Problems and Proposal of Ethical Review on Clinical Application of Medical Technology
10.12026/j.issn.1001-8565.2023.01.06
- VernacularTitle:医疗技术临床应用的伦理审查问题及建议
- Author:
Lu LIU
1
;
Qiuju ZHANG
2
;
Dan LIU
3
;
Jin ZHENG
4
;
Jiyin ZHOU
3
Author Information
1. Department of Gastroenterology,the Second Affiliated Hospital, Army Medical University, Chongqing 400037, China
2. School of Basic Medicine, Air Force Medical University, Xi’an 710032, China
3. National Drug Clinical Trial Institution, the Second Affiliated Hospital, Army Medical University, Chongqing 400037, China
4. Scientific Research Office, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, China
- Publication Type:Journal Article
- Keywords:
Medical Technology;
Clinical Application;
Ethical Review;
Ethics Committee
- From:
Chinese Medical Ethics
2023;36(1):33-40
- CountryChina
- Language:Chinese
-
Abstract:
With the change of medical technology from "access management" to "filing management" in China, it is necessary for medical institutions, as the main responsibility, to pass standardized ethical review and supervision. However, there are many problems at present, such as the absence of regulations and guidelines for ethical review of clinical application of medical technology, the lack law of medical technology ethical review standard operating procedures, the insufficient review capacity, the lack of standardization in the choice of ethical review methods, the elements of informed consent and its examination need to be discussed, the lack of appropriate continuing review mode, as well as the confirmation of technical team members and department qualifications is not clearly defined. In order to safeguard the safety and rights of patients, it is important to take the following measures, including carrying out the whole-process supervision of medical institutions, clarifying the supervision process, improving the multi-departmental communication and cooperation mechanism, establishing a management committee for clinical application of medical technology, standardizing the review system of the medical technology ethics committee, clarifying submit the list of materials for ethical review, implementing classified ethical review and supervision to improve efficiency, exploring the tracking review mode, ensuring the whole-process supervision, and carrying out popular and professional ethics training. In the review of ethics committee, more attention should be paid to the main points of review, such as technical scheme, informed consent, qualifications of technical team members and departments, management system, risk assessment and emergency plan, patient compensation and other materials. While ensuring the safety and rights of patients, it also helps to accelerate the healthy development of medical technology.
