Informed consent in clinical studies involving human participants: ethical insights of medical researchers in Germany and Poland

Background The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods To gain an understanding of how clinicians view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies

Photometric Confirmation of MACHO Large Magellanic Cloud Microlensing Events

We present previously unpublished photometry of three Large Magellanic Cloud (LMC) microlensing events and show that the new photometry confirms the microlensing interpretation of these events. These events were discovered by the MACHO Project alert system and were also recovered by the analysis of the 5.7 year MACHO data set. This new photometry provides a substantial increase in the signal-to-noise ratio over the previously published photometry and in all three cases, the gravitational microlensing interpretation of these events is strengthened. The new data consist of MACHO-Global Microlensing Alert Network (GMAN) follow-up images from the CTIO 0.9 telescope plus difference imaging photometry of the original MACHO data from the 1.3m "Great Melbourne" telescope at Mt. Stromlo. We also combine microlensing light curve fitting with photometry from high resolution HST images of the source stars to provide further confirmation of these events and to show that the microlensing interpretation of event MACHO-LMC-23 is questionable. Finally, we compare our results with the analysis of Belokurov, Evans & Le Du who have attempted to classify candidate microlensing events with a neural network method, and we find that their results are contradicted by the new data and more powerful light curve fitting analysis for each of the four events considered in this paper. The failure of the Belokurov, Evans & Le Du method is likely to be due to their use of a set of insensitive statistics to feed their neural networks.Comment: 29 pages with 8 included postscript figures, accepted by the Astrophysical Journa

Normative framework of informed consent in clinical research in Germany, Poland, and Russia

Background Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements

Access to Prenatal Testing and Ethically Informed Counselling in Germany, Poland and Russia

The development of new methods in the field of prenatal testing leads to an expansion of information that needs to be provided to expectant mothers. The aim of this research is to explore opinions and attitudes of gynecologists in Germany, Poland and Russia towards access to prenatal testing and diagnostics in these countries. Semi-structured interviews were conducted with n = 18 gynecologists in Germany, Poland and Russia. The interviews were analyzed using the methods of content analysis and thematic analysis. Visible in all three countries is a connection of prenatal medicine with the politically and socially contentious issue of pregnancy termination. Respondents in Poland and Russia concentrated on the topic of inadequate resources. Quality of information for expectant mothers is an important point in all three countries. Only in Germany was the issue of language barriers in communication raised. With regard to non-invasive prenatal testing (NIPT) respondents in Germany focused on the ethical issues of routinization of testing; in Poland and Russia they concentrated on fair access to NIPT. Challenges in all three countries arise from structural factors such as imprecise and prohibitive regulations, lack of resources or organization of healthcare services. These should be addressed on a political and medico-ethical level

Exploring the disc/jet interaction in the radio-loud quasar 4C +74.26 with Suzaku

We report on a 90 ks Suzaku observation of the radio-loud quasar 4C +74.26. The source was observed in its highest flux state to date, and we find that it brightened by about 20 per cent during the observation. We see evidence of spectral hardening as the count rate increases and also find that the rms variability increases with energy up to about 4 keV. We clearly detect a broadened Fe line but conclude that it does not require any emission from inside about 50 r_g, although a much smaller inner radius cannot be ruled out. The large inner radius of our best fit implies that the inner disc is either missing or not strongly illuminated. We suggest that the latter scenario may occur if the power-law source is located high above the disc, or if the emission is beamed away from the disc.Comment: 11 pages, 9 figures. Accepted for publication in MNRA

MRPR: a MapReduce solution for prototype reduction in big data classification

In the era of big data, analyzing and extracting knowledge from large-scale data sets is a very interesting and challenging task. The application of standard data mining tools in such data sets is not straightforward. Hence, a new class of scalable mining method that embraces the huge storage and processing capacity of cloud platforms is required. In this work, we propose a novel distributed partitioning methodology for prototype reduction techniques in nearest neighbor classification. These methods aim at representing original training data sets as a reduced number of instances. Their main purposes are to speed up the classification process and reduce the storage requirements and sensitivity to noise of the nearest neighbor rule. However, the standard prototype reduction methods cannot cope with very large data sets. To overcome this limitation, we develop a MapReduce-based framework to distribute the functioning of these algorithms through a cluster of computing elements, proposing several algorithmic strategies to integrate multiple partial solutions (reduced sets of prototypes) into a single one. The proposed model enables prototype reduction algorithms to be applied over big data classification problems without significant accuracy loss. We test the speeding up capabilities of our model with data sets up to 5.7 millions of instances. The results show that this model is a suitable tool to enhance the performance of the nearest neighbor classifier with big data

Observation of Electroweak Production of a Same-Sign W Boson Pair in Association with Two Jets in pp Collisions root s=13 TeV with the ATLAS Detector

This Letter presents the observation and measurement of electroweak production of a same-sign W boson pair in association with two jets using 36.1     fb − 1 of proton-proton collision data recorded at a center-of-mass energy of √ s = 13     TeV by the ATLAS detector at the Large Hadron Collider. The analysis is performed in the detector fiducial phase-space region, defined by the presence of two same-sign leptons, electron or muon, and at least two jets with a large invariant mass and rapidity difference. A total of 122 candidate events are observed for a background expectation of 69 ± 7 events, corresponding to an observed signal significance of 6.5 standard deviations. The measured fiducial signal cross section is σ fid = 2.89 + 0.51 − 0.48 ( stat ) + 0.29 − 0.28 ( syst )     fb

Empathie ou courtoisie. Expulsés allemands et Sibériens polonais unis par le destin dans une petite ville polonaise ?

Depuis plus de deux décennies, des expulsés allemands rencontrent officiellement dans plusieurs villes polonaises des citoyens polonais qui ont comme eux perdu leur patrie durant la Seconde Guerre mondiale. Dans le cadre de ces rencontres est évoquée de plus en plus souvent une expérience commune, ou apparentée, de la perte de la patrie. Des commémorations communes ont alors lieu au cours desquelles l’idée de destin partagé occupe une place centrale. Précisément à une époque où l’on tend à un..