Recommendation 3:

Embryonic Stem Cell Research Oversight (ESCRO) committees or their equivalents should divide research proposals into three categories in setting limits on research and determining the requisite level of oversight:

(a) 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.

(b) Research that is permissible only after additional review and approval by an ESCRO committee or other equivalent body designated by the investigator’s institution.

  1. The ESCRO committee should evaluate 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 requests should be accompanied by evidence of Institutional Review Board approval of the procurement process.

  2. All research involving the introduction of hES cells into nonhuman animals at any stage of embryonic, fetal, or postnatal development should be reviewed by the ESCRO committee. Particular attention should be paid to the probable pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues.

  3. 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 committee review and approval.

(c) Research that should not be permitted at this time:

  1. 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 occurs first.

  2. Research in which hES cells are introduced into nonhuman primate blastocysts or in which any ES cells are introduced into human blastocysts.

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