2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (2007) / Chapter Skim
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2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research
2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research
Pages 1-14
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Because human embryonic stem (hES) cell research touches on many ethical, legal, scientific, and policy issues that are of concern to some people, the Guidelines are intended to make explicit how research with hES cells can be pursued most responsibly.
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they urged the National Academies to consider correcting or clarifying as pects of the Guidelines in the light of experience. Responding to these requests for revision and ongoing monitoring, the Human Embryonic Stem Cell Research Advisory Committee was estab lished in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute.
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; 2A summary of the AAMC meeting was subsequently published as "Human Embryonic Stem Cell Research: Regulatory and Administrative Challenges." This AAMC monograph is available at |
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advice for ESCRO committees in establishing criteria for considering the science in hES cell research proposals. CLARIFYING THE PHRASE "PROVENANCE OF THE CELL LINES" The National Academies' Human Embryonic Stem Cell Research Advi sory Committee has received many comments from the scientific community questioning the meaning of the phrase "provenance of the cell lines," which occurs in Sections 1.2(a)
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In particular, the Guidelines require informed consent from all embryo, gamete, and somatic cell donors, even anonymous gamete donors. For the 4"President Discusses Stem Cell Research," August 9, 2001.
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. The intention of "grandfathering" the NIH-approved cell lines is to avoid precluding hES cell research that would otherwise be ren dered difficult or impossible for investigators using NIH funding who wish to follow the National Academies' Guidelines.
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For example, hES cell line derivations in the United Kingdom are managed through a licensing procedure that differs from the IRB and ESCRO committee review processes recommended in the Guidelines. Within the United States, state laws may vary from the Guidelines.
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This is in accord with the requirement in Section 2.0 of the Guidelines that calls for ESCRO committees to maintain regis tries listing the cell lines in use at their institutions. ESCRO COMMITTEES SERVING MULTIPLE INSTITUTIONS The report Guidelines for Human Embryonic Stem Cell Research laid out a series of recommendations pertaining to the composition and role of ESCRO committees.
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ESCRO committee was unintentionally omitted from the wording of Section 2.0 of the Guidelines. Furthermore, since the Guidelines were issued in April 2005, it has become clear that there are other models for establishing ESCRO committees consistent with the principles of the Guidelines.
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2.0 ESTABLISHMENT OF AN INSTITUTIONAL EMBRY ONIC STEM CELL RESEARCH OVERSIGHT COMMITTEE To provide oversight of all issues related to derivation and use of hES cell lines and to facilitate education of investigators involved in hES cell research, each institution should have activities involv ing hES cells overseen by an Embryonic Stem Cell Research Over sight (ESCRO) committee.
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FROZEN IVF BLASTOCYSTS DERIVED FROM ANONYMOUS SPERM DONORS: ABSENCE OF INFORMED CONSENT Members of the scientific community raised concerns that the National Academies' Guidelines require that donors of all embryos, gametes, and somatic cells give informed consent for the use of their tissues for the derivation of human embryonic stem cell lines. Specifically, Section 3.3 of the Guidelines states that "When donor gametes have been used in the IVF process, resulting blastocysts may not be used for research without consent of all gamete donors." This requirement might preclude the use of frozen blastocysts from IVF clinics, which do not customarily request informed consent from sperm donors.
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to reflect accurately outcomes of the procedures commonly used in IVF practices.8 The information returned in response to the Committee's request indicated that the number of blastocysts created with anonymous donor sperm in SART member practices is only about 3.5 percent.9 Given this small number, it is the Committee's view that maintaining the requirement for sperm donor consent in cases where human embryonic stem cell lines are to be derived from excess IVF clinic blastocysts should not significantly affect the availability of blastocysts for donation to research. The Committee, therefore, has concluded that it is not necessary to modify the Guidelines by "grandfathering" the frozen embryo population in IVF clinics and exempting them from the informed consent requirement for sperm donors.
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Additional questions arise in considering protocols involving introduction of hES cells or cellular derivatives thereof into an animal host to form a chimera. Some of those questions were addressed in the 2005 Guidelines for Human Embryonic Stem Cell Research, and the committee intends to revisit these issues in future discussions.
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