Setting the Rules for Stem Cell Donors

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To pay or not to pay egg donors? That was the question facing a task force of experts from the International Society of Stem Cell Researchers (ISSCR), who have spent the last six months trying to come up with a set of guidelines to regulate what's currently the wild west field of human embryonic stem cell research. They were in part motivated by the misconduct of South Korean stem cell researcher Woo Suk Hwang, who admitted earlier this year to paying women to donate eggs for study, a practice that many scientists believe is unethical because it could lead to coercion.

The scandal highlighted the patchwork system that currently oversees the few labs conducting cutting-edge research on human embryonic stem cells. With no rules to regulate the field in the U.S., most labs here abide by regulations created by their own institution — while others overseas have to walk the line between the requirements of their own institutes and national laws that have been passed to govern certain parts of the field. (In South Korea, for example, it is now illegal to pay women to donate eggs.)

The question of whether women who donate eggs for purely altruistic reasons — volunteering to undergo the extensive hormonal preparation prior to donation, as well as the invasive procedure of harvesting the eggs themselves — should be paid for their troubles "occupied our time more than any other topic," said Kathy Hudson, a task force member from Johns Hopkins. Some members felt strongly that women should be compensated for the exhaustive procedure, while others were equally adamant that eggs should be treated no differently from any other human tissue that's donated.

The task force ultimately came to a consensus to prohibit paying women who donate eggs, but allow reimbursement for travel or other directly related expenses such as lost wages. (Incidentally, the Harvard Stem Cell Institute, which last month became the first U.S. academic facility to begin recruiting women to donate eggs for stem cell studies, adopted the same restriction; they will not pay women for donating, but will compensate them for travel and other expenses related to their participation.) The task force released a draft of its proposed guidelines to its 2300 membership in a town hall forum at the Society's annual meeting in Toronto Friday afternoon. Members will have 60 days to comment on the draft, and the committee will reconvene to amend the guidelines in the fall.

For the most part, the ISSCR's draft follows guidelines released by the National Academy of Sciences in the US, with a few notable exceptions. The NAS recommended that each institute establish its own Stem Cell Research Oversight Committee, while ISSCR is suggesting a broader approach, allowing for this review to occur at the institute, national or international level. Most importantly, the ISSCR will provide researchers with template documents that cover critical safety and ethical issues such as informed consent that review boards need to consider in trials involving the use of human embryonic stem cells — and even the transport of these cells among different labs in different countries.

"The goals of stem cell research are widely endorsed by scientists and diverse scientific societies, but recognizing that in order for scientists to be seen acting in the best interest of science and the public, ISSCR called for guidelines for ethical conduct," said George Daley, chair of the task force and a stem cell researcher at Children's Hospital in Boston.

How binding these guidelines will be, once they are passed, remains to be seen. Neither NAS nor ISSCR has any enforcement authority, but ISSCR hopes that by taking a leading role, it will promote other groups — and perhaps even governments — to join them and streamline the guidelines to ensure that human embryonic stem cell research is conducted in a safe and ethical way. "The fact that ISSCR now has a draft means that the international research community now has a common language," says Jan Helge Solbakk, a task force member from the University of Bergen in Norway. "When we have a common language, we can start to discuss what is the right way proceed, and what is the wrong way to proceed, and how we should we resolve conflicts."

For more on the NAS guidelines, see http://www.nap.edu/books/0309096537/html

For more information on ISSCR, see http://www.isscr.org/