Restrictions Are Eased for Research Using Embryonic Stem Cells
Tuesday, July 7, 2009
Hundreds of embryonic stem cell lines, whose use in the United States had effectively been curtailed by the Bush administration, can be used to study disorders and develop cures if researchers can show the cells were derived using ethical procedures, according to new rules issued by the federal government yesterday.
President Obama had promised during last year's campaign to ease restrictions on the use of stem cells in research, and he has cited the promise of stem cell research in finding cures for disorders that have so far proved intractable.
The use of embryonic stem cells was not prohibited under the Bush administration, but federal funding was limited to a very small number of stem cell lines, which choked off most research. The new guidelines, issued by the National Institutes of Health, permit federal funding for research using many of the approximately 700 embryonic stem cell lines that are believed to be in existence.
In a move that drew praise from advocates of stem cell research and bitter criticism from opponents, the NIH said it will allow the use of any existing stem cell line that was created ethically. Acting NIH Director Raynard Kington said an NIH committee comprising scientists, ethicists and advocates will evaluate older lines to assess how each was derived.
He said all embryonic stem cell lines that qualified for federal funding would have to meet a series of ethical requirements: The embryo that was destroyed to create a line must have been discarded after an in vitro fertilization procedure, and the donors must have been informed that the embryo would be destroyed for stem cell research and made fully cognizant of their choices, including donating the embryo to another couple who want a baby. No donors could have been paid for an embryo, and no threats or inducements could have been used to nudge couples toward making a donation.
The new guidelines achieve Obama's vision to expand stem cell research in the United States, while also strengthening ethical standards in conducting the research, Kington said. Explaining the new guidelines, he added that during the years that George W. Bush was president, privately funded researchers in the United States and some foreign laboratories had used a variety of protocols to obtain informed consent from donors. He said it did not make sense to reject such stem cell lines because the ethics procedures used were slightly different from the specific procedures that are to be used from now on. Earlier cell lines, he said, may have derived through different procedures the same standard of ethics the government plans to enforce.
Kington indicated that once the NIH committee established that the procedure for any one stem cell line matched the new ethics requirements, all the lines that used similar procedures could see expedited approval. He said the NIH would set up a Web site that would list all the approved stem cell lines.
"I think it is a huge step forward," said R. Alta Charo, an ethicist at the University of Wisconsin at Madison. "They are making it absolutely possible to move this field forward and fund the research in a responsible way."
Stem cells have been widely hailed as a research tool that could one day lead to cures for many illnesses. These cells have the capacity to grow into a variety of cells and tissues. More recently, scientists have managed to obtain stem cells from adult cells, a process that does not require the destruction of an embryo. Critics of stem cell research prefer that the field be restricted to non-embryonic stem cells; advocates for the research say that this would stymie the field's medical potential.
Kington said the NIH committee would also be charged with reviewing stem cell lines developed abroad. Lines obtained through procedures that matched or exceeded the rigor of U.S. ethics requirements would be acceptable, and scientists using such lines for research could be eligible for federal funding.
The use of stem cells in research has become the subject of bitter national controversy, with advocates suggesting it is immoral for the federal government not to fund research that could save thousands of lives, and with opponents arguing it is immoral to fund research that requires the destruction of embryos.
"For the first time in history, the federal government will encourage the destruction of human life at a very early stage for federally funded research," said Richard Doerflinger of the U.S. Conference of Catholic Bishops. "These guidelines encourage researchers to go out and destroy embryos for taxpayer-funded research. . . . You and I were once human embryos, and each embryo has the inherent potential to grow into you and me."