Role of accreditation in quality improvement of institutional Review Board.

AIM

The aim of this study was to evaluate the process of accreditation resulting in improvement of the Institutional Review Board (IRB) functioning.

METHODOLOGY

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.

RESULTS

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.

CONCLUSION

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.