Guidelines for Human Embryonic Stem Cell Research (2005) / Chapter Skim
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3 Addressing Ethical and Scientific Concerns Through Oversight
3 Addressing Ethical and Scientific Concerns Through Oversight
Pages 47-62
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From page 47... ...
Because in the final analysis the issues involved are scientific and moral rather than financial the proposed oversight system should apply to all hES cell research regardless of the source of funding. ETHICAL CONCERNS The principle ethical and religious objection to hES cell research is that the derivation of hES cells involves the destruction of the blastocyst, which is regarded 47
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From page 48... ...
Finally, some object to the use of NT to derive hES cells because they fear that the use of NT for research purposes could lead to its use to produce a child. The Special Status of the Human Embryo Like all scientific work involving human embryos, hES cell research raises profound questions about the status of the human embryo, the extent to which it is justifiable to use human embryos to expand knowledge and ameliorate human suffering, and the conditions under which these goals may be pursued.
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From page 49... ...
Those issues are discussed in greater depth below and in Chapter 5. Transferring hES Cells into Nonhuman Animals The transfer of hES cells into nonhuman animals has received less attention than some of the other ethical and policy issues surrounding stem cell research.
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From page 50... ...
Perhaps no organ that could be exposed to hES cells raises more sensitive questions than the animal brain, whose biochemistry or architecture might be af fected by the presence of human cells. Human diseases, such as Parkinson's disease, might be amenable to stem cell therapy, and it is conceivable, although unlikely, that an animal's cognitive abilities could also be affected by such therapy.
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From page 51... ...
For example, most require that hES cell research projects aim to advance scientific and medical knowledge to benefit human health. Alternative methods (such as the use of existing hES cell lines or adult stem cells)
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From page 52... ...
For example, even under its relatively liberal policy, the United Kingdom, in its Code of Practice for the Use of Human Stem Cell Lines, requires that all hES cell research be conducted under special licenses obtained from the government. The rationale is, in part, to ensure protection of the status of the human embryo: The special regulations which govern the creation and use of human embryonic stem cells reflect the fact that the human embryo has a special moral status.
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From page 53... ...
In the absence of a federal regulatory regime designed specifically to provide comprehensive coverage of hES cell research, the committee proposes an oversight system with both local and national components that meets the important goals identified by the other advisory bodies, including the President's Council on Bioethics in its report on NT (President's Council on Bioethics, 2002) : • To support the current consensus against attempts to create children through NT; • To create a forum for further deliberation on these questions; • To ensure that legitimate research includes efforts to gather information from animal models and other avenues before utilizing hES cells; and • To show respect for the deep moral concerns of those who have ethical objections to the research.
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From page 54... ...
In general, research institutions are likely already to have rules in place for research involving other biological tissues, and, as with any other form of biological or biomedical research, hES cell research would be covered by these rules. But in the case of hES cell research, it will be critically important for investigators and institutions to know the provenance of hES cell lines, particularly if the cell lines are imported to the institu tion from another site.
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From page 55... ...
Because of the sensitive nature of some aspects of hES cell research, it is critical that the scientific community propose and implement limits on what is to be allowed and provide clear guidance on which research activities require greater scrutiny. Thus, a primary activity of the ESCRO committee will be to ensure that inappropriate research is not conducted and that controversial research is well justified and subject to appropriate additional oversight.
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From page 56... ...
The committee would also serve to review basic hES cell research using preexisting anonymous cell lines that does not require consider ation by an Institutional Review Board. Recommendation 2: Through its Embryonic Stem Cell Research Oversight (ESCRO)
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From page 57... ...
Research that is permissible after notification of the research institution's ESCRO committee and completion of the reviews mandated by current requirements. Purely in vitro hES cell research with pre-existing coded or anonymous hES cell lines in general is permissible provided that notice of the research, documentation of the provenance of the cell lines, and evidence of compliance with any required Institutional Review Board, Institutional Animal Care and Use Committee, Institutional Biosafety Committee, or other mandated reviews is provided to the ESCRO committee or other body designated by the investigator's institution.
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From page 58... ...
Recommendation 4: Through its Embryonic Stem Cell Research Oversight (ESCRO) committee, each research institution should establish and maintain a registry of investiga tors conducting hES cell research and record descriptive information about the types of research being performed and the hES cells in use.
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From page 59... ...
However, in line with the longstanding practice in the United States of using local review boards for human subjects research, animal research, and biohazards, the committee believes that local review of individual research proposals by ESCRO committees (with involvement of IRBs, IACUCs, IBCs, and other panels as described above) will be the best mechanism of oversight of hES cell research.
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From page 60... ...
Recommendation 7: The hES cell research community should ensure that there is sufficient genetic diversity among cell lines to allow for potential translation into health-care services for all groups in our society. CONCLUSION The proposed local ESCRO committees and national forum should help to ensure that conventional and well founded research practices and protections apply to hES cell research.
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From page 61... ...
The next chapter addresses the specific regulatory issues that might apply to hES cell research.
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