Bugarín González Rosendo, Romero-Yuste Susana María, López Vázquez Paula Mª, Casariego Rosón Juan, Carballeda Feijóo Nuria, Cruz Del Río Juana Mª, Cueva Bañuelos Juan Fernando, Fernández Rial José Álvaro, Fernández Trisac José Luis, Ferreira Díaz Mª José, Millán Calenti Rafael Álvaro, Pía Morandeira Agustín, Prado Casal Jorge, Rodríguez-Tenreiro Sánchez Carmen, Santos García Diego, Vázquez Lago Juan Manuel, Verdejo González Mª Asunción, Zarra Ferro Irene
Comité de Ética de la Investigación con medicamentos de Galicia (CEIm-G). Servizo Galego de Saúde. España.
Rev Esp Salud Publica. 2020 Nov 3;94:e202011146.
The health crisis caused by COVID-19 required the prompt launch of research in order to generate scientific evidence pertaining to the new disease oriented to control its devastating effects and continuous spread. Therefore, it was essential to adapt the work flow of Research Ethics Committees, to prioritize and to accelerate the evaluation of projects related to this disease.
This work analyses the evaluation conducted by our Regional Ethics Committees during the initial period of the health emergency (between 13th March and 28th May 2020).
81 research projects were evaluated, 73 of them of regional scope (62 single-centre), 4 national and 4 international. 57 projects obtained a favourable opinion, 4 were withdrawn by the sponsors, 6 did not require ethics approval and 14 did not respond to the clarifications requested up to the date of the study's closure.
The most important research procedures to be analysed in this context are those related to the methodology and informed consent process. It is also essential to address aspects related to the privacy of personal data, and to take into account the workload of the researchers. As an improvement proposal, we think that greater collaboration between the different research teams should be encourage to obtain more robust results.
由新型冠状病毒肺炎(COVID-19)引发的健康危机需要迅速开展研究,以便生成与这种新疾病相关的科学证据,从而控制其毁灭性影响和持续传播。因此,调整研究伦理委员会的工作流程、对与该疾病相关的项目评估进行优先排序并加快评估速度至关重要。
本研究分析了我们地区伦理委员会在卫生紧急情况初期(2020年3月13日至5月28日)进行的评估。
共评估了81个研究项目,其中73个为地区范围的项目(62个单中心项目),4个为国家级项目,4个为国际级项目。57个项目获得了正面意见,4个项目被申办方撤回,6个项目无需伦理批准,14个项目直至研究结束时仍未对所要求的澄清作出回应。
在此背景下需要分析的最重要的研究程序是那些与方法学和知情同意过程相关的程序。处理与个人数据隐私相关的问题并考虑研究人员的工作量也至关重要。作为一项改进建议,我们认为应鼓励不同研究团队之间加强合作,以获得更可靠的结果。