Biomedical Information, Misc

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. (shrink)

Epidemiological crisis during recrudescence of pandemic like COVID-19 may stir fear and anxiety leading to prejudices against people and communities, social isolation and stigma. Such behavioral change may wind up into increased hostility, chaos and unnecessary social disruptions. A qualitative exploratory approach was utilized to conduct an extensive review of secondary literature. The case-studies were gathered from academic literature like articles, opinions and perspective pieces published in journals and in grey literature like publications in humanitarian agencies and media reports. Grey (...) literature was included in the scope as the COVID-19 situation is still evolving. I discuss some of the mechanisms of stigmatization and how social connectedness and empathetic understandings can be a way out of negative stereotyping and discrimination met out to the sufferer of the communicable diseases as COVID-19. Empathetic understanding paves a way to approach a problem from the perspective of ‘we’ not limiting one only to ‘I’. The moment when we make an approach from ‘I’ to ‘We’ actually then we embark on a journey of illness to wellness. Keywords: COVID-19, pandemic, stigma, discrimination, mental health, empathy, India, Face-to-face communication, social distancing, suicide. (shrink)

Our technological lifeworld has become an info-computational media populated by data and algorithms, an artificial environment for life and shared experiences. In this chapter, I tried to sketch three new assumptions for bioethics – it is hardly possible to substantiate ethical guidelines or an idea of normativity in an aprioristic manner; moral status is a function of data entities, not something solely human; agency is plural and thus is shared or sometimes delegated – in order to chart a proposal for (...) a posthuman bioethics. Posthuman is perhaps not the best expression available, but it covers the idea of a shift from a world centered on self-contained and exclusively human agency to a more comprehensive and relational way of thinking. The “posthuman” label should be understood as a rebuttal of biocentrism and anthropocentrism by moving closer to conceptions we encounter in population ethics or in discourse about biosocial and technical systems. Posthuman bioethics is “environmentalist” without losing the humanistic stance. The question regarding how suitable an infocentric bioethics is in practice remains to be settled. The moral principles in bioethics could be reconceived as relying on these new assumptions, in a postindividualistic manner that accepts formal primacy of causal digital artifacts in affording actions in a world of ambient algorithmic intelligence. (shrink)