Administrative Measures for Researcher-Initiated Clinical Research Conducted by Medical and Health Institutions (Trial)
Release Date:
2021-09-15 17:18
Recently, the National Health Commission convened in Beijing a kickoff meeting for the pilot program on standardized management of clinical research in medical and health institutions, at which it officially released the Measures for the Administration of Investigator-Initiated Clinical Research Conducted by Medical and Health Institutions (Trial) and announced that the measures would be implemented on a pilot basis starting October 1, 2021, in Beijing, Shanghai, Guangdong Province, and Hainan Province. The full text is as follows:
Healthcare institutions conduct investigator-initiated Administrative Measures for Clinical Research (Trial)
Chapter 1 General Provisions
Article 1 In order to standardize the management of clinical research, enhance the quality of clinical research, promote the healthy development of clinical research, and strengthen the capacity of medical and health institutions in diagnosis and treatment as well as disease prevention and control, these Measures are formulated in accordance with relevant laws, regulations, and departmental rules, including the Basic Medical and Health Care and Health Promotion Law, the Science and Technology Progress Law, the Practicing Physicians Law, the Drug Administration Law, the Regulations on the Administration of Medical Institutions, and the Measures for Ethical Review of Biomedical Research Involving Human Subjects.
Article 2 Investigator-initiated clinical research conducted by medical and health institutions (hereinafter referred to as “clinical research”) refers to activities undertaken by such institutions that take individual persons or populations—including medical and health information—as the subjects of study, are not aimed at the registration of pharmaceuticals, medical devices (including in vitro diagnostic reagents), or other products, and seek to investigate disease diagnosis, treatment, rehabilitation, prognosis, etiology, prevention, and health maintenance.
For the purposes of these Measures, “medical and health institutions” include medical institutions of all levels and types, disease prevention and control institutions, blood collection and supply institutions, and maternal and child health care institutions.
Article 3 Medical and health institutions shall conduct clinical research solely to explore the principles of medical science and accumulate medical knowledge; they shall not, under the guise of clinical research, engage in clinical diagnosis and treatment or population-based disease prevention and control activities that exceed the scope of their authorized functions.
All clinical studies shall undergo scientific review and ethical review.
During the conduct of clinical research, healthcare institutions and their researchers shall fully respect the right of research subjects to informed consent and their right to autonomous decision-making.
Article 4 Medical and health institutions and their researchers conducting clinical research shall obtain the clinical qualifications required by laws and regulations and possess the requisite capabilities and adequate financial resources.
Article 5 Healthcare institutions are the principal entities responsible for conducting clinical research. When undertaking such research, they must comply with relevant laws and regulations, departmental rules, normative documents, technical guidelines, and ethical standards; develop practical and effective implementation procedures for clinical research management; establish and improve organizational structures, quality assurance systems, mechanisms for preventing conflicts of interest, and mechanisms for protecting the rights and interests of research participants to ensure that clinical research is conducted in a scientific, standardized, and orderly manner; and strengthen quality assurance and full-process management of clinical research. They should also actively support and organize academic exchanges and training in the field of clinical research.
Medical and health institutions shall, based on their specific circumstances, appropriately assess the risks associated with clinical research and implement categorized management of such research in accordance with factors such as the type of study and the interventions employed.
Article 6 The principal investigator of a clinical study is responsible for the scientific integrity and ethical compliance of the study, shall strengthen the training and management of other investigators, and shall fulfill an appropriate duty of care toward research participants and provide appropriate management when necessary.
Principal investigators and other researchers in clinical research shall uphold research integrity. In accordance with relevant laws and regulations, departmental rules, normative documents, technical guidelines, ethical standards, and the internal rules and regulations established by medical and health institutions, they shall strengthen self-inspection of the clinical research process and promptly and accurately report any relevant matters.
Article 7 Provincial-level and higher health administrative departments shall establish expert committees or select relevant specialized institutions to comprehensively monitor and regularly review the conduct of clinical research by medical and health institutions within their jurisdictions. Through professional academic guidance, ethical review and oversight, and research funding support, they shall strengthen the supervision, management, and coordinated planning of clinical research; support and organize academic exchanges and training in clinical research; and promote improvements in the quality and effectiveness of clinical research.
Article 8 During the emergency response to a public health emergency, provincial-level and higher health administrative departments, or designated specialized institutions under their authority, may, on the basis of scientific justification and in accordance with the scope of the emergency response, take the lead in organizing clinical research at the provincial or national level.
When clinical research independently conducted by medical and health institutions conflicts with the aforementioned research, the institutions shall prioritize the completion of the latter while suspending the enrollment of new participants in their own independently conducted clinical research.
Chapter 2: Basic Classification and Principle-Based Requirements
Article 9 Clinical research can be classified into observational studies and interventional studies depending on whether the researcher actively imposes a specific intervention—hereinafter referred to as a research intervention—based on the study objectives.
Article 10 Observational studies shall be conducted without imposing any research interventions on the study subjects and without subjecting them to additional health (disease) risks or financial burdens that exceed those inherent in routine clinical care or disease prevention and control.
When the study subjects, by participating in an observational study, undergo additional examinations, tests, diagnostics, or other interventions that exceed the scope of routine clinical care or disease prevention and control, and such procedures may pose risks exceeding the minimal risk level, they shall be governed in accordance with the regulations for interventional studies.
Article 11 Conduct intervention studies in which the investigational interventions comply with fundamental medical theories and ethical standards, are grounded in robust prior research, are supported by scientifically sound study protocols and risk management plans, and have undergone both scientific review and ethical review.
Medical and health institutions and researchers shall assess the potential risks associated with interventional studies, possess appropriate capabilities to manage such risks, and duly safeguard the health rights and interests of research subjects (hereinafter referred to as “subjects”). They shall
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