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.

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.

Use of human embryonic stem cells and umbilical cord blood stem cells for research and therapy: a prospective survey among health care professionals and patients in Switzerland

BACKGROUND: Scientific progress in the biology of hematopoietic stem cells (HSCs) provides opportunities for advances in therapy for different diseases. While stem cell sources such as umbilical cord blood (UCB) are unproblematic, other sources such as human embryonic stem cells (hESCs) raise ethical concerns. STUDY DESIGN AND METHODS: In a prospective survey we established the ethical acceptability of collection, research, and therapy with UCB HSCs versus hESCs among health care professionals, pregnant women, patients undergoing in vitro fertilization therapy, parents, and HSC donors and recipients in Switzerland. RESULTS: There was overall agreement about an ethical justification for the collection of UCB for research and therapy in the majority of participants (82%). In contrast, research and therapy with hESCs was acceptable only by a minority (38% of all responders). The collection of hESCs solely created for HSC collection purposes met overall with the lowest approval rates. Hematologists displayed among the participants the highest acceptance rates for the use of hESCs with 55% for collection, 63% for research, and 73% for therapy. CONCLUSIONS: This is the first study assessing the perception of hESCs for research and therapy in comparison with UCB HSCs in different target groups that are exposed directly, indirectly, or not at all to stem cell-based medicine. Our study shows that the debate over the legitimacy of embryo-destructive transplantation medicine is far from over as particularly hESC research continues to present an ethical problem to an overwhelming majority among laypersons and even among health care professionals.

[Swiss Research Agenda for Nursing (SRAN): the development of an agenda for clinical nursing research in Switzerland]

In many Anglo-Saxon and North European countries nursing research agendas have been developed to address priorities in nursing research in accordance with a nationally defined health policy. In Switzerland, due to lack of a nationwide governmental health policy, co-ordination of nursing research so far was scarce. The "Swiss Research Agenda for Nursing (SRAN)" project developed an agenda for clinical nursing research between 2005 and 2007. Based on literature reviews, expert panels and a national survey a project team formulated an agenda which passed a consensus conference. The agenda recommends aspects that should lead research and defines seven research priorities for nursing in Switzerland for the time between 2007 and 2017. Nursing research should prioritize to investigate 1) the effectiveness of nursing interventions; 2) the influences of service adaptations in a changing health care system; 3) the phenomena in patients requiring nursing care; 4) the influence of the work environment on the quality of nursing care; 5) the functioning of family and social systems; 6) varieties of life circumstances and their integration; and 7) the implementation of ethical principles in nursing. Written in German and French, the Swiss Research Agenda for Nursing for the first time formulates priorities for nursing research in Switzerland and can be used for strategic discussions. As a next step, the development of an action plan to enhance nursing research will take place in Switzerland.

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.

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.