Ethical review. Engaged in biomedical new technology clinical research, should pass the ethical review, and in the appropriate conditions of the medical institutions; human clinical research operations, should be carried out by the appropriate conditions of health professionals and technicians.
The state implements retroactive management of important equipment and special biological factors related to biosafety. The purchase or introduction of important equipment and special biological factors included in the control list shall be registered to ensure traceability, and reported to the relevant departments of the State Council for the record.
Biomedical new technology to regulate the clinical application
Emphasis on the main responsibility of the institution: clear to carry out (including leading or participating in) clinical research of medical institutions to assume the main responsibility. Clearly carry out clinical research medical institutions should have certain conditions, the specific conditions are formulated separately.
The main person in charge of the medical institution is the first person responsible for the management of the organization's clinical research. Medical institutions for other institutions to provide technical support, research sites, provide human cells, tissues, organs and other samples, to assist in the recruitment of volunteers, the institution and the participants also bear the corresponding responsibility.
Reference to the above? Baidu Encyclopedia - Regulations on the Administration of Clinical Application of New Biomedical Technologies