Journal of Molecular Biomarkers and Clinical Trials

Improving and Preventing Lapse in Institutional Review Board Continuing Review Approval

* Min-Fu Tsan
Department Of Molecular Biomarkers, USA , United States

*Corresponding Author:
Min-Fu Tsan
Department Of Molecular Biomarkers, USA , United States
Email:minfu.tsan@gmail.com

Published on: 2017-11-25

Abstract

Continuing review of on-going research is one way by which institutional review boards (IRBs) ensure the protection of human subjects participating in clinical trials. However, little is known about the prevalence of lapse in IRB continuing reviews, factors that may contribute to it, and measures to prevent its occurrence. Analysis of the United States Department of Veterans Affairs (VA) research facility’s IRB continuing review performance metric data revealed that lapse in IRB continuing reviews was the most commonly identified noncompliance, with lapse rates of 6-7% over a 4-year period from 2010 through 2013. However, investigators from less than 3% of lapsed protocols continued research activities during the lapse. The types of IRB used and the sizes of human research programs had no correlation with the facility’s IRB continuing review lapse rates. While 60% of facilities had no lapse in IRB continuing reviews, approximately 20% of facilities had lapse rates of >10% each year. High IRB continuing review lapse rates could be readily improved by implementing measures such as tracking expiration dates of IRB approval; notifying investigators at least 60 days prior to approval expiration; investigator training and education; follow-up with investigators to ensure that continuing review applications were submitted in time for IRB review; and stopping all research activities when lapse occurs. Future studies should be directed toward defining the most cost-effective approaches to prevent and improve lapse in IRB continuing reviews.

Keywords

Human Subjects Protection; Institutional Review Board; Continuing Review

Introduction

Protection of human research subjects is an ethical mandate for all contemporary clinical trials. Continuing review of on-going research is one way by which institutional review boards (IRBs) ensure that human subjects participating in research are adequately protected. It is through continuing reviews that IRBs determine whether research is conducted according to the approved protocols, adverse events are properly reported, and risks to subjects remain reasonable relative to anticipated benefits from the research [1-3].