and should have the resources needed to coordinate the management of the various other reviews required for a particular protocol. A preexisting committee could serve the functions of the ESCRO committee provided that it has the recommended expertise and representation to perform the various roles described in this report. For example, an institution might elect to constitute an ESCRO committee from among some members of an IRB. But the ESCRO committee should not be a subcommittee of the IRB, as its responsibilities extend beyond human subject protections. Furthermore, much hES cell research does not require IRB review. The ESCRO committee should

  1. provide oversight over all issues related to derivation and use of hES cell lines,

  2. review and approve the scientific merit of research protocols,

  3. review compliance of all in-house hES cell research with all relevant regulations and these guidelines,

  4. maintain registries of hES cell research conducted at the institution and hES cell lines derived or imported by institutional investigators, and

  5. facilitate education of investigators involved in hES cell research.

An institution that uses an external ESCRO committee should nevertheless ensure that the registry and educational functions of an internal ESCRO committee are carried out by the external ESCRO committee on its behalf or internally by other administrative units.


2.1 For projects that involve more than one institution, review of the scientific merit, justification, and compliance status of the research may be carried out by a single ESCRO committee if all participating institutions agree to accept the results of the review.

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



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