Rosendo Bugarín González, Susana María Romero-Yuste, Paula Mª López Vázquez, Juan Casariego Rosón, Nuria Carballeda Feijóo, Juana Mª Cruz Del Río, Juan Fernando Cueva Bañuelos, José Álvaro Fernández Rial, José Luis Fernández Trisac, Mª José Ferreira Díaz, Rafael Álvaro Millán Calenti, Agustín Pía Morandeira, Jorge Prado Casal, Carmen Rodríguez-Tenreiro Sánchez, Diego Santos García, Juan Manuel Vázquez Lago, Mª Asunción Verdejo González, Irene Zarra Ferro
{"title":"[伦理委员会在 COVID-19 紧急事件中的经验,简要报告]","authors":"Rosendo Bugarín González, Susana María Romero-Yuste, Paula Mª López Vázquez, Juan Casariego Rosón, Nuria Carballeda Feijóo, Juana Mª Cruz Del Río, Juan Fernando Cueva Bañuelos, José Álvaro Fernández Rial, José Luis Fernández Trisac, Mª José Ferreira Díaz, Rafael Álvaro Millán Calenti, Agustín Pía Morandeira, Jorge Prado Casal, Carmen Rodríguez-Tenreiro Sánchez, Diego Santos García, Juan Manuel Vázquez Lago, Mª Asunción Verdejo González, Irene Zarra Ferro","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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of regional scope (62 single-centre), 4 national and 4 international. 57 projects obtained a favourable opinion, 4 were withdrawn by the sponsors, 6 did not require ethics approval and 14 did not respond to the clarifications requested up to the date of the study's closure.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":47152,"journal":{"name":"Revista Espanola De Salud Publica","volume":"94 ","pages":""},"PeriodicalIF":0.9000,"publicationDate":"2020-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582809/pdf/","citationCount":"0","resultStr":"{\"title\":\"[Ethics Committee experience during COVID-19 emergency. A brief report.]\",\"authors\":\"Rosendo Bugarín González, Susana María Romero-Yuste, Paula Mª López Vázquez, Juan Casariego Rosón, Nuria Carballeda Feijóo, Juana Mª Cruz Del Río, Juan Fernando Cueva Bañuelos, José Álvaro Fernández Rial, José Luis Fernández Trisac, Mª José Ferreira Díaz, Rafael Álvaro Millán Calenti, Agustín Pía Morandeira, Jorge Prado Casal, Carmen Rodríguez-Tenreiro Sánchez, Diego Santos García, Juan Manuel Vázquez Lago, Mª Asunción Verdejo González, Irene Zarra Ferro\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":47152,\"journal\":{\"name\":\"Revista Espanola De Salud Publica\",\"volume\":\"94 \",\"pages\":\"\"},\"PeriodicalIF\":0.9000,\"publicationDate\":\"2020-11-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11582809/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Revista Espanola De Salud Publica\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revista Espanola De Salud Publica","FirstCategoryId":"3","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
[Ethics Committee experience during COVID-19 emergency. A brief report.]
Objective: 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.
Methods: 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).
Results: 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.
Conclusions: 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.