February 06, 2007

International Society for Stem Cell Research Releases Guidelines for Stem Cell Research. Yawn.

Our David Magnus writes in the Mercury News that the new guidelines by ISSCR are pointless or worse:
The International Society for Stem Cell Research (ISSCR) has announced its recommended guidelines.

For many of us who work on oversight committees for stem-cell research, this report is too little, too late.

The prestigious National Academy of Sciences has already issued an extremely influential report on stem-cell research, and here in California, we already have a set of laws, regulations and guidelines (mostly based on the NAS report) that governs research. Do we really need another set of guidelines?

There are three important points that these guidelines raise:

• We have seen a growing number of organizations coming up with guidelines for stem-cell research, and most cover the same issues. It gets hard for oversight committees to know who to listen to. Here in California, stem-cell research is governed by the regulations from the California Institute for Regenerative Medicine if it is funded by Proposition 71 money. If such research is privately or federally funded, it falls under a law that mandates several issues and additionally directs the state health department to issue guidelines. Clearly, the law comes first -- but to what extent do we need to pay attention to other guidelines? At this point, less is more.

• The one really novel stand the ISSCR group has taken concerns payment of women who agree to donate their eggs for research. This is a difficult ethical issue. Many argue that creating a market in eggs for research will lead to the exploitation of poor women to develop treatments for the wealthy. Others argue that failure to provide compensation means that women are exploited as they are exposed to risk for no benefit.

We are inconsistent in the way we approach payment. Women are allowed to take large sums of money in exchange for ``donating'' their eggs for infertility treatments, but people cannot legally take money to donate their bone marrow for transplantation, although the risks are similar and the procedures similarly invasive.

The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.

Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance.

• The final issue raised by the guidelines is what is missing. The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.

All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells.

The California Stem Cell Research Oversight Committee has come up with the first guidance on this issue, but much more needs to be done. There are many other pressing issues that have received little attention. It is time for groups to stop going over the same ground and to try to break new ground.

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