Schober Sophie, Klee Sascha, Trautinger Franz
Commission on Ethics and Scientific Integrity, Karl Landsteiner University of Health Sciences, Dr.-Karl-Dorrek-Straße 30, 3500, Krems, Austria.
Institute of Science and Technology (ISTA), Am Campus 1, 3400, Klosterneuburg, Austria.
Wien Klin Wochenschr. 2025 Jul;137(13-14):432-437. doi: 10.1007/s00508-024-02462-x. Epub 2024 Oct 10.
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.
涉及人类受试者或可识别的人类材料和数据的研究必须由伦理委员会进行评估。卡尔·兰德施泰纳健康科学大学设立了伦理与科学诚信委员会,以评估其教职员工、学生以及附属医院开展的医学研究。对2018年至2023年间提交给伦理与科学诚信委员会的所有项目的主要特征、评估过程持续时间和投票结果进行了分析。在观察期内,共收到520份电子提交的申请。大多数研究是肿瘤学、心理学和外科领域的回顾性数据分析。大多数研究纳入的志愿者少于100名。50%的申请在5个月内获得最终投票,在此期间进行了几轮修订。总体而言,观察期内发出的投票中约77%为赞成票,2%为否决票。11%的申请因撤回而结案。11%的申请在观察期结束时因需要修订而悬而未决最终投票。我们的研究结果以卡尔·兰德施泰纳大学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空白。需要不断制定标准、操作程序以及开展国家和国际合作,以评估并尽量降低对试验受试者的风险,为人类医学及相关领域的研究提供安全且富有成效的环境。