INTRODUCTION:Ethics committees are a necessary resource to guarantee ethical integrity in human research; they must apply international standards in their ethical evaluation of research projects involving human subjects. OBJECTIVE:The ethics committees for human research of Colombia were characterized, and recommendations for strengthening them were formulated. MATERIALS AND METHODS:In 2003, 280 groups with research projects involving human subjects were selected from a list of research groups which form part of the science and technology network of Colciencias. (Colciencias is the Colombian national agency that promotes and funds science and technology.) Eighty percent (224) of the projects were associated with 40 institutions, consisting of universities, hospitals, and public or private research centers. Thirty of these institutions had at least one ethics committee for evaluating use of human subjects. A questionnaire was mailed to each of these Committees, requesting information concerning its their compostition, regulations, multidisciplinarity, plurality, representativity and independence. The World Health Organization's Operational Guidelines for Ethic Committees that Evaluate Biomedical Research (TDR/PRD/ETHICS/2000) was used as reference for the analysis. In 5 of the cities, supplemental information was obtained by direct discussions with members of the ethics committees. RESULTS:Twenty-six committees responded to the questionnaire. The results indicated that 47% of the committee members were physicians, but only 23% of the committees had representatives from the community. In 60% of the Committees, members were not independent from the organization in which it was based. Seventy percent had established operating procedures. Lack of national regulations and limited education in research ethics were mentioned as the main drawbacks in providing effective guidance. CONCLUSIONS:These observations led to the conclusion that national guidelines must be established for ethics committees that correspond to international standards. Committee members must be trained before accepting committee responsibilities. Finally, new committees must be created along with the improvement of the currently existing committees for reinforcing and promoting the importance of ethical integrity in research.

译文

简介:伦理委员会是确保人类研究伦理完整的必要资源。他们必须在对涉及人类受试者的研究项目进行道德评估时采用国际标准。
目的:对哥伦比亚人类研究伦理委员会进行了描述,并提出了加强伦理委员会的建议。
材料与方法:2003年,从构成Colciencias科学技术网络一部分的研究组列表中选择了280个研究项目涉及人类主题的研究组。 (Colciencias是促进和资助科学技术的哥伦比亚国家机构。)80%的项目(224个)与40个机构相关,这些机构包括大学,医院以及公共或私人研究中心。这些机构中有30个设有至少一个道德委员会来评估人类受试者的使用情况。向每个委员会邮寄了一份调查表,要求提供有关其组成,法规,多学科性,多元化,代表性和独立性的信息。分析使用了世界卫生组织《评估生物医学研究的伦理委员会操作指南》(TDR / PRD / ETHICS / 2000)。在五个城市中,通过与道德委员会成员的直接讨论获得了补充信息。
结果:26个委员会对此问卷进行了答复。结果表明,委员会成员中有47%是医师,但是只有23%的委员会中有社区代表。在60%的委员会中,成员并非独立于其所在的组织。 70%的人已经建立了操作程序。提到缺乏国家法规和研究伦理学方面的教育有限,是提供有效指导的主要弊端。
结论:这些观察得出的结论是,必须为与国际标准相对应的伦理委员会建立国家准则。在接受委员会职责之前,必须对委员会成员进行培训。最后,必须建立新的委员会,并完善现有的委员会,以加强和促进研究中道德操守的重要性。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录