The return of individual research results and incidental findings from biobanking research is a much debated ethical issue globally but has extensive relevance in India where the burden of out of pocket health care expenses is high for the majority. The views of 21 ethics committee (EC) members and 22 researchers from Bengaluru, India, concerning the ethics of biobanking research were sought through in‐depth interviews using an unfolding case vignette with probes. A shared view among most was that individual research (...) results which are ‘actionable’ or have ‘clinical significance’ should be returned to the sample contributors through their treating physicians. This was seen as an ethical obligation and a moral duty on the side of the researcher to “give back” to the person who contributed to the research. The challenges foreseen were that of resources, both financial and personnel, for the time and counseling needed to accompany the disclosure of results. Perceptions of ‘ownership’ appear to influence the concept of benefit sharing. While benefit sharing in financial terms was considered ethically challenging, certain researchers and ethics committee members made a case for “two way altruism” where the researcher in return for the altruistic ‘valuable contribution’, shares with the contributor/ community, benefits of the research which could include research findings, improved patient care, and more affordable access to the new diagnostic tests or products arising from the research. This defines the emerging ethic of “giving back” which goes beyond individual rights and ensures reciprocity and distributive justice. (shrink)

The formal oversight of medical education in India occurred with the promulgation of the Indian Medical Degrees Act in 1916. Despite an awareness of the need to train ethical doctors and the formal discussion of this as early as 1955, the formal teaching of medical ethics has been restricted to a few colleges as it has not been part of a mandated requirement. In August, 2019, all medical colleges in India will adopt a new Medical Council of India mandated curriculum. (...) An embedded AETCOM module across all years of training is a part of this curriculum and is the first attempt to introduce medical ethics uniformly in close to 500 medical colleges in the country. This paper traces the historical attempts to include medical ethics in medical education in India, and describes the current plan to implement ethics teaching in the undergraduate medical curriculum in India. (shrink)

Research using Controlled Human Infection Models is yet to be attempted in India. This study was conducted to understand the perceptions of the lay public and key opinion makers prior to the possible introduction of such studies in the country. 110 respondents from urban and rural Bangalore district were interviewed using qualitative research methods of Focus Group Discussions and In-depth Interviews. The data was analyzed using grounded theory. Safety was a key concern of the lay public, expressed in terms of (...) fear of death. The notion of infecting a healthy volunteer, the possibility of continued effects beyond the study duration and the likelihood of vulnerable populations volunteering solely for monetary benefit, were ethical concerns. Public good outcomes such as effective treatments, targeted vaccines and prevention of diseases was necessary justification for such studies. However, the comprehension of this benefit was not clear among non-medical, non-technical respondents and suggestions to seek alternatives to CHIMs repeatedly arose. There was a great deal of deflection—with each constituency feeling that people other than themselves may be ideally suited as participants. Risk takers, those without dependents, the more health and research literate, financially sound and those with an altruistic bent of mind emerged as possible CHIM volunteers. While widespread awareness and advocacy about CHIM is essential, listening to plural voices is the first step in public engagement in ethically contentious areas. Continued engagement and inclusive deliberative processes are required to redeem the mistrust of the public in research and rebuild faith in regulatory systems. (shrink)

BackgroundA requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed.AimsThe aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation.MethodsIn an observational cohort study (...) of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process.ResultsIn total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location.ConclusionsThe findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease. (shrink)

O artigo apresenta uma reflexão sobre a guerra a partir de Carl Schmitt e Hannah Arendt. Para tanto, realiza-se um recorte na obra de cada autor. De Carl Schmitt, discute-se o livro O conceito do político (2009) que contém ainda A teoria do Partisan. De Hannah Arendt, restringe-se a Sobre a violência (2001), A promessa da política (2020), e alguns ensaios contidos em Entre o passado e o futuro (2009). Neste sentido, Carl Schmitt permite discutir o papel da inimizade para (...) a decisão acerca da guerra e como essa situação-limite, ao mesmo tempo, constitui e afeta a dimensão do político. Já Hannah Arendt permite delinear certos traços constitutivos das guerras modernas que escapam à preocupação central Schmittiana, sobretudo o perigo intrínseco da inimizade produzir não a intensificação do político, mas a eliminação da vida humana sobre à Terra. Trata-se, enfim, de pensar o efeito do avanço tecnológico no campo dos assuntos humanos e como essa tópica transforma o estatuto da guerra. (shrink)

Este artigo procura apresentar algumas considerações acerca do entrecruzamento do pensamento político de Hannah Arendt e a questão ambiental. Para tanto, o seguinte questionamento servirá de guia para a reflexão aqui pretendida: se o âmbito natural é perturbado pelas ações humanas, é razoável a crença de que a própria ação humana possa ser capaz de frear o atual cenário de catástrofe? Assim sendo, assume-se, aqui, como procedimento metodológico uma análise bibliográfica que recorre ao livro A condição humana (The human condition, (...) 1958 [2010]) e alguns ensaios da coletânea Entre o passado e o futuro (Between Past and Future, 1961 [2009]). De modo geral, busca-se desenvolver o argumento de que embora não se possa enquadrar Hannah Arendt no rol das “historiadoras das ciências”, tampouco uma “pensadora da ecologia”, é certo que ela nunca deixou de se interessar e comentar os eventos científicos de seu tempo, bem como de se preocupar com as consequências das ações humanas. Logo, os assuntos relacionados aos avanços tecnológicos e científicos constituem assuntos de primeira grandeza e importância tanto para o mundo quanto para a política. Em suma, pretende-se sustentar a hipótese de que para Hannah Arendt, a imagem adotada da natureza – ao menos desde a época moderna –, e as ações humanas cometidas a partir desta compreensão, afetam diretamente nossa existência política. (shrink)

Neste artigo, discute-se algumas das contribuições de Hannah Arendt para a reflexão acerca do fenômeno da desobediência civil. Inicialmente, interroga-se em que medida a contestação civil pode ser identificada com a objeção de consciência. Discutir essa questão permite compreender o desenvolvimento da argumentação de Arendt que visa ressaltar o sentido político dos atos de desobediência civil em oposição à caracterização negativa deste fenômeno, defendida por juristas, na tentativa de incluir pelo direito ações extralegais de contestação. Com efeito, essa leitura jurídica, (...) que se baseia na ideia de que a contestação tem por fundamento a moralidade de consciência, negligencia determinados aspectos que são fundamentais para a compreensão da desobediência civil segundo a perspectiva de Arendt, sobretudo seu caráter público, o compartilhamento de um interesse ativo no mundo e, por fim, a não-violência. Em um segundo momento, explicita-se a influência da tradição filosófica na maneira típica de se compreender a desobediência civil, sendo Sócrates e Henry Thoreau elencados por Arendt como seus interlocutores neste debate. Com esse percurso argumentativo, pretende-se mostrar alguns potencias do ensaio de Arendt que contribuem para reatualizar a discussão sobre o papel político central do ato de divergir publicamente. (shrink)