the autonomy and privacy of those who donate gametes, blastocysts, or somatic cells and be sensitive to public concerns about research that involves human embryos.

2.0 ESTABLISHMENT OF AN INSTITUTIONAL EMBRYONIC STEM CELL RESEARCH OVERSIGHT COMMITTEE

To provide oversight of all issues related to derivation and use of hES cell lines and to facilitate education of investigators involved in hES cell research, each institution involved in hES cell research should establish an Embryonic Stem Cell Research Oversight (ESCRO) committee. The committee should include representatives of the public and persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research. It must have suitable scientific, medical, and ethical expertise to conduct its own review and should have the resources needed to coordinate the management of the various other reviews required for a particular protocol. A pre-existing 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.

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

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.



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