Tuesday, July 29, 2008

CIRM Revising Rules on Pre-2006 Cell Lines

The CIRM Standards Working Group had a plateful last week, dealing with the question of whether it can finance human embryonic stem cell research involving cell lines that were derived prior to CIRM regulations.

The short answer is provided by John M. Simpson, stem cell project director of the Consumer Watchdog group, who attended the meeting. He wrote on his group's blog:

"A stem cell line may be deemed acceptably derived before November 2006 if the following criteria are met:

"Informed consent from woman or couple in IVF (and no indication that original donor would not consent for research).

"Approval of the donation protocol by an Institutional Review Board.

"Compliance with prevailing ethical and legal standards in place at the time of derivation in the jurisdiction where the derivation was carried out.

"The process to determine if the criteria had been met would begin with a request to CIRM. The staff would review the request and make a recommendation to the oversight board, the Independent Citizens Oversight Committee.  The review would have to include consideration of the scientific significance of the stem cell line.  The ICOC would consider the request in a public meeting after publicly posting it."

The Standards Working Group did not have a quorum so its "plan" will go to directors, presumably at their August meeting, as representing the "sense of the group" but without a formal recommendation. Such a practice is commonplace with CIRM since it has perennial problems with securing quorums at meetings.

If you see problems with the CIRM proposal or support it, now is the time to send something along to the agency.

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