[伦理委员会在 COVID-19 紧急事件中的经验,简要报告]

IF 0.9 4区 医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Revista Espanola De Salud Publica Pub Date : 2020-11-03
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of regional scope (62 single-centre), 4 national and 4 international. 57 projects obtained a favourable opinion, 4 were withdrawn by the sponsors, 6 did not require ethics approval and 14 did not respond to the clarifications requested up to the date of the study's closure.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}
引用次数: 0

摘要

目的:COVID-19 所引发的健康危机要求迅速开展研究,以获得与这种新疾病相关的科学证据,从而控制其破坏性影响和持续传播。因此,必须调整研究伦理委员会的工作流程,确定优先次序,加快对与该疾病相关的项目进行评估:这项工作分析了我们的地区伦理委员会在卫生紧急状态初期(2020 年 3 月 13 日至 5 月 28 日)进行的评估:对 81 个研究项目进行了评估,其中 73 个属于地区范围(62 个单个中心),4 个属于国家范围,4 个属于国际范围。57 个项目获得了赞成意见,4 个项目被发起人撤回,6 个项目不需要伦理审批,14 个项目在研究结束前未对所要求的澄清做出回应:在这种情况下,需要分析的最重要的研究程序是与研究方法和知情同意程序有关的程序。此外,还必须解决与个人数据隐私有关的问题,并考虑到研究人员的工作量。作为一项改进建议,我们认为应鼓励不同研究小组之间加强合作,以获得更可靠的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
[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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Revista Espanola De Salud Publica
Revista Espanola De Salud Publica PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
2.00
自引率
0.00%
发文量
106
审稿时长
12 weeks
期刊最新文献
[Recommendations for the patient during the treatment of colorectal cancer through the enhanced recovery.] [Chemical pollution, exposome and health in the Canary Islands population: An assessment of the situation.] [World Breastfeeding Week 2022: a call for deliberation.] [COVID-19 exposure setting, social and gender determinants in a mediterranean region.] [Effect of prebiotics, probiotics, and symbiotics on molecular markers of inflammation in obesity.]
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1