Research project «Clinical Research in Russia through Participants’ Eyes»

Currently clinical trials play an essential role in ascertaining safety and efficacy of new treatments. In the recent years clinical trials have been rising in numbers, simultaneously expanding outside of Europe and North America to other settings. By now trials have undoubtedly become a global enterprise. Ethics of human subject research travel together with these medical experiments in a form of guidelines, such as Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice (ICH GCP) Guideline, and ethical principles that have informed these influential documents. The bioethical regulations aspire for universal standards for human subjects protection irrespectively of where clinical trials are carried out.

At the same time, qualitative studies have shown that novel, sometimes unforeseen, tensions occur when clinical trials are carried out in various culturally and economically diverse settings, questioning the possibility of smooth diffusion of bioethical regulations. Examples of such tensions include divergent expectations regarding benefits of clinical research, potentially coercive contrasts between conditions at trial sites and limited locally available healthcare, and conflicting views on the role and duties of trialists. The common thread running through the growing body of qualitative research on globalizing clinical trials conduct is that adequate human subject protection requires understanding of local contexts, including particularities of culture, social conditions and political situations, in addition to universal standards.
Against the delineated background, this study explores views and experiences of clinical trials participants in Russian Federation. Russia is one of the emergent clinical trial regions, where numbers of international and locally initiated clinical trials have been significantly rising over the course of the two recent decades. As it is projected to remain an important clinical trials location, it is necessary to gain more in-depth knowledge of local perspectives and practices related to trial conduct.

Principal Investigator:
Olga Zvonareva, Research Fellow at the Department of Health, Ethics and Society, Maastricht University, and at the Centre for Policy Analysis and Studies of Technology at Tomsk State University

Currently a new stage of this research on clinical trial participation project began. This stage focuses on healthy volunteers taking part in the phase I clinical trials, where risks for trial participants are particularly high. Apart from Olga Zvonareva, the core research team now includes Evgeny Kulikov, the Head of Scientific Department at Siberian State Medical University, and Igor Pimenov, senior student at Siberian State Medical Universit

Research project «Opisthorchiasis in Siberia: sociocultural patterns»

Currently innovations in public health and health care are considered central for improving health and quality of life in modern societies. Results of social science studies show, however, that innovations need to be carefully adapted to local sociocultural conditions to make them effective.

One of the fields of clinical medicine that lacks novel effective approaches is the field of prevention of helminthic invasion and associated diseases. Specifically, the Opisthorchis felineus fluke invasion is wide spread in several regions of the Russian Federation. Control of this invasion is possible only with development and implementation of new integrated approaches which include sociological aspects alongside the biomedical and epidemiological ones. The development of integrative and locally adapted programmes for the Opisthorchiasis infection control, which would take into account social, cultural and economic characteristics of endemic regions, is a priority task for the Russian health care.

The goal of this project is the investigation of the sociocultural patterns in spread of Opisthorchiasis infection in the Western Siberia for the purpose of the subsequent development of the infection control programme that would be adapted to the local context.

Core project team members:
Olga Zvonareva, Research Fellow at the Department of Health, Ethics and Society, Maastricht University, and at the Centre for Policy Analysis and Studies of Technology at Tomsk State University
Olga Fedorova, professor of Faculty Pediatrics Department of Siberian State Medical University

Research project «Pharmapolitics: making drugs and nation-building in Russia»

In the first decade of the XXI century the Russian government put forward a set of initiatives to ensure “innovative development” of the local pharmaceutical industry and, in particular, to boost local drug research, development and production. The importance of these tasks was highlighted by the highest country politicians. Moreover, science, technology and innovation have been called upon, as policy documents and officials’ public statements testify, to ensure national pharmaceutical security and independence. The resulting action has become a curious mixture of technoscience and politics. It is this mixture, where construction of innovations becomes related to political processes and the production, exercise and contestation of power, that this study explores.

To many people engagements between science, technology and politics may seem like an odd topic. Not only it appears to be out of tune with conventional ideas about science as independent, objective and value-free, but also its salience to the world at large may look questionable since, one can argue, political intrusions into the territory of scientific reason and technological progress would be limited to the settings marked by authoritarian trends in governance. However, even a brief look into recent intractable public controversies, be it global warming or biotechnology, suggests close engagements between politics, science and technology worldwide. Albeit these engagements are context specific and, hence, diverse in kind and focus, they are generally inevitable. The issues, such as, for instance, stem cells and their use in research and medical practice, and conflicts around them essentially concern societal and individual risks and benefits that have to do with values and identities just as much as with biological mechanisms and pathways. Therefore, these issues are inevitably political just as they are technological and scientific. Yet, how relations between technoscience and politics evolve and are being shaped for the most part remains unclear. Also, importantly, so far even less attention has been devoted to what the existence and dynamics of these relations imply for innovation — popularly placed nowadays at the centre of economic and social development.

This research aims to fill this gap. Pharmaceutical innovation in the particular sociocultural context of the Russian Federation is used here as an example to explicate linkages between politics, science technology and innovation and explore more general implications of these linkages. The central question this study addresses is, thus, how do politics and pharmaceutical science and technology relate to each other in Russia and what does this mean for governance of drug innovation?

Principal Investigator:
Olga Zvonareva, Research Fellow at the Department of Health, Ethics and Society, Maastricht University, and at the Centre for Policy Analysis and Studies of Technology at Tomsk State University

Book project «Politicising innovations and innovating politics for health: science and technology beyond the high-income world»

This book investigates how the construction of innovations for health is related to political processes and the production, exercise and contestation of power. Importantly, empirical work on politics and science and technology as well as medical innovations with several notable exceptions, has been mostly focused on established liberal democracies of the West. But as health is increasingly becoming a matter of global concern and focus of transnational industries and humanitarian efforts, it is crucial to investigate how and by whom related decisions are being made, represented and “framed”, what kinds of assumptions operate within these processes, how choices are being legitimised and stakes negotiated in various kinds of societies. Against the background of the lack of analytical attention to societies beyond the West, we also know little about the utility of available theoretical frameworks and concepts in diverse political environments. This book contributes into filling this void through going beyond industrialised long democratic nations and bringing into analysis detailed empirical studies of politicisation of health innovations in locations, including (post-)Soviet settings. Beyond advancing our understanding of dynamics and outcomes of political processes, seeing politics at work in the field of health innovating may further open up new opportunities for critical appraisal, explanation and social action.

Core team members:
Olga Zvonareva, Research Fellow at the Department of Health, Ethics and Society, Maastricht University, and at the Centre for Policy Analysis and Studies of Technology at Tomsk State University
Evgeniya Popova, Associate Professor, Department of Political Science at Tomsk State University, Director of REC Centre for Policy Analysis and Studies of Technology at Tomsk State University.
Klasien Horstman, Professor of Philosophy of Public Health, Maastricht University.