[IIT] Announcement on Public Comment Soliciting on the “Administrative Measures for Investigator Initiated Clinical Trials by Medical and Health Institutions (Draft for Comments)”

Measures for the Administration of Clinical Research Initiated by Medical and Health Institutions

(Draft for Comments)

Chapter I General Provisions

Article 1 (Purpose) In order to standardize the management of clinical research, improve the quality of clinical research, promote the healthy development of clinical research, and enhance the ability of medical and health institutions to diagnose, treat, prevent and control diseases, these Measures are formulated in accordance with the Basic Medical and Health Care and Health Promotion Law, the Science and Technology Progress Law, the Practicing Physician Law, the Drug Administration Law, the Medical Institution Management Regulations, the Measures for the Ethical Review of Biomedical Research Involving Human Beings and other relevant laws and regulations.

Article 2 (Research Definition) The term "investigator-initiated clinical research" (hereinafter referred to as clinical research) as used in these Measures refers to activities such as the diagnosis, treatment, rehabilitation, prognosis, etiology, prevention and health maintenance of diseases conducted by medical and health institutions (hereinafter referred to as institutions) with human individuals or groups (including medical and health information) as research subjects and not for the purpose of drug and medical device registration.

Article 3 (Basic Principles) Institutions conduct clinical research to explore the laws of medical science and accumulate medical knowledge. They shall not conduct clinical diagnosis and treatment or group disease prevention and control activities beyond the scope in the name of clinical research.

During clinical research, institutions and their researchers must fully respect the subjects' right to know and right to make independent choices.

Article 4 (Research Qualifications) Institutions and their researchers shall obtain the qualifications prescribed by laws and regulations, and have the corresponding capabilities and necessary financial guarantees to conduct clinical research.

Article 5 (Institutional Responsibilities) Institutions are the responsible entities for the implementation of clinical research. They shall comply with relevant laws and regulations, departmental regulations, normative documents, technical standards, and ethical norms when conducting clinical research, formulate effective implementation rules for clinical research management, establish and improve the organizational system, quality system, conflict of interest prevention mechanism, and research subject rights protection mechanism to ensure scientific, standardized, and orderly clinical research, and strengthen the verification and whole-process management of clinical research. Actively support and organize academic exchanges and training on clinical research.

Institutions shall reasonably judge the risks of clinical research based on their own actual conditions, and implement classified management of clinical research based on research types, intervention measures, etc.

Article 6 (Responsibilities of Researchers)  The principal investigator of clinical research shall be responsible for the scientificity and ethical compliance of clinical research, shall strengthen the training and management of other researchers, perform appropriate attention obligations to research subjects, and properly handle them when necessary.

The principal investigators and other researchers of clinical research shall abide by the scientific research integrity, shall not fabricate or tamper with data, and shall not plagiarize the achievements of others. According to the requirements of relevant laws and regulations, departmental regulations, relevant normative documents, technical standards, ethical norms and rules and regulations formulated by the institution, strengthen the self-examination of the clinical research process and report relevant matters in a timely and truthful manner.

Article 7 (Professional Management)  The provincial and above health administrative departments shall establish expert committees or designate relevant professional institutions to comprehensively grasp and regularly sort out the clinical research conducted by institutions within their jurisdiction, strengthen the supervision and management of clinical research and overall coordination through professional academic guidance, ethical review supervision, research funding support, etc., support and organize academic exchanges and training on clinical research, and promote the quality and efficiency of clinical research.

Article 8 (Emergency)  During the emergency response to public health emergencies, the National Health Commission or its designated national professional institutions may take the lead in organizing clinical research across the country on the basis of scientific demonstration.

When the clinical research independently conducted by the institution conflicts with the above research, the institution shall give priority to completing the above research and suspend the enrollment of new subjects in the clinical research independently conducted by the institution.

Specific news link: "Administrative Measures for Investigator-Initiated Clinical Research Conducted by Medical and Health Institutions"