Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others

BACKGROUND: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied. METHODS: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg (Germany) in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications. RESULTS: 299 study protocols were included. The most frequent study design was randomised controlled trial (141; 47%), followed by uncontrolled studies (61; 20%), laboratory studies (30; 10%) and non-randomised studies (29; 10%). 182 (61%) were multicentre studies including 97 (53%) international collaborations. 152 of 299 (51%) had commercial (co-)funding and 46 (15%) non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication (total 210 articles); the publication rate was 48%. 168 of 210 identified publications (80%) were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication (range 0-1151). CONCLUSIONS: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research.

Moving Beyond Hastiness and Superficiality: Being an Ethical Technical Communicator via Digital Communication Technologies in Health Care

This thesis examines digital technologies used by technical communicators in healthcare settings. I show that technical communicators, who function as users, advocators and evaluators, need a useable framework for ethical engagement with digital technologies, which integrally affect the physician-patient relationship. Therefore, I apply rhetorical methodology by producing useable knowledge and phenomenological methodology by examining lived experiences of technical communicators. Substantiation comes from theories spanning technical communication, philosophy, and composition studies. Evidence also emerges from qualitative interviews with communication professionals working in healthcare; my concerns arise from personal experiences with electronic recordkeeping in the exam room. This thesis anticipates challenging the presumed theory-practice divide while encouraging greater disciplinary reciprocity. Because technical communication infuses theory into productive capacity, this thesis presents the tripartite summons of the ethical technical communicator: to exercise critically-reflective action that safeguards the physician-patient relationship by ways of using digital technologies, advocating for audiences, and evaluating digital technologies.

[Mass culling in the context of animal disease outbreaks--veterinarians caught between ethical issues and control policies]

In recent years controversial discussions arose during major animal disease outbreaks in the EU about the ethical soundness of mass culling. In contrast to numerous publications about ethical issues and laboratory animals/animal experiments, literature concerning ethical deliberations in the case of mass culling as a means of outbreak control remain scarce. Veterinarians in charge of decision about and implementation of mass culling actions find themselves in an area of conflict in between the officially required animal disease control policy and a public that is increasingly critical. Those veterinarians are faced with the challenge to defend the relevant decisions against all stakeholders and also themselves. In this context an interdisciplinary workshop was initiated in Switzerland in October 2007 with ethicians and (official) veterinarians from Germany, Switzerland and Austria. With the aim to identify ethical components of animal disease control for official veterinarians, talks and moderated group discussions took place. This article summarizes selected discussion points and conclusions.

Consumer Behavior in Moral Markets. On the Relevance of Identity, Justice Beliefs, Social Norms, Status and Trust in Ethical Consumption

This article addresses ethical consumer behavior and uses the purchase of Fair Trade (FT) coffee to gain insights into determinants of ‘moral behavior’ in the marketplace. Our primary concern is to clarify which theoretical concepts and determinants are more useful than others in explaining FT consumption. We compare the explanatory power of consumer budget restrictions, consumer identity, social and personal norms, social status, justice beliefs, and trust. Our second aim is methodological; we contrast data on self-reported consumption of FT coffee with experimental data on hypothetical choices of different coffee products. To gain insights into the robustness of our measurement and findings, we test our propositions using two samples of undergraduate students from Germany and the United States. Our data show that consumer identity and personal norms are the major determinants of FT consumption in both samples, the results from survey-based data and from our experimental data are similar in this regard. Further, we demonstrate that studies based on a limited number of determinants might overestimate effects; the effect of justice beliefs for instance vanishes if other determinants are taken into account.

Operationalizing Professionalism: A Course in Ethical Decision Making

All U.S. medical schools require some medical ethics education and must now ensure that their graduates, residents, and faculty exhibit competence in the area of professionalism and professional medical ethics. However, there remain many challenges to implementing formal ethics and professionalism education into medical school curricula. [See PDF for complete abstract]

Toward the Development of Ethical Guidelines for Family Preservation

Family preservation workers need a standard set of ethical guidelines to assist them in providing their service in a proper manner. This paper describes how ethical codes have been developed for the "traditional" mental health care disciplines and why such codes are not sufficient for the type of work done in family preservation. The paper further provides examples of the types of ethical dilemmas family preservation workers encounter as well as suggestions for workers, supervisors, and agencies in dealing with such dilemmas.

Folklore, fad, and fashion: The concept of misconduct in science redefined

This study is an analytical investigation of the nature and implications of the current conceptions of scientific misconduct, arguing that the question of what constitutes misconduct in science is significantly more complex than what conventionally has been believed. Complicating the definitions of misconduct are the differences between professional science and non-scientific professions, in their respective norms of what constitutes valid knowledge, and what counts as appropriate and inappropriate practice. While institutionalized science claims that there is clear differentiation between its standards of validity and those of the non-scientific professions, this paper argues that, when it comes to misconduct, the perceived boundaries between the scientific and non-scientific professions are breached; the practice standards that science currently employs in self-policing misconduct have come to resemble the minimal juridical standards of practice that other professions employ. This study attempts, despite erosion of these traditional boundaries, to move from legalistic standards of scientific practice to intramural standards of practice, and in so doing, to hold scientific practice to a higher standard than ordinary public conduct. The result is a clearer understanding of scientific misconduct to aid those individual scientists who are required to make onerous determinations about the appropriateness of specific practices by their peers. ^

Ethical Consumption and Social Context: Experimental Evidence from Germany and the United States

This research examines the role of social context in ethical consumption, specifically, the extent to which anonymity and social control influence individuals' decisions to purchase organic and Fair Trade coffee. Our research design overcomes biases of prior research by combining framing and discrete choice experiments in a survey. We systematically vary coffee growing method (organic or not), import status (Fair Trade or not), flavor, and price across four social contexts that vary in degree of anonymity and normative social control. The social contexts are buying coffee online, in a large grocery store, in a small neighborhood shop, and for a meeting of a human rights group. Subjects comprise 1,103 German and American undergraduate students. We find that social context indeed influences subjects' ethical consumer decisions, especially in situations with low anonymity and high social control. In addition, gender, coffee buying, and subjective social norms trigger heterogeneity regarding stated ethical consumption and the effects of social context. These results suggest previous research has underestimated the relevance of social context for ethical consumption and overestimated altruistic motives of ethical consumers. Our study demonstrates the great potential of discrete choice experiments for the study of social action and decision making processes in sociology.

Tsava'ot ge'one Yis'rael : Hebrew ethical wills

selected and ed. by Israel Abrahams

Ethical procedures and patient consent differ in Europe.

BACKGROUND Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING Twenty-four hospitals in 11 European countries. PARTICIPANTS From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process. RESULTS The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions. CONCLUSION There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved. TRIAL REGISTRATION euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.