Department of Law, University of Modena and Reggio Emilia, Modena, Italy.
Environmental, Genetic and Nutritional Epidemiology Research Center (CREAGEN), Section of Public Health, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Acta Biomed. 2022 May 11;93(2):e2021579. doi: 10.23750/abm.v93i2.12582.
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).
作为一个对生物医学研究的实施有重大影响的立法领域，在欧盟内外，人们普遍认识到需要改进公共卫生、毒理学和临床医学中伦理委员会的组织和运作的法律规则。鉴于研究人员经常抱怨伦理委员会在授权新研究时，申请和审查过程既复杂又冗长，因此似乎有必要对其立法进行调整。考虑到即将于 2022 年初生效的新临床试验法规，在欧盟内部，这似乎也更加及时。对于这一过程，可以从 COVID-19 大流行以及为应对卫生紧急情况带来的特殊情况而采取的伦理委员会运作变化中吸取宝贵的经验教训。大流行的经验清楚地表明，伦理委员会的申请审查制度可以更加灵活和实用，同时在伦理问责方面保持可接受的透明度和可靠性水平。出于这个原因，意大利等国应该考虑根据大流行的经验，对管理伦理委员会审查程序的公共法律规则进行重大修订。（www.actabiomedica.it）。
