This article provides a thorough ethico-legal analysis of Article 23b(1) of the Polish Act on the Professions of Physician and Dentist (APPD). The analyzed provision regulates the permissibility of paying participants in medical experiments in the form of reimbursement of incurred expenses as well as in the form of “incentives and financial rewards”. First, we define the scope of Article 23b(1) of the APPD within the context of the legal concept of a medical experiment. Then, we discuss the regulatory gaps and interpretive issues posed by Article 23b(1). We highlight significant discrepancies between the Polish regulations on payment for participation in medical experiments and relevant EU provisions on payment for participation in clinical trials. We also compare Article 23b(1) with the guidelines on research payment endorsed by important international ethical and legal standards for human medical research. Ultimately, we conclude that the analyzed provision of the APPD requires revision to better protect participants of medical experiments, as well as to provide researchers and research ethics committees with clearer, more coherent, and better-justified payment guidance.
REFERENCES(64)
1.
Adashek J. J., LoRusso P. M., Hong D. S., Kurzrock R., Phase I trials as valid therapeutic options for patients with cancer, „Nature Reviews. Clinical Oncology” 2019, vol. 16, no. 12, [doi: 10.1038/s41571-019-0262-9].
Anderson J.A., Weijer C., The research subject as wage earner, „Theoretical Medicine and Bioethics” 2002, vol. 23, no. 4, [doi: 10.1023/a:1021265824313].
Appelbaum P. S., Roth L. H., Lidz C., The therapeutic misconception: informed consent in psychiatric research, „International Journal of Law Psychiatry” 1982, vol. 5, no. 3-4, [doi: 10.1016/0160-2527(82)90026-7].
Appelbaum P. S., Roth L. H., Lidz C. W., Benson P., Winslade W., False hopes and best data: Consent to research and the therapeutic misconception", „The Hastings Center Report” 1987, vol. 17, no. 2.
Bosek L., Gałązka M., Eksperyment medyczny [in:] System prawa medycznego (eds. in chief M. Safjan, L. Bosek). Vol II: Szczególne świadczenia zdrowotne, eds. L. Bosek, A. Wnukiewicz-Kozłowska, Warszawa 2018.
Borysowski J., Górski A., Wnukiewicz-Kozłowska A., Terapia eksperymentalna [in:] System prawa medycznego (eds. in chief M. Safjan, L. Bosek). Vol II: Szczególne świadczenia zdrowotne, eds. L. Bosek, A. Wnukiewicz-Kozłowska, Warszawa 2018.
Dean A., Rose F., Jones K., Scantlebury A., Adamson J., Knapp P., Why do people take part in vaccine trials? A mixed methods narrative synthesis, „Patient Education and Counseling” 2023, vol. 114: 10786, [doi: 10.1016/j.pec.2023.107861].
Dickert N., Grady C., What’s the price of a research subject? Approaches to payment for research participation, „New England Journal of Medicine” 1999, vol. 341, [doi: 10.1056/NEJM199907153410312].
Dickert N., Grady C., Incentives for research participants [in:] The Oxford textbook on the ethics of clinical research, eds. J.E. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F. G. Miller, D. Wendler, Oxford University Press, New York 2008.
Gałęska-Śliwka A., Eksperymenty medyczne po nowelizacji ustawy o zawodach lekarza i lekarza dentysty – wybrane zagadnienia, „Prawo i Prokuratura” 2022, no. 10.
Gałęska-Śliwka A., Eksperyment medyczny w nowej rzeczywistości prawnej, „Medycyna Ogólna i Nauki o Zdrowiu” 2023, vol. 29, no. 3, [doi: 10.26444/monz/171323].
Gąsior M., Medical experiments in the light of the amendment of the Act on the Profession of a Physician and a Dentist, „Wiadomości Lekarskie” 2021, vol. 74, no. 8, [doi: 10.36740/WLek202108136].
Gelinas L., Largent E. A., Cohen I. G., Kornetsky S., Bierer B. E., Fernandez Lynch H., A framework for ethical payment to research participants, „New England Journal of Medicine” 2018, vol. 378, no. 8, [doi: 10.1056/NEJMsb1710591].
Halpern J., Paolo D., Huang, A., Informed consent for early-phase clinical trials: therapeutic misestimation, unrealistic optimism and appreciation, „Journal of Medical Ethics” 2019, vol. 45, no. 6, [doi: 10.1136/medethics-2018-105226].
Kerasidou A., Trust me, I’m a researcher!: the role of trust in biomedical research, „Medicine, Health Care and Philosophy” 2017, vol. 20, no. 1, [doi: 10.1007/s11019-016-9721-6].
Kimmelman J., Is participation in cancer phase I trials really therapeutic?, „Journal of Clinical Oncology” 2017, vol. 35, no. 2, [doi: 10.1200/JCO.2016.67.9902].
Konieczniak P., Eksperyment medyczny [in:] System prawa medycznego (editor-in-chief E. Zielińska). Vol. II Regulacja prawna czynności medycznych [part II], eds. M. Boratyńska, P. Konieczniak, Warszawa 2019.
Kubiak R., Odpowiedzialność karna za przestępstwa związane z nielegalnym przeprowadzeniem eksperymentu medycznego, „Diametros” 2023, vol. 20, no. 78, [doi: 10.33392/diam.1946].
Largent E.A., Fernandez Lynch H., Paying research participants: regulatory uncertainty, conceptual confusion, and a path forward, „Yale Journal of Health Policy, Law, and Ethics” 2017, vol. 17, no. 1.
Phillips T., A living wage for research subjects, „The Journal of Law, Medicine & Ethics” 2011, vol. 39, no. 2, [doi:10.1111/j.1748-720X.2011.00593.x].
Pietrzykowski T., Gąsior M., Badanie ludzkiego materiału biologicznego w świetle ustawy o zawodach lekarza, „Przegląd Prawa Medycznego” 2022, vol. 10, no. 1.
Resnik D.B., Bioethical issues in providing financial incentives to research participants, „Medicolegal and Bioethics” 2015, vol. 5, [doi: 10.2147/MB.S70416].
Różyńska J., Regulacja ryzyka i potencjalnych korzyści badania biomedycznego z udziałem człowieka w standardach międzynarodowych, „Prawo i Medycyna” 2016, vol. 18, no. 2.
Różyńska J., Research participants should be rewarded rather than ‘compensated for time and burdens’, „The American Journal of Bioethics” 2021, vol. 21, no. 3, [doi: 10.1080/15265161.2020.1870770].
Różyńska J., The ethical anatomy of payment for research participants, „Medicine, Health Care and Philosophy” 2022, vol. 25, no. 3, [doi: 10.1007/s11019-022-10092-1].
Różyńska J., Kaczmarek E., Protecting research participants against undue influence and exploitation. An ethico-legal analysis of Article 23b(2) of the Polish Act on the Professions of Physician and Dentist, „Przegląd Prawa Medycznego” 2025, no 4., forthcoming.
Świerczyński M., Problem wynagradzania uczestników [in:] Prawo farmaceutyczne, 3rd Edition, eds. M. Krekora, M. Świerczyński, K. Traple, Warszawa 2000.
Wertheimer A., Exploitation in clinical research [in:] The Oxford textbook on the ethics of clinical research, eds. J.E. Emanuel, C. Grady, R.A. Crouch, R.K. Lie, F. G. Miller, D. Wendler, Oxford University Press, New York 2008.
Wnukiewicz-Kozłowska A. Badania kliniczne dorosłych, 5.2. [in:] System prawa medycznego (eds. in chief M. Safjan, L. Bosek). Vol. IV. Prawo farmaceutyczne, ed. J. Haberko, Warszawa 2019.
Wrzesińska-Wal I., Hajdukiewicz D., Augustynowicz A., Janiszewska L., Sarnacka E., Waszkiewicz M., New regulations on current medical problems, „Wiedza Medyczna” 2022, vol. 4, no. 1, [doi: 10.36553/wm.133].
Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Health-Related Research Involving Humans, Geneva, Switzerland 2016, https://cioms.ch/wp-content/up... [Accessed 12.02.2025].
Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Beings with regard to the Application of Biology and Medicine. Convention on Human Rights and Biomedicine, ETS 164, Oviedo, Spain 1997, https://rm.coe.int/168007cf98 [Accessed 12.02.2025].
Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, CETS 195, Strasbourg, France 2005, https://rm.coe.int/168008371a [Accessed 12.02.2025].
Council of Europe, Explanatory Report to the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, CETS 195, Strasbourg, France 2005, https://rm.coe.int/16800d3810 [Accessed 12.02.2025].
European Commission, Expert Group on Clinical Trials for the Implementation of Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use, Ethical considerations for clinical trials on medicinal products conducted with minors. Recommendations of the Expert Group on Clinical Trials for the Implementation of Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use, 2017, https://health.ec.europa.eu/do... [Accessed 12.02.2025].
European Commission, Clinical Trials Coordination and Advisory Group, Compensation for trial participants, version 5, June 2023, https://health.ec.europa.eu/do... [Accessed 12.02.2025].
National Center for Bioethics at the Medical Research Agency of Poland, Compensation for trial participants: an analysis of current legal regulations regarding the compensation of participants in clinical trials, May 7, 2025, https://kcb.abm.gov.pl/kcb/kom... [Accessed 12.08.2025].
World Medical Association, WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants, Helsinki, Finland, October 2024, https://www.wma.net/policies-p... [Accessed 12.02.2025].
Government Legislative Center, Opinion of June 1, 2021 on the Draft Act on Clinical Trials on Medicinal Products for Human Use (UC63) [in PL], https://legislacja.rcl.gov.pl/... [Accessed 12.02.2025].
Employers' Union of Innovative Pharmaceutical Companies INFARMA, Polish Association of Employers of Companies Conducting Clinical Trials on Contract POLCRO, Polish Association for Good Clinical Practice GCPpl, Joint opinion of May 28, 2021 on the Draft Act on Clinical Trials on Medicinal Products for Human Use (UC63) [in PL], https://legislacja.rcl.gov.pl/... [Accessed 12.02.2025].
Ministry of European Union Affairs, Opinion of June 10, 2021 on the Draft Act on Clinical Trials on Medicinal Products for Human Use (UC63) [in PL], pp. 1-2, https://legislacja.rcl.gov.pl/... [Accessed 12.02.2025].
Ministry of European Union Affairs, Opinion of January 26, 2022 on the Draft Act on Clinical Trials on Medicinal Products for Human Use (UC63) [in PL], p. 1-2, https://legislacja.rcl.gov.pl/... [Accessed 12.02.2025].
Report on Public Consultations and Comments on the Draft Act on the Professions of Physician and Dentist and Certain Other Acts (UD27) Concerning Medical Experiments [in:] Draft Act Amending the Act on the Professions of Physician and Dentist and Certain Other Acts, Parliamentary Print No. 172 of January 16, 2020, Regulatory Impact Assessment, Annex 2 [in PL], https://orka.sejm.gov.pl/Druki... [Accessed 12.02.2025].
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