...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Emerging Infectious Diseases >Institutional Review Boards: Developing Countries Consideration
【24h】

Institutional Review Boards: Developing Countries Consideration

机译：机构审查委员会：发展中国家的考虑

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Institutional review boards (IRBs) play an essential role in protecting the rights of volunteers involved in research projects. Their function has become more complex, particularly concerning projects conducted in developing countries. But can IRBs in the United States guarantee the protection of human subjects involved in research projects in developing countries? IRBs have no effective way of controlling what goes on in the field. The complex ethical clearance process does not determine whether persons engaged in research projects in developing countries are fully aware of the major aspects of the studies they participate in. The clearance process includes the IRB approval and consent forms. Required U.S. consent forms are too long and the language too complicated to be certain all participants have a full understanding of the study. The forms also appear to be intended more to offer legal protection to sponsoring agencies than to protect the welfare of the volunteer. Most importantly, the forms do not guarantee that volunteers have fully understood the objectives, risks, and benefits of the study and the extent of their voluntary participation. To protect volunteers as well as all persons and institutions involved, these forms must not only communicate necessary information concerning the study to be conducted but also evaluate volunteers’ knowledge and their desire to participate. To achieve this goal, we propose to use a simple questionnaire administered by a team not involved in the volunteer recruitment process. We have used such a questionnaire to evaluate potential volunteers for a phase-II HIV vaccine trial. Although volunteers had three intensive, 2-hour counseling sessions, only half responded correctly to all 21 questions. The others were referred for additional counseling and reevaluation.
机译：机构审查委员会（IRB）在保护参与研究项目的志愿者的权利方面起着至关重要的作用。它们的功能变得更加复杂，特别是在发展中国家进行的项目方面。但是，美国的IRB是否可以保证对发展中国家研究项目中涉及的人类受试者的保护？ IRB没有有效的方法来控制现场发生的事情。复杂的道德审查程序无法确定在发展中国家从事研究项目的人员是否完全了解其参与的研究的主要方面。审查程序包括IRB批准书和同意书。所需的美国同意书太长，语言太复杂，无法确定所有参与者都对这项研究有充分的了解。这些表格似乎还旨在为赞助机构提供法律保护，而不是保护志愿者的福利。最重要的是，表格不能保证志愿者完全了解研究的目的，风险和收益以及他们自愿参加的程度。为了保护志愿者以及所有相关人员和机构，这些表格不仅必须传达有关将要进行的研究的必要信息，而且还必须评估志愿者的知识及其参与意愿。为了实现此目标，我们建议使用一个简单的问卷，该问卷由不参与志愿者招募过程的团队管理。我们已经使用这种问卷调查来评估潜在的II期HIV疫苗试验志愿者。尽管志愿者进行了3次密集的2小时辅导，但只有一半正确回答了所有21个问题。其他人被转介接受其他咨询和重新评估。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号