Understanding Informed Consent: Targeting Areas That Cultivate Procedural and Therapeutic Misconceptions in Online Clinical Trial Resources

Abstract

This research used a content analysis to analyze the construal of general clinical trial information across various online resources. Pharmaceutical company websites, hospital and clinic websites, and clinical trial registries and databases were analyzed across five major categories. These include: definitions of clinical trials, explanations of key terms and concepts, representations of risks and benefits, suggestions for questions to ask health care professionals, and the framing of informed consent and Institutional Review Boards. Each of these categories were identified as areas that may cultivate procedural and therapeutic misconceptions, defined as misunderstandings of general and specific clinical trial processes, that detrimentally affect the informed consent process. This study is motivated by the desire to ensure trial participants have a comprehensive understanding of general biomedical research procedures prior to subscribing to participate, and in the Internet era, identifies online resources as one of the first instances where participants might be exposed to this information. In an attempt to reduce the prevalence of these misconceptions that may pervade the informed consent process, it becomes important for online resources to balance motivations to recruit participants with the need to provide comprehensive trial information. This represents the critical challenge of clinical research. Addressing this challenge can empower trial participants and allow them to make informed decisions during informed consent.