Evaluation of the effectiveness of intervention to improve the quality of Ethics Committees in biomedical research in Northern, Central and Southern Vietnam, 2016 - 2018

Abstract

The aim of this quasi-experimental study was to evaluate the operational quality of the Institutional Review Board in biomedical research in several City/Provinves in Northern, Central and Southern, Vietnam during 2016 - 2018. There were purposefully selected 10 Institutional Review Board representing 04 IRBs universities, 03 IRBs research institutes and 03 IRBs leading hospitals. Study design is an experimental pseudo-intervention. The intervention content includes: amending and supplementing some regulations on the organization and operation of the IRB; modifcations to some of the IRB’s comment forms; training on SOPs for IRBs. The collected data about the situation of 10 IRBs before and after intervention were compared. The results showed that, after the intervention, IRBs operation arcording to 09 newly added topics relating to Institutional Review Board members criteria and 12 revised topics in current legal affairs ensure the independence and justice
of Ethics Committees in Vietnam. Moreover, 04 forms have been in used among activities of Institutional Review Board to be completly designed in this study, which contain the check list for each criteria assesment of the form. Especialy, the impacts on improving the quality of Institutional Review Board operations were recorded among 10 interventioned IRBs, 8 out of
10 Institutional Review Boards have successed to develope SOP set for their operations. The results suggested that the IRBs need to self-assess to improve the quality of progress in order participate in International accrediting organizations.