Monday July 6, 2009

New US stem cell rules loosen some restrictions

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - The U.S. government released final rules on Monday governing federally funded research on human embryonic stem cells, loosening some requirements that scientists said could have cost them a decade of work.

But the new rules, which take effect on Tuesday, keep many of the restrictions on the research. U.S. federal funds may not be used to actually make the cells using human embryos -- only to work with them after someone else has made them.

But the National Institutes of Health agreed with arguments that proposed regulations published in April could have forced researchers to throw away work done with stem cell batches, or lines, created over the past few years.

"We allow a case-by-case review," acting NIH director Dr. Raynard Kington told reporters in a telephone briefing.

In March, President Barack Obama lifted restrictions on human embryonic stem cell research that had been put into place by his predecessor, former president George W. Bush. He asked the NIH to draw up new guidelines.

The NIH guidelines take into account many of the arguments put forward during nearly 10 years of debate over how best to use the potential of human embryonic stem cells, which have the power to give rise to all the cells and tissues in the body.

Supporters say work on the cells can transform medicine, with new understanding of how to regenerate tissues destroyed in diabetes, by injuries and by diseases such as amyotrophic lateral sclerosis or Lou Gehrig's disease.

Opponents say it is wrong to destroy human embryos for any reason and the issue has become a politically divisive one.

But over the years Congress reached a middle ground, with many social conservatives, such as Utah Republican Senator Orrin Hatch, saying they could support such research if it used embryos left over at fertility clinics.

BROAD PUBLIC SUPPORT

"The guidelines reflect the broad public support for federal funding of research using human embryonic stem cells created from such embryos based on wide and diverse debate on the topic in Congress and elsewhere," the new rules said.

The new rules limit such research to these in vitro fertilization or IVF leftovers. They also establish stringent "informed consent" rules meant to make clear to the people whose eggs and sperm were used to make the embryos what they will and will not be used for.

The new guidelines also loosen restrictions on using human embryonic stem cells made in other countries.

In April when the guidelines were published some scientists said the informed consent rules were so strict that they might force labs to discard some of the work they had been doing with non-federal funds.

Kington agreed.

"It was unreasonable to apply new standards retroactively," he said. Instead, scientists who want to use federal money to work with cell lines created before this week will have to submit their proposals to a new NIH panel.

The rules prohibit federal funding of embryos made by cloning, using a human egg only in a process called parthenogenesis, and those created specifically for research.

They do not affect what scientists do using private funds or state funds.

U.S. legislation called the Dickey Amendment forbids the use of federal funds for the creation or destruction of human embryos for research and the guidelines confirm this, Kington said.

U.S. Representatives Diana DeGette, a Democrat, and Michael Castle, a Republican, have said they would introduce legislation broadening the guidelines further.

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