Chen Xiayan, Meng Jiaxue, Chu Hongling, Wu Yangfeng, Li Huijuan
Peking University First Hospital, No. 8 Xishiku St., Xicheng District, Beijing, 100034, China.
Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, No. 38 Xueyuan Rd., Haidian District, Beijing, 100191, China.
Health Res Policy Syst. 2024 Dec 18;22(1):165. doi: 10.1186/s12961-024-01264-x.
The Measures for Management of Investigator-Initiated Studies (IISs) Conducted by Healthcare Institutions (trial version) (referred to as Management Measures) has been piloted successively in 12 provincial regions across China since 1 October 2021 and took effect nationwide on 1 October 2024. This study aimed to examine the perspectives, attitudes and challenges of administrators and investigators within healthcare institutions in Beijing regarding IIS management to provide further strategic guidance in China.
This descriptive qualitative study included 13 focus group discussions among 74 participants from 25 healthcare institutions stratified selected in Beijing, including 13 executive-level administrators, 41 functional administrators and 20 investigator representatives. The focus groups were conducted from November to December 2021. The discussion topics focussed on current status of IIS management in healthcare institutions and the participants' attitudes and challenges in implementation of the Management Measures, mainly on the specific management system establishment, independent scientific review, management by study type and whole-process supervision.
Opinions varied among institution presidents/directors regarding the establishment of clinical research management committees and offices, with significant challenges identified in insufficient human resources and difficulties in integrating with existing management models. While scientific review was seen as essential, there was disagreement on how to implement it. Interviewees raised concerns about redundancy for grant-supported projects, unclear distinctions between scientific and ethical reviews, efficiency delays, reviewer qualifications and intellectual property risks. Although management by study type might help control risks, the qualification restrictions on the leading sites and investigators were viewed as excessively stringent. No institution has achieved whole-process supervision of all IISs, primarily due to insufficient human resources, ineffective supervision and management systems, and insufficiently trained professionals.
This study reveals that the current management of IISs is generally weak in Beijing and should be strengthened by implementing Management Measures. However, major challenges existed for the implementation, mainly including: a lack of clear and feasible management models to follow, insufficient human resources for both scientific review and whole-process supervision, and worries about restricting research initiatives. It takes time to overcome these challenges, which may be achieved through building management capacity at national, regional and institutional levels, learning successful management models that were piloted in various regions and further policy research to develop specific guidance.
《医疗机构开展研究者发起的研究管理办法（试行）》（以下简称《管理办法》）自2021年10月1日起先后在全国12个省级地区开展试点，并于2024年10月1日起在全国实施。本研究旨在探讨北京医疗机构管理人员和研究者对研究者发起的研究（IIS）管理的看法、态度和挑战，为我国提供进一步的战略指导。
本描述性定性研究包括在北京分层选取的25家医疗机构的74名参与者进行的13次焦点小组讨论，其中包括13名行政管理人员、41名职能管理人员和20名研究者代表。焦点小组讨论于2021年11月至12月进行。讨论主题集中在医疗机构IIS管理的现状以及参与者在实施《管理办法》时的态度和挑战，主要涉及具体管理体系的建立、独立科学审查、按研究类型管理和全过程监督。
机构负责人/主任对临床研究管理委员会和办公室的设立意见不一，在人力资源不足以及与现有管理模式整合困难方面发现了重大挑战。虽然科学审查被视为至关重要，但在如何实施方面存在分歧。受访者对资助项目的冗余、科学审查与伦理审查之间的区别不明确、效率延迟、审查员资质和知识产权风险表示担忧。尽管按研究类型管理可能有助于控制风险，但对牵头机构和研究者的资质限制被认为过于严格。没有机构实现对所有IIS的全过程监督，主要原因是人力资源不足、监督管理体系无效以及专业人员培训不足。
本研究表明，目前北京IIS的管理总体薄弱，应通过实施《管理办法》加以加强。然而，实施过程中存在重大挑战，主要包括：缺乏明确可行的管理模式可遵循、科学审查和全过程监督的人力资源不足以及担心限制研究积极性。克服这些挑战需要时间，这可以通过在国家、地区和机构层面建设管理能力、学习各地区试点的成功管理模式以及进一步开展政策研究以制定具体指导来实现。
