SGER: Cell Cultures, Institutional Cultures and the Regulatory Terrain-The Role of Stakeholders in the California Stem Cell Institute

University Of California-San Francisco, San Francisco CA

Investigators

Abstract

SGER: Cell Cultures, Institutional Cultures and the Regulatory Terrain - The Role of Stakeholders in the California Stem Cell Institute SES-0647987, Project Abstract This project will explore stakeholder roles in the California Institute for Regenerative Medicine (the Institute) from the time the California Research and Cures Initiative (Proposition 71) was introduced, to recognition of the Institute as a potentially viable, if fragile, research institution. This is a qualitative eighteen-month pilot study, which will take advantage of a real time laboratory to study the changing perceptions of stakeholders during the Institute's organizational period, and the impact of stakeholders on the framing of the Institute's governance, management and oversight infrastructure. It will be a "baseline" observation of an interesting and important organization, intended to serve as a precursor to a broader study examining the initial period of Institute development. The 2004 passage of the Initiative marked a turning point in the political history of scientific research in the United States. The Initiative codified stem cell research as a constitutional right of the people of California, and authorized three billion dollars in public state-issued bonds over 10 years, to fund stem cell research and facilities throughout the state. This is possibly the first time that a dedicated scientific institution has been created by a public ballot initiative. The intellectual merit of the project is based on recognition that the Initiative process and the Institute itself raise fundamental questions about the role of various publics in science: --How do stakeholders and stakeholder coalitions impact publicly funded research? --How should stakeholders be included in the Institute's organizational structure? --How has the Institute and its governing bodies responded to the demands of diverse stakeholders in key organizational areas such as ethical oversight, strategic planning and grant approval policies? The Initiative process brought a third party -- stakeholders-- into the existing dyadic relationship between scientific researchers and government regulators. This research will provide preliminary insight into how these concerns may affect implementation of the Initiative, although concrete answers will await further study. The specific objectives of the research are: (1) To identify the key stakeholder interest coalitions in Institute governance and oversight processes; (2) To identify stakeholder perceptions about key issues of stem cell research; and (3) To study which stakeholder groups have been most successful in achieving presence, influence and voice, and how that success has been achieved. We will collect two types of data: (1) semi-structured stakeholder interviews, and (2) documentary data from Institute and stakeholder organization archives. The data will address two dimensions of success: organizational success, e.g. whether specific objectives of the Initiative are met; and informal success; e.g. stakeholder perceptions of success. Data will assess the participation of stakeholders on the Institute's Oversight Committee and Working Groups, and the responses of the Oversight Committee and Working Groups to the stakeholders. Long-term impact involves the production of new knowledge regarding the broader theoretical issues of governance and oversight of scientific research. Another impact is the potential usefulness of these pilot data for a broader multi-disciplinary, longitudinal study of the continued evolution of the Institute's mechanisms for scientific governance and oversight, focusing on the roles of federal and state government and on the emergence of national stakeholders.