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*The guidelines clarify that an institution's ESCRO
committee may conduct an "expedited review" for research done exclusively in a laboratory dish or test tube that does not create new lines of stem cells but uses previously derived human embryonic stem cell lines.
Those involved in the hESC research enterprise--providers, distributors, intellectual property holders, researchers, IRBs, and ESCRO
committees--should be attentive to these consent problems in their deliberations about which kinds of research to pursue or allow, and should not presume that the consent processes have been adequately reviewed either by the NIH or by the NAS.
No animal embryonic stem cells should be transplanted into a human blastocyst, and approval by an ESCRO
committee should be secured before any human embryonic stem cells are put into an animal.
committees begin to materialize in institutions around the country--as new international guidelines are revealed and debated in the global community--and as NT-hESC research moves forward in laboratories around the world, bioethicists will have important work to do both locally and internationally.
Although an ESCRO committee should approve new stem cell research, the report notes federal regulations already require IRBs to review the procurement of all egg blastocysts to be used in generating new stem cell lines, and they should continue to do so according to the panel.
The ESCRO committees should review all research that takes stem cells from excess blastocysts at in vitro fertilization clinics, blastocysts created expressly for stem cell research, and blastocysts created by nuclear transfer (therapeutic cloning), the panel said.
Proposals to generate additional human embryonic stem cell lines by any means should be reviewed and approved by an ESCRO committee, the guidelines say.
Under these proposals, each institution engaged in embryonic stem cell research would establish an Embryonic Stem Cell Research Oversight (ESCRO
) committee to oversee all issues related to the derivation and use of embryonic stem cells, review all proposals for scientific merit, maintain records of research that takes place at the institution, and educate investigators.