Considerations of ethical issues in clinical trials for medical equipments from the perspective of the Belmont Report
10.3760/cma.j.issn.1006-1924.2013.02.004
- VernacularTitle:从贝尔蒙报告审视医疗器械临床试验的伦理问题
- Author:
Chengdong JI
;
Yan JIANG
;
Ming ZHU
;
Weimin WU
;
Juerong ZHOU
;
Kan ZHANG
- Publication Type:Journal Article
- Keywords:
The Belmont Report;
Medical equipment;
Clinical trials;
Ethical issues
- From:
Chinese Journal of Medical Science Research Management
2013;(2):84-88
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trial is the most direct and the most effective way to test the performance of medical equipments.The Belmont Report is the statement of the basic moral principles and guidelines,used to help solve the moral problems produced in scientific researches involving human subjects.This apaper examines the ethical issues in clinical trials for medical equipments from the perspective of the Belmont report.It first introduces the background and basic concepts of Belmont report,background concept and the concept and the basic process of medical equipment clinical trials.Then the three principles of the Belmont Report is presented and how to apply the Report to solve ethical problems arising in medical equipment trials.Application of informed consent risk and benefits assessment,and selection of subjects participants and the distribution of research results to address the ethical issues arising in clinical trials.
