Tuesday, February 07, 2006

Are Women Ready to Donate Their Eggs for 'Nothing?'

Ready to dig into the question of whether women should be allowed to sell their eggs or, put another way, how much should they be allowed to receive?

The latest version of proposed CIRM rules dealing with such questions is now available online for your reading pleasure. Basically CIRM is ready to answer that if women want to sell their eggs, none of its researchers are buying. And it wants to put limits on what the women can receive – no more than expenses, including lost wages. Of course, women who want to sell their eggs can go elsewhere, where CIRM standards are not applicable.

But what CIRM decides at the meeting of its Oversight Committee on Friday is likely to establish a national model for stem cell research standards. As CIRM points out in a press release, the rules would make CIRM the first agency in the country 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;
"protect health of women donating eggs for research;
"guarantee that all cell lines used by CIRM-funded researchers are
derived without compensation to egg donors."

It is impossible to cover all eventualities when drafting such ethical standards. It is also impossible to stop all persons determined to violate ethical codes or the law, but some questions appear to remain in the draft.

One involves the use of eggs from distant sources. It is relatively easy to check out procedures used by egg providers in the United States. This country has a relatively uniform ethical approach in science, although there are always a few rogues. But distant locations such as Thailand, which already is notorious for its sex industry, are harder to assess. To what lengths are California researchers going to go to ascertain whether an egg supplier in Thailand has similar informed consent procedures to those here? How will payments to foreign donors be evaluated? "Necessary and reasonable costs directly incurred" could mean something far different in another culture than in California.

The proposed rules put much of the burden of answering these questions on the recipients of the grants, both the individual and institutions. How well the standards will be applied will depend, in many ways, on the rigor of the recipients. CIRM proposes penalties for failure to comply. Of course, if problems arise, the ethical standards can be strengthened.

The proposed rules additionally require that unspecified "steps shall be taken to enhance the informed consent process. " They require the researcher to ascertain that the donor understands the "essential aspects of the research." Couple that with reimbursement of donor expenses, it could lead to the hiring of expensive consultants for donors or creation of costly donor education conferences, both of which could be deemed a reimbursable expense. Such activities may well be appropriate but they do open the door to potential abuse. Again the recipients and their institutions will play a critical role in regulating activities. They are likely to want to play it safe in terms of ensuring informed consent, both to comply with CIRM rules and ward off potential lawsuits. That comes at a price. Not to mention the possibility of kickbacks by unprincipled consultants to donors who hire them.

Again, these are difficult issues to address, and any set of rules can be circumvented or abused. Oversight of the ethics standards should be a top priority for the CIRM.

While we are on the subject of standards, reporter Dan Levine of the San Francisco Business Times put together a good overview of many of the issues involved.

Levine quotes David Magnus, director of the Stanford Center for Biomedical Ethics, as saying, "If Massachusetts decides they are going to allow payment of egg donors, and California decides they aren't, then we won't be able to share cell lines derived from one state to another. Whatever policies wind up getting put in place for this kind of an issue, it's really important that everybody be on the same page and have the same policies."

Levine also quotes Ronald Green, director of the Ethics Institute at Dartmouth College and chair of the ethics advisory board of Advanced Cell Technology, as saying, Our experience is that they (women) are not willing to step forward and donate eggs for nothing. It is not enjoyable to be injected with powerful drugs that alter your mood and hurt you, and the whole process and potential for organ failure, all culminating in a transvaginal needle harvest through the back wall of the vagina. How many women are going to do that to assist research to understand diabetes?"

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  1. Anonymous6:42 PM

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