Sunday, April 03, 2005

Difficult Questions: Eggs to FDA

What type of expenses of human egg donors are appropriate to be reimbursed? Lost wages? Travel expenses?

What kind of privacy protections should be in place for cell donors? If they are guaranteed anonymity, what happens when later research turns up information that could be medically important to the donor?

In the international world of stem cell research, how are conflicting standards reconciled between nations?

When does the FDA become involved?

These are just a few of the questions facing California's stem cell agency. Alta Charo, a bioethicist from the University of Wisconsin, last month briefed the CIRM oversight committee on these and other legal, ethical and practical issues facing the agency.

Her comments are now available online in a transcript from that meeting. While they are looser than a formal text might be, they give a valuable overview and some insight into a few of the concerns of committee members.

Charo's subjects included protection of human subjects, privacy, reimbursement of donor expenses, international and conflicting patient and research standards, international collaboration, FDA involvement, stem cell banking, underlying medical conditions of donors and more. Some of her comments were brief but all illuminated one or another subject and are worth reading.

Here are samples from her presentation:

“Just working with cell lines, just collecting the embryos functionally means you are in a position to be studying the donors and not just their materials, and it's the ability to study the donors as people that triggers the need to treat them as research subjects.”

“How much should be told to your potential donors about the range of research uses? There are research uses that are coming down the pike that are probably going to sound very alarming to most members of the public. These might include genetic manipulation of the embryonic stem cells. That is already going on if only to just insert markers so that one can actually observe where the cells are differentiating.”

“Even the context of reimbursement has some ambiguities built into it,” Charo said. She cited examples of preferential medical treatment for donors or in-kind benefits such as fertility treatment, in addition to the possibility of donors requesting reimbursement for “outlandish” travel expenses. “You may find it worthwhile to simply make (language in Prop. 71) that much more explicit so there's no possibility for confusion.”

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