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

Browse Comments Beginning With:
Record ID:
Entry Date:
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.



|First 100 Records   Back 1000 Records   Back 100 Records   Records 47115 - 47214 of 49015 Forward 100 Records   Forward 1000 Records   Last 100 Records|

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

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

 
47116 05/26/2009 at 03:12:45 PM Self     -I am opposed to your draft guidelines for embryonic stem cell research, which force me as a taxpayer to subsidize research requiring the destruction of innocent human life. Support should be directed to stem cell research and treatments that do not destroy human life and are already proven successful. There is no case under which government support should be extended to human cloning or the creation of human embryos for research purposes.

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

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

For Life,

 
47117 05/26/2009 at 03:12:53 PM Self     I support the position of the California Institute for Regenerative Medicine (CIRM) to improve the new federal stem cell research funding guidelines.

 
47118 05/26/2009 at 03:13:00 PM Self     Dear Ma’am/Sir,

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

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

Very sincerely and respectfully

 
47119 05/26/2009 at 03:13:24 PM Self     No human embryos should be used for experimental purposes whether or not they are "destined" for disposal. The promise for cures lies in using ethical adult stem cells which does not destroy life. Human life deserves our respect from the very beginning at the union of sperm and egg.

 
47120 05/26/2009 at 03:13:31 PM Self     I am opposed to embryonic stem cell research. This is an immoral act of science and it is well known that there are more humane ways to go about this.

 
47121 05/26/2009 at 03:13:49 PM Self     I oppose human stem cell research. It is immoral. It is wrong to use tax money to fund this endeavor.

 
47122 05/26/2009 at 03:13:51 PM Self     As described in these draft Guidelines, human embryonic stem cells are cells that are derived from human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos. Studies of human embryonic stem cells may yield information about the complex events that occur during human development. Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation. A better understanding of the genetic and molecular controls of these processes could provide information about how such diseases arise and suggest new strategies for therapy. Human embryonic stem cells may also be used to test new drugs. For example, new medications could be tested for safety on differentiated somatic cells generated from human embryonic stem cells. Perhaps the most important potential use of human embryonic stem cells is the generation of cells and tissues that could be used for cell-based therapies. Today, donated tissues and organs are often used to replace ailing or destroyed tissue, but the need for transplantable tissues and organs far outweighs the available supply. Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases and conditions, including Parkinson's disease, amyotrophic lateral sclerosis, spinal cord injury, burns, heart disease, diabetes, and arthritis.

 
47123 05/26/2009 at 03:13:54 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47124 05/26/2009 at 03:13:54 PM Self     The NIH Human Stem Cell Guidelines must respect the dignity of all human life and actively and aggressively uphold a consistent ethic of life. If they do not present and adhere to a consistent ethic of life (that is to say, a definition of what a human being is that is consistent across all scientific and social fields) they will lead the NIH into much confusion and hypocrisy, trying to improve life by taking life, for instance.

In societies around the world and throughout history, certain groups have been excluded from basic human and civil rights, or deemed to be less than full human beings, most often for the exploitative benefit of those in power.

If America did not claim to be the Land of the Free, the NIH would not have as difficult a job as it does drafting human stem cell guidelines.

However, if America truly is a free country, the first and only one of its kind, that liberates the powerless and frees the captives, that takes in the poor, tired, and huddled masses yearning to breathe free, then it cannot follow this pattern of exclusion and exploitation. It is Un-American at best and treacherous at worst.

 
47125 05/26/2009 at 03:13:57 PM Self     I fully support federal funding for stem cell research. I would like to see the guidelines expanded to provide funding for all existing stem cell lines, grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease.

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

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

Thank you,

 
47126 05/26/2009 at 03:14:06 PM Self     Please do not support government-funded stem cell research. If stem-cell research is so promising, than the private sector would be all over funding it themselves. Also, if we start allowing the government to get in the role of destroying human embryos, where will the line be drawn? What about human cloning? or making a genetically-perfect man made and selected embryo. Let nature do its job, and you do yours. A government's job is to keep the people safe.

On a side note, we have enough debt as it is. Please do not add to our gigantic debt by adding another tax-funded program that isn't even that promising in the first place.

 
47127 05/26/2009 at 03:14:13 PM Self     I oppose all research involving the manipulation and/or destruction of human embryos outside of the wombs of their mothers. I am pleased that the proposed guidelines prohibit somatic cell nuclear transfer, parthenogenesis, and the creation of embryos for research purposes. However, informed consent for the donation of "leftover" IVF embryos does not make the destruction of those embryos ethical. We would never allow for parents to consent to "donate" a 3-month-old child for a research experiment that would not benefit the child in any way and that would assuredly lead to his or her death. Likewise, we should only be horrified that parents, who have been adequately informed, would consent to their embryonic children being dissociated and used as mere biological matter. If this research were so valuable, there would be adequate private funds supporting it and federal funds would not be needed. Please stop using my taxes to support this research."

 
47128 05/26/2009 at 03:14:24 PM Self     I fully support federal funding for stem cell research. I would like to see the guidelines expanded to provide funding for all existing stem cell lines, grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease.

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

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

Thank you,

 
47129 05/26/2009 at 03:14:49 PM Organization The University of Pittsburgh   May 26, 2009

Via Email and Overnight Mail

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

Re: Comments on Draft NIH Human Stem Cell Guidelines

Dear Mr. Kington:

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

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

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

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

Sincerely yours,

 
47130 05/26/2009 at 03:14:52 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.

 
47131 05/26/2009 at 03:14:54 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.

 
47132 05/26/2009 at 03:15:04 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

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

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

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

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

 
47133 05/26/2009 at 03:15:17 PM Self     I am writing to oppose more federal funds for human embryonic stem cell experiments, which will delay cures for Americans by diverting dollars away from real treatments - ADULT stem cell treatments. Many lives have been helped & saved using adult stem cells and NONE have been helped or saved using embryonic stem cells. Every dollar going to fund embryonic stem cell experimentation delay's adult stem cell treatments & cures. Please devote our tax dollars to experiments that work and produce results (adult stem cells) and NOT to experiments that do not (embryonic stem cells). Thank You.

 
47134 05/26/2009 at 03:15:18 PM Self     There are three reasons that I support the California Institute for Regenerative Medicine’s position on the new stem cell guidelines.

1. 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.

2. 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. Let's find a cure and stop squabbling!

3. Everyone deserves the best medical care science can provide. We have a right to recover.

 
47135 05/26/2009 at 03:15:20 PM Organization Arthritis Foundation   The Arthritis Foundation appreciates the opportunity to submit comments on the National Institutes of Health (NIH) draft Guidelines for Human Stem Cell Research as published in the Federal Register on March 9, 2009.

The Arthritis Foundation supports human embryonic stem cell research to potentially alleviate human suffering, particularly as it relates to arthritis and related diseases. The Arthritis Foundation commends President Obama’s Executive Order 13505 to support ethically responsible and scientifically worthy stem cell research. We are particularly pleased that the NIH specifically noted and recognized the promise of the use of human embryonic stem cells to treat arthritis. It is because of this great potential and application of stem cell strategies as a solution for arthritis that the Arthritis Foundation supports the new guidelines with the following comments.

Why does the use of stem cells potentially help people with arthritis?

Current treatments for arthritis and related diseases include analgesic medications, anti-inflammatory drugs, immunosuppressive agents, biologic response modifier therapies and surgery. Although these treatments provide relief of symptoms and improve quality of life in a large number of patients, they are unable to induce clinical remission in all patients and do not “cure” the underlying disease. Recent studies show that stem cell-based therapies offer exciting new opportunities for the treatment of arthritis and related diseases. Human stem cells, both adult and embryonic, offer tremendous promise in the search for ways to prevent, treat and cure musculoskeletal diseases. Human embryonic stem cells – the basic building blocks of the body from which the organs and other cells develop – can replicate themselves indefinitely, making them particularly useful in the search for new treatments and cures for arthritis.

Stem cells are important for patients with arthritis for a number of reasons that relate specifically to remaining pain free and ambulatory. Osteoarthritis (OA), which affects at least 21 million people in the USA; rheumatoid arthritis (RA), which affects at least 1.3 million; and juvenile arthritis (JA), which impacts 300,000 children, are all good candidates for stem cell research. Altogether, the cost of arthritis to the US economy is $128 billion. Research with stem cells holds the promise that a cure could be possible.

Osteoarthritis: As an example, presently there are no effective medical treatments for OA, the most common form of arthritis. At advanced stages, which is a very common outcome in increasingly younger individuals, the only option is the surgical replacement of the involved joint. In the United States, about 1,000,000 joint replacements are performed each year. Although surgical solutions do exist that generally provide significant pain relief, these joint replacements typically last only about 15 years before the implants wear down or become loose and have to be replaced. The need for joint replacement surgery is expected to grow exponentially due to the aging of the population and increasing rates of obesity. This growth will further strain our current health care system. Thus, there is an urgent need for an alternative approach.

Current studies show that it is possible to induce stem cells to form cartilage, which is the tissue that lines the contact surfaces of joints. It is the cartilage that is most directly affected as OA impairs joint function. Stem cells readily differentiate into chondrocytes – which are the cells that form cartilage – as well as the nucleus pulposus – the central part of the intervertebral disc. Two key challenges remain: inducing the newly derived chondrocytes to form the strongest type of cartilage and finding a suitable structure to house the cells within the treated joint as the repair process is accomplished. However, much progress has been made in both areas. Some companies have already brought stem cell products to the market, but additional studies are required to adapt these approaches to wide use in humans. These examples are important because they emphasize the potential usefulness of stem cells as a treatment for arthritis.

Rheumatoid Arthritis/Juvenile Arthritis: Currently, researchers have been using hematopoetic stem cells to replace an autoimmune immune system with a normal immune system (this approach is also relevant to scleroderma and other autoimmune diseases). Another viable use of stem cells is to regenerate specific tissues, such as joint cartilage, tendons, etc. Future potential uses include organ-specific stem cells, which are thought to have important roles in wound healing. This type of treatment might be useful for restoring tissues, such as muscle damaged through inflammatory myopathies, for example.

How can the draft guidelines be improved?

The Arthritis Foundation opposes the exclusion of federal support for studies of certain types of stem cells, such as those derived through parthogeneis or transfer of somatic cell nuclei. As noted by several stem cell research organizations, these alternative types of stem cells may have unique applications of importance to solving human diseases. The guidelines should at least state the rationale for excluding these types of stem cells and should reconsider lifting the restriction on use of federal funds for support of studies based on these types of stem cells. We understand the intent of Executive Order 13505 is to permit federal funding of human embryonic stem cell research in an ethical and scientifically valid manner. We understand there are concerns in the research community that these new guidelines could in fact have a chilling effect on current use of stem cells and that unless a “grandfather” clause be included, years of research could now be ineligible for federal support moving forward. We urge the NIH to consider revising the proposed guidelines to permit and fund current stem cell research and utilize the new guidelines for research that has not yet begun.

Summary: The mission of the Arthritis Foundation is to improve lives through leadership in the prevention, control and cure of arthritis and related diseases – the nation’s most common cause of disability. With more than 46 million Americans with doctor-diagnosed arthritis, it is an organizational priority to support and pursue research opportunities that show promise of providing substantial relief to the millions of adults and children now living with all forms of arthritis. The Arthritis Foundation believes that human stem cell research holds that promise.

The Arthritis Foundation is the largest non-governmental funder of arthritis research in the world and has contributed more than $350 million to arthritis-related research over the past 50 years. We are interested in working with the NIH as the agency finalizes these guidelines and would be pleased to discuss this issue in more detail. If you would like discuss the Foundation’s comments or have any questions please contact the *****

Thank you for the opportunity to provide comments on behalf of the 46 million Americans with arthritis.

 
47136 05/26/2009 at 03:15:23 PM Self     Embryonic stem cell research holds great promise for millions of Americans, myself included, 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 as well. 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 for your concideration.

 
47137 05/26/2009 at 03:15:27 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47138 05/26/2009 at 03:16:09 PM Self     It opens the door for all kinds of horrific abuses- such as we hear of in China today.

We don't need it at all. It's a waste of money because adult stem cell research has proven much more effective.

Scientists close to the situation confirm that we don't need it at all.

Why waste the money on immoral research when we don't need it and we can't afford it?

 
47139 05/26/2009 at 03:16:13 PM Self     Embryonic stem cell research is one of the most important areas of research:

Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am a member of the Parkinson’s community and 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.

 
47140 05/26/2009 at 03:16:38 PM Self     Move stem cell research forward!

 
47141 05/26/2009 at 03:16:44 PM Self     I am strongly opposed to any stem cell research that requires human embryos to be destroyed.

 
47142 05/26/2009 at 03:17:06 PM Self     Knowing of a full range of possibilities for adult and cord blood stem cells that do not require the destruction of a human embryo... why in the name of all that is sacred about our being do it!? I am against embryonic stem cell research. A society is judged on how it defends the defenseless.

 
47143 05/26/2009 at 03:17:41 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

 
47144 05/26/2009 at 03:17:46 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.

 
47145 05/26/2009 at 03:18:29 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47146 05/26/2009 at 03:18:30 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

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

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

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

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

 
47147 05/26/2009 at 03:18:42 PM Self     My 17 year old daughter ***** has had diabetes since she was a 17 month old toddler. Stem cell research holds more promise in the search for a cure than anything to date, as well as hope for 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! My daughter takes 4 to 5 shots a day now. She tests her blood sugar numerous times. She counts carbs to know how much insulin she needs. It's a controllable disease, though in her 16 years with diabetes, she has never truly been in good control. It is hard work, and though the physical challenges are great, so are some of the emotional ones. With a cure, her life would be so different, and she would feel so "normal". Even if stem cell research doesn't find a cure immediately, I'm confident it will provide insight into better ways to control both Type 1 and Type 2 diabetes.

I strongly support the draft guidelines on embryonic stem cell research and the fact that it demonstrates the ability of NIH to create a research framework that allows 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. My daughter is counting on a cure in her adolescent years! Thanks for giving her hope.

 
47148 05/26/2009 at 03:18:48 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.

 
47149 05/26/2009 at 03:19:00 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

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

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

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

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

 
47150 05/26/2009 at 03:20:11 PM Self     I am against the use of taxpayer money to support scientific testing of human embryoes especiually embryonic stem cell testing. There are ample alternatives available that are not being funded and that have proven effective. We must not spend money unwisely in these hard economic times and we must not be so careless anytime with these lives with which we are entrusted.

 
47151 05/26/2009 at 03:20:48 PM Self     As far as I know, there NEVER has been a breakthrough in Research using "EMBRYO" Stem Cells! All the breakthrough' ALL have come through OTHER THEN Embryo stem cells. In other words, success has been achieved with Stem Cells gathered from other sources so why on earth do you want to continue TO KILL BABIES???

 
47152 05/26/2009 at 03:21:23 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47153 05/26/2009 at 03:22:35 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
47154 05/26/2009 at 03:22:51 PM Self     I strongly urge that the NIH refrain from any destructive human embryonic stem cell research and that the institutes instead focus their attention on the more viable adult and umbilical-cord stem-cell research. Current embryonic stem cell research results in the destruction of the embryo and therefore a human life. This is a violation of the oath that medical practitioners make to do no harm and is unethical and immoral. Beyond the moral issues, further advancement of adult and umbilical-cord stem-cell research I a sound scientific approach because all of the conditions that President Obama cited when he signed his executive order on March 9 cancer, juvenile diabetes, Parkinson’s disease, spinal cord injury, heart disease – have been shown in peer-reviewed studies to benefit from clinical trials using human stem cells.

 
47155 05/26/2009 at 03:26:03 PM Self     I object to the following portion of the guidelines- These draft Guidelines would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose. Adult stem cells have been and continue to be found successful in the development of treatments for varying conditions. We should not divert dollars from these efforts to research using embryonic stem cells. I also find this language vague "no longer needed" and thus problematic when it comes to using such cells. I think this will lead to needless court battles and controversy further wasting time, money, and government resources. Eliminate the use of embryonic stem cells and productive research can continue making the best use of tax dollars.

 
47156 05/26/2009 at 03:26:12 PM Self     I am opposed to the draft guidelines for embryonic stem cell research. This would force taxpayers to subsidize research requiring the destruction of innocent human life.

Even using embryos from the in-vitro process is still destroying a life, and a potential for life with couples who long for children. I have friends who adopted frozen embryos through Snowflake Adoption. The woman was implanted with the embryos on two different occasions, and they are now the proud parents of a boy and girl. These children are precious and beautiful, enjoying life with their parents. How terrible to think they could have been destroyed for research!

Instead, support should be directed to research that does not destroy human life. There are other types of stem cell research which has already proven successful, such as adult stem cells. This latter research is ethical and has been shown effective. Why not keep doing what works? I have read that "embryo-destructive stem cell research has shown to be ineffective and even dangerous, forming uncontrollable tumors and causing rejection problems." This does not sound like promising research to me.

We should not fund controversial research that destroys human life when we have other options that do not destroy human life. Under no circumstances should government support be given to human cloning or the development of human embryos for research purposes. That is barbaric.

Also, the proposed regulations do not prevent future funding for embryonic stem cell research that may lead to the development of clones and human-animal hybrids. This is a loophole that must be closed.

 
47157 05/26/2009 at 03:26:16 PM Self     Dear President Obama, Please do not turn your head the other way just to continue your political ambitions, but turn your mind inward to your conscience and stop this idea of using the very beginning of human life to perform experiments for what, to further some one else's life is immoral as is the taking of your life to further some one else's life. Please stop research on embryos. Respectfully,

 
47158 05/26/2009 at 03:27:17 PM Self     I fully support federal funding for stem cell research. I would like to see the guidelines expanded to provide funding for all existing stem cell lines, grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease.

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

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

Thank you,

 
47159 05/26/2009 at 03:27:49 PM Self     I am a behavioral optometrist who works in vision therapy with patients who have sustained many different kinds of head trauma that results in visual dysfunctions. I am in favor of embryonic stem cell research. From all I have researched, I find that this line of research would have the potential to help many of my patients regain normal visual function which would greatly improve their quality of life. Please let me know if there is anything I can do to help keep this important research continuing in California.

 
47160 05/26/2009 at 03:28:18 PM Organization Thomas More Society  

May 26, 2009

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

Re: Draft Guidelines on Human Embryonic Stem Cell Research

Dear Sir or Madam:

This letter is in response to the Administration’s invitation to submit comments on the draft National Institutes of Health guidelines to expand the circumstances under which federal funding of embryonic stem cell research will be available. The Thomas More Society strongly opposes the proposed guidelines. This opposition is based upon the well-recognized medical and scientific fact that human life begins at conception, understood as fertilization, and the principle that no innocent human life should be intentionally destroyed for research or any other asserted reason. The Thomas More Society also notes, in comments that are developed in greater detail in other submissions, that, unlike adult stem cells, embryonic stem cells have never been used successfully to cure or ameliorate any known disease or condition.

The Thomas More Society is a public interest law firm based in Chicago, Illinois. It was founded in 1997 to meet the burgeoning needs of the pro-life movement. Incorporated as a § 501(c)(3) not-for-profit corporation under the laws of the State of Illinois, the Thomas More Society provides legal advice and assistance to those who face harassment, employment discrimination, unjust treatment, civil litigation or criminal prosecution as a result of their pro-life views or their peaceful protest activities. In recent years, the Thomas More Society has provided legal services and assistance in a wide range of cases, including several in the United States Supreme Court, where it has represented parties and amici curiae. In addition to the legal representation it provides, the Thomas More Society also recognizes (and supports before legislative, executive and judicial bodies) appropriate public policy measures that are intended to protect innocent prenatal human life. Consistent with its core mission and the respect for human life that mission implies, the Thomas More Society respectfully opposes the Department’s proposal to expand the circumstances under which federal funding is available for embryonic stem cell research.

What is the Applicable Principle?

It is a well accepted moral and legal principle that forbids the intentional destruction of innocent human life. Application of this principle runs the gamut from prohibiting the terror-bombing of civilian populations in war time to restricting the necessity defense in criminal law to the infliction of non-lethal injuries. Although, by virtue of the Supreme Court’s decision in Roe v. Wade, 410 U.S. 113 (1973), this principle cannot presently be applied to ban abortion, nothing in Roe requires either the federal government or the States to subsidize or otherwise pay for the costs of elective or therapeutic abortions. See Harris v. McRae, 448 U.S. 297 (1980); Williams v. Zbaraz, 448 U.S. 358 (1980). Accordingly, regardless of whether the intentional destruction of human embryos ex utero for purported research needs falls inside or outside the scope of the “abortion liberty” recognized in Roe, there is clearly no constitutional obligation to fund such research (indeed, for the reasons set forth in the submission by the United States Conference of Catholic Bishops, such funding is prohibited by the Dickey-Wicker Amendment). Thus, the principle that forbids the intentional destruction of innocent human life should bar public funding of embryonic stem cell research if such research would result in the intentional destruction of “human life.” It is undisputed that embryos used for research purposes will not be implanted and allowed to mature naturally in utero. In other words, they will die. Does their death mark the end of a “human life”? The answer to that question turns upon the answer to another question, when does human life begin?

Does the Principle Apply to the Intentional Destruction of Human Embryos?

The morality of destroying human embryos for purposes of research does not involve the termination of a “pregnancy,” as such, but in answering the question, “When does human life begin?,” it is instructive to consider whether pregnancy itself is understood as commencing with conception, understood as fertilization, or implantation. Although the American College of Obstetricians & Gynecologists (ACOG) has taken the position that a “pregnancy” does not begin until implantation of the embryo in the uterine wall (sometimes referred to as an “established pregnancy”), ACOG’s position is not one widely shared in the medical and scientific communities. The American Medical Association defines “pregnancy” as “[t]he process of carrying a developing embryo or fetus in the uterus from conception on.” AMA Complete Medical Encyclopedia 1011 (2003). “Conception,” in turn, is defined as “[t]he fertilization of an egg by a sperm that initiates pregnancy.” Id. at 392.[n. 1] The AMA’s terminology is supported by a wealth of medical and scientific sources, including standard embryology texts,[n. 2] obstetrics texts,[n. 3] and medical dictionaries.[n. 4] Although two medical dictionaries define conception solely in terms of implantation,[n. 5] the majority of medical dictionaries and medical encyclopedias now in use agree with the AMA in defining conception as “[t]he fertilization of an egg by a sperm that initiates pregnancy.” In addition to the definitions from Melloni’s, Mosby’s, Dye and Barron’s, quoted above, the following dictionary and encyclopedia definitions may be cited: Black’s Medical Dictionary 156 (41st ed. 2006): “Conception signifies the complex set of changes which occur in the OVUM and in the body of the mother at the beginning of pregnancy. The precise moment of conception is that at which the male element, or spermatozoon, and the female element, or ovum, fuse together.” Dorland’s defines an “embryo” (in humans) as “the developing organism from fertilization to the end of the eighth week [of pregnancy].” Dorland’s Illustrated Medical Dictionary 614 (31st ed. 2007). And “pregnancy” is defined as “the condition of having a developing embryo or fetus in the body, after union of an oocyte and spermatozoon.” Id. at 1531.

Stedman’s defines an embryo (in humans) as “the developing organism from conception until approximately the end of the second month [of pregnancy].” Stedman’s Medical Dictionary 627 (28th ed. 2006). And “conception” is defined as “[f]ertilization of [an] oocyte by a sperm.” Id. at 425. See also Bantam Medical Dictionary 146 (5th ed. 2004)(same).[n. 6] One medical encyclopedia defines “pregnancy” as “[t]he period from conception to birth,” Gale Encyclopedia of Medicine, Vol. 4, p. 3005 (3rd ed. 2006), “conception” being understood as fertilization. Further, pregnancy is described as “a state in which a woman carries a fertilized egg inside of her body.” Id., vol. 4, p. 3006. The understanding of “conception” as “fertilization” is also reflected in standard English language dictionaries.[n. 7] Given the weight of medical and scientific opinion that pregnancy begins with conception, understood as fertilization, not implantation, the intentional destruction of a fertilized embryo may be said to end a human life.

Apart from determining when pregnancy begins, the fact that human life, in biological terms, begins at conception (understood as fertilization) is supported by a wealth of scientific and medical evidence. After reviewing many authorities and hearing testimony from world-renowned geneticists, biologists and physicians, the Subcommittee on Separation of Powers of the Senate Judiciary Committee stated: “[C]ontemporary scientific evidence points to a clear conclusion: the life of a human being begins at conception, the time when the process of fertilization is complete.” Report of the Subcommittee on Separation of Powers, Senate Judiciary Committee, on S. 158, the Human Life Bill, 97th Congress, 1st Sess, at 7 (1991). “Physicians, biologists, and other scientists agree that conception marks the beginning of the life of a human being–of a being that is alive and a member of the human species.” Id. And that scientific consensus continues to the present day.

In addition to the authorities cited above, especially Moore and Persaud, The Developing Human at 15, see M.J.T. Fitzgerald and M. Fitzgerald, Human Embryology 1 (1994) (“[t]he prenatal period of life commences at the moment of fertilization, and terminates at birth”); R. O’Rahilly and F. Muller, Human Embryology & Teratology 8 (3rd ed. 1996) (“[a]lthough life is a continuous process, fertilization . . . is a critical landmark because, under ordinary circumstances, a new, genetically distinct human organism is formed when the chromosomes of the male and female pronuclei blend in the oocyte”); F.J. Dye, Human Life Before Birth 53 (2000) (“[t]wo cells on the verge of death are the participant in fertilization, one of the most though-provoking events in biology. If these two cells undergo fertilization, a new individual may result”); Wm. Larsen, Human Embryology 1 (3rd ed. 2001) (“we begin our description of the developing human with the formation and differentiation of the male and female sex cells or gametes, which will unite at fertilization to initiate the embryonic development of a new individual”).[n. 8]

Both legislatures and courts have recognized this scientific and medical reality. After a review of the current medical and scientific evidence on human development, a special task force created by the South Dakota Legislature found that “the new recombinant DNA technologies indisputably prove that the unborn child is a whole human being from the moment of fertilization . . . .” Report of the South Dakota Task Force to Study Abortion 31 (December 2005). More recently, the Eighth Circuit Court of Appeals considered the constitutionality of a South Dakota informed consent statute that requires a physician to advise a woman seeking an abortion that the procedure “will terminate the life of a whole, separate, unique, living human being.” S.D. Codified Laws § 34-23A-10.1(1)(b). “Human being,” in turn, is defined as “an individual living member of the species of Homo sapiens, including the unborn human being during the entire embryonic and fetal ages from fertilization to full gestation.” Id. § 34-23A-1(4). The court of appeals held that, taking into account the definition of “human being” set forth in § 34-23A-1(4), the disclosure required by § 34-23A-10.1(1)(b) is neither “untruthful [n]or misleading.” Planned Parenthood Minnesota, North Dakota, South Dakota vs. Rounds, 530 F.3d 724, 737 (8th Cir. 2008) (en banc). Rather, the statute simply requires the physician “to disclose truthful and non-misleading information as part of obtaining informed consent to a procedure.” Id.

There is a scientific and medical consensus that human life, in biological terms, begins with conception, understood as fertilization. By definition, embryos are fertilized ova. Accordingly, their intentional destruction, for research or other purposes, violates the principle that forbids the intentional destruction of innocent human life. Accordingly, federal funding of such research should not be expanded.

Conclusion

We oppose the draft guidelines for expanding federal funding for embryonic stem cell research and respectfully request that they be withdrawn in accordance with the principles set forth in this submission.

Very truly yours, ***** ***** Thomas More Society Thomas More Society

Notes

1. This usage continues in the AMA’s Concise Medical Encyclopedia 1, 184, 565 (2006).

2. See, e.g., Keith L. Moore and T.V.N. Persaud, The Developing Human, Clinically Oriented Embryology 2 (8th ed. 2008) (“Human development is a continuous process that begins when an oocyte (ovum) from a female is fertilized by a sperm (spermatazoon) from a male”), id. at 15 (“[h]uman development begins at fertilization when a male gamete or sperm unites with a female gamete or oocyte to form a single cell, a zygote. This highly specialized, totipotent cell marks the beginning of each of us as a unique individual”); R. Jones and K. Lopez, Human Reproductive Biology 253 (3rd ed. 2006) (stating that “pregnancy begins at conception”), id. at 231 (defining “conception” in terms of “fertilization”); G. Thibodeau and K. Patton, Anatomy and Physiology 1167 (6th ed. 2007).

3. See Scott, DiSaia, Hammond and Spellacy, Danforth’s Obstetrics and Gynecology 29 (8th ed. 1999); Cunningham, Gant, Leveno, Gilstrap, Hauth and Wenstrom, Williams Obstetrics 86-87 & Figure 2-1 (21st ed. 2001) (defining conception in terms of fertilization and distinguishing conception from implantation); see also Cunningham, Leveno, Bloom, Hauth, Gilstrap and Wenstrom, Williams Obstetrics 92 & Figure 4-1 (22nd ed. 2005) (equating conception with fertilization).

4. See Melloni’s Illustrated Medical Dictionary 526 (4th ed. 2002) (defining “pregnancy” as the “[c]ondition of the female from conception to delivery of the fetus or embryo,” id. at 138 (defining “conception” in terms of fertilization); Mosby’s Dictionary of Medicine, Nursing & Health Professions 1512 (7th ed. 2006) (defining “pregnancy” as “the gestational process, comprising the growth and development within a woman of a new individual from conception through the embryonic and fetal periods to birth”), id. at 436 (defining “conception” as “the beginning of pregnancy, usually taken to be the instant that a spermatozoon enters an ovum and forms a viable zygote,” or, alternatively, “[f]ertilization of [an] oocyte by a sperm”); F.J. Dye, Dictionary of Developmental Biology and Embryology 124 (2002) (defining “pregnancy” as “[t]he condition of a woman who is carrying a conceptus (the product of conception or fertilization”), id. at 31 (defining “conceptus” as “[t]hat which results from conception (fertilization), i.e., the embryo or fetus and its associated membranes”); Mikel A. Rothenberg and Charles E. Chapman, Barron’s Dictionary of Medical Terms 471 (5th ed. 2006) (defining “pregnancy” as “the period during which a woman carries a developing fetus in the uterus, from the time of conception to the birth of the child”), id. (“[p]regnancy lasts 266 days from the day of fertilization”), id. at 137 (defining “conception” as the “fertilization of the female egg cell (ovum) by a male spermatozoon, the beginning of pregnancy”).

5. See Joseph C. Segan, Concise Dictionary of Modern Medicine 159 (2006), and Taber’s Cyclopedic Medical Dictionary 464 (20th ed. 2005).

6. Two other medical dictionaries define “conception” as either fertilization or implantation See Merriam-Webster’s Medical Dictionary 163 (rev. ed. 2005) (defining “conception” as “the process of becoming pregnant involving fertilization or implantation or both”); Miller-Keane, Encyclopedia and Dictionary of Medicine, Nursing and Allied Health 406 (7th ed. 2003) (defining “conception” as “the onset of pregnancy, marked by implantation of the BLASTOCYST; the formation of a viable ZYGOTE”), id. at 662-63 (fertilization occurs when the head of the sperm unites with the oocyte to form the zygote).

7. See Webster’s Third New International Dictionary (unabridged) 469 (2002) (defining “conception” as the “act of becoming pregnant; formation of a viable zygote”); Funk and Wagnalls New International Dictionary of the English Language 270 (2003) (defining “conception,” in biological terms, as “[t]he impregnation of an ovum”); Random House Webster’s Unabridged Dictionary 422 (2nd ed. 1998) (defining “conception” as “fertilization; inception of pregnancy”).

8. Additional authorities may be found in R. George and C. Tollefsen, Embryo: A Defense of Human Life (2008).

 
47161 05/26/2009 at 03:28:22 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am entering the medical feild and, having a mother with a neurodegenerative disease who I see wax and wane in her health, I strongly beliee that stem cell therapy may become her only option. 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.

 
47162 05/26/2009 at 03:28:29 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

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

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

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

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

 
47163 05/26/2009 at 03:28:42 PM Self     As a senior postdoctoral researcher of the University of Michigan Center for Stem Cell Biology, I would like to comment on the draft NIH Guidelines for Human Stem Cell Research, which appeared in the Federal Register on April 23, 2009. The guidelines were drafted in response to Executive Order 13505, Removing Barriers to responsible Scientific Research Involving Human Stem Cells. To be brief I would only like to say that I support NIH's efforts to loosen restrictions on embryonic stem cell research, and that I fully support comments on the guidelines that have been submitted by ISSCR or ASCB.

Sincerely,

 
47164 05/26/2009 at 03:29:27 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47165 05/26/2009 at 03:29:31 PM Self     I support Draft NIH Human Stem Cell Guidelines. My husband has parkinson. My hope is that Stem Cell research will help some future parkinson patient.

 
47166 05/26/2009 at 03:31:10 PM Self     My family finds it incredibly appalling that the Federal Government is considering the destruction of fully viable, fully HUMAN embryos for scientific research. We are appalled for many reasons.

To begin with, to date, NO CURES have been discovered from embryonic stem cell research even though it has been going on for years (sure without federal funding but let us not forget that globally experiments have been taking place and no benefit has been found.) Why not choose to fund and increase funding for adult stem cell and umbilical cord stem cell research? As we all know, adult stem cells are ALREADY being used in MANY medical treatments. Logic would seem to say that this route has the best potential and least destruction to human life.

We see the federal funding of human embryonic stem cells as a giant push down a slippery slope towards a future where one's value to society is judged by one's state in life (wait, that's exactly what is already going on here! Small human embryos and pre-born humans who cannot defend themselves are already outside the scope of legal protection!) This consideration demonstrates the understanding that the potential for these tiny humans does not rest in their humanity, but rather in their usefulness to enhance the lives of those lucky enough to have been born.

While it is true that many of these embryos would have otherwise been destroyed, this is not a strong enough reason for deciding to further support their unfortunate fate by encouraging it!

If the lives of these tiny pre-born humans are not protected by our administration, a message would be sent far and wide that other less useful humans may also NOT be protected. What would stop the funding of experiments on foster children? They, like the embryos, are not wanted by their parents. What if the foster children's parents sign them over for scientific research?

While this may sound ridiculous when first heard, it really isn't. These embryos are fully HUMAN and if given the chance would develop into nothing other than HUMAN BEINGS. Unfortunately, their real parents do not want them and so, the reasoning goes, donate them to science.

But what about the fact that the HUMAN embryos can not defend themselves.

Is that why we choose to not protect them? If so, then how about all those nursing home patients. Maybe they too, especially the ones with no family to want them, should be donated to science also. Just imagine the potential there!

You can see where this line of reasoning takes us.

As an American citizen, I find it incredibly disturbing that our government has already chosen not to protect an entire class of people (the pre-born). And is now considering funding their destruction.

This entire situation sounds incredibly similar to an episode in recent history where a certain government also felt it would be beneficial and profitable to destroy a certain class of people. As a matter of fact, our country's classrooms time and again teach about the evil that was caused by Hitler's regime.

Why do we choose to NOT see the similarities between the experiments Hitler's regime forced on HUMANS and this current proposal?

We prayerfully ask that God have mercy on our country and the misguided officials who feel the destruction of one class of people is fine so long as it POTENTIALLY benefits another class.

Sincerely,

 
47167 05/26/2009 at 03:31:20 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.

 
47168 05/26/2009 at 03:31:59 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47169 05/26/2009 at 03:32:04 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47170 05/26/2009 at 03:32:58 PM Self     As a household with a person with advanced idopathic Parkinson's disease (*****), we strongly support stem cell research. Now is the time! Do not delay. Individuals like *****, for whom every hour of every day is an uncertain and debilitating challenge, stand to benefit tremendously from further research with stem cells. Please make sure that final guidelines for use of stem cells allow use of the stem cell lines that were available at the time the guidelines were created. Final guidelines should also permit use of other sources of stem cells. Please, for the sake of millions of Americans.

 
47171 05/26/2009 at 03:34:19 PM Self     "Although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos." This quote from the April 23, 2009 Federal Register Notice Guidelines on NIH stem cells. Meaning that human lives (human babies) are killed in order to have these stem cells from the source of human life. Adult stem cells, which do not insult our country's sense of moral values, have been shown a satisfactory way to obtain viable stem cell research & success. I would hope that NIH would consider stems cells other than human embryotic stem cells to carry out their mission.

 
47172 05/26/2009 at 03:34:26 PM       Advances in stem cell research will lead to treatments and cures for many diseases. The federal gov't should devote significant funds to this effort.

 
47173 05/26/2009 at 03:34:31 PM Self     As my husband is the victim of a virtually unknown disease, Progressive Supranuclear Palsy, it is imperitive for the NIH Human Stem Cell research. To us and others it is a matter of life or a very cruel death.

Last Day to Support Stem Cell Guidelines NIH comment period closes at 11pm tonight! More Info Today is the last day to comment on NIH’s draft stem cell guidelines. Your support for human embryonic stem cell research is needed -- each comment is recorded and counted! Although the vast majority of Americans support stem cell research, as of last week, most of the comments NIH has received are in opposition to stem cell research. We must do everything we can to shift that balance. Please submit comments if you have not done so already. Once you have submitted your comments, encourage your friends and family to voice their support for stem cell research as well. PAN has also submitted organizational comments on the NIH draft guidelines. Generally, PAN is pleased that the draft guidelines greatly expand the availability of federal funds for stem cell research. PAN’s detailed comments also identify regulatory adjustments and clarifications that are needed in the final guidelines, which is far more detail than what individuals need to submit. The comment period closes at the end of the day today. Please take five minutes to express your support for this important research now! How to Submit Your Comments: To access the NIH comment form, visit: http://nihoerextra.nih.gov/stem_cells/add.htm Provide your name, and select ‘self’ for Affiliation; and Copy and paste the text below into the comment box, edit as appropriate, provide the security check ID on the form, and click ‘submit comments.’ Suggested Comment Text: Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
47174 05/26/2009 at 03:34:46 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.

 
47175 05/26/2009 at 03:34:49 PM Self     I do not believe. In committing murder. And that what this is doing. We killed more babies. Then all the wars combined. Now we are asked to commit more murders. And this the reason. The Lord is going pronounce judgement on this nation. As he is doing right now.

When it gets to the point. That humane life doesn't matter. Next it will be the seniors, handicapped, the blind. There be no end.

 
47176 05/26/2009 at 03:35:01 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

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

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

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

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

 
47177 05/26/2009 at 03:35:10 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.

 
47178 05/26/2009 at 03:36:09 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47179 05/26/2009 at 03:36:20 PM Self     It is simply wrong to use parts of someone's body to do research without their consent. In the case of embryonic stem cells, it is impossible to receive consent of these human beings to use their bodies in this manner, it remain wrong to do so. Futhermore, I believe many would justify abortion, which is the murder of the innocent by using the human stem cells from a unborn baby to do research. It is morally wrong to do such things, even if good were to come of it...it does not change the wrong that it is. It is no different than killing a human being after birth for the purpose of doing research of their bodies. Even in the case of accidental death, it is wrong to take a persons remains and use it for whatever purpose you would want and showing no respect for the dead. I believe some people would purposely become pregnant in order to abort the child to create stem cells to use for a dying member of the family. I have read of such cases that young women have done just that and though good came out of it...saving their relative...it was immoral and wrong to do so. Does our society want to slip down even further and consider such acts proper and worse heroic? I believe that it could and likely would open a black market for aborted babies...furthering the disrespect of the unborn and their families who ignorantly aborted them thinking they were doing the right thing. Are there not better ways to get stem cells for research...are we being lied to and lead to believe that this research is only possible at the expense of the unborn? Perhaps it is just easier to do research this way and yet do we not have an obligation to keep ethics in the scientific research above progress or results.

 
47180 05/26/2009 at 03:37:12 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.

 
47181 05/26/2009 at 03:37:39 PM Self     We are against any form of embryonic stem cell research.

 
47182 05/26/2009 at 03:37:40 PM Self     Would like to see funds not diverted from adult stem cell research so that further treatments under development can be quickly brought to bear on those needing treatment.

 
47183 05/26/2009 at 03:37:41 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.

 
47184 05/26/2009 at 03:37:45 PM Self     The proposed NIH stem cell guidelines, if adopted as is, would essentially create a situation in which human embryonic stem cell research would be starting from almost zero. The intent of President Obama's Executive Order was to expand the number of lines eligible for federal funding. Because these guidelines are to be applied retroactively - to lines created over the last 10 years, many if not all of the hESC lines scientists have been working with and have become "standards" in the field would not be eligible for federal funding, including those lines that had been on NIH's approved list after President Bush's directive in August 2001. Applying today's ethical standards and norms to yesterday's science is not often without negative consequences, as would be the case here. In addition, many of the informed consent guidelines under which future hESC lines must be derived if they are to be eligible for federal funding, must be in the written informed consent document and thus could be burdensome to the entire process. One must ask why it is necessary for the proposed guidelines to be this prescriptive with regards to the written informed consent documents. Finally, the guidelines do not permit federal funding to be used for hESC lines created from SCNT, parthenogenesis, and IVF for research purposes. This restriction will provide yet one more limitation that researchers using hESC in the United States will face."

 
47185 05/26/2009 at 03:38:27 PM Organization University of California, San Francisco   Dear Dr. Kington,

We applaud President Obama’s executive order of March 9, 2009 to remove the funding “limitations on scientific inquiry, … expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind” [The President, March 9, 2009]. As an institution conducting stem cell research, we are dedicated to this goal of pursuing new discoveries and therapies that will benefit people around the world. We welcome timely promulgation of draft guidelines by the NIH to implement this executive order. We believe that these draft guidelines can be improved in several important ways, to better carry out the President’s goal of reducing the barriers to the conduct of “responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law” [The President, March 9, 2009].

Unnecessary barriers without increased protection for embryo donors: The draft guidelines require specific wording in consent forms for the donation of embryos to derive human embryonic stem cell (hESC) lines. This requirement will create significant barriers to research without increasing meaningful protection for the embryo donors. Instead, we suggest that federal funding for research with a hESC line be contingent on a determination by an institutional review board (IRB) that the decisions to donate embryos for the hESC derivation were informed and voluntary.

Many existing hESC lines – including several approved for NIH funding under the Bush Administration and now widely used -- 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. But if the consent forms do not have every element (items II-B.-7a-i) or the precise words in the draft guidelines, these lines would be ineligible. The same is likely true of many frozen embryos donated for research instead of being discarded but not yet used to derive hESC lines. At the same time, consent forms with the required language might exist for donations done in circumstances that would prompt most IRBs to question the quality of the consent. Thus we recommend that the judgment that embryos were donated with voluntary and informed consent not depend solely on the presence or absence of certain wording in the consent form.

Instead, an IRB should review the entire consent process, as required by existing federal regulations for the protection of human subjects (the Common Rule), which apply to the donation of all biological materials for research. The Common Rule already requires that certain information – basic and additional elements of informed consent -- must be provided during the informed consent process [45 CFR 46.116]. The requirements for detailed consent language in the draft guidelines are unnecessary and fail to add significant protections for donors. We agree that consent from donors should be obtained even if donors could not be identified, a requirement that is a stricter than the Common Rule.

At UCSF, our Stem Cell Research Oversight Committee (SCRO), working closely with the IRB, has analyzed consent to donate embryos for hESC research [Lo et. al., Cell Stem Cell. 2009 Feb 6;4(2):115-23]. We believe that IRBs and SCROs have the expertise and experience to judge whether consent to donate embryos for hESC research was voluntary and informed. The National Academy of Sciences has issued helpful peer-reviewed consensus recommendations on this issue [http://dels.nas.edu/bls/stemcells/].

Our recommendation that IRBs should determine that consent for donation was informed and voluntary works for old and new lines; for foreign and domestic lines; and for hESC lines approved in 2001 for NIH funding as well as additional lines. Overall, our recommendation requires that every hESC line studied with NIH funds meets the high standards already required by federal regulations.

As currently drafted, the guidelines overemphasize the wording in consent forms and would exclude the use of responsibly collected embryos and responsibly derived stem cell lines (including many on the NIH registry). There are important scientific advantages to conducting research with existing lines that have been well characterized and are readily grown in the laboratory. Because of the cumulative nature of scientific discovery, investigators should be permitted to rely on previous determinations that certain lines qualify for federal funding, and on determinations by qualified IRBs that there was an acceptable consent process for donation of source materials. Furthermore, to withdraw federal funding for lines that had been deemed eligible for NIH funding by the Bush Administration would cause severe disruption to research.

Missed opportunities to reduce barriers to responsible and scientifically worthy research: To increase the potential for “new discoveries and therapies that benefit humankind,” [The President, March 9, 2009], we urge the NIH to develop guidelines that not only allow scientifically worthy and ethically responsible hESC research to proceed without unnecessary regulatory barriers or uncertainty but also to facilitate such important research.

Reduce burden of collecting and reviewing information about the provenance of hESC lines If the guidelines are revised to simply require IRB approval that the derivation was carried out in accordance with the Common Rule, the documentation process would be greatly simplified, without weakening protections for donors of biological materials. As written, the NIH draft guidelines require documentation without specifying precisely what materials must be presented to the NIH. Under our proposed approach, the only documentation would be a copy of the IRB approval letter, as is the case for other NIH-funded research. NIH could go one step further and create an online clearinghouse for information about the derivation of commonly used lines. This clearinghouse could include consent forms and IRB approval letters for the original donation of embryos for hESC derivation. The clearinghouse would greatly ease burdens of documentation for researchers, IRBs at their institutions, and compliance officials. It would be particularly helpful for gathering information about hESC lines derived at foreign institutions.

Provide guidance about the use of federally funded resources to support research with ineligible materials “NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed” under the draft guidelines, and the Dickey-Wicker amendment prohibits the use of federal funds for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.” Researchers at major research institutions that have significant levels of NIH funding commonly obtain non-federal funding to perform hESC research with materials ineligible for federal funding. Such research includes the derivation of new hESC lines and comparisons of the characteristics of NIH-eligible lines and other hESC lines.

There are a number of questions regarding such research, including: • Under what circumstances can equipment (e.g. incubators, microscopes, freezers, biosafety cabinets, mass spectrometers, NMR machines, cell sorters, genome sequencers, computers) purchased with federal funds be used for research with ineligible materials? • What is a derivative of a stem cell line, and are derivatives of ineligible lines eligible for federal funding? • Can space that is used for research with ineligible lines be included in the base for negotiating indirect costs? • Can federal funds be used to publish data that was the result of non-federally funded experiments with ineligible materials?

However, the NIH has not issued guidelines for how to conduct such research. The resulting regulatory uncertainty led many institutions to adopt highly cautious approaches that waste valuable resources. For example, some institutions did not allow work with ineligible lines to occur in the same laboratory space as any federally funded research, leading to duplication of laboratories, equipment, and personnel. As a result, scientific progress has been impeded and investigators – established investigators as well as students and fellows – have been deterred from entering the field of stem cell research. In addition, research institutions have spent considerable time and resources trying to determine what the rules are.

We urge NIH to clarify how such research should be handled. Such clarification would help achieve President Obama’s goal of allowing responsible and scientifically worthy research to proceed without unnecessary regulatory barriers or uncertainty in order to increase the potential for “new discoveries and therapies that benefit humankind” [The President March 9, 2009].

Facilitate the gathering and dissemination of scientific information about eligible hESC lines The draft guidelines address the ethics of the derivation of hESC cell lines in determining their eligibility for federal funding. To promote the ultimate goal of safe and effective therapies for patients, the NIH also should facilitate the gathering and disseminating scientific information about eligible hESC lines to help researchers determine which lines to use and provide guidance to study sections that review proposals for NIH funding. We urge the NIH to establish a clearinghouse of peer-reviewed data about the characteristics of the proposed lines, such as: • Is the cell line aneuploid or karyotypically unstable? Does the line have other genetic abnormalities such as duplication or deletion of particular genes? • Does the cell line have identifiable characteristics such as genetic fingerprints that are consistent with its established identity? • Does the cell line have a propensity to differentiate along certain lineages (e.g., endoderm, mesoderm, ectoderm) and/or make certain types of derivatives (e.g., nerve cells or heart muscle)? • Is there information about the tumorigenicity of the cells when transplanted? • Have the cells been in contact with animal products that could render them unsafe for transplantation into humans?

Conclusion: In summary, the goals of President Obama’s Executive Order could be better achieved if the draft NIH guidelines were revised to require that hESC lines to be used in NIH-funded research be derived with informed and voluntary consent from donors, in accordance with the Common Rule, and that the donation be approved by an IRB. This simpler guideline would ensure that high ethical standards were met and allow scientifically meritorious hESC research to proceed with NIH funding. Furthermore, the NIH could lower barriers to the conduct of research that is responsible and scientifically worthy by providing guidance about how to conduct research with ineligible materials using federally-funded resources and facilitating the gathering and dissemination of scientific information about eligible hESC lines.

Sincerely,

 
47186 05/26/2009 at 03:38:29 PM Organization University of California system   May 26, 2009

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

RE: Draft National Institutes of Health Guidelines for Human Stem Cell Research Notice [Federal Register Vol. 74, No. 77, April 23, 2009]

Dear Dr. Kingston:

I am writing on behalf of the University of California system to provide comments on the Draft National Institutes of Health (NIH) Guidelines for Human Stem Cell Research published in the Federal Register on April 23, 2009. The University of California system comprises ten campuses – Berkeley, Davis, Irvine, Los Angeles, Merced, Riverside, Santa Barbara, Santa Cruz, San Diego, and San Francisco –that are actively engaged in stem cell research. Because of prior federal funding restrictions, most of our existing stem cell work is funded with non-federal funds.

Stem cell science and regenerative medicine are enormously promising areas of research, and the University of California strongly supports expanded federal funding in this area, including for work involving human embryonic stem cells (hESC). We therefore welcomed President Obama’s Executive Order 13505, Removing the Barriers to Responsible Scientific Research Involving Human Stem Cells, and applaud NIH for acting quickly to implement the President’s Order so that this work can move ahead with much-needed federal funds.

We do have a number of comments and suggestions that we ask you to consider before publishing final Guidelines in this area:

NIH Should Remove Restrictions Based on Sources of Stem Cells:

We were pleased that President Obama’s Executive order authorized NIH to support and conduct responsible, worthy scientific hESC research, and that it did not place any restrictions on that authority (other than to note that research is authorized “to the extent permitted by law.”). We are disappointed that in its Draft Guidelines, NIH chose to narrowly circumscribe the type of hESC research that it will support. The Draft Guidelines preclude funding for hESC research using cells derived from sources other than from embryos created for reproductive purposes, such as cells derived from parthenogenesis, somatic cell nuclear transfer (SCNT), and IVF embryos created for research purposes. Such cell lines can play an important role in enabling study of specific diseases that cannot be studied as effectively using lines developed from IVF embryos created for reproductive purposes. Without the potential for federal support, the scientific promise of many of these techniques may not be fully realized.

**We strongly urge the NIH to allow funding for research using human embryonic stem cells derived from other sources in addition to discarded IVF embryos created for reproductive purposes, while still requiring appropriate ethical oversight and responsible derivation.

NIH Should Avoid Retroactive Application of Detailed Technical Consent Provisions:

The NIH Draft Guidance sets out a number of detailed prescriptive elements that must be documented in order to meet the consent standard, including specific statements that must have been included in the written consent form provided to a donor of an embryo from which stem cells were derived. If any one of those statements was not included in the consent form at the time of donation, any resulting stem cells would not be eligible for use in NIH-funded research.

We strongly agree that NIH should fund research only on those hESC lines derived from embryos for which voluntary informed consent was obtained from the donors. We believe, however, that the degree of specificity of the elements set out under Section II.B of the Draft Guidelines may be unnecessary to ensure that voluntary, informed consent was obtained, and may -- particularly if applied retroactively – prove unduly burdensome and have the unintended consequence of precluding the use of existing lines that were developed in accordance with high ethical review standards.

Voluntary, informed consent is a well-understood principle that is already implemented under the existing Common Rule as it applies to human subject research. Although not all stem cell research is human subject research, as NIH appropriately recognizes in its Draft Guidelines, NIH should, nonetheless, consider adopting a standard like the one that applies under the Common Rule, where voluntary, informed consent is required, but where the specific technical elements of such consent are not mandated via federal regulation or policy. This would have the advantage of applying a well-understood high standard of responsible research, while allowing institutions flexibility to individually evaluate whether the standard has been met in a particular case. Under existing rules, such case-by-case evaluations are made routinely by Institutional Review Boards reviewing human subject research. NIH could use a similar process here, allowing institutions to evaluate whether voluntary informed consent was obtained in a particular case by using either Institutional Review Boards or the Stem Cell Research Oversight committees that many institutions have established in accordance with NAS and state guidelines.

Even if NIH chooses to retain the provisions in Section II.B. that set out new specific informed consent requirements, we strongly suggest that such requirements not be applied retroactively. Doing so would have the unfortunate consequence of precluding federal funding for research involving existing stem cell lines that, while responsibly and ethically derived, may not meet each of the technical elements detailed in the Draft Guidelines. This is true for many lines developed in accordance with the National Academies of Sciences (NAS) Guidelines for Human Embryonic Stem Cell Research, lines created overseas in compliance with the laws and guidelines of other countries; and even lines developed prior to 2001 that were eligible for federal funding under the previous Presidential policy. The ongoing scientific work being done with existing lines can serve as an important foundation for future research. We believe that it would be short-sighted to require that federally funded research now start from scratch without being able to take advantage of well-characterized lines that were developed through significant state and private investment, under guidelines that ensured responsible ethical practices.

**We urge the NIH to incorporate flexibility into the guidelines by including language that states that hESC lines are eligible for federal funding if they were created under prevailing ethical standards that required voluntary, informed consent and that prohibited undue financial inducements for the donation of the embryo.

NIH Should Clarify That the Guidelines Apply Only to Federally Funded Stem Cell Research:

Section I. of the Draft Guidelines states that the Guidelines are intended to describe the circumstances under which human embryonic stem cells are eligible for use in extramural NIH-funded research. We therefore suggest that the title of the document be changed from “NIH Guidelines for Human Stem Cell Research” to “NIH Guidelines for Federal Funding of Human Embryonic Stem Cell Research.” This more accurately captures the scope of the document, and avoids giving the mis-impression that the guidelines apply to research funded by other sources.

Similarly, we suggest that the title of Section II. be amended to read “Guidelines for Eligibility of Human Embryonic Stem Cells for Use in Federally-funded Research,” and that the title of Section IV. be changed from “Other Non-Allowable Research,” to “Other Research Ineligible for Federal Funding.” It may also be helpful for NIH to clarify that it expects that other federal agencies that fund hESC research will adopt the same guidelines (so that there is a consistent standard with respect to federal funding). If that is not the case, then it may be more appropriate for the titles referenced above to use the phrase “NIH funding” instead of “Federal funding.”

NIH Should Support and Maintain a Registry:

Under the Presidential policy that was in effect for the last eight years, NIH maintained a registry listing all lines eligible for federal funding. NIH should explore the possibility of funding and maintaining a similar registry under the new Guidelines. Such a central database would either list hESC lines that have been found to meet the voluntary consent standards established by NIH (and that would therefore be eligible for federal funding without additional documentation requirements), or would at least compile the documentation needed for individual institutions to determine whether the consent standard has been met. This would help reduce the burden on institutions of having to independently gather the same documentation.

Thank you for the opportunity to provide these comments, which supplement the joint comments that the University of California is submitting as part of the California Research University Network (CRUN). We greatly appreciate the efforts of NIH to move forward in quickly implementing President Obama’s Executive Order expanding federal funding for human stem cell research.

Sincerely,

***** *****

cc:*****

 
47187 05/26/2009 at 03:38:56 PM Self     I am writing to oppose the Federal funding of Embryonic Stem Cell Research. ESCR has proven, not only ineffective, but detrimental to the health of the individuals who have participated in medical studies using these cells. More importantly, the harvesting of these cells requires the destruction of embryonic human life. I vehemently oppose the spending of my tax dollars to destroy one human body in order to grow tumors in another.

Sincerely,

 
47188 05/26/2009 at 03:39:09 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47189 05/26/2009 at 03:39:51 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
47190 05/26/2009 at 03:40:01 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.

 
47191 05/26/2009 at 03:40:18 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.

 
47192 05/26/2009 at 03:41:25 PM Self     I fully support federal funding for stem cell research.

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

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

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

Thank you,

 
47193 05/26/2009 at 03:41:42 PM Self     There are two many ethical problems with human embryonic stem cell research. You must reject this executive order because a human embryo is killed in order to derive a human embryonic stem cell. This goes against the conscience of scientists. It is wrong to kill an innocent human being, even if this person is in the embryonic stage of life. You cannot remove ethical principles from Science. Otherwise you will be acting like the Nazi scientists. You must tell the President that you are making a conscientious objection to this executive order and cannot in good conscience implement it.

More funding should instead be spent on animal studies and Adult human stem cells. These approaches do not have ethical problems and have much promise.

Giving birth by cesarean section was developed by a doctor who did not want to kill a baby at birth whose head was too large. He came up with a solution that was ethically sound and thus solved the problem. No human being has to be killed. You must use the same approach to find a creative solution that does not involve killing an innocent human being.

The first two principles of medical ethics are to do good and avoid evil. You cannot intentionally do an evil. You cannot intentionally kill an innocent human being, which is what the embryo is. You must do no harm, as the Hypocratic Oath tells us. The end does not justify the means. Killing a human embryo does not justify any good that might come from human embryonic stell research. It is always wrong to kill an innocent human being.

 
47194 05/26/2009 at 03:41:55 PM Self     As a voter in New York state and a friend of many lawyers and judges I support all stem cell research as appropriate scientific and humanistic endeavor.

 
47195 05/26/2009 at 03:42:13 PM Self     As a American citizen I do not want my tax money paying for destructive embryonic stem cell research or human cloning. I don't understand why the government is not funding adult stem cell research since it is already proving beneficial in fighting many diseases, and it does not destroy human life as is done in embryonic stem cell research. Every human being starts out as a group of cells. Creating human beings and then destroying them for their stem cells is, simply put, killing people. I agree with Cardinal Rigali that the Guidelines is a "new chapter in divorcing biomedical research from its ethical foundation."

 
47196 05/26/2009 at 03:42:14 PM Self     I am against stem cell research on the grounds that there is no scientic evidence that no postive results have been seen. Adult stem cell research has been shown to be very positive.

 
47197 05/26/2009 at 03:43:04 PM Self     I am writing on behalf of myself as a I have a disease,Progressive Supernuclear Palsy,that nothing is really known. My only hope at this time is in research in NIH Human Stem Cell Research as I really becoming an invalid quite rapidly

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.

 
47198 05/26/2009 at 03:43:06 PM Self     My family and I do not support using embryonic stem cells for research. Each human life is sacred. Using adult stem cells has proven success.

 
47199 05/26/2009 at 03:43:41 PM Self     I do not want my tax dollars to pay for experiments with embryonic stem cells, from destroyed human embryos. There have been no successful outcomes from embryonic stem cells. The only successful treatments and cures come from adult stem cells, taken from bone marrow, umbilical cord blood, fat tissue and other body tissues.

Please protect human embryos from destruction. Please, instead, focus on adult stem-cell research, which already has provided dozens of therapies and treatments for humans.

Thank you.

 
47200 05/26/2009 at 03:44:01 PM Self     "I support embryonic stem cell research, and am glad some of the restrictions are being loosened."

 
47201 05/26/2009 at 03:44:52 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.

 
47202 05/26/2009 at 03:44:56 PM Self     Use of embryonic stem cells for any research, treatment, or solution for a medical ill is morally and logically wrong. Regardless of current laws on abortion, an embryo a distinct individual and is entitled to all the protections and rights that the law provides. Embryonic stem cells can only be attained through the destruction of this life, which is a great moral evil.

Any “potential” solutions that embryonic stem cells might produce, is the moral equivalent of an individual who is kidnapped, killed, and their body parted out for the good of the community. Regardless of how many people benefited from these body parts, the whole of the individual is always greater than the sum of the parts.

 
47203 05/26/2009 at 03:45:01 PM Self     I support embryonic stem cell research, and am glad some of the restrictions are being loosened.

 
47204 05/26/2009 at 03:45:57 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.

 
47205 05/26/2009 at 03:46:32 PM Self     I humbly ask that you support and uphold the fundamental principle that all human life is of value - and no life is worth more or less than any other just because one is weaker or does not vote. To be consistent that means all children in the womb, all young children that are not able to survive on their own, the disabled and handicapped, the elderly, those on death row, the poor. Adult Stem Cells should be the only ones that are allowed to be utilized in research. If there is a life in the balance you cannot weigh one life against the other. The ends do not justify the means. You simply have to, regardless of how hard the road may be, find another way. Death is never an answer and there is no way to rationalize it away. Thank you for your time and consideration.

 
47206 05/26/2009 at 03:49:02 PM Self     I support federal funding for stem cell research. I support this work. I would like to see the guidelines expanded to provide funding for all existing stem cell lines, grandfathering in those that have been derived since 1998, since they are necessary for the most comprehensive study of disease. I support such groundbreaking technologies as somatic cell nuclear transfer, and that it needs to be supported.

 
47207 05/26/2009 at 03:49:18 PM Self     I am a physician and professor at the University of Colorado School of Medicine who has spent decades doing research on Parkinson's disease and other disorders. It is critically important that the federal government support stem cell research in all of its forms. Embryonic stem cell research has been particularly promising for creating specific kinds of cells to treat diabetes, Parkinson's disease, and spinal cord injury. Other kinds of adult stem cells are also proving useful for studying disease and developing treatments.

Now is the best time there has ever been for doing medical research. We scientists need to able to use all the tools available to develop new therpies for disease.

Appropriate regulations are already in place for stem cell research to go forward. As we have seen with genetic research in the past, the scientific community is happy to help in refining regulations that allow ethical research to proceed.

 
47208 05/26/2009 at 03:49:53 PM Organization Council on Governmental Relations (COGR)   A copy of this comment is attached; a paper copy to follow by USPS.

COUNCIL ON GOVERNMENTAL RELATIONS ***** *****

May 26, 2009

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

SUBJECT: Guidelines for Human Stem Cell Research

Dear Dr. Kington:

The Council on Governmental Relations (COGR) is an association of 179 research universities and their affiliated academic medical centers and research institutes. COGR concerns itself with the influence of federal regulations, policies, and practices on the performance of research conducted at its member institutions. Our member institutions welcomed President Obama’s Executive Order 13505 Removing the Barriers to Responsible Scientific Research Involving Human Stem Cells and share the President’s belief that this research has the potential to lead to advances in our understanding and treatment of debilitating diseases and conditions with innovative cell-based therapies.

We support the approach NIH has taken in requiring an assurance in applications and progress reports that cell lines used or to be used in NIH-funded research are derived consistent with the Guidelines and we recognize the organization’s responsibility to maintain appropriate documentation demonstrating that consistency. We appreciate the flexibility NIH provides by not outlining a process for meeting these requirements, thus, allowing grantees the ability to address the requirements in a manner best suited to the institution.

One approach may be the creation of a standard community-designed materials transfer agreement with appropriate appended materials including the consent documentation. Such a material transfer agreement could address access to identifiable private information related to the cell line, including, as appropriate, a prohibition on the release of such information to the investigator. This approach would help clarify whether or not the use of a particular cell line constitutes human subject research. The research community would be well served if NIH would maintain a registry, akin to the current Human Embryonic Stem Cell Registry of lines that meet that are eligible for funding under the Guidelines. A registry will streamline the process of identifying eligible cell lines and assist the community in meeting the requirements for the derivation of lines. Our concerns with the Guidelines are principally with what is not included in the Guidelines or discussed in the Supplemental Information and what is prohibited under the proposed Guidelines.

Current Stem Cell Lines NIH must address the status of currently available human embryonic stem cell lines with regard to eligibility for Federal funding. The Guideline’s eligibility and documentation requirements including written consent for the donation of human embryos for research provide a strong framework consistent with but inevitably different from current community-based standards. We believe that embryos donated and stem cell lines that have been responsibly received and/or derived prior to the adoption of the final funding Guidelines should be eligible for Federal funding. We recommend that, human embryonic stem cell lines created up to the date of NIH’s adoption of final Guidelines, institutions be required to assure that the derivation of the cell lines occurred under the prevailing ethical standards. Specifically, the institution would assure or attest that:

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

The method the institution uses to provide such an assurance should not be limited by NIH nor should the newly defined informed consent requirements be applied to these lines de novo. The same approach should be used for embryos donated for research prior to the issuance of the final NIH Guidelines but not yet used in research.

We are concerned that without a process for “grandfathering” in existing lines, stem cell lines currently in use in research that were responsibly derived may not meet and/or cell line owners may not have documentation that meets the written informed consent criteria outlined in the proposed Guidelines. This may be true of cell lines currently on NIH’s Human Embryonic Stem Cell Registry being used in NIH-supported research. Thus, on-going research with existing lines that provide an important foundation for future work may have to be abandoned. It would be short-sighted to abandon research using well-characterized lines that were developed under guidelines that ensured responsible ethical practices.

Restrictions Based on Sources of Stem Cells

We are disappointed with NIH’s limitation of Federal funding to stem cells derived from embryos created for reproductive purposes and no longer needed for these purposes. Stem cell lines derived from other sources including somatic cell nuclear transfer, parthenogenesis and in vitro fertilization embryos created for research purposes provide lines with significant scientific potential that is beyond what is possible with human embryonic stem cells. The EO placed no such limitations. On the contrary, the President allows support for “scientifically worth human stem cell research, including human embryonic stem cell research, to the extent permitted by law.”

We urge NIH to reconsider its decision to limit the source of stem cell lines for Federally funded research. We are unaware of any scientific or legal reason to deny support for research using stem cell lines derived from these other sources as long as the donation meets the safeguards outlined in the proposed Guidelines. If NIH allows for a broader source of cell lines, those sections of the Guidelines linked specifically to “embryos that were created for reproductive purposes and no longer needed for this purpose” will need to be revised appropriately and the section of the Guidelines that describe Other Non-Allowable Research (Section IV) deleted from the Guidelines.

Removal of Restrictions on Current Grantees

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

Applicability of the Guidelines

The Guidelines for Human Stem Cell Research (the Guidelines) proposed by the National Institutes of Health provide a path for establishing eligible cell lines for Federal funding of human embryonic stem cell research. We believe the title of the Guidelines should be revised to more accurately reflect this scope: NIH Guidelines for Federal Funding of Human Embryonic Stem Cell Research. The proposed Guidelines appropriately apply to NIH funded research. Nonetheless, we urge NIH to take a leadership role in encouraging other Federal agencies that may fund human embryonic stem cell research to adopt the same approach. With a common set of Guidelines, research organizations can offer the assurance required with confidence.

Consent Requirements

We share the concerns expressed by others that the informed consent provisions are very formal and structured in a way that may make it difficult to meet the standards in all cases. For example, the withdrawal of consent until the embryos are used in research is appropriate but should be modified to include use and/or when personal identifiers have been removed, if applicable. NIH should consider providing principles or general standards for informed consent – voluntary, no financial inducements for donation, etc – and allow some flexibility to institutions in evaluating whether the standard has been met.

We appreciate the opportunity to offer comment on the proposed Guidelines.

Sincerely, [Signed]

File Link (.txt)
47209 05/26/2009 at 03:49:57 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 SCI community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

I have lived with a progressive spinal cord condition called Syringomyelia which is an increasing fluid filled space in the center of the cord which over time obliterates ones movements. Stem Cells are my ONLY viable help for my condition and others like me.

 
47210 05/26/2009 at 03:50:57 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.

 
47211 05/26/2009 at 03:51:09 PM Self     I am oppose to the killing of human embryos. The proposed regulations will force taxpayers like me to fund research I believe is unethical because it requires the killing of human embryos. The proposed regulation creates a financial incentive for the creation of more human embryos to be destroyed to obtain their embryonic stem cells. The guideline do not require full informed consent from the parents of the human embryos so that they understand that their options include permission for infertile couples to adopt them.

 
47212 05/26/2009 at 03:52:29 PM Self     Please do not allow public monies to fund research with embryonic stem cells. The progress has been with adult stem cells. We believe it to be not only unnecessary to destroy embryos for research but immoral.

Sincerely,

 
47213 05/26/2009 at 03:52:36 PM Self     This is to inform you that I am completely opposed to the use of my federal tax dollars for embryonic stem cell research as has been proposed by the Obama administration. This decision is immoral and against the wishes of millions of American citizens. The overwhelming scientific and medical conclusion is that each human life begins at conception when the sperm fertilizes the egg. Sex, hair and eye coloring, and many other human attributes are already determined at conception. Hopefully, NIH and its proposed Guidelines will not overlook this scientific evidence and testimony.

 
47214 05/26/2009 at 03:52:47 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 



Go to NIH Stem Cell Information Page