Procedural Misconceptions and Informed Consent: Insights from Empirical Research on the Clinical Trials Industry

Abstract

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.Quite recently, I was struck by the realization that I did not get truly informed consent from subjects participating in my research project. This is not to say that I violated any federal or institutional regulations. Quite the contrary, I did everything by the book and so did my university institutional review board (IRB). 1 Moreover, the project itself is an empirical study of informed consent in the context of private-sector research within the clinical trials industry, so as I was developing the project, I was keenly aware of my responsibility to be ethically commendable in my own interactions with human subjects. What went wrong? And what generalizable implications does my experience have for thinking about human subjects research and informed consent?This article is based on 12 months of qualitative research examining the for-profit clinical trials industry in the southwestern United States. 2 The purpose of the study was to investigate the new relations, structures, and logics that have been produced within the research clinic through the privatization of pharmaceutical research. Using a mode of multi-sited, institutional ethnography, 3 my research was particularly attuned to the roles of the informants-i.e., physician investigators, coordinators, monitors, and even human subject volunteers-and the ethical conflicts, of various degrees of intensity, that they described and that were observed through their practices-e.g., recruitment of subjects, informed consent processes, and study retention and compliance. Studying approximately 20 for-profit research organizations in two major cities, I conducted 57 semi-structured interviews that were clustered to get the perspective of multiple employees at individual investigative sites-i.e., those conducting contract research-including 10 physicians, 18 research coordinators, 9 administrators, and 10 human subjects. Investigative sites represented a diverse sample of organizational forms, such as private practices, dedicated research sites, and large (nonacademic) hospitals. The sample also included interviews at two not-for-profit, nonhospital investigative sites. In addition, the research included attendance at industry conferences, the monitoring of publications produced by industry professional organizations, and participant observation in which I was screened for a Phase I, healthy volunteer clinical trial.

Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

“…By directing inquiry into the structural conditions impacting upon ethical decision-making, the approach of scholars in the social sciences attends to multiple ways in which ethics are understood and enacted by various research communities (e.g., Epstein, 1996;Evans, 2002;Fisher, 2006b). For example, changes in science and medicine, such as the increasing prevalence of research on the clinical application of genetics, shape physicians' as well as patients'/subjects' perceptions of ethical uses of biological information (Hedgecoe, 2004;Konrad, 2005).…”

Reaching for Informed Revocation: Shutting Off the Tap on Personal Data

“…Another concern surrounding achieving informed consent [6] is how free the individual is to participate. Particularly in medical environments, people often decide to consent before they read the consent form.…”

“…Fisher [6] also argues that researchers experience the same phenomenon. They perceive that participants share the same understanding and have the same perception about the process of consent with them and incorrectly conclude that the form they sign is informative enough for the consent of the patient to be informed.…”

Ethical Review and Children's Research in Ireland

“…In clinical research, participants frequently have significant difficulties in understanding some research methodologies like randomised control trials (Cox, 2000;Daugherty et al, 1995;Joffe et al, 2001), although the extent of this misunderstanding might be unclear . Participants generally seem to operate under the mistaken assumption (referred to as 'therapeutic misconception' in the literature) that participation in such trials will guarantee receipt of an effective therapeutic intervention (appelbaum, 2002;appelbaum et al, 2004;Bamberg and Budwig, 1992;Fisher, J.a., 2006;Jansen, 2006;Kimmelman, 2007;King et al, 2005;Miller and Brody, 2003;Miller and Joffe, 2006;Stead et al, 2005). One of the concerns in the literature has been what investigators contribute to this misunderstanding and whether there are effective means to avoid or correct the therapeutic misconception (hochhauser, 2002;Jansen, 2006;Joffe et al, 2001;King, 2000).…”