Main Article Content
Ethics Committee, comparative public law, European Union legislation, COVID-19, public health
As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications’ review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it)
2. Thompson IE. Fundamental ethical principles in health care. Br Med J (Clin Res Ed) 1987; 295 (6611): 1461-5. https://doi.org/10.1136/bmj.295.6611.1461.
3. Riera AV. [Research ethics committees: A necessary good]. Invest Clin 2013; 54 (4): 343-5.
4. World Medical Association. Declaration of Helsinky. 1975. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed November 11, 2021.
5. Guillemin M, Gillam L, Rosenthal D, et al. Human research ethics committees: Examining their roles and practices. J Empir Res Hum Res Ethics 2012; 7 (3): 38-49. https://doi.org/10.1525/jer.2012.7.3.38.
6. Ng LC, Hanlon C, Yimer G, et al. Ethics in global health research: The need for balance. Lancet Glob Health 2015; 3 (9): e516-7. https://doi.org/10.1016/S2214-109X(15)00095-9.
7. Minacori R, Refolo P, Sacchini D, et al. Research Ethics Committees and clinical research in Italy: Where are we going? Eur Rev Med Pharmacol Sci 2015; 19 (3): 481-5.
8. Lough S. Streamlining the ethics review system. CMAJ 2016; 188 (1): E10. https://doi.org/10.1503/cmaj.109-5199.
9. Marinelli E, Busardo FP. The role of the Ethics Committees in the application of the European Regulation No 536/2014. Eur Rev Med Pharmacol Sci 2016; 20 (5): 789-91.
10. Petrini C, Fiori G, Gussoni G, et al. The increasing need for a new Italian legislation to facilitate execution of observational studies assuring ethics and the highest standards of scientific and methodological quality. Editorial. Ann Ist Super Sanita 2020; 56 (3): 257-9. https://doi.org/10.4415/ANN_20_03_01.
11. Petrini C. What is the role of ethics committees after Regulation (EU) 536/2014? J Med Ethics 2016; 42 (3): 186-8. https://doi.org/10.1136/medethics-2015-103028.
12. Ashcroft RE, Newson AJ, Benn PM. Reforming research ethics committees. BMJ 2005; 331 (7517): 587-8. https://doi.org/10.1136/bmj.331.7517.587.
13. Petrini C, Brusaferro S. Ethics committees and research in Italy: Seeking new regulatory frameworks (with a look at the past). Commentary. Ann Ist Super Sanita 2019; 55 (4): 314-8. https://doi.org/10.4415/ANN_19_04_02.
14. Petrini C. Are the Italian ethics committees ready for Europe? Commentary. Ann Ist Super Sanita 2018; 54 (4): 270-1. https://doi.org/10.4415/ANN_18_04_02.
15. Montanari Vergallo G, Petrini C. An overview of trends in the regulation of clinical ethics committees: An opinion from the Italian National Bioethics Committee article. Cuad Bioet 2018; 29 (97): 221-31. https://doi.org/10.30444/CB.7.
16. Tusino S, Furfaro M. Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic. Br J Clin Pharmacol 2022; 88 (1): 40-6. https://doi.org/10.1111/bcp.14871.
17. European Commission. L 275, 31 July 2021. COMMISSION DECISION (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council Official Journal of the European Union 2021.
18. Ostuzzi G, Gastaldon C, Petrini C, et al. Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries. Epidemiol Psychiatr Sci 2020; 29: e126. https://doi.org/10.1017/S2045796020000396.
19. Giannuzzi V, Altavilla A, Ruggieri L, et al. Clinical trial application in Europe: What will change with the new regulation? Sci Eng Ethics 2016; 22 (2): 451-66. https://doi.org/10.1007/s11948-015-9662-0.
20. Pan American Health Organization. Guidance and strategies to streamline ethics review and oversight of COVID-19 related research. 2020. https://iris.paho.org/handle/10665.2/52089. Accessed November 11, 2021.
21. O'Sullivan L, Killeen RP, Doran P, et al. Adherence with reporting of ethical standards in COVID-19 human studies: A rapid review. BMC Med Ethics 2021; 22 (1): 80. https://doi.org/10.1186/s12910-021-00649-9.
22. Kasherman L, Madariaga A, Liu Q, et al. Ethical frameworks in clinical research processes during COVID-19: A scoping review. BMJ Open 2021; 11 (7): e047076. https://doi.org/10.1136/bmjopen-2020-047076.
23. IJkema R, Janssens M, van der Post JAM, et al. Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators. PLoS One 2021; 16 (7): e0255040. https://doi.org/10.1371/journal.pone.0255040.
24. Monaco E, Pisano L, Nasato L, et al. Ethics committees in the time of COVID-19. Epidemiol Prev 2020; 44 (5-6 Suppl 2): 113-8. https://doi.org/10.19191/EP20.5-6.S2.109.
25. Zhang H, Shao F, Gu J, et al. Ethics Committee reviews of applications for research studies at 1 hospital in China during the 2019 novel coronavirus epidemic. JAMA 2020; 323 (18): 1844-6. https://doi.org/10.1001/jama.2020.4362.
26. Filippini T, Zagnoli F, Bosi M, et al. An assessment of case-fatality and infection-fatality rates of first and second COVID-19 waves in Italy. Acta Biomed 2021; 92 (S6): e2021420. https://doi.org/10.23750/abm.v92iS6.12241.
27. Signorelli C, Odone A, Gianfredi V, et al. COVID-19 mortality rate in nine high-income metropolitan regions. Acta Biomed 2020; 91 (9-S): 7-18. https://doi.org/10.23750/abm.v91i9-S.10134.
28. Odone A, Delmonte D, Gaetti G, et al. Doubled mortality rate during the COVID-19 pandemic in Italy: Quantifying what is not captured by surveillance. Public Health 2021; 190: 108-15. https://doi.org/10.1016/j.puhe.2020.11.016.
29. European Network of Research Ethics Committees. Position of the European Network of Research Ethics Committees (EUREC) on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic. 2020. http://www.eurecnet.org/documents/Position_EUREC_COVID_19.pdf.
30. Taylor HA, Serpico K, Fernandez Lynch H, et al. A Snapshot of U.S. IRB Review of COVID-19 Research in the Early Pandemic. J Clin Transl Sci 2021; 5 (1): e205. https://doi.org/10.1017/cts.2021.848.
31. Liberati A. Research Ethics Committees: Can they contribute to the improvement of clinical research in Europe? J Ambul Care Manage 2004; 27 (2): 154-65. https://doi.org/10.1097/00004479-200404000-00012.
32. Council of Europe. Guide for Research Ethics Committee Members 2012. https://www.coe.int/en/web/bioethics/guide-for-research-ethics-committees-members
33. Naureen Z, Beccari T, Marks RS, et al. Ethics committees for clinical experimentation at international level with a focus on Italy. Acta Biomed 2020; 91 (13-S): e2020016. https://doi.org/10.23750/abm.v91i13-S.10643.
34. Filippini T, Vinceti SR. Italian National Recovery and Resilience Plan: A Healthcare Renaissance after the COVID-19 crisis? Acta Biomed 2021; 92 (S6): e2021463. https://doi.org/10.23750/abm.v92iS6.12339.
35. Ma X, Wang Y, Gao T. Challenges and strategies to research ethics in conducting COVID-19 research. J Evid Based Med 2020; 13 (2): 173-7. https://doi.org/10.1111/jebm.12388.
36. Gozzo L, Longo L, Vitale DC, et al. The regulatory challenges for drug repurposing during the COVID-19 pandemic: The Italian experience. Front Pharmacol 2020; 11: 588132. https://doi.org/10.3389/fphar.2020.588132.