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Guidelines for Human Embryonic Stem Cell Research
implement limits on what is to be allowed and provide clear guidance on which research activities require greater scrutiny (as discussed in the full report). Thus, a primary activity of ESCRO committees will be to ensure that inappropriate research is not conducted and that sensitive research is well justified (as explained in the full report) and subject to appropriate additional oversight. Oversight will in many instances conform to a higher standard than required by existing laws or regulations. ESCRO committees should have suitable scientific and ethical expertise to conduct their own reviews and should have the resources to coordinate the various other reviews that may be required for a particular protocol. A pre-existing committee could serve the functions of the ESCRO committee provided that it has the recommended expertise to perform the various roles described in this report.
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.
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.
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.
Research in which personally identifiable information about the donors of the blastocysts, gametes, or somatic cells from which the hES cells were
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