The June 2005 session of the Council on Governmental Relations (COGR) addressed the complexities faced by universities conducting stem cell research outside the parameters set for federally funded projects. University representatives from Massachusetts, California, and other states discussed the evolving landscape of regulations and oversight at both state and institutional levels. Key issues highlighted included the need for robust public education when introducing new legislation, the expansion of responsibilities for institutional review boards and biosafety offices, and the establishment of operational “firewalls” between financial and research activities. Financial management protocols at institutions like Harvard were adapted to treat stem cell projects in line with established research cost allocation guidelines, requiring additional efforts in legal clarification, equipment tracking, and collaboration with hospitals.
The panel further explored faculty engagement, emphasizing heightened interest and the necessity of training and oversight, amid ongoing ambiguities in federal guidance, particularly from the NIH. Intellectual property matters were discussed, particularly in California, where revenue sharing is not legislatively required and the focus is on broader economic and societal benefits rather than immediate commercial returns. Equipment use and classification also emerged as a significant administrative challenge, leading to detailed inventory and usage protocols. The session concluded by acknowledging the political sensitivity of stem cell research and underscoring the value of clear definitions and transparent advocacy. The panel recommended the recently issued National Academy of Sciences report for its comprehensive guidance, suggesting that widespread adoption of its recommendations could better position academic institutions against regulatory and political challenges.
