Results by Title
books about Institutional review boards (Medicine)
Behind Closed Doors: IRBs and the Making of Ethical Research
University of Chicago Press, 2011
Library of Congress R852.5S837 2012 | Dewey Decimal 174.28
Although the subject of federally mandated Institutional Review Boards (IRBs) has been extensively debated, we actually do not know much about what takes place when they convene. The story of how IRBs work today is a story about their past as well as their present, and Behind Closed Doors is the first book to meld firsthand observations of IRB meetings with the history of how rules for the treatment of human subjects were formalized in the United States in the decades after World War II.
Drawing on extensive archival sources, Laura Stark reconstructs the daily lives of scientists, lawyers, administrators, and research subjects working—and “warring”—on the campus of the National Institutes of Health, where they first wrote the rules for the treatment of human subjects. Stark argues that the model of group deliberation that gradually crystallized during this period reflected contemporary legal and medical conceptions of what it meant to be human, what political rights human subjects deserved, and which stakeholders were best suited to decide. She then explains how the historical contingencies that shaped rules for the treatment of human subjects in the postwar era guide decision making today—within hospitals, universities, health departments, and other institutions in the United States and across the globe. Meticulously researched and gracefully argued, Behind Closed Doors will be essential reading for sociologists and historians of science and medicine, as well as policy makers and IRB administrators.
Ethics by Committee: A History of Reasoning Together about Medicine, Science, Society, and the State
University of Chicago Press, 2022
Library of Congress R852.5.J33 2022 | Dewey Decimal 174.209492
How liberal democracies in the late twentieth century have sought to resolve public concerns over charged issues in medicine and science.
Ethics boards have become obligatory passage points in today’s medical science, and we forget how novel they really are. The use of humans in experiments is an age-old practice that records show goes back to at least the third century BC, and it has been popular as a practice since the early modern period. Yet in most countries around the world, hardly any formal checks and balances existed to govern the communal oversight of experiments involving human subjects until at least the 1960s. Ethics by Committee
traces the rise of ethics boards for human experimentation in the second half of the twentieth century.
Using the Netherlands as a case study, historian Noortje Jacobs shows how the authority of physicians to make decisions about clinical research in this period gave way in most developed nations to formal mechanisms of communal decision-making that served to regiment the behavior of individual researchers. This historically unprecedented change in scientific governance came out of the growing international wariness of medical research in the decades after World War II and was meant to solidify a new way of reasoning together in liberal democracies about medicine and science. But what reasoning together meant, and who was invited to participate, changed drastically over time. In detailing this history, Jacobs shows that research ethics committees were originally intended not only to make human experimentation more ethical but also to raise its epistemic quality and intensify the use of new clinical research methods. By examining complex negotiations over the appropriate governance of human subjects research, Ethics by Committee
is an important contribution to our understanding of the randomized controlled trial and the history of research ethics and bioethics more generally.