Morality in science: How research is evaluated in the age of human subjects regulation.

다국어 초록 (Multilingual Abstract)

This dissertation examines how social factors help explain the way in which distinctions between right and wrong have been draw in the United States since the 1950s regarding the treatment of human subjects in research. By examining the history and present-day practices of Institutional Review Boards (IRBs), this dissertation explains why decisions about the treatment of human subjects have been defined as valid by different criteria over time; how decisions are made through social interactions today; and how the human subjects review system shapes the production of knowledge in science and medicine in the twenty-first century. The first, historical section of this dissertation describes the relocation of authority on how to treat human subjects from individual investigators to federally-mandated review committees. Evidence is drawn from the archives of federal agencies and of one professional scientific organization (the American Psychological Association). The second, ethnographic section is an analysis of audio recordings and field notes of IRB deliberations at three universities, interviews with members of these boards, and interviews with a sample of IRB chairs from major American research universities. This dissertation argues that the judgments and decision-making dynamics of IRBs today are shaped by the design of the boards, which crystallized in the United States between the 1950s and 1970s. It further argues that present-day decisions about the treatment of human subjects that seem idiosyncratic, uneven, or inappropriate when viewed from outside of IRBs can be understood as systematic when placed in historical context, and when IRBs judgments are observed as processes over time.