Revision of the Standard Operation Procedure Regarding the Taipei Veterans General Hospital Institutional Review Board

Introduction

For the past few years, the rights and interests of the subject participated in the domestic and overseas human research are respected increasingly. Any human related research must be reviewed by the Institutional Review Board (hereinafter referred to as “IRB”). TVGH IRB has been established for more than twenty years. With rigorous and attentive attitudes for the plan review, TVGH IRB has always been a model for the IRB of other domestic medical units. The global and domestic regulations of human research have been improved continuously. The requirements and expectations for the IRB are increased day by day. Therefore, TVGH found three IRBs starting from January, 2010. The quality and effectiveness of the review have been enhanced significantly.

Information is exchanged frequently among countries. The IRB of other domestic institutions strive for the best.

The Ministry of Health and Welfare authorizes the Joint Commission of Taiwan to inspect the IRB of nation-wide institutions. Domestic IRBs communicate with each other more often. Therefore, TVGH IRB is responsible for continuously creating a fair and impartial review system, improving the efficiency and modifying the procedure.

The modification of the standard operation procedure complies with the AAHRPP accreditation. Essential modifications are made to this procedure in coordination with the adjustment of the "Protocol Tracking & Management System (PTMS)" and relevant operations. Therefore, this procedure becomes well timed and complete. TVGH IRB has thirty-six standard operation procedures for now. The "Multinational and Multicenter Trials" and "Interest Avoidance Review Procedure" are revised and enlarged so that the submission process is more complete.

The staff of the Secretariat checks, modifies and writes the standard operation procedure of IRB. The members of the standard operation procedure team review and finalize the documents for this procedure. These documents are reviewed and approved by all members. They are also submitted to the IRB review meeting and presented to the Chair for approval. This procedure will be implemented and published afterwards.

Institutional Review Board, Taipei Veterans General Hospital

Chairman

06.16.2015