Guidelines for Human Embryonic Stem Cell Research (2005) / Chapter Skim
Currently Skimming:
6 National Academies Guidelines for Research on Human Embryonic Stem Cells
6 National Academies Guidelines for Research on Human Embryonic Stem Cells
Pages 97-108
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 97... ...
cell lines. They provide an oversight process that will help to ensure that research with hES cells is conducted in a responsible and ethically sensitive manner and in compliance with all regulatory requirements pertaining to biomedical research in general.
|
From page 98... ...
Many, but not all, of the guidelines and concerns addressed in this report are common to other areas of human stem cell research, such as (1) Research that uses human adult stem cells.
|
From page 99... ...
(2) Research in which hES cells are introduced into nonhuman primate blasto cysts or in which any embryonic stem cells are introduced into human blastocysts.
|
From page 100... ...
3.0 PROCUREMENT OF GAMETES, BLASTOCYSTS, OR CELLS FOR hES GENERATION 3.1. An IRB, as described in federal regulations at 45 CFR 46.107, should review the procurement of all gametes, blastocysts, or somatic cells for the purpose of generating new hES cell lines, including the procurement of blastocysts in excess of clinical need from infertility clinics, blastocysts made through IVF specifically for research purposes, and oocytes, sperm, and somatic cells donated for development of hES cell lines derived through NT or by parthenogenesis or androgenesis.
|
From page 101... ...
Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person.
|
From page 102... ...
(g) A statement that the hES cells and/or cell lines might be used in research involving genetic manipulation of the cells or the mixing of human and nonhuman cells in animal models.
|
From page 103... ...
As hES cell research advances, it will be increasingly important for institutions that are obtaining, storing, and using cell lines to have confidence in the value of stored cells -- that is, that they were obtained ethically and with the informed consent of donors, that they are well characterized and screened for safety, and that the conditions under which they are maintained and stored meet the highest scientific standards. Institutions engaged in hES research should seek mechanisms for establishing central repositories for hES cell lines -- through partnerships or augmentation of existing quality research cell line repositories and should adhere to high ethical, legal, and scientific standards.
|
From page 104... ...
(v) A website that contains scientific descriptions and data related to the cell lines available.
|
From page 105... ...
(e) Clear criteria for distribution of cell lines, including but not limited to evidence of approval of the research by an Embryonic Stem Cell Research Oversight committee or equivalent body at the recipient institution.
|
From page 106... ...
To help ensure that these guidelines are taken seriously, stakeholders in hES cell research -- sponsors, funding sources, research institutions, relevant oversight com mittees, professional societies, and scientific journals, as well as investigators -- should develop policies and practices that are consistent with the principles inherent in these guidelines. Funding agencies, professional societies, journals, and institu tional review panels can provide valuable community pressure and impose appro priate sanctions to ensure compliance.
|
From page 107... ...
Both the state of hES cell research and clinical practice and public policy surrounding these topics are in a state of flux and are likely to be so for several years. Therefore, the committee believes that a national body should be established to assess periodically the adequacy of the policies and guidelines proposed in this document and to provide a forum for a continuing discussion of issues involved in hES cell research.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.