Doctoral Dissertation Research: Institutionalizing Standards in Clinical Genome Editing

University Of California-Berkeley, Berkeley CA

Investigators

Abstract

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.