Vrbová H, Hrubantová L
IIIrd Department of Internal Medicine, 1st Faculty of Medicine, Charles University, Prague, Czech Republic.
Sb Lek. 1997;98(3):237-41.
The purpose of this contribution is to inform about the activities of the local ethics commission established at one of our largest teaching (University) hospitals. In 1995 the following priorities were recognized: studying international ethical standards of research involving human subjects and strictly adhering to them; bilingual administrative agenda in Czech and English; enforcing the patients' rights in health care and emphasizing them in education of medics and other students of health related disciplines; stimulating effective communication between doctors, other health care workers and lay persons in the commission as well as between the members of the commission and authors of research projects applying for ethical evaluation. Since 1993 the commission has been revising and storing in the archives more than 600 research projects. In 1996, 181 new research projects were reviewed, which is 35% more than in 1995. Approval was granted in 154 cases (85.08%), 3 cases (1.66%) were rejected, 15 cases (8.29%) approved on condition of complying with the recommendations of the commission, 6 cases (3.31%) recommended for another commission, and in 3 cases reviewing the project was postponed for lack of necessary data. The members of the commission agree that the future activities should lead to forming a broader group of consultants of the commission and other professional and lay people interested in clinical ethics. According to their meaning, legislation concerning ethical commissions in the Czech Republic, including material and financial support and administrative help, is urgently needed.
本文旨在介绍我们最大的教学(大学)医院之一所设立的地方伦理委员会的活动情况。1995年确定了以下优先事项:研究涉及人类受试者的国际伦理标准并严格遵守;制定捷克语和英语双语行政议程;在医疗保健中维护患者权利,并在医学及其他健康相关学科的学生教育中予以强调;促进委员会中医生、其他医护人员和非专业人员之间以及委员会成员与申请伦理评估的研究项目作者之间的有效沟通。自1993年以来,该委员会已对600多个研究项目进行了修订并存档。1996年,对181个新研究项目进行了审查,比1995年多35%。154个项目获得批准(85.08%),3个项目被否决(1.66%),15个项目在符合委员会建议的条件下获得批准(8.29%),6个项目被建议提交另一个委员会审议(3.31%),3个项目因缺乏必要数据而推迟审查。委员会成员一致认为,未来的活动应促成一个更广泛的委员会顾问群体以及其他对临床伦理感兴趣的专业人员和非专业人员的形成。他们认为,捷克共和国迫切需要有关伦理委员会的立法,包括物质和财政支持以及行政协助。