CYIL vol. 14 (2023)

CYIL 14 (2023) CONFLICT OF INTEREST IN MEDICAL RESEARCH For a starter, it has been recognized that a lack of transparency regarding conflicts of interest and their inadequate further management may jeopardize the public trust in research results or the recommended or chosen treatment. 10 Regarding conflicts of interest in medical research, besides endangering the fiduciary relationship 11 between the public and scientists, there are data suggesting that the influence of commercial funding might itself be materialized in restricting the scope or specific direction of the research or how results are published 12 . In more extreme cases, financial conflicts of interest might lead to research spin, or biased or even falsified results of clinical trials, both in favor of the drug tested, 13 or to the detriment of it. 14 Thus, unmanaged conflicts of interest might under extreme conditions lead to compromising research and professional integrity, and, subsequently, putting patients’ lives and health at risk. The pharmacological industry is massive and so is its impact on research. 15 In order to protect the quality, objectivity and independence of medical research, whole systems of laws, policies, or internal regulations on conflict of interest have been put in place in some countries or by international entities. Provisions on conflict of interest are also enlisted in some of the current influential codes of research conduct (e.g., the Code of Conduct for Responsible Research, 16 or the European Code of Conduct for Research Integrity 17 ). In this paper, I briefly introduce the legal framework in the US and on the EU level and will discuss how conflicts of interest in research are regulated in the Czech Republic. Whilst doing so, my primary focus will be on conflicts of interest of researchers (investigators, research project applicants), together with the responsibilities of research institutions applying for research projects. I will for the most part leave aside the regulations of conflicts of interest of regulatory/scientific bodies involved in authorizing the marketing applications and main public research funds (e.g., conflicts of interest policies targeting the employees of the Food and Drug Administration 18 or European Medicines Agency 19 ). 10 BRENNAN, T. A. ROTHMAN, D. J., BLANK, L. et al. Health Industry Practices That Create Conflicts of Interest. a Policy Proposal for Academic Medical Centers. JAMA . 2006;295(4):429-433. doi:10.1001/ jama.295.4.429. 11 KELLY, T. Conflicts about Conflict of Interest: A Comparison of Performance-Based and Trustworthiness Models in the Context of Detailing and Gifts to Physicians. Cambridge Quarterly of Healthcare Ethics: CQ . 2016;25(3):526-535. doi:10.1017/S0963180116000177. 12 FABBRI, A., LAI, A., GRUNDY, Q., BERO, L. A. The Influence of Industry Sponsorship on the Research Agenda: a Scoping Review. Am J Public Health . 2018;108(11):e9-e16. doi:10.2105/AJPH.2018.304677. 13 LUNDH, A., LEXCHIN, J., MINTZES, B., SCHROLL, J. B., BERO, L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews . 2017;(2). doi:10.1002/14651858.MR000033.pub3. 14 DEER, B. How the case against the MMR vaccine was fixed. BMJ . 2011;342:c5347. doi:10.1136/bmj.c5347. 15 TOMA, S. G., CATANA, S. Big Pharma, Big Business. Ovidius University Annals: Economic Sciences Series . 2021;XXI(1):677-683. 16 World Health Organization. Code of Conduct for responsible research, 2017. Accessed August 15, 2023. https://www.who.int/about/ethics/code-of-conduct-for-responsible-research 1. 17 ALLEA – All European Academies. The European Code of Conduct for Research Integrity . ALLEA – All European Academies; 2023. Accessed August 15, 2023. https://doi.org/10.26356/ECoC. 18 Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA also provides accurate, science-based health information to the public. In : Food and Drug Administration | USAGov. Accessed June 22, 2023. https://www. usa.gov/agencies/food-and-drug-administration. 19 The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible

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