Question: What support can companies provide to researchers in clinical studies initiated by researchers (IIT/IIR)? How to avoid conflicts of interest
Answer: In IIT/IIR, the applicant is the hospital/unit where the researcher is located. Pharmaceutical enterprises should consider formulating the corresponding SOP for the management of IIT/IIR, and also refer to Article 25 of the Administrative Measures for Medical and Health Institutions to Conduct Clinical Research Initiated by Researchers (Trial) issued by the Health Commission in 2021. If medical and health institutions are entrusted by other institutions to carry out clinical research or participate in multi center clinical research, they should sign a clinical research agreement with the entrusted, funded institutions or multi center clinical research leading institutions, Clarify the rights, obligations, and responsibility sharing of both parties. Enterprises can entrust and fund researchers to carry out IIT in various ways, such as providing research drugs and devices, or providing research funding. However, regardless of the type of funding, a clinical research agreement must be signed that clearly defines the rights, obligations, responsibilities, and intellectual property ownership of all parties. Enterprises should comply with relevant laws, regulations, and norms, formulate management policies to avoid conflicts of interest, combat corruption and bribery, and SOP for funding delegation to regulate these behaviors.