Clinical trials with the domestic registration certificate of photonic instrument NMPA must meet strict ethical requirements to protect the rights and safety of trial participants. The following are typical ethical requirements:
Medical Ethics Review: Before a clinical trial can be conducted, the trial protocol must be submitted for review by the Medical Ethics Board (IRB). The IRB will review the trial protocol, including the purpose of the study, trial design, risk assessment, subject recruitment, informed consent procedures, etc.
Informed Consent: All trial participants must provide informed consent to voluntarily agree to participate in the trial after fully understanding the purpose, process, risks, and benefits of the trial. The informed consent form must be written in a language that the subject can understand, while the privacy of the subject must be protected.
Protection of the rights and interests of trial participants: During the trial, the rights and safety of trial participants must be protected. This includes knowing and respecting the wishes of the subjects, ensuring that their privacy is protected, and minimising any harm that may be caused to the subjects during the trial.
Risk assessment and management: In the trial protocol, it is important to assess the risks that may arise from the trial and take steps to minimize the risks. The safety and well-being of trial participants should always be a top priority.
Data Confidentiality and Protection: The data generated during the test must be kept confidential and handled in strict accordance with relevant laws and regulations. It is essential to protect the privacy of trial participants.
Handling of unforeseen events: During the trial, unforeseen events or adverse reactions may occur. In such cases, the tester must immediately take appropriate action, including suspending the test, adjusting the test protocol, or providing an appropriate **.
Review and supervision: The trial should be reviewed and supervised regularly during the trial to ensure that the trial complies with ethical requirements and relevant regulations, and that the rights and interests of the subjects are protected.
When conducting clinical trials with the domestic registration certificate of photonic instrument NMPA, the above ethical requirements must be strictly observed, and the legality, scientificity and feasibility of the test protocol must be ensured. It is recommended to cooperate with a professional clinical research team and medical ethics committee to ensure the smooth conduct of the trial and the protection of the rights and interests of the trial participants.