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    THE N.I.H. NEEDS TO HEAR FROM YOU! (Seriously, this is very important.)

    from Don C. Reed

    The new National Institutes of Health Guidelines for Human Stem Cell Research have just been issued.

    They would significantly loosen the Bush restrictions. If you are glad about that, it is important to say so—because the opposition is mounting a full-scale attack.

    This is the all-important public comment period. For the next 3 weeks, until May 26th, 2009, comments on the guidelines will be accepted from you, me, everybody.

    Some folks will say, hey, I am not a scientist, I don’t know what kind of guidelines are good-- what does this have to do with me?

    Everything.

    Here’s why.

    Those who oppose the research will definitely be writing in.

    Opponents are already being organizing a mass letter-writing campaign.

    Every letter will be tabulated, divided into counted piles: for, or against.

    What if the majority of people writing in are against embryonic stem cell research? That figure will be used against us at every opportunity: quoted by every anti-research legislator, at every budget hearing from now on.

    The NIH needs to hear from you.

    If you only send a one sentence letter, that would be great. The little electronic letter box is right below. It is so easy to fill it out.

    Folks, this is for everyone, and accordingly, everyone needs to weigh in on it.

    Here is an electronic form, which you can use. Or go to http://nihoerextra.nih.gov/stem_cells/add.htm and post your comments there.

    Or, write a snail mail letter, to: NIH Stem Cell Guidelines, MSC 7997
    9000 Rockville Pike, Bethesda, Maryland, 20892-7997

    Below is the form you can use, followed by some comments from CAMR, the Coalition for the Advancement of Medical Research (the outstanding national organization which leads the way in virtually everything on stem cell research), and then the link to the complete information from the NIH itself.



    Draft NIH Human Stem Cell Guidelines
    Comments Form

    Comments Deadline:
    11:00pm EST on May 26, 2009.

    Comments are requested below, as announced
    in the April 23, 2009 Federal Register Notice.

    ( * = Required Field )





    Name of Individual(s)
    Submitting Comments:






    Affiliation:



    Commenting on behalf of:

    Self
    Organization:
    Name of Organization:
    Address of Organization:



    * Comments:




    Please enter your comments on the Draft NIH Human Stem Cell Guidelines, as announced in the April 23, 2009 Federal Register Notice. Please reference specific sections in the document, when applicable. Please note that comments will be publicly available, including those containing personally identifiable or confidential business information.

    You may want to copy and paste from a word processor into the text box. Note that text will not be formatted (e.g. will not retain bold, colors and other formatting).



    Attachment:



    If you need to attach a file with any additional comments or information, the file must have an extension of "txt" (text only).

    Note that the form will not submit if an invalid path or filename is entered, so please be sure to click the "Browse" button, then select the file to be uploaded.

    Browse to File:
    File Description:



    * Security Check:



    Please Enter the following Random Number in the Box below: 7222

    Enter 7222 in this Box.


    Note: Collection of this information is authorized under 5 U.S.C. 301; 44 U.S.C. 3101. The primary use of this form is to collect public comments on the draft NIH Human Stem Cell Guidelines. NIH will consider all comments. This information will be used by staff of the NIH, its contractors and others, for the purpose of reviewing, collating or analyzing the comments in developing final NIH Stem Cell Guidelines. Submission of this information is voluntary. By providing comments, you are consenting to their consideration and use by the NIH. All comments received before the close of the comment period, including those containing personally identifiable or confidential business information, will be made available at http://stemcells.nih.gov/index.asp after May 26, 2009. This includes the name and affiliation of those submitting comments (if provided). NIH will not post comments that are not related to the draft Stem Cell Guidelines or that NIH has determined as inappropriate or offensive.

    If you have any questions regarding the submission of your comments, please contact StemCellGuidelines@mail.nih.gov.



    Go to NIH Stem Cell Information Page







    (the next part is from CAMR)
    Help Ensure Strong Federal Support for Embryonic Stem Cell Research –
    Submit Comments to the NIH on its Draft Guidelines

    As you know, President Obama recently issued an Executive Order instructing the National Institutes of Health (NIH) to develop guidelines to establish a framework for federal funding of embryonic stem cell research. NIH has released its draft guidelines, and the public has the opportunity to comment on the draft over the next few weeks. NIH will be analyzing the content, as well as volume, of the comments as it finalizes the guidelines.

    Although the Executive Order was a major step forward, there are sections of the draft guidelines that should be changed and/or clarified to ensure that the framework created builds on current progress. A background document is attached for your information.

    It will be critical for NIH to hear from the public on these issues during the comment period. Please follow the instructions below to submit your comments to ensure that the final guidelines are crafted in a way that ensures that this science advances as quickly as possible. And, please forward this alert to your family, friends, and people you know who support embryonic stem cell research.

    How to submit your comments:
    · Click http://nihoerextra.nih.gov/stem_cells/add.htm to be connected to the NIH comment form;
    · Provide your name, and select ‘self’ for Affiliation; and
    · Copy and paste the text below into the comment box, provide the security check ID on the form, and click ‘submit comments.’

    Suggested comment text (copy and paste into Comment section of NIH comment form and edit as appropriate for you):

    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.

    NIH Draft Guidelines

    Background
    On March 9th, President Obama issued an Executive Order instructing the National Institutes of Health (NIH) to develop guidelines to establish a framework for federal funding of embryonic stem cell research. The NIH, in implementing the Executive Order, recently published draft guidelines in the Federal Register. The full text can be obtained at http://edocket.access.gpo.gov/2009/pdf/E9-9313.pdf. The public has thirty days to submit comments on the draft guidelines; comments must be received by NIH by May 26th. Once the comment period is over, NIH will review the content and volume of comments as it drafts its final guidelines, expected to be issued on or before July 7th.

    Summary
    The draft guidelines establish a framework for federal funding of embryonic stem cells that were derived from embryos created for reproductive purposes and were in excess of clinical need. In addition, to be eligible for federal funding, the guidelines impose significant eligibility criteria on the donation process of the embryo used to derive the stem cell line. The criteria include:
    · All options for the use of the embryos were explained to the donor;
    · No inducements were offered for the donation;
    · A policy was in place at the facility where the embryos were donated that ensures that the decision to donate embryos for research would not affect the quality of care provided;
    · There was a separation between the donor’s decision to create embryos for reproductive purposes and the donor’s decision to donate embryos for research;
    · Consent for the donation was obtained at the time of donation from the individual who sought reproductive services;
    · Whenever practicable, the physician responsible for the donor’s reproductive clinical care was not the same person as the researcher deriving the stem cells; and
    · Written informed consent was obtained from individuals who sought reproductive services and who elected to donate embryos for research purposes (specific criteria is listed for the informed consent process).

    We believe that these ethical parameters are appropriate for new stem cell lines that are created in 2009 and thereafter. Unfortunately, the draft guidelines do not explicitly ensure that current lines that are already being used in research will be eligible for federal funding. It is our recommendation that the final guidelines include a provision that allows for inclusion of current lines, already being used in very important research, if those lines were derived using the prevailing ethical practices at the time.

    The draft guidelines prohibit federal funding of research using embryonic stem cells derived from other sources such as somatic cell nuclear transfer ( SCNT ), IVF embryos created for research purposes, and parthenogenesis. It is our belief that these very promising research techniques have potential that is beyond what is possible with embryonic stem cell lines that are derived from the IVF process and should be eligible for federal funding.

    Why it’s Important to Submit Comments and How You Can Help
    Although the draft guidelines represent a big step forward and create an ethical framework that will allow for federal funding of additional stem cell research in the future, there are a number of areas where the guidelines need to be clarified and/or changed to ensure that current research is allowed to continue and no new bureaucratic hurdles are created that would slow the pace of progress.

    The main areas of concern are highlighted in the template we have provided to you.

    NIH will be evaluating the public’s response to the draft guidelines and both the content of the remarks as well as the volume will guide the NIH as it finalizes the guidelines. It is critical that you help us generate as many comments focused on the points highlighted in the template as possible between now and the May 26th filing deadline. You do not need to be a researcher to submit comments – each comment will be recorded and counted. Please use the template provided to submit your comment and forward it on to your family, friends, colleagues, and anyone you know who supports embryonic stem cell research. If you have any questions about the current status of human embryonic stem cell research, please visit www.camradvocacy.org/resources/camr_wp.pdf or contact CAMR at 202-725-0339.



    Don C. Reed
    Sponsor, Roman Reed Spinal Cord Injury Research Act
    Founder and Co-Chair, Californians for Cures

    Don Reed is also Vice President of Public Policy for Americans for Cures Foundation; opinions voiced here as an individual may or may not reflect those of the Foundation.
    My blog: Living Life at Butt Level

    Ignite Phoenix #9 - Wheelchairs and Wisdom: Living Life at Butt Level

    "I will not die an unlived life. I will not live in fear of falling or catching fire. I choose to inhabit my days, to allow my living to open me, to make me less afraid, more accessible, to loosen my heart until it becomes a wing, a torch, a promise. I choose to risk my significance; to live so that which comes to me as seed goes to the next as blossom and that which comes to me as blossom, goes on as fruit."

    Dawna Markova Author of Open Mind.

    #2
    It took less than 1 minute for me to copy and paste the suggested comment to the form on the provided link, add my name and click SEND.
    Please take a few more minutes to ask family and friends to do the same. : ]
    Karen M
    C 3/4 inc. central cord
    10/29/1992 - 18 years, but who counts?

    Comment


      #3
      added mine. Mike

      Comment


        #4
        Done! Very easy to do.

        Comment


          #5
          I sent a comment.
          ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

          Comment


            #6
            I'm in.

            Comment


              #7
              Thanks for posting this Jen, I would have missed it otherwise.
              T7-8 since Feb 2005

              Comment


                #8
                Thanks. My family and I have sent our comments.

                Comment


                  #9
                  Thanks JenJen,

                  done


                  only a couple weeks left to speak up
                  http://justadollarplease.org/

                  2010 SCINet Clinical Trial Support Squad Member

                  "You kids and your cures, why back when I was injured they gave us a wheelchair and that's the way it was and we liked it!" Grumpy Old Man

                  .."i used to be able to goof around so much because i knew Superman had my back. now all i've got is his example -- and that's gonna have to be enough."

                  Comment


                    #10
                    Sent my comment and will spread the word to others.

                    Thanks Jen.
                    Foolish

                    "We have met the enemy and he is us."-POGO.

                    "I have great faith in fools; self-confidence my friends call it."~Edgar Allan Poe

                    "Dream big, you might never wake up!"- Snoop Dogg

                    Comment


                      #11
                      done.

                      Comment


                        #12
                        I just heard from somebody who attended a meeting at NIH that of the 6000+ comments that NIH has received concerning the draft guidelines, 99% were from people who opposed embryonic stem cell research.

                        There are many scientists who believe that these NIH guidelines are unacceptable and unnecessarily shut off research that are not prohibited by law. For example, the guideline says that parthenogenesis is prohibited by law. Parthenogenesis (i.e. the stimulation of an egg so that it believes that it has been fertilized) does not necessarily lead to creation of an embryo.

                        The language of the draft guidelines, if strictly interpreted, may actually prevent NIH funding of studies of the cell lines that have already been derived. Specifically, NIH appear to be requiring specific informed consent language that may result in NIH not allowing even the so-called Presidential lines to be studied with NIH funds.

                        Finally, the guidelines does not address specific important issues regarding pluripotent stem cells and the creation of human-nonhuman chimeric animals. This is very important because such prohibitions will prevent very important research based on misunderstandings of what human cells do when they are transplanted into animals.

                        If people support embryonic stem cell research, it is very important that they write to NIH saying that they support embryonic stem cell research and that the proposed guidelines are unnecessarily restricting research that are not required by law. I will post a detailed analysis of the guidelines soon. The deadline for all comment is May 24.

                        Wise.
                        Last edited by Wise Young; 9 May 2009, 11:24 AM.

                        Comment


                          #13
                          Thanks Wise. Unless you tell me not to, I will hold off submitting my comments and asking friends and family to do so until I have those specifics.

                          Comment


                            #14
                            Originally posted by Random View Post
                            Thanks Wise. Unless you tell me not to, I will hold off submitting my comments and asking friends and family to do so until I have those specifics.
                            Here is my "draft" response to them... I am still adjusting it.

                            COMMENT ON DRAFT NIH GUIDELINES FOR HUMAN STEM CELL RESEARCH
                            by Wise Young, PhD MD,
                            Rutgers University, 604 Allison Road
                            Piscataway NJ 08854-8082
                            email: wisey@pipeline.com
                            10 May 2009

                            The National Institutes of Health (NIH) is requesting public comment on draft guidelines, entitled “National Institutes of Health Guidelines for Human Stem Cell Research” [1]. These draft guidelines were created in response to Executive Order 13505 by President Barack Obama [2], requesting that NIH establish policy and procedures under which NIH will fund research in the area in accordance to applicable law. Below, I will refer to these as Draft Guidelines.

                            The deadline for public comments is May 26, 2009 and can be entered at http://nihoerextra.nih.gov/stem_cells/add.htm or mailed to
                            NIH Stem Cell Guidelines, MSC 7997
                            9000 Rockville Pike
                            Bethesda, Maryland, 20892-7997

                            The applicable law include the “Dickey-Wicker Amendment” [3] which prohibits NIH funding of research that harms human embryos. In addition, there is a long-standing Department of Health and Human Services regulation for Protection of Human subjects, 45 C.F.R. 46 , which establishes safeguards for individuals who are the sources of human tissues used in research. The following are my comments.

                            Misdefinition of Human Embryonic Stem Cells

                            The Draft Guidelines misdefines human embryonic stem cells (HESC) as “cells that are derived from human embryos, are capable of dividing without differentiation for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.” This definition covers some cells that are not human embryonic stem cells and fails to cover some cells that are.

                            The more accepted scientific definition of HESC is the inner mass cells located in a developing blastocyst or pluripotent cells derived from such cells. The length of time that they can divide in culture without differentiation is irrelevant to the definition. Likewise, the stipulation of “dividing without differentiation” depends on culture conditions and should not be part of the definition.

                            The definition excludes some cells that would be considered HESC. For example, some cells derived from the inner mass of blastocysts cannot develop into cells and tissues of all three primary germ layers but are still considered HESC because they can make many kinds of cells, including themselves. If HESC is defined only as those stem cells that produce all three primary germ layers, the guidelines would not pertain many HESC lines or their progeny.

                            The definition includes many cells that would not be considered HESC but are nevertheless derived from human embryos and are pluripotent. For example, several widely used cancer and human teratoma cell lines would fall under the definition. Teratoma cell lines are likely to have originally derived from an embryo, are usually pluripotent, but would be considered cancer cells and not HESC.

                            Finally, the term “embryo” includes all stage of fetal development. HESC are derived from blastocysts, which are pre-embryonic. An blastocyst does not become an embryo until a midline develops. As written, the definition of HESC stipulating derivation from embryo would include all derived or induced pluripotent cells from any stage of embryonic development. This definition is not only wrong and misleading but introduces unintended and unnecessary regulatory problems.

                            Mischaracterization of Human Embryonic Stem Cell Research

                            The Draft Guidelines state that “studies of human stem cells may yield information about the complex events that occur during human development”. Likewise the Guidelines state that HESC “may also be used to test new drugs”. This use of “may” is unnecessarily conservative and misleading in this situation. HESC are already yielding important information on human development and are being used by the pharmaceutical industry to test drugs. The use of the word “may” in this context suggests political motivation to downplay the importance of HESC research.

                            The Guidelines fail to mention one very important application of HESC. HESC derived from individuals with genetic diseases or genetically modified HESC would allow study of these disease in vitro or in vivo, i.e. HESC cells transplanted into human or animals. Having cells lines that contain human genetic disease, particularly complex genetic diseases tha involve multiple genes, provide powerful tools for studying human disease.

                            Finally, the statement that “Perhaps the most important potential use of human embryonic stem cells is the generation of cells and tissues that could be used for cell-based therapies” is simply wrong. Clinical application of HESC is the least likely of the many potential uses of HESC. This because HESC (unless they are derived from SCNT) are not immune compatible. The role of HESC for transplantation is being supplanted by induced pluripotent stem cells (IPSC).

                            It is gravely disappointing that NIH should write Draft Guidelines that provide misleading information to the public concerning the science and potential of embryonic stem cells. It should be written by somebody who is more aware of the latest research in the field.

                            Unnecessary Restrictions of Human Embryonic Stem Cell Research.

                            The Draft Guidelines “would allow funding for research using only those human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and are no longer needed for that purpose”. This restriction was not stipulated in Executive Order 13505, the Dickey-Wickers amendment, nor the basic HHS Policy for Protection of Human Research Subjects.

                            The restriction came originally from the Clinton Administration who had proposed that IVF Clinics provide a source of HESC that may be politically acceptable to the public. The Clinton Administration side-stepped the Dickey-Wickers amendment by having outside groups isolate the cells from blastocysts that would be discarded but are donated by the parents for research. This subterfuge relieves NIH of the onus of directly funding handling of blastocysts.

                            A decade has passed since the original recommendation from the Clinton Administration to use blastocysts from IVF clinics. Much science has developed including many methods for deriving and creating pluripotent stem cells. Given this situation, why has the NIH chosen to restrict the study of HESC to IVF sources? Why have they decided to prohibit cells derived from “somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes”?

                            The Guidelines said “Funding will continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells”. Unfortunately, it did not define induced pluripotent stem (IPS) cells. For example, would IPS cells from fetal cells be allowed? As IPS cel research has progressed, it has become clear that pluripotency is a condition that is induced by relatively few genes from an enormous variety of cells.

                            The Guidelines provide no rational, moral, or legal framework for what it prohibits. For example, it is not clear at all why it is all right to study HESC derived IVF blastocysts that are “no longer needed” by the parents but it is not all right to study cells derived from parthenogenesis, a process where an unfertilized egg is fooled into dividing and producing some stem cells, even though it cannot develop further. No human parthenote has ever been produced nor considered possible.

                            By failing to provide rational, moral, or legal basis for its restrictions, the Guidelines risks being hypocritical and will not be able to withstand the criticism of those who seek to abolish HESC research altogether. For example, the guidelines assume that there is an important moral distinction between embryos that are created for procreation and are no longer needed versus parthenotes, i.e. an never-fertilized egg that is fooled into dividing to produce HESC but cannot develop into a fetus. What is that distinction? Why is one okay and the other not?

                            Retroactive Informed Consent Requirements

                            The Draft Guidelines will limit the sources of HESC even more than the Bush Administration. For example, the Guidelines will impose additional requirements on the source of HESC cells. For example, it requires that “all options pertaining to the use of embryos no longer needed for reproductive purposes” be explained to potential donors. Depending on how this is interpreted, this seemingly innocuous requirement can rule out all the HESC stem cells created to date because informed consents from donors are unlikely to include “all options”.

                            The Guidelines further requires that “no inducements were offered for the donations”, that “a policy is in place at the health care facility where the embryos were donated that neither consenting nor reusing to donate embryos for research would affect the quality of care provided to the potential donor(s)”, that “there was a clear separation between the prospective donor(s)’s decision to create human embryos for reproductive purposes and the... decision to donate human embryos for research purposes”, and a long list of other specific requirements.

                            It is unclear that any or all these requirements have been met, even in the so-called Presidential lines derived before August 2001. The wording of the Guidelines suggest intent to impose that requirements on existing cell lines. If so, this would essentially rule out NIH funding of any HESC line derived before the Guidelines. The Guidelines specify that these informed consent requirement apply to future cell lines that are derived and not to previously derived cell lines.

                            Unnecessary Restrictions on HESC and IPSC Transplants into Animals

                            The Guidelines prohibit two types of research that are not prohibited by current law or regulation. The first is “research in which human embryonic stem cells (even if derived according to these Guidelines) or human induced pluripotent stem cells are introduced into non-human primate blastocysts. The second is “research involving the breeding of animals where the introduction of human embryonic stem cells or human induced pluripotent stem cells may have contributed to the germ line.

                            At the present, all NIH-funded human stem cell research that is conducted with animals must be reviewed by the Institutional Review Board (IRB) of the research institution, the HESC board of the institution, the Institutional Animal Care and Use Committee, and by several NIH peer-review and ethics boards. Instead of allowing existing mechanisms to review the grant application, the Guidelines are imposing poorly worded sweeping regulations that restrict most human-animal chimera research. Let me explain why.

                            One of the most important demonstrations of pluripotency at the present is to transplant a putative stem cell line into an immune-suppressed animal and showing that the cells will contribute to many types of tissues or form a teratoma that have many types of cells. The former is usually done by introducing a cell into developing animal blastocyst (the easiest stage to introduce cells). The latter is more difficult and injected into an adult immune-suppressed animal.

                            Likewise, one of the most important tools for biomedical research is the creation of animal strains that contain human cells that allow prediction of human responses to treatment. The clearest example of this, for example, a mouse strain that was created by Irv Weissman, that has a human immune system. This mouse is a mainstay of human immunological research, allowing the study of human cells in a mouse. Under the proposed rules, the creation of such an animal strain using NIH funds would no longer be allowed.

                            Even though the Executive Order requested guidelines for use of HESC only, these Draft Guidelines extended HESC prohibitions human IPS cells (IPSC). IPS cells have nothing to do with HESC or embryos. These restrictions will make it significantly more difficult for scientists to develop ways to validate pluripotent cell lines. The Guidelines should require more stringent ethical review of such research but should not issue unnecessary and short-sighted prohibitions in this fashion.

                            Conclusions

                            These Guidelines have the unfortunate potential to impose unnecessary regulations on HESC and IPSC research by NIH than the prohibitions under the Bush administration. The Guidelines impose a scientifically incorrect definition of HESC that covers cells that are not HESC and does not cover some cells that are HESC. It misrepresents the promise of HESC research and appears to have been written by non-scientists. Worse, it imposes additional regulations on HESC and IPSC research that are not mandated by existing law or regulations at NIH. As written, these Guidelines will cause more harm to HESC research than it helps. The Guidelines are poorly written, scientifically inaccurate, and impose new restrictions on both HESC and IPSC with little rational, legal, or ethical basis.

                            Recommendations

                            I recommend that these Guidelines be changed in the following ways:

                            1. The definition of HESC should be rewritten to refer specifically to inner mass cells obtained from blastocysts or progeny of these cells.

                            2. The section on the promise of HESC research should be written by a scientist based on the latest information about HESC.

                            3. Informed consent requirements should not be imposed retrospectively on HESC lines derived in the past.

                            4. The Guideline should focus only on HESC and should not refer to IPSC research, which have nothing to do with embryos.

                            5. The Guidelines should not restrict research not prohibited by current law or regulations, including use of HESC and IPSC in animals.

                            6. Separate guidelines should be developed for parthenogenesis- and somatic cell nuclear transfer (SCNT) derived HESC.


                            References

                            1. Stem Cell Information [World Wide Web site]. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2009 [cited Saturday, May 09, 2009] Available at http://stemcells.nih.gov/policy/2009draft

                            2. Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells (108KB PDF http://edocket.access.gpo.gov/2009/pdf/E9-5441.pdf)

                            3. Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/09

                            4. “Basic HHS Policy for Protection of Human Research Subjects, Title 45 Public Welfare Department of Health and Human Services, Part 46 Protection of Human Subjects, revised June 23, 2005. http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf




                            Last edited by Wise Young; 9 May 2009, 4:33 PM.

                            Comment


                              #15
                              Embryonic vs. Adult Stem Cell

                              Originally posted by Wise Young View Post
                              I just heard from somebody who attended a meeting at NIH that of the 6000+ comments that NIH has received concerning the draft guidelines, 99% were from people who opposed embryonic stem cell research.

                              There are many scientists who believe that these NIH guidelines are unacceptable and unnecessarily shut off research that are not prohibited by law. For example, the guideline says that parthenogenesis is prohibited by law. Parthenogenesis (i.e. the stimulation of an egg so that it believes that it has been fertilized) does not necessarily lead to creation of an embryo.

                              The language of the draft guidelines, if strictly interpreted, may actually prevent NIH funding of studies of the cell lines that have already been derived. Specifically, NIH appear to be requiring specific informed consent language that may result in NIH not allowing even the so-called Presidential lines to be studied with NIH funds.

                              Finally, the guidelines does not address specific important issues regarding pluripotent stem cells and the creation of human-nonhuman chimeric animals. This is very important because such prohibitions will prevent very important research based on misunderstandings of what human cells do when they are transplanted into animals.

                              If people support embryonic stem cell research, it is very important that they write to NIH saying that they support embryonic stem cell research and that the proposed guidelines are unnecessarily restricting research that are not required by law. I will post a detailed analysis of the guidelines soon. The deadline for all comment is May 24.

                              Wise.
                              This is something I received in my email a couple of days ago. This may influence people to decide that adult stem cell would be better to use than embryonic. Here's their link that was sent out with this brief message:

                              As you know, embryonic stem cells (ESC's) have ruled the airwaves for the last decade. Less known by the public are adult stem cells (ASC's). ASCTA has recently published a white paper on the research of embryonic vs. adult stem cells. Since educating the public about the potential of ASC's is a goal of ASCTA, please take a minute to click on the link below and share this with family and friends. It shows that the research is much more plentiful and mature on adult than on embryonic cells. Enjoy!

                              http://www.safestemcells.org/uploads....Embryonic.pdf

                              I would like to know who these people are and what type of hog wash their trying to sell to the public. Granted there are some good benefits and useage of adult stem cell for some people but not all people. People have to understand that if these cryogenically preserved embryos aren't used they will be flushed down the toilet.
                              Aggie Mom 2007

                              Comment

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