Last week, U.S. Reps. Diana DeGette (D-Colo.) and Mike Castle (R-Del.) introduced bipartisan legislation to regulate federal funding of human embryonic stem cell research. The Stem Cell Research Advancement Act is designed to codify President Obama’s executive order, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells,” which outlined his administration’s policy on stem cell research. The bill is an important first step in providing consistency for researchers, but requires revision to ensure researchers working on previously approved cell lines are not penalized.
As proposed, the legislation would strengthen President Obama’s directive by providing an ethical foundation for future research, regardless of the political party in control of the presidency or Congress. The bill would retain the ethical requirements for embryonic stem cell research implemented last summer by the National Institutes of Health (NIH); compel the NIH to provide guidelines on all human stem cell research; and ban the use of federal funding for human cloning. Furthermore, the act would require the NIH to review the guidelines every three years and report to Congress biennially. The bill’s prospects for approval appear strong. Similar bills passed both the House and the Senate first in 2005 and then in 2007 only to be vetoed by President George W. Bush. Taking into account this prior congressional approval and President Obama’s advocacy of embryonic stem cell research, it seems reasonable to infer this bill may be signed into law in the near future.
Unfortunately, this act fails to address a major problem in NIH policy and could prove to be a major blow to the advancements already made in the field of stem cell research. Current policy demands all human embryonic stem cell lines meet NIH standards established in July 2009. This means that 21 lines previously approved by the Bush administration must now be re-evaluated to determine if they meet the new ethical criteria, even though scientists have based studies on these lines for the past nine years. The approved Bush-era lines were created prior to August 9, 2001, when the ethical standards were less specific. Thus, many researchers have been forced to either halt their work and wait for their cell line to be re-approved, which may never happen, or switch to one of the 43 lines approved by the NIH since July 2009. While some researchers may be able to switch lines fairly easily, others at a more advanced stage in their work may be forced to start over, resulting in the loss of time, taxpayer money and effort.
While it is imperative that research utilizing human embryonic stem cells be subjected to strict ethical criteria, legislators should also consider including a provision to “grandfather” the most commonly used cell lines from the Bush era. It is possible the informed consent process during that time may not have been up to current standards, but the NIH would still be able to control all new lines seeking approval. Losing the ability to work on previously approved cell lines (and thus the research resulting from those efforts) would be a significant blow to the field.
Kirstin Matthews is a fellow in science and technology policy at the Baker Institute. Her research focuses on the intersection between traditional biomedical research and public policy. Matthews’ current projects include the Baker Institute International Stem Cell Policy Program, the Civic Scientist Lecture Series and policy studies in research and development funding, genomics and climate change.
Jesse M. Flynn is a graduate intern for the Science and Technology Policy Program at the Baker Institute. Flynn is also a graduate student at The University of Texas M.D. Anderson Cancer Center studying mouse muscular development.