The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole. Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 155
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
OCR for page 156
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
OCR for page 157
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
OCR for page 158
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
OCR for page 159
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
OCR for page 160
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
OCR for page 161
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
OCR for page 162
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
OCR for page 163
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
OCR for page 164
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
OCR for page 165
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
OCR for page 166
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
Items in cart [0]
