RESUMO
It is the responsibility of a clinical research institution to protect the rights and interests of research subjects. For the full process supervision of clinical research projects, the construction of a Human Research Protection Program (HRPP) which is suitable to the hospital’s situation can gradually improve the ethical review quality, and provide comprehensive protection measures for participants and potential participants throughout the entire clinical research process. Combined with the characteristics of clinical research and ethical review of Traditional Chinese Medicine(TCM), this paper introduced the construction of an HRPP system that highlights TCM characteristics. At the same time, this paper systematically analyzed the division of responsibilities, communication and cooperation of different committees and departments within the HRPP system to ensure the effective operation of the entire HRPP system, improve the quality of TCM clinical research and the protection level of the HRPP system, in order to achieve the goal of promote the healthy, orderly and scientific development of clinical research.
RESUMO
Objective:Improve the quality of clinical research at different stages for better protection of human subject.Methods:Introduce the operational and the administrative experiences of establishing the human research protection program in our hospital.Results:Establish human research protection program can promote the direct communication and cooperation among relevant departments of clinical research, strengthen the whole process management of clinical research.Conclusions:Developing comprehensive human research protection program and related policies play a positive role in promoting the high-quality development of clinical research in hospitals.
RESUMO
The paper introduced the preparations of the hospital in applying for AAHRPP accreditation, and the positive push on improving the human research protection program. This proved that such application can learn from overseas experiences in scientific management and improve our human research protection system in a short timeframe. The accreditation can promote the understanding of both administrators and investigators for the importance of protecting human subjects in research, especially the detailed protection procedures, and promoting clinical researches in world class quality.
RESUMO
Based on recently developed biotechnology, many new drugs have been developed for improving patient treatment outcomes. To develop novel drugs, proper clinical trials are essential. As clinical trials involve humans in research, the protection of participants is important not only for the participants' safety but also for future patients. Ethics in a clinical trial is not the same as in clinical practice with enough evidence. Hence, the whole procedure of a clinical trial should be well organized, scientifically and ethically planned, and monitored properly by an Institutional Review Board (IRB). Here the importance of ethics in clinical trials, related issues, and the monitoring system will be discussed.