Thursday, January 26, 2006

CIRM Nearing Final Action on Ethics and Research Standards

The California stem cell agency next week will move forward on research and ethical standards that it says will lead the nation in several areas.

According to a press release from CIRM, it will be the first in the nation to:

"legally mandate specialized review by a Stem Cell Research Oversight(SCRO) committee;

"enhance state and federal policies in the areas of voluntary-informed consent;

"and ensure that women's reproductive needs are protected and
prioritized before the research."

The complex, 10-page draft of regulations is due to be considered at a Los Angeles meeting of the Standards Working Group on Monday and Tuesday. Its recommendations will go to the full Oversight Committee Feb. 10, a meeting that is already scheduled to take up another complex subject, intellectual property.

Whether the draft will satisfy its critics is yet to be determined. One, the Center for Genetics and Society, has raised concerns that the agency is considering a loophole that would allow use of eggs from other countries that have lower standards than California.

The draft rules contain language stating that CIRM-funded research is limited to cells obtained "under the oversight of an IRB (or, in the case of foreign sources, an IRB-equivalent)." It goes on to state that CIRM-funded research requires that "the donation of gametes, blastocysts, somatic cells or tissue occurred without payment beyond reasonable compensation for participation. A determination of reasonable compensation shall be performed in accordance with the policies governing the institution involved in derivation activities."

Prop. 71 forbids payments to egg donors in California, but it allows for reimbursement of expenses. Just how those expenses are defined has been debated extensively by the working group. The working draft contains the following definition: "necessary and reasonable costs directly incurred or expended as a result of donation or participation in research activities." A footnote on page 6 adds that expenses "is not used here to allow for differences…that may exist in outside (non-CIRM funded) institutions."

It was not clear from the draft whether the "necessary and reasonable expenses" rule would entitle a woman to be reimbursed for the hiring of a $500-an-hour lawyer/consultant to help her during many hours of wading through the complex informed consent documents and procedures. That hourly figure may sound high to some, but many lawyers, including those who work for CIRM, regularly charge such fees.

The draft does require development of procedures to ascertain whether a donor fully understands "the essential aspects of the research."

The standards group has held eight meetings around California to develop the documents scheduled to be discussed Monday. You can find links to all the proceedings here. Monday's agenda with several background documents is posted here.

The meeting cannot be heard at any offsite locations, but only at the Luxe Hotel in Los Angeles. That is unfortunate, given the important nature of its deliberations. It is the policy of CIRM not to make meetings of the Oversight Committee and its Working Groups, the most important entities within the agency, available to the public beyond their physical locations. Cost was cited as a reason by one official.

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