Journal of Clinical Research & Bioethics

The possibility of the use of single Institutional Review Board (IRB) for multi-site research in China

3^rd International Conference on Advanced Clinical Research and Clinical Trials

September 20-21, 2017 Dublin, Ireland

Shuo Chen and Lijun Liu

Institute of hematology and Blood Diseases Hospital �?? CAS, China

Scientific Tracks Abstracts: J Clin Res Bioeth

Abstract:

With the rapid development of biomedicine in recent years, multi-site research has become the world trend; as a result, there is no other way but to apply for multi-IRB review for the commencement of the trial. The duplicate IRB review by each site increases administrative burdens and cost for sponsors and brings no substantive good to the human subject protection. In October 2016, National Health and Family Planning Commission in China issued Guideline on the IRB review on the biomedical research involving human subjects. It mentions in order to keep the consistency and efficiency of multi-center research, the IRB in each site can establish a collaborative review mechanism, which means the lead site reviews the protocol and rely site reviews its feasibility. In June 2016, the National Institutes of Health (NIH) issued new guidance on single-IRB review of multicenter studies, which brings a new era in multicenter studies.

Biography :

Lijun Liu has his expertise in the administrative work of clinical trial. He has been working for the clinical trials in the hospital. He was also the secretary of the ethic committee in hospital, who did a lot of pioneering work for the initiation of ethic committee. He is one of the CFDA (China Food and Drug Administration) inspectors in China and helped inspection work several times.