research.

Let us all be thankful that the ability to reprogram ordinary adult cells into “induced pluripotent stem cells” (iPS cells) is rapidly replacing embryonic stem cells in research among some of the world’s most distinguished researchers.

Let us say yes to induced pluripotent stem cell research and no to embryonic stem cell research.

Thank you for your consideration.

Sincerely,

***** *****

c. The Catholic Bishops of New Jersey

 
47064 05/26/2009 at 02:57:34 PM       I support federal funding for stem cell research. I believe the guidelines should be expanded to provide funding for all existing stem cell lines, including those that have been developed since 1998, since they permit the most comprehensive study of disease. I also support innovative technologies such as somatic cell nuclear transfer. Federal funding should support stem cell research in a broad and flexible way, not in a narrow, restrictive way. Thank you.

 
47065 05/26/2009 at 02:57:37 PM Organization Shepherd Center   Very supportive of the policy and think it is the most sensible way to go forward.

 
47066 05/26/2009 at 02:57:47 PM Self     I write this on behalf of my mother, who has Parkinson's. Embryonic stem cell research offers hope for the millions with Parkinson's and similar diseases for a real cure.

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.

 
47067 05/26/2009 at 02:57:53 PM Organization Do No Harm, et al.   Please see .txt attachment and .pdf version sent via e-mail.

Do No Harm: The Coalition of Americans for Research Ethics, molecular biologists and stem cell researchers Dr. Theresa Deisher and Dr. James L. Sherley, the Family Research Council, Concerned Women for America, the Christian Medical Association, Advocates International, and the Alliance Defense Fund (collectively “Do No Harm et al.” or “Commentators”), whose interests are more fully described in Appendix A, hereby respectfully submit the following comments (including the accompanying attachments) on the above-referenced “Draft NIH Guidelines for Human Stem Cell Research” (“Guidelines”). We request that this letter and each of its appendices be made part of the public record of the proceedings and that NIH consider this letter and its appendices as relevant matter to be taken into account in any statement of the basis and purpose of this rulemaking action under 5 U.S.C. § 553.

File Link (.txt)
Do No Harm et al. Comments re: Proposed NIH Stem Cell Guidelines
47068 05/26/2009 at 02:58:30 PM Self     Viable stem cell lines have been created by private funding and state governments in order to work around the limitations set by the Bush Administration. Please do not make our scientist start over. Instead, allow them to use these cells and lines created under other policies. Make sure that the new NIH guidelines allow these cells to be implemented into continued research using federal funds.

 
47069 05/26/2009 at 02:58:36 PM Self     I oppose killing human embryos. The proposed regulations will force taxpayers like me to fund research I believe is unethical because it requires the killing of human embryos. Expanding funding to new human embryonic stem cell lines will divert federal funds away from promising research that is treating people now with non-embryonic stem cells and will also divert funds away from other sources of embryonic-like stem cells that have been generated without the use of human embryos. The proposed regulations create a financial incentive for the creation of more human embryos to be destroyed to obtain their embryonic stem cells. The guidelines do not require any separation between an IVF doctor and an ESCR researcher. The guidelines say they "should" be separate, but only when practicable. The guidelines allow any IVF doctor to create more embryos than are needed for fertility purposes in order to generate more so-called "leftover" embryos for ESCR research using taxpayer funds. Instead of preventing any future expansion of funding for ESCR on unethical experiments involving human clones and human-animal hybrids, these regulations open the door for such funding upon the order of NIH. The guidelines do not require full informed consent for the parents of the human embryos so that they understand that their options include permission for infertile couples to adopt them.

 
47070 05/26/2009 at 02:58:45 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47071 05/26/2009 at 02:59:04 PM Self     I am opposed to embryonic stem cell research. Life begins at conception. This is conducting research on a living being. I am opposed to it in all respects.

 
47072 05/26/2009 at 02:59:13 PM Self     How is this research ethically responsible when it involves the taking of human lives in the the millions? Medical texts (William's Obstetrics and expert United States Senate testimony in the early 1980's state emphatically that human life begins at conception. What kind of a nation will we become if we let this slaughter of innocence go forward? The ones allowing this to happen and the ones doing it will have to account to the ultimate Judge one day. On a secondary note, the only success has come from the use of cord blood, skin cells and other humane and morally acceptable experiments.Tumors and freakish results have occurred when experimenting on destroyed human embryoes. Even nature is telling a story. Put your efforts into solving problems through value-based and morally acceptable experiments.Don't kill innocent small human embryoes.Knowing what you know,this would be the height of irresponsibility and tragedy.

 
47073 05/26/2009 at 02:59:26 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47074 05/26/2009 at 02:59:33 PM Organization UMASS Medical School   Dear NIH:

We appreciate the efforts of the Administration and the NIH to create a less restrictive environment for embryonic stem cell research in the U.S. It is our belief that this research has enormous promise for the development of new strategies for drug discovery and development as well as potential therapies for a range of diseases. The March 9, 2009 Executive Order and these draft guidelines seem to be positive steps towards expanding NIH funding of embryonic stem cell research. However, there are aspects of the draft guidelines that are of concern.

Restrictive guidelines for informed consent: The guidelines state that NIH funding requires the ES lines used for research to be derived with written informed consent as detiled in Section B7 (a-i). A document published last year (Streiffer, Hastings Center Report, 2008) studied the informed consent process for the cell lines available for NIH funding prior to March 9, 2009. These lines are the most heavily used and studied hESC lines, including the Wisconsin lines H1 and H9, are found in almost every hESC laboratory and stem cell core facility in the U.S., and are the basis for over half of the publications in the hESC field. According to this study, few, if any, of the old “NIH approved” hESC lines would meet all of the informed consent criteria outlined in the current draft guidelines.

So, based on these issues: 1. It is possible that few currently existing lines would meet all criteria in the guidelines. 2. The most commonly lines may not meet the criteria, limiting their continued use though they have been studied in the U.S. and worldwide for many years. 3. The ban on creation of new lines would not allow development of cell lines using the required informed consent.

Given these issues, hESC researchers may be in a more restrictive environment than they were before March 9, 2009.

It would seem that some of these potential problems could be avoided if the old “NIH approved” lines could be grandfathered in so that research using these lines could continue. We strongly support an exemption for as many existing lines as possible even in cases where there is insufficient documentation of the conditions under which they were derived

Embryos created for reproductive purposes: In the draft guidelines, Section II.B. “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,…”

This statement is a bit ambiguous. For instance, some valuable disease-specific hESC lines have been derived from embryos that went through preimplantation genetic diagnosis (PGD) testing and were found to carry specific disease mutations. Would these still fall under the concept of “no longer needed for this purpose”? Other lines have been developed form poor quality embryos. At a minimum, maybe the guidelines should state “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 or were found to be unsuitable for this purpose,…”

The draft guidelines also state that research using stem cells derived from sources other than from embryos created for reproductive purposes, such as somatic cell nuclear transfer, parthenogenesis, and IVF embryos created for research purposes, is not allowed under these guidelines. We believe that these techniques have potential to develop cell lines that may not be possible using “standard” embryonic stem cell derivation for embryos created for reproductive purposes and should be allowed.

Safe Harbor – Registry: The NIH will need to develop a registry or use an existing registry to provide guidance for researchers as to which lines are available for funding under the new guidelines. It would be very burdensome for each individual research institution to individually ascertain which lines meet the eligibility requirements especially since comprehensive documentation of informed consent is often difficult to obtain. We suggest that the NIH create and advisory panel and request provenance information for lines that developers would like to submit for NIH approval.

Financial Inducements: Guidelines section B.2. No inducements were offered for the donation.

Very specific language may be needed regarding financial inducements. For instance, was there reimbursement for expenses, payments to gamete donors, etc. Should “no inducements” be clarified?

Guidelines for other federally funded research: The draft guidelines state that these guidelines will pertain only to extramural NIH-funded research, while noting that intramural research will be subject to corresponding policies. We suggest that there should be a statement that other federal agencies, such as the FDA that may fund or oversee this type of research are expected to adopt the same parameters.

We hope that the NIH will move quickly to adopt the recommended changes to the draft guidelines in order to expand funding for this important field of research.

Sincerely,

 
47075 05/26/2009 at 02:59:38 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.

 
47076 05/26/2009 at 02:59:49 PM Organization The University of Pittsburgh   May 26, 2009

By Facsimile and Overnight Mail

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

Re: Comments on Draft NIH Human Stem Cell Guidelines

Dear Mr. Kington:

Kindly accept these comments, submitted on behalf of the University of Pittsburgh---Of the Commonwealth System of Higher Education (“University”), in response to the Draft NIH Stem Cell Guidelines (“Guidelines”) to implement President Obama’s Executive Order 13505 requiring NIH to issue draft guidelines for public comment governing the conduct of NIH research involving human stem cells (as published in the April 23, 2009 Federal Register). The University, through its Stem Cell Research and Oversight Committee, applauds and supports the NIH in its effort to establish comprehensive guidelines to govern the conduct of NIH research involving human stem cells. Although the Guidelines provide a good starting point and framework for expanding this important area of research, the University believes that there are certain points in the Guidelines requiring clarity and some points which have not yet been addressed in the current draft.

• The University recommends that the Guidelines specifically include “approval” of or a “safe harbor” for continuing use of all existing human embryonic stem cell (“hESC”) lines on the current NIH Registry. The Guidelines are not clear on this point. The University strongly recommends that the existing lines on the NIH Registry should be grandfathered and remain eligible for NIH funding to ensure that important research contemplated or already approved using the lines in the NIH Registry may be continued without interruption. If the approved NIH cell lines do not remain approved and eligible for NIH funding, researchers utilizing these lines would need to re-establish the foundation of their research program, resulting in unacceptable loss of time and resources. Accordingly, the University Raynard S. Kington May 26, 2009 Page Two

recommends existing cell lines currently on the NIH Registry remain approved and that this continued approval be clearly stated in the final guidelines, when issued.

• The University recommends that the NIH continue to maintain a registry of hESC lines which are eligible for NIH research funding. Once new hESC lines are identified which meet the stringent provenance requirements set forth in the Guidelines, the new lines should be added to the existing NIH Registry. The University is concerned that its researchers and research staff may not have the resources and expertise to determine whether a particular hESC cell line meets all of the provenance requirements set forth in the current draft Guidelines. The documentation requirements set forth in the Guidelines will be quite burdensome on University research staff and this burden on grantee researchers would result in unnecessary duplication of this effort nationwide.

The University of Pittsburgh received over $394 million from NIH in Fiscal Year 2007, placing it among the top 10 universities in the country for research and development funding from NIH. The University looks forward to expanded research opportunities and accomplishments in the stem cell field with the addition of more funding resources and stem cell lines which will be made available to University researchers with the issuance of the final Guidelines. The University understands the NIH is trying to strike the right balance in the Guidelines by addressing the ethical concerns within the confines of existing laws and regulations. The University hopes these Guidelines mark the beginning of further expansion of stem cell resources and funding, and that Congress reconsider legislative barriers to expanding stem cell research such as the Dickey-Wicker Amendment.

Sincerely yours,

***** cc: *****

 
47077 05/26/2009 at 03:00:03 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.

 
47078 05/26/2009 at 03:00:20 PM Self     Embryonic stem cell research has proved to be unsuccessful. It is throwing good money after bad research. Why can you not admit that this is only a ruse to keep abortion legal? Adult stem cell & umbilical stem cells have proven to be successful in almost every research done. Would it not be better to spend our tax money on this type of research? Would you spend your own money on something that has proven a failure? I don't think you are that stupid although sometimes you seem to prove me wrong.

 
47079 05/26/2009 at 03:00:23 PM Self     I oppose taxpayer funds to be used to subsidize research which destroys innocent human life.

 
47080 05/26/2009 at 03:00:29 PM Self     NIH FUNDING SHOULD BE CONCENTRATED AND DEDICATED TO FURTHER HARNESSING THE CONVERSION OF A PATIENT'S SKIN CELLS INTO THE EMBRYONIC STATE SINCE THIS STAGE OF THE ART OR SCIENCE..

--IS PROGRESSING FASTER THAN THE CONVERSION OF RAW (DONATED) EMBRYONIC STEM CELLS INTO PLURIPOTENT CELLS FROM A CURRENT ARRAY OF HUMAN DONATED EMBRYONIC STEM CELL LINES NOW NUMBERING UPWARDS OF 900 WORLD WIDE. --AVOIDS THE USE OF COSTLY IMMUNE SUPRESSANTS AND THE EXPECTED WEAKENING OF A PATIENT'S IMMUNE SYSTEM. --MINIMIZES THE UNKNOWN RISK OF CONTRACTING LURKING MUTANT GENES THAT MAY EXIST IN DONATED EMBRYOS. --FACILITATES A BETTER MEDIUM TO PERSONALIZE GENETIC CORRECTIONS THROUGH GENETIC ENGINEERING...SINCE ONLY ONE SET OF DNAS ARE INVOLVED. --PROVIDES AN OPPORTUNITY TO READILY CULTURE AND MODIFY A PATIENT'S EMBRYONIC STEM CELLS SOURCED FROM HIS OR HER SKIN CELLS. --IS POTENTIALLY MUCH MORE COST EFFECTIVE NOT ONLY IN GAINING QUICKER PROSPECTIVE FDA TESTING AND APPROVALS THAN WOULD BE NECESSARY FOR THE CERIFICATION OF FOREIGN DONATED CELLS BUT ALSO IN TRYING TO ASSEMBLE CLOSER DNA "MATCH UPS" FOR PARTICULAR PATIENTS FROM AN ARRAY OF DNA DONATED BANKS. --PROVIDES THE POTENTIAL TO INVESTIGATE ON SITE A PATIENT'S SPECIFIC GENE OR GENES ON TEST ANIMALS NECESSARY FOR CORROBORATING A POTENTIAL TREATMENT PLUS SIDE EFFECTS.

 
47081 05/26/2009 at 03:00:37 PM Organization The University of Pittsburgh   May 26, 2009

By Facsimile and Overnight Mail

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

Re: Comments on Draft NIH Human Stem Cell Guidelines

Dear Mr. Kington:

Kindly accept these comments, submitted on behalf of the University of Pittsburgh---Of the Commonwealth System of Higher Education (“University”), in response to the Draft NIH Stem Cell Guidelines (“Guidelines”) to implement President Obama’s Executive Order 13505 requiring NIH to issue draft guidelines for public comment governing the conduct of NIH research involving human stem cells (as published in the April 23, 2009 Federal Register). The University, through its Stem Cell Research and Oversight Committee, applauds and supports the NIH in its effort to establish comprehensive guidelines to govern the conduct of NIH research involving human stem cells. Although the Guidelines provide a good starting point and framework for expanding this important area of research, the University believes that there are certain points in the Guidelines requiring clarity and some points which have not yet been addressed in the current draft.

• The University recommends that the Guidelines specifically include “approval” of or a “safe harbor” for continuing use of all existing human embryonic stem cell (“hESC”) lines on the current NIH Registry. The Guidelines are not clear on this point. The University strongly recommends that the existing lines on the NIH Registry should be grandfathered and remain eligible for NIH funding to ensure that important research contemplated or already approved using the lines in the NIH Registry may be continued without interruption. If the approved NIH cell lines do not remain approved and eligible for NIH funding, researchers utilizing these lines would need to re-establish the foundation of their research program, resulting in unacceptable loss of time and resources. Accordingly, the University Raynard S. Kington May 26, 2009 Page Two

recommends existing cell lines currently on the NIH Registry remain approved and that this continued approval be clearly stated in the final guidelines, when issued.

• The University recommends that the NIH continue to maintain a registry of hESC lines which are eligible for NIH research funding. Once new hESC lines are identified which meet the stringent provenance requirements set forth in the Guidelines, the new lines should be added to the existing NIH Registry. The University is concerned that its researchers and research staff may not have the resources and expertise to determine whether a particular hESC cell line meets all of the provenance requirements set forth in the current draft Guidelines. The documentation requirements set forth in the Guidelines will be quite burdensome on University research staff and this burden on grantee researchers would result in unnecessary duplication of this effort nationwide.

The University of Pittsburgh received over $394 million from NIH in Fiscal Year 2007, placing it among the top 10 universities in the country for research and development funding from NIH. The University looks forward to expanded research opportunities and accomplishments in the stem cell field with the addition of more funding resources and stem cell lines which will be made available to University researchers with the issuance of the final Guidelines. The University understands the NIH is trying to strike the right balance in the Guidelines by addressing the ethical concerns within the confines of existing laws and regulations. The University hopes these Guidelines mark the beginning of further expansion of stem cell resources and funding, and that Congress reconsider legislative barriers to expanding stem cell research such as the Dickey-Wicker Amendment.

Sincerely yours,

***** cc: *****

 
47082 05/26/2009 at 03:00:50 PM Self     The guidelines must be made broad enough to encompass not only the extensive research done to date, but broad enough to encompass all research not found to be unethical or medically irresponsible. Just as in space, there should be no limits (beyond ethics and responsibility) on stem cell research. We can't know where a trail will lead unless we check it out. The guidelines should be helpful, not burdensome.

 
47083 05/26/2009 at 03:00:54 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

 
47084 05/26/2009 at 03:01:52 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
47085 05/26/2009 at 03:02:56 PM Self     To whom it may concern: I am writing to say that I *strongly* oppose using tax dollars to support embryonic stem cell research. Thank you for your time. Sincerely,

 
47086 05/26/2009 at 03:03:16 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47087 05/26/2009 at 03:03:21 PM Self     I urge the NIH to adopt alternative criteria for the the acceptable derivation of stem cell lines that will allow federal money to be used with stem cell lines currently approved for NIH funding. Eliminating federal support for use of these lines would seriously undermine current research programs. I recommend that the alternative criterion for acceptable derivation be oversight of embryo donation by an Institutional Review Board (IRB) or its equivalent for stem cell lines creted before 2009. The IRB should ensure that the informed consent process conformed to accepted regulations and guidelines at the time and place of donation. This alternative IRB criterion for informed consent continues support for current research programs and supports use of an expanded set of valuable stem cell lines.

Also, I support the use of NIH funds with stem cell lines derived through parthenogenesis as long as they meet standards for ethical derivation. These lines are a valuable research tool.

Thank you,

 
47088 05/26/2009 at 03:03:56 PM Organization Parkinson Education Program   Please allow human embryonic stem cell research to proceed in its entirety!

 
47089 05/26/2009 at 03:04:09 PM Self     I applaud the proposal by NIH of a draft for guidelines for human embtryonic stem cell research in the United States. However, I would like to support the proposal that no retroactivity for the new informed consent should be impossed for established or existing lines, created under ethical standards.

 
47090 05/26/2009 at 03:04:14 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.

It's long past time that we stop discarding this most valuable research resource. 1/2d

 
47091 05/26/2009 at 03:04:16 PM Self     There is not doubt that stem cell research is very important in the future of medicine but as a Catholic Christian I find it is my duty to voice my oposition to embryonic stem cell research. The advancement of medicine can not come at the cost of human life and there is plenty of scientific evidence supporting other forms of stem cell research that are more successful. I am completely and totally opposed to my tax dollars being used in such a manner. We must keep morality in all things including science and therefore please do not include embryonic stem cell research as a viable option. Our nation is called to be an example for the world and I believe we need to set the appropriate and the only morally correct example. Thank you for your time and consideration.

 
47092 05/26/2009 at 03:04:29 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

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

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

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

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

 
47093 05/26/2009 at 03:04:41 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.

 
47094 05/26/2009 at 03:04:53 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.

 
47095 05/26/2009 at 03:05:13 PM Self     The greatest horrors of the 20th Century, ones many Americans fought and died opposing, were governments that saw human beings as material goods or a means to an end. There are some lines that when crossed reduce the best of human development into barbarism. The blatant destruction of human beings, no matter how small or seemingly insignificant, under the guise of scientific or medical advancement, reduces our humanity in unacceptable ways. If the NIH is unwilling to oppose research that destroys human beings, at the least they should refrain from funding it with public monies.

 
47096 05/26/2009 at 03:05:13 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities. Please promote funding for effective adult stem cell therapies and research. Thank you

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.

 
47097 05/26/2009 at 03:05:37 PM Self    

Gentlemen: I am opposed to your draft guidelines for embryonic stem cell research, which force me as a taxpayer to subsidize research requiring the destruction of innocent human life. Support should be directed to stem cell research and treatments that do not destroy human life and are already proven successful. There is no case under which government support should be extended to human cloning or the creation of human embryos for research purposes.

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

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

I disagree most vehemently to President Obama's order that allows my tax dollars to be spent on the destruction of human life.

 
47098 05/26/2009 at 03:05:50 PM Self     I oppose all research involving the manipulation and/or destruction of human embryos outside of the wombs of their mothers. I am pleased that the proposed guidelines prohibit somatic cell nuclear transfer, parthenogenesis, and the creation of embryos for research purposes. However, informed consent for the donation of "leftover" IVF embryos does not make the destruction of those embryos ethical. We would never allow for parents to consent to "donate" a 3-month-old child for a research experiment that would not benefit the child in any way and that would assuredly lead to his or her death. Likewise, we should only be horrified that parents, who have been adequately informed, would consent to their embryonic children being dissociated and used as mere biological matter. If this research were so valuable, there would be adequate private funds supporting it and federal funds would not be needed. Please stop using my taxes to support this research.

 
47099 05/26/2009 at 03:05:58 PM Self     It is lack of scientific knowledge which led the administration to this decision. The liberal media got this issue wrong and parroted enough to make some people believe that theres promise on embryonic cell research. What a monumental waste of money!

 
47100 05/26/2009 at 03:06:00 PM Self     This executive order violates the Dickey-Wicker amendment, which states that "none of the funds made available in the 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." This executive order seeks to fund embryo-destructive with federal funds, which is a direct violation of the Dickey-Wicker amendment.

Secondly, the executive order does nothing to limit reproductive cloning. It trades on the alleged distinction between "therapeutic" and "reproductive" cloning, but there is no difference between these two types of cloning when it comes to what is made. Cloning is a form of asexual reproduction, which is essentially what happens during twinning. Yet we do not set twins aside for destructive research. The fact is that all cloning creates a human being and this executive order approves the production of human beings solely for the purpose of killing them. This is simply barbaric.

Third, even though the order says that it will "lift the ban on federal funding for promising embryonic stem cell research," there never was a ban on such research, only a ban on research that destroyed new embryos to make new lines. The pejorative manner in which this is phrased might make good copy, but it is historically disingenuous.

Finally, the order states that embryonic stem cell cell research will be funded "only when it is ...scientifically worthy." The problem is the induced pluripotent stem cells are putting classically-made embryonic stem cells out of business. None of this embryo-destructive research is necessary.

 
47101 05/26/2009 at 03:06:15 PM Self     As the prepared text below attests, it is high time that our country, through NIH funded research,increases the odds of real progress in the treatment of dibiliatating illnesses that otherwise rob individuals and their families from full and contributing lives. I wish these advances were available to my own family some 15 years ago. My father's own research resulted in thousands of babies worldwide being saved from a life of certain significant cognitive and physical disabilities brought on by PKU. His discoveries in the 60s through the late 8os were made possible from funds derived from NIH. Ironically, when a diagnosis of Parkinson's forced an end to his days in the laboratory, there was limited effective treatment. His was a life dedicated to prevention- but there was nothing he could do to prevent his or other family illnesses from cutting short life as productive members of our communities. Please be advised by the well- considered comments below- and don't let other families sit by without hope when chronic, dibilitating strikes at any time of life.

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.

 
47102 05/26/2009 at 03:06:49 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.

 
47103 05/26/2009 at 03:07:00 PM Self     The bill is still too restrictive. Why can't a women donate eggs directly to research? Why isn't the funding available for a wider range of research?

 
47104 05/26/2009 at 03:08:09 PM Self     It has come to my attention that, following President Obama’s laudable lifting of the Bush “Presidential ESC Lines” funding restrictions, that the National Institute of Health has issued draft guidelines for future regulation of embryonic stem cell research funded with public monies. I applaud the NIH’s concern for both best scientific practice and the moral implications that arise with ESC. Recent articles in scientific journals, however, and their coverage in the news has led me to be concerned about a few of the draft provisions. I provide these comments as a scientist taxpayer interested in providing scientists with the guidelines and support necessary for the efficient and enlightened conduct of their research.

I urge the National Institute of Health to carefully consider the question of retroactivity raised by Patrick L. Taylor in his Cell Stem Cell article “Retroactive Ethics in Rapidly Developing Scientific Fields,” published June 5, 2009 (please see the file that I have attached to this comment). The potential benefits from performing research on existing stem cell lines should not be discarded on the basis of new ethics regulation requiring forms or documentation that for practical or other reasons simply could not be completed for these older lines.

I also urge the National Institute of Health to allow funding for embryos developed outside the reproductive context, specifically for research purposes. IVF embryos, while doubtless essential, are not representative of the US population. Restricting NIH funding to IVF embryos would make it difficult for researchers to gain access to a variety of disease-prone genotypes, especially those associated with minority and economically disadvantaged populations that are underrepresented in the IVF pool. NIH stem cell funding (and the medical advancements therefore achieved) should not be restricted to the genes of wealthy Americans.

I would also like to point out that I am a young scientist in the biotech field working in *****. As a student I had the opportunity to take part in a summer research program that exposed me to ESC research. I learned not only about the science of stem cells but the policies and politics of the field as well. I am by no means an expert on the legal details of how stem cell research is carried out but I can say that the previous policies both restricted and hindered the work being done. Unfortunately, It is also apparent that this new “retroactive” legislation will also limit the field much in the same way the Bush policies did. Even though the Bush policies were restrictive, some researchers benefited from private funding that allowed for the stem cell field to progress. It would be disastrous for the stem cell field if this new legislation was carried out because it would not be as if the past eight years were simply restricted by stem cell politics, it would be as if all the research in the past eight years did not occur! That would be a significant setback to the already infant stem cell field requiring years of research to be redone and reaffirmed.

Thank you for your time and attention.

File Link (.txt)
Link to Article - Retroactive Ethics in Rapidly Developing Scientific Fields by Taylor
47105 05/26/2009 at 03:08:13 PM Self     I want to have a better quality of life and healthy quantity of life free of parkinson's disease and antiquated unsucessful treatments and NO cure or early detection! My Mother was incapacitated in a HURSING HOME for 7 yrs. from 1980-1987 when she died of complications of Parkinson's. Brilliant people with great minds have languished for years without bringing valuable services to people who needed them: my cancer doctor and cancer researcher, Dr. *****, had his surgical career cut very short, and his active social life, and humanitarianism was lost for years. Also, my last, living Aunt, is 90 however the past year she's had "dementia with luedes" whose symptoms are like both Parkinson's and Alzheimer's. We've got to have stem cell research, as well as other treatment options developed rapidly for cures NOW! The USA has put a man on the moon and brought them safely back to earth using a slide rule. Now let's give the scientists the tools to cure Parkinson's, Alzheimer's, spinal cord injuries and other devistating conditions. THINK OF THE MONEY SAVED BY PREVENTING FIRST AND USING EFFECTIVE TREATMENTS using stem cells for now!!

 
47106 05/26/2009 at 03:08:28 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.

 
47107 05/26/2009 at 03:09:14 PM Self     I am writing to oppose the draft Guidelines proposed by the National Institutes of Health (NIH) as they seriously contradict the ‘Right to Life' of the unborn HUMAN members of our society. Also, the draft Guidelines contradict existing law, namely the Dickey/Wicker amendment to the annual Labor/HHS appropriations bills. In addition to being morally unacceptable and legally flawed, the Guidelines are also medically unnecessary, as advances using adult and cord blood stem cells have ALREADY treated dozens of ailments and disabling conditions. How can these words from the man who first isolated and cultured human embryonic stem cells be ignored: “If human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough.” This man, Dr. Thompson, admittedly struggled with his conscience over destroying human embryos, and finds induced pluripotent stem cell research both more promising AND morally acceptable. The act of protecting human life, at any age and any condition, WILL NEVER compromise a civilized society. On the other hand, these Guidelines, will serve to compromise our society in many unconscionable ways. Respectfully submitted,

 
47108 05/26/2009 at 03:10:03 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47109 05/26/2009 at 03:10:46 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.

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

 
47110 05/26/2009 at 03:11:04 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47111 05/26/2009 at 03:11:34 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.

 
47112 05/26/2009 at 03:11:52 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 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.

 
47113 05/26/2009 at 03:11:55 PM Self     I have been struggling with diabetes since age 9. It is continually taking a toll on my body. I don't know how I am going to keep up with the daily demands of it as I age. I live alone, have no husband or children because diabetes is my full time partner. Like it or not. I feel totally hopeless at times. Until now with the hope that Stem Cells are going to finally give a cure. Or help. Diabetes costs me a tremendous amount of money to care for, and drains the insurance and medicaid/medicare systems. This is our only hope. Please help!!!

 
47114 05/26/2009 at 03:12:17 PM Self     The current NIH draft guidelines are a dramatic improvement over the restrictive 2001 funding policy for embryonic stem cell (hESC) research, but they could be even better. The draft guidelines will expand hESC research by increasing the range of available cell lines for NIH-funded research. The issue is which lines can be used in NIH research. That, in turn, depends on whether they were derived from embryos that were donated in an acceptable manner. First, the draft guidelines are redundant. The federal “Common Rule” regulations for the protection of tissue donors apply to all federally funded research and have been voluntarily adopted by most institutions for all research under their auspices. These regulations include a comprehensive system of independent oversight by Institutional Review Boards (IRBs), and documentation of proper standards and procedures for informed, voluntary consent free of any undue inducements. Many existing hESC lines were derived from embryos donated by couples who were fully informed of their options and of the purposes of the research, and whose donations were overseen by an IRB. Despite this, if their consent forms do not have the precise words listed in the draft guidelines, there is a risk these lines will be ruled ineligible for use in NIH-funded research. The same risk attaches to lines developed pursuant to the laws and regulations of various states and foreign countries, even if their requirements are substantially equivalent to those in the U.S. It is my belief that the following points conform to President Obama’s goal of expanding research on human embryonic stem cell research with an ethical process mandated by the Federal government that has demonstrated effectiveness for years.

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

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

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

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.

 
47115 05/26/2009 at 03:12:34 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47116 05/26/2009 at 03:12:45 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.

For Life,

 



Go to NIH Stem Cell Information Page