New Panel To Set Minimum Monitoring Requirements in Clinical Trials Studies Involving Stem Cells
Saturday, April 12th, 2008There will now be a more systematic approach to minimum monitoring requirements in clinical trials studies that involve stem cells, since the National Academy of Sciences is setting up a new committee. Research with human embryonic stem cells, including stem cell clinical trials, will now be overseen by the informal committee to ensure that protocols are followed and that decisions are made about which types of research are “ethical.” If anyone wonders why monitor clinical trials, it should be easy to see in regards to stem cells. While stem cell clinical trials have brought positive results, they are still controversial.
Most minimum monitoring requirements in clinical trials studies are governed by the National Institutes of Health, the government agency that finances most biomedical research. Since stem cell clinical trials are very controversial and there have been some contentious moments with the government, however, the institute has been unable to specify what kinds of research are ethically acceptable. The National Academy of Sciences will be paid for by private sponsors and not funded by the government. They will enforce minimum monitoring requirements in clinical trials studies and other forms of research that involve stem cells, but they will not call all the shots.
Why monitor clinical trials that involve stem cells with a private committee? “Our very strong feeling was that some sort of oversight was vastly preferable to the vacuum we have now,” said Richard L. Sprott, executive director of the foundation, in The New York Times. He added that the committee will “fill the gap in federal oversight and make sure the private sector does not call all the shots.” And researchers who are specifically involved in stem cell clinical trials will not be on the panel, so there will not be a conflict of interest.
This new panel intends to make updates to policy when stem cell clinical trials yield new knowledge and information, and serve as an unbiased non-government monitoring system.