Dear list members,
The National Institutes of Health Guidelines for Research Using Human
Pluripotent Stem Cells (15 pages) and additional info. is now
available at http://www.nih.gov/news/stemcell/index.htm
Lest anyone expects the US government to rush into funding this
research, read the following, from article in the Aug. 23 Buffalo News :
1. "According to one source who partcipated in an NIH briefing, the
agency plans to appoint an advisory committee of scientists and ethicists
called the Human pluripotent stem cell review group, to review all
embryo cell grant applications submitted to NIH. That committee will have
it's first meeting in December."
2. "Applications that pass first muster will be forwarded to the NIH
scientific review advisory committee" -- which meets in January.
3. Promising applications then go to the grant-judging committees of the
individual institutes.
4. "That means the first awards could be announced late next year at the
earliest --- ASSUMING THAT CONGRESS OR THE NEXT PRESIDENT DO NOT
INTERFERE WITH THE PROCESS" (my caps)
While I do understand why the NIH is very cautiously implementing this
funding, in the meantime, the clock continues to tick for us and for
people with other diseases that might be helped by the results of this
research.
Here is a summary of the guidelines:
NIH FACT SHEET ON HUMAN PLURIPOTENT STEM CELL RESEARCH GUIDELINES
Embargoed until 9 a.m., August 23, 2000
The Promise of Stem Cell Research
Human pluripotent stem cells are a unique scientific and medical
resource.
They can develop into most of the specialized cells and tissues of the
body, such as muscle cells, nerve cells, liver cells, and blood cells and
they can divide for indefinite periods in the laboratory, making them
readily available for research, and potentially, treatment purposes.
Scientists derived these unique cells from human embryos and from
non-living fetuses.
The establishment of human pluripotent stem cell lines represents a major
step forward in the understanding of human biology. These unique cells
have
captured the interest of scientists and the public, particularly patients
and their advocates. Although such research promises new treatments and,
possibly even cures for many debilitating diseases and injuries,
including
Parkinson=s disease, diabetes, heart disease, multiple sclerosis, burns
and
spinal cord injuries, the NIH acknowledges that the ethical issues
related
to this research need due consideration.
The Need for Guidelines to Govern Research Using Pluripotent Stem Cells
Federal law currently restricts the use of Department of Health and Human
Services (DHHS) funds for human embryo research. DHHS funds cannot be
used
for the derivation of stem cells from human embryos. The Congressional
restriction, however, does not prohibit funding for research utilizing
human pluripotent stem cells because such cells are not embryos.
The purpose of the NIH Guidelines is to prescribe procedures to help
ensure
that NIH-funded research in this area is conducted in an ethical and
legal
manner. By issuing these Guidelines, the NIH aims to enhance both the
scientific and ethical oversight of this important arena of research and
the pace at which scientists can explore its many promises. These
Guidelines will encourage openness, help make certain that researchers
can
make use of these critical research tools, and help assure public access
to
the practical medical benefits of research using these cells.
In an effort to help ensure that any research utilizing human pluripotent
stem cells is appropriately and carefully conducted, the NIH sought the
advice of scientists, patients and patient advocates, ethicists,
clinicians, lawyers, the National Bioethics Advisory Commission (NBAC),
members of Congress, among others in drafting these Guidelines. The draft
Guidelines were published for public comment in the Federal Register and
after reviewing and considering all comments, the NIH will publish the
final NIH Guidelines in the Federal Register on August 25, 2000.
Specifics of the Guidelines
The Guidelines prescribe the documentation and assurances that must
accompany requests for NIH funding for research using human pluripotent
stem cells derived from human embryos or fetal tissue.
* For studies using cells derived from human embryos, NIH funds may be
used only if the cells were derived from frozen embryos that were
created for the purposes of fertility treatment and were in excess
of
clinical need.
* The Guidelines prohibit the use of inducements, monetary or
otherwise,
for the donation of the embryo. There must also have been a clear
separation between the fertility treatment and the decision to
donate
embryos for this research.
* Investigators who propose to use human pluripotent stem cells from
fetal tissue will be expected to follow both the Guidelines and all
laws and regulations governing human fetal tissue and human fetal
tissue transplantation research.
* The Guidelines require that the informed consent specify whether or
not information that could identify the donor(s) will be retained.
* They require that the donation of human embryos or fetal tissue be
made without any restriction regarding the individual(s) who may be
the recipient of the cells derived from the human pluripotent stem
cells for transplantation.
* They also require review and approval of the derivation protocol by
an
Institutional Review Board.
* The informed consent should include statements that the embryos or
fetal tissue will be used to derive human pluripotent stem cells for
research, that may include human transplantation research; that
derived cells may be kept for many years; that the research is not
intended to provide direct medical benefit to the donor; and, for
cells derived from embryos, that embryos donated will not be
transferred to a woman=s uterus and will not survive the stem cell
derivation process.
* The informed consent must also state the possibility that the
results
of the research may have commercial potential, and that the donor
will
not receive any benefits from any such future commercial
development.
Areas of Research Ineligible for NIH Funding
As required by law, NIH funds cannot be used for the derivation of
pluripotent stem cells from human embryos. The Guidelines also set forth
several other areas of research that are ineligible for NIH funding,
including: 1) research in which human pluripotent stem cells are utilized
to create or contribute to a human embryo; 2) research utilizing
pluripotent stem cells that were derived from human embryos created for
research purposes; 3) research in which human pluripotent stem cells are
derived using somatic cell nuclear transfer; 4) research utilizing human
pluripotent stem cells that were derived using somatic cell nuclear
transfer; 5) research in which human pluripotent stem cells are combined
with an animal embryo; and 6) research in which human pluripotent stem
cells are derived using somatic cell nuclear transfer for the purposes of
reproductive cloning of a human.
Requirements for Investigators Applying for Funds
A request for NIH funds for research using these cells must include a
signed assurance that the cells were derived from human embryos in
accordance with the Guidelines and that the institution will maintain
documentation in support of the assurance.
This assurance must also affirm that:
* The human pluripotent stem cells to be used in the research were, or
will be, obtained through a donation or through a payment that does
not exceed the reasonable costs associated with the quality control,
processing, transportation, preservation, and storage of the stem
cells.
* The proposed research is not a class of research that is ineligible
for NIH funding.
Investigators must also submit:
* A sample informed consent document, with patient identifier
information removed, and a description of the informed consent
process
along with documentation of IRB approval of the derivation protocol.
* An abstract of the scientific protocol used to derive human
pluripotent stem cells along with a title of the research proposal
that proposes the use of human pluripotent stem cells.
Ensuring Compliance with the Guidelines
Investigators requesting NIH funds for research using pluripotent stem
cells will need to provide documentation that they are in compliance with
the Guidelines prior to receiving NIH funds for this class of research.
Submitted documentation will be reviewed by a newly-created NIH working
group called the Human Pluripotent Stem Cell Review Group (HPSCRG).
Members of the working group will:
* Review documentation of compliance with the Guidelines for funding
requests that propose the use of human pluripotent stem cells
* Advise the NIH Center for Scientific Review Advisory Committee
(CSRAC)
of the outcome of their review, which, if appropriate, will be
approved by the CSRAC. This decision will be forwarded to the
funding
Institute or Center.
* Hold public meetings when a request proposes the use of a line of
human pluripotent stem cells that has not been previously reviewed
by
the HPSCRG.
In no event will NIH fund research or allow existing funds to be used for
research using human pluripotent stem cells derived from human embryos or
human fetal tissue until the derivation protocol has received HPSCRG
review
and CSRAC approval. Continued compliance with the Guidelines is a term
and
condition of the NIH award.
Additional information about stem cells can be found on the NIH Web site
at
http://www.nih.gov/news/stemcell/index.htm. (The final guidelines will be
available on this site as soon as they are released.)
