Biomedical research is crucial for developing scientific knowledge about effective medical interventions. Yet, obstetric patients have been excluded from biomedical research due to concerns about vulnerability, risk, and harm, and their prohibition from participating in biomedical research through the Common Rule, which governs human subjects regulations in the United States. This has led to a dearth of scientific knowledge about this population. However, recent changes to the Common Rule now enable the inclusion of this group in biomedical research. It is unclear how such a shift will impact scientific knowledge production about reproduction, conceptualizations of ethical research practices, and care for obstetric patients. This CAREER project thus examines regulatory changes regarding obstetric patients and biomedical research over time. In so doing, it contributes to pressing scientific, medical, ethical, and policy discussions about the goals and consequences of research regulations and scientific knowledge production. The project also elucidates how the production of knowledge about reproduction matters for health and health disparities. This project's education plan centers on expanding instruction in science and technology studies and ethics, offering students who will be going into applied research, clinical work, public sector positions, and academia productive training for critically assessing, managing, and studying key issues in population health and research ethics. The broader impacts of this project also include producing white papers, training graduate students, and convening an interdisciplinary workshop that advances academic and public dialogue about reproduction and research.
Drawing on multiple methods, including archival research, content analysis, oral histories, ethnographic observations, and interviews with multiple stakeholder groups, this project documents past and present changes in research regulations pertaining to obstetric patients, and it analyzes how stakeholders respond to regulatory revisions related to reproduction. It asks: What social, cultural, political, and ethical factors have influenced research regulations regarding obstetric patients over the past eight decades? How do changes in regulatory categories with respect to obstetric patients and clinical research get taken up, deployed, and implemented? How do stakeholders respond to changes in the cultural and regulatory landscape around reproduction and biomedical research? In answering these questions, this project enhances basic understanding within the history and sociology of medical science, and advances theory in science and technology studies about processes of knowledge production and outcomes of regulatory change. This project also increases scholarly and public understandings of the ethics and morality of human subjects research and builds a theoretical framework for the social production of ethics at the intersection of science studies and bioethics. Organizing a national workshop enables this project to bridge science studies scholarship with wider conversations about reproduction and bioethics.
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.
