临床研究利益冲突管理的构建及运行

Establishment and operation on the conflict of interest management of clinical researches

为保证临床研究的客观性和伦理审查的公正性,医疗机构需要构建完善的利益冲突管理机制和政策。在利益冲突管理过程中,可以及时识别可能存在的利益冲突。在临床研究的全流程管理中,利益冲突的规范化管理,可以尽量避免利益冲突对临床研究的客观性和受试者权益造成不良的影响,协调临床研究各方对利益冲突的识别和有效管理。作者详细阐述了医疗机构临床研究利益冲突管理中利益冲突管理委员会的组织架构、管理范围、审查职责,以及对组织机构、伦理审查、研究人员等临床研究涉及的各方利益冲突的识别披露及处理措施。在医疗机构临床研究开展过程中需要注重利益冲突管理的主动公开、沟通交流,接受主管部门或认证机构的监督与评估,规范临床研究全流程各方的行为,提高临床研究的质量,保护受试者的安全和权益。

In order to ensure the objectivity of clinical research and the fairness of ethical review,medical institutions should establish a series of mechanisms and policy on the management of conflict of interest(COI)among clinical researches.During the management process,possible COI should be identified timely.In the whole process management of clinical research,standardized COI management can avoid the adverse impact on the objectivity of clinical research,as well as the interests of research subjects,and coordinate the identification and effective management of COI by all parties during clinical research.The author elaborates on the organizational structure,management scope,and review responsibilities of the COI Committee in the COI management of clinical research among medical institutions,as well as the identification,disclosure and management of COI among parties,such as organizational institutions,ethics committee,and investigators in clinical researches.It is necessary to active disclosure COI and communication among different parties during the clinical research process.The medical institution should accept the administration supervision as well as the evaluation of certification authorities,in order to standardize the behavior of all parties in the whole process of clinical research,improve the quality of clinical research,and protect the safety and rights of research subjects.