Assistant Professor Laura Stark hopes her new book can inform scientists, scholars, students and research participants of new research regulations created by the Office of Human Research Protections.
In this issue of The Wesleyan Connection, we ask 5 Questions of Laura Stark, assistant professor of sociology, assistant professor of science in society, assistant professor of environmental studies. Stark recently published a new book, Behind Closed Doors: IRBs and the Making of Ethical Research.
Q: Professor Stark, what inspired you to study institutional review boards (IRBs), which regulate research on human subjects?
A: I first became interested in this project in 2002 because of a great coincidence of scholarship. At the time, I was reading historical works that explained why the Nuremberg Code after World War II had so little effect on medical research in the U.S. I was also going through IRB training to conduct interviews as part of a research study, and found that the IRB training manuals attribute the modern origins of American research ethics to the Nuremberg Code. The two contradictory accounts intrigued me. I am generally interested in how new knowledge is produced in science and medicine, and I also think it’s important to use research methods appropriate to the question at hand (which is why I use both ethnographic and historical methods in the book). As a result, I started to explore how the ethics evaluation process developed historically and how it works today, and investigate the conflicting accounts of the importance of the Nuremberg Code.
I was excited at the prospect of exploring uncharted territory by observing IRB meetings and reconsidering the history of IRBs using new historical materials from the National Institutes of Health.
Q: What was most striking about the IRBs you observed?
A: As an ethnographer, I was struck by how similar these different IRB “field sites” felt to me. Each was a day’s drive from my home, each was composed of quite different individuals, and each used a lot of discretion in evaluating researchers’ proposal. Yet their methods for reaching decisions were remarkably similar. The three boards didn’t communicate with each other and they certainly weren’t trying to model on each other, and yet they use similar decision-making techniques.
As I argue in the book, these similarities are a function of the common configuration of IRBs all around the country. Since 1966, The U.S. surgeon general has required all universities, hospitals and other organizations that receive federal funding for research on people to get prior approval from a human-subjects
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