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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47215 05/26/2009 at 03:52:56 PM Organization American Society for Reproductive Medicine and Society for Assisted Reproductive Technology   On behalf of the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) we appreciate the opportunity to comment on the Draft National Institutes of Health Guidelines for Human Stem Cell Research.

ASRM is a voluntary, non-profit organization devoted to advancing knowledge and expertise in reproductive medicine, including infertility, menopause, contraception, and sexuality. Founded in 1944, we are an organization of more than 8,000 physicians, researchers, nurses, technicians, and other professionals. Affiliated societies include the Society for Assisted Reproductive Technology, the Society for Male Reproduction and Urology, the Society for Reproductive Endocrinology and Infertility, and the Society of Reproductive Surgeons. An affiliate of ASRM, the Society for Assisted Reproductive Technology (SART) is the primary organization of professionals dedicated to the practice of assisted reproductive technologies (ART) in the United States. SART includes 406 member practices, performing over 85% of the ART cycles done in the United States.

As the medical professionals who work most closely with the patients who will be the source for the materials used to originate these stem cell lines, we are very supportive of the NIH funding research using human embryonic stem cell lines and are, in general, very supportive of these draft guidelines. Increased federal funding for human embryonic stem cell research will provide more options for infertility patients as they make decisions about embryos beyond their clinical need, and hopefully the results of this research will add to our knowledge of many diseases and conditions.

Going forward, we find the guidelines conceived out and scientifically sound, with adequate protections for the gamete providers and infertility patients. We are pleased the draft guidelines make clear that it is the patients who are the “human subjects” involved and not the embryos. In fact, we are pleased to see that the draft guidelines are quite similar to the recommendations contained in the ASRM/SART Ethics Committee Report on Donating Embryos for Stem Cell Research released earlier this year. See http://www.asrm.org/Media/Ethics/donatingspare.pdf.

While supportive of embryonic stem cell research and of the draft guidelines, we feel that there are a few points in the guidelines that require modification:

1. Section B. Number 1 states “All options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donors.” Not every IVF clinic will be able to offer every possible option to every patient. For example, not every program will be looking for embryos for non-stem cell purposes. Clinics should only be required to explain the options they have available to patients, not every conceptual alternative. The language should be changed to reflect this reality.

2. Section B. Number 4 calls for a clear separation between the decision to create embryos for reproductive purposes and a decision to donate. We would like to see more specificity here. Simply adding that this refers to a separation of these two acts would improve it.

3. Section B Number 5 states that the consent should come from those who had sought reproductive services. We think this should be more explicit stated, that it is those patients with dispositional control of the embryos (s) who must provide consent. The guidelines must state explicitly that if an embryo donor used a gamete donor in the course of the infertility treatment, it is the patients seeking reproductive services, not the gamete donor, who provides consent to donate an embryo for stem cell research.

4. Section C calls on funding recipients and their institutions to provide assurances that the stem cells lines were derived in accordance with NIH guidelines. While this is a reasonable responsibility for the participants in the derivation process, it may not be reasonable to expect every researcher working with a stem cell line to meet this requirement. We would prefer to have the NIH establish and maintain a registry of lines that have previously been approved as having met the guidelines. Alternatively, the guidelines could specify that documentation of a stem cell line’s derivation in compliance with the guidelines, provided by the institution deriving the cell line and accompanying the cells when they are sent to researchers who will be using them in federally funded studies, be acknowledged as sufficient to meet the assurances.

5. Section IV proscribes some other forms of non-allowable research. We would ask for the removal of this section. It is clear to all that NIH will not fund research that is not allowed by statute. There is no need to have this section in a guidance document about what is allowable by law.

6. A challenging, but very important, issue is how to ensure that scientists can obtain or maintain funding to work on human embryonic stem cell lines that came into existence prior to the release of these guidelines. It would be terribly wasteful to not allow the use of lines which were derived according to the best standards at the time of their creation, not to be used because they were not derived according to the standards now in place. Therefore we would ask that guidelines be modified to allow funding on lines derived prior to these guidelines coming into force, provided that assurances are provided that the derivation of the line was performed according to sound policy in place at the time the source material was obtained. That policy could be previous federal standards, those promulgated by state governments, by professional organization such as the National Academies of the Sciences (NAS) or International Society of Stem Cell Research (ISSCR) or one approved by a chartered Institutional Review Board.

ASRM and SART support the National Institutes of Health in developing guidance that will promote research using human embryonic stem cells. This research will advance the development of new therapies to cure disease. We are happy to provide further assistance in this initiative

Thank you.

 
47216 05/26/2009 at 03:53:33 PM Self     I support federal funding for stem cell research. I would like to see the guidelines expanded to provide funding for all existing stem cell lines, and grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease.

I support such groundbreaking technologies as somatic cell nuclear transfer, and that it needs to be supported.

The new guidelines are so cautious and conservative they would disqualify funding for almost all the embryonic stem cell lines made since 1998, when the field began. We owe the brave men and women scientists who worked in a terrifically hostile political climate-their courage, and their work, deserve to be supported now. The economy of the world depends on cure research. Last year, America alone spent $2.3 trillion on medical care costs-more than all federal income taxes put together ($1.8 trillion)-and 75% of that mountain of money went to pay for chronic (incurable) illness and disability.

My family deserves the best medical care science can provide. Christopher Reeve once said, "Our government is supposed to do the greatest amount of good for the greatest amount of people." Let's make that a reality.

 
47217 05/26/2009 at 03:54:19 PM Self     I strongly urge the National Institutes of Health to 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.

Not only this, but the use of embryonic stem cells is no longer even urged by many scientists, who now consider it superseded by more promising types of stem-cell research. We desperately need better guidelines than this.

 
47218 05/26/2009 at 03:54:19 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47219 05/26/2009 at 03:54:47 PM Self     I oppose any federal funds for the use of embryonic stem cell research.

 
47220 05/26/2009 at 03:54:47 PM Self     As a type 1 diabetic, stem cell research is really my only hope for a cure. I have been told for over 30 years a cure was around the corner but in fact there has been no cure. Please allow the stem cell research to move forward in the most aggressive method possible.

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.

Please give me and millions of other Americans hope before it is too late.

Thank you for your consideration,

***** Type 1 since age 5

 
47221 05/26/2009 at 03:54:57 PM Self     I am opposed to your draft guidelines for embryonic stem cell research, which force me as a taxpayer to subsidize research requiring the destruction of innocent human life. Support should be directed to stem cell research and treatments that harm no one and are already producing good results. In no case should government support be extended to human cloning or other morally reprehensible creation of human embryos for research purposes. There is no moral difference between what is being proposed for embroynic research and the research carried out by the Nazis during WWII for which they were justly condemned

 
47222 05/26/2009 at 03:55:18 PM Organization Servants of Our Lady of Guadalupe   Science is both a gift and a responsibility. In order for science to be valid there must be both a positive moral and ethical evaluation of its means and its ends. Science is an authentic good to the extent that it is at the service of humanity. Good science respects each human individual in its pursuit for truth and the common good. It is not ever permissible to sacrifice an innocent individual for the sake of the many, regardless of their need. Science loses validity whenever it resorts to killing, such as in the dreadful examples of In Vitro Fertilization where labs routinely destroy innocent human individuals just as others do in surgical abortion facilities or in the hidden liquidating of human beings in the earliest stages of life through chemical abortifacients. In your responsibility to guide ethical research, please keep foremost in mind the reality that each human individual is a unique, sacred and inviolable human being with equality in dignity and in the gift of life, the same as all other human beings, regardless of age or size. Be alert to reject any protocol which reflects a eugenic ideology that would claim the weak or the young human beings are expendable for the sake of the strong. No human being is ever expendable, regardless of their age or stage of biological development. Likewise, be careful to move beyond a mere functionalist view of the human person, a view that would devalue a human being simply because it is small and in the first developing stages of life. Such an erroneous philosophical outlook would tend to always place that smaller individual as a reduced "means" to achieve an goal outside of itself, even in spite of itself, so that he or she is sacrificed for the sake of some older and larger human beings. A human being is never a "means" to achieve a scientific goal, he or she must be treated with just respect and therefore, as an "end" in and of himself. Science should remained anchored in a proper anthropological ethic which eradicates every false utilitarian pragmatism that would overlook the individual human person for some proposed "greater" purpose. Whenever science sidesteps ethics, it can be guaranteed that some human individuals will have to pay a dear price. In the development of NIH/HHS guidelines for stem-cell research, do not allow the human persons at the embryonic stage of development to pay that dear and deadly price. Prevent all unjust violence against human embryos, and do not allow even one of these fragile human beings to be annihilated for any reason, as it is obvious that no proposed reason could possibly be justified for their personal benefit, nor ultimately for ours. -----

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.

 
47223 05/26/2009 at 03:55:37 PM Self     I staunchly oppose any and all funding for embryonic stem cell research. The taking of human life for any reason is a grave wrong--embryonic stem cell research requires the killing of preborn children. Therefore it is a grave wrong.

 
47224 05/26/2009 at 03:56:05 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.

 
47225 05/26/2009 at 03:56:08 PM Self     Dear NIH: President Obama’s Executive Order 13505 represents a tremendous opportunity for the NIH to support ethically responsible and scientifically worthy stem cell research. The NIH deserves credit for producing draft Guidelines quickly to provide time for public comment. However, I am worried that that the NIH proposal will exclude funding for many existing stem cell lines ethically created over the last eight years. I appreciate the opportunity to comment on the Draft National Institutes of Health Guidelines for Human Stem Cell Research and urge you to take the following into consideration: [1] Develop final Guidelines that allow the NIH to fund research utilizing established hESC lines derived in accordance with the core principles in the ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research. These guidelines recommend independent oversight, voluntary and informed donor consent and no undue inducements. Most established hESC lines that are widely used in research today have been obtained in accordance with these principles. To ensure continued international collaboration, these principles should be applied to the evaluation of existing lines. I am a post-doctoral fellow at Children’s Hospital ***** and rely a lot of my research on human embryonic stem cell lines H1, H9, and BGO1. I published a paper in the year 2007 that would not have been possible if these lines were not eligible for funding by the NIH. [2] Most existing U.S. lines have been derived in accordance with the core principles in the ISSCR’s guidelines and consistent with the established federal regulatory framework involving IRB oversight and approval. In some instances, additional specialized embryonic stem cell research oversight committees (ESCROs), and other oversight methods in other countries (referred to as SCROs in ISSCR Guidelines), have also provided oversight. Established policy has demonstrated that this self-regulatory structure has provided a sound ethical foundation for stem cell research. In developing the final Guidelines the NIH should consider this well-established framework of independent oversight and give weight to its determinations. [3] Specifically, for funding eligibility purposes, the ethical provenance of existing U.S. cell lines should be judged based on the standards that prevailed at the time they were derived, provided the protocol under which donations were accepted, and any amendments, were approved by an IRB operating under federal regulations. Non-US lines should be eligible for funding within the US if the IRB and/or SCRO for the US institution receiving NIH funding determines that the protocol under which the underlying donation occurred met operative standards of the time and core ethical principles. In addition, new requirements that go beyond established U.S. and international practice should be applied prospectively only, and after a time period for affected parties, including IVF clinics, to adapt. We specifically ask the NIH to reconsider those aspects that go beyond existing ISSCR standards, including, for example, the proposed mandatory dual IVF consent the proposed guidelines would require, and the proposed requirement that the informed consent form is the sole source for ethical validation. [4] It will be essential that investigators know with some certainty what lines are eligible for funding. I therefore urge the NIH to work with organizations such as the ISSCR to develop a list or registry of hESC lines available for NIH-funding or resources to support the oversight process. The ISSCR has in development a registry to document that hESC derivation was performed in accordance with ethical requirements, and make associated documentation available to reviewing IRBs and stem cell oversight bodies. Such a registry would reduce uncertainty and improve research efficiency. While that registry is being finalized, a useful and easy place to start in the meantime would be for the NIH to publish, on a Web site, the lines that are determined to be fundable based on IRB and SCRO determinations. Thank you for the opportunity to comment on the draft Guidelines.

 
47226 05/26/2009 at 03:56:31 PM Self     I wholeheartedly support government funding for stem cell research. There are so many conditions, like Parkinsons, arthritis, diabetes, etc. that may be treated using replaced cells and tissues that is only possible by continued stem cell research! I strongly feel the public should be educated on the fact that these are not human embryos! This is not manufacturing of embryos for the sole purpose of a science experiment. These cells might otherwise be destroyed when they are no longer needed for reproductive purposes. It is SO important that these can be used to treat illness and disease!

 
47227 05/26/2009 at 03:57:23 PM Self     Just weeks before his third birthday we rushed our son, *****, to our local Children’s hospital to discover that, what we thought was a persistent flu bug, was actually Type 1, Juvenile Diabetes. At first we did not really know what that meant. We soon learned it meant a lifestyle change for our family. It meant life altering and life long changes for *****. Until there is a cure, ***** is dependant on insulin injections to stay alive. For two years ***** required multiple shots to his arms and legs. Today, he is attached to an insulin pump that when programed transfers insulin from the pump and through a tube that is inserted under his skin. Ethan must maintain a strict diet and he must test his blood several time each day by pricking his fingers with a lancet to draw blood. When he has a cold, or bug of some sort, (you know, the times when you least want pokes and pricks) he must test even more frequently until the illness passes. But the truly cruel part of this disease is the fact that without a cure, ***** is at a much higher risk of blindness, loss of limbs, heart and kidney disease and a shorter life. As a father, I simply cannot stand for this. So sir. We must fix this. Please help me.

Please, help me to help ***** and the millions of others suffering from this disease.

I am appealing to you 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 and I thank you for helping this father who desperately wants to find a cure for his son.

 
47228 05/26/2009 at 03:57:47 PM Self     Any Limitations upon use of Stem Cell should not be. Too often medical advancements are politically hindered. As Stem Cells possibility hold the ability to cure and treat many existing ailments, injuries and diseases. I just don't understand how applying any limitations with any potential can be, as chances are You whom are reading these words stand to benefit. Perhaps not directly, but for your children and future bloodline. Its ignorant to believe such future is secure. In my view, all possible resources should be used to ensure such survival.

 
47229 05/26/2009 at 03:58:13 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am a physicist with a background in biophysics as well as a member of the Parkinson’s community -- my wife is a Parkinson's patient who would benefit greatly if this country had a more active program in embryonic stem cell research. I realize that significant strides have indeed been made over the past decade, and that 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. It is essential, however,that the final guidelines be crafted so as not to 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.

 
47230 05/26/2009 at 03:58:25 PM Self     I oppose devoting my tax dollars to experiments with embryonic stem cells, from destroyed human embryos. The only successful treatments and cures come from adult stem cells, taken from bone marrow, umbilical cord blood, fat tissue, and other body tissues. Thousands of patients have had their health improved and their lives saved with adult stem cells. Dozens of diseases and injuries including cancer, juvenile diabetes, heart disease, spinal cord injury, multiple sclerosis, and Parkinson's disease have already been treated using adult stem cells, and more treatments are being developed.

Money spent for human embryonic stem cell experiments will delay adult stem cell treatments and cures. This new policy puts the health of Americans in danger. We need to put the patients first, and put federal funds toward the real treatments and real promise of adult stem cells.

 
47231 05/26/2009 at 03:58:28 PM Self     Regarding the president's decision overturning the previous administrations restrictive policies on embryonic stem cell research and derivation. Please do not do anything that would discard occlytes that could be studied and perhaps provide insight into womens health issues.

 
47232 05/26/2009 at 03:59:06 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
47233 05/26/2009 at 04:00:03 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.

 
47234 05/26/2009 at 04:00:06 PM Self     I would suggest that the nomenclature of some aspects of stem cell research be altered, in order to dispel any misconceptions in the mind-set of the ordinary citizen.

You could more properly term Embryonic Stem Cells as Blastocyte Stem Cells, (The name 'embryonic' stem cell, although technically sccurate to a scientist, invokes in the mind of the general public a developed foetus)

Adult Stem Cells as Somatic Stem Cells ('adult' here is a misnomer, since a small child can have 'adult'stem cells - since 'somatic' means 'of the body', it removes any incorrect links with the 'germ cells'. ie ovum agamete.)

Cloning as Replicating (1950s horror movies have a lot to answer for).

 
47235 05/26/2009 at 04:00:07 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.

 
47236 05/26/2009 at 04:00:17 PM Self     I am appalled that I would be forced to support the use of embryonic stem cells in research. Adult stem cells have proven to be more productive; that would make the use of embryonic stem cell a political decision instead of an intelligent decision supported by any science.

 
47237 05/26/2009 at 04:00:28 PM Self     I oppose all funding of embryonic stem cell research. There is no difference between experimenting on and killing a three month old infant and an embryonic human. We are naturally horrified at the first; why is the latter any different? I oppose having my tax dollars used on human experiments where the subjects have no voice regarding their participation. Put the funding towards iPS cell research--that is where the major breakthroughs are anyway.

 
47238 05/26/2009 at 04:00:56 PM Self     I support embryonic stem cell research, and am glad some of the restrictions are being loosened.

 
47239 05/26/2009 at 04:01:23 PM Self     Please do everything to speed stem cell research. I have a grand daughter with type 1 diabetes and she is only ten years old. She has to check her sugar levels at least four times a day besides checking before eating. She also has to wear a pump as to not be in trouble while sleeping. I also know other children with the same problem. If you have childern or grand childern please consider what a fantastic thing it would be if the problem could bve solved by stem cell research. I would hate to think that she will have to fight the rest of her life without your help.

Thank You,

 
47240 05/26/2009 at 04:01:26 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.

 
47241 05/26/2009 at 04:01:42 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.

 
47242 05/26/2009 at 04:02:10 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.

 
47243 05/26/2009 at 04:02:14 PM Self     I oppose all funding of embryonic stem cell research. There is no difference between experimenting on and killing a three month old infant and an embryonic human. We are naturally horrified at the first; why is the second any different? I object to having my tax dollars used on human experiments where the subjects have no voice regarding their participation. Put the funding towards iPS cell research--that is where the major breakthroughs are anyway.

 
47244 05/26/2009 at 04:02:34 PM Self     Embryonic stem cell research is unethical and should not be funded or in any way supported by the US government or its agencies. There is no ethical justification for producing and then killing embryos to help cure (or maybe help cure) undesirable conditions for another human being that already have had the freedom to live, and have many other sources of help with whatever affliction they may have. Do not think embryos are non-persons, as this is the same thinking that Hitler had about Jews, Stalin had about most everyone, and US southern states had about slaves. Obama is doing wrong by his directive forcing those to object on ethicial grounds to pay with enforced taxation.

 
47245 05/26/2009 at 04:02:52 PM Self     I am writing to ask that you protect embryos and not use them for stem-cell research as adult stem cells already have a proven track record of success.

 
47246 05/26/2009 at 04:03:27 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 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.

Thank you!

 
47247 05/26/2009 at 04:03:38 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

 
47248 05/26/2009 at 04:03:38 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.

 
47249 05/26/2009 at 04:03:44 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I 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.

Thank you!

 
47250 05/26/2009 at 04:03:49 PM Self     I oppose taxpayer funds being used on behalf of stem cell research.

 
47251 05/26/2009 at 04:03:56 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I 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.

Thank you!

 
47252 05/26/2009 at 04:04:26 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.

 
47253 05/26/2009 at 04:04:35 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47254 05/26/2009 at 04:04:58 PM Self     Please support research with adult stem cells only as this seems to offer the most promise and the best hope for future progress.

Thank you

 
47255 05/26/2009 at 04:05:10 PM Organization University of Missouri   To Whom It May Concern:

The University of Missouri-Columbia appreciates the opportunity NIH is providing to respond to the proposed guidelines for human stem cell research. We believe these guidelines represent a strong first step in delivering on President Obama’s request for NIH guidance in this important area of research. These guidelines, however, should work in concert with standing regulatory requirements – such as the “Common Rule” – and complement those rules without adding additional administrative burden. We agree in sum with comments submitted by Dr. Bernard Lo, et. al., and submit this letter in support of their comments and suggestions.

The Code of Federal Regulations at Title 45 Part 46, the DHHS citation for the Common Rule, provides regulatory protection to human subjects and applies to all federally funded research. Our institution, as with many others, has voluntarily adopted these rules for all research conducted on our campus regardless of funding source. These rules include a comprehensive system of independent oversight by Institutional Review Boards (IRBs), and documentation of proper standards and procedures for informed voluntary consent. Where consent to use tissue for research includes collecting any identifying information about the donors, that donation is also covered, even if the donors are not themselves the subject of the study. The draft guidelines set out parallel requirements, but add terminology and procedures that would require new interpretations and possibly new forms of oversight and documentation. We agree that such duplicity is unnecessary.

Institutional assurance sought in the draft guidelines can best be provided by existing IRBs. This would represent a level of rigor, transparency and accountability to the draft guidelines without increasing administrative burden on institutions. Additionally, academic journals have come to rely on, and in some cases require evidence of, IRB review prior to acceptance of research results for publication. Guidelines which allow IRBs to perform review of consent language avoid unnecessary questions of interpretation and give the appropriate oversight to a body already well-versed in human subjects protections.

The Common Rule also requires oversight of every aspect of the donation, from initial approach to the donors to the final receipt of the embryo, in order to ensure that there are no misunderstandings or undue inducements. In addition, the regulatory regime provides a mechanism for auditing research sites and imposing sanctions on those who fail to abide by these rules. Specifying procedures in the draft guidelines, such as language in the consent forms, establishes an extra burden that is unnecessary.

Funding should be available for work using lines derived from embryos that were donated by individuals who gave voluntary informed consent without undue inducement. Existing hESC lines – whether approved or not by the Bush Administration -- derived from embryos donated by couples who were fully informed of their options and of the purposes of the research, would not be accessible under the draft guidelines because the consent forms did not meet the specific language requirements. The same problem attaches to lines developed pursuant to the laws and regulations of various states and foreign countries, even if the requirements are substantially equivalent to those in the United States. The same standard for approval should be used both for lines that already exist and for those yet to be derived. The Common Rule promulgates such a rigorous, well understood, and comprehensive standard. Its provisions already incorporate all the core principles espoused in the draft guidelines. Consistency of approach for all lines, regardless of funding or timing of derivation, enhances high quality oversight by reducing redundancy and confusion.

Coordinating the guidelines with the Common Rule provides for strong oversight and ethical structure which is already well understood. It applies the same high standard of responsible research practices to every line used in NIH research, whether derived in the past or the future, here or abroad, including those approved for use by President Bush. It eliminates the risk that lines derived with voluntary informed consent will be disqualified for simply failing to match exact language. It builds upon an existing regulatory oversight system by which IRBs assure the federal government that their investigators are in compliance. It clarifies the documentation process as both investigator and NIH will know that IRB approval is required. Finally, the HHS Office for Human Research Protections has the power to audit, investigate, and sanction if credible allegations of misconduct arise.

In sum, instead of building a parallel set of guidelines, NIH should simply 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. This approach will relieve administrative barriers while promoting ethically responsible, scientifically worthy, and legally compliant hESC research.

We want to reiterate our appreciation of NIH’s public participation in development of these guidelines. We feel these recommendations will assist in the implementation of appropriate guidelines. Thank you for this opportunity to comment.

Sincerely,

 
47256 05/26/2009 at 04:05:14 PM Self     Please continue to fund stem cell research. The positive benefits from this research remain to be seen. The application for scientific investigation serves as a bridge notwithstanding the abortion issue. Thank You,

 
47257 05/26/2009 at 04:05:33 PM Self     Stem cell research should not be limited in any way.

 
47258 05/26/2009 at 04:05:47 PM Self     Stem cells, preferably from yourself, are the only way to go. Like antibiotics cured so much, so will stem cells. There are only two problems: 1. Ignorant people will think you only obtain them from a baby starting to grow, or an embryo. 2. Medical people will be highly enraged, having to stop traditional healing, treatments. We must go ahead anyway.

 
47259 05/26/2009 at 04:05:54 PM Self     The current NIH draft guidelines are a dramatic improvement over the restrictive 2001 funding policy for embryonic stem cell (hESC) research, but they could be even better. The draft guidelines will expand hESC research by increasing the range of available cell lines for NIH-funded research. The issue is which lines can be used in NIH research. That, in turn, depends on whether they were derived from embryos that were donated in an acceptable manner.

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

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

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

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

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

 
47260 05/26/2009 at 04:06:00 PM Self Self   I am writing to tell you that I feel your forcing me to contribute tax dollars to support research using stem cells and emriyos is a violation of my freedom of religion. You are trying to force me to support somethin I believe is a sin and violates my faith and conscience. Also, I think there is a huge danger that this will lead to human cloning and creation of animal/human hybrids, both of which I object to. Please show me you respect my rights as well as the rigths of innocent undeveloped human life. Please stop going down this slippery slope. Sincerely,

 
47261 05/26/2009 at 04:06:12 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 Type-one diabetes 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. Bush's 8 year delay probably already will cost me my life. I just don't want the same to happen to my daughter.

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

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

I'm sure you'll be bombarded by the Taliban-like right wing religious zealots protesting this. They claim to be Christian, but aren't. www.secretrecordings.com proves this beyond doubt. Your decision should be based on medical science, not mistaken religious beliefs.

 
47262 05/26/2009 at 04:07:39 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 the daughter of a Parkinson's patient 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.

 
47263 05/26/2009 at 04:07:59 PM Self     I oppose all embryonic stem cell research. Most of the promisng advances in stem cell research are being made in other areas; this is where funding should be directed. Mreover, destroying an embryo is destroying a being with a human nature. How cna this be licit, especially when more promising alternatives are available?

 
47264 05/26/2009 at 04:08:21 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.

 
47265 05/26/2009 at 04:08:34 PM Self     I support the new guidelines and urge the NIH to adopt them as soon as possible.

 
47266 05/26/2009 at 04:08:51 PM Organization Human Pluripotent Stem Cell Research Oversight Committee, University of Michigan   I am responding on behalf of the University of Michigan Human Pluripotent Stem Cell Research Oversight Committee (HPSCRO). The HPSCRO is constituted to include at least the following: two UM faculty members with expertise in the life sciences, including one with scientific expertise in hES cell research, a faculty member who is a practicing physician, a faculty member with legal or regulatory expertise, a faculty member with bioethics expertise, and a non-affiliated community member.

Areas of major concern: • We believe it is important to allow for the “grandfathering” and continuing use of certain cell lines previously created and considered allowable under previous NIH guidelines. Under the current proposed guidelines, some cell lines previously approved by NIH would no longer be considered appropriate for funding because consent forms or existing documentation would fail to meet the new proposed requirements. NIH should consider a mechanism that enables continued use of these established lines.

• The draft guidelines do not appear to recognize any established banking authorities, so that lines currently considered “acceptably derived” may no longer qualify as such. Under the proposed guidelines, each investigator and institution would be responsible for assuring that the guidelines are met for the cell lines that it uses. The burden would fall on each individual investigator and institution to collect proof of provenance or other documentation to determine the acceptability of the lines used in order to give these “assurances” to NIH. A more centralized process should be considered. The NIH is in a unique position to coordinate a registry that would identify and register all established hESC lines that comply with NIH guidelines.

Comments specific to the proposed guidelines

I. SCOPE OF GUIDELINES: No comments

II. GUIDELINES FOR ELIGIBILITY OF HUMAN EMBRYONIC STEM CELLS FOR THE USE IN RESEARCH A. No comments B.1 (All options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donor(s)): “All options” are not specifically defined, and “all options” may not apply to all embryos. For example, abnormal Pre-implantation Genetic Diagnosis (PDG) embryos would not be suitable to donate to another couple, an option that might be considered for some embryos. Also, it is not clear how this standard would be documented for existing cell lines. We recommend that this element either be applied only to prospective donations, or that the addition of “as appropriate” be considered to qualify this requirement.

B.2 (No inducements were offered for the donation): Clarification is needed regarding the possibility of reimbursement to donors for expenses incurred and whether hESC lines derived via a paid reproductive egg/sperm donor would be eligible.

B.3 (A policy was in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donors): NIH should consider harmonization with the Common Rule 45 CFR 46.116(a)(8) which states that a consent form must include “a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.”

B.4 (There was a clear separation between the prospective donor(s)’s decision to create human embryos for reproductive purposes and the prospective donor(s)’s decision to donate human embryos for research): Clarity needs to be established as to what constitutes “clear separation between the prospective donor(s)’s decision to create human embryos for reproductive purposes and the prospective donor(s)’s decision to donate embryos for research purposes.” Would it be sufficient to gain consent for IVF in the morning, and then later on the same day gain research consent? If the IVF consent mentions research as an option, are the embryos disqualified?

B.5 (At the time of donation, consent for that donation was obtained from the individual(s) who had sought reproductive services. That is, even if potential donors had given prior indication of their intent to donate to research any embryos that remained after reproductive treatment, consent for the donation should have been given at the time of the donation, donor(s) were informed that they retained the right to withdraw consent until the embryos were actually used for research”):

What constitutes “embryos were actually used for research”?

How would this element apply to embryos that are de-identified?

Does research begin with the shipment of embryos from the health care facility where embryos were generated?

What if embryos have been shipped and stored at a facility that is NOT the health care facility where embryos were generated (storage facility; e.g. ReproTech; or another health care facility for frozen embryo transfer)?

If research in this instance is defined as “initiation of hESC derivation” one could envision that embryos would be generated at a health care facility, shipped to a “non-health care or research facility”, stored at the “non-health care or research facility” until hESC derivation is attempted (could be days, weeks, months, years). If donors withdraw consent once embryos are at the “non-health care or research facility” but before “initiation of hESC derivation”, what is the disposition of said embryos? - Concern would exist for any subsequent use of embryos for reproductive purposes (donor(s) or adoption) because embryos have now been shipped from a FDA-registered, CLIA88-compliant clinical health care facility to a non-FDA-registered, non-CLIA88-compliant research non-health care facility. Health care facility chain of custody has been broken. Alternatively, withdrawing from research means the embryo would be destroyed. Returning the embryo for possible implantation would not be an option.

Potential Solutions: - Research defined as the “time or event initiating shipment of embryos from the health care facility to the non-health care or research facility.” - Disposition directives (non-reproductive) of embryos that have transferred from a clinical health care facility to a research non-health care facility, that have not been used to derive hESCs, and for which donor(s) wish to withdraw consent. - Redefine the event or time for which withdraw of consent can occur. Example: “You may withdraw your consent for whatever reason at any time before embryos are shipped to XX (research non-health care facility). In other words once your embryos have initiated shipment to XX you have made a completed donation and the embryos cannot be returned to you or used for fertility treatment.” - Keep the current right “to withdraw” terminology. Allow donor(s) to withdraw consent of embryos up to the time of hESC derivation. Allow donor(s) to use said embryos for reproductive purposes. This would require that all hESC derivation laboratories be FDA-registered, CLIA88-compliant clinical health care facilities. B.7.a (All options pertaining to the use of embryos no longer needed for reproductive purposes were explained to the potential donor(s)). This requirement for “all options” is ambiguous and may not apply to all embryos as noted above. B.7.c (A statement that the embryos would be used to derive human embryonic stem cells for research) [Grandfathering issue] Few of the older stem cell lines, including the NIH registered lines, explicitly state that the embryos will be used to create embryonic stem cell lines.

B.7.h (Written informed consent was obtained from individual(s) who sought reproductive services and who elected to donate human embryos for research purposes. The following information, which is pertinent to making the decision of whether or not to donate human embryos for research purposes, was in the written consent form for donation and discussed with potential donor(s) in the informed consent process: * * * “A statement as to whether or not information that could identify the donor(s) would be retained prior to the derivation or the use of the human embryonic stem cells…..”) If B.5 is meant to allow withdraw of consent up to time of derivation, and allow donor(s) to use said embryos for reproduction, then all donor(s) would have to provide information that could identify them as donor(s) and be linkable to donated embryos. Thus, one could not de-identify donated embryos. We recommend that an option to receive de-identified embryos be allowed.

II. B. Requires that (1) the funding recipients must ensure that the embryonic stem cells were derived consistent with sections II.A and B of these Guidelines and (2) that the grantee institution maintains appropriate documentation demonstrating such consistency. NIH should consider providing more specific direction as to what constitutes “appropriate documentation.” Some of NIH’s proposed guidelines overlap with NAS guidelines, but some are new and unique and call for documentation that might not be readily available.

III. RESEARCH USING HUMAN EMBRYONIC STEM CELLS AND/OR HUMAN INDUCED PLURIPOTENT STEM CELLS….: No Comment

IV. OTHER NON-ALLOWABLE RESEARCH: No Comment

 
47267 05/26/2009 at 04:09:23 PM Self     I totally support stem cell research using excess embryos, with federal funding & oversight by an ethics group.

 
47268 05/26/2009 at 04:09:51 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.

 
47269 05/26/2009 at 04:10:19 PM Organization     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.

 
47270 05/26/2009 at 04:11:07 PM Self     Embryonic stem cell research holds great promise for millions of Americans facing the challenges of living with many diseases and disorders. I have been following progress in this field with great interest and understand the importance that it holds for people living with chronic diseases like multiple sclerosis. I am encouraged to see the field of human embryonic stem cell research expanded through the issuance of these guidelines and the change in federal policy around funding for this important scientific field. Much progress has been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

 
47271 05/26/2009 at 04:11:22 PM Self     Place use whatever technology is available to cure and prevent diabetes

 
47272 05/26/2009 at 04:12:36 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.

 
47273 05/26/2009 at 04:12:48 PM Self     Please give science a chance to prove whether stem cell research is a promising idea for finding therapies and cures for millions of people suffering from diabetes, parkinsons disease, etc... I have young-onset Parkinson's disease and I hope to one day be cured of this terrible disease.

 
47274 05/26/2009 at 04:13:01 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.

 
47275 05/26/2009 at 04:13:43 PM Self     As a scientist, I extend my support for embryonic stem cell research. It is long past the time when U.S. scientists should be able to utilize government grant money for the advancement of science in this critical area of research.

 
47276 05/26/2009 at 04:14:33 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

 
47277 05/26/2009 at 04:14:34 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.

 
47278 05/26/2009 at 04:14:38 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 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.

I am opposed to embryo-destructive stem cell research that has been 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.

It is important to note that 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.

 
47279 05/26/2009 at 04:14:55 PM Self     Comment Text (please copy and paste into Comments section)

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

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

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

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

 
47280 05/26/2009 at 04:15:05 PM Self     26 may 2009 I STRONGLY oppose killing human embryos, which is murdering unborn children. The proposed regulations will force taxpayers, especially those that work, to fund research they STRONGLY oppose, since they, and I, know it is unethical, because it requires the killing of human embryos

 
47281 05/26/2009 at 04:15:21 PM Self     I myself was once an embryo. I find it offensive that I would be forced to pay my taxes toward the destruction of human life.

 
47282 05/26/2009 at 04:15:32 PM Self     I BELIEVE ABORTION IS MURDER.

 
47283 05/26/2009 at 04:16:03 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.

 
47284 05/26/2009 at 04:16:12 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.

 
47285 05/26/2009 at 04:16:24 PM Organization The Endocrine Society   The Endocrine Society appreciates the opportunity to comment on the National Institutes of Health (NIH) draft guidelines on human embryonic stem cell (hESC) research. Founded in 1916, The Endocrine Society is the world’s oldest, largest and most active organization devoted to research on hormones and to the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of more than 14,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied and clinical interests in endocrinology.

The Society supports expansion of the availability of hESC for research and therapeutic purposes as intended by Executive Order 13505. We encourage NIH to continue to fund research on adult stem cells and on induced pluripotent stem cells even as the availability of hESC is increased. We agree with the stringent but reasonable guidelines NIH has outlined to ensure that excess embryos from fertility treatments are obtained ethically for the derivation of hESC lines. The Society has concerns, however, about potential negative consequences that may arise if the eligibility guidelines are retroactively applied to currently available hESC lines. Furthermore, we recommend that the scope of research allowed under federal funding be broadened to include research on cells derived from somatic cell nuclear transfer (SCNT). Though we understand that it is currently not allowed by law, we feel that NIH support for the generation of new hESC lines would greatly facilitate the needed expansion of available lines. Our concerns and recommendations are detailed below.

Retroactive application of the eligibility guidelines could impose unintended limitations on currently available cell lines. The Society supports the human subject protection and informed consent criteria outlined in the draft guidelines. However, it is concerned that retroactive application of these criteria to previously derived and well characterized stem cell lines could limit scientists’ access to a valuable resource. The Society encourages NIH to consider the spirit of the executive order and take steps to ensure that the implementation of any guidelines would not restrict the eligible sources of stem cell lines for research.

The scope of allowable research should be broadened to include cells derived from SCNT. In response to comments received regarding the 2000 draft guidelines on stem cell research, NIH stated that it would disallow research on cells derived from SCNT because the agency felt that research on such cells “has not received adequate discussion and consideration by the public.” If NIH were to clearly and logically outline the scientific basis for its support of this technology, it could establish the scientific tone for public debate regarding this powerful therapeutic technology. SCNT presents a unique opportunity to study cells with disease-causing mutations and to develop patient-specific therapies. Furthermore, SCNT is the only means by which scientists can accurately identify and study reprogramming factors in the oocyte cytoplasm. Given the enormous potential to understand basic biological processes and to create genetically defined hESC lines with SCNT, The Endocrine Society feels that government funding for research on these lines should be allowed.

The number of hESC lines should be expanded. The Society would also like to take this opportunity to state its view that federal funding should be allowed for the derivation of new hESC lines. We understand that NIH is currently barred from funding derivation of hESC by the Dickey-Wicker amendment, but the Society feels it is important that NIH, as the nation’s major scientific agency, act as a champion for scientific progress and state its support for this potentially life-saving avenue of research. We support a continued ban on reproductive cloning, but this scientifically distinct process must be separated from the derivation of hESC in legislation and public policy. Not only is it critical that scientists be allowed to generate useful and informative cell lines, but by funding their derivation, the government would be able to exert more control over the ethical considerations involved. At this time, private funds are the only allowable source of funding for the derivation of hESC, and the Society feels that the federal government is better equipped to enforce the ethical generation of these cell lines. Once again, we understand the current legal limitations, but we emphasize the need for the scientific community to ensure that the public debate is well informed.

The Endocrine Society looks forward to the expansion of hESC lines eligible for federal funding. We encourage NIH to support all avenues of stem cell research. If you have any questions, or if the Society can be of any assistance moving forward, please contact

 
47286 05/26/2009 at 04:16:43 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

Sincerely,

 
47287 05/26/2009 at 04:17:26 PM Self     We are strongly opposed to tax dollar funding for embryonic stem cell research. The obvious reason we feel this way is because we are strongly opposed to embryonic stem cell research. We can agree that there are many who don't share our belief that the embryo is a living person in the earliest stage of life, however for those of us who do believe this, gov. demanding our hard earned money to fund this research is criminal! Perhaps you should include on all tax forms a box individuals can check as to whether they wish to "donate" to your cause. At least then we would feel as though we have a voice; that as Americans, we actually have the freedom to choose. How can feedom exist in America if we are forced to support something we so strongly and morally oppose?

 
47288 05/26/2009 at 04:17:35 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47289 05/26/2009 at 04:17:36 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.

 
47290 05/26/2009 at 04:18:01 PM Organization American Diabetes Association   May 26, 2009

Dr. Raynard S. Kington Acting Administrator The National Institutes of Health Attention: NIH Stem Cell Guidelines MSC 7997 9000 Rockville Pike Bethesda, MD 20892-9779

Re: Comments of the American Diabetes Association: National Institutes of Health Guidelines for Human Stem Cell Research; EO 13505; FR Doc. E9-9313

Dear Dr. Kington:

The American Diabetes Association (ADA) welcomes the opportunity to respond to the National Institutes of Health (NIH) Guidelines for Human Stem Cell Research. ADA’s mission is to prevent and cure diabetes and improve the lives all people affected by diabetes. Stem cell research holds the promise that the nearly 24 million Americans currently with diabetes, and millions more in the future, can hope for a life without diabetes and its deadly complications.

ADA applauds President Obama’s March 9th Executive Order which ended the blanket ban on federal funding of research using embryonic stem cell lines developed after August 9, 2001 and instructed the NIH to develop guidelines to establish a framework for federal funding of embryonic stem cell research.

Stem cell research offers significant new hope in finding a cure and new treatments for many serious medical conditions, including diabetes, cancer, birth defects, Parkinson’s disease, Alzheimer’s disease, heart disease, stroke, arthritis, spinal cord injury, and burns. Specifically for diabetes 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 by serving as a replenishable source of cells for islet cell transplantation, and could provide a powerful tool for controlling chronic type 2 diabetes.

ADA continues to give the issues surrounding stem cell research careful consideration. Given the enormous promise of stem cells in the development of new therapies for devastating and chronic diseases such as diabetes, the Association believes it is important to pursue various types of promising stem cell research, including research on embryonic stem cells. We also support continued dialogue among scientists, policy makers, ethicists, theologians, and the public to consider issues that emerge with the advancement of stem cell research. There is much to gain by open discussion on the implications of this promising area of research.

Specific Recommendations

ADA strongly supports the draft guidelines, however there are technical corrections that the Association believes should be made to ensure that the final guidelines enable research on promising diabetes therapies and cures. We are concerned that under these guidelines stem cell lines in existence before the effective date of the new guidelines, including those previously eligible for federal funding, will be ineligible for federally-funded research. The ADA urges that current stem cell lines that were derived using prevailing ethical practices at the time be considered for federal funding and, as part of the final rule, urges NIH to be open to review other sources of stem cell lines (excluding reproductive cloning) for future federal funding.

We appreciate NIH’s willingness to consider the Association’s recommendations for stem cell research and stand ready to work with NIH to propose further suggestions and comments in order to accomplish our mutual goals. Should you have questions regarding this comment please contact ***** Sincerely,

 
47291 05/26/2009 at 04:18:08 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.

 
47292 05/26/2009 at 04:18:11 PM Self     This should not allow funding for research using human embryonic stem cells. -As announced in the April 23, 2009 Federal Register Notice.

 
47293 05/26/2009 at 04:18:43 PM Organization University of Washington, Institute for Stem Cell and Regenerative Medicine   University of Washington Institute for Stem Cell and Regenerative Medicine Response to NIH Draft Guidelines for Human Stem Cell Research My name is *****, and I am the ***** for the Institute for Stem Cell and Regenerative Medicine (ISCRM) at the University of Washington in *****. I am writing on behalf of the investigators at ISCRM regarding our thoughts on the proposed guidelines. We wish to express our appreciation of President Obama’s Executive Order 13505, revoking the Presidential Statement of August 9, 2001 and Executive Order 13435 of June 20, 2007 (which supplemented the Aug. 9, 2001 statement). We are pleased that the NIH is taking efforts to expand the number of hESC lines eligible for NIH funding. However, there are several problematic issues in the NIH Draft Guidelines for Human Stem Cell Research, which I will address below. To present some background: Investigators at the Institute are performing research involving the human embryonic stem cell (hESC) lines that were made available under the Bush Presidential Statement of August 9, 2001 (the NIH lines). In addition, we have begun an effort to create new hESC lines using excess embryos from fertility clinics. We have received gift money (non-Federal money) for the latter purpose, and we have an IRB-approved protocol to consent fertility clinic patients seeking to donate their excess embryos produced in the course of undergoing in vitro fertilization procedures. We do not do any active recruiting; potential donors find out about us by word of mouth. We receive phone calls from individuals who have undergone reproductive treatments, who have completed their families, and who now seek to donate their excess embryos to research. The embryos were frozen and have been in storage. To begin, the Institute views the guidance through two lenses, 1) as a user of existing hESC lines and 2) as a developer of new hESC lines. The proposed guidelines pose challenges from both perspectives. Regarding the perspective of a developer of new hESC lines from excess embryos, for the most part, our consent forms are in accordance with the NIH proposed guidelines, the latter of which, like our consent forms, appear to be modeled after the suggestions of the NAS “Guidelines for Human Embryonic Stem Cell Research” (2005, amended in 2007 and 2008). However, that said, there are problematic issues with the NIH proposed guidelines, which we address in detail in Section B, below. We will discuss the perspective as users of existing hESC lines in Section A. A. Perspective as users of existing hESC lines. In this area, we see significant challenges to applying the proposed guidelines, in addition to undue burdens on researchers and their institutions. As users of existing hESC lines, both pre-Aug. 2001, and post-Aug. 2001, we do not have control over the consent form or the consent process implemented for donation of the embryos from which those lines were made. In the guidance, the NIH implies that an investigator applying for NIH funds (and/or possibly an institutional committee), must ensure, and document, that the foundational consents, and the circumstances under which consent was given, are in compliance with the guidelines. We feel that this would place an undue burden on the hESC researchers and also that it would lead to redundancy of effort if every researcher applying for NIH funds would have to determine the adequacy of foundational consent. Two questions come to mind: First, does the NIH hold that the existing lines (pre- and post-Aug. 2001 but prior to the writing of the guidelines) must meet the consent requirements stated in the guidelines, guidelines written after the lines were made and characterized? And, if so, second, could the NIH itself determine the adequacy of foundational consent? Regarding the first question, in terms of grandfathering in previously existing lines, we strongly feel that the pre-August 2001 lines need to remain eligible for NIH funding. An enormous amount of effort and Federal dollars have already been spent on these lines, at our Institute and others, and this investment would be wasted were these lines removed from eligibility. Indeed, the field of human embryonic stem cell research has depended on and will continue to involve the pre-Aug. 9, 2001 hESC lines. Moreover, we would ask that the NIH consider as eligible for NIH funds the lines made and characterized post-Aug. 2001 up until now. Again, an enormous amount of time, effort, and money (private money) have been devoted to characterization of these lines. It would seem unreasonable to require guidelines that were not in existence at the time that the lines were made to be requirements of NIH funding eligibility. The NIH could best leverage tax-payer dollars by allowing eligibility of these lines. We are aware that the NIH is making a push towards translational research. By allowing those lines which already in existence, and well-characterized, to be eligible for NIH funding, translation of laboratory findings to clinical application will be accelerated. Regarding the issue of redundancy of effort, should investigators/their institutions be asked to determine the adequacy of consent forms and processes for existing lines, if the existing lines would have to meet the consent requirements, would it be possible for the NIH to determine which of the lines meet the requirements and make this information publicly available on the NIH website? Perhaps the NIH could develop a “certification” system whereby the NIH determines what existing hESC lines do or do not meet the NIH’s specifications. This would be enormously helpful to researchers and their internal review committees (Embryonic Stem Cell Research Oversight Committees, Institutional Review Boards, and Institutional Animal Care and Use Committees) and would aid in the acceleration of research translation. Finally, we wish to comment on the use of hESC lines that have been made in countries other than the U.S. Because U.S. law has no jurisdiction over research in other countries, we would anticipate that hESC lines from institutions in other countries may not now or ever be “in compliance” with NIH guidelines. Would study of these lines therefore never be eligible for NIH funding? In that research is global, a prohibition of funding of hESC lines from other countries would significantly hamper research progress in the U.S. B. Perspective as developers of new hESC lines The guidelines seek to apply human subjects protection regulations (research principles) to the activity of obtaining embryos for research. While we in principle agree with this approach, and understand the applicability of 45 CFR 46 to the acquisition of human tissue for research purposes, a problem arises in the implementation of that approach. Fertility clinics, in our experience, are staffed by care deliverers who do not do research. Because the mandate of the fertility clinic is, appropriately, to create successful pregnancies, with no intention or plan to create embryos for research, fertility clinics, in their “consent for care” will not necessarily have all of the elements of research informed consent that are required (details are listed below). Additionally, we do not see that the NIH or researchers have jurisdiction over the way patients are consented for care in a fertility clinic. Were the NIH or researchers to get involved in designing the consent process at a clinic, it could be interpreted that the NIH/researchers were directing the clinic to get involved in making embryos for research purposes. We would stipulate that it is outside of the purview of research institutions unaffiliated with fertility clinics, such as our Institute, to dictate to fertility clinics what they say in their consent forms for care. Yet, if we would want to be able to receive excess embryos from a fertility clinic, the guidelines would inherently require us to dictate to the clinic how they consent patients for care. 1) Section II.B.3. - Documentation of fertility clinic policies, and II.B.1. – Consent requirements Keeping this in mind, we note that section II.B.3. of the proposed guidelines states that the source of the embryos for NIH-eligible lines must be fertility clinics with “a policy . . . in place . . . that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s),” and that we, as the recipients of excess embryos for research, must assure that there is documentation that the fertility clinics have that policy. Because their primary goal is helping people achieve successful pregnancies, fertility clinics may or may not have a written policy stating that “refusing to donate embryos for research would not affect the quality of your care.” While informing patients that “refusing to participate in research will not affect the quality of your care” is a standard statement in research consent forms and is familiar to physicians who do research, it may be unfamiliar to providers at fertility clinics, and unknown in fertility clinic consent forms and processes. Moreover, the clinics may not see the necessity of having such a statement because it is not their goal to perform reproductive treatments to create embryos for research, and certainly not their goal to create embryos for research institutions with which they are not associated. When we consent donors for embryo donation, we inform them that, “Your decision whether or not to donate will not affect the treatment you receive at the clinic or at the University of Washington and affiliated institutions.” However, by the time we consent the donors, they have completed their fertility treatments, and may no longer be interacting with the clinic that provided the reproductive services. Not only can we not influence the operations of the fertility clinics, but our research has no impact on the care the donors already received. For similar reasons, consent requirement II.B.1. presents compliance challenges for researchers, stating “all options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donor(s).” As researchers, we have no control or authority over what the fertility clinics tell their patients regarding what the options are for the disposition or use of excess embryos generated and stored at their clinic. In our IRB-approved consent form, we can and do describe to our potential donors what types of research we wish to perform using the embryos, but we cannot describe “all options” that might be available to the donors. All we can tell the donors is: “If you think you may eventually want or need the embryos, you should not donate them. Even if you may not want or need the embryos, you still do not have to donate them to our research. You will not be penalized or lose any benefits to which you are entitled. If you do not donate the excess frozen embryos to our research, the clinic will tell you your other options. This may include discarding the embryos.” Again, we cannot present to the donors all of the options for disposition of the embryos. We are not in the position to do anything with embryos that are not under our domain. Once potential donors contact us, it may have been quite some time since they underwent consent for fertility treatments, underwent the treatments, and had excess embryos stored. Under the suggested guidelines, it is possible that we can go through an entire consenting process to receive embryos, using our IRB-approved consent form, at the end of which we would learn that we cannot use the embryos for research. This is because, as members of a research institution, we have minimal interactions with potential donors’ fertility clinics other than to contact the clinics after the donors have consented to donate their embryos to us. We do not ask fertility clinics to show us their consent forms and policies before we have consented the potential donors, and this would only seem appropriate. Our procedures are that we contact the fertility clinic to arrange embryo transfer to us after we have administered informed consent to the donors, after the donors have no further questions, and after the donors have signed the clinic’s form (typically, a notarized form required by the clinic) to allow the release of the embryos to us. The suggested guideline would require us to ask the clinic for documentation of the fertility clinic’s policies (that the decision to donate or not has no affect on the quality of care, and that all options for pertaining to use of the embryos have been explained) after the consenting and notarization for the embryo release has already taken place. If the donors were never “informed” of these policies (e.g., in writing), according to the proposed guideline, they would not be able to donate their embryos and we would not be able to receive them, despite having gone through an IRB-approved process at our institution. Thus, we find II.B.1 and II.B.3. to be unworkable, if these are requirements of what the fertility clinic tells their patients. We do not think these requirements should be in the NIH guidelines. As a research institution, we can generically explain to our potential donors that they “have options” with regard to what they decide to do with their excess embryos, although we do not know exactly what the options are in their clinics or in their communities. Likewise, we can tell our potential donors that we would not give them worse care if they do not donate; however, we are not in fact giving them care. In reality, we have no influence over what a fertility clinic does or does not tell their patients. In addition, it is an undue burden on our investigators and our institution to request “consent for care” consent forms and policy documents from every fertility clinic from which our donors received treatment. We believe this would be an unwelcome burden to fertility clinics, as well, whose focus is on creating successful pregnancies. 2) Section II.B.5. - Timing of right to withdraw consent Section II.B.5. of the proposed guidelines states that donors should be informed that they “retain the right to withdraw consent until the embryos were actually used for research.” Our preference would be that the donors retain the right to withdraw consent until the embryos are transferred to the research facility. There are several reasons for this, one having to do with the way we (and perhaps other research institutions) store the embryos, and the other having to do with the substantial lag time between the first donation discussion with the potential donors and our receipt of the embryos (allowing plenty of time to withdraw consent). First, we have set up our facility such that the embryos do not retain links to identifying information about donors. Embryos are stripped of names and clinic numbers and are re-numbered shortly after entering our facility. No link to names or original numbers is kept, so that the embryos become anonymized. We do this to protect the confidentiality of the donors. The proposed NIH guidelines would require that we maintain the link until such time that we begin the research on the embryos. This may not happen until some months after we receive the embryos; it is hard to predict when research will start. We believe that donor confidentiality is better protected if we are able to anonymize the embryos and are not required to maintain the link. Our IRB has approved this procedure. Second, we wish to point out that there is a considerable delay (generally weeks or months) between the time that a potential donor first contacts us (usually by telephone) and the time when we pick up or are sent the embryos from the clinic. This is because it takes considerable time to get all concerned parties together to administer informed consent, more time for the donors to get the clinic-required forms signed and notarized, and more time for the clinics to find the time to send us or arrange for us to pick up the embryos. Anytime during this period of weeks or months the potential donors have time to change their minds about donating and may withdraw consent. 3) Section II.B.7. - Consent form requirements We find the following consent form required statement to be awkward: f) “A statement that the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefit from the use of the stem cells.” We understand the intent of this statement. However, this statement presupposes that the embryo will be successfully turned into an embryonic stem cell line and that the hESC line will be used clinically, and that the clinical use may be (or even will be) successful. Not only is this statement awkward and misleading, but it is also overly optimistic. We would suggest that the NIH not require such a statement. The corollary statement that we have in our IRB-approved consent form, under “Benefits,” reads as follows: You will not personally benefit from this research. However, society may benefit. Human embryonic stem cell research may provide significant new knowledge that could benefit human health. In addition, human embryonic stem cells have the ability to develop into any cell type. For this reason, they may someday be used to develop therapies for serious diseases such as Alzheimer’s Disease, Parkinson’s Disease, and diabetes, among many others. In these diseases the patient’s cells are not working properly and it is thought that human embryonic stem cells or products from human embryonic stem cells could possibly cure the illness.” Section i. requires, “A statement that the results of research using the human embryonic stem cells may have commercial potential, and a statement that the donor(s) would not receive financial or any other benefits from any such commercial development.” Our IRB has informed us that, because a consent form is not allowed to appear to “waive rights,” the appropriate way to state this would be, “Research using your donated embryos may lead to the development of commercial products. There are no plans to provide compensation to you should this occur.” The latter statement was approved by our IRB. 4) General question - Legal donors vs. biological donors Our research institution has been contacted by several potential donors whose embryos were created using donated sperm. Although the fertility clinics with which we are familiar consider the couples who use donated gametes for production of embryos to be the “legal guardians” of the resulting embryos, we have been uncertain as to whether it is appropriate to accept such embryos for research. We have therefore accepted embryos only when the biological oocyte and biological sperm donor are known and willing and able to give informed consent. The draft guidelines do not address this issue. Are embryonic stem cell lines made from IVF excess embryos (for which one of the gamete donors is unknown) eligible for NIH funding? 5) Section IV.A. Prohibition on NIH funding of the derivation of stem cells from human embryos We understand that the destruction of human embryos is prohibited by the annual appropriations ban on funding of human embryo research, known as the Dickey-Wicker Amendment, and we understand that it is outside the purview of the NIH to overturn that Amendment. While we do have private funds that allow for hESC line derivation experiments (and therefore embryo destruction), it is our hope that the Dickey-Wicker amendment will eventually be overturned/not reauthorized. We are struck by the inherent ethical contradiction of refusing to fund research that would cause embryo destruction, but agreeing to fund research that uses cell lines created as a result of embryo destruction. Moreover, the prohibition on Federal funding of the derivation of stem cells from human embryos hinders the very research process that the NIH wishes to promote, and delays the translation of basic laboratory results to clinical investigation and clinical application. During our consent process with embryo donors, several of our donors have specifically asked us to confirm that their embryos would not be used to create a pregnancy. In our consent form and in our informed consent process, we inform the donors that stem cells will be derived from their embryos, and that the embryos will therefore be destroyed in the process of our research. Our donors want the embryos to be used for research, are informed that the embryos will be destroyed, and with full informed consent give permission for their embryos to meet this fate. That the Dickey-Wicker Amendment prohibits Federal funding of this necessary step – embryo destruction - for the creation of fundable NIH hESC lines, and that we have obtained full informed consent from the embryo donors themselves to perform this necessary step, is regulatorily and ethically inconsistent and illogical. 6) Conclusions on perspective as developers of new hESC lines The system for embryo donation used at the University of Washington Institute for Stem Cell and Regenerative Medicine (ISCRM) Given all these comments, we wish to assert our belief that the system we at the University of Washington ISCRM have set up to obtain embryos for research purposes provides the best protection for potential donors: Donors who have received treatment at fertility clinics, solely to establish successful pregnancies, approach our research institution of their own free will, after they feel their families are completed. We do not approach or advertise for embryo donors; they hear about us by word of mouth. Donors make their decision to donate excess embryos completely separately, in time, from their decision to undergo fertility treatments. The informed consent process to donate embryos is completely separate from the informed consent process to receive reproductive care: the two consent processes are conducted with different forms by unrelated entities (the fertility clinic using a “consent for care” consent form, and our research institution using a research consent form). No payment or reimbursements are made to donors. We have an IRB-approved protocol to receive embryo donations, and an IRB-approved consent form, which complies with 45 CFR 46, with which to consent donors. Finally, our local Embryonic Stem Cell Research Oversight (ESCRO) Committee has reviewed the research that is to be conducted with the donated embryos. Thus, in our view, the rights of our donors are preserved on all levels, and our research meets the highest ethical standards. C. Perspectives as both users of hESC lines and developers of hESC lines 1) Section II.C. - Documentation requirements As indicated above, we are concerned about the documentation responsibilities required of NIH funding recipients. To ensure that “the human embryonic stem cells were derived consistent with sections II.A. and B. of these Guidelines,” in order to receive NIH funds, recipients of hESC lines must obtain copies of the consent forms used, and copies of the documentation of the fertility clinic policies in force, when the embryos from which the human embryonic stem cell lines were obtained. Again, this is problematic for many reasons. First, researchers and research institutions have no purview over fertility clinics. Second, the documentation requirement presents an undue paperwork and regulatory burden on recipient investigators. Third, the requirement to scrutinize and review the original consent forms could trigger the requirement for Institutional Review Board review of research otherwise considered not under the jurisdiction of 45 CFR 46 (e.g., laboratory work with hESC lines in vitro or in animal models). Finally, should the consent forms and fertility clinic documentation be unavailable or not in compliance with the guidelines, drastically fewer of the hESC lines that have been created and characterized in the last few years will be eligible for Federal funds, representing an enormous waste of potential, effort, time, and money. We would like to reiterate our suggestion that the NIH determine what existing lines are eligible for NIH funding, provide certification to attest to that fact, and create a database of acceptable lines. (And again, we ask that the pre-August 9, 2001 lines remain eligible, and that the problematic consent requirements discussed above be removed.) Absent NIH’s determination, the creators of each of the hESC lines should consider providing, to recipient investigators/their ESCRO committees (if they have one), the necessary documentation to attest to the provenance and full eligibility of their lines. It is beyond the range of reasonable responsibilities to ask recipient investigators to document eligibility of the lines for which they wish to receive NIH funding. In conclusion, together with the investigators at the University of Washington Institute for Stem Cell and Regenerative Medicine, I wish to express our appreciation for this opportunity to comment on the draft guidelines. Thank you for your consideration. Sincerely,

 
47294 05/26/2009 at 04:18:46 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.

 
47295 05/26/2009 at 04:19:31 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47296 05/26/2009 at 04:19:36 PM Self     No federal funding of destructive embryonic stem-cell research. The only successful treatments and cures come from adult stem cells, taken from bone marrow, umbilical cord blood, fat tissue and other body tissues.

 
47297 05/26/2009 at 04:19:50 PM Self     I am against Pres Obama's unretricted use of embryonic tissue for reseach when adult stem cells hold more promise.

 
47298 05/26/2009 at 04:20:04 PM Self     Comment On March 9, 2009, President Barack Obama signed Executive Order 13505 “Removing barriers to responsible scientific research involving human stem cells” (“Executive Order”). The Executive Order set forth important policies regarding the use of human embryonic stem cells and their potential to better understand and treat diseases. The order recognizes that, during the past eight years, the authority of the Department of Health and Human Services, including the NIH, to fund and conduct human embryonic stem cell research was limited by Presidential actions. The purpose of the Executive Order is to remove these limitations on scientific inquiry, to expand NIH support for stem cell research, and in so doing to enhance American contributions to new discoveries and therapies for the benefit of the entire world. These goals of the Executive Order are laudatory. WiCell applauds President Obama for his leadership on research involving human stem cells and is heartened by the lifting of restrictions on federal funding for promising and responsible stem cell research. In remarks made upon the signing of the Executive Order, President Obama promised to deliver the change that so many have worked for during the last eight years: “we will vigorously support scientists who pursue this research. And we will aim for America to lead the world in the discoveries it one day may yield." The Executive Order assigned NIH the responsibility for the draft Guidelines that are the subject of this Request for Comments. The expectation was that the Guidelines would permit funding of research on additional human embryonic stem (hES) cell lines beyond those currently approved for NIH funding (stemcells.nih.gov/research/registry/available.asp). However, our analysis indicates that instead of effectuating the President’s vision of allowing (and indeed encouraging) federal funding for research on hES cells, the draft Guidelines would have the consequence of thwarting the President’s promises by making currently approved hES cell lines and hundreds of existing but currently un-approved hES cell lines ineligible for NIH funding. These existing hES cell lines would be ineligible for NIH funding because the draft Guidelines are more restrictive than eligibility criteria that met ethical standards that were in place at the time these cell lines were created. The consequence of adopting the draft Guidelines would be to limit hES cell research funding to unidentified existing cell lines and future cell lines that meet the new eligibility criteria. We contend that this would have a significant negative impact on hES cell research in the U.S. and potentially world-wide. We recommend that the NIH establish policies that would permit NIH funding for hES cell lines that met ethical standards that existed at the time they were created. hES cell lines that met accepted standards at the time they were produced include most of the cell lines on the NIH Stem Cell Registry (http://stemcells.nih.gov/research/registry/). These NIH-approved hES cell lines have been widely distributed and serve as reference cell lines for the hES cell research community. As of March 31, 2009, the NIH’s National Stem Cell Bank (www.nationalstemcellbank.org) alone has filled 964 orders for these cell lines to over 460 labs around the world. Moreover, the majority of publications that report results from hES cell line experiments were based on the use one or more of the NIH-approved cell lines. Indeed, these NIH-approved hES cell lines are represented in three quarters of all publications listed in the University of Massachusetts International Stem Cell Registry (www.umassmed.edu/iscr/index.aspx). These hES cell lines have been utilized in many international collaborative research projects including those organized by the International Stem Cell Initiative (www.stemcellforum.org/isci_project.cfm). As we move forward in deriving new hES cell lines that meet the new guidelines, it will be critical to maintain well-characterized reference hES cell lines so that the behavior of the new cell lines can be better understood and compared to past research results. The goal of the new guidelines should be to promote responsible human embryonic stem (hES) cell research, not to hinder it. Therefore the guidelines should set out criteria that are easy to implement and follow. We believe that the new guidelines should be prospective to ensure that new hES cell lines adhere to ethical guidelines such as those promoted by the International Society for Stem Cell Research (ISSCR) (“Guidelines for the Conduct of Human Embryonic Stem Cell Research”, www.isscr.org/guidelines/) or the National Academy of Sciences (“Guidelines for Human Embryonic Stem Cell Research” (dels.nas.edu/bls/stemcells/guidelines.shtml). However, we do not believe that every provision of the guidelines should be applied retrospectively to earlier, extensively studied, hES cell lines that met ethical guidelines that existed at the time they were produced. Existing hES cell lines represent a wealth of genetic diversity that cannot be replicated quickly or easily. Ending funding for these cell lines and waiting until new lines are derived in accordance with new NIH guidelines will slow the field, to the detriment of the people waiting for new diagnostics, faster ways to test new drugs, and the development of new regenerative therapies. Indeed, existing NIH-approved hES cells lines are currently being used in a clinical trial (http://www.washingtonpost.com/wp-dyn/content/story/2009/01/26/ST2009012601250.html)and to test drug efficacy and toxicity (http://wistechnology.com/articles/5276/). Hence, we strongly recommend that the NIH guidelines reflect the extraordinary human value of existing hES cells lines that were produced under then-existent ethical guidelines. Instead of using the draft Guidelines to establish eligibility criteria for the funding of hES cell research, we recommend that the NIH place the donation of materials for hES cell research within the framework of the Common Rule and the Institutional Review Board (IRB) system (www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm), which provide a sensible, well-developed regulatory system for the protection of human donors of tissue. The Common Rule supports ethically responsible and scientifically worthy research by: (1) Requiring independent oversight such as through IRBs which have extensive experience reviewing informed consent in the context of human tissue research; (2) Ensuring a process for voluntary informed consent including the review of consent procedures performed outside the United States; and (3) Requiring no undue inducements to donors. Additional eligibility criteria not covered by the Common Rule that are unique to the use of donated embryos for hES cell line derivation could be appended to the IRB approval process. Institutions represented by an IRB would provide an assurance that the hES cell lines conform to the Common Rule and any additional policies specific to hES cells. In summary, the NIH should abandon efforts 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 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. 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.

 
47299 05/26/2009 at 04:20:07 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47300 05/26/2009 at 04:20:21 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, ESPECIALLY CONSIDERING THAT SUCH RESEARCH IS CONSIDERED UNNECESSARY BY THE SCIENTIFIC COMMUNITY. EMBRYONIC STEM CELLS HAVE NEVER BEEN AS STABLE OR USEFUL FOR RESEARCH AS NON-EMBRYONIC CELLS. Nonetheless, taking the life of a person for research should never be endorsed by law. 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.

 
47301 05/26/2009 at 04:21:42 PM Organization Association of American Universities   May 26, 2009

Attn: NIH Stem Cell Guidelines MSC 7997 9000 Rockville Pike Bethesda, MD 20892-7997

Dear Sir or Madam:

The Association of American Universities (AAU) comprises 60 leading U.S. research universities which together perform approximately 60 percent of the extramural research funded by the National Institutes of Health (NIH). I write to offer AAU’s views on the Draft National Institutes of Health Guidelines for Human Stem Cell Research of April 23, 2009.

The President’s Executive Order of March 9, 2009, which lifted the constraints on NIH funding for human stem cell research (hESC) established in 2001, was an inspirational moment for the biomedical research enterprise, the scientists who will pursue this promising research and, most importantly, for the patients and their families who will see its therapeutic benefits. We commend NIH for its swift issuance of draft guidelines to implement the Executive Order. Our faculty and institutions are anxious to begin new hESC research and the President’s Executive Order and NIH’s prompt action will enable them to pursue scientific advances this year.

Although we are supportive of the Executive Order and NIH’s proposed guidelines, and look forward to working with the Administration in implementing them, we do have three major and several minor concerns with what has been proposed.

Three Major Concerns:

1. AAU’s first major concern is that the proposed guidelines, as drafted, may render the hESC lines that are currently being used in NIH-supported research ineligible for future federal funding. Such lines, which were derived before August 9, 2001 and used in subsequent research according to NIH guidelines, may not meet newly proposed standards for consent, consent that, given the passage of time and the elimination of any identifiers for such cells, may now be impossible to acquire. Similarly, stem cell lines derived after August 9, 2001 and according to guidelines of the NIH, the National Academies or the International Society for Stem Cell Research, should also be made eligible for federally supported research.

Not only would rendering these cell lines ineligible for NIH-funded research undermine the purpose of the President’s March 9, 2009 Executive Order, but the disruption—and indeed waste—of years of past and ongoing scientific research is unthinkable. The four principles that have governed hESC research for the past eight years remain valid and require that:

• the stem cells must have been derived from an embryo that was created for reproductive purposes; • the embryo was no longer needed for these purposes; • informed consent must have been obtained for the donation of the embryo; and • no financial inducements were provided for donation of the embryo.

We submit that the eligibility standards for stem cell lines of the past eight years are adequate for their continued use, and should not be subject to regulation, approval and consent processes created de novo. Stem cell lines currently eligible for NIH funding, those derived after August 9, 2001 and up until the effective date of the proposed April 23, 2009 stem cell research guidelines, and according to the principles listed above, must be eligible for NIH funding.

2. Secondly, the limitation of federally funded research to hESCs derived from surplus in vitro fertilization (IVF) embryos is unnecessarily narrow, and is neither scientifically, ethically nor legally justified. AAU joins with the patient advocacy and scientific communities in expressing disappointment that hESC lines derived from somatic cell nuclear transfer (SCNT), parthenogenesis and IVF embryos created for research purposes are excluded from NIH funded research.

To be sure, there is great scientific and therapeutic promise in hESC research using stem cell lines derived from surplus IVF embryos. The scientific opportunities in developmental biology; new understandings of the interplay of genetics and the environment in human development and disease genesis and progression; and, ultimately, the possibility that hESC research will lead to therapies in which diseased organs and tissues can be targeted or replaced by tissues derived from stem cells, have made this research among the most exciting and promising lines of scientific inquiry at the dawn of this new century.

However, the shortest path to all of the promise of stem cell research is through stem cell lines derived by SCNT from living patients. Such tissues will be an exact genetic match for the patient and therefore, prevent immune rejection of transplanted tissue or the need for immunosuppressive drugs that cause further stress to patients and leave them vulnerable to other infections and side effects. As the National Academies explains in the 2001 report, Stem Cells and the Future of Regenerative Medicine:

A substantial obstacle to the success of transplantation of any cells, including stem cells and their derivatives, is the immune-mediated rejection of foreign tissue by the recipient’s body. In current stem cell transplantation procedures with bone marrow and blood, success can hinge on obtaining a close match between donor and recipient tissues and on the use of immunosuppressive drugs, which often have severe and life-threatening side effects. To ensure that stem cell-based therapies can be broadly applicable for many conditions and individuals, new means to overcome the problem of tissue rejection must be found. Although ethically controversial, somatic cell nuclear transfer, a technique that produces a lineage of stem cells that are genetically identical to the donor, promises such an advantage. Other options for this purpose include genetic manipulation of the stem cells and the development of a very large bank of embryonic stem cell lines. In conjunction with research on stem cell biology and the development of stem cell therapies, research on approaches that prevent immune rejection of stem cells and stem cell-derived tissues should be actively pursued.

However promising stem cell lines from surplus IVF embryos may be, the scientific and therapeutic promise of cell lines from SCNT, parthenogenesis and IVR embryos created for research purposes is far greater. NIH and federally supported scientists must be able to work with stem cell lines that have been derived from sources other than IVF embryos, lines in which the genomes of such cell lines can be selected or, as appropriate and ethical, designed. The greatest scientific opportunity arises from the ability of scientists to work with stem cell lines that can model the earliest stages of human development and disease development and progression. As was explained in the 2002 National Academies report Scientific and Medical Aspects of Human Reproductive Cloning:

In addition to possible uses in therapeutic transplantation, embryonic stem cells and cell lines derived by nuclear transplantation could be valuable tools for both fundamental and applied medical and biological research. This research would begin with the transfer of genetically defined donor nuclei from normal and diseased tissues. The resulting cell lines could be used to study how inherited and acquired alterations of genetic components might contribute to disease processes. The properties of the cell lines could be studied directly, or the embryonic stem cells could be studied as they differentiate into other cell types. For example, the way in which cells derived by nuclear transplantation from an Alzheimer’s disease patient acted while differentiating into brain cells, compared with those derived from a normal patient, might yield new clues about Alzheimer’s disease. Such cell lines could also be used to ensure that research covers a more genetically diverse human population than that represented in the blastocysts stored in IVF clinics, promoting studies of the causes and consequences of genetic diseases by allowing researchers to study how embryonic stem cells with different genetic endowments differ in the way that they form cell types and tissues. Finally, studies of genetic reprogramming and genetic imprinting will be substantially enhanced through the use of stem cells derived by nuclear transplantation, compared with studies with stem cells derived from other sources. AAU’s member presidents and chancellors have long been committed to the derivation of stem cells through SCNT, as the AAU Statement on Human Cloning, adopted by the AAU Membership on April 23, 2002 attests:

AAU therefore supports nuclear transplantation to produce stem cells, also known as somatic cell nuclear transfer, as nonreproductive cloning, and as therapeutic cloning. AAU concurs with the NAS that nuclear transplantation to produce stem cells has considerable potential for advancing our fundamental knowledge and developing new medical therapies to treat debilitating diseases. Continuing the investigation of stem cells produced by nuclear transplantation is the only way to assure that the value of this nascent technology is realized. Before applications to humans should be considered, we need further study of cells derived from the process of nuclear transplantation, subject to federal safeguards.

AAU understands that NIH-funded scientists must adhere to the legal limitations imposed by the Dickey Wicker Amendment, prohibiting federal funding for any research in which a human embryo is created or destroyed for such research. But, the draft guidelines put the situation best: “Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos.”

Although SCNT is only a theoretical possibility at this point, the technical barriers to its successful use are falling away rapidly, and it will likely become widely available—and used in the private sector and in privately-supported research—in coming months or years. Furthermore, as SCNT is one of only three methods of deriving stem cells, along with derivation from IVF embryos and derivation using iPSC, it would be unwise to exclude this method from those available to the scientific community for research of benefit to human health. This work can be done in full compliance with ethical and legal considerations. If we are to realize the full therapeutic and scientific potential of human embryonic stem cell research, cell lines derived by SCNT and other methods must be eligible for federal funding.

3. AAU’s final major concern is that the use and sharing of approved cell lines might be hindered by omissions or a lack of clarity in the draft guidelines about eligibility standards, and how and under what terms such research use and sharing occurs. NIH’s intent to require institutional assurances that cell lines have been derived according to the guidelines is the correct approach. Institutions have an obligation to implement policies according to the guidelines and maintain the appropriate documentation to demonstrate compliance. Institutions will likely address these requirements by negotiating standard materials transfer agreements that include the documentation and consents upon which such assurances are based.

The necessity of assurances that cell lines have been derived and transmitted according to regulation provides yet another argument for NIH to continue to maintain the existing stem cell registry. Such a registry would assist institutions in meeting the guidelines and streamline the identification and certification of approved cell lines.

NIH has not mandated that IRBs review hESC lines and should not mandate such review going forward. At present, IRBs are required only to review those studies involving research in which cell lines are derived, or in which cell lines are used in humans or if the cells’ donors can be identified, but not studies that only involve the use of cell lines in vitro or in animals. We think it is entirely appropriate to require and rely on IRB review when human participants are involved as recipients of treatment or can be identified as cell donors. We do not feel that additional review should be required. The proposed guidelines do not mandate IRB review for any non-human subject research, but they do impose more stringent restrictions regarding informed consent than those required by the Common Rule. We believe that the consent form requirements in the Common Rule (45 CFR 46) are sufficient. As in other types of research using human tissues, continued IRB review is necessary only in cases where cell lines have identifiable information.

NIH should rely upon existing methods, such as standardized material transfer agreements and institutional assurances, to govern the exchange of stem cell lines. IRB review of such lines should not be mandated, except as called for under existing regulation.

Additional, secondary concerns:

• The title of the regulation should be modified to say that the guidelines govern federal funding for human stem cell research.

• The Administration is urged to ensure that standards governing federal support for stem cell research are applied government-wide, not just at NIH.

• Regarding IVF embryo donor consent, it is only proper that donors retain the right to withdraw an embryo up until the moment the research begins. Similarly, such a right to withdraw should be retained up to the moment that the tissue is anonymized for research purposes.

• As stated in the Executive Order and in the draft guidelines, and given the great promise and the potential for rapid progress offered by stem cells, NIH should review the stem cell research guidelines on a regular basis. At a minimum, NIH should state when the next review of these guidelines will occur.

In conclusion, and notwithstanding the concerns raised above, AAU supports the guidelines and looks forward to working with NIH and the Administration in implementing them. The draft guidelines will, in the words of the President’s Executive Order “expand NIH support for the exploration of human stem cell research, and in so doing . . . enhance the contribution of America’s scientists to important new discoveries and new therapies for the benefit of humankind.”

Sincerely,

 
47302 05/26/2009 at 04:22:00 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.

 
47303 05/26/2009 at 04:22:29 PM Self University Health Network   Dear NIH:

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

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

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

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

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

 
47304 05/26/2009 at 04:22:41 PM Self     I AM OPPOSED TO THE DRAFT NIH HUMAN STEM CELL GUIDELINES AS WRITTEN WHICH APPROVE THE USE OF EMBRYONIC STEM CELLS. SUCH USE IN RESEARCH IS BOTH UNWARRANTED (SINCE HUMAN STEM CELL RESEARCH HAS ALREADY BEEN PROVEN SUCCESSFUL), AND, UNNECESSARY IN THAT IT WILL RESULT IN THE FUNDING, AT TAXPAYER'S EXPENSE, OF THE SAME KIND OF CORPORATE INEPTITUDE AND/OR GREED WHICH HAS LED TO THE CURRENT ECONOMIC CRISIS.

SCIENTISTS OF INTEGRITY READILY ACKNOWLEDGE THAT RESEARCH USING HUMAN STEM CELLS OFERS MORE AND BETTER POTENTIAL BENEFITS FOR MANKIND THAN CAN BE REASONABLY FORESEEN IN THE USE OF EMBRYONIC STEM CELLS WHICH ARE OBTAINABLE ONLY BY DESTROYING A HUMAN LIFE.

AS A CITIZEN AND TAXPAYER I AM ALSO CONCERNED THAT THE DRAFT REGULATIONS FAIL TO EXPLICITLY BAN THE USE OF STEM CELLS FOR THE CLONING OF ANY KIND. IN ACTUALITY, THE PROPOSED REGULATIONS - - BECAUSE OF THE ABSENCE OF SUCH A BAN - - MAY BE DEEMED TO IMPLICITLY AUTHORIZE SUCH CLONING AS WELL AS THE CREATION OF A HUMAN-ANIMAL HYBRID. SUCH RESEARCH AND USAGE WOULD BE ABHORRENT TO MOST, IF NOT ALL, RATIONAL PERSONS.

 
47305 05/26/2009 at 04:22:50 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.

 
47306 05/26/2009 at 04:22:58 PM Self     There is no logical or scientific reason for the killing of embryos. Absolutely no cure or treatment has proved to work yet adult stem cells are currently able to treat a multitude of diseases. Why can't the government put funding into collecting valuable stem cells from newborn babies? This option is very viable yet hardly discussed. Last fall I tried to get a collection agency to receive my newborn daughter's blood. However, my doctor was not aware of the amount of blood needed and the blood volume fell short of acceptable. If there were trained collectors at hospitals, lots of stem cells would be available for many person's with diseases such as sickle-cell anemia and leukemia.

 
47307 05/26/2009 at 04:23:38 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.

 
47308 05/26/2009 at 04:24:04 PM Self     Your guidelines regulating the donation of embryos for stem-cell research seem thorough and ethical to this admittedly inexperienced supporter.

 
47309 05/26/2009 at 04:24:24 PM Self     I am living with Parkinson's Disease and I feel strongly that embryonic stem cell research holds great promise for me and for millions of Americans suffering from many diseases and disorders. I am a physician 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 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. We must explore all stem cell options with urgency. 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.

 
47310 05/26/2009 at 04:24:48 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47311 05/26/2009 at 04:24:51 PM Self     move forward with Federally funded stem cell research. This Let us hahttp://edocket.access.gpo.gov/2009/E9-9313.htms been postponed long enoell research will provide the answers by fanaticals who are thwarting the progress of modern science due to religious ideology. Thousands need treatment which can restore quality of life and there is every indication that Stem cell research can provide the answerhttp://edocket.access.gpo.gov/2009/E9-9313.htms.

 
47312 05/26/2009 at 04:24:53 PM Self     I oppose all funding of human embryonic stem-cell research.

 
47313 05/26/2009 at 04:25:27 PM Self     NIH Stem Cell Guidelines, MSC 7997 9000 Rockville Pike Bethesda, MD 20892

Dear Dr. Kington and Stem Cell Guidelines Committee:

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

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

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

Yours truly,

 
47314 05/26/2009 at 04:25:42 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 



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