This study examined possible ways to ensure that participants provide fully informed consent for online surveys. Participants were randomly assigned to read either a traditional informed consent or one of three modified versions: enhanced, consent for each key element, or a combination of these two. Those who read the combination version scored higher on a comprehension quiz, guessed at fewer questions, and were more likely to read all of the informed consent than those who received the traditional version. These findings (...) suggest that comprehension can be improved by adopting alternatives to the traditional informed consent. (shrink)

Deep brain stimulation (DBS) is currently in pivotal trials as an intervention for treatment-resistant depression (TRD). Although offering hope for TRD, DBS also provokes ethical concerns—particularly about decision-making capacity of people with depression—among bioethicists, investigators, institutional review boards, and the public. Here, we examine this critical issue of informed consent for DBS research using available evidence regarding decision-making capacity and depression. Further, we explore the implications of the nature of TRD as well as that of the intervention (invasive brain surgery) (...) for informed consent. Based on these analyses, we argue that additional safeguards specific to DBS research for TRD, beyond those that might be used in any higher risk study, are not supported by available empirical evidence. We nevertheless underscore the limited data on such invasive procedures in severely ill psychiatric patients and advocate a research agenda for the systematic study of ethical issues raised by these research endeavors. (shrink)