Introduction The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics. Methods A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot-tested and item discrimination was calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessment tools were created. These assessment (...) tools were administered as a pre-test and post-test to a cohort of 58 Indian junior health research investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course online, the other half in person. Item discrimination was calculated for each question and Cronbach's α for each assessment tool. A final version of the assessment tool that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills 3 months after course delivery. Results The final version of the REKASA includes 41 items and had a Cronbach's α of 0.837. Conclusion The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment tool in research ethics capable of not only measuring basic knowledge in research ethics and oversight but also assessing learners' ability to apply ethics knowledge to the analytical task of reasoning through research ethics cases, without reliance on essay or discussion-based examination. These promising preliminary findings should be confirmed with additional groups of learners. (shrink)

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examines 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES - and in particular, behavioral health (...) - research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work. (shrink)

Recent economic and political advances in developing countries on the African continent and South East Asia are threatened by the rising death and morbidity rates of HIV/AIDS. In the first part of this paper we explain the reasons for the absence of affordable access to essential AIDS medication. In the second part we take a closer look at some of the pivotal frameworks relevant for this situation and undertake an ethical analysis of these frameworks. In the third part we discuss (...) a few of the proposed solutions to the problem and conclude with an argument in support of our preferred course of action. In this article we argue for compulsory licensing of essential AIDS medications in the current conditions of public health emergency. We argue on broadly consequentialist grounds that compulsory licensing is preferable both morally and pragmatically to the alternatives, notably the currently offered price cuts and drug donation schemes. (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)

Research ethics education in the biosciences has not historically been a priority for research universities despite the fact that funding agencies, government regulators, and the parties involved in the research enterprise agree that it ought to be. The confluence of a number of factors, including scrutiny and regulation due to increased public awareness of the impact of basic research on society, increased public and private funding, increased diversity and collaboration among researchers, the impressive success and speed of research advances, and (...) high-profile cases of misconduct, have made it necessary to reexamine how the bioscience research community at all levels provides ethics education to its own. We discuss the need to and reasons for making ethics integral to the education of bioscientists, approaches to achieving this goal, challenges this goal presents, and responses to those challenges. (shrink)

A model is described for implementing a program in research ethics education in the face of federal and institutional mandates and current resource, disciplinary, and infrastructure limitations. Also discussed are the historical background, content and evaluation process of the workshop at the heart of the program, which reaches a diverse group of over 250 students per year—from first-year graduate students in basic research labs to clinical fellows. The workshop addresses central issues in both everyday laboratory ethics and in larger societal (...) questions. Goals include improving overall awareness of ethics guidelines and philosophy and enhancing skills in identifying and then analyzing the ethical components of situations. Pedagogies used and their effectiveness and that of the overall workshop and extended program are addressed. Programs like these have initiated a shift in the culture of basic research, which is a critical need given the current atmosphere. (shrink)