METHODS: Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature.
RESULTS: This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties.
CONCLUSIONS: These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.
方法:IFCC伦理工作组成员基于相关文献进行综合讨论。
结果:这份临床研究项目清单应该有助于在提交给IRB或其同等机构之前从伦理角度评估研究建议,从而降低废品率,并导致更多的时间有效的项目。旨在评估实验室医学道德行为的清单可用于自我评估(内部审核)和第三方执行的认证/认可过程。
结论:这些清单是简单但功能强大的工具,可用于指导专业人员在实践中遵守道德原则,特别是在发展中国家,认可的伦理委员会可能很难找到。