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Ethics and regulatory compliance : competing or complementary approaches? -- An ethical framework for research -- Solving ethical problems : analyzing ethics cases and justifying decisions -- Informed consent -- Decision-making capacity and the involvement of surrogates -- Thinking about harms and benefits -- Justice in recruitment and research -- Research questions and study design -- Protecting privacy and confidentiality -- Identifying and managing conflicts of interest

Adolf Reinach was one of the leading figures of the Munich and Göttingen circles of phenomenology, and Husserl's first real co-worker. Although his writings are highly original and remarkably clear, Reinach's tragic death in the First World War prevented him from formulating a definitive statement of his phenomenology, leaving his name virtually unknown to all but a small circle. In his ground-breaking study, Judgment and Sachverhalt, DuBois shows how Reinach succeeds in developing a realist ontology and epistemology based on rigorous argumentation and phenomenological elucidation. Drawing from numerous texts and the developments of Reinach's students and colleagues - Roman Ingarden, Alexander Pfänder and Dietrich von Hildebrand above all - DuBois presents, refines and defends Reinach's `phenomenological realism'. Confrontations of Reinach's theories of states of affairs, concepts and speech acts with the work of contemporary authors like Chisholm and Searle allow readers to evaluate Reinach's philosophy, not only in the light of the later developments of Husserl, but also in the light of certain Anglo-American developments

Koepsell et al. (2009) describe an ideal biomedical ethics committee environment with efficiencies such as electronic and universal application forms and consent templates, automated decision-trees, and broad sharing of data. However, it is unclear that a biomedical ethics ontology (BMEO) is necessary or even helpful in establishing such environment. Two features of any applied ontology are particularly problematic in establishing a useful BMEO: (1) an ontology is a description of a domain of reality; and (2) the description is subject to ongoing revision as it is developed through open processes, e.g., the use of a wiki. A BMEO would need to address two main kinds of entities, regulatory definitions and ethical concepts, and is ill-suited to both. Regulatory definitions are fiats and ought to be adopted verbatim to ensure compliance, but in such cases we do not need the assistance of ontologists, and their modes of working (constant revision within open wiki-based communities) might even be counterproductive. Ethical concepts within pluralistic societies are social constructs, not a priori concepts or biological natural kinds, and the prospects of generating intuitive definitions that enjoy broad acceptance across cultures and institutional settings are slim. In making these arguments, I draw from the writings of leading applied ontologists and Koepsell et al.'s own proof of concept.

This special section of the Journal of Empirical Research on Human Research Ethics ( JERHRE) is based upon the assumption that much of the best empirical data relevant to research ethics is hidden from the view of Research Ethics Committee (REC) members and others who are interested in research ethics. There are at least three different senses in which ethics-relevant empirical research may be hidden: (1) it may be published in a journal that ethics committee members would not regularly read, (2) it may not use key words that would guide one to its ethics-relevant content, or (3) it may be sequestered in part of a research article that is about something else. This special section of JERHRE reviews all of these types of "hidden ethics" articles on the following issues: What is the relative frequency of hidden ethics articles in journals that focus on vulnerable populations? What does the non-ethics literature in clinical research and experimental economic decision theory teach us about ways of improving subjects' comprehension of risk information? How satisfied are parents and children with their experience with pediatric psychotrophic medication trials? And, how can retention rates be improved in longitudinal studies of difficult regimens such as drug rehabilitation? There is a major amount of ethics-relevant literature that is hidden. Without better ways of communicating the existence of this literature through use of key words, or recasting of the information to highlight its relevance to research ethics in journals that ethics committee members read, the benefits of evidence-based ethical problem solving will be lost.

There is a growing trend in social science research to share qualitative data in a repository for others to access. However, some researchers are reticent to share qualitative data. One major concern is how to de-identify qualitative data while maintaining adequate contextual detail to allow secondary users to meaningfully interpret de-identified data. To help inform discussions regarding qualitative data sharing, we reviewed 100 qualitative health science studies to determine what potentially identifying variables (PIVs) are reported in the published literature. There are relatively few PIVs reported in each qualitative study; the majority of studies (n=64) reported two or fewer PIVs. The most commonly reported PIVs were profession, sex or gender, and age. Our findings can help guide de-identification efforts going forward as presumably the PIVs that are most commonly reported provide essential contextual details that will also be needed by secondary users, while PIVs that are rarely reported may not provide essential contextual information for interpretation of data. This suggests it is possible to share qualitative data that are both de-identified and useful for secondary analysis. As data are shared, we recommend researchers mask study sites, as these may uniquely increase the chance of re-identification.

Principal investigators are responsible for a myriad of leadership and management activities in their work. The practices they use to navigate these responsibilities ultimately influence the quality and integrity of research. However, leadership and management roles in research have received scant empirical examination. Semi-structured interviews with 32 National Institutes of Health (NIH)-funded genetic researchers revealed that they considered leadership and management essential for effective research, but their scientific training inadequately prepared them. We also report management practices that the researchers described using in their labs, as well as their perceptions of a proposed intervention to enhance laboratory leadership. These findings suggest best practices for the research community, future directions for scientific training, and implications for research on leadership and management in science.

We hypothesized that a significant amount of empirical data pertinent to research ethics is currently inaccessible to research ethics committee or Institutuional Review Board (IRB) members for at least three reasons: It is published in non-ethics journals; articles are not adequately indexed using ethics-related keywords; and articles do not discuss the ethical significance of their data. We reviewed all articles from three health journals from January 2005 to December 2006, and identified 26 articles that contained data pertinent to research ethics. Only 7 articles contained keywords clearly related to research ethics; 15 of the articles contained no discussion of the ethical significance of their findings. Overall the articles we found constituted 2.2% of the research articles published in the three journals during the two-year period. If the same average number of articles were extrapolated to the top 100 of the approximately 5,000 journals indexed in MEDLINE, then at least 433 hidden ethics articles would be published each year. We conclude that better indexing of articles is needed, that IRB members and researchers need training to identify relevant data in the literature, and that IRB composition should include members from diverse disciplines familiar with ethics-relevant empirical data in their respective disciplines.

State medical boards (SMBs) protect the public by ensuring that physicians uphold appropriate standards of care and ethical practice. Despite this clear purpose, egregious types of wrongdoing by physicians are alarmingly frequent, harmful, and under-reported. Even when egregious wrongdoing is reported to SMBs, it is unclear why SMBs sometimes fail to promptly remove seriously offending physicians from practice. Legal and policy tools that are targeted, well-informed, and actionable are urgently needed to help SMBs more effectively protect patients from egregious wrongdoing by physicians. Past reviews of SMB performance have identified features of SMBs associated with higher rates of severe disciplinary actions against physicians, including political and professional independence and adequate funding and staffing. However, there has been little attention paid to elements of the state-level legal framework that governs SMB licensing and disciplinary function, or what legal or policy tools would make SMBs more effective at protecting patients in serious cases. This Article offers solutions in the form of model language with commentary for five high-impact statutory provisions that address board composition and function, reporting to the board, and adjudication of disciplinary matters. It brings together consensus recommendations from an expert panel, the results of legal mapping of relevant state laws, and original legal and policy analysis. The model provisions and commentary are intended to serve as a new resource for SMBs, state legislatures, and other policymakers to encourage and support examination of existing medical practice acts to improve SMB function and better protect patients from harmful physicians.

ABSTRACTWe found no studies in the United States that explored research participants' perspectives about sharing their qualitative data. We present findings from interviews with 30 individuals who participated in sensitive qualitative studies to explore their understanding and concerns regarding qualitative data sharing. The vast majority supported sharing qualitative data so long as their data were deidentified and shared only among researchers. However, they raised concerns about confidentiality if the data were not adequately deidentified and about misuse by secondary users if data were shared beyond the research community. These concerns, though, did not deter them from participating in research. Notably, participants hoped their data would be shared and may have expected or assumed this was already happening. While many could not recollect details about data‐sharing plans for studies in which they participated, they trusted researchers and institutions to appropriately handle data sharing. If individuals view data sharing as an extension or integral part of their participation in qualitative research, then researchers may have a stronger obligation to share qualitative data than previously thought. Guidelines and tools to assist researchers and institutional review board members in ethical and responsible qualitative data sharing are urgently needed.