Abstract

With the rapid development of biotechnology, ethical issues of scientific activities are more and more serious, while the ethical review as the main means of suppressing research ethics problems, it also has many problems in the process of practice. This article from the ethics review committee’s organizational structure, operation specifications, capacity, the scope of review and external regulation summarize the main problems of China's research ethics review, and on this basis, we put forward the corresponding countermeasures, hoping to provide certain reference of our country's research ethics review practice, and to better safeguard the healthy development of our country's scientific research.

Highlights

  • The Necessity of Research Ethics ReviewWith the rapid development and deepening of biotechnology, the contemporary scientific research is combined closely with commerce, market, financing funds, and the purpose and test pattern of the biomedical trials involving the human body has occurred and is undergoing a profound change, there are complex links between the various stakeholders, making scientific research process hide complex interst conflicts, many scientific research infringe upon the rights of the subjects, the project approval, design implementation, papers publishing, and the results reporting process filled with complex and sharp ethical issues

  • This article from the ethics review committee’s organizational structure, operation specifications, capacity, the scope of review and external regulation summarize the main problems of China's research ethics review, and on this basis, we put forward the corresponding countermeasures, hoping to provide certain reference of our country's research ethics review practice, and to better safeguard the healthy development of our country's scientific research

  • The regulatory model for ethical safeguards has attracted a lot of attention: ethical review has evolved into a "research ethics industry." Western countries with complete ethics review system all have a specialized agency to oversee the operation of ethical review committee, such as the U.S OHRP, UK NRES and the Swedish central ethical review committee

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Summary

The Necessity of Research Ethics Review

Modern ethics review originated in Western, in 1946 "Nuremberg Code" make regulations for human medical trials to follow the ethical principles, and put forward four principles of human medical trials. In 1974 the U.S Congress named the agency reviewing those research program involving human subjects Institutional Review Board, abbreviated as IRB[3]. The ethical review system has been running for more than thirty years in the West, and become the important measure to protect human research subjects. Technology and health authorities recognize the importance of ethical review, and increasing the force of review biomedical research involving human research and application. In the context of the rapid development of biomedical research, how to be in line with international standards, build research ethics review system with Chinese characteristics and promote the healthy development of biomedical research, is both a practical problem needing to be solved and a theoretical problem needing in-depth study

Organization Building
Operating Specifications
Members Capability
Review Scope
External Oversight
Countermeasures and Suggestions
To Establish Standard Operating Procedures
To Strengthen the Training and Continuing Education for Members
To Establish the Feedback and Tracking Review Mechanisms
To Speed up the Construction of Regulatory System
Summary
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