RESUMEN
In the implementation of exemption from ethical review， medical institutions equate exemption from ethical review with no ethical review or simple review， misunderstand the scope of exemption from ethical review， confuse the concepts of de-identification and anonymization， and equate privacy with personal information. The implementation faced challenges such as the coordination of conditions for exempt review with other regulations， the lack of clear decision-making subjects for exempting from ethical review， the legality and compliance of using general informed consent for biological samples and information data， as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review. Measures such as improving relevant laws and regulations， perfecting the construction and management of information databases and biological sample libraries， strengthening the project management and process supervision of exemption from ethical review， and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.
RESUMEN
The release of the Measures of Ethical Review of Life Sciences and Medical Research Involving Humans has brought new requirements to the field of ethical review in health management research. Based on the background of new regulations and combining the characteristics of the health management discipline， this paper explored the needs and necessity of ethical review in health management research. In the Measures， the ethical governance of health management research was updated， the concept of exemption from the ethical review was put forward， as well as the importance of protecting the rights and interests of research participants and the protection of personal information were emphasized. This paper also explored the ethical review framework for health management research， including the formulation of operational standards for exemption from ethical review， the refinement of standardized ethical review work systems and processes， and the clarification of information data source verification. These explorations aimed to provide an ethical guarantee for health management research， promote its healthy development， and ensure that the rights and interests of research participants are fully respected and protected. Through research， it is hoped that the ethical level of health management research can be further improved， promoting the development of the discipline and social progress.
RESUMEN
Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans. "Exemption from ethical review" was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023. To implement the exemption from ethical review within the permitted scope of laws and regulations, and to protect the privacy and rights of research participants when utilizing their data information and biological samples, multiple factors need to be considered, including the person responsible for exemption from ethical review, the conditions for exemption from ethical review, and the specific process for exemption from ethical review. As with other review procedures, exemption from ethical review also required the development of corresponding systems, implementation of responsibilities, and reliance on the construction of subject protection systems. It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.