This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2 weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific (...) content areas. Results support the use of corrected feedback for improving consent recall. (shrink)

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction cannot be observed in non-drug-dependent humans, it (...) is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans. (shrink)

Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that now that research in these groups is expected to (...) expand, this undifferentiated minimal risk and burden requirement does not suffice any more. In the upcoming revision of the Declaration, the paragraph at stake should be refined in such a way that it is not unnecessarily restrictive or more permissive than can be ethically justified. Our first recommendation is to stimulate research ethics committees to identify more accurately those risks and burdens that the research subjects must undergo solely for research purposes by distinguishing between two types of study procedures instead of between two types of studies. Our second recommendation is to allow for exceptions to the minimal risk and burden requirement in cases of exceptionally valuable studies that involve subjects who can give their assent to participate in the study and that involve at most a minor increase over minimal risk and/or burden. (shrink)

Heroin prescription involves the medical provision of heroin in the treatment of heroin addiction. Rudimentary clinical trials on that treatment modality have been carried out and others are currently underway or in development. However, it is questionable whether subjects considered for such trials are mentally competent to consent to them. The problem has not been sufficiently appreciated in ethical and clinical discussions of the topic. The challenges involved throw new light on the role of value and accountability in contemporary discussions (...) of mental competence. (shrink)