: This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function (...) as root causes of therapeutic misconceptions. (shrink)

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in (...) the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. (shrink)

The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached (...) 139 volunteers to participate, and 138 completed the questionnaire . The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study. (shrink)

According to the standard view of informed consent, a prospective subject's consent to participate in a research study is invalid if the individual fails to comprehend the information about the study standardly disclosed to him. I argue that this involves three mistakes. First, the standard view confuses an ethical aspiration with a minimum ethical standard. Second, it assigns the entire responsibility for producing comprehension in study participants to the investigators. Most importantly, the standard view requires the termination of many otherwise (...) perfectly ethical research studies. This last conclusion follows from appreciating a pervasive phenomenon that is known as the "therapeutic misconception." I argue that a prospective subject's consent to participate in research can be perfectly valid even if he or she does not comprehend the information that investigators are required to disclose. Furthermore, I explain that this alternative view does not in the least compromise the vital goal of ensuring the protection of subjects in research. (shrink)