When Is Institutional Review Board Approval Necessary for Quality Improvement Projects?

Quality improvement and evidence-based practice change projects and the institutional review board: is approval necessary?

T here is often confusion in determining whether quality improvement (QI) projects and evidence-based practice (EBP) change projects require Institutional Review Board (IRB) approval. The distinction between research and QI-EBP change projects begins with an understanding of their distinct definitions. Research is defined in the U.S. Department of Health and Human Services Federal Regulations (...

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...

Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study

The purpose of this paper is to report the variance in institutional review board (IRB) reviews as part of the implementation of a multisite, quality improvement study through the Improvement Science Research Network (ISRN) and recommend strategies successful in procuring timely IRB approval. Using correspondence documents as data sources, the level of review was identified and time to submissi...

Need for Clinical Trial Registry and Institutional Review Board Approval in Human Subjects Research

Declaration (revised edition of 2004) and in principle undergo scrutiny of an independent IRB which reviews ethical issues of the human experiment. But, in clinical studies, the approval of the IRB and patient’s consent must be received and stated on paper.” We must change our guidelines according to the revised act by changing ‘clinical studies’ to “human subjects research.” Some researchers m...

Protecting vulnerable research subjects: practical realities of institutional review board review and approval.