Desai Abhidnya Vasant, Hawaldar Rohini W, Divatia Jigeeshu V
Department of Institutional Review Board, Tata Memorial Hospital, Mumbai, Maharashtra, India.
Department of Anaesthesiology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
Perspect Clin Res. 2017 Jul-Sep;8(3):145-147. doi: 10.4103/2229-3485.210445.
The aim of this study was to evaluate the process of accreditation resulting in improvement of the Institutional Review Board (IRB) functioning.
Randomly selected projects from years 2007 (before accreditation), 2010 (after accreditation), and 2013 (after reaccreditation) were evaluated to assess parameters, namely, submission of good clinical practices (GCPs), completeness of IRB submission form, fulfillment of quorum, documentation of the declaration of conflict of interests, and submission of the status reports. Compliance to these parameters was compared over a period of 3 years.
A total of seventy projects were evaluated retrospectively. Compliance of the principal investigators regarding submission of GCP certificates increased substantially from 5% to 53.1%. Completeness of IRB forms was 80% in 2007 while it became 100% in 2010 and continued even in 2013. Fulfillment of quorum increased significantly from 35% in 2007 to 100% in 2010 and 2013 after the accreditation procedures. Out of the selected twenty projects (2007), nonfinancial conflict of interest was not declared in all three applicable projects, while of 18 projects (2010), nonfinancial conflict of interest was declared in all three applicable cases. Of 32 projects (2013), nonfinancial conflict of interest was declared in seven out of eight applicable cases. Timely submission of status reports increased from 10% in 2007 to 38.9% in 2010 and 37.5% in 2013.
Accreditation plays a vital role in the improvement of IRB. The policies and procedures formulated and implemented during the process of accreditation resulted in improvement of IRB performance. Continuing training of the IRB and researchers is required to maintain the accreditation.
本研究旨在评估认证过程对机构审查委员会（IRB）运作改进的影响。
从2007年（认证前）、2010年（认证后）和2013年（再认证后）随机选取项目，评估以下参数：良好临床实践（GCP）的提交情况、IRB提交表格的完整性、法定人数的满足情况、利益冲突声明的记录以及状态报告的提交情况。对这些参数在3年期间的合规情况进行比较。
共回顾性评估了70个项目。主要研究者提交GCP证书的合规率从5%大幅提高到53.1%。2007年IRB表格的完整性为80%，2010年达到100%，2013年仍保持这一水平。认证程序后，法定人数的满足率从2007年的35%显著提高到2010年和2013年的100%。在所选的20个项目（2007年）中，所有3个适用项目均未声明非财务利益冲突；而在18个项目（2010年）中，所有3个适用案例均声明了非财务利益冲突。在32个项目（2013年）中，8个适用案例中有7个声明了非财务利益冲突。状态报告的及时提交率从2007年的10%提高到2010年的38.9%和2013年的37.5%。
认证在IRB的改进中起着至关重要的作用。认证过程中制定和实施的政策与程序使IRB的表现得到了改善。需要对IRB和研究人员进行持续培训以维持认证。
