Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.
In this article we describe our approach to understanding wrongdoing in medical research and practice, which involves the statistical analysis of coded data from a large set of published cases. We focus on understanding the environmental factors that predict the kind and the severity of wrongdoing in medicine. Through review of empirical and theoretical literature, consultation with experts, the application of criminological theory, and ongoing analysis of our first 60 cases, we hypothesize that 10 contextual features of the medical environment (...) (including financial rewards, oversight failures, and patients belonging to vulnerable groups) may contribute to professional wrongdoing. We define each variable, examine data supporting our hypothesis, and present a brief case synopsis from our study that illustrates the potential influence of the variable. Finally, we discuss limitations of the resulting framework and directions for future research. (shrink)
Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs - now mandated by IRBs - offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This (...) article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality. (shrink)
Monshi and Zieglmayer's case study presents Sri Lankan participants as having views on the privacy of health information that differ radically from those commonly found in Western nations. This article explores 2 questions that their case study raises for the ethical review of research in international settings: First, are allegedly universal ethical principles - of the sort promulgated in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978) - useful in international settings?, (...) and second, how should research oversight bodies address the challenges that arise in international behavioral and social science research? (shrink)
This article examines the clergy sexual abuse crisis in the Roman Catholic Church from an ethical point of view. The article uses the RRICC values model of ethical decision making (i.e., responsibility, respect, integrity, competence, concern) to review the behavior of Catholic bishops and other religious superiors as they have tried to manage clergy sex offenders and their victims. Hopefully, the recent press attention and resulting policy changes on these matters from the U.S. Council of Catholic Bishops will increase the (...) chances that future decisions will be ethical ones. (shrink)