奥地利机构伦理委员会的作用 :卡尔-兰德斯坦纳卫生科学大学伦理与科学诚信委员会 2018-2023 年报告》。

IF 1.9 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL
Sophie Schober, Sascha Klee, Franz Trautinger
{"title":"奥地利机构伦理委员会的作用 :卡尔-兰德斯坦纳卫生科学大学伦理与科学诚信委员会 2018-2023 年报告》。","authors":"Sophie Schober, Sascha Klee, Franz Trautinger","doi":"10.1007/s00508-024-02462-x","DOIUrl":null,"url":null,"abstract":"<p><p>Research involving human subjects or identifiable human material and data must be assessed by an ethics committee. The Karl Landsteiner University of Health Sciences has established a Commission on Ethics and Scientific Integrity to evaluate medical research conducted by its faculty and students and at its affiliated hospitals.All projects submitted to the Commission on Ethics and Scientific Integrity between 2018 and 2023 were analyzed regarding their major characteristics, the duration of the evaluation process, and votes issued.A total of 520 applications were electronically submitted during the observation period. Most of the studies were retrospective data analyses in the field of oncology, psychology and surgery. Most studies included less than 100 volunteers. Of the applications 50% received a final vote within 5 months, during which several revision rounds took place. Overall, about 77% of votes issued during the observation period were positive and 2% were rejections. In 11% files were closed due to withdrawal. In 11% final votes were pending at the end of the observation period due to requests for revisions.Our results emphasize the importance of institutional ethics committees using the example of the Commission on Ethics and Scientific Integrity at the Karl Landsteiner University. Such committees fill a gap in evaluating research not covered by Austrian legal regulations. Continuous development of standards, operating procedures, and national and international collaborations are required to assess and minimize risks to trial subjects and to provide a safe and productive environment for research in human medicine and related fields.</p>","PeriodicalId":23861,"journal":{"name":"Wiener Klinische Wochenschrift","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The role of institutional ethics committees in Austria : Report of the Commission on Ethics and Scientific Integrity of the Karl Landsteiner University of Health Sciences 2018-2023.\",\"authors\":\"Sophie Schober, Sascha Klee, Franz Trautinger\",\"doi\":\"10.1007/s00508-024-02462-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Research involving human subjects or identifiable human material and data must be assessed by an ethics committee. The Karl Landsteiner University of Health Sciences has established a Commission on Ethics and Scientific Integrity to evaluate medical research conducted by its faculty and students and at its affiliated hospitals.All projects submitted to the Commission on Ethics and Scientific Integrity between 2018 and 2023 were analyzed regarding their major characteristics, the duration of the evaluation process, and votes issued.A total of 520 applications were electronically submitted during the observation period. Most of the studies were retrospective data analyses in the field of oncology, psychology and surgery. Most studies included less than 100 volunteers. Of the applications 50% received a final vote within 5 months, during which several revision rounds took place. Overall, about 77% of votes issued during the observation period were positive and 2% were rejections. In 11% files were closed due to withdrawal. In 11% final votes were pending at the end of the observation period due to requests for revisions.Our results emphasize the importance of institutional ethics committees using the example of the Commission on Ethics and Scientific Integrity at the Karl Landsteiner University. Such committees fill a gap in evaluating research not covered by Austrian legal regulations. Continuous development of standards, operating procedures, and national and international collaborations are required to assess and minimize risks to trial subjects and to provide a safe and productive environment for research in human medicine and related fields.</p>\",\"PeriodicalId\":23861,\"journal\":{\"name\":\"Wiener Klinische Wochenschrift\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-10-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Wiener Klinische Wochenschrift\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00508-024-02462-x\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Wiener Klinische Wochenschrift","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00508-024-02462-x","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

摘要

涉及人体或可识别人体材料和数据的研究必须经过伦理委员会的评估。卡尔-兰德斯坦纳卫生科学大学成立了伦理与科学诚信委员会,对该校师生及附属医院开展的医学研究进行评估。我们对2018年至2023年期间提交给伦理与科学诚信委员会的所有项目的主要特点、评估过程的持续时间以及投票情况进行了分析。大部分研究为肿瘤学、心理学和外科领域的回顾性数据分析。大多数研究涉及的志愿者不足 100 人。50%的申请在 5 个月内获得了最终投票,在此期间进行了几轮修改。总体而言,在观察期内,约 77% 的投票结果是肯定的,2% 是否定的。11% 的申请因撤回而被关闭。我们的研究结果以卡尔-兰德斯坦纳大学的伦理与科学诚信委员会为例,强调了机构伦理委员会的重要性。此类委员会填补了奥地利法律法规未涵盖的研究评估工作的空白。为了评估和最大限度地降低试验对象的风险,并为人类医学及相关领域的研究提供一个安全、富有成效的环境,需要不断制定标准、操作程序,并开展国内和国际合作。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The role of institutional ethics committees in Austria : Report of the Commission on Ethics and Scientific Integrity of the Karl Landsteiner University of Health Sciences 2018-2023.

Research involving human subjects or identifiable human material and data must be assessed by an ethics committee. The Karl Landsteiner University of Health Sciences has established a Commission on Ethics and Scientific Integrity to evaluate medical research conducted by its faculty and students and at its affiliated hospitals.All projects submitted to the Commission on Ethics and Scientific Integrity between 2018 and 2023 were analyzed regarding their major characteristics, the duration of the evaluation process, and votes issued.A total of 520 applications were electronically submitted during the observation period. Most of the studies were retrospective data analyses in the field of oncology, psychology and surgery. Most studies included less than 100 volunteers. Of the applications 50% received a final vote within 5 months, during which several revision rounds took place. Overall, about 77% of votes issued during the observation period were positive and 2% were rejections. In 11% files were closed due to withdrawal. In 11% final votes were pending at the end of the observation period due to requests for revisions.Our results emphasize the importance of institutional ethics committees using the example of the Commission on Ethics and Scientific Integrity at the Karl Landsteiner University. Such committees fill a gap in evaluating research not covered by Austrian legal regulations. Continuous development of standards, operating procedures, and national and international collaborations are required to assess and minimize risks to trial subjects and to provide a safe and productive environment for research in human medicine and related fields.

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
Wiener Klinische Wochenschrift
Wiener Klinische Wochenschrift 医学-医学:内科
CiteScore
4.70
自引率
3.80%
发文量
110
审稿时长
4-8 weeks
期刊介绍: The Wiener klinische Wochenschrift - The Central European Journal of Medicine - is an international scientific medical journal covering the entire spectrum of clinical medicine and related areas such as ethics in medicine, public health and the history of medicine. In addition to original articles, the Journal features editorials and leading articles on newly emerging topics, review articles, case reports and a broad range of special articles. Experimental material will be considered for publication if it is directly relevant to clinical medicine. The number of international contributions has been steadily increasing. Consequently, the international reputation of the journal has grown in the past several years. Founded in 1888, the Wiener klinische Wochenschrift - The Central European Journal of Medicine - is certainly one of the most prestigious medical journals in the world and takes pride in having been the first publisher of landmarks in medicine.
×
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
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
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 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信