Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.