Compliance review and risk prevention in international cooperation agreements for medical institutions under human genetic resources management
10.3760/cma.j.cn113565-20250427-00108
- VernacularTitle:人类遗传资源管理视角下医疗机构国际合作协议的合规性审查及风险防控
- Author:
Shuanglei KONG
1
;
Pengcheng SUN
;
Luopei WEI
;
Lingling BAI
;
Tingting QU
Author Information
1. 北京大学肿瘤医院暨北京市肿瘤防治研究所科研处，恶性肿瘤发病机制及转化研究教育部重点实验室，北京 100142
- Publication Type:Journal Article
- Keywords:
Human genetic resource;
Risk prevention and control;
International cooperation;
Agreements review
- From:
Chinese Journal of Medical Science Research Management
2025;38(5):376-381
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the current status and challenges in legal compliance regarding the collection, utilization, sharing, cross-border transfer, and disposal of human genetic resources (HGR) in international collaboration agreements, and to explore key review points for medical institutions in international cooperation agreements to mitigate legal risks and ensure compliance in HGR-related global collaborations.Methods:We reviewed international collaborative research projects involving Peking University Cancer Hospital that were approved or filed on the National Health Commission (NHC) Administrative Service Platform between July 2019 and April 2025, analyzed the utilization of human genetic resources (HGR) materials and information in these studies, assessd compliance clauses in international agreements related to HGR management, identified gaps, and proposed actionable recommendations.Results:A total of 410 international cooperation projects on human genetic resources were analyzed, of which 302 cooperation agreements signed with sponsors stipulated that research should obtain administrative approval or complete filing for human genetic resources before implementation(73.7%). However, 113 agreements had errors in citing legal provisions or incomplete agreements. A mtotal of 385 studies involved human genetic resource materials, of which 277 agreed on the compliant use of biological samples, but mainly focused on the collection and testing process, with insufficient agreements on the disposal of remaining samples. Some agreements only stipulate that ″compliant collection and use of samples″ is the sole responsibility of medical institutions, ignoring the relevant responsibilities of the sponsor, and the risk allocation is unreasonable. 361 studies involved human genetic resources information, but only 72 explicitly agreed that China′s human genetic resources information should be collected, preserved, used and shared within the approved scope of human genetic resources (less than 20%).Conclusions:The expression of human genetic resources related content in most agreements is not standardized; The management agreement for human genetic resources materials is incomplete and does not cover the entire cycle of sample processing; The responsibilities that the applicant should bear in the cooperation are unclear; The management of human genetic resource information is easily overlooked. It is recommended that medical institutions closely monitor changes in relevant laws, regulations, and management methods, and update the corresponding clauses of the agreement in a timely manner, and improve the situations that should be submitted for administrative approval or filing in the agreement; All parties involved in the cooperation should make compliance commitments for human genetic resources; Clearly stipulate the full cycle management of human genetic resources materials; Pay attention to risk prevention and control in the management of human genetic resources information; Pay attention to the systematic coverage of intellectual property types and the operability of rights implementation in international cooperation.
