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Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
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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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×

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

Suggested Citation:"Index." Institute of Medicine and National Research Council. 2005. Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11278.
×
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Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.

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