Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

Background. Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding. Objectives. To assess participants’ understanding of IC of the research trial that they agreed to participate in.Methods. A (...) descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.Results. Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.Conclusion. Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)