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

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On April 23, 2009, the National Institutes of Health (NIH) published draft stem cell guidelines for public comment in the Federal Register. The purpose of these guidelines are to implement President Barack Obama’s Executive Order 13505 “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells,” which was issued on March 9, 2009.

NIH received 49,015 comments by May 26, 2009, the closing date of the comment period, and have compiled these comments on this website. Any comments received via email or mail after the May 26 deadline are not included on this website. In reviewing the comments, NIH determined that 60 comments were inappropriate (i.e., contained SPAM responses or offensive language), and these comments have been excluded from this website. In addition, to protect the identities and personal information of individuals who submitted comments, NIH has removed personally identifiable information from the comments on this website even though individuals consented that the information provided could be made available for public review and posting.



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48215 05/26/2009 at 10:30:58 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.

 
48216 05/26/2009 at 10:31:10 PM Self     I strongly oppose the destruction (killing) of human embryos to obtain stem cells for research purposes and am, therefore, very much troubled by the proposed new guidelines. I did not support the decision of President Bush which for the first time permitted federally funded human embryonic stem cell research; though I do acknowledge there may be a legitimate comparison of that allowance (which limited use to lines available on or before August 9, 2001) to research using human cadavers. Changing the Bush policy according to the proposed new guidelines, however, is a very different matter; allowing for destruction of countless more human embryos. I believe such destruction to be totally unethical, and citizens like me should not be forced to fund such activity. In our country we do not permit destruction of a human life for any research purposes--regardless of the possibility that such research might lead to treatments and cures of many serious human conditions and diseases--that is, so long as the human life has achieved birth. We should not discriminate against a human life because of stage of development. Every embryo will develop though all stages to birth unless death occurs. Death by the hands of a researcher should not be permitted simply because a human life is at one of the earliest stages of development. It is a matter of justice. Further, aside from these considerations of morality and ethics, it does not seem feasible or logical for ANY available funding to be diverted from research that is already showing such promise in treatments and cures using non-embryonic stem cells obtained from adult tissue and placental cord blood, etc., while research utilizing embryonic stem cells has not provided even a single effective such result. The proposed guidelines open the door to terrible vistas for the respect and dignity of humanity. There is much discussion of "leftover" frozen embryos in fertility clinics. Even if an embryo has been abandoned, however, this does not make it moral or ethical for researchers to have the right of destruction; much less to require taxpayers to pay the cost of that destruction. Biomedical research must not be divorced from respect for human life---at any stage of human life. Patients who are suffering in their lives from devastating illnesses do deserve the best efforts of science and medicine on their behalf, but not at the cost of the destruction of the human life of another--at any stage of development. They absolutely do deserve as much funding as is available for research to be used for that research which shows the most promise. In this matter this is clearly not embryonic stem cell research. It has been reported that Director Zerhouni expressed that the Bush policy was sufficient for basic research. Even in all the privately funded research, use of embryonic stem cells has not produced evidence of the promise already proven using non-embryonic stem cells. We have the proof that non-embryonic stem cells can treat and cure. Why divert resources away from that which is already proving successful and does not have the accompanying moral and ethical complications? Finally, I find it frightening to consider how guidelines such as those proposed could usher in a most terrible policy of "creating to kill".... i.e., the creation of human embryos purposefully generated for research requiring their destruction. This is against every principal of a moral humanity. In his address at Notre Dame, President Obama spoke urging the honoring of consciences and also urged his listeners to "Remember that each of us, endowed with the dignity possessed by all children of God, has the grace to recognize ourselves in one another..." Must we not admit that each of us began our journey to whatever stage of human development we have now reached from the embryonic stage, and had that one and only embryo--which was as surely the person who we are then as is the person who we are today--been destroyed, there would never ever be in the world the persons who are us? These proposed guidelines which violate the consciences of so many whose tax dollars would be used for research we consider unethical and immoral would be a travesty of humane and responsible research guidelines.

 
48217 05/26/2009 at 10:31:46 PM Self     I oppose! That is all needed to be said!

 
48218 05/26/2009 at 10:31:46 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.

 
48219 05/26/2009 at 10:31:59 PM Organization The Stem Cell Advisors, Inc. PO Box 20513; Palo Alto, CA 94309 The Stem Cell Advisors, Inc., (SCA) www.stemcelladvisors.com submits the following comments on the National Institutes of Health (NIH) April 17, 2009 draft guidelines entitled “Draft National Institutes of Health Guidelines for Human Stem Cell Research.” SCA is a public benefit non-profit corporation formed by five faculty members from Stanford University and the University of California. Its mission is to address a growing regulatory gap in the United States and abroad through independent review and oversight of stem cell research for the corporate and non-profit sectors. It has undertaken path-breaking work with non-profit and for-profit entities that have no internal stem cell research oversight (SCRO) capability. SCA also provides consultation and training to scientists, business executives, and regulators on issues of ethics, law, regulation, and policy. SCA is the only such organization in the nation. The principals of the firm have likely reviewed more hESC research protocols than any group in the world.

Our comments focus on the draft guidelines’ treatment of the provenance of stem cell lines eligible for use in NIH funded research, a field in which our firm has particularly relevant experience. Our experience shows that revisions to the draft guidelines relating to these topics are essential to bring the guidelines in line with Executive Order 13505, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.” Of paramount concern are the needs to revise the draft guidelines to avoid (i) inefficiencies and uncertainties in evaluating hESC [human embryonic stem cell] line provenance and eligibility for federal funding, and (ii) the retroactive disqualification of otherwise responsibly derived human stem cell lines.

As a California based entity, SCA and its principals have extensive experience in interpreting different and inconsistent regulatory regimes to academic and commercial stem cell research protocols. We have learned the practical impact of guidelines such as those proposed by the NIH. The application of what may seem to be straightforward standards are often difficult, unclear, time consuming and expensive. Most importantly, ill-conceived rules compromise the quality scientific work, confuse what is expected of researchers, and diminish the value of the science to the public. Well intentioned and thought out rules may inadvertently impose wasteful costs and insurmountable barriers to very research the rules were intended to foster.

Comment 1: Proposed Guideline II.C. This guideline requires funding recipients to ensure that (1) hESC lines used in NIH funded research were derived consistently with the NIH guidelines and (2) their institutions retain “appropriate documentation” to demonstrate that consistent derivation. This guideline, if adopted, would create a redundancy in information collection and evaluation across the field and impede or prevent valuable multi-site (domestic and international) scientific research collaborations. The consequences would extend beyond NIH funded research projects. States and private foundations, the source of significant research dollars, often adopt federal regulations and guidelines as standards applicable to their funded research, and commercial enterprises investing in development of federally funded inventions often require assurances that all work complied with federal requirements.

A centralized hESC line provenance clearinghouse would be a far more efficient method to confirm that a cell line proposed to be used in NIH funded research is appropriately derived. The draft guidelines require each funding recipient or institution to undertake its own data collection and provenance evaluation of cell lines to be used in funded research. Our experience makes it clear that both the data collection and the evaluation process are complicated tasks in which researchers and research institutions are not necessarily expert. Having this information collected and processed by multiple institutions neither advances the objective of Executive Order 13505 nor removes barriers to responsible scientific research.

The user of a hESC line is in the best position to collect derivation documentation. Users and their institutions could supply this information to a central repository in connection with the initial use of lines in an NIH funded project. The repository would have expertise in identifying and evaluating documentation necessary to establish that a cell line was appropriately derived. The clearinghouse would not be a biological registry of line characterization, but an ethical repository of appropriate documentation necessary to ensure that hESC lines used in NIH funded research were derived consistently with the agency’s guidelines. Having a central authority evaluate and store provenance documentation will better protect the public’s interest, ensuring that the NIH only funds research on lines that were derived consistently with federal law and regulation.

While there is some initial cost to setting up the national provenance clearinghouse, it would permit a more efficient use of federal research dollars. Grantees would not have to spend time and resources on redundant tasks of provenance for which they are not expert and which is far from their core mission. While many provenance decisions our straightforward, our experience has shown that some lines present difficult questions. Either a potential grantee will have to avoid using those lines (even if there is a valid scientific reason for their use) or face ongoing uncertainty over liability for unintentionally breaching the guidelines. Additionally, because of uncertainty in whether an applicant made the proper evaluation, co-funders (such as private capital) may demand additional ethical reviews. Similarly, research collaborators will expend resources to justify to each other that their evaluations are correct and negotiate who will bear the risk of a substandard evaluation. At best, this process will result in time delays and needless expenditures; at worst, it will prevent valuable collaborations from taking place.

Comment 2: Proposed Guideline II.B. IIB should be revised to permit continued use of certain cell lines allowable under current NIH guidelines. The proposed rules do not recognize that the concept of responsible derivation evolves with technological advances and community experience with that technology. The lines that the NIH currently permits to be used in its funded research—and other lines used in research worldwide—were made in compliance with the standards for responsible derivation that existed at the time of their creation. Contrary to the executive order, guidelines that remove lines from eligibility for NIH funded research erect rather than remove barriers to responsible scientific research. In finalizing the guidelines, it is critical that NIH provide for the funding and continued use by government grantees of these pre-existing, responsibly derived hESC lines.

Thank you for your consideration of these comments.

 
48220 05/26/2009 at 10:32:00 PM Organization University of Wisconsin Stem Cell and Regenerative Medicine Center T608 Waisman Center, 1500 Highland Ave, Madison, WI 53705 INTRODUCTION I am commenting as ***** of the University of Wisconsin-Madison Stem Cell and Regenerative Medicine Center (SCRMC). The SCRMC includes more than 65 faculty members in a diverse range of disciplines who focus scholarly activity on the study of stem cells and regenerative medicine. Given the pioneering discovery of human embryonic stem (ES) cells by Dr. James Thomson at the UW-Madison, there is a substantial body of ongoing research utilizing human ES cells on our campus. Therefore, I felt it imperative to comment on behalf of the SCRMC regarding the proposed NIH guidelines for human ES cell research.

The signing of Executive Order 13505 by President Barack Obama on March 9, 2009, heralded a major shift in the federal support of human stem cell research. The purpose of the executive order was to remove undue limitations on human ES cell research and to expand NIH support for stem cell research. This policy shift was enthusiastically welcomed by the scientific community including members of the SCRMC. The new policy seeks to ensure responsible research while accelerating discovery and advancing revolutionary therapies for a host of different diseases. However, the proposed new NIH guidelines for human ES cell research would create possible unintended consequences that could actually impede and delay this important area of research. The following problems have been identified.

PROBLEMS 1) The draft guidelines are redundant. Federal regulations protect tissue donors as overseen by Institutional Review Boards with well-defined standards and procedures. Creating separate oversight for human embryonic stem cell research is confusing and wasteful of precious resources.

2) The proposed guidelines in section II are highly prescriptive with regard to the language in the consent process rather than simply focusing on the fundamental principles of informed consent. The consequence of implementing such guidelines could be to exclude human ES cell lines that were derived using fully informed consent. Such excluded lines could include many currently NIH-funded lines for which significant scientific progress has been made. Losing access to these lines and waiting for new ‘approved’ lines would squander major federal investments in this research and substantially delay progress.

3) The documentation required for each ES cell line for each investigator in Section II C is administratively burdensome and time-consuming.

4) Section IV B describing Other Non-allowable Research is unnecessary and could exclude scientifically powerful approaches. Techniques such as somatic cell nuclear transfer, parthenogenesis and others expand the possibilities for research beyond that of embryonic stem cells and should not be categorically excluded.

RECOMMENDATIONS 1) NIH should fund research using lines derived from embryos that adhere to the following core principles: a. Voluntary informed consent according to the Common Rule; b. No undue inducements for participation; c. Independent oversight and review by an Institutional Review Board or an equivalent body.

2) NIH should establish a registry of approved lines to reduce needless administrative efforts and should not require new documentation for current grantees using currently approved lines.

3) Section IV B should be removed from the guidelines, and the NIH should periodically review the guidelines and update them as new scientific approaches become possible.

Thank you for considering these comments.

 
48221 05/26/2009 at 10:32:13 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
48222 05/26/2009 at 10:32:36 PM Self     I request that the NIH use morally acceptable methods of stem cell research (using stem cells obtained from consenting adults and umbilical cord blood) to the extent possible. I urgently request that NIH refrain from using unethical forms of stem cell research, including embryonic stem cells, as this usually destroys the embryo, and thus, a human life. Even if these embryos are "left over" from in vitro fertilization procedures, they are still human beings, and as such, should not be treated as disposable medical tools. Past experience has shown that adult and cord blood cells show more promise and success than embryonic stem cells.

 
48223 05/26/2009 at 10:32:39 PM Self     Stem cell research holds much promise in the search for a cure and better treatments for the nearly 24 million American adults and children with diabetes, as well as those with many other serious medical conditions.

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

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

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

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

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

 
48224 05/26/2009 at 10:33:09 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.

 
48225 05/26/2009 at 10:33:49 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.

 
48226 05/26/2009 at 10:33:57 PM Self     I am opposed to your draft guidelines for embryonic stem cell research, which force me as a taxpayer to subsidize research requiring the destruction of innocent human life. Support should be directed to stem cell research and treatments that harm no one and are already producing good results. In no case should government support be extended to human cloning or other morally reprehensible creation of human embryos for research purposes.

 
48227 05/26/2009 at 10:34:09 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.

 
48228 05/26/2009 at 10:34:17 PM Organization The Ohio State University *****, 190 N. Oval Mall, Columbus, OH 43210 May 26, 2009

Raynard S. Kington, M.D., Ph.D. Interim Director, National Institutes of Health MSC 7997 9000 Rockville Pike Bethesda MD 20892-7997

RE: NIH Guidelines for Stem Cell Research

Dear Director Kington:

Stem cell scientists nationwide are gratified at President Obama’s decision to reverse the severe restrictions placed on embryonic stem cell research under President Bush’s Executive Order of August 9, 2001. The previous eight years in the United States have been a time when U.S. scientists were unable to take full advantage of much of the most exciting, innovative discoveries in stem cell biology due to far-reaching strictures placed on federal funding for embryonic stem cell research. In addition, stem cell scientists in many states were also embroiled in political and moral debates with anti-stem cell activists, which in some cases further eroded promising areas of stem cell research. Thus, the decision made by the President on March 9, 2009 to lift the 2001 Executive Order was a very positive step in uncoupling the scientific debate about optimal stem cell methodologies and potential applications from the polititization of stem cell research.

On behalf of The Ohio State University, we applaud the newly published NIH Draft Guidelines for the renewed promotion of responsible embryonic stem cell research. Many of the elements found within the draft guidelines are quite appropriate; specifically, those provisions outlined in Sections II (“Guidelines for Eligibility of Human Embryonic Stem Cells for Use in Research”) and III (“Research Using Human Embryonic Stem Cells and/or Human Induced Pluripotent Stem Cells That, Although the Cells May Come From Allowable Sources, Is Nevertheless Ineligible for NIH Funding”). The provisions in Section II will serve to protect the rights of individuals who wish to donate preimplantation embryos/blastocysts created for reproductive purposes, but no longer needed for such purpose, while the language in Section III would prevent inadvertant or intentional creation of human/animal chimeras.

However, it is unfortunate that the draft guidelines do not permit support for innovative technologies such as somatic cell nuclear transfer, parthenogenic embryos and the like as outlined in Section IV (“Other Non-Allowable Research”). This is due to the Dickey-Wicker Amendment which attaches to all federal appropriations legislation for the Department of Health and Human Services. Without access to these most innovative experimental strategies and repeal of the embryonic stem cell funding prohibition under Dickey-Wicker, it is very likely that the intent of the President’s reversal of the 2001 Executive Order will not be fully realized.

Finally, as the draft guidelines continue to evolve, it should be emphasized that the NIH must be the leader in this critical area of biomedical research policy, because the void will be filled by a widening of the current tapestry of state legislative measures that, in many instances, threaten rather than promote advancements in stem cell research discovery.

Thank you for the opportunity for the community of research universities to provide vital feedback to NIH for this exciting new development.

Sincerely yours,

****, Ph.D. ***** ***** ***** The Ohio State University

 
48229 05/26/2009 at 10:34:48 PM Organization The Ohio State University *****, 190 N. Oval Mall, Columbus, OH 43210 May 26, 2009

Raynard S. Kington, M.D., Ph.D. Interim Director, National Institutes of Health MSC 7997 9000 Rockville Pike Bethesda MD 20892-7997

RE: NIH Guidelines for Stem Cell Research

Dear Director Kington:

Stem cell scientists nationwide are gratified at President Obama’s decision to reverse the severe restrictions placed on embryonic stem cell research under President Bush’s Executive Order of August 9, 2001. The previous eight years in the United States have been a time when U.S. scientists were unable to take full advantage of much of the most exciting, innovative discoveries in stem cell biology due to far-reaching strictures placed on federal funding for embryonic stem cell research. In addition, stem cell scientists in many states were also embroiled in political and moral debates with anti-stem cell activists, which in some cases further eroded promising areas of stem cell research. Thus, the decision made by the President on March 9, 2009 to lift the 2001 Executive Order was a very positive step in uncoupling the scientific debate about optimal stem cell methodologies and potential applications from the polititization of stem cell research.

On behalf of The Ohio State University, we applaud the newly published NIH Draft Guidelines for the renewed promotion of responsible embryonic stem cell research. Many of the elements found within the draft guidelines are quite appropriate; specifically, those provisions outlined in Sections II (“Guidelines for Eligibility of Human Embryonic Stem Cells for Use in Research”) and III (“Research Using Human Embryonic Stem Cells and/or Human Induced Pluripotent Stem Cells That, Although the Cells May Come From Allowable Sources, Is Nevertheless Ineligible for NIH Funding”). The provisions in Section II will serve to protect the rights of individuals who wish to donate preimplantation embryos/blastocysts created for reproductive purposes, but no longer needed for such purpose, while the language in Section III would prevent inadvertant or intentional creation of human/animal chimeras.

However, it is unfortunate that the draft guidelines do not permit support for innovative technologies such as somatic cell nuclear transfer, parthenogenic embryos and the like as outlined in Section IV (“Other Non-Allowable Research”). This is due to the Dickey-Wicker Amendment which attaches to all federal appropriations legislation for the Department of Health and Human Services. Without access to these most innovative experimental strategies and repeal of the embryonic stem cell funding prohibition under Dickey-Wicker, it is very likely that the intent of the President’s reversal of the 2001 Executive Order will not be fully realized.

Finally, as the draft guidelines continue to evolve, it should be emphasized that the NIH must be the leader in this critical area of biomedical research policy, because the void will be filled by a widening of the current tapestry of state legislative measures that, in many instances, threaten rather than promote advancements in stem cell research discovery.

Thank you for the opportunity for the community of research universities to provide vital feedback to NIH for this exciting new development.

Sincerely yours,

*****, Ph.D. ***** ***** ***** The Ohio State University

 
48230 05/26/2009 at 10:35:02 PM Organization Wisconsin Evangelical Lutheran Synod (WELS) Christian Life Resources, Milwaukee, WI 53222 Never kill a 'potential' child so that the Multiple Sclerosis that I now have will be healed. If advances can be made without causing the death of a humanlife as I understand it can be done, I am for it 100%. But never, never, never kill a potential life!

 
48231 05/26/2009 at 10:35:45 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
48232 05/26/2009 at 10:36:03 PM Self     NIH guidelines as currently proposed prohibits funding for somatic cell nuclear transfer (SCNT). SCNT is a technique that creates disease specific human embryonic stem cells for research and to test therapies. The point of stem cell research, and the spirit of Executive Order 13505, is to expeditiously steam-line therapies and cures for diseases that are debilitating, terminal and currently incurable. For NIH guidelines to exclude funding for the SCNT technique, which is specifically tailored to study and cure disease, seems to go against the very purpose in developing stem cell technology. It reduces the Executive Order signed by President Obama on March 9, 2009 to just another poorly managed federal program from the outset. Also, stem cell research is moving at such a fast pace, and so much is still unknown, that prohibiting funding for particular stem cell lines could slow progress in attaining answers to questions that will lead to saving American lives. Questions that Americans like myself, diagnosed with Amyotrophic Lateral Sclerosis, want answered sooner rather than later.

 
48233 05/26/2009 at 10:36:46 PM Self     Embryonic stem cell research is never ethically responsible as it destroys human life. It is also not scientifically worthy as no cures have come from this destruction of life. Adult stem cells, on the other hand, have produced many exciting breakthroughs--this is where the research and money should be focused.

 
48234 05/26/2009 at 10:37:30 PM Self     I oppose all funding for stem cell research.

 
48235 05/26/2009 at 10:37:35 PM Self     I am opposed to the use of Federal tax payers money being used for the destruction of human embryonic stem cells. Please consider the following information and refrain from using my tax dollars for the destruction of human life. "The beginning of a single human life is from a biological point of view a simple and straightforward matter - the beginning is conception." Dr. Watson A. Bowes, University of Colorado Medical School It is obvious that the current experimentation and research using human embryonic stem cells results in the destruction of a newly developing human being. The research and experimentation necessarily and in premeditated fashion causes the death of a new human life. What is the justification at law for taking human life? Usually, a human life can only be taken when done in self-defense and when there is no other reasonable option. Taking the lives of these new embryonic human lives can hardly be justified as a self-defense measure.

 
48236 05/26/2009 at 10:37:58 PM Self     The proposed text is unclear on who the "donor" is. Does "donor" refer to the female who gave the egg, the male who provided the sperm, or both? Or, does "donor" refer to a third party (or parties) who, being biologically unable to conceive, arranged for fertilization and embryo storage? In the worst-case scenario, a male sperm donor, female egg donor, and a divorced couple are at odds to the disposition of the embryo. Who has the final say?

While the text prohibits financial reimbursement to the "donor", the text is silent concerning the payment to reproductive service providers. It is common that fertility clinics have a "more is better" approach, which results many times in multiple pregnancies (think OctoMom). This practice often puts the mother's health in jeapordy, and imposes increased medical costs to the mother and to society (again, think OctoMom). The guidelines, as written, create a financial incentive for clinics to create additional unwanted embryos, not for the good of the patient, but for the financial gain of the clinic. The patient will bear the expense of creating these embryos. **This is unacceptable**.

 
48237 05/26/2009 at 10:38:53 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders--such as multiple sclerosis. I am not a scientist, but I have been following progress in this field with great interest.

Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

Thank you!

 
48238 05/26/2009 at 10:38:59 PM Self     I support the position of the California Institute for Regenerative Medicine (CIRM) to improve the new federal stem cell research funding guidelines.

 
48239 05/26/2009 at 10:39:57 PM Organization Prevent Cancer Foundation 1600 Duke Street, Alexandria, VA 22314 Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders, including cancer. The Prevent Cancer Foundation has been following progress in this field with great interest and has engaged in advocacy in support of a Federal commitment to embryonic stem cell research. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

Thank you.

 
48240 05/26/2009 at 10:40:08 PM Self     Dear Sir or Madam,

We are writing today to express our profound objection to the proposed regulations around embryonic stem cell research. We oppose the thought that a human embryo would be subjected to having genes or cells removed for the purpose of having experiments done on them, and then killing the embryo after those cells are removed. It is a scientific fact that an embryo is a unique human individual, with DNA unlike any other person. The rights of these human persons in the earliest moments of their development must be upheld as they are for each of us.

We are also opposed to embryonic stem cell research, which force us as taxpayers to subsidize research requiring the destruction of 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.

From all the research and data submitted to your organization it is evident that embryo-destructive stem cell research has not produced any benefits or even hinted at treatment for any other human. Furthermore, we are not a nation that lethally forces one person to provide cells or organs for another, therefore it is inconsistant that embryonic stem cells can be taken for any reason, against that embryo's and parent's consent. On the other hand, adult stem cells are 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.

Lastly, the proposed regulations do not stop funding for embryonic stem cell research that might lead to cloning and human-animal hybrids. This loophole is more than amoral and must be closed immediately.

 
48241 05/26/2009 at 10:40:27 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.

 
48242 05/26/2009 at 10:40:29 PM Self     This is to inform you that I am absolutely 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. Furthermore, it is completely opposed to the most recent scientific data, which proves the effectiveness of adult stem cell research, and the utter uselessness of embryonic stem cell research, morality aside. On the point of morality, howver, 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.

 
48243 05/26/2009 at 10:40:44 PM       Why use cells from human embryos when there is no positive research that these live cells frozen or from aborted babies are successful in saving lives. Spend the research money on adult stem cells or the cord from delivered babies. Embryonic stem cell research could become barbaric. Don't risk it.

 
48244 05/26/2009 at 10:40:48 PM Self     I oppose killing human embryos. The proposed regulations will force taxpayers like me to fund research I believe is unethical because it requires the destruction of human embryos. Expanding funding to new human embryonic stem cell lines will divert federal funds away from promising research treating people now with adult stem cells and will divert funds away from other sources of embryonic-like stem cells that have been generated without the use of any human embryos. The proposed regulations create a financial incentive for the creation of more human embryos to be destroyed to obtain their embryonic stem cells. The guidelines do not require any separation between an IVF doctor and an ESCR researcher. The guidelines say they "should" be separate, but only when practicable. The guidelines allow any IVF doctor to create more embryos than are needed for fertility purposes in order to generate more so-called "leftover" embryos for ESCR research using taxpayer funds. Instead of preventing any future expansion of funding for ESCR on unethical experiments involving human clones and human-animal hybrids, these regulations open the door for such funding whenever NIH wants in the future. The guidelines do not require full informed consent for the parents of the human embryos as to their options for their human embryos to be adopted by other infertile couples.

 
48245 05/26/2009 at 10:40:52 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.

 
48246 05/26/2009 at 10:41:37 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

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

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

 
48247 05/26/2009 at 10:41:40 PM Self     These guidelines should not be enacted because they provide a financial incentive to create human embryos for the purpose of destroying them to obtain their embryonic stem cells. There is also a significant risk that millions of poor, disadvantaged women will be exploited in the process (see http://www.stemcellresearchfacts.com/articles/PiaDeSolenniTestimony.pdf ). Promoting such a state of affairs is unethical and irresponsible. It is especially so when adult stem cell research has yielded so many successful cures and treatments without destroying or harming human life. Expanding funding to new human embryonic stem cell lines will divert federal funds away from the promising research with adult stem cells. This will delay adult stem cell treatments and cures. These new guidelines put the health of Americans in danger. To ensure that NIH-funded research is ethically responsible and scientifically worthy, it must avoid the incentives to destroy human life and exploit women while putting patients first by directing federal funds toward the real treatments and real promise of adult stem cells.

 
48248 05/26/2009 at 10:41:53 PM Organization The Tennessee Center for Bioethics & Culture   The Tennessee Center for Bioethics & Culture supports ethical research that benefits people. To that end, adult stem cell research and research utilizing induced pluripotent stem cells (iPS cells) should be encouraged. Embryonic humans are not appropriate subjects for research, as they are, by nature of their immaturity, unable to give consent, and are destroyed in the research process. Embryonic stem cell research is not a venue in which our tax dollars should be used. Even Ian Wilmut, famed cloner of Dolly, sees the utility of iPS cells as a better alternative than embryonic stem cells. (http://www.genethique.org/tribunes_mensuelles/mai_2009.asp)

Regarding the “Draft National Institutes of Health Guidelines for Human Stem Cell Research Notice”, under "II. Guidelines for Eligibility of Human Embryonic Stem Cells for Use in Research", we propose the following alterations:

7 (b) should be modified to include this: Embryos are humans in the earliest stages of development. Therefore, alternatives specified should include the implantation into the hormonally prepared uterus of the donor or chosen surrogate mother, as well as donation to research.

To 7 (g) should be added " . . . and any patents or profits from this research will not benefit the donors or the embryos."

 
48249 05/26/2009 at 10:42:22 PM Self University of Chicago Chicago, IL 60615 The guidelines as formulated are unacceptable for the following reasons: 1. The rationale for retrieval of stem cells from embryos is the hope of more knowledge and therapeutic effectiveness. But stem cells derived from adult tissue have already provided scientific knowledge and have proved therapeutically effective in treatment of specific conditions. 2. Unlike embryonic stem cells, stem cells derived from adult tissue are a means of overcoming the risk of immunorejection (when transferred to the same adult). 3. Retrieval of embryonic stem cells directly destroys the possibility of further development of the embryo; it thus differs from permitting embryos to expire. This difference is analogous to the difference between directly killing people (always illegal and immoral) and allowing them to die (legal and morally justifiable in certain circumstances). It is surely morally wrong to kill a living human being just because no one is willing or able to prolong its life. 4. Although human embryos are not legally persons, they are indisputably human and living as long as they continue to have the capacity to develop. 5. Although US law does not consider developing human embryos as persons, neither does it preclude that possibility (despite Roe v Wade). A basic principle of ethics is that the possibility of a great good (in this case, ongoing development) implies obligation to act so as not to curtail that possibility.

 
48250 05/26/2009 at 10:42:31 PM Organization California State University, Fullerton 800 N. State College Blvd, Fullerton, CA, 92831 Two critical changes need to be made to the current draft guidelines. First, I believe that a major flaw exists in section II. B, "Eligibility of Human Embryonic Stem cells for Use in Research". While this section provides a reasonable standard for the eligibility of human embryonic stem cell lines derived in the future, it does not recognize the existence of hundreds of stem cell lines currently in use in research labs across the United States. While these existing lines were derived according to the most ethical standards recognized at the time of derivation, they may not meet in every detail the new, more rigorous standards set forth in the NIH draft guidelines. To prohibit their eligibility for federal funds under this new policy would do great harm to the field of stem cell research. Federally funded researchers would be forced to stop their work and wait for a yet unknown number of new embryonic stem cells that comply with the new NIH guidelines to be derived. Such a halt to research would be detrimental to the scientific community's progress and devastating to patients around the world who might benefit from this important research. Therefore, I urge the NIH to include a provision within Section II to allow human embryonic stem cell lines previously and ethically derived to be eligible for use in federally funded research under these guidelines. Instead of requiring previously derived cell lines to comply with either the National Academy of Sciences (NAS) guidelines or the guidelines by the International Society of Stem Cell Research (ISSCR), I ask the NIH to consider a different standard. I recommend that the final guidelines allow NIH funding for any lines derived prior to the implementation of the new policy that had been derived: a) with informed consent, b) without undue inducement, and c) with oversight by an ethics advisory committee, such as an Institutional Review Board. Second, I also urge the replacement of section II C, "Prior to the Use of NIH Funds". The requirement that each recipient of federal funds ensure the compliance of the cell lines to be used would be administratively burdensome and unnecessarily restrict research. Under the draft guidelines, each investigator who wishes to use a cell line in his or her research must provide assurances that the cell line complies with the NIH Guidelines. This repeated reauthorization of the same cell lines seems unnecessary. It is also possible that different institutions might judge the eligibility of the same cell line differently. This lack of uniformity threatens the free flow of scientific investigation. To avoid bureaucratic and legal confusion, I ask the NIH to establish an NIH registry of human embryonic stem cell lines available for federally funded research. When a cell line is first used in federally funded research, assurance documentation should be submitted to an NIH-run registry. The registry would allow researchers to review the cell lines that meet the NIH guidelines and then apply to use those stem cells lines. Thank you for your time.

 
48251 05/26/2009 at 10:42:41 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.

In brief, since I don't want anyone to kill me, I don't want taxes paid by me to support the killing of anyone else, including the tiniest of human beings, human embryos.

 
48252 05/26/2009 at 10:43:38 PM Self     I am a stem cell researcher at the University of Wisconsin. I strongly support the change in policy put forth in President Obama’s March executive order regarding human embryonic stem (ES) cell research. However, the proposed NIH guidelines may have unintended consequences and greatly impede current research efforts by disqualifying some widely used and currently NIH-eligible human ES cell lines. Although I strongly support the derivation of human ES cells following rigorous ethically standards, the highly prescriptive consent language proposed in the guidelines may exclude cell lines that were derived in adherence to the relevant ethical standards. The inability to continue the use of currently available human ES cells would be highly detrimental to many ongoing research projects and be wasteful of the millions of dollars that the NIH has invested in these studies. Furthermore, the ability to expand the scope of available human ES cell lines for NIH-funded research will be greatly delayed if the strict consent form language is required, since most privately funded lines do not exactly adhere to the proposed language.

As an alternative approach, I suggest that the final guidelines allow NIH funding for any lines that have been derived: a) with informed consent, b) without undue inducement, and c) with independent oversight by an Institutional Review Board or equivalent body.

A second suggestion is that the NIH or a designated body maintain a registry of approved lines to avoid unnecessary administrative efforts that could delay the research.

Thank you for considering these concerns and suggestions

 
48253 05/26/2009 at 10:43:40 PM Self     In the current guidelines the donors of the egg and sperm are the only ones who can give permission for the use and destruction of the embryo in order to obtain embryonic stem cells. These donors are actually the "parents" of this new human life. Can parents ordinarily "sacrifice" their children for research and experimentation which is not intended for the benefit of the children? Could parents agree to give up both kidneys of their child to help another human being, knowing this double-kidney donation will cause their child's death? I assume the answers to these questions are obvious. Please note that I have two biological children with type 1 diabetes. Can we find a cure for this disease without taking another PERSONS life for research and experimentation?

 
48254 05/26/2009 at 10:44:19 PM Self     Referring to the summary: it is precisely because research using human embryonic stem cells is neither "ethically responsible" nor "scientifically worthy" that I object to the proliferation of this research.

In every era, individuals viewed as forward-thinking try to explain why denying human rights to a very small or weak or disenfranchised segment of humanity will benefit the rest of us. Let us not keep making the same mistake.

The therapeutic potential of induced pleuripotent stem cells has so rapidly outstripped embryonic stem cells that leaders in the field have proclaimed HESC research "over." The ready availability of the cells, the match to the recipient obviating the need for chemotherapy, and the lack of tumor growth in induced pleuripotent stem cells are only three reasons why HESC research should not be funded by taxpayers.

Thank you for your attention to this matter. *****, M.D.

 
48255 05/26/2009 at 10:44:36 PM Self     I believe that if anyone's own life or family member's life was at stake they would encourage this type of research. I am in favor of science and all that it has brought us in the past and will bring us in the future.

 
48256 05/26/2009 at 10:45:27 PM Self     Stem cell is an opportunity to cure and give individuals with debilitating diseases the chance for a normal life. Stem Cell research needs to be funded and kept going. Drugs and the greed from the drug manufacturers is not the answer for cures. Please keep stem cell research alive.

 
48257 05/26/2009 at 10:45:36 PM Self     Please reconsider your position on stem cell research and allow this valuable research to continue at places like the Buck Institute in California.

 
48258 05/26/2009 at 10:45:58 PM Self     I oppose killing human embryos. The proposed regulations will force taxpayers like me to fund research I believe is unethical because it requires the destruction of human embryos.

 
48259 05/26/2009 at 10:46:15 PM Self     I totaly am against my tax dollar being used for a kind of research that is harmful (tumors causing) and costly. All our efforts should be used in adult or umbilical cord stem cells. Even researchers have stated that the cures and advancements found in stem cells are the most worth while. This administration has proven itself to be on top of things, yet you are ignoring the obvious. This makes the public suspicous as to why the Obama administration is so insistant on following this course of action in using embryonic stem cells. The political campagin promises and rhetoric are perhaps where the pressure is coming to bear.Prove yourself; you do not want the media to do to you what they did to the Bush administration.

 
48260 05/26/2009 at 10:46:19 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
48261 05/26/2009 at 10:46:23 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.

I ask that you use my tax dollars for adult stem cell research and not for destroying embryos. Thank you for your consideration.

 
48262 05/26/2009 at 10:47:25 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.

 
48263 05/26/2009 at 10:48:08 PM Self     The National Institutes of Health should rescind its guidelines proposing to use federal funds for stem cell research that requires destroying live human embryos. It is especially troubling that some supporters of this research are urging the NIH to endorse an even broader policy, encouraging the deliberate use of in vitro fertilization or cloning to produce human embryos for stem cell research. Such creation of new life solely to destroy it would mark the final reduction of human beings to mere objects or commodities.

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

 
48264 05/26/2009 at 10:48:18 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.

 
48265 05/26/2009 at 10:48:35 PM Self     Adult Stem Cell research has cured 73 diseases. Embryonic destructive stem cell research has cured NONE. Score: 73 - 0. Adult stem cell research helps save lives, while embryonic destructive research destroys lives at taxpayer's expense. Neither my husband nor myself want our taxes going toward destructive of human lives. According to our moral and religious beliefs, embryonic stem cell research is wrong and violates our consciences.

According to science, embryonic stem cell research in ineffective. Therefore, it is a waste of our money.

 
48266 05/26/2009 at 10:48:50 PM Self     mbryonic 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.

 
48267 05/26/2009 at 10:48:54 PM Self     Re: Scientifically worthy - Although billions of dollars have been poured into embryonic stem cell research (using private dollars), there has not been one single cure for any human illness with embryonic stem cells. Non-embryonic stem cells, however, continue to provide cures for a few thousand patients with over 70 diseases.

Embryonic stem cells have also consistently proved that fatal tumors can form when the cells are manipulated in order to use in a variety of treatments. An additional problem with embryonic stem cells has occurred because they are not patient-specific. Many have had severe immune rejection reactions.

 
48268 05/26/2009 at 10:49:13 PM Self     Please stop all federal funding of embryonic stem cell since it has never proven to heal/ help anything as adult stem cells have as well as IPCS has so much potential without the ethical issues. Respect our beliefs when using our money.

 
48269 05/26/2009 at 10:49:15 PM Self     To President Obama's administration and the NIH, I am opposed to these draft guidelines for embryonic stem cell research. I do not want this research to be funded especially as it requires taxpayers to fund it. I was an embryo and each of you began as an embryo. This research requires the destruction of human life and I oppose this. Our government should NEVER support the creation of human embryos for research purposes and it should NEVER support human cloning. Because embryonic stem cell research has shown itself as ineffective, even dangerous (due to forming uncontrollable tumors and causing rejection problems), I only support adult stem cell research. Adult stem cells are ethical, non-controversial and have been EFFECTIVE in treating patients. Why should we fund research that destroys human life (embryonic stem cell research) when adult stem cell research is available and we have proof that it works??? Finally, the proposed regulations has a loophole that does NOT prevent future funding for embryonic stem cell research that could lead to the creation of human clones and human-animal hybrids. This loophole must be closed. As a mother, neonatal ICU nurse, and as a former embryo, I oppose these guidelines. Our government's job is to protect human life, not to destroy it.

 
48270 05/26/2009 at 10:49:19 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.

 
48271 05/26/2009 at 10:50:04 PM Self     We need to keep up with the other countries and stem cell is the answer. The U.S. is forcing its citizens to seek answers in other countries because they are so much further advanced. We need to grant our country the same rights and support something positive that gives people a chance for a better life.

 
48272 05/26/2009 at 10:50:08 PM Self     Please do not force taxpayers with your guidelines for EMBRYONIC stem cell research to subsidize research requiring the destruction of human life. It is commonly known in the scientific community that life begins at fertilization. Please direct your efforts toward ADULT stem cell research, which is showing promise and not tumors - and can be considered ethically responsible and scientifically worthy. The proposed regulations do not prevent future funding for EMBRYONIC stem cell research that could lead to clones and human-animal hybrids. Please close this loophole.

 
48273 05/26/2009 at 10:50:15 PM Self     I oppose killing human embryos. The proposed regulations will force taxpayers like me to fund research I believe is unethical because it requires the destruction of human embryos. The draft regulation guidelines do not require full informed consent for the parents of the human embryos as to their options for their human embryos to be adopted by other infertile couples.

 
48274 05/26/2009 at 10:50:42 PM Self     These guidelines should not be enacted because they provide a financial incentive to create human embryos for the purpose of destroying them to obtain their embryonic stem cells. There is also a significant risk that millions of poor, disadvantaged women will be exploited in the process (see attached testimony or the link http://www.stemcellresearchfacts.com/articles/PiaDeSolenniTestimony.pdf ). Promoting such a state of affairs is unethical and irresponsible. It is especially so when adult stem cell research has yielded so many successful cures and treatments without destroying or harming human life. Expanding funding to new human embryonic stem cell lines will divert federal funds away from promising research with adult stem cells. This will delay adult stem cell treatments and cures. These new guidelines put the health of Americans in danger. To ensure that NIH-funded research is ethically responsible and scientifically worthy, it must avoid the incentives to destroy human life and exploit women while putting patients first by directing federal funds toward the real treatments and real promise of adult stem cells.

File Link (.txt)
Testimony by Pia de Solenni, Ph.D.
48275 05/26/2009 at 10:51:22 PM Self     Adult Stem Cell research has cured 73 diseases. Embryonic destructive stem cell research has cured NONE. Score: 73 - 0. Adult stem cell research helps save lives, while embryonic destructive research destroys lives at taxpayer's expense. Neither my wife nor myself want our taxes going toward destructive of human lives. According to our moral and religious beliefs, embryonic stem cell research is wrong and violates our consciences.

According to science, embryonic stem cell research in ineffective. Therefore, it is a waste of our money.

 
48276 05/26/2009 at 10:51:50 PM Self     The proposed regulations will force taxpayers like me to fund research I believe is unethical because it requires the killing of human embryos.

To expand the funding to new human embryonic stem cell lines will divert federal funds away from promising research that is treating people now with non-embryonic stem cells and will also divert funds away from other sources of embryonic-like stem cells that have been generated without the use of human embryos.

The proposed regulations create a financial incentive for the creation of more human embryos to be destroyed to obtain their embryonic stem cells.

The guidelines do not require any separation between an IVF doctor and an ESCR researcher. The guidelines say they "should" be separate, but only when practicable. The guidelines allow any IVF doctor to create more embryos than are needed for fertility purposes in order to generate more so-called "leftover" embryos for ESCR research using taxpayer funds.

Instead of preventing any future expansion of funding for ESCR on unethical experiments involving human clones and human-animal hybrids, these regulations open the door for such funding upon the order of NIH.

Rather, funding should be used to promote ethical, non-embryonic/ adult stem cells.

 
48277 05/26/2009 at 10:53:33 PM Self     The portion of the document that states, "The purpose of these draft Guidelines is to... help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law." begs the question of WHAT STANDARD is being used to define ETHICAL. The only absolute standard is God's law, and the Bible is clear that the unborn are to be treated as human life. This executive order and those who endorse it are encouraging the destruction of HUMAN LIFE, and using MY TAX DOLLARS to fund it. I am strongly opposed to the destruction of human life for any purpose, no matter how noble it is made to sound.

"those 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."

Life was created by a couple for "Reproductive purposes". Once fertilization occurred, mission accomplished. Life was formed. The option to destroy that life, because the couple "no longer needs it" is not justification for the destruction of life. This poorly executed decision devalues human life, and opens the door to consider the elimination of other people that might be "no longer needed", and I am against its implementation.

 
48278 05/26/2009 at 10:54:17 PM Self     I am completely against utilizing human embryonic stem cells for any type of experimentation. I am opposed to human embryonic stem cell destruction, and using federal funds for hyman embryonic stem cell experiments.

 
48279 05/26/2009 at 10:54:19 PM Self     1. THE MISSING KEY CONDITION JUSTIFYING USE OF AN EMBRYO AS AN HESC SOURCE Demand by funded investigators for human embryonic stem cells (‘hESC’) will induce embryo-destructive derivations of hESC. Heeding this, the drafters of the Guidelines recognize that using a line hESC will be morally permissible only if the previously occurring derivation of those hESC was permissible. For permissibility of hESC derivation from an embryo, the Guidelines demand the satisfaction of conditions pertaining to the embryo’s donation. These conditions are set forth as II.B.1–7 of the Guidelines and hereafter called the ‘Guideline Donative Conditions’ (‘GDC’).

As the following will explain, NIH is correct to suppose that the permissibility of a derivation turns on the circumstances of embryo donation. But the GDC present a problem of underinclusiveness and overinclusiveness. On the one hand, conspicuous by its absence from the GDC is the condition most crucial to the moral permissibility of using donated embryos solely as means (the general practice of which hESC derivation is a special case). The omitted condition is that the embryo donors have prohibited intrauterine transfer. On the other hand, some of the GDC are not requisites of permissibility. The straightforward solution to this problem is to insert the crucial condition and to omit the nonrequisites. The dual effects of this solution will be, first, to establish tenable criteria determining which new cell lines will be eligible for use in funded research, and second, to provide in a principled way for eligibility of extant lines. I recently published a study, *****, hereafter denoted as ‘M,’ that presents a putative consensus justification for embryo use in medicine, and for embryonic stem cell research in particular. Much of the reasoning presented below encapsulates reasoning developed there. Bracketed references to M below denote the full development of the respective topics. The first section of these comments, directed toward the first of the foregoing effects, will present reasons for the following. (1) The significance of the GDC, and any alternative conditions of embryo donation, is not scientific but moral. The test of adequacy is whether satisfaction of proposed conditions yields a tenable moral justification for embryo sacrifice. (2) To be tenable, a candidate justification must be a justification on which a federal agency operating within our constitutional system may predicate policy, and must be a justification that falls within an overlapping consensus on conceptions of justice, as best we may espy such, within our pluralistic society. (3) The respective insularities and defects of the commonly invoked defenses for using donated embryos disqualify any of those standard defenses from serving as a consensus justification. Although informed consent is necessary for use of cells taken from fertility patients and their coprogenitors, informed consent by them does not justify use of embryos formed from those cells. The set of plausible justificatory conditions has been winnowed to that condition that happens to be missing from the GDC. (4) The justification clinched by a progenitor prohibition on intrauterine transfer may be advanced within public reason without appeal to any premise peculiar to any particular moral or religious view, and hence such justification occupies a place in an overlapping consensus. (5) Absent such prohibition, embryo use is not justified. (6) It is therefore appropriate to adopt a rule in a text to be proposed setting forth requisites for use of embryos as hESC sources. (7) Nonrequisite conditions warrant a place in the Guidelines, but should be recast as indicia of satisfaction of the requisites.

1.1 DONATIVE CONDITIONS ARE MORAL CONDITIONS

Given the separation of church and state, not to mention the range of moral and religious views held within our pluralistic society, the drafters of the Guidelines do not regard themselves as arbiters between rival moral views. But the drafters inexorably are crafting rules for moral effect. No scientific considerations the conditions that a fertility patient has received an explanation of options. Or that no one has offered her inducements, or that she has consented to something. It is concern for morality, knowing that embryos are an object of moral concern, that motivates such rules. Because hESC research lies at the intersection of science, morality, and policy, the drafters are faced with the need to define research that, by some account that the government may tenably suppose, is morally justified (or in their phrase, is “ethically responsible” [74 Fed. Reg. 18578]). Given this motivation of the GDC, we must ask the question, are the GDC the factual conditions of a tenable justification?

1.2 THE CONSTRAINT OF PUBLIC REASON

The only way to answer that question is to ascertain the methods and sources to which the government may have recourse in deciding what constitutes a justification of embryo use. Moral permissibility is not a matter of fact, but often a bone of contention between competing moral views. But this is a case in which we as citizens, and the government on our behalf, may productively seek an understanding of what is permissible by confining ourselves to reasoning that does not invoke any premise peculiar to any particular moral or religious view. We may impose on ourselves the constraint of “public reason” developed by the philosopher John Rawls (“The Idea of Public Reason Revisited,” 64 University of Chicago Law Review 765–807 [1997]). When operating within public reason, we accord respect to verdicts rendered by comprehensive moral and religious views, but on questions of justice discussed in the public arena, we demand of all discussants not only that they conform to principles of reasoning and rules of evidence, but that they support their verdicts with reasons that lie within an overlapping consensus of conceptions of justice. Discussants may press a conclusion by appeal to a doctrine of their particular moral or religious view only if they can independently support the conclusion by reasoning that falls within an overlapping consensus. For example, the Aristotelian-Thomistic view that a conceptus is not ensouled until day 40 in the male and day 90 in the female [M, 155–158], or the Judaic doctrine that a conceptus is “mere water” prior to day 40, cannot be offered as justifications for hESC research, since those tenets lack such independent support. When a resolution of an issue is reached through public reason, the resolution will enjoy better prospects for stability and harmony than those of resolutions reached by mere majoritarian rule, or by selecting one secular view over others. Sometimes adherence to public reason issues in a resolution even of vexing matters, and sometimes not. I have constructed, by adhering to public reason, a consensus justification for the use of donated embryos in service of humanitarian ends, of which hESC research is a special case. This is mentioned in section 1.4. Its value will become more clear by first mustering the other defenses of such research. We discover that after subjection to the tests of logic and public reason, none of the nonsecular defenses are left standing. 1.3 FAILURE OF CONVENTIONAL DEFENSES OF EMBRYO USE

1.3(a) STANDARD NONSECULAR ARGUMENTS

Leaving aside secular arguments, which unless independently supported are unavailable to the government by virtue of the separation of church and state, not to mention the constraint of public reason, the most familiar argument for embryo use is that the subject embryos will die anyway. This argument is defective. Imminent death by one means does not alone justify a killing by another means [M, 51–52]. A utilitarian defense of embryo use also founders, this for inability to adduce unit comparable interval scale utility measures, and of course holds no water for nonutilitarians [M, 12–19]. The nonindividuation argument predicated on the possibility of monozygotic twinning has been refuted by the counterexample of mitosis, and exposed as unsound in other respects, while all attempts at rehabilitation have failed [M, 59–98, 148]. The view that a microscopic embryo “does not seem like a person to me” is parried by discussants who declare that every embryo “does seem like a person to me.” The contention that an embryo is a “clump of cells” is refuted by noting that the contention fails to take account of potential. The surprising discovery is that, even when sympathetically viewed, each of the nonsecular arguments for embryo use founders in some way [M, 4, 56, 146, 148, 189–190, 214–217]. 1.3(b) INFORMED CONSENT OF PROGENITORS, THOUGH NECESSARY TO JUSTIFY USE OF CELLS TAKEN FROM THEM, IS NOT SUFFICIENT TO JUSTIFY USE OF EMBRYOS

The orthodox justification for use of a human subject in research is informed consent. Many drafters of hESC policy and legislation, with ample support from commentators, have supposed that justification of embryo use follows from informed consent of embryo progenitors. So the drafters have trained their sights on prescribing that donees of embryos obtain progenitor informed consent. They draft procedures therefor, or they prescribe compliance with the Common Rule (45 CFR Part 46). In the GDC, apart from the conditions that the embryos were created “for reproductive purposes” and “were no longer needed,” the principal weight-bearing member is informed consent, as evidenced by a “written consent form for donation” (II.B.7, par. 1). The other conditions of the GDC may be understood to subserve this member insofar as they provide for its parts (e.g., voluntariness and understanding of pertinent information). But the aforementioned supposition that embryo use is justified by progenitor informed consent is mistaken [M, 231–232]. Informed consent is justificatory if (i) the research subject and the person consenting are identical, or (ii) for subjects incapable of consenting or of discerning their best interests, if another person consents while acting on behalf of and in furtherance of the best interests of the subject. In the case of embryos donated for use in experiments that will destroy them, neither (i) nor (ii) obtains. An embryo is not a body part of either progenitor, but a distinct cleaving human organism, the embryo is incapable of consenting, and there is no sense in which killing the embryo may be said to serve its interests. While informed consent avails for experiments involving subjects whose welfare is protected (as in 45 CFR 46.116) in the hope that they will survive, it does not avail for subjects that assuredly will be killed.

Informed consent is necessary for permissibility of embryo creation in fertility care. (The mother’s informed consent is necessary to justify recovery and use of her oocyte; the male coprogenitor’s consent is necessary for use of his sperm. Some may argue that paternal consent is not requisite, but promulgation of the present policy does not seem an appropriate occasion for the federal government to stake a claim to that controverted position.) But progenitor informed consent is not sufficient for use of embryos as means. There is a progenitor act that does ground a justification of embryo use. To that we now turn.

1.4 ARGUMENT FROM NONENABLEMENT AND ITS LINCHPIN

The aforementioned consensus justification for hESC research rests on the following “argument from nonenablement” [M, 21–58]. A woman from whose oocyte an extracorporeal embryo is formed is, with the coprogenitor, the only person in the world privileged to decide whether the embryo will be transferred to a uterus. Although progenitors do not own embryos, we deny that anyone but progenitors is privileged to meddle in decisionmaking about them. The progenitor privilege is exclusive in default of anyone else possessing the privilege. A woman does not lie a duty to undergo a transfer into her of an embryo existing outside her. Nor does she lie under a duty to surrender for adoption an embryo that she declines to bear, as imposing that duty would present such adverse incentives and consequences for fertility patients, including compelled remote parenthood, that we should be hard pressed to find any moral view asserting the duty. A decision to decline intrauterine transfer into self or other is a morally permissible exercise of discretion. Suppose then a progenitor exercise of discretion to decline intrauterine transfer of an embryo, followed by donation of the embryo under instructions specifying that the embryo be used in medical research or therapy, and forbidding transfer of the embryo or of any totipotent cell taken from the embryo into a woman or into an artificial uterus. This is a restricted gift, a donation conditioned on a prohibition. While a genetic account of developmental potential eludes us, we may observe the boundedness of situation-dependent potential as represented by a probability density function of a continuous random variable defined on a sample space of developmental outcomes. In consequence of the progenitor prohibition on intrauterine transfer conditioning the gift, the embryo will never gain the enabling environment of a uterus and is confined to the tissue culture dish. There its developmental potential is so bounded that the embryo will not complete gastrulation. We, any of us, could not gain anything for this embryo—nor for any other being—by classifying the embryo as a person for purposes of the duty not to harm. We cannot provide the embryo gestation, which has permissibly been barred, nor spare the embryo discomfort or frustration, as the embryo cannot attain the capacity to experience either. By forgoing use of the embryo in research, we may only assure that the embryo perishes in vain. During the embryo’s remaining life, it is not nomologically possible for it to acquire any morally significant property that it does not already possess. Hence if we do not presently classify the embryo as a person, no possible person may plausibly be said to correspond to the embryo. Meanwhile scientists reasonably believe that use of embryos in research could contribute to the relief of human suffering. Embryos barred from the womb present a means by which we might relieve suffering in actual lives at no cost in potential lives. In this situation, the duty of mutual aid—the duty to aid those in need when we may do so without imposing an unreasonable burden—bids us undertake such research. Whereupon it becomes not only permissible and virtuous to use donated embryos in such research, but a fulfillment of a collective duty.

The argument from nonenablement is a consensus argument insofar as it does not invoke any premise peculiar to one or another moral or religious view. The bounded developmental potential of an embryo in the dish is a biological circumstance. The duty of mutual aid, the discretion of persons to elect whether they shall undergo medical procedures—these are common to all leading moral and religious views. Hence it can be shown that the argument from nonenablement compels assent even within those moral and religious views commonly interpreted to condemn all embryo use [M, 140-180]. In short, the argument from nonenablement occupies a place in an overlapping consensus of conceptions of justice.

Public policy may gather the widest and most stable support by locating hESC research transparently within conduct shown morally permissible—this as best public reason allows us to see the conditions that confer permissibility. On the basis of the argument from nonenablement, we arrive at the following Public Policy on Embryo Use: “Scientists may conduct, and the government shall support, biomedical research using human embryos that, before or after formation, have been donated to medicine under donor instructions forbidding intrauterine transfer” [M, 234]. (As the phrase “before or after formation” indicates, the argument from nonenablement justifies creation of embryos in research as well as use of surplus embryos. But only the latter practice is pertinent to the Guidelines.) According to the argument from nonenablement, permissible exercise of discretion to bar an embryo from the womb so bounds the developmental potential of the embryo as to ground a justification for its use by a donee. The justification of hESC use thus devolves from autonomous decisions of people from whose cells extracorporeal embryos originate. These are active and unilateral decisions, not mere consents to what someone else proposes. First, progenitors who give embryos to medical research and therapy do not merely acquiesce, they choose. Apart from the earlier mentioned inefficacy of progenitor informed consent, the expression “written consent form for donation” [II.B.7, par. 1] clashes with common usage. When someone transfers an object to another without demanding anything in return, we do not say that they “consented to the transfer” of the object, we say that they “gave” the object to the other [M, 232]. Second, in the circumstances in which the consensus justification arises, progenitors do not merely consent to a condition that intrauterine transfer shall not occur. Rather they direct that intrauterine transfer shall not occur [M, 28]. By contrast, a requirement for “a statement that embryos donated will not be transferred to a woman’s uterus” appeared in NIH’s previous “Guidelines for Research Using Human Pluripotent Stem Cells” (65 Fed. Reg. 51976, 51980 [August 25, 2000], II.A.2.e[vii]). But this requirement was only that such a statement be “included” in “the informed consent process”—a condition so weak as to be satisfiable by a sentence in a document written by an investigator whom a donor never meets. Clarity about who originates the prohibition on intrauterine transfer and its unilateral character is indispensable because, as we have seen, there is only one person in the world (with coprogenitor) privileged to impose that prohibition.

1.5 ABSENT A PROHIBITION ON INTRAUTERINE TRANSFER, NO CONSENSUS JUSTIFICATION OF EMBRYO USE

In default of a progenitor prohibition on intrauterine transfer of an embryo, all of the following obtain: intrauterine transfer remains permissible, the embryo’s developmental potential is not bounded at gastrulation, it is nomologically possible that the embryo attains sentience and develops to term, and therefore the consensus justification of embryo use does not apply to that embryo. Whereupon it may plausibly be argued that classifying the embryo as a person could gain birth for its developmental successor, that a possible person corresponds to the embryo, and that it is wrong to interfere with the embryo’s development [M, 26, 232, 245].

1.6 RECOMMENDED ELIGIBILITY RULE

1.6(a) TEXT

On the basis of the foregoing reasoning, it is recommended that the following replace the first paragraph of II.B.: “Human embryonic stem cells may be used in research using NIH funds if (1) the cells were derived from an embryo created in the course of clinical treatment for infertility, (2) the progenitors of the embryo donated the embryo on the conditions, set forth in written instructions accepted by the recipient, that (a) the recipient shall use the embryo solely in medical research or therapy, and (b) never may the embryo or any totipotent cell taken from the embryo be transferred into a woman or into an artificial uterus, (3) the progenitors did not receive any financial or other consideration in exchange for donation of the embryo, and (4) the progenitors were informed, prior to the donation, that (if such be the case) the embryos will be sacrificed to derive embryonic stem cells, and that a line of such cells many be maintained indefinitely. The foregoing is hereafter referred to as the ‘eligibility rule’ (‘ER’).”

1.6(b) EXPLANATION

ER is intended to be inclusive of all conditions that should be mandatory. The following explains some of its provisions. In ER’s clause (1), the empirical fact that ministrations to a woman fall within the category of infertility treatment is both more verifiable and attainable than the condition that an embryo was “created for reproductive purposes” (II.B., par. 1). The mental states of patients lie beyond direct observation, and such indications as we have suggest that patients do not intend procreation as to every embryo created [M, 50–51]. (Clause [1] does no work in the argument from nonenablement, and hence is not necessary to the consensus moral justification, but is retained here because it expresses an NIH decision on scope.) In (2) of ER (on which see [M, 27ff.]), “medical research or therapy” is appropriately narrower than the Guideline’s phrase “research purposes.” Clause (3) differs from the condition in the GDC that “no inducements were offered for the donation,” which could prove too broad. If patients read convincing yet circumspect presentations, in disclosure documents composed by hESC investigators and delivered to them by their physicians, concerning the promise of hESC research, such presentations might appropriately induce embryo donations. The reasoning for omitting the condition that an embryo was “no longer needed for this purpose” is as follows. When fertility patients decide whether to store embryos, they do not speak of what their needs, but instead of their wishes, their wants. ‘Need’ suggests some kind of clinical calculation of embryo inventory against planned transfer procedures, and this betokens physician involvement. Such was yet more strongly suggested in the predecessor of this phrase, “were in excess of clinical need,” used in NIH’s 2000 guidelines (65 Fed. Reg. 51979–51980) and recent proposed legislation (H. R. 7141, The Stem Cell Research Enhancement Act of 2008). Reference to ‘need’ risks getting the order of authority muddled. It should be kept clear that the physician proposes, the patient disposes. In order to make applicable the argument from nonenablement, a decision against intrauterine transfer must be made solely by progenitors. When such a decision is taken, it becomes manifest that the progenitors no longer need or want the embryo for reproductive purposes. Thus when ER operates, no condition about lack of need or want would make any nonredundant contribution.

In defense of redundancy, it might be surmised that requiring the condition that an embryo “is no longer desired for this purpose” would somehow block the possibility that a patient might begin fertility treatment intending to donate some resultant embryos to research. The notion would be to discourage creation of embryos for research purposes. But imposing that condition or any other like it would not deter such behavior, since whenever patients chose to donate embryos, they could easily affirm such a condition. It appears that many patients expect, when they begin fertility treatment, that they will end with surplus embryos and that they will donate at least some of them to research.

Clause (4) corresponds to the conditions at II.B.7.c, d., and e.

1.7 RECOMMENDED ENUMERATION OF INDICIA OF ELIGIBILITY

It is recommended that II.B. continue with

“The following are relevant indicia, to which investigators should be alert, of the fulfillment of the requirements of ER, particularly in respect of the understanding by a prospective embryo donor of circumstances pertinent to donation, and of the voluntariness of the donation”,

and that the rest of the GDC, suitably modified, be enumerated thereafter except as noted below. The following comments on those conditions.

‘Donation’ implies voluntariness. Hence condition 7a. is redundant and may be omitted. Conditions 3., 4., 5., and 6., are useful as indicia of voluntariness, but are not mandatory of themselves for moral justification by the argument from nonenablement. Conditions 1., 7b., 7h., and 7i. provide very useful information whose disclosure should be encouraged. It may be pointed out that donors should be fully informed about the context as they decide to give embryos to a suitable donee for use in hESC research, and that the information that they possess will bear upon interpretation of the donative instruments concerning what donees may do with the donated embryos. Mention of 1., 7b., 7h., and 7i. could well be preceded by, “Prior to donation, the donor received a written disclosure, prepared by the principal investigator who received the donation, of the following pertinent information.” [M, 232–233] But ignorance of 1., 7b., 7h., and 7i. would not be so material as to preclude voluntary donation, and so they may remain indicia. Conditions 7f. and 7g. are vestigial from rules designed to prevent the prospect of direct benefit from research from becoming an incentive to elect an abortion. These conditions are dispensable here insofar as the risk of an objectionable incentive is different: an embryo produced by IVF would not be a genetic match to either progenitor or their children.

On the plausible assumption that fertility patients undergo fertility care voluntarily, their informed consent concerning embryo creation, while obviously mandatory, is not and need not be mentioned in the Guidelines. The conditions enumerated within 7., which follow the informed consent provisions of the Common Rule (45 CFR. 46.116), are here endorsed solely as indicia of fulfillment of the requirements of ER. The Common Rule is inapplicable here, as it is designed to satisfy an abiding concern—that the welfare of the subject must be protected—that ex hypothesi is ignored here. Thus contrary to the mistaken supposition noted in sec. 1.3(b) above, the Common Rule is inapplicable to use of surplus embryos in hESC research. It is inapplicable to progenitors because as to creation of embryos from their cells, they are patients and not research subjects, and it is inapplicable to embryos as research subjects because the research will sacrifice its subjects.

2. SOLUTION TO PROBLEM OF EXTANT CELL LINES

2.1 REQUIREMENTS CONCERNING PROVENANCE APPROPRIATE

That NIH imposes requirements on the provenance of cell lines is entirely appropriate inasmuch as the morality of using embryo derivatives depends upon the morality of the derivations. The fact that the requirements pertain to the past does not impugn their appropriateness. Insisting on a specific sort of provenance will not constitute an ex post facto law of the sort prohibited by Art. I, sec. 9 of the Constitution. NIH is not penalizing past conduct. The agency is not enforcing anything. Nor do NIH's requirements abrogate any contract rights, past or present, since there is no entitlement to a grant (the last a familiar point reiterated in Executive Order 13505, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells,” 74 Fed. Reg. 10667–10668 [March 11, 2009], §4[c]). NIH may condition research grant eligibility on the provenance of research subjects just as NIH may condition training grant eligibility on the provenance (e.g., graduation from a doctoral program) of a candidate. 2.2 EVIDENCING BY DOCUMENTS

NIH has come in for criticism for requiring documentary evidence when, it is said, what matters is whether an appropriate condition has not been met, not whether a document evidences it. This criticism asserts a cogent point, but as directed here, it misses the mark. This occurs because of the following circumstance. NIH can impose requirements only on its funded investigators who are the recipients of embryonic derivatives, not on unfunded persons performing the derivations. NIH appropriately demands that its downstream funded investigators intrude into the events of derivation so as assure that the embryonic derivatives were permissibly derived. (This mandated intrusion undermines the notion that the downstream studies are not conflatable with the derivations, and hence part of “research in which a human embryo or embryos are destroyed.” This in turn furnishes another compelling reason for legislation overriding the Dickey Amendment so as to provide either that (i) NIH may fund studies of hESC and impose conditions on donation of their embryonic sources, notwithstanding the provision barring funding of “research in which a human embryo or embryos are destroyed,” or (ii) NIH may fund derivations.) NIH has appropriately recognized that because its applicants will not have been present at derivations, and because scientists who perform the derivations may have an incentive to gloss over past circumstances and sign certifications perfunctorily, documents originating at the time of embryo donation and bearing donor signatures become the best evidence obtainable by downstream investigators. But despite this defense of the drafters’ predicament, the predicament for investigators is that conditions may have been satisfied without satisfaction having been documented.

2.3 RECOMMENDATION

The solution recommended here, in general, is to rely on the ability to infer compliance with ER from any competent evidence. More particularly, NIH could resolve the use of extant cell lines according to when the pertinent grant was or will be issued. (a) For studies already funded (which by dint of prior policy would pertain to presidential lines), NIH could require that there have occurred an explicit or inferable compliance with ER clauses (1), (2), and (4). As to the linchpin condition (2), NIH could allow the inference that a donation to research known to destroy its embryo subjects, a fact known when (4) obtains, implies a decision against intrauterine transfer. NIH could also introduce a presumption that clause (3) of ER was satisfied in the absence of evidence of an inducement there proscribed. Investigators studying lines that do not pass muster under this policy could be given time and funds by NIH to restructure their research so as to substitute lines conforming to the Guidelines. (b) For future studies, NIH could allow inferences of satisfaction in the case of extant lines as above, but should insist on satisfaction of ER as to any line created after the effective date of the Guidelines. Since a ban on intrauterine transfer is the crux of moral justification, a principled ground does not obtain for waiving insistence upon it.

2.4 GRANDFATHERING?

The foregoing principled ground for funding contrasts with appeals solely to the expediency of using extant lines. The inconvenience of having to forego use of an extant line will not alone be a moral argument for using the line, but reliance on inferences can be.

3. RELIANCE ON AN INFERENCE NOT APPROPRIATE FOR LINES DERIVED IN FUTURE

An inference should not be deemed sufficient when an opportunity arises to be explicit [M, 232]. Hence a prohibition of intrauterine transfer, and the other conditions of ER, should be mandatory for lines created after the effective date of the Guidelines.

4. CHIMERAS

4.1 PROHIBITION UNWARRANTED

Because the argument from nonenablement justifies experimentation with any embryo barred from the womb, III.A. could be deleted. But it is evident that NIH regards it as of importance in public perception.

4.2 INELIGIBILITY OF DOWNSTREAM STUDIES, IF INTENDED

The question arises whether studies ofn derivatives of blastocysts described in III.A. would be fundable. Presumably NIH intends not. But to read III.A. as barring such, NIH would have to take a fusionist reading of its phrase ‘research in which,’ a reading of the same phrase that it must reject in order to maintain, in respect of the Dickey Amendment, that it may fund use of hESC even if no

 
48280 05/26/2009 at 10:54:34 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.

 
48281 05/26/2009 at 10:54:47 PM Self     I would simply like to express my objection to the use of tax payer monies to fund any form of embryonic-destructive stem cell research. Not only is this kind of research reprehensible, it is unnecessary! I do however support adult stem cell research. Thank you.

 
48282 05/26/2009 at 10:55:39 PM Self     There is never any reason that can justify the intentional destruction of a human life for the purpose of saving or simply improving the quality of life of another. Every individual human has the right to the exact same treatment, and to allow parents to give their child over to be slaughtered in the name of science is a moral evil that should never even be considered a viable option. From the moment that a person comes into existence, regardless at what point in development, whether they are called a zygote, embryo, baby, child, teen, adult, they are still a living, unique person, capable of living a full life, only so far as they are allowed. Anyone who thinks that they can simply take that away in order to make a profit absolutely cannot be called an American. Once the ideals of life, liberty and the pursuit of happiness are beginning to be denied to the smallest and most defenseless, what is to guarantee those rights for anyone else. Do not allow the evil of embryonic stem cell research to persist and become commonplace.

 
48283 05/26/2009 at 10:55:49 PM Self     Embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. I am not a scientist, but I am a member of the Parkinson’s community and have been following progress in this field with great interest. Significant strides have been made over the past decade, and the final guidelines issued by NIH must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress. I am pleased that these draft guidelines -- in Section II B -- would appear to permit federal funding of stem cell lines previously not eligible for federal funding and for new lines created in the future from surplus embryos at fertility clinics. However, as drafted, Section II B does not ensure that any current stem cell line will meet the criteria outlined and thus be eligible for federal funding. It will be important for the final guidelines to allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived. This will ensure that the final guidelines build on progress that has already been made. I also believe that the final guidelines should permit federal funding for stem cell lines derived from sources other than excess IVF embryos, such as somatic cell nuclear transfer (SCNT). Sections II B and IV of the draft guidelines do not permit such federal funding and I recommend that the final guidelines provide federal funding using stem cell lines derived in other ways. If not, it is essential that the NIH continue to monitor developments in this exciting research area and to update these guidelines as the research progresses.

 
48284 05/26/2009 at 10:57:03 PM Self     We thank the NIH for these ethical guidelines. They represent an opportunity to make strides in stem cell research for all those living with chronic illness. We appreciate the Obama administration for lifting the ban on stem cell research. We look forward to the wealth of knowledge and potential treatments that may arise from this research. We hope that you succeed in finding something that will help our family who is living with Parkinson's disease.

 
48285 05/26/2009 at 10:57:04 PM Organization Wisconsin Stem Cell Now, Inc. 4230 N. Oakland Ave. #249 Shorewood, WI 53211 May 26, 2009 NIH Stem Cell Guidelines MSC 7997 9000 Rockville Pike Bethesda, Maryland, 20892-7997

Dear Sirs:

I am writing on behalf of Wisconsin Stem Cell Now, Inc. to comment on the National Institutes of Health (NIH) Guidelines for Human Stem Cell Research (the “Proposed Guidelines”). The Obama Administration is to be commended for lifting the ban on federal funding for embryonic stem cell research on lines derived after August of 2001. The ban imposed by the Bush Administration needlessly delayed progress in the use of human stem cells to understand and treat many diseases and chronic health conditions. Thank you for the opportunity to comment on the NIH’s Proposed Guidelines.

Wisconsin Stem Cell Now is a nonprofit, nonpartisan organization formed five years ago. Our mission is to educate the public about the science and ethics of all forms of stem cell research and to advocate on behalf of increased government funding for regenerative medicine. We firmly believe that medical research using human stem cells, including embryonic stem cells, can be conducted ethically and morally and will lead to the alleviation of human suffering. We also strongly support government sponsored scientific research against any artificial political or theological restrictions. Wisconsin Stem Cell Now is proud of the numerous scientists and researchers in the State of Wisconsin who are among the nation’s leaders in this important field. We are aware that the subject of embryonic stem cell research is controversial, and that many Americans of good faith have religious objections to this science. It is common knowledge that opponents of embryonic stem cell research have organized a campaign to submit negative comments on the Proposed Guidelines. This is their right under the law. However, opponents of medical research go too far when they use the administrative process or the courts of law as a vehicle for delay and obstruction, rather than as a forum for presenting their views. We urge the NIH to protect the integrity of its rulemaking process. The agency should recognize and reject tactics that are designed solely to delay the implementation of any rules that include the federal funding of embryonic stem cell research.

The debate over the morality of embryonic stem cell research is often portrayed as a battle between science and religion. In actuality, the debate is between religious sects that have varying theological beliefs regarding the point at which the developing human embryo becomes a fully formed person. This debate among people of faith can never be resolved, because it is beyond human comprehension to know the answer. What is clear, however, is that the federal government is forbidden from taking a side in this debate. The Proposed Guidelines go far towards re-establishing the neutrality of the federal government on this question of faith.

There are two aspects of the Proposed Guidelines that are of concern to our organization, however. First, the Proposed Guidelines establish a requirement that already created embryonic stem cell lines shall only be eligible for federal funding if grant applicants can fully document the consent of the donors of the embryos used to create the stem cell lines. There is no ethical or practical reason to apply the comprehensive and specific consent requirement contained in the Proposed Guidelines to pre-existing embryonic stem cell lines. The lack of documentation in the exact format anticipated by the Proposed Guidelines does not mean that the embryos were obtained without full consent, or that nonconforming consent procedures are unethical. The consent documentation requirements contained in the Proposed Guidelines should only be applied to embryonic stem cell lines created after May 2009.

Second, the Proposed Guidelines do not provide for federal funding of any embryos created outside of the in vitro fertilization process. The Dickey-Wicker Amendment prohibits the federal funding of the creation of embryos for research, but does not prohibit the funding of research using stem cell lines derived from embryos created outside of the in vitro fertilization process. Therefore, the Proposed Guidelines could be amended to allow for federal funding of research on stem cell lines created using somatic cell nuclear transfer without contravening any congressional statute.

However, we have spoken with researchers in Wisconsin who believe that the Proposed Guidelines, limited as they are, will nonetheless allow them to conduct research using diverse genetic material and disease-specific stem cell lines. In other words, the researchers that we have spoken with are not yet convinced that it is necessary to expand the universe of eligible stem cell lines beyond the excess embryos obtained via the in vitro fertilization process in order to advance the science. Accordingly, while we believe that the limitation contained in the Proposed Guidelines is less than optimal, we do not currently advocate a different approach.

Thank you once again for the opportunity to comment on the Proposed Guidelines. The hopes and prayers of millions of people are with the researchers performing this vital work. Respectfully submitted, ***** Wisconsin Stem Cell Now, Inc.

 
48286 05/26/2009 at 10:57:27 PM Self     Ethical responsibility

Destruction of human life for research purposes is not ethical, no matter what the perceived benefit may be. Ethical principles state that "One must never do evil so that good may come from it." Destroying one human being to benefit another violates moral principles and religious sensibilities of millions of taxpayers. Sound research is not considered ethincal if it only benefits those who are not morally offended. Countless Americans refuse to accept vaccines produced from aborted fetal cell lines.

Scientific responsibility

After 20+ years of research and billions of dollars spent on embryonic stem cell research using private funds, to date, there has not been one single cure for any human illness using embryonic stem cells, while adult stem cells continue to provide cures for thousands of patients with over 70 diseases.

In addition, embryonic stem cells have consistently proved that tumors, some fatal, form whenever they are manipulated for use in treatments. These type of treatments are prone to severe immune rejection in human patients.

Accordance with Existing Law

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

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

 
48287 05/26/2009 at 10:57:28 PM Self     Expansion of human stem cell research to include human embryonic stem cells is morally and ethically wrong. Life begins at conception, and it is immoral to kill one person in order to save another. The intrinsic value of the embryo does not change simply because it has been discarded by its parents and is intended for destruction. Simple human dignity should prohibit research on these embryos.

Research using adult stem cell lines and IPS cells has shown great promise and advancement. Let us increase funding to these morally acceptable lines and promote embryo adoption, not embryo research.

Specific areas of concern regarding the draft guidelines include the following:

The guidelines will violate the statue of the Dickey-Wicker Amendment, which prohibits federal funding of any “research in which” human embryos are in any way injured. See Dickey-Wicker SEC. 509. (a) None of the funds made available in this Act may be used for (1) the creation of a human embryo or embryos for research purposes; OR (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). (b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Section II, Part B, number 6, of the guidelines state that “Whenever it was practicable, the attending physician responsible for reproductive clinical care and the researcher deriving and/or proposing to utilize human embryonic stem cells should not have been the same person.” What happens when the attending physician and the researcher are the same person? This potential situation raises questions regarding conflict of interest, as the physician may promote the production of excess embryos for use in his/her research.

The Guidelines should include language to promote currently successful research that does not destroy human embryos. Failure to include such language may inadvertently minimize the advances and successes of these lines.

Acceptance of these draft guidelines may lead to further funding of embryo-destructive research, such as research on stem cell lines derived from human cloning. When do we stop?

 
48288 05/26/2009 at 10:57:32 PM Self     I oppose the Draft NIH Human Stem Cell Guidelines because I do not want too be forced to subsidize the killing of live human embryos to take human embryonic stem cells to perform experiments that have harmed people in the past from tumors. It is dehumanizing to utilize human embryos for commodities that enrich researchers and Corporations.

Please support adult stem cell research which is ethically sound, harms one, and has already produced effective treatments.

 
48289 05/26/2009 at 10:58:17 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.

 
48290 05/26/2009 at 10:58:23 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.

 
48291 05/26/2009 at 10:58:40 PM Self     Please do not use embryonic stem cells in research. The research means their destruction. In just 21 days of life, these embryos have a very faint heart beat and in 45 days they have brain waves. Please use my tax dollars to fund adult stem cell research, the ethical option. Thank you!

 
48292 05/26/2009 at 10:59:01 PM Self     If by chance research and development would help someone you love be free of constent support; for lifes most basic needs,would you? Please help a loveone live a normal life.

 
48293 05/26/2009 at 10:59:08 PM Self     While I appreciate the limitations that these guidelines place on embryonic stem cell research (ESCR), there are several points that I, as a tax-payer, find deeply troubling.

First, while the document makes it clear that potential donors must not be offered any “inducements” (referring, presumably, to monetary compensation) and that reproductive clinics are to present potential donors with all the available alternative options, what’s to prevent the reproductive service providers from presenting a heavily biased version of the “alternatives”? It’s easy to imagine a scenario in which research laboratories are pressuring reproductive clinics to provide embryos and clinics are, in turn, pressuring clients to decide in favor of donating their embryos for research. The presentation of the options would go something like, “Of course, you could do X,Y or Z with the embryos, but that would be a complete waste. Or, you could contribute to the progress of science and possibly save people’s lives by donating your embryos for research.” Would a reproductive service provider really suggest that the potential donor think seriously about whether or not the destruction of the embryo for research purposes is ethical?

Second, I find the phrase, “whenever it was practicable” (II,B,6) problematic. It seems that if ever it were not “practicable” and the attending physician were also the researcher in question, that would be a clear violation of the ethical principals underpinning these guidelines. In such a case, there would be an even greater likelihood of a biased presentation of the alternatives, as described above.

Most problematic, however, is the fact that this document does not address the question whether embryonic stem cell research is either medically expedient or ethically sound in the first place. Granted, as the document maintains, the field of stem cell research offers great promise. As stated in the section called “Supplementary Information,” stem cells “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.” However, there is no clear indication here, let alone supportive evidence, that embryonic stem cells offer this possibility any more readily than adult stem cells. Is ESCR simply more convenient for researchers, or is there a real medical necessity for it?

The real linchpin in the whole enterprise, though, for me and for many other Americans who believe as I do, is the question of when recognizable human life begins. Presumably, the respect accorded human life outside the womb ought also to be shown to any human life, if such exists, within the uterus – and, for that matter, to human life originating in the laboratory. To be sure, there exists a variety of answers to the question of when human life begins, each with its own set of philosophical arguments and medical “evidence.” As far as I am concerned, however, there is enough evidence in favor of the view that human life begins at fertilization (as opposed to implantation or later points), and little enough evidence against such a view, that we are morally obligated to treat the embryo – from the zygote stage – as human until it is conclusively proven that the case is otherwise. While there remains the nagging question of how to deal with the thousands of embryos that have already been created for reproductive purposes, so does the nagging question of how to deal with plenty of other groups of human beings considered superfluous or undesirable by others. The fact that the embryos are available for research does not in itself justify their use for that purpose, nor does the end justify the means.

Why should the taxes that I pay go to fund research that I believe to be ethically unsound, especially when I remain unconvinced that ESCR is any more promising than adult stem cell research?

 
48294 05/26/2009 at 10:59:29 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.

 
48295 05/26/2009 at 10:59:29 PM Self     Please please do not use embryonic stem cells! We must respect human life in all of it's forms. There are alternatives such as skin cells and adult stem cells. Please, no death involved!

 
48296 05/26/2009 at 10:59:34 PM Self     First of all, many thanks to the NIH for extending the opportunity to members of the general public to comment on the proposed changes to the policies concerning public funding of research utilizing stem cells derived from human embryos. This manifestation of democratic process is greatly appreciated, with apologies to the people dutifully reading all these comments.

The stated purpose of the open forum for comment is to "help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law." Certainly the potential medical benefits are consistent with the idea that the research is scientifically worthy. The draft Guidelines, in Section I (Scope of Guidelines, point out that the embryonic stem cells used for research are not themselves human embryos but are derived from human embryos. The question of ethical responsiblity then begins with the question of whether human life is being terminated in the course of obtaining these cells. If embryonic stem cells can be harvested without destroying (i.e. compromising the viability of) the source embryos, the ethics of the research become unassailable. Alternatively, if for the purposes of ethical considerations the embryos are considered deceased before the harvesting of cells, the process becomes analogous to organ donation, with consent given by the parent or parents with the considerations given in the Code of Federal Regulations Title 45 Public Welfare Part 46 Protection of Human Subjects (hereafter 45 CFR Part 46) Subpart B--Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research. The definition of a dead fetus is given in 45 CFR Part 46 as "a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord". This is possibly not the most useful definition of death for the purposes of considering whether life is being terminated in the harvesting of embryonic stem cells, but then again 45 CFR Part 46 also defines a fetus as "the product of conception from implantation until delivery", making separate legislation concerning embryonic stem cells understandably necessary, since the definition does not address these never-implanted embryos. Does this mean they were never alive? Certainly some will make this argument. Perhaps, under the circumstances, viability would be a better measure of what is being sacrificed by the harvesting of embryonic stem cells.

Since viability must be defined, may I suggest the definition given in 45 CFR Part 46 as it pertains to neonates as a starting point? Viability is there defined as "being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration." Provisions are made to protect the viability of neonates used as research subjects. If the viability of a newborn is important to maintain, why is the viability of an embryo less important? Because they are, as the Guidelines suggest, "no longer needed"? Is that what we say to people; that they are no longer needed?

Concerning the area of research "conducted in accordance with applicable law", am I correct in the understanding that financing for the actual derivation of embryonic stem cells using public funds will continue to be prohibited by the Dickey-Wicker Amendment but public funding for research using these embryonic stem cells once derived will be available pursuant to Executive Order 13505? This bizarre compromise on the ethics of using public funds for actions that are morally objectionable to a significant portion of the public is preferable to the use of public funds for the derivation of stem cells from human embryos in a manner that would compromise the viability of these embryos (at least for this taxpayer), but gives rise to the imagining of a rather convoluted scenario in which a public university, wishing to use public funds to finance embryonic stem cell research, offers certain intellectual property usage rights to a pharmaceutical or biotechnology company in exchange for that company's agreement to finance the derivation of stem cells from an embryo, then provide the cells to the university, which would use an NIH grant to finance research that used these embryonic stem cells.

In the cause of scientifically worthy research, I would be very interested in a method of harvesting embryonic stem cells that did not compromise the viability of the embryos involved, and in research that would be conducted on such cultures of embryonic stem cells. As a scientist with a background in molecular biology, I look forward to the opportunity to participate in such ethically responsible research.

 
48297 05/26/2009 at 10:59:50 PM Self     Subject: Public Comments submission to The National Institutes of Health for its Draft Guidelines on Embryonic Stem Cell Research

The NIH states their intention is to create guidelines that are "ethically responsible, scientifically worthy, and conducted in accordance with applicable law." Yet any ethical understanding of law and science admits that above any other purpose laws should protect vulnerable human life, and that science should be used to preserve life. This understanding would prohibit research that destroys human embryos or exploits their deaths for the supposed benefit of others creating demand for more destruction.

I urge the National Institutes of Health to work to return medical science to its once noble purpose and oppose any research on stem cells of unborn human beings deliberately destroyed through abortion, parental abandonment, or for purposes of the research itself.

The following quote comes not from a religious text or a pro-life pamphlet, but from the 1973 Taber's medical dictionary under the entry for "life": "Biologically, unitary life begins at the moment of conception and ends at death. However, for legal and other reasons the definition of when life begins has been subject to a variety of interpretations. Nevertheless, it is undeniable that life is a continuum which can be arbitrarily but not logically indicated as having begun at some point in time or development past the moment of conception." In other words, it is an undeniable medical fact that life begins at conception, and to believe otherwise is illogical. But our society keeps up a mock debate as a smokescreen for killing unwanted human beings, and now also for the purpose of harvesting them for research and experiments.

Those of us who recognize the destruction of an embryo or fetus as the killing of a defenseless human being would be ethically bound to reject any medical treatments developed from the illicit harvest of the unborn. The situation cannot be likened to receiving an organ from a victim of a shooting. The shooting victim's death will be punished severely because he or she was recognized as a person with rights. Using the organs will not create any demand for or encourage more such murders, because the punishment would be harsh and long-term. But the killing of the unborn is legal and if we accept the therapeutic and experimental medical use of our unborn, there is nothing to prevent some level of supply and demand effect from operating-the possibility of beneficent use for someone could tip the scales toward abortion for individual women facing the "choice" and at the very least lends an air of legitimacy and respectability to the abortion culture. Therefore, as long as legal abortion remains the law of the land, we who are pro-life, do not want to benefit, medically or otherwise, from these unjust deaths. By making abortion-derived treatments and prophylaxis a part of everyday medical practice-more and more people become implicated in the act of abortion, even if only in a remote way. If the scientific and medical establishment consistently takes the most unethical road toward "progress" we must ask ourselves why? Do they hope to pressure desperate patients into accepting ethically clouded "cures" obtained by means the patients themselves find abhorrent? By indirectly involving increasing numbers of Americans in the injustice of abortion do they hope to inure us to the point where we will turn a blind eye to the victimization of the unborn so we may benefit from the fruits of their stolen lives. I hope that is not the case, and that you will take action to redress the situation immediately.

Neither the newborn, the toddler, nor the newly formed embryo is "fully developed" in terms of its final biological goal-all aim towards adulthood. Yet only one is deprived of the right-to-life on this account. Like unborn fetuses, born infants also lack the qualities and abilities we associate with "personhood"-yet the killing of a newborn is punished as murder while the killing of the unborn is a legal "choice."

If the medical profession and scientific community loses its respect for the value of human life, no amount of technical proficiency or gained knowledge can make up for it.

 
48298 05/26/2009 at 11:00:00 PM Self     I want to express my opposition to the use of taxpayer’s money to fund embryonic stem cell research or human cloning. The federal government should support adult stem cell research that do not require the destruction of human life. Your draft guidelines will use my tax dollars to promote methods that are ethically unacceptable to me and many other citizens.

 
48299 05/26/2009 at 11:00:00 PM Self     I know your intention is to create guidelines that are “ethically responsible, scientifically worthy, and conducted in accordance with applicable law”.

 
48300 05/26/2009 at 11:00:00 PM Self     I am writing to let you know that I strongly oppose the use of federal dollars to fund such a medical research that involves the destruction of human embryos. It is sad to see what we are doing to God’s helpless little ones. We all started out as embryos. You will all be in my prayers to do the right thing.

 
48301 05/26/2009 at 11:00:00 PM Self     I, ****, oppose killing human embryos. The proposed reglulations will force taxpayers like me to fund research I believe is unethical because it requires the killing of human embryos. The proposed regulations create a financial incentive for the creation of more human embryos to be destroyed to obtain their embryonic stem cells. The proposed regulations are absolutely horrible and must be stopped!

 
48302 05/26/2009 at 11:00:00 PM Self     I oppose killing human embryos. I oppose funding that opens the door to human cloning. I agree with non-embryonic stem cell research and healing.

 
48303 05/26/2009 at 11:00:00 PM Self     Do not kill any embryonic persons in the quest for disease cures. These embryos have 46 chromosomes like any of us, they are human beings. Yes, they can be killed in abortion by a false law that will be overturned if justice prevails. Adult stem cell research was recently applauded by a famous scientist on the Oprah show with Mr. Fax the great promoter of embryonic stem cell research. If the adult stem is from the patient there will be no rejection of the body part which is the big stumbling block in cures. This was this famous scientist’s main point. Put money into the more likely procedure for success as long as you aren’t killing someone.

 
48304 05/26/2009 at 11:00:00 PM Self     I oppose the killing of human embryos, and resist the funding which will come from my tax dollars, making me complicit in this carnage. From the practical point of view, the money could be better spent in the area of adult stem-cell research which is already yielding a harvest of new treatments for patients. Please register my aversion and consider not going ahead with this abhorrent and immoral research on human life.

 
48305 05/26/2009 at 11:00:00 PM Self     Please record me as being strongly against the use of embryonic stem cells for research.

 
48306 05/26/2009 at 11:00:00 PM Self     I am writing to say I do not want my tax dollars supporting stem cell research involving the destruction of human embryos. This is life and will only contribute to a culture of violence.

 
48307 05/26/2009 at 11:00:00 PM Self     The purpose of this letter is to voice my concern over the guidelines that have been drawn up to implement President Obama’s directive concerning stem cell research. It is my hope that you will direct your scientific research to those areas that have proved the most helpful in the past and not toward embryonic stem cell research. Even though you may see it as a viable avenue, it is still destruction of human life, granted in its earliest stages, but still life.

 
48308 05/26/2009 at 11:00:00 PM Self     The use of human embryonic stem cells for research is morally wrong, without unconditional respect for the life of each and every member of the human race, research does not represent true progress. All human life is sacred, not disposable.

 
48309 05/26/2009 at 11:00:00 PM Self     No guidelines in the ‘Draft NIH Human Stem Cell Guidelines’ is morally acceptable. Taking an innocent human life is morally unacceptable. You looked like this embryonic human once, and then as now you are a valuable human. Please drop these guidelines all together.

 
48310 05/26/2009 at 11:00:00 PM Self     Please be advised that we do not want you to use our tax dollars to promote destructive embryonic stem cell research which destroys innocent human life. Adult stem cell research holds far greater promise for improving our health and does not destroy innocent human life. Furthermore, adult stem cell research is rapidly developing a track record of success without doing anything immoral. Thank you for giving favorable consideration to our request.

 
48311 05/26/2009 at 11:00:00 PM Self     "Stop the Funds". Do not use them to murder live embryonic stem cells. (President Obama’s flip flopping decision). The pharmaceutical and research industries are only enacting or manufacturing drugs to keep sick people alive so far none of these are fighting off disease… that is not yet in their agenda. It will stop the flow of money. I am not talking about scientists and especially those in your noble institute who have for years now done the research and solution use our hand it to the pharmaceutical companies. May God Bless and help those who are working arduously to wipe out the 2 killers of mankind, Cancer and Heart Disease.

 
48312 05/26/2009 at 11:00:00 PM Self     Do not use my tax dollars for the destructive stem cell research. Instead please support adult stem cell research, which is ethically sound, harms no one and is already producing treatments that work. Why is this county about dealth?

 
48313 05/26/2009 at 11:00:00 PM Self     Please don’t destroy the human embryo for stem cell research. I think it’s wrong for the government to fund this research. We need to support cure we can all live with.

 
48314 05/26/2009 at 11:00:00 PM Self     I don’t want my tax dollars to fund research that uses stem cells derived from human embryos resulting in their death. The killing of one class of humans to benefit another class of humans is profoundly wrong. Instead, please direct research toward adult and cord blood stem cells, which is ethical and has proven to be successful.

 



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