Exploration of Ethical Review Disputes and Regulatory Pathways of Off-label Drug Use
The ethical risks of off-label clinical use of drugs include many risks, incomplete laws and regulations, difficulties in risk-benefit assessment, and challenges in managing conflict of interest management and obtaining informed consent. There are no clear regulations in China that require ethics co...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | Chinese |
| Published: |
Editorial Office of Medicine and Philosophy
2025-02-01
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| Series: | Yixue yu zhexue |
| Subjects: | |
| Online Access: | https://yizhe.dmu.edu.cn/article/doi/10.12014/j.issn.1002-0772.2025.04.06 |
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| Summary: | The ethical risks of off-label clinical use of drugs include many risks, incomplete laws and regulations, difficulties in risk-benefit assessment, and challenges in managing conflict of interest management and obtaining informed consent. There are no clear regulations in China that require ethics committees to review off-label drug use in clinical settings, and it is difficult to provide complete documents for ethics review for each off-label drug use case. There is a lack of standardized operating procedures and corresponding forms for the ethical review of off-label drug use. It is recommended that higher-level departments uniformly assess off-label drug use in clinical practice, rather than allowing ethics committees to arbitrarily expand their review scope. Healthcare institutions should strengthen supervision from an ethical perspective, which could serve as a supplement to the imperfect supervision of laws and regulations, further promoting the safe and standardized use of drugs. |
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| ISSN: | 1002-0772 |