Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores (...) were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

Theorists of the Russian conservatism have made a considerable contribution to the development of axiology, the philosophy of history and comparativistics. In their studies of the local civilisations existing at different times and at different places they have focused on the dynamics of their origin, development, collapse or transformation into new civilisational forms. The best known slavophiles such as A. Khomyakov, K. Axakov, I. Kireyevskiy saw the mission of the Russian civilisation in synthesising Europe and Russia which has preserved the (...) true Christianity – the Orthodoxy. According to N. Danilevskiy, the founder of the culturohistorical school of thought, Europe has an irreconcilable hostility towards Russia. He proves that Europe and Russia are two different culturohistoricaltypes (local civilisations). He understood Russia’s mission as that of unification of Slavic peoples. K. Leontiev develops the so-called theory of Byzantism, according to which the West is doomed and Russia will be saved thanks to its Orthodoxy and the oriental despotism underlying its statehood. He advocates a merger between Russian and oriental traditions. From the point of view of the proponents of the Eurasian theory such as P. Savitskiy, N. Trubetskoy, etc., the merger has already occurred, so Russians should be viewed as Eurasians and Russia as a Eurasian civilisation. Russian thinkers were criticising the so-called Eurocentrism in their efforts to prove that progress should be measured not only by the accumulation of material wealth, but also by the development of various spiritual aspects of human beings. The anthroposociogenesis does not have any predetermined patterns, its development is of co-evolutionary, often broken, discrete nature. (shrink)

BackgroundPatients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clinical practice (GCP)], legislation to protect participants’ privacy, research ethics committees (RECs) and informed consent. The International Committee of Medical Journal Editors (ICMJE) advises researchers to document compliance with these safeguards. Adherence to publication guidelines has been suboptimal in other specialty fields. The aim of this rapid review was to determine whether COVID-19 (...) human research publications report compliance with these ethical safeguards.MethodsA rapid systematic literature review was conducted in MEDLINE using the search term ‘COVID-19’. The search was performed in April 2020 with no start date and repeated to include articles published in November 2020. Filters were ‘Full free text available’ and ‘English Language’. Two reviewers assessed article title, abstracts and full texts. Non-COVID-19 articles and non-clinical studies were excluded. Independent reviewers conducted a second assessment of a random 20% of articles. The outcomes included reporting of compliance with the Declaration of Helsinki and GCP, REC approval, informed consent and participant privacy.ResultsThe searches yielded 1275 and 1942 articles of which 247 and 717 were deemed eligible, from the April search and November respectively. The majority of journals had editorial policies which purported to comply with ICMJE ethical standards. Reporting of compliance with ethical guidelines was low across all study types but was higher in the November search for case series and observational studies. Reporting of informed consent for case studies and observational studies was higher in the November search, but similar for case series. Overall, participant confidentiality was maintained but some case studies included a combination of details which would have enabled participant identification. Reporting of REC approval was higher in the November search for observational studies.ConclusionsWhile the majority of journal’s editorial policies purported to support the ethical safeguards, many COVID-19 clinical research publications identified in this rapid review lacked documentation of these important safeguards for research participants. In order to promote public trust, ethical declarations should be included consistently. (shrink)