Stem cell working group of Cal's CIRM creates guidelines

The Scientific and Medical Accountability Standards Working Group, one of the advisory committees established by Proposition 71, met on January 31 and February 1. Recommendations were made, covering topics ranging from informed consent of donors to the make-up of individual oversight committees, in a Bel-Air hotel conference room by scientists, ethicists and patient advocates who make up the 19-member group. The advisory group's 10-page draft guidelines now go to CIRM's governing board, which meets Feb. 10 at Stanford University. Seven months in the making, the proposed regulations were hailed by committee members as a model for other states wading into stem cell research.

Absent from this week's sessions was committee member Jose Cibelli, a researcher from Michigan State University who recently withdrew from participation pending the outcome of an academic review over the 2004 paper in Science he co-authored with Dr. Hwang Woo-suk, the South Korean scientist who apparently faked studies about creating the first-ever stem cell lines from cloned human embryos. The paper has been retracted. “None of us should draw judgment on this until we know the facts and the investigation (of Cibelli's work) is complete,” said Sherry Lansing, co-chair, noting that Cibelli himself requested the university look into his part in the apparently tainted study.

from the Sacremento Bee:

Cibelli has participated in some of the five previous working group meetings where the standards were discussed for future stem cell grants. The state program has not handed out any money because two lawsuits have effectively blocked its ability to sell the $3 billion in bonds voters approved to finance it.

The working group leaders noted the reasons for Cibelli's absence and frequently cited the South Korean scandal in developing standards to avoid the ethical minefields in this relatively new field of scientific inquiry.

"It would be very difficult to guarantee that what happened in South Korea won't happen here," Hall said. "It is very hard to catch (errant researchers) unless you are sitting at their bench and watching what they are doing."

But he said scientists seeking to replicate another researcher's result would uncover most frauds - as they have in the past. [IPBiz note: scientists seeking to replicate Hwang's research did NOT uncover Hwang's fraud. Scientists seeking to replicate Jan-Hendrik Schon's research did NOT uncover Schon's fraud.]

While standards can't prevent fraud, the ones adopted this week seek to prevent the unethical payments Hwang's team used to secure eggs. His team paid nearly $1,500 to each woman, a sum considered large enough to coerce her into undergoing the potentially risky egg extraction.

The working group, after much debate, determined only a donor's expenses could be reimbursed.

But it liberally defined those expenses to include lost wages, child care, travel and meals.

Some members of the public wanted to limit reimbursement even further to avoid creating a market in eggs.

Several working group members contended women should profit because egg extraction is onerous and potentially risky.

Ann Kiessling, a Harvard University biologist who runs an independent nonprofit lab harvesting eggs for stem cell research, said donors spend up to 200 hours on travel, legal reviews and medical procedures to provide eggs for research.

"That women shouldn't be compensated is the most unethical position," said panel member Jonathan Shestack.

They were overruled by Proposition 71, the initiative that created the state stem cell program. It limited payments to egg donors to reimbursement of expenses.

See http://www.sacbee.com/content/politics/story/14139331p-14968069c.html