Doctoral Dissertation Research: Institutionalizing Standards in Clinical Genome Editing

该项目调查了制定监管指导方针和实践标准的过程：最佳实践和标准操作协议如何成为正式政策、指导方针和规范的制度化？这是为了基因组编辑技术，特别是DNA编辑工具CRISPR及其所代表的技术突破。为了解决这些技术带来的社会和伦理问题，科学家们召开了公开的会议论坛，但学术界和工业界的科学家们在很大程度上是闭门不出地就研究方向、疗效和测量标准以及临床方案的安全性做出决定。研究结果将有助于科学家的培训和有关科学的决策。有关确定指南和实践标准的数据将通过访谈、参与者观察和美国食品和药物管理局（FDA）生物制品评估和研究中心（CBER）和商务部国家标准与技术研究所（NIST）的档案研究来收集。该项目的方法建立在实验室研究惯例的基础上，使用人种学的扩展案例方法，该方法依赖于比较数据和多地点参与者观察来追踪分散的过程。通过描述由制度化战略地点的利益相关者制定监管准则的过程，该项目对科学技术社会学、组织社会学和政治社会学做出了贡献。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This project investigates the process by which regulatory guidelines and standards of practice are developed: How do best practices and standard operating protocols become institutionalized into formal policies, guidelines and norms? It does so for the technology of genome editing, specifically for the case of the DNA editing tool CRISPR and the technological breakthrough it represents. To address social and ethical implications raised by these technologies, scientists have convened open conference forums, but academic and industry scientists largely make decisions about the direction of research, the standards of efficacy and measurement, and the safety of clinical protocols behind closed doors. Findings will contribute to the training of scientists and decision-making concerning science.Data concerning determination of guidelines and standards of practice will be gathered through interviews, participant observation, and archival research at the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) and at the National Institute of Standards and Technology (NIST) in the Department of Commerce. The project's methodology builds on the conventions of laboratory studies by using the extended-case method of ethnography, which relies on comparative data and multi-site participant observation to trace decentralized processes. By describing the process by which regulatory guidelines are produced by stakeholders at strategic sites of institutionalization, this project contributes to the sociology of science and technology, organizations and political sociology.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.