Improving the Quality of Informed Consent to Research

Article excerpt

A substantial body of work has demonstrated that many research subjects have significant misunderstandings about the clinical trials in which they agreed to participate, despite lengthy informed consent documents and detailed explanation of the research during the informed consent process. (1) These failures of comprehension range from factual errors to misconceptions about the very nature of clinical research and how it differs from ordinary treatment. (2) Thus, a signature on an informed consent document does not guarantee that an individual understands or appreciates what it means to be a research subject in a clinical trial.

Although there has been broad awareness of this problem for the past 20 years, efforts to address it have been largely unavailing. Data on innovative approaches to obtaining informed consent show no consistent effects of these efforts. (3) Although well-intentioned investigators and Institutional Review Boards (IRBs) have developed more detailed consent forms, it has become clear that more information per se does not necessarily lead to better understanding. In fact, it may be that as the amount of information increases, prospective subjects may have more difficulty grasping essential information, (4) thus leaving the research community with a disturbing ethical dilemma.

Some researchers, recognizing that no approach to informed consent is perfect, have begun to use brief questionnaires during the consent process to assess the understanding of potential research participants. (5) This enables specific deficits to be identified and addressed. Potential participants can then be retested before being accepted into a study. Obviously, though, this approach is not perfect. Investigators must identify the truly crucial information to include in their few questions and must determine what constitutes a "passing grade"; over time, collaboration between investigators and IRBs may lead to an evolving consensus as to which information is the most important to include and how much of it potential subjects must grasp. And there is the risk that prospective subjects will simply be fed a script by the person conducting the consent process--often not the Principal Investigator (PI) but another member of the research team--resulting in no real increase in understanding or appreciation of the purpose and features of the clinical trial. Finally, IRBs concerned with ensuring that individuals enrolled in trials truly grasp the nature of the study have no way of monitoring the results of the educational process or the accuracy of the resulting scores.

Our contribution here is focused on the question of how investigators and IRBs might monitor the informed consent process--including the disclosure of information as well as the testing, reeducating, and retesting of prospective subjects--all with an eye to improving the quality of the consent process. One possibility is to record the consent process using inexpensive digital recorders (available for less than $100) that can fit into a pocket. The recorded conversations can be saved to a computer hard drive or compact disc and subsequently accessed when needed, thus minimizing storage costs. …