Dealing with Ethical Issues in Clinical Trials: The ussr in the Global Context

Abstract

This paper discusses several ethical issues related to clinical trials within the Soviet system of drug development and testing, which reflected larger ideological principles of healthcare organization in the ussr, with its focus on eradicating market elements from drug development. The centralized state-controlled system was thought to combat such drawbacks of free-market drug development as high prices and aggressive advertising; also to discourage the duplication of research by numerous independent actors that was perceived to be common in capitalist countries. Another significant ethical issue was the Soviet emphasis on the unity of scientific research and clinical treatment. Their strict separation, introduced to support normative standards defined by the U.S. pharmaceutical drug testing system, was rejected in the ussr where knowledge of new treatment options came from treatment practice, not laboratory-like experimental conditions of randomized controlled double-blind trials. The Soviet design was closer to so-called ‘pragmatic trials’ that focus on solving ‘real-life’ problems in clinical practice. Not all ethical problems were successfully addressed in the Soviet model, where there were always significant gaps between neatly postulated theory and messy clinical practice. The unity of scientific research and clinical practice was difficult to achieve. Archival research shows potential ethical issues related to geographic disparities in carrying out clinical trials, and the importance of personal and informal connections in the Soviet model.

Medical professionals’ agency and pharmaceuticalization: Physician-industry relations in Russia

“…Arrival of evidence-based medicine (EBM) ideas to the country contributed to yet another level of ambiguity regarding physicians’ professional autonomy and authority. In Soviet healthcare the EBM paradigm was a subject of ideological critique as unethical and capitalist—one that prioritizes not the pragmatics of clinical tasks, but abstract scientific principles, and corresponds to for-profit interests of pharmaceutical companies rather than to the public good ( Vasilyev et al., 2021 ). While it was welcomed in Russia in the 1990s on the wave of healthcare internationalization, its actual implementation in clinical settings was impeded by institutional obstacles, including lack of material resources, outdated medical educational programs, and rigid bureaucracy ( Geltzer, 2009 ).…”

Informed Consent in Clinical Studies Involving Human Participants: Ethical Insights of Medical Researchers in Germany and Poland

“…In the first two decades after the end of the Soviet era, we could find severe criticism on the slow progress in establishing independent institutional review boards and the implementations of international norms, such as the Declaration of Helsinki, in relation to informed consent in former socialist countries ( 9 , 10 ). Furthermore, it is unclear how strong informal connections between clinicians, as central as they are in former socialist countries, allow sufficient enforcement of ethical norms in decentralized research systems ( 11 , 12 ). A comparison of these two countries will provide us different perspectives on the implementation of research ethics norms in relation to informed consent in Germany and Poland from the practical experience of clinicians active in clinical research involving human participants.…”