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Pages 155-166

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From page 155...
... See Assisted reproductive technology personal, informing donors there will be Asilomar Conference, 26–27, 70 none, 9, 84 ASRM. See American Society for Reproductive Best Practices for the Licensing of Genomic Medicine Inventions, 64 Assisted human reproduction agency, in Canada, Bioethics Advisory Committee 27 in Israel, 78 Assisted reproductive technology (ART)
From page 156...
... , 64–66, 68 Bush, George W., 2, 18, 21 Code of Practice for the Use of Human Stem Cell Lines, 52 Collaborations, substituting equivalent foreign C procedures in, 58, 106, 125 Common Rule, 54n, 64n Cadaveric fetal tissue, derivation of stem cells Compliance from, 16–17 imposing sanctions to ensure, 14, 106–107 California Institute for Regenerative Medicine, recommendations for, 11–12, 71, 126 76 with relevant FDA regulations, 74, 126 Canada, 78–79, 84 Confidentiality, 4, 56, 82 national body established in, 59 Conflict of interest, 107 procurement practices in, 66 Conscience, personnel objecting to hES cell Canadian Assisted Human Reproduction Agency, research for reasons of, 11, 92, 102, 128 27 Consent. See Informed consent of donors Canadian Institute for Health Research, 78 Contamination, concerns about, 18 Cash payments, not offering to donors, 9–10, 85 Contraception, developing better techniques for, Categories of research proposals, 7–8, 57–58, 77 98–99, 124–125 Coriell, 93 research not permissible at this time, 8, 57– "Council of Europe Recommendation R(97)
From page 157...
... See also Investigational new drugs; need for an oversight system, 51–53 Targeting objections to the use of NT for reproductive immunosuppressive, 34, 118 purposes, 51 recommendations regarding, 53–60 respect for donors of human embryos and E gametes, 49 special status of the human embryo, 48–49 EAB. See Ethics Advisory Board transferring hES cells into nonhuman animals, Ectoderm, 31, 116 49–50 Ectopic sites, 44 Ethical Issues in Human Stem Cell Research, 20 Electroporation, 33, 116 Ethics Advisory Board (EAB)
From page 158...
... , 72 using IVF, 4 Food and Drug Administration (FDA) , 3, 6, 12, coverage of, 4–5, 98 19, 39, 51, 63–64, 72, 74, 82–83 derivation of hES cell lines, 102–103 letter to investigators/sponsors, 20n, 51n dividing research proposals into categories, Forum for a continuing discussion of issues, 98–99 national body needed to provide, 59–60, establishment of institutional ESCRO 126 committees, 100 Funding sources for hES cell research, 14, 18–19, international collaboration, 106 59, 106 national body needed to assess adequacy of, nonfederal, 106 59–60, 126 public, 19, 106 need for, 18–22 obligations of investigators and institutions, 99–100 G procurement of gametes, blastocysts, or cells for hES generation, 100–102 Gametes, 30, 117 research use of hES cell lines, 105–106 donors of, 4, 7–9, 57, 100, 106 somatic cell nuclear transfer (NT)
From page 159...
... See Financial incentives; Nonfinancial Human embryonic stem cell research incentives clearinghouse for proposals, 5, 54 Incorporation of hES cells or cells derived from current regulation of, 28, 63–79 them prerequisites to, 4, 26 into nonhuman blastocysts, 40–41 public sponsorship of, 19 into postgastrulation stages of another Human embryonic stem cells (hES cells) , 1, 32, 118 species, 40 genetic modification of, 42 into postnatal animals of another species, 39– knowing the provenance of, 54 40
From page 160...
... , 6–7, 54, Infertility treatments, 1, 11, 48, 77 57, 70, 99 Influence, 85–86, 101, 126 Institutional oversight of hES cell research, 53–58 Informed consent of donors, 4, 18, 56, 66, 88– in collaborations, substituting equivalent 91, 101–102, 125, 127–128 foreign procedures, 58, 106, 125 obtaining from each donor at time of establishing uniform guidelines and record donation, 88, 101, 127 keeping processes approved by an IRB, and the potential discovery of clinically 94, 103–104, 128 significant information, 89–91 oversight of, 53–58 requiring an invitation, if donors' identities registry of investigators conducting hES cell are retained, to be notified in the future of research and records of research being what was learned from studying their cell performed and cell types used, 58, 105, lines, 90, 101, 127 125 requiring assurance that all researchers will Institutional Review Boards (IRBs) , 5–12, 39, 49, follow best practices in their handling of 54–56, 64–69, 82–87, 93–94, 99–102, cells and tissues, 90, 101–102, 127 104–106 requiring disclosure of whether donors' Intellectual property issues, 26 identities will be readily ascertainable to International collaboration, 12, 106 researchers, 90, 101, 127 International regulations, 4, 26 requiring disclosure regarding possible uses of Interpretation of genetic information, 4 cells derived for human transplantation, Interspecies mixing, 38–41 90, 101, 127 incorporation of hES cells into nonhuman requiring disclosure that cells and cell lines blastocysts, 40–41 could be used in genetic manipulation or incorporation of hES cells or cells derived mixing with animal cells, 91, 102, 127 from them into postgastrulation stages of requiring disclosure that cells and cell lines another species, 40 may be kept for many years, 90, 102, 127 incorporation of hES cells or cells derived requiring disclosure that embryos will be from them into postnatal animals of destroyed in deriving hES cells, 91, 102, another species, 39–40 128 use of nonhuman oocytes as recipients of requiring disclosure that no restriction or human somatic nuclei in NT, 41 direction can be made regarding possible Introduction of hES cells into nonhuman recipients, 90, 101, 127 animals, research permissible only after requiring disclosure that research could have additional review and approval of the commercial potential, without benefit to ESCRO committee, 7, 57, 99, 105–106, the donors, 91, 102, 128 124 requiring disclosure that research is not Investigational device exemptions (IDEs)
From page 161...
... , 3, 5, 19– 21, 26, 51, 64, 97 L guidelines for research on human embryonic stem cells, 97–107 Laboratory practice, 71 National Bioethics Advisory Commission Legal issues, 1, 26. See also Federal legislation; (NBAC)
From page 162...
... See Ovarian hyperstimulation syndrome directing development of hES cells down Oocytes, 30, 34–38, 43, 48, 66, 83, 119. See also particular pathways to generate cells Sources of oocytes for NT ES cells restricted to specific developmental fates, donors of, 37–38 43–44 excess, 37 ensuring stability of genotype, epigenetic matured from ovariectomies or fetal ovaries status, and phenotypic properties of ES from pregnancy terminations, 37 cells grown in long-term cultures, 43 risks associated with retrieval, 4 generating additional hES cell lines, 42 Oophorectomy, 85 generating hES cells of defined genetic backgrounds, 42
From page 163...
... , 64 tissues, 90, 101–102, 127 Policy on Humane Care and Use of disclosure of whether donors' identities will Laboratory Animals, 71 be readily ascertainable to researchers, 90, Public Health Service Act, 72 101, 127 Section 361, 73 disclosure regarding possible use of cells derived for human transplantation, 90, 101, 127 R disclosure that cells and cell lines could be used in genetic manipulation or mixing RAC. See Recombinant DNA Advisory with animal cells, 91, 102, 127 Committee disclosure that cells and cell lines may be kept Radiation safety committees, 54 for many years, 90, 102, 127 rDNA.
From page 164...
... 164 Index invitation, if donors' identities are retained, to review of the procurement and informed be notified in the future of what was consent process, 83–87 learned from studying their cell lines, 90, timing of decision to donate excess 101, 127 blastocysts, 88 statement of risks involved to donors, 91, Refusal, right of, 82, 104 102, 128 Regenerative medicine, 2, 30–31, 60 statement that neither consenting nor refusing Registry, of investigators conducting hES cell to donate embryos for research will affect research, 58, 105, 125 quality of future care provided potential Regulation of human embryonic stem cell donors, 91, 102, 128 research, 28, 63–79 Recommendations regarding institutional of clinical research with cell lines and oversight of hES cell research, 5–8, 53–58 differentiated tissue, 71–74 dividing research proposals into categories, 7– of hES cell and NT research in other 8, 57–58, 98–99, 124–125 countries, 76–79 Recommendations regarding standards of clinical implications of the privacy rule and human care, 10–11 subjects protections in research with consenting or refusing to donate gametes or biological materials for hES cell research, embryos for research not affecting the care 67–69 potential donors receive, 91, 128 patchwork of existing, 1 personnel objecting to hES cell research for of procurement of gametes, somatic cells, and reasons of conscience not being required blastocysts, 64–66 to participate, 11, 92, 102, 128 professional and international, 4 researchers not pressuring or paying any third U.S. state law on hES cell research, 74–76 party to obtain oocytes for them, 11, 92, of in vitro and animal studies using hES cell 102, 128 lines, 69–71 Recommendations regarding the procurement Regulation of in vitro and animal studies using process, 8–9, 66, 100–102, 125 hES cell lines, 69–71 blastocysts produced by donor gametes used animal care and use, 70–71 in IVP never being used without consent compliance with all relevant regulations, 71, of all gamete donors, 83, 101, 126 126 hES researchers not having any influence over laboratory practice, 71 IVF decisions, 85, 101, 126 recombinant DNA research, 69–70 no cash or in kind payments being made for Regulatory oversight donating excess blastocysts, 85, 101, 126 gaps in, 63 women undergoing hormonal induction to through public funding of research, 19 generate oocytes being reimbursed only Reimbursement, only for direct expenses for direct expenses, 87, 101, 127 incurred, 9, 11 Recommendations regarding timing of decision Reproductive technology, 20 to donate excess blastocysts, consent for Research blastocyst donation being obtained from funding, 14, 18 each donor at time of donation, 88, 101, institutions conducting hES cell research, 14, 127 59, 106 Records meritorious, 8 need for maintaining meticulous, 12 not permissible at this time, 8, 57–58, 99, of research being performed and cell types 124–125 used, 58, 105, 125 permissible after notification of the ESCRO Recruiting donors, 28, 81–96 committee, 7, 57, 99, 124 adherence to standards of clinical care, 91–92 using hES cell lines, 105–106 banking and distribution of cell lines, 92–95 voluntary moratoria to delay, 20 informed consent requirements, 88–91, 101– Research collaborations, substituting equivalent 102, 127–128 foreign procedures in, 58, 106, 125 Research ethics boards (REBs)
From page 165...
... , 68, 73, 106–107 89–90 Scholarly journals. See Scientific journals Standards of clinical care, 91–92 Science, social investment in, 60 consenting or refusing to donate gametes or Scientific and Medical Aspects of Human embryos for research not affecting care Reproductive Cloning, 4, 20, 98 potential donors receive, 91, 128 Scientific background of human embryonic stem personnel objecting to hES cell research for cell research, 1, 28–45 reasons of conscience not being required interspecies mixing, 38–41 to participate, 11, 92, 102, 128 nuclear transfer to generate stem cells, 33–37 recommendations for adherence to, 10–11
From page 166...
... , 72 standardization of and validation of results, 4 University of Wisconsin, 15 Stem Cells and the Future of Regenerative U.S. state law on hES cell research, 74–76 Medicine, 19 USC.


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