Understanding “Understanding”: An Important Step Toward Improving Informed Consent to Research

Abstract

What is known about how well research subjects understand the information communicated to them during the informed consent process is not encouraging. Although there is some diversity in the literature, in general studies suggest that research subjects are unable to recall much—in many cases most—of the information that has been conveyed to them by researchers (Verheggen and Wijmen 1996). Subjects typically fail to grasp the purpose of research studies, the likelihood of benefit, and the range of risks (e.g., Daugherty et al. 2000). This has been found to be true for a broad array of research subjects suffering from a wide range of disorders. In addition to purely factual information about the study, which presents challenges of its own, subjects seem to have a particularly difficult time grasping some of the ways in which participation in a clinical trial differs from engaging in ordinary treatment (Appelbaum et al. 2004; Joffe et al. 2001). In this issue of AJOB Primary Research, Sand, Kassa, and Loge (2010) demonstrate the conceptual and methodological chaos of the literature on which these conclusions are based. Definitions of what is being measured are often imprecise and vary widely across studies. Subjects are interviewed at disparate time periods after passing through the consent process. Methods range from semi-structured interviews to structured questionnaires based on free response, yes/no, or multiple-choice approaches. Instruments are often developed ad hoc for each study, frequently with little effort at validation, and typically with questions specific to the context being assessed. Hence, few instruments are—or can be—used in more than a single study. Indeed, had Sand, Kassa, and Loge included a broader selection of studies in their review, including the large number that have involved what they term “vulnerable” and “normal” populations, it seems clear that even greater variation would have been apparent. That this is not a desirable situation seems indisputable. Although many questions come to mind, three force themselves to the front of the line: 1) What implications do these