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PARKINSN  February 2000, Week 3

PARKINSN February 2000, Week 3

Subject:

NIH stem cell guidelines

From:

Linda J Herman <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange Network <[log in to unmask]>

Date:

Sun, 20 Feb 2000 14:10:31 -0500

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (160 lines)

Greg wrote earlier:"I may be wrong, but my interpretation of McCain's
stand on stem-cell research is that he is for it as long as no aborted
human embryos or fetal material is used."

Does anyone know exactly where any of the candidates,  Republican and
Democrat stand in regards to the proposed guidelines on stem cell
research?  I haven't been able to find any information on this -- the
only place I remember reading about McCain, was on this list. And it's
not clear what kind of stem cell research he opposes (see below).  A
survey of candidates  - not only for President, but of congressional
candidates as well could be very helpful to voters like us who are
especially concerned.  Of course there are differing opinions on this
issue, but we all need to know the facts to make our own decisions.

The deadline for public comments to NIH is Feb 22. They can be emailed
to:  [log in to unmask]

I thought the following  Fact Sheet from the NIH gave a clear explanation
of the proposed guidelines. In case anyone is still deciding about
writing, I'm reposting it below.
 In short, they would allow NIH funding for  research utilizing  two
types of stem cells, those derived  (1) from early-stage embryos in
excess of clinical need donated by people who were undergoing fertility
treatment in an in vitro fertilization (IVF) clinic  or  (2) stem cells
derived from non-living fetuses obtained from pregnancies that had been
terminated, in which case the research must be in compliance with all
existing laws and regulations governing human fetal tissue research. Also
federal funds cannot be used  for the derivation of stem cells from human
embryos.

 NATIONAL INSTITUTES OF HEALTH
 Office of the Director
 Wednesday, December 1, 1999
 Fact Sheet on Human Pluripotent Stem Cell Research Guidelines

     The NIH is seeking public input on draft Guidelines for
NIH-supported
     research involving human pluripotent stem cells. These draft
     Guidelines recommend procedures to help ensure that NIH funded
     research in this area is conducted in an ethical and legal manner.

     The Promise of Stem Cell Research
        * Human pluripotent stem cells are a unique scientific and
medical
          resource in that they can divide for indefinite periods in
          culture, and can develop into most of the specialized cells and
          tissues of the of body, such as muscle cells, nerve cells,
heart
          cells, blood cells.

        * These human pluripotent stem cells were isolated using two
          different methods. One group of scientists derived the
          pluripotent stem cells from early-stage embryos in excess of
          clinical need donated by people who were undergoing fertility
          treatment in an in vitro fertilization (IVF) clinic. Another
          group of scientists isolated the pluripotent stem cells from
          non-living fetuses obtained from pregnancies that had been
          terminated.

     Legal
        * Federal law currently restricts the use of DHHS funds for human
          embryo research. DHHS has determined, however, that the
          Congressional restriction does not prohibit funding for
research
          utilizing human pluripotent stem cells because such cells are
not
          embryos. DHHS funds cannot be used for the derivation of stem
          cells from human embryos.

     Development of Stem Cell Guidelines
        * In an effort to help ensure that any research utilizing human
          pluripotent stem cells is appropriately and carefully
conducted,
          the NIH convened a Working Group of the Advisory Committee to
the
          Director (ACD), NIH to advise the ACD on guidelines and
oversight
          for research involving human pluripotent stem cells. The
working
          group was composed of scientists, patients and patient
advocates,
          ethicists, clinicians and lawyers.

        * In developing the draft guidelines, NIH considered advice from
          the National Bioethics Advisory Commission (NBAC), the public,
          and the Congress.

        * Draft guidelines for this research will be published for public
          comment in the Federal Register on December 2 , 1999. After
          reviewing and considering all comments received, the NIH will
          make revisions to the guidelines, as appropriate, and publish
the
          final guidelines in the Federal Register. The draft guidelines
          can be found on the Web at
          http://www.nih.gov/news/stemcell/draftguidelines.htm.

        * Until the final guidelines and the oversight process are in
          place, the DHHS will not fund research using human pluripotent
          stem cells derived from either human embryos or fetal tissue.

     Draft NIH Guidelines
        * The guidelines apply to research applications or proposals for
          NIH funding or support that involve the utilization of human
          pluripotent stem cells derived (without NIH funding) from early
          human embryos and the derivation or utilization of human
          pluripotent stem cells derived from human fetal tissue.

        * HHS will fund research using human pluripotent stem cells
derived
          from early human embryos only if investigators use cells
derived
          from frozen embryos that were created for the purposes of
          infertility treatment and were in excess of clinical need. In
          addition, the investigator can offer no inducements, monetary
or
          otherwise for the donation of the embryo and there must be a
          clear separation between the infertility treatment and the
          decision to donate embryos.

        * With regard to deriving or using cells from fetal tissue,
          investigators will be expected to follow the NIH Human
          Pluripotent Stem Cell Guidelines and all laws and regulations
          governing human fetal tissue research. Because cells derived
from
          fetal tissue may later be utilized in human fetal tissue
          transplantation research, NIH will fund this research only if
          investigators comply with the fetal tissue transplantation
          research statute.

        * The Guidelines specify what should be contained in the informed
          consent document for the donation of human embryos or human
fetal
          tissue.

        * In submitting an application or proposal for funding,
          investigators will be required to provide documentation showing
          compliance with the Guidelines. This documentation will be
          submitted to a newly established Human Pluripotent Stem Cell
          Review Group (HPSCRG). The review group will hold public
meetings
          when a funding request proposes the use of a newly derived line
          of human pluripotent stem cells. The HPSCRG will also compile a
          yearly report which will include the number of applications
          reviewed, and the titles of all awarded applications.

        * The Guidelines state that no NIH funds may be used to derive
          pluriptotent stem cells from human embryos.

        * The Guidelines also address the other areas of research that
are
          ineligible for funding, including studies in which human
          pluripotent stem cells are: utilized to create or contribute to
a
          human embryo; combined with an animal embryo; used for
          reproductive cloning of a human; derived using somatic cell
          nuclear transfer into a human or animal egg; derived using
          somatic cell nuclear transfer into a human or animal egg;
derived
          from human embryos created for research purposes.
FROM: http://www.nih.gov/news/stemcell/index.htm

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December 2003, Week 5
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April 2003, Week 5
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April 2003, Week 3
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March 2003, Week 1
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February 2003, Week 1
January 2003, Week 5
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January 2003, Week 1
December 2002, Week 5
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June 2002, Week 5
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April 2001, Week 3
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April 2001, Week 1
March 2001, Week 5
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March 2001, Week 3
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February 2001, Week 2
February 2001, Week 1
January 2001, Week 5
January 2001, Week 4
January 2001, Week 3
January 2001, Week 2
January 2001, Week 1
December 2000, Week 5
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December 1999, Week 5
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