The effort involves what the agency calls “Alpha” stem cell clinics. The agency said its proposed $70 million, Alpha network will support its own projects along with products developed worldwide and brought to California.
The plan will come before the stem cell agency's standards group tomorrow at a meeting in San Francisco. The agency's staff has recommended alteration of some of the agency's regulations to avoid duplication in connection with review and approval of clinical trials.
The staff document said a workshop earlier this year developed a “consensus that it would be beneficial if the CIRM (the stem cell agency) regulations reflected existing state and federal requirements with regard to delegation of responsibility and avoid unnecessary duplication of effort, such as the IRB (institutional review board) responsibility for the risk and benefit assessment.”
The staff is recommending that “CIRM’s regulatory requirements for clinical research should be modified to avoid duplication of IRB’s responsibility for review and approval of clinical trials.”
The staff also said,
“CIRM’s existing regulatory requirements for notification, review and approval of basic and pre-clinical research appear effective at this time without creating undue burdens. In fact, mature systems appear to be in place to efficiently incorporate ESCRO (embryonic stem cell research oversight) operations into institutional compliance programs.”Also on the standards group agenda are issues dealing with informed consent by providers of somatic cells “obtained under general (biomedical) research protocols" in connection with iPSC (induced pluripotent stem cell) derivation.
Dubbed the “Discuss Project,” its goal is “to initiate a process designed to develop consensus for the use of previously collected specimens for iPSC research" and to publish "final considerations" in early 2014.
Another item on the agenda tomorrow involves an update on the “progress of CIRM iPSC bank and donor consent protocol.”
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