Adil E Sharnoo Pengarang

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research David B. Resnik, J.D., Ph.D. National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina, USA ABSTRACT One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks. Pesticides, Neurodevelopmental Disagreement, and Bradford Hill’ s Guidelines Kristin Shrader-Frechette, Ph.D.a and Christopher ChoGlueck B.S., B.A.b aDepartments of Biological Sciences and Philosophy, University of Notre Dame, Notre Dame, Indiana, USA; bDepartment of History and Philosophy of Science & Medicine, Indiana University, Bloomington, Indiana, USA ABSTRACT Neurodevelopmental disorders such as autism affect oneeighth of all U.S. newborns. Yet scientists, accessing the same data and using Bradford-Hill guidelines, draw different conclusions about the causes of these disorders. They disagree about the pesticide-harm hypothesis, that typical United States prenatal pesticide exposure can cause neurodevelopmental damage. This article aims to discover whether apparent scientific disagreement about this hypothesis might be partly attributable to questionable interpretations of the Bradford-Hill causal guidelines. Key scientists, who claim to employ Bradford-Hill causal guidelines, yet fail to accept the pesticide-harm hypothesis, fall into errors of trimming the guidelines, requiring statistically-significant data, and ignoring semi-experimental evidence. However, the main scientists who accept the hypothesis appear to commit none of these errors. Although settling disagreement over the pesticide-harm hypothesis requires extensive analysis, this article suggests that at least some conflicts may arise because of questionable interpretations of the guidelines. KEYWORDS Bradford-Hill; cause; neurodevelopment; pesticide; statistical significance; trimming the data The Ghost Collaborator David Shaw, Ph.D., M.A., M.Sc., M.M.L.a and Bernice Elger, M.D., Ph.D.a,b aInstitute for Biomedical Ethics, University of Basel, Basel, Switzerland; bCenter for Legal Medicine, University of Geneva, Geneva, Switzerland ABSTRACT Collaboration is increasingly important for researchers in all disciplines. Universities and funding bodies tend to prefer projects that involve interdisciplinarity, collaboration between different institutions, and international consortiums. Such projects can yield great benefits, but they also pose particular challenges for certain aspects of research integrity, and particularly for awarding credit and authorship. In this article, we describe and analyze the phenomenon of the ghost collaborator, who is initially fully involved and makes a full contribution to a project’s design, but then finds him- or herself excluded from meetings and publications. KEYWORDS Authorship; conflict of interest; justice in research; misconduct in research; research integrity; science funding