2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (2008) / Chapter Skim
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2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research
2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research
Pages 1-19
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From page 1... ...
The National Academies established the Human Embryonic Stem Cell Research Advisory Committee for that purpose in 2006 with support from the Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute. It issued its first set of amendments to the Guidelines in 2007 (NRC and IOM, 2007)
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The Human Embryonic Stem Cell Research Advisory Committee contin ues to engage in a number of efforts to gather information about the need, if any, for revision of the Guidelines. For example, the Committee conducted three regional meetings (in southern California, Chicago, and the Boston area)
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. • urther enumerate the registration and auditing responsibilities of F institutions conducting hES cell research to improve public access to information and ensure that ESCRO committees are carrying out their responsibilities appropriately -- Section 2.0.
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has been amended by adding definitions for the terms hPS cells and multipotent, and the entire glossary is reprinted as Appendix B APPLICABILITY OF THE GUIDELINES TO NON-EMBRYONIC HUMAN PLURIPOTENT STEM CELLS The original Guidelines released in 2005 were addressed specifically to research with hES cell lines, although institutions and investigators conduct ing research on human adult stem cells or fetal stem cells were encouraged to "consider which individual provisions of these guidelines are relevant to their research." Because the Guidelines were developed primarily for research with hES cells, however, it was not made explicit which provisions of the Guidelines might apply to other types of stem cells.
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For those reasons and in response to inquiries from the scientific community, the Human Embryonic Stem Cell Research Advisory Committee has consulted with experts and carefully considered potential modifications of the Guidelines to cover other pluripotent and multipotent stem cells, which the Committee presents herein. The intention is not to extend unnecessarily the oversight of stem cell research where it is already adequately monitored under existing regulations and guidelines.
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The earlier ver sions of the Guidelines placed responsibility for review of such experiments with hES cells in the hands of ESCRO committees and Institutional Animal Care and Use Committees (IACUCs) , and it is logical to do the same for hPS cells and for stem cells with more limited potential for differentiation.
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From Section 3 3 .1 An IRB, as described in federal regulations at 45 CFR 46.107, should review all new procurements of all gametes, blastocysts, or somatic cells for the purpose of generating new hES or hPS cell lines. This includes the procurement of blastocysts in excess of clinical need from infertility clinics; blastocysts made through IVF specifically for research purposes; and oocytes, sperm, and somatic cells donated for development of hES cell lines derived
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(g) statement that the hES or hPS cells and/or cell lines might A be used in research involving genetic manipulation of the cells or mixing of human and nonhuman cells in animal models.
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N ew derivations of stem cell lines from banked tissues obtained prior to the adoption of these guidelines are permissible provided that the original donations were made in accordance with the le gal requirements in force at the place and time of donation. This includes gametes, blastocysts, adult stem cells, somatic cells, or other tissue.
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Section 7 7 .0 Recommendations for Research on non embryo-derived human pluripotent stem cells (hPS CELLS) 7.1 Derivation B ecause non-embryo-derived hPS cells are derived from human material, their derivation is covered by existing IRB regulations concerning review and informed consent.
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, including informed consent to genetic manipulation of resulting pluripotent stem cells and their use for transplantation into animals and hu mans and, potentially, in future commercial development. 7.2 Use in in Vitro Experiments U se of hPS cells in purely in vitro experiments need not be sub ject to any review beyond that necessary for any human cell line except that any experiments designed or expected to yield gametes (oocytes or sperm)
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7.4 Multipotent Neural Stem Cells I t is also relevant to note that neural stem cells, although not pluripotent, are multipotent and may have the potential to con tribute to neural tissue in chimeric animals. ESCRO committees should decide whether they wish to review and monitor such experiments with neural stem cells in a similar fashion.
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. Thus, the ESCRO committee -- not the investigator -- must decide whether the proposed research is purely in vitro research with existing hES cell lines that meet appropriate standards for procurement.
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1 .3(a) hES cell research permissible after currently mandated reviews P urely in vitro hES cell research that uses previously derived hES cell lines is permissible provided that the ESCRO committee or equivalent body designated by the investigator's institution (see Sec tion 2.0)
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PUBLIC OPENNESS AND ESCRO COMMITTEE AUDITS Research that uses hES cells remains controversial in the United States and is still subject to intense political scrutiny. Therefore, it is important to sustain public confidence in the integrity of the institutions and researchers conducting hES cell research; this is one of the reasons that the Guidelines were developed.
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The amended wording (underlined) of Section 2.0 is as follows: 2 .0 ESTABLISHMENT OF AN INSTITUTIONAL EMBRY ONIC STEM CELL RESEARCH OVERSIGHT COMMITTEE T o 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 in volving hES cells overseen by an Embryonic Stem Cell Research Oversight (ESCRO)
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CLARIFICATION OF POLICY REGARDING REIMBURSEMENT OF OOCYTE DONORS It was pointed out in the report Guidelines for Human Embryonic Stem Cell Research (NRC and IOM, 2005) that although there is widespread consensus that donors should not be paid for blastocysts donated for research,
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The recommendation made by the Committee on Guidelines for Human Embryonic Stem Cell Research in 2005 was that women who undergo hor monal induction to generate oocytes specifically for research purposes should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an Institutional Review Board. Thus, the National Acad emies' Guidelines prohibit cash or in-kind payments for donating oocytes for research purposes.
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that allows reimbursement of oocyte donors for "permissible expenses," which are clearly defined to include "actual lost wages." The state of Massachusetts has a similar policy. Although the original National Academies' Guidelines did not specifically mention lost wages as a reimbursable category of direct expenses, institutions and states that perform or support hES cell research should view the National Academies' Guidelines as open to the interpretation that "lost wages" is a legitimate category of reimbursable expenses.
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