Guidelines for Human Embryonic Stem Cell Research (2005) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-28
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From page 15... ...
Two of the 1998 reports were published by independent teams of scientists that had accomplished the isolation and culture of human embryonic stem cells (hereafter referred to as hES cells) and human embryonic germ cells (hereafter referred to as hEG cells)
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From page 16... ...
A more likely benefit of the technology is that it would further facilitate a wide range of experiments to explore the underpinnings of genetic disease and possible forms of amelioration and cure, many of which would not be possible using hES cells derived from blastocysts generated by in vitro fertilization (IVF) , whose nuclear genomes are not defined.
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From page 17... ...
Embryonic stem cells show a much greater capacity for self-renewal, can be cultured to generate large numbers of cells, and are pluripotent -- they have the potential for differentiation into a very wide variety of cell types. In contrast, adult stem cells appear to be capable of much less proliferation and, in general, have a restricted range of developmental capacities; that is, they can differentiate into only a limited array of cells (Wagers and Weissman, 2004)
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From page 18... ...
If hES cell research and therapy are to be thoroughly investi gated, cell lines that are more genetically diverse and free of animal contaminants must be available. A first step in that direction was taken in February 2005 with the publication of a paper documenting the first successful growth of hES cell lines without mouse feeder cells, although contact with a growth supplement derived 1"Notice of Criteria for Federal Funding of Research on Existing Human Embryonic Stem Cells and Establishment of NIH Human Embryonic Stem Cell Registry (Nov.
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From page 19... ...
The report argued for federal funding of research deriving and using hES cells from multiple sources, including NT, asserting that, without government funding of basic research concerning stem cells, progress toward medical therapies is likely to be hindered. It noted that public sponsorship of basic research would help to ensure that many more scientists could pursue a variety of research questions and that their results would be made widely accessible in scientific journals -- two factors that speed progress substantially.
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From page 20... ...
, NBAC recommended that federal funds be available for the derivation and use of hES cells and that, for the moment, federal funding be restricted to research in which the cells were derived from blastocysts that remained after IVF or were derived from fetal tissue while research with cells derived in other ways remained legal and privately funded. The commission sug gested that following this recommendation would make sufficient hES cells avail able for research.
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From page 21... ...
. Because there is widespread agreement in the international scientific community about the potential value of hES cell research -- including the use of NT to derive hES cell lines -- and because there is, at present, general agreement that NT should not be used to produce a child, the best possible way to move forward with hES cell research in pursuit of new therapies is to have a set of guidelines to which the U.S.
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From page 22... ...
Not all scientists want to or have the resources to derive new stem cell lines, so the ability to share cell lines will create greater access for qualified scientists to participate in human stem cell research. A uniform set of criteria for deriving hES cell lines and reviewing research will help to assure that research institutions that derive, store, and maintain hES cells meet a standard set of require ments for provenance and ethical review.
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From page 23... ...
The absence of a federal mechanism for the review of controversial research protocols continued until 1993, when the NIH Revitalization Act effectively ended the de facto moratorium on support of IVF and other types of research involving human embryos by nullifying the regulatory provision that mandated EAB review. In response, NIH Director Harold Varmus convened a Human Embryo Research Panel (HERP)
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From page 24... ...
These guide lines prescribed the documentation and assurances that had to accompany requests for NIH funding of research with human hES cells, and designated certain areas of hES cell research that were ineligible for NIH funding: • the derivation of hES cells from human embryos, • research in which hES cells are utilized to create or contribute to a human embryo, • research utilizing hES cells that were derived from human embryos created for research purposes rather than for fertility treatment, • research in which hES cells are derived using NT, that is, the transfer of a human somatic cell nucleus into a human or animal oocyte, • research utilizing hES cells that were derived using NT,
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From page 25... ...
STATEMENT OF TASK In light of the absence of federal guidelines, the Committee on Guidelines for Human Embryonic Stem Cell Research was asked to develop voluntary guidelines to encourage responsible practices in hES cell research -- regardless of source of funding -- including the use and derivation of new stem cell lines derived from surplus blastocysts, from blastocysts generated with donated gametes, and through the use of NT. The guidelines should take ethical and legal concerns into account and encompass the basic science and health sciences policy issues related to the development and use of hES cells for research and eventual therapeutic purposes, such as 1.
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From page 26... ...
To conduct its work, the committee surveyed the current state of science in this field and likely pending developments, reviewed the policy and ethical issues posed by the research, examined professional and international regulations and guidelines affecting hES cell research, and conducted a 2-day workshop with speakers who represented many scientific, ethical, and public policy perspectives. It did not revisit the debate about whether hES cell research should be pursued; rather it assumed that both hES cell and adult stem cell research would continue in parallel with federal and nonfederal funding.
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From page 27... ...
CONCLUSION In the absence of federal guidelines broadly governing the generation and research use of hES cells, the scientific community and its institutions should step forward to develop and implement its own, much in the spirit of Asilomar, which resulted in the RAC guidelines in use today. Such guidelines are needed by the scientific community as a framework for hES cell research and would reassure the public and Congress that the scientific community is attentive to ethical concerns and is capable of self-regulation while moving forward with this important research.
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From page 28... ...
The next chapter describes the current status of research involving hES cells. It also addresses possible novel sources of hES cell lines not yet developed and the use of human/nonhuman chimeras in research.
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