Objective:To understand the current status and existing issues of intellectual property ownership arrangements in international cooperation agreements concerning human genetic resources, and to explore suggestions for medical institutions to strengthen the management of Sino-foreign cooperation agreements, in order to safeguard the rights of medical institutions to benefit-sharing and promote the sustainable development of international cooperation involving human genetic resources.Methods:This study reviewed the international cooperative scientific research projects approved or completed for filing by Peking University Cancer Hospital on the National Health Commission′s Government Service Platform from July 2019 to December 2024. This study analyzed the nature of the research and the provisions regarding patent rights and intellectual property rights of other scientific and technological achievements in the hospital′s international cooperation agreements with sponsors. Existing issues in intellectual property ownership arrangements was summarized, and corresponding recommendations were proposed.Results:A total of 390 international cooperation projects on human genetic resources were analyzed. Among them, there were 66 exploratory research projects, 138 marketing research projects, and 186 projects included both exploratory research and marketing research. Among the cooperation agreements containing exploratory research, 78.6% did not specify the specific connotation of exploratory research. All agreements stipulated that the hospital alone or jointly held the patent rights for the achievements generated from exploratory research. 15.1% of the agreements restricted the geographical scope of the patent rights, 13.1% restricted the hospital′s implementation of the patent rights, 8.7% unilaterally restricted the hospital's external licensing and transfer of the patent rights, and 43.7% did not stipulate the ownership of other scientific and technological achievements other than the patent rights.Conclusions:There is a lack of clear and standardized regulations regarding the scope of exploratory research. The intellectual property arrangements in the agreements show an interest-oriented tendency. The sponsors restrict the implementation, transfer, and licensing of shared patent rights by medical institutions through agreements. For other scientific and technological achievements derived from the cooperation, apart from patent rights, medical institutions have not fully exercised the rights stipulated by law. It is recommended that medical institutions clearly specify the scope of application of exploratory research. They should pay attention to the stipulations of specific rights such as the right to enforce, transfer, and license patents. They should also make full use of the enabling provisions of the law, clearly define in the agreement the ownership of other scientific and technological achievements and the distribution of rights and interests, so as to achieve a balance of interests with their partners.

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.

Objective:To understand the current status and existing issues of intellectual property ownership arrangements in international cooperation agreements concerning human genetic resources, and to explore suggestions for medical institutions to strengthen the management of Sino-foreign cooperation agreements, in order to safeguard the rights of medical institutions to benefit-sharing and promote the sustainable development of international cooperation involving human genetic resources.Methods:This study reviewed the international cooperative scientific research projects approved or completed for filing by Peking University Cancer Hospital on the National Health Commission′s Government Service Platform from July 2019 to December 2024. This study analyzed the nature of the research and the provisions regarding patent rights and intellectual property rights of other scientific and technological achievements in the hospital′s international cooperation agreements with sponsors. Existing issues in intellectual property ownership arrangements was summarized, and corresponding recommendations were proposed.Results:A total of 390 international cooperation projects on human genetic resources were analyzed. Among them, there were 66 exploratory research projects, 138 marketing research projects, and 186 projects included both exploratory research and marketing research. Among the cooperation agreements containing exploratory research, 78.6% did not specify the specific connotation of exploratory research. All agreements stipulated that the hospital alone or jointly held the patent rights for the achievements generated from exploratory research. 15.1% of the agreements restricted the geographical scope of the patent rights, 13.1% restricted the hospital′s implementation of the patent rights, 8.7% unilaterally restricted the hospital's external licensing and transfer of the patent rights, and 43.7% did not stipulate the ownership of other scientific and technological achievements other than the patent rights.Conclusions:There is a lack of clear and standardized regulations regarding the scope of exploratory research. The intellectual property arrangements in the agreements show an interest-oriented tendency. The sponsors restrict the implementation, transfer, and licensing of shared patent rights by medical institutions through agreements. For other scientific and technological achievements derived from the cooperation, apart from patent rights, medical institutions have not fully exercised the rights stipulated by law. It is recommended that medical institutions clearly specify the scope of application of exploratory research. They should pay attention to the stipulations of specific rights such as the right to enforce, transfer, and license patents. They should also make full use of the enabling provisions of the law, clearly define in the agreement the ownership of other scientific and technological achievements and the distribution of rights and interests, so as to achieve a balance of interests with their partners.

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.

Objective:According to the international cooperation project of Peking University Cancer Hospital on human genetic resource management practices, combined with the development direction of human genetic resource management laws and regulations, and propose reference suggestions for medical institutions to strengthen human genetic resource management.Methods:Sort out the projects that Peking University Cancer Hospital obtained international cooperation approval on the government platform of the Ministry of Science and Technology from July 2019 to June 2023, analyze the current situation of human genetic resource management in the hospital, summarize the challenges brought by the implementation of new regulations on human genetic resource management in medical institutions, and propose corresponding suggestions.Results:A total of 1276 international cooperation projects on human genetic resources have been approved, including 345 initial declarations and 931 change declarations. Involving 453 studies, including 286 clinical trials of drugs or devices on the market, accounting for 63.13%, and 100 clinical trials of Phase I drugs, accounting for 34.97% of the market studies. On average, there are 3.14 changes per project for listed research, and 1.56 changes per project for non listed research.Conclusions:Regulations on the Management of Human Genetic Resources ( short for Rules) limit the management scope of international cooperation projects involving human genetic resources and delegate management authority to medical institutions. Adjusting the scope of application for international cooperative clinical trial filing may result in some administrative approval projects being transferred to filing. The approval process for international cooperative scientific research projects on human genetic resources has been adjusted. Suggest medical institutions to strengthen the management of samples and intellectual property outside the scope of application of Rules.Strengthen the entire process management of international cooperation in scientific research. Pay attention to and timely communicate the dynamics of human genetic resource management.

Objective:To understand the legal disputes that are prone to arise in judicial practice regarding service inventions, this study aims to explore prevention strategies for patent disputes related to service inventions in medical research institutions from the perspective of scientific research management, guided by the standardization of intellectual property management and the promotion of achievement transformation.Methods:This study sorted out the judgments of patent related cases related to official inventions on the China Judgment Document Network from January 1, 2018 to December 31, 2023, analyzed the case situation, summarized the types of disputes, the reasons for disputes, and propose countermeasures.Results:A total of 469 dispute cases related to service invention patents were analyzed, with over 90% being ownership disputes. Among them, 413 cases involved patent ownership disputes, and 73.1% of the cases were judged as service inventions. There were only 14 cases involving disputes over the authorship rights of inventors and designers of inventions and creations, and 78.6% of cases had made judgments against disputed inventors and designers who were not the actual inventors or designers of the patent in question. There were 42 cases involving disputes over the distribution of benefits such as rewards and remuneration for inventors and designers in the field of service inventions and creations. In most cases, the judgment units should pay bonuses to inventors and designers.Conclusions:This study suggests that research institutions establish a disclosure system for job related scientific and technological achievements, guiding researchers to actively and timely disclose job related scientific and technological achievements to their respective research institutions, stimulate innovation enthusiasm, improve intellectual property management system and service mechanism, strengthen the construction of scientific research integrity and avoid scientific research integrity issues such as the naming of patent inventors and designers.

Objective:This paper aims to explore the management of human genetic resources in medical institutions, according to reflections of the management mode of a particular hospital, providing possible reference for other medical institutions.Methods:The management system of human genetic resources was constructed refer to the McKinsey 7S model. Approved projects information includes the types of projects, characteristics of human genetic resources involved and the characteristics of principal investigator are analyzed.Results:A total number of 82 projects were approved Since the implementation of newly updated Regulation of the People′s Republic of China on the Administration of Human Genetic Resources (hereinafter referred to as the regulations), and majority of which are drug clinical trials. The human genetic resources materials and data involved are mainly blood, urine, serum, plasma, clinical data, imaging data, etc. Most of the principal investigators with senior professional title are from key disciplines.Conclusions:McKinsey 7S model provides a new reference path for medical institutions to carry out human genetic resources management.

Objective To analyze the research achievements and their outcome influence factors of the National Natural Science Foundation of China (NSFC) funding projects in Peking University Cancer Hospital during the "Twelfth Five-Year Plan".Methods Based on project data and outcomes of 68 projects supported by NSFC from 2011 to 2015,this paper studies the number of SCI papers,Chinese Journal papers and conference papers published,the citations per paper and talent cultivation of different subcategories of projects,as well as different professional titles,academic degrees,genders,ages,occupations of the principle investigator,and component of project team members.Results 90％ of the 68 projects published SCI papers,basically completed the intended research objectives set in the application.41.7％ of the SCI papers were published in the 1-5 year after the project closure.Research team collaborated between clinical and scientific research staff has higher output.Conclusions Scientific research management department should strengthen the process management and the tracking of project achievements,and should promote the combination of basic and clinical research to achieve mutually complementary.

Based on the project data and SCI output data of 5431 projects supported by National Natural Science Foundation of China (NSFC) in oncology from 2008 to 2012,this paper took advantage of the Web of Science database,studied the number of papers published and the citations per paper of different research fields in oncology,different subcategories of projects,top 20 institutions funded by NSFC.Based on the study findings,we tried to make some suggestions for the funding agency,researchers,as well as research management personnel for increase the effectiveness of funding use,improve the administration work and policy-making concerns.

The National Natural Science Foundation of China is one of the most important fund channels for basic research in Peking University Cancer Hospital (hereinafter referred to as our hospital).Peer review was used for application review.In this article,the feedback opinions of applications from 2010 to 2014 for our hospital were categorized,summarized and analyzed.The common reasons of failure and corresponding measures were put forward to provide references for the applicants and scientific research managers for formulating relevant plicies.