Self-Assesment of Whether QI/ClinicalAudit Projects Require IRB Approval

Introduction

There are often legislative requirements that stipulate research projects involving people or their health information must be reviewed by a designated Research Ethics Board (REB. CCH=IRB). This raises a number of questions. For example, what should be done with projects that are not considered research but involve people or their health information? Should quality improvement, quality assurance, or program evaluation projects also be reviewed by an REB? What are the characteristics of research verus quality/evaluation projects? Some of these questions remain the subject of lengthy debate.2
Recommended References
1. Dixon, N. Review of Ethics Issues related to Clinical audit and quality Improvement Activities. [literature review] Available at http://www.hqip.org.uk/ [Accessed 2009-10-03].
2. ARECCI Ethics Screening Tool developed by the Alberta Research Ethics Community Consensus Initiative (ARECCI) Network (2005, revised 2008) at www.ahfmr.ab.ca/arecci/screening [Accessed 2010-02-15].

Strategy: from the beginning of the year 2010, all quality improvement and clinical audit projects in the Changhua Christian Hospital league of hospitals must be reviewed for ethics issues and whether the project should apply for IRB approval. This self-assessment tool will help to screen projects. The result will be one of the following three IRB categories:
  • Full review
  • Expedited Review
  • Exempt from Review
and will be documented as such by the IRB committee and seal.


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Article Information
Title: Self-assessment of QIRB
Subtitle: Self-assessment of Ethics Issues Related to Quality Improvement and Clinical Audit
Author:
Article URL: http://www.qi.org.tw/Surveys/qirb.aspx
Created: 2010-03-01 17:40
Updated: 2010-03-02 21:33
Keywords: Ethics, Quality Improvement,Clinical Audit
Description: Self-assessment of Ethics Issues Related to Quality Improvement and Clinical Audit