Index

A

Abnormalities, found in cloned animals, 34

Accountability issues, 51

Adult stem cells, 17, 115

Advanced Cell Technology, 15

Alzheimer’s disease, 33

American Society for Reproductive Medicine (ASRM), 27

Ethics Committee, 27, 52

American Type Culture Collection, 93

Androgenesis, 37, 100, 103, 115

diploid androgenetic mES cells, 36

Animal care and use, 70–71

handling chimeras with human-like characteristics, 50

Animal cells, mixing with, disclosure that cells and cell lines could be used in, 91, 102, 127

Animal feeder cells, 18

Animal Welfare Act, 71

ART. See Assisted reproductive technology

Asilomar Conference, 26–27, 70

ASRM. See American Society for Reproductive Medicine

Assisted human reproduction agency, in Canada, 27

Assisted reproductive technology (ART), 81, 91–92

services offering, 10

Australia, 76–77

national body established in, 59

procurement practices in, 66

Authorizations, 68–69, 126

Autologous transplantation, 9, 34, 44, 84, 115

Autonomy, 9, 58, 85, 101

B

Banking and distribution of hES cell lines, 92–95, 103–105

facilities for implementing specific recommended standards, 94–95, 104–105, 129–130

institutions establishing uniform guidelines and record-keeping processes approved by an IRB, 94, 103–104, 128

recommendations for, 12–13

Benefits

of hES cell research, just distribution of, 60

personal, informing donors there will be none, 9, 84

Best Practices for the Licensing of Genomic Inventions, 64

Bioethics Advisory Committee

in Israel, 78

in Singapore, 78

Biohazards, 59



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Guidelines for Human Embryonic Stem Cell Research Index A Abnormalities, found in cloned animals, 34 Accountability issues, 51 Adult stem cells, 17, 115 Advanced Cell Technology, 15 Alzheimer’s disease, 33 American Society for Reproductive Medicine (ASRM), 27 Ethics Committee, 27, 52 American Type Culture Collection, 93 Androgenesis, 37, 100, 103, 115 diploid androgenetic mES cells, 36 Animal care and use, 70–71 handling chimeras with human-like characteristics, 50 Animal cells, mixing with, disclosure that cells and cell lines could be used in, 91, 102, 127 Animal feeder cells, 18 Animal Welfare Act, 71 ART. See Assisted reproductive technology Asilomar Conference, 26–27, 70 ASRM. See American Society for Reproductive Medicine Assisted human reproduction agency, in Canada, 27 Assisted reproductive technology (ART), 81, 91–92 services offering, 10 Australia, 76–77 national body established in, 59 procurement practices in, 66 Authorizations, 68–69, 126 Autologous transplantation, 9, 34, 44, 84, 115 Autonomy, 9, 58, 85, 101 B Banking and distribution of hES cell lines, 92–95, 103–105 facilities for implementing specific recommended standards, 94–95, 104–105, 129–130 institutions establishing uniform guidelines and record-keeping processes approved by an IRB, 94, 103–104, 128 recommendations for, 12–13 Benefits of hES cell research, just distribution of, 60 personal, informing donors there will be none, 9, 84 Best Practices for the Licensing of Genomic Inventions, 64 Bioethics Advisory Committee in Israel, 78 in Singapore, 78 Biohazards, 59

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Guidelines for Human Embryonic Stem Cell Research Biological therapies, 3 Biomedical research, 21–22, 31 Blastocoel, 29–30, 115 Blastocysts, 1–2, 29–31, 34–36, 47–48, 66, 83, 115. See also Mouse blastocysts discarding, 10, 82 donors of, 4, 7–9, 57, 100, 106 excess, 42 implanting, 30 increasing the yield of, 36 produced by donor gametes used in IVF, 83, 101, 126 safe handling, storage, and transportation of, 4, 90, 101–102, 127 safeguards against misuse of, 4, 26 Bone marrow, 17, 115 Brown, Louise, 22 Bush, George H. W., 23 Bush, George W., 2, 18, 21 C Cadaveric fetal tissue, derivation of stem cells from, 16–17 California Institute for Regenerative Medicine, 76 Canada, 78–79, 84 national body established in, 59 procurement practices in, 66 Canadian Assisted Human Reproduction Agency, 27 Canadian Institute for Health Research, 78 Cash payments, not offering to donors, 9–10, 85 Categories of research proposals, 7–8, 57–58, 98–99, 124–125 research not permissible at this time, 8, 57–58, 99, 124–125 research permissible after notification of the ESCRO committee, 7, 57, 99, 124 research permissible only after additional review and approval of the ESCRO committee, 7–8, 57, 124 Cell-based therapies, 20, 44 Cell lines banking and distribution of, 92–95 ensuring sufficient genetic diversity among, 60, 125 Cells restricted to specific developmental fates, development of hES cells down particular pathways to generate, 43–44 CFR. See Code of Federal Regulations CGTP. See Current good tissue practices Chimeras, 6–8, 17, 30, 39–41, 116 preventing from breeding, 40, 55, 58, 106 Choice. See Autonomy CLIA. See Clinical Laboratory Improvement Amendments Clinical care. See Standards of clinical care Clinical Laboratory Improvement Amendments (CLIA), 90 Clinton, William J., 20, 23 Cloning of Dolly the sheep, 2, 16, 34 human reproductive, 5 producing abnormalities, 34 therapeutic, 19 Cloning-for-biomedical-research now, 21 Cloning Human Beings, 20 Code of Federal Regulations (CFR), 64–66, 68 Code of Practice for the Use of Human Stem Cell Lines, 52 Collaborations, substituting equivalent foreign procedures in, 58, 106, 125 Common Rule, 54n, 64n Compliance imposing sanctions to ensure, 14, 106–107 recommendations for, 11–12, 71, 126 with relevant FDA regulations, 74, 126 Confidentiality, 4, 56, 82 Conflict of interest, 107 Conscience, personnel objecting to hES cell research for reasons of, 11, 92, 102, 128 Consent. See Informed consent of donors Contamination, concerns about, 18 Contraception, developing better techniques for, 77 Coriell, 93 “Council of Europe Recommendation R(97)5 on the Protection of Medical Data,” 74n Cryopreserved embryos, 81 Culture conditions, not including mouse feeder cells and bovine serum, 43 Current good tissue practices (CGTP), 72 D Department of Health, Education, and Welfare (DHEW), 22–23 Department of Health and Human Services (DHHS), 24, 54n, 64 Office for Human Research Protections, 65–67

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Guidelines for Human Embryonic Stem Cell Research Derivation of hES cell lines, 102–103 of new hES cell lines, permissible only after additional review and approval of the ESCRO committee, 7, 57, 99, 124 of oocytes from nonreproductive material, 38 DHEW. See Department of Health, Education, and Welfare DHHS. See Department of Health and Human Services Diabetes. See Type I diabetes Dickey-Wicker amendment, 24 Differentiation, 32–33, 43 assaying, 116 Diploid androgenetic mES cells, 36 Disease development and progression treating, 50 understanding, 2, 17 DNA, 36, 79, 116, 117 Documentation, 6, 55, 68, 99 of the provenance of hES cells, 6–7, 56, 105, 123 Dolly the sheep, cloning of, 2, 16, 34 Donors. See also Informed consent of donors advertising for, 85 anonymous, 73, 75 of blastocysts, 4, 6, 57 disclosure of whether identities will be readily ascertainable to researchers, 90, 101, 127 disclosure that research could have commercial potential without benefit to, 91, 102, 128 disclosure that research is not intended to directly benefit, 91, 102, 128 ensuring authorizations comply with the HIPAA, 68–69, 126 of gametes, 4, 6, 57 physical interactions with, 65 protecting, 82, 106 suitability rules for, 68, 83 Drugs. See also Investigational new drugs; Targeting immunosuppressive, 34, 118 E EAB. See Ethics Advisory Board Ectoderm, 31, 116 Ectopic sites, 44 Electroporation, 33, 116 Embryoid bodies (EBs), 31–32, 116 Embryonic disk, 29, 116 Embryonic Stem Cell Research Oversight (ESCROs) committees, 5–6, 12, 14, 53–59, 79, 98–100, 102, 105–106 establishing, 5–6, 56, 100, 123 institutional, 100 Embryonic stem cells (ES cells), 1–2, 29–33, 41, 116 derived from mouse blastocysts, 1 Embryos, 116 buying and selling of forbidden, 75, 78 cryopreserved, 81 disclosure that these will be destroyed in deriving hES cells, 91, 102, 128 respect for donors of human, 49 special status of human, 48–49 Endoderm, 31, 116 Endogenous genes, 31, 42 Endothelial cells, 31–32 Epigenetics, 43, 117 ES cells. See Embryonic stem cells ESCRO. See Embryonic Stem Cell Research Oversight Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning , 78 Ethical and scientific concerns addressed through oversight, 1–2, 28, 41, 47–61, 70, 106. See also Moral issues ensuring sufficient genetic diversity among cell lines, 60, 125 institutional oversight of hES cell research, 53–58 just distribution of the benefits of hES cell research, 60 national body needed to assess adequacy of guidelines proposed and provide a forum for a continuing discussion of issues, 59–60, 126 need for a national perspective, 58–60 need for an oversight system, 51–53 objections to the use of NT for reproductive purposes, 51 recommendations regarding, 53–60 respect for donors of human embryos and gametes, 49 special status of the human embryo, 48–49 transferring hES cells into nonhuman animals, 49–50 Ethical Issues in Human Stem Cell Research, 20 Ethics Advisory Board (EAB), 22–23 Ethics Committee (ASRM), 27, 52

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Guidelines for Human Embryonic Stem Cell Research Ethics review bodies, 52 EU Data Protection Directive, 74n European Commission, 84 European Union, collaborations with members of, 74 Excess oocytes and unfertilized eggs, from IVF procedures, 37 Exclusion criteria, medical, 4 Exogenous genes, delivering, 33 Expertise, calling upon suitable, 107 Extracellular matrices, 32 F Facilities obtaining and storing hES cell lines, implementing specific recommended standards, 94–95, 104–105, 129–130 FDA. See Food and Drug Administration FDCA. See Food, Drug, and Cosmetic Act Federal legislation, 2, 18, 23–24, 63–79, 86 Feeder cell layer, 18, 30, 32, 43, 73, 117 Fertility clinics, 84 Fertilization, 29, 51, 117 Fetal tissue, derivation of stem cells from cadaveric, 16–17 Fetuses, 30–31 Fibroblasts, 30, 32, 117 Financial incentives, 4. See also Cash payments; In kind payments Food, Drug, and Cosmetic Act (FDCA), 72 Food and Drug Administration (FDA), 3, 6, 12, 19, 39, 51, 63–64, 72, 74, 82–83 letter to investigators/sponsors, 20n, 51n Forum for a continuing discussion of issues, national body needed to provide, 59–60, 126 Funding sources for hES cell research, 14, 18–19, 59, 106 nonfederal, 106 public, 19, 106 G Gametes, 30, 117 donors of, 4, 7–9, 57, 100, 106 respect for donors of, 49 Gearhart, John, 15 Gene therapy, 42, 79 Generation of additional hES cell lines, 42 of hES cells of defined genetic backgrounds, 42 Genetic disease, experiments exploring underpinnings of, 16, 77 Genetic diversity among cell lines, ensuring sufficient, 60, 125 Genetic manipulation, disclosure that cells and cell lines could be used in, 42, 91, 102, 127 Genetically altered nuclei, 36 Genital ridges, 31, 117 Genotype, 42–43, 117 Germline cells, 39–40, 44, 117 GLP. See Good Laboratory Practice regulations Glycolipids, antigenic, 18 Gonadal ridge, 117 derivation of stem cells from primordial, 16 Good Laboratory Practice (GLP) regulations, 12, 71 Graft rejection, averting, 20 Guidance on Research Involving Coded Private Information or Biological Specimens, 93 Guidelines for Research Involving Recombinant DNA Molecules, 69 Guidelines for research on human embryonic stem cells, 97–107 banking and distribution of hES cell lines, 103–105 blastocysts made for reproductive purposes and later obtained for research from IVF clinics, 4 blastocysts made specifically for research using IVF, 4 coverage of, 4–5, 98 derivation of hES cell lines, 102–103 dividing research proposals into categories, 98–99 establishment of institutional ESCRO committees, 100 international collaboration, 106 national body needed to assess adequacy of, 59–60, 126 need for, 18–22 obligations of investigators and institutions, 99–100 procurement of gametes, blastocysts, or cells for hES generation, 100–102 research use of hES cell lines, 105–106 somatic cell nuclear transfer (NT) into oocytes, 4 “Guidelines for the Security of Information Systems,” 74n

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Guidelines for Human Embryonic Stem Cell Research H Handling of cells and tissues, assurance that all researchers will follow best practices in, 90, 101–102, 127 HCT/Ps. See Human cells, tissues, and cellular and tissue-based products Health Insurance Portability and Accountability Act (HIPAA), 11–12, 68, 74, 82 Standards for Privacy of Individually Identifiable Health Information (Privacy Rule), 68, 73, 89–90 hEG cells. See Human embryonic germ cells Hematopoietic stem cells (HSCs), 31–32, 40–41, 117 HERP. See Human Embryo Research Panel hES cells. See Human embryonic stem cells HFEA. See Human Fertilisation and Embryology Authority (United Kingdom) HIPAA. See Health Insurance Portability and Accountability Act Histocompatibility antigens, 45, 118 immune rejection due to, 44–45 History, of U.S. discussions and policies regarding research involving human embryos, 22–25 Homologous recombination, 42, 118 Honoraria, paying, 86 Hormonal induction, 10 HSCs. See Hematopoietic stem cells Human brain cells, implanting into nonhuman animals, 54 Human cells, tissues, and cellular and tissue-based products (HCT/Ps), 72 Human Cloning Act, in Australia, 76 Human Cloning and Human Dignity: An Ethical Inquiry, 21 Human dignity, protecting, 48–49, 55, 76 Human disease. See Disease development and progression Human Embryo Research Panel (HERP), 23–24, 52 Human embryonic germ cells (hEG cells), 31 Human Embryonic Stem Cell Registry, 18 Human embryonic stem cell research clearinghouse for proposals, 5, 54 current regulation of, 28, 63–79 prerequisites to, 4, 26 public sponsorship of, 19 Human embryonic stem cells (hES cells), 1, 32, 118 genetic modification of, 42 knowing the provenance of, 54 maintaining a registry of, 8 self-renewing capacity of, 17, 32, 43 using already derived, 6, 56, 72 Human embryos, special status of, 49 Human Fertilisation and Embryology Authority (HFEA), in the U.K., 27, 52–53, 77 Human reproductive cloning, 5. See also Cloning Human subjects protection system, 9 Human transplantation, disclosure regarding possible use of derived cells for, 90, 101, 127 Hwang, Woo Suk, 35 I IACUC. See Institutional Animal Care and Use Committee IBC. See Institutional Biosafety Committee Iceland, collaborations with scientists in, 74 IDE. See Investigational device exemption Immune rejection, due to histocompatibility problems, 44–45 Immune system cells, 44, 118 Immunogenicity, reducing, 34, 118 Immunosuppressive drugs, 34, 118 Imprinted genes, 73 In kind payments, not offering to donors, 9–10, 85 In vitro experiments, 6, 31–32, 37, 40, 44, 55, 57–58, 78, 118 culture of any intact human embryo past 14 days, 8, 57 growing hES cells, 32 In vitro fertilization (IVF), 2, 4, 10–11, 16, 21, 37, 42–43, 76, 81–83, 85, 87, 98, 100–101, 118 commercial practices regarding, 2, 4, 10–11, 16, 21, 37, 43, 76, 81–83, 85, 87, 100–101, 118 researchers not having any influence over IVF decisions, 85, 101, 126 In vivo experiments, 44–45 differentiation, 32, 118 Incentives. See Financial incentives; Nonfinancial incentives Incorporation of hES cells or cells derived from them into nonhuman blastocysts, 40–41 into postgastrulation stages of another species, 40 into postnatal animals of another species, 39–40

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Guidelines for Human Embryonic Stem Cell Research IND. See Investigational new drugs Infertility treatments, 1, 11, 48, 77 Influence, 85–86, 101, 126 Informed consent of donors, 4, 18, 56, 66, 88–91, 101–102, 125, 127–128 obtaining from each donor at time of donation, 88, 101, 127 and the potential discovery of clinically significant information, 89–91 requiring an invitation, if donors’ identities are retained, to be notified in the future of what was learned from studying their cell lines, 90, 101, 127 requiring assurance that all researchers will follow best practices in their handling of cells and tissues, 90, 101–102, 127 requiring disclosure of whether donors’ identities will be readily ascertainable to researchers, 90, 101, 127 requiring disclosure regarding possible uses of cells derived for human transplantation, 90, 101, 127 requiring disclosure that cells and cell lines could be used in genetic manipulation or mixing with animal cells, 91, 102, 127 requiring disclosure that cells and cell lines may be kept for many years, 90, 102, 127 requiring disclosure that embryos will be destroyed in deriving hES cells, 91, 102, 128 requiring disclosure that no restriction or direction can be made regarding possible recipients, 90, 101, 127 requiring disclosure that research could have commercial potential, without benefit to the donors, 91, 102, 128 requiring disclosure that research is not intended to directly benefit the donors, 91, 102, 128 requiring statement of risks involved to donors, 91, 102, 128 requiring statement that neither consenting nor refusing to donate embryos for research will affect quality of future care provided potential donors, 91, 102, 128 voluntary, 83 written, 10 Informed refusal by donors, 82, 104 Inner cell masses, 30–31, 40, 118 Institutional Animal Care and Use Committee (IACUC), 6–7, 54, 57, 71, 99, 105 Institutional Biosafety Committee (IBC), 6–7, 54, 57, 70, 99 Institutional oversight of hES cell research, 53–58 in collaborations, substituting equivalent foreign procedures, 58, 106, 125 establishing uniform guidelines and record-keeping processes approved by an IRB, 94, 103–104, 128 oversight of, 53–58 registry of investigators conducting hES cell research and records of research being performed and cell types used, 58, 105, 125 Institutional Review Boards (IRBs), 5–12, 39, 49, 54–56, 64–69, 82–87, 93–94, 99–102, 104–106 Intellectual property issues, 26 International collaboration, 12, 106 International regulations, 4, 26 Interpretation of genetic information, 4 Interspecies mixing, 38–41 incorporation of hES cells into nonhuman blastocysts, 40–41 incorporation of hES cells or cells derived from them into postgastrulation stages of another species, 40 incorporation of hES cells or cells derived from them into postnatal animals of another species, 39–40 use of nonhuman oocytes as recipients of human somatic nuclei in NT, 41 Introduction of hES cells into nonhuman animals, research permissible only after additional review and approval of the ESCRO committee, 7, 57, 99, 105–106, 124 Investigational device exemptions (IDEs), 72 Investigational new drugs (INDs), 72 IRBs. See Institutional Review Boards Islam, views on the human embryo, 48 Israel buying and selling of embryos forbidden in, 78, 116 national body established in, 59 procurement practices in, 66 Israel Academy of Sciences and Humanities, Bioethics Advisory Committee, 78 Issues to Consider in Research Use of Stored Data or Tissues, 93 IVF. See In vitro fertilization

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Guidelines for Human Embryonic Stem Cell Research J Johns Hopkins University, 15 Joint Commission for the Accreditation of Health Care Organizations, 27 Journals. See Scholarly journals Judaism, views on the human embryo, 48 Just distribution, of the benefits of hES cell research, oversight of, 60 K Karyotypes, 32, 118 Korean scientists, 16, 35–36 L Laboratory practice, 71 Legal issues, 1, 26. See also Federal legislation; State legislation Leukemia inhibitory factor (LIF), 30–31, 118 Liechtenstein, collaborations with scientists in, 74 LIF. See Leukemia inhibitory factor Life sciences, scientific self-regulation in, 26 Long-term cultures, ensuring stability of genotype, epigenetic status, and phenotypic properties of ES cells grown in, 43 M Manipulation of life, 49. See also Genetic manipulation Markers, 32 Material Transfer Agreement, 105 Matrigel, 32 Medical exclusion criteria, 4 Medical Research Council, in the U.K., 77, 84, 87 Medical risks, considered unacceptable, 16 Medicare reimbursement, 27 MEF. See Mouse embryonic fibroblast mES. See Mouse embryonic stem cells Mesoderm, 31, 118 Mexico City conference, calling for a global ban on NT for human reproduction, 21 Mitochondria, 34 Mixing with animal cells, disclosure that cells and cell lines could be used in, 91, 102, 127 Monkey virus experiment, 26 Moral issues, 60–61, 85 Moratoria to delay scientific research, voluntary, 19, 34 Morula, 29–30, 36, 118 Mouse blastocysts, embryonic stem cells derived from, 1 Mouse embryonic fibroblast (MEF), 30, 32, 119 Mouse embryonic stem cell (mES), 30–32, 34 diploid androgenetic, 36 Mouse gonads, 31 N National Academy of Sciences (NAS), 3, 5, 19–21, 26, 51, 64, 97 guidelines for research on human embryonic stem cells, 97–107 National Bioethics Advisory Commission (NBAC), 20–21, 48, 52 National body needed to assess adequacy of guidelines proposed, 59–60, 126 to provide a forum for a continuing discussion of issues, 59–60, 126 National Cancer Institute, 93 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 22 National Health and Medical Research Council Licensing Committee, 77 National Heart, Lung and Blood Institute, 93 National Institutes of Health (NIH), 18, 20, 22–26, 64, 69–70, 84, 95 efforts to encourage the sharing and dissemination of important research resources, 95 Human Embryo Research Panel, 52 Revitalization Act, 23–24 Stem Cell Task Force, 25 National perspective, 58–60 oversight of, 58–60 recommendations for a national policy review, 13 National Science Foundation, 20 NBAC. See National Bioethics Advisory Commission Neural stem cells (NSCs), 39, 119 Neurodegenerative diseases, 40 Neuronal progenitors, 31, 39–40 New York Times, 16

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Guidelines for Human Embryonic Stem Cell Research NIH. See National Institutes of Health Nonfinancial incentives, avoiding all, 9 Nonhuman animals implanting human brain cells into, 54 transferring hES cells into, 49–50 Nonhuman oocytes, 38 using as recipients of human somatic nuclei in NT, 41 using for NT, 43 Nonhuman primate ES cells, 41 “Nonpersonalizing” data, 74 Normal preimplantation development, compared with nuclear transfer, 35 Norway, collaborations with scientists in, 74 NRC. See National Research Council NSCs. See Neural stem cells NT. See Nuclear transfer Nuclear genomes, 2 Nuclear transfer (NT), 2, 4, 16, 34, 47, 75, 84–85, 91, 119 calls for a global ban on using for human reproduction, 21 fears of its use for producing a child, 2 to generate stem cells, 33–37 normal preimplantation development compared with, 35 reproductive uses of, 4 Nuclei, genetically altered, 36 O Objections to the use of NT for reproductive purposes, 51. See also Personnel objecting to hES cell research Obligations informing donors they have none, 9 of investigators and institutions, 99–100 Office for Human Research Protections (OHRP), 65–67, 93 Office of Technology Assessment, 22 OHRP. See Office for Human Research Protections OHSS. See Ovarian hyperstimulation syndrome Oocytes, 30, 34–38, 43, 48, 66, 83, 119. See also Sources of oocytes for NT ES cells donors of, 37–38 excess, 37 matured from ovariectomies or fetal ovaries from pregnancy terminations, 37 risks associated with retrieval, 4 Oophorectomy, 85 Organ donation, 37 Organ transplants. See Transplantation Ovarian hyperstimulation syndrome (OHSS), 87 Ovariectomy, 37, 119 Oversight system for hES cell research, 14, 21, 51, 58–59, 78, 106 need for, 51–53 P Parkinson’s disease, 50 Parthenogenesis, 36–37, 100, 103, 119 Patient advocacy groups, 22 Payments, not offering to donors, 9–10, 85–86 PCB. See President’s Council on Bioethics Penalties, informing donors there are none, 9 Personal health information (PHI) about donors, 11, 68–69 being readily ascertainable, 7–8, 57, 99, 124 “deidentification” of, 68–69 Personnel objecting to hES cell research, for reasons of conscience, 92, 102, 128 PGD. See Preimplantation genetic diagnosis procedures Pharmaceuticals. See Drugs PHI. See Personal health information PHS. See Public Health Service Placenta, 29–31, 119 Pluripotent cells, 15, 17, 29–30, 34–35, 39, 119 Policy issues, 1, 10. See also National perspective Political independence of researchers, 107 Poverty issues, 86 Pregnancy terminations, 37 Preimplantation development, 30 Preimplantation genetic diagnosis (PGD) procedures, 33, 42, 119 President’s Council on Bioethics (PCB), 21, 53 Priorities for hES cell research, 41–45 alternative sources of human oocytes, 43 developing culture conditions that do not include mouse feeder cells and bovine serum, 43 directing development of hES cells down particular pathways to generate cells restricted to specific developmental fates, 43–44 ensuring stability of genotype, epigenetic status, and phenotypic properties of ES cells grown in long-term cultures, 43 generating additional hES cell lines, 42 generating hES cells of defined genetic backgrounds, 42

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Guidelines for Human Embryonic Stem Cell Research genetic manipulation of hES cells, 42 immune rejection due to histocompatibility problems, 44–45 maintaining the self-renewing capacity of hES cells over long-term culture and expansion, 43 separating progenitors of restricted developmental potential from hES cells, 44 testing the potential of the derived cells to contribute usefully when implanted, 44 testing therapeutic drugs, 45 using nonhuman oocytes for NT, 43 Privacy Rule, HIPAA, 68–69, 73, 89–90 Procedural requirements, 52 Procurement process. See also Sources of oocytes for NT ES cells recommendations for review of, 8–9, 66, 100–102, 125 Professional societies overseeing hES cell research, 14, 59, 106 regulations from, 4, 26 Profit motive, 38 Progenitors of restricted developmental potential, separating from hES cells, 44 Proposition 71, in California, 75, 87 Protestant denominations, views on the human embryo, 48 Pseudopregnant females, 30, 119 Public concern, 22, 58, 100, 106 Public Health Service (PHS), 64 Policy on Humane Care and Use of Laboratory Animals, 71 Public Health Service Act, 72 Section 361, 73 R RAC. See Recombinant DNA Advisory Committee Radiation safety committees, 54 rDNA. See Recombinant DNA REB. See Research Ethics Board (Canada) Recombinant DNA Advisory Committee (RAC), 20, 26–27, 70, 79 guidelines from, 27 Recombinant DNA (rDNA) research, 27, 47, 69–70 Recommendations, 66 for addressing ethical and scientific concerns through oversight, 53–60 for banking of hES cell lines, 12–13 compilation of, 123 for compliance with all relevant FDA regulations, 74, 126 for compliance with all relevant regulations, 11–12, 71, 126 for ensuring authorizations received from donors comply with the HIPAA, 68–69, 126 for a national policy review, 13 for review of the procurement process, 66, 125 “Recommendations of the Council of the OECD concerning Guidelines on the Protection of Privacy and Trans-border flows of Personal Data,” 74n Recommendations regarding banking and distribution of cell lines facilities obtaining and storing hES cell lines implementing specific recommended standards, 94–95, 104–105, 129–130 institutions establishing uniform guidelines and record-keeping processes approved by an IRB, 94, 103–104, 128 Recommendations regarding informed consent of donors, 9–10, 66, 90–91, 101, 125, 127–128 assurance that all researchers will follow best practices in their handling of cells and tissues, 90, 101–102, 127 disclosure of whether donors’ identities will be readily ascertainable to researchers, 90, 101, 127 disclosure regarding possible use of cells derived for human transplantation, 90, 101, 127 disclosure that cells and cell lines could be used in genetic manipulation or mixing with animal cells, 91, 102, 127 disclosure that cells and cell lines may be kept for many years, 90, 102, 127 disclosure that embryos will be destroyed in deriving hES cells, 91, 102, 128 disclosure that no restriction or direction can be made regarding possible recipients, 90, 101, 127 disclosure that research could have commercial potential, without benefit to the donors, 91, 102, 128 disclosure that research is not intended to directly benefit the donors, 91, 102, 128

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Guidelines for Human Embryonic Stem Cell Research invitation, if donors’ identities are retained, to be notified in the future of what was learned from studying their cell lines, 90, 101, 127 statement of risks involved to donors, 91, 102, 128 statement that neither consenting nor refusing to donate embryos for research will affect quality of future care provided potential donors, 91, 102, 128 Recommendations regarding institutional oversight of hES cell research, 5–8, 53–58 dividing research proposals into categories, 7–8, 57–58, 98–99, 124–125 Recommendations regarding standards of clinical care, 10–11 consenting or refusing to donate gametes or embryos for research not affecting the care potential donors receive, 91, 128 personnel objecting to hES cell research for reasons of conscience not being required to participate, 11, 92, 102, 128 researchers not pressuring or paying any third party to obtain oocytes for them, 11, 92, 102, 128 Recommendations regarding the procurement process, 8–9, 66, 100–102, 125 blastocysts produced by donor gametes used in IVP never being used without consent of all gamete donors, 83, 101, 126 hES researchers not having any influence over IVF decisions, 85, 101, 126 no cash or in kind payments being made for donating excess blastocysts, 85, 101, 126 women undergoing hormonal induction to generate oocytes being reimbursed only for direct expenses, 87, 101, 127 Recommendations regarding timing of decision to donate excess blastocysts, consent for blastocyst donation being obtained from each donor at time of donation, 88, 101, 127 Records need for maintaining meticulous, 12 of research being performed and cell types used, 58, 105, 125 Recruiting donors, 28, 81–96 adherence to standards of clinical care, 91–92 banking and distribution of cell lines, 92–95 informed consent requirements, 88–91, 101–102, 127–128 review of the procurement and informed consent process, 83–87 timing of decision to donate excess blastocysts, 88 Refusal, right of, 82, 104 Regenerative medicine, 2, 30–31, 60 Registry, of investigators conducting hES cell research, 58, 105, 125 Regulation of human embryonic stem cell research, 28, 63–79 of clinical research with cell lines and differentiated tissue, 71–74 of hES cell and NT research in other countries, 76–79 implications of the privacy rule and human subjects protections in research with biological materials for hES cell research, 67–69 patchwork of existing, 1 of procurement of gametes, somatic cells, and blastocysts, 64–66 professional and international, 4 U.S. state law on hES cell research, 74–76 of in vitro and animal studies using hES cell lines, 69–71 Regulation of in vitro and animal studies using hES cell lines, 69–71 animal care and use, 70–71 compliance with all relevant regulations, 71, 126 laboratory practice, 71 recombinant DNA research, 69–70 Regulatory oversight gaps in, 63 through public funding of research, 19 Reimbursement, only for direct expenses incurred, 9, 11 Reproductive technology, 20 Research funding, 14, 18 institutions conducting hES cell research, 14, 59, 106 meritorious, 8 not permissible at this time, 8, 57–58, 99, 124–125 permissible after notification of the ESCRO committee, 7, 57, 99, 124 using hES cell lines, 105–106 voluntary moratoria to delay, 20 Research collaborations, substituting equivalent foreign procedures in, 58, 106, 125 Research ethics boards (REBs), in Canada, 78–79

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Guidelines for Human Embryonic Stem Cell Research Research Involving Human Embryos Act, in Australia, 76 Research permissible only after additional review and approval of the ESCRO committee, 7–8, 57, 124 derivation of new hES cell lines, 7, 57, 99, 124 introduction of hES cells into nonhuman animals, 7, 57, 99, 105–106, 124 where personally identifiable information about the donors is readily ascertainable, 7–8, 57, 99, 124 Research proposals, categories of, 98–99 Researchers following best practices in their handling of cells and tissues, 90, 101–102, 127 not pressuring or paying any third party to obtain oocytes for them, 11, 92, 102, 128 Respect for donors of human embryos and gametes, 49, 58 Review of the procurement and informed consent process, 66, 83–87, 125 blastocysts produced by donor gametes used in IVP never used without consent of all gamete donors, 83, 101, 126 ensuring donations are voluntary, 84–85 hES researchers should have no influence over IVF decisions, 85, 101, 126 no cash or in kind payments may be made for donating excess blastocysts, 85, 101, 126 recruiting and paying gamete donors for research purposes, 85–87 women undergoing hormonal induction to generate oocytes should be reimbursed only for direct expenses, 87, 101, 127 Right of refusal, 104 Risks associated with retrieval of oocytes, 4 involved to donors, statement of, 87, 91, 102, 128 S Sanctions, imposing to ensure compliance, 14, 106–107 Scholarly journals. See Scientific journals Science, social investment in, 60 Scientific and Medical Aspects of Human Reproductive Cloning, 4, 20, 98 Scientific background of human embryonic stem cell research, 1, 28–45 interspecies mixing, 38–41 nuclear transfer to generate stem cells, 33–37 Scientific concerns. See Ethical and scientific concerns addressed through oversight Scientific journals reporting on hES cell research, 14, 59, 106 requiring evidence of compliance before publication of results, 14, 59 Scientific self-regulation in the life sciences, 26, 106 precedents for, 26–27 SCNT. See Somatic cell nuclear transfer Self-regulation. See Scientific self-regulation Self-renewing capacity of hES cells, 17, 32 maintaining over long-term culture and expansion, 43 Sensitivities, 47 Serum-free growth media, 32 Singapore, 78 forbidding all NT, 78 national body established in, 59 procurement practices in, 66 Single-gene defects, 33 Skin cell transplants, 17 Society for Assisted Reproductive Technologies, 27 Somatic cell nuclear transfer (SCNT), 2, 16, 43, 119. See also Nuclear transfer Somatic cells, 66, 119 donors of, 4, 7–9, 57, 100, 106 Sources of oocytes for NT ES cells, 37–38 alternative, 43 derivation of oocytes from nonreproductive material, 38 excess oocytes and unfertilized eggs from IVF procedures, 37 oocyte donation, 37–38 oocytes matured from ovariectomies or fetal ovaries from pregnancy terminations, 37 use of nonhuman oocytes, 38 Spinal-cord injuries, combating, 40 Stability of genotype, epigenetic status, and phenotypic properties, of ES cells grown in long-term cultures, ensuring, 43 Standards for Privacy of Individually Identifiable Health Information (Privacy Rule), 68, 73, 89–90 Standards of clinical care, 91–92 consenting or refusing to donate gametes or embryos for research not affecting care potential donors receive, 91, 128 personnel objecting to hES cell research for reasons of conscience not being required to participate, 11, 92, 102, 128 recommendations for adherence to, 10–11

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Guidelines for Human Embryonic Stem Cell Research researchers not pressuring or paying any third party to obtain oocytes for them, 11, 92, 102, 128 State legislation, 75–76, 106 Statistical data, 66, 68 Statutory bans, 16 Stem Cell Bank, in the UK, 44, 77, 92 Stem Cell Oversight Committee, 78 Stem Cell Task Force, 25 Stem cells, 15, 50, 119 derivation of, 16 safe handling and storage of, 4, 90, 101–102, 127 standardization of and validation of results, 4 Stem Cells and the Future of Regenerative Medicine, 19 Stored cells confidence in the value of, 12 disclosure that cells and cell lines may be kept for many years, 90, 102, 127 T Targeting in the development of drugs, 2 in genes, 117 Taxonomies, 49 Teratomas, 31–32, 36, 120 Testing potential of derived cells to contribute usefully when implanted, 44 therapeutic drugs, 45 Therapeutic potentials, 50, 76 involving cloning, 19 Thomson, James, 1, 15 Timing of consent to donate excess blastocysts, 88 obtaining from each donor at time of donation, 88, 101, 127 Tissue culture, 30–33, 120 Tissue rejection, overcoming, 34 Tracking, 72 Transfection, 33, 120 Transgenes, 42, 120 Transparency, 51 Transplantation uses, 34, 42, 44–45, 67, 72–73, 105, 120 Trophectoderm, 29–31, 120 Type I diabetes, 33 U U.N. General Assembly, 74n, 76 Undifferentiated cells, 32, 120 United Kingdom, 77 national body established in, 59 procurement practices in, 66 United States Code (USC), 72 University of Wisconsin, 15 U.S. state law on hES cell research, 74–76 USC. See United States Code Uterus, 29–30, 34 V Varmus, Harold, 23 Viral infections, 33 Voluntary donations, ensuring to all donors, 84–85 W Web-based primer, 56 Women possible exploitation of, 48 undergoing hormonal induction to generate oocytes, 87, 101, 127 X Xenograft or xenotransplant, 39, 73, 120 Z Zygote, 29–30, 120