I期临床试验受试者招募过程中的伦理问题

摘要

Subject recruitment is an important part of clinical researches. It should follow the ethical principles of fairness and representativeness. The recruitment process should pay attention to protecting the privacy of sub-jects. Various recruitment materials must be approved by the ethics committee before use. Whether could recruit el-igible subjects during Phase I clinical trials will have a significant impact on the results, which should attract the relevant persons′attention including the ethics committee, researchers, clinical research associate and the sponsor.%受试者招募是临床研究的重要环节，应遵循公平性与代表性的伦理原则，招募的过程应注意保护受试者的隐私，研究所需的各种招募材料必须经过伦理委员会的审查批准后方可使用。 I期临床试验能否招募到合格的受试者，将会对试验结果产生重大的影响，应引起包括伦理委员会、研究者、临床监察员和申办方在内的相关人员的重视。