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

SGER：细胞培养、机构培养和监管地形-利益相关者在加州干细胞研究所的作用SES-0647987，项目摘要本项目将探讨利益相关者在加州再生医学研究所的作用从加州研究和治疗计划开始，（第71号提案），承认该研究所是一个潜在的可行的研究机构，如果脆弱的。这是一项为期18个月的定性试点研究，将利用一个真实的时间实验室，研究利益攸关方在研训所组建期间不断变化的看法，以及利益攸关方对研训所治理、管理和监督基础设施框架的影响。这将是对一个令人感兴趣和重要的组织的"基线"观察，旨在作为审查研训所发展初期的更广泛研究的先驱。2004年该倡议的通过标志着美国科学研究政治史上的一个转折点。该倡议将干细胞研究编纂为加州人民的宪法权利，并授权在10年内发行30亿美元的公共债券，为全州的干细胞研究和设施提供资金。这可能是第一次由公众投票倡议创建一个专门的科学机构。该项目的知识价值是基于这样一种认识，即倡议进程和研究所本身提出了关于各种公众在科学中的作用的基本问题：-利益攸关方和利益攸关方联盟如何影响公共资助的研究？- -如何将利益攸关方纳入研究所的组织结构？研究所及其理事机构如何回应不同利益攸关方在关键领域的要求， 组织领域，如道德监督、战略规划和赠款审批政策？该倡议进程将第三方-利益攸关方-纳入科学研究人员与政府监管机构之间现有的二元关系。这项研究将使人们初步了解这些关切可能如何影响倡议的执行，但具体答案有待进一步研究。 研究的具体目标是：（1）确定研究所治理和监督过程中的主要利益相关者利益联盟;（2）确定利益相关者对干细胞研究关键问题的看法;（3）研究哪些利益相关者群体在实现存在，影响力和发言权方面最成功，以及如何取得成功。我们将收集两种类型的数据：（1）半结构化的利益相关者访谈，以及（2）来自研究所和利益相关者组织档案的文件数据。这些数据将涉及成功的两个方面：组织上的成功，例如倡议的具体目标是否实现;以及非正式的成功，例如利益攸关方对成功的看法。数据将评估利益攸关方参与研训所监督委员会和工作组的情况，以及监督委员会和工作组对利益攸关方的回应。 长期影响包括产生关于科学研究的管理和监督的更广泛的理论问题的新知识。另一个影响是，这些试点数据可能有助于对研究所科学治理和监督机制的持续演变进行更广泛的多学科纵向研究，重点是联邦和州政府的作用以及国家利益攸关方的出现。

SGER: Cell Cultures, Institutional Cultures and the Regulatory Terrain - The Role of Stakeholders in the California Stem Cell InstituteSES-0647987, Project AbstractThis 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.