Source: bioethicsforum.org | Written by: SUSAN GILBERT
For nearly seven years, federal funding of human embryonic stem cell research has been banned in the United States on ethical grounds. Now, looking ahead to a new administration, proponents of lifting the ban are ramping up their effort to fight ethics with ethics.
In addition to the usual ethical argument – that federal support of stem cell research could speed up the discovery of cures for Alzheimer’s disease, diabetes, and other serious conditions – proponents raise a another issue: that it could finally open the way to ethical review of stem cell research.
There is no federal ethical oversight of stem cell research in this country. That means that there are no limits on what stem cell researchers can do. Should human embryonic stem cell research be limited to embryos left over from fertility treatments? Must donors give informed consent? Can they be paid? Should there be limits on the purpose of the research – to develop life-saving therapies but not, say, cosmetics? No one knows. With no well-reasoned legal guidelines, researchers, research institutions, and policy-makers are left to go with their guts.
Hoping to change that, Rep. Diana DeGette (D-Co.) announced on May 8 that she and Rep. Michael Castle (R-Del.) would introduce legislation this summer to permit federal funding of human embryonic stem cell research and authorize the National Institutes of Health to construct a framework for ethical oversight of stem cell research.
The latest legislation will be the third attempt to repeal the ban on federal funding of human embryonic stem cell research but the first attempt to mandate a process for determining which stem cell research activities are unethical and should be illegal.
The need for this process became evident just three days after DeGette’s announcement, when The Sunday Times of London reported that Cornell University researchers had created what is believed to be the first genetically modified human embryo. Gut reactions raged immediately as critics condemned the researchers for opening the door to the creation of “designer babies.”
The researchers defended their work, saying that they had intended to use the test-tube embryo to extract stem cells for research and that the embryo, which was abnormal to begin with, could never develop into a baby. Do these factors make the research ethical? Or does genetically manipulating a human embryo for any purposes cross an ethical line? The Weill Cornell hospital IRB that approved the research thought it was okay. But no one really knows.
The need to sort out answers to these difficult questions is growing more urgent now that the first clinical trials of stem cell therapies are on the horizon. On May 14, six days after DeGette’s announcement, the first clinical trial of an embryonic stem cell therapy was put on hold by the Food and Drug Administration. The trial was for a therapy for spinal cord injuries developed by Geron Corporation.
The FDA gave no reason for its decision, but researchers speculated that it might be due to the lack of criteria on how to assess the safety of stem cell trials, a significant ethical concern. Meanwhile, other stem cell therapies being readied for clinical trials include treatments for macular degeneration and diabetes.
A federal ethical review process for stem cell research would help the FDA decide which stem cell trials should proceed, and it would assure everyone else that the decisions were based on solid, transparent criteria, not on gut reactions. Speaking about the legislation that she is drafting, Ms. DeGette told CongressDaily: “I want to be ready when we have a new president and a new Congress to pass legislation that both reverses the president’s order and makes a new commitment to ethical cell-based research.”
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