The ethics committee shall keep all records of the ethics review, including ethics review applications and related materials, ethics review meeting minutes and resolutions, and ethics review correspondence and feedback.
1. Ethical review application and related materials
Ethical review application is a document submitted by a researcher or doctor to the ethics committee, which includes a detailed description of the research or medical plan, research participants Recruitment methods, informed consent forms, questionnaires, and use of experimental equipment. These materials are the basis for ethical review and record the researcher's or doctor's research intentions, methods, and measures to protect the rights and interests of research participants.
2. Ethical review meeting minutes and resolutions
The ethics committee will hold a meeting to discuss ethical review applications and review each application in accordance with ethical guidelines and standards. Ethical review meeting minutes include meeting agenda, list of participants, discussion content, expert opinions, resolution results, etc. These records are an important basis for the decision-making process of the ethics committee and are also a way to be disclosed to the outside world to track and supervise the procedures and results of the ethical review.
3. Communication and feedback on ethics review
Records of communication and feedback between the ethics committee and researchers or doctors should also be kept. These communications include ethics review opinions, review results notifications, letters requesting modifications or supplementary materials, etc. Keeping these records helps researchers or doctors understand the requirements and recommendations for ethical review, and also ensures that communication and feedback between the ethics committee and the applicant are transparent and consistent.
Notes on ethical review:
1. Ensure the transparency and fairness of ethical review
Ethical review should be based on the principles of fairness, objectivity and transparency. The review process should be made public and the results of the review should be reported to relevant parties in a timely manner. Avoid problems such as abuse of power and information asymmetry, and protect the interests of those being reviewed.
2. Ensure the legitimacy of ethical review
Ethical review should comply with relevant laws and regulations to ensure the legitimacy of the review process and results. Review agencies should have appropriate legal authority and establish clear review rules and procedures.
3. Ensure the professionalism of ethical review
Ethical review should be conducted by experts with relevant professional knowledge and experience. The review agency should establish a professional review team, including ethicists, legal experts, medical experts, etc., to ensure the scientificity and reliability of the review process and results.
4. Ensure the comprehensiveness of ethical review
Ethical review should comprehensively consider various factors, including scientific rationality, social benefits, risk and benefit balance, etc. Review agencies should develop corresponding ethical review guidelines and standards to ensure the comprehensiveness and comprehensiveness of the review process and results.
5. Ensure the timeliness of ethical review
Ethical review should be conducted in a timely manner to avoid delays in scientific research progress or medical treatment and other activities due to review. The review agency should establish an efficient review mechanism to provide rapid review services while ensuring the quality and reliability of the review process.