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.

[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.

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.

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.

Ethical considerations for a global concept of sustainable land use

The paper gives an overview of current land husbandry problems in different agro-ecological zones of the world. It then lists four ethical principles, conceived at the global level, needed to achieve sustainable land use (SLU). Finally, it develops guidelines which can be used to facilitate a more effective implementation and realization of SLU. In the year of the UN Conference on Environment and Development (UNCED), such recommendations are important for improving the competence of political and economic decision-makers in taking action at national and international levels.

Do Information, Price, or Morals Influence Ethical Consumption? A Natural Field Experiment and Customer Survey on the Purchase of Fair Trade Coffee

We address ethical consumption using a natural field experiment on the actual purchase of Fair Trade (FT) coffee in three supermarkets in Germany. Based on a quasi-experimental before-and-after design the effects of three different treatments – information, 20% price reduction, and a moral appeal – are analyzed. Sales data cover actual ethical purchase behavior and avoid problems of social desirability. But they offer only limited insights into the motivations of individual consumers. We therefore complemented the field experiment with a customer survey that allows us to contrast observed (ethical) buying behavior with self-reported FT consumption. Results from the experiment suggest that only the price reduction had the expected positive and statistically significant effect on FT consumption.

New Sites, New Challenges? Ethical and Methodological Questions in the Context of Research on Migration Exclusion

The challenges of research ethics and methodologies have been reflected on extensively, but – aside from the context of feminist methodologies – less so in relation to research on particular migration sites such as in transit, detention centres, at the borders or within migration administration. First attempts in this direction have been made (Düvell et al. 2010, Fresia et al. 2005, Riedner 2014, van Liempt/Bilger2009), however, more reflection and theorization is needed, considering the contested nature of these temporal and volatile sites. In this workshop, we thus aim at examining methodological as well as ethical questions that arise during field work: We attempt to reflect the power relations involved in the research process, the ethics of research design, the dissemination of research results, the question of gaining access to and – whenever necessary – staying in contact with our research subjects. How can we negotiate informed consent with subjects whose life is currently marked by transit and insecurity concerning their own future, and who are in an uncertain situation in which substantial information (legal, social, cultural etc.) is likely to be missing? How do we deal with the dilemma of possibly contributing to knowledge production that might facilitate removals and deportations in the future, considering that the reception of the results is not in the hands of the researchers? How do we deal with the anticipated as well as unexpected impacts of our research on social and political practice? Regarding fieldwork in state institutions, how do we negotiate the multiple loyalties we often find ourselves faced with as social researchers, both with the excluded migrants and with the authorities implementing the exclusions – two groupings considered to be opposite to each other (Lavanchy 2013)? Which different roles do researchers need to take on? The aim of our workshop is first and foremost to exchange experiences on fieldwork with others doing qualitative research on related topics and to consider its possible implications – including affective dimensions – for all participants involved in the research process: the migrants, the security staff of detention centres, its social workers, border police and bureaucrats and, last but not least, the researchers themselves. Furthermore, we generally wish to reflect upon the question of how best to conduct research in this contested field, applying an interdisciplinary perspective.