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All research proposing to use Human Embryonic Stem (hES) cells must be approved by the ESCRO committee in addition to other mandated review committees required by the University. The ESCRO application should be submitted electronically to lowman@unc.edu.
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 for approval.
(i) The ESCRO committee evaluates all requests for permission to attempt derivation of new hES cell lines from donated blastocysts, from in vitro fertilized oocytes, or by nuclear transfer. The scientific rationale for the need to generate new hES cell lines, by whatever means, should be clearly presented, and the basis for the numbers of blastocysts or oocytes needed should be justified. Such request should be accompanied by evidence of Institutional Review Board approval of the procurement process.
(ii) All research involving the introduction of hES cells into nonhuman animals at any stage of embryonic, fetal, or postnatal development is reviewed by the ESCRO committee. Particular attention should be paid to the probable pattern and effects of differentiation and integration of the human cells in to the nonhuman animal tissues.
(iii) Research in which personally identifiable information about the donors of the blastocysts, gametes, or somatic cells from which the hES cells were derived is readily ascertainable by the investigator also requires ESCRO review and approval.
(i) Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever comes first.
(ii) Research in which hES cells are introduced into nonhuman primate blastocysts or in which any embryonic stem cells are introduced into human blastocysts.
(iii) No animal into which hES cells have been introduced at any stage of development should be allowed to breed.
The ESCRO application and approval do not take the place of Institutional Review Board (for research with human subjects), the Institutional Animal Care and Use Committee (for research with laboratory animals), or the Institutional Biosafety Committee (for research using recombinant DNA) approvals in accordance with all relevant University policies and federal regulations. Any University research project involving human embryonic stem cells must be reviewed and approved by the University’s Institutional Review Board designated to have oversight of research with human embryonic stem cells (currently the Biomedical Institutional Review Board). Such review shall be in accordance with all relevant University policies and federal regulations. See also: the University’s policy on Human Embryonic Stem Cells in Research.