Posted on Apr 30, 2009, 4 p.m.
By gary clark
Draft rules recently issued by the National Institutes of Health will put some scientifically valuable stem cell lines off limits, including lines already approved under the Bush Administration, creating concerns for California’s stem cell scientists.
Simply because the federal government has lifted the ban on stem cell research doesn't mean research will move forward full speed ahead. In fact, draft rules issued by the National Institutes of Health (NIH) earlier in April may actually put some scientifically valuable cell lines, including those already approved under the Bush Administration, off-limits. Specifically, the new NIH rules require that couples must state in writing that they have been informed of "alternative options" before donating their embryos. California researchers have expressed concerns that the limits could cause confusion and red tape should their own standards set forth by the California Institute of Regenerative Medicine (CIRM) not be in line with federal restrictions.
CIRM is the largest funding body of human embryonic stem cell research in the world, and its rules have approval from the National Academy of Sciences and International Society for Stem Cell Research. According to a statement issued by the Institute, "CIRM has an interest in ensuring that the NIH rules are consistent with CIRM's medical and ethical standards." And furthermore, it states that "if the feds set too high a bar for eligibility, some scientifically significant lines may not qualify." Creating a registry of "compliant lines" and asking the NIH to consider "grandfathering" in established lines that might otherwise not qualify were among suggestions made by the CIRM.
The CIRM statement also pointed out that often studies involve a combination of federal and state funding, and as a result, rules among various organizations need to be consistent. While consent procedures could potentially be standardized, when it comes to the source of stem cells, there remains a disconnect between federal and state rules. Deriving new cell lines involves the destruction of embryos, which is forbidden by Congress and as a result, the use of federal funds for research on embryos is banned. The CIRM is creating a task force to assess the NIH's draft guidelines.
News Release: California's stem cell scientists fear federal red tape www.blogs.sciencemag.org April 28, 2009