this research involves the derivation of new cell lines, should maintain and use their ESCRO committees as they did prior to July 7, 2009. An ESCRO committee could be internal to a single institution or established jointly with one or more other institutions. Alternatively, an institution may have its proposals reviewed by an ESCRO committee of another institution, or by an independent ESCRO committee. An ESCRO committee should include independent representatives of the lay public as well as 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 expertise recommended here 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 would:

(a)

Provide oversight over all issues related to derivation and use of hES cell lines.

(b)

Provide oversight over issues related to the use of hES cell lines not otherwise covered by NIH guidelines.

(bc)

Review and approve the scientific merit of research protocols.

(cd)

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

(de)

Maintain registries of hES cell research conducted at the institution and hES cell lines derived or imported by institutional investigators. An institution conducting stem cell research should make information from the registries (including, but not necessarily limited to, project abstracts and source of funding) available to the public and the media through the institution’s Web site.

(ef)

Facilitate education of investigators involved in hES cell research.

An institution that maintains its own ESCRO committee should also conduct periodic audits of the committee to verify that it is carrying out its responsibilities appropriately. Auditable records include documentation of decisions regarding the acceptability of research proposals and verification that cell



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