{"title":"[德国伦理审查委员会多中心学术研究申请]。","authors":"Nicola Gökbuget, Ralph Naumann","doi":"10.1159/000348270","DOIUrl":null,"url":null,"abstract":"<p><p>Before the start of a clinical trial, approval by the responsible institutional ethical review board (IRB) is required. In Germany, nearly 50 independent IRBs may be responsible for the different participating sites of a multicenter study. In trials for rare diseases, the participation of many centers is required. Therefore, the application procedure for academic multicenter trials in malignant hematologic diseases is often a bureaucratic nightmare. Different aspects of IRB application and possible approaches for improvement are presented.</p>","PeriodicalId":19684,"journal":{"name":"Onkologie","volume":"36 Suppl 2 ","pages":"29-35"},"PeriodicalIF":0.3000,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000348270","citationCount":"6","resultStr":"{\"title\":\"[Application for academic multicenter studies at German ethical review boards].\",\"authors\":\"Nicola Gökbuget, Ralph Naumann\",\"doi\":\"10.1159/000348270\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Before the start of a clinical trial, approval by the responsible institutional ethical review board (IRB) is required. In Germany, nearly 50 independent IRBs may be responsible for the different participating sites of a multicenter study. In trials for rare diseases, the participation of many centers is required. Therefore, the application procedure for academic multicenter trials in malignant hematologic diseases is often a bureaucratic nightmare. Different aspects of IRB application and possible approaches for improvement are presented.</p>\",\"PeriodicalId\":19684,\"journal\":{\"name\":\"Onkologie\",\"volume\":\"36 Suppl 2 \",\"pages\":\"29-35\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2013-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1159/000348270\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Onkologie\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1159/000348270\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Onkologie","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1159/000348270","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
[Application for academic multicenter studies at German ethical review boards].
Before the start of a clinical trial, approval by the responsible institutional ethical review board (IRB) is required. In Germany, nearly 50 independent IRBs may be responsible for the different participating sites of a multicenter study. In trials for rare diseases, the participation of many centers is required. Therefore, the application procedure for academic multicenter trials in malignant hematologic diseases is often a bureaucratic nightmare. Different aspects of IRB application and possible approaches for improvement are presented.