Enhancing Capacity in Human Subject Protections for Chinese Research Studies

Falletta, John

Abstract

Enhancing capacity in human subject protections for Chinese research studies The goal of this proposal is to enhance the capacity of investigators in the People's Republic of China to meet both their national standards for protecting human research subjects and international standards so that their research data are accepted widely. This new effort to ensure the protection of human subjects in research will be presented to the research community as a comprehensive Human Research Protection Program (HRPP). The initial focus of this proposal will be to develop a new Institutional Review Board (IRB) at the Peking University Clinical Research Institute (PUCRI). This new IRB will function in compliance with all Chinese regulations and guidance, as well as with International Conference on Harmonization-Good Clinical Practice Guidelines (ICH- GCP E6), and where applicable, U.S. Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations and guidance. The new PUCRI IRB and its associated HRPP will serve as a model for other human research review programs within Peking University, as well as for such programs in affiliated hospitals in Beijing, and for hospitals in 5 northern provinces of China that are affiliated with PUCRI through a separate NIH Research Centers of Excellence (COE) grant funded by the U.S. National Heart, Lung and Blood Institute.
The specific aims of this research are to: 1) Constitute and promote development of the newly created PUCRI IRB;2) Enhance human subjects training materials available for newly created PUCRI IRB;and 3) Disseminate ethics training to affiliated institutions in Beijing and supplement training to the NHLBI-funded Center of Excellence partner institutions.

Public Health Relevance

""""""""As a result of this project, the research studies involving humans conducted at the Peking University Clinical Research Institute (PUCRI) and collaborating sites will be reviewed by specially trained experts. Approval of research studies by these experts will indicate that the safety, rights and welfare of human subjects who participate in this research at PUCRI will be protected in a manner comparable to how such subjects would be protected if the research were conducted at accredited research institutions in the U.S.""""""""