BackgroundAccurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience (...) health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants.MethodsWe searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second.ResultsThe search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12–6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined “sex” and/or “gender.” No publication carried out a comprehensive sex and gender analysis.ConclusionsFindings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research. (shrink)

Background: Ethics support services are growing in Europe to help doctors in dealing with ethical difficulties. Currently, insufficient attention has been focused on the experiences of doctors who have faced ethical difficulties in these countries to provide an evidence base for the development of these services.Methods: A survey instrument was adapted to explore the types of ethical dilemma faced by European doctors, how they ranked the difficulty of these dilemmas, their satisfaction with the resolution of a recent ethically difficult case (...) and the types of help they would consider useful. The questionnaire was translated and given to general internists in Norway, Switzerland, Italy and the UK.Results: Survey respondents ranged in age from 28 to 82 years, and averaged 25 years in practice. Only a minority reported having access to ethics consultation in individual cases. The ethical difficulties most often reported as being encountered were uncertain or impaired decision-making capacity , disagreement among caregivers and limitation of treatment at the end of life . The frequency of most ethical difficulties varied among countries, as did the type of issue considered most difficult. The types of help most often identified as potentially useful were professional reassurance about the decision being correct , someone capable of providing specific advice , help in weighing outcomes and clarification of the issues . Few of the types of help expected to be useful varied among countries.Conclusion: Cultural differences may indeed influence how doctors perceive ethical difficulties. The type of help needed, however, did not vary markedly. The general structure of ethics support services would not have to be radically altered to suit cultural variations among the surveyed countries. (shrink)

The study ascertained (1) whether an observer's scope of justice with reference to either the moral agent or the target person of a moral act, would affect his/her judgements of the ethicality of the act, and (2) whether observer judgements of ethicality parallel the moral agent's decision processes in systematically evaluating the intensity of the moral issue. A scenario approach was used. Results affirmed both research questions. Discussions covered the implications of the findings for the underlying cognitive processes of moral (...) judgements, for the link between judgements of fairness and ethicality, as well as for the debate of ethical absolutism versus relativism. (shrink)

Continuous recordings of brain electrical activity were obtained from a group of 176 patients throughout surgical procedures using general anesthesia. Artifact-free data from the 19 electrodes of the International 10/20 System were subjected to quantitative analysis of the electroencephalogram (QEEG). Induction was variously accomplished with etomidate, propofol or thiopental. Anesthesia was maintained throughout the procedures by isoflurane, desflurane or sevoflurane (N = 68), total intravenous anesthesia using propofol (N = 49), or nitrous oxide plus narcotics (N = 59). A set (...) of QEEG measures were found which reversibly displayed high heterogeneity of variance between four states as follows: (1) during induction; (2) just after loss of consciousness (LOC); (3) just before return of consciousness (ROC); (4) just after ROC. Homogeneity of variance across all agents within states was found. Topographic statistical probability images were compared between states. At LOC, power increased in all frequency bands in the power spectrum with the exception of a decrease in gamma activity, and there was a marked anteriorization of power. Additionally, a significant change occurred in hemispheric relationships, with prefrontal and frontal regions of each hemisphere becoming more closely coupled, and anterior and posterior regions on each hemisphere, as well as homologous regions between the two hemispheres, uncoupling. All of these changes reversed upon ROC. Variable resolution electromagnetic tomography (VARETA) was performed to localize salient features of power anteriorization in three dimensions. A common set of neuroanatomical regions appeared to be the locus of the most probable generators of the observed EEG changes. (shrink)

The present article allows to explore, analyze and reflect on the consequences and problems posed by biobanks and attempts to prove the need of social and humanitarian support in establishing and functioning of biobanks as a new type of scientific institutions. The basis of the article is the latest publications devoted to social and humanitarian aspects of biobanking and Russian experience of the initial formation of this subject domain. The article marks and classifies different aspects of biobanking that objectively demands (...) the participation of specialists in ethics and social sciences. The cases of biobanking development and risks are estimated; the objective need of applied ethics and social sciences specialists’ participation in biobanking is proved. (shrink)

This book assesses how Vatican II opened up the Catholic Church to encounter, dialogue, and engagement with other world religions. Opening with a contribution from the President of the Pontifical Council for Interreligious Dialogue, Cardinal Jean-Louis Tauran, it next explores the impact, relevance, and promise of the Declaration Nostra Aetate before turning to consider how Vatican II in general has influenced interfaith dialogue and the intellectual and comparative study of world religions in the postconciliar decades, as well as the contribution (...) of particular past and present thinkers to the formation of current interreligious and comparative theological methods. Additionally, chapters consider interreligious dialogue vis-à-vis theological anthropology in conciliar documents; openness to the spiritual practices of other faith traditions as a way of encouraging positive interreligious encounter; the role of lay and new ecclesial movements in interreligious dialogue; and the development of Monastic Interreligious Dialogue. Finally, it includes a range of perspectives on the fruits and future of Vatican’s II’s opening to particular faiths such as Judaism, Islam, Hinduism, and Buddhism. (shrink)

We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical (...) biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems. (shrink)

Update on donation of bodily material in the UKIn March 2010, the Human Tissue Authority announced that the first pooled kidney transplants, each involving three living donors and three recipients, had been performed in the UK. 1 While the vast majority of living donor transplants take place between people who are genetically related or are otherwise emotionally close, the Human Tissue Act 2004 introduced greater flexibility, permitting, for example, altruistic, paired and pooled donation. The HTA commented that these types of (...) donation represent one in three of all kidney transplants in the UK. Under the system of paired and pooled donation, in which someone needs a donor organ and has a friend or relative willing to donate, but the two are not compatible with each other, they can pair up with one or more other incompatible donor and recipient pairs in an organ exchange. In paired donation, donor A gives an organ to recipient B and donor B gives to recipient A; in pooled donation, more than two donor–recipient pairs take part in an organ exchange, coordinated by the HTA . Under the human tissue legislation, all cases of paired and pooled donation need to be considered by an independent assessor and approved by a panel of at least three members of the HTA, to ensure that all parties fully understand the risks involved and the donors are not under any pressure to donate.The first pooled transplant took place late in 2009, and was followed shortly afterwards by a second. Several paired living kidney transplants, involving two couples, had already taken place, however, with 16 such transplants going ahead between 1 April 2008 and 31 March 2009. Also in March 2010, a …. (shrink)

The Search for the Legacy of the USPHS Syphilis Study at Tuskegee is a collection of essays from experts in a variety of fields seeking to redefine the legacy of the infamous Tuskegee Syphilis Study. The essayists place the legacy of the study within the evolution of racial and ethnic relations in the United States. Contributors include two leading historians on the study, two former United States Surgeons General, and other prominent scholars from a wide range of fields.

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This (...) framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)