Perceptions of clinicians and research ethics boards regarding ethical issues in investigator-initiated trials: a multicenter qualitative study in China

Abstract

Abstract Purpose This multicenter qualitative study aimed to explore the perceptions of clinicians and research ethics boards (REBs) regarding ethical issues in Investigator Initiated Trials (IITs). Methods Between February and April 2024, semi-structured interviews were conducted with 27 participants from 15 tertiary hospitals, including clinical doctors and members of REBs. Responses were grouped and analyzed using a descriptive phenomenological approach. Results Clinicians expressed challenges in navigating the formal review process due to limited access to information and unclear guidelines. Academic review highlighted a deficiency in research literacy among clinical investigators, leading to flawed study design. Ethical review revealed concerns about inadequate ethical awareness among clinicians, resulting in failed ethical approvals. Moreover, delays in review processes and resource shortages were noted, hindering the efficient conduct of IITs. Conclusion The findings underscore the need for comprehensive training programs to enhance clinicians’ research literacy and ethical awareness. Establishing a comprehensive system to support IITs, including enhanced guidance and support from REBs, is essential to ensure the quality and integrity of IITs in China.

Keywords

• Ethical issues
• Investigator-initiated trials
• Clinical researchers
• Research Ethics boards