Stem cell research rules require donor consent

 

The National Institutes of Health unveiled final rules Monday designed to unlock the restrictions on federal funding of research on human embryonic stem cells.

The new rules will primarily finance research on stem cells donated by fertility clinic patients "who gave voluntary written consent for the human embryos to be used for research purposes." Donors must not receive payment for the embryos or expect medical or financial benefits later, the rules state.

Older stem cell colonies, called "lines," including those eligible for grants during the Bush administration, will be reviewed for possible funding by a new panel of scientists and ethicists.

 

A microscopic view shows a colony of human embryonic stem cells (light blue) growing on fibroblasts (dark blue).

CERTAIN CELLS INELIGIBLE

Under new NIH rules, some types of human embryonic stem cells remain ineligble for federal money:

• Cloned cells

• Cells grown from unfertilized eggs, not embryos

• Cells that are a mix of human and animal cells

Says the NIH's Raynard Kington: "Society has not had a full discussion of the scientific and ethical implications."

In March, President Obama overturned a decision by President Bush in 2001 to limit federal funding of human embryonic stem cell research to 21 lines created before that date. Bush and other opponents of the research, such as Richard Doerflinger of the U.S. Council of Catholic Bishops in Washington, D.C., decried the destruction of embryos necessary to obtain the cells.

Obama called for new, rigorously enforced guidelines to open funding to newly established cell lines.

"We anticipate a substantial expansion of stem cell research," says acting NIH director Raynard Kington. He noted that work on donated cells would also be reviewed by the science/ethics panel.

Human embryonic stem cells are precursors to all specialized tissues, including blood, brain, bone and all organs. Lab researchers first grew them from embryos in 1998. Medical researchers have since looked to the cells to study organ development, test drugs and, most famously, grow rejection-free replacement organs for patients with diabetes, paralysis and other ailments.

"I'm confident we'll have hundreds of additional cell lines," says George Daley of Children's Hospital Boston, a former head of the International Society for Stem Cell Research. "Coming forward, we should see great advances for stem cell science."

The NIH received roughly 49,000 comments on a draft version of the rules in April. "The comments filed by tens of thousands of Americans opposing the use of taxpayer funds for destructive embryonic stem cell research were simply ignored," Doerflinger says.

NIH spent $938 million on all stem cell research last year, and $88 million went to human embryonic cells. Other research projects involved human adult or animal cells. Kington says he hopes to fund some research grants of newly approved cell lines this year, but he expects that the bulk of newly eligible cell-line funding will start in 2010.

The guidelines draft led to complaints from researchers, including Oleg Verlinsky of the Reproductive Genetics Institute of Chicago, a pioneer in creating "disease-specific" cell lines from excess fertility-clinic embryos. The "informed consent" documentation requirements, which said donors had to sign off in a new multi-step way, effectively ruled out old embryonic stem cell lines.

Provisions in the final rules for the older lines "respond to researchers' concerns," Kington says. But, he cautions, "not all the lines put forward will receive approval."

 

Posted via web from swathidharshananaidu's posterous