The Stem Cell

Susan Stayn is a Stanford lawyer who has published comparative analyses of state regulatory schemes supporting stem cell research.

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By Susan Stayn

Since August 9, 2001—the date George W. Bush restricted the use of federal funds for human embryonic stem cell (hESC) research—at least 11 states have committed to advance the research through formal legal measures and in many cases, state funding. These states— including California, Connecticut, Illinois, Iowa, Maryland, Massachusetts, Missouri, New Jersey, New York, Rhode Island, and Wisconsin—have passed their own individual statutes, regulations, executive orders, or ballot initiatives that provide a framework in which research can proceed. States that fund the research have built grant-making infrastructures and developed terms to award tens or hundreds of millions of dollars in public funds for research grants, facilities development, and related support.

Until earlier this year, these states had no formal means of communicating with each other about the content or compatibility of their frameworks for stem cell research. In other core areas, including human clinical trials and animal research, federal regulations and policies provide common legal standards or at least a uniform floor, which generally facilitates the conduct of multi-center clinical trials and other cross-institutional initiatives. In hESC research – a highly specialized, evolving field that can significantly benefit from collaboration within the U.S. and abroad – the growth of state frameworks intended to support the research has given rise to new questions about how researchers and their entities can work effectively with their peers and experts in other states. For example, the varying state approaches raise questions about whether hESC lines made in Massachusetts or Connecticut would be acceptable for use in California and vice versa, and whether one state’s grant money can be used in part to pay for costly equipment available at an out-of-state institution. For all involved in supporting this research, it is important to know the answers to such questions in advance, to reduce uncertainty and liability risks, to ensure efficient use of state resources, and to maximize the scientific value of state-funded research in the broader scientific community.

In March 2007, a conference hosted by the State of Connecticut brought together policymakers and other stakeholders to discuss the opportunities and challenges for interstate collaboration in hESC research. This workshop led to a proposal to create the Interstate Alliance on Stem Cell Research (IASCR), a voluntary body whose mission is to promote information-sharing among states to facilitate advances in stem cell research. The IASCR has met two additional times during 2007 (most recently last week), with meetings facilitated by the National Academy of Sciences and the Connecticut Department of Public Health. Policymakers or advisors from nine states that support stem cell research have participated, along with representatives of the consulates of the United Kingdom, Canada, and the International Society of Stem Cell Research.

This new interstate body offers significant promise to enhance understanding of the commonalities and differences among the supportive states’ regulatory and funding programs. This understanding may pave the way for collaborations among researchers in different states, as well as researchers outside of the U.S. (for whom state-specific regulatory schemes may be perceived as an even greater obstacle, absent practical comparative information). Initial areas of attention include, for example, how states have set up their grant-making programs, how states have interpreted their consent and nonpayment provisions, and whether lines derived in one state under its regulatory scheme would be accepted for use in other states.

For more information about the IASCR, contact Warren Wollschlager at the Connecticut Department of Public Health.

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