Fourth Annual Medical Research Summit April 21-23, 2004 Evolution of an IRB Quality Improvement Program Ada Sue Selwitz, M.A. Director, Office of Research.

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Presentation transcript:

Fourth Annual Medical Research Summit April 21-23, 2004 Evolution of an IRB Quality Improvement Program Ada Sue Selwitz, M.A. Director, Office of Research Integrity Adjunct Associate Professor, Behavioral Sciences, College of Medicine University of Kentucky J:\Data\rso\Jennifer\Presentation Materials\PowerPoint\handouts\4th Annual Medical Res Summit QIP handout.ppt

Purpose To Describe the Evolution of an IRB Quality Improvement Program (QIP) at the University of Kentucky To Discuss Lessons Learned in Developing the Quality Improvement Program (QIP)

Key Issues to Consider In Setting Up Program Lessons Learned Key Issues to Consider In Setting Up Program

What Are Your Objectives? Quality Assurance Quality Improvement QA and QI

What Standards Will You Use? 45 CFR 46 OHRP Policies 21 CFR 50 & 56 21 CFR 312, 314 ICH GCP IRB Policy

Who Oversees the Program? Internal to IRB Office External to IRB Combination

Who Assesses Findings? IRB QI – QA Staff PI ?

Existing Organization Resources What Shapes Decisions? Objectives Existing Organization Resources

IRB QA – QI at UK

’96-’97 UK Objectives Determine if Study Implemented as Approved Evaluate IRB/ORI Procedures/Ethical Decisions Identify Issues for Education Examine Informed Consent Process

’96-’97 Program Staffed Internal to IRB Standards: 45 CFR 46 IRB Made Determination of Additional Action on Protocol Finding ORI Director Took Action on ORI/IRB Findings

Random Selection Protocol On-Site Review/Chair/Staff ‘96-’97 Program Random Selection Protocol On-Site Review/Chair/Staff Inspect Corresponding IRB Files/Minutes Etc. Compare with Sponsored Project File

Labor Intensive Necessary Expertise Lessons Learned J:\Data\rso\Jennifer\Presentation Materials\PowerPoint\handouts\4th Annual Medical Res Summit QIP handout.ppt

Used 3 of 4 Original Objectives ’98-2002 UK Used 3 of 4 Original Objectives Hired 1 Full Time Staff Broadened Standards

Goal Improve Programs

Good News/Bad News IRB Loved the Program

Lessons Learned QI vs. QA Set Policy Through Noncompliance Labor Intensive Necessary Expertise

2003-? Objectives To Assess Individual Protocol Compliance as Directed by IRB or ORI To Evaluate ORI/IRB Procedures for Compliance and Efficiency To Assist Investigator/Staff in Complying, Monitoring and Responding to External Reviews

2003-? Components Objective 1: IRB Directed On-Site Reviews Objective 2: Administrative IRB/ORI Reviews Objective 3: Routine On-Site Reviews Objective 3: PI Self-Assessment/Subject Survey

Purpose To Describe the Evolution of an IRB Quality Improvement Program (QIP) at the University of Kentucky To Discuss Lessons Learned in Developing the Quality Improvement Program (QIP)

References Prentice, Ernest D., Ada Sue Selwitz and Gwen S.F. Oki. “Chapter 2-6 Audit Systems.” Institutional Review Board: Management and Function. Editors Robert Amdur and Elizabeth Burkhart. Jones and Bartlett Publishers. 2002; pp. 66-75. Wolf, Delia and Pearl O’Rourke. “Ensuring Investigator Compliance and Improving Study Site Performance: Implementing a Quality Assurance and Quality Improvement Program in Academic Health Center.” Clinical Researcher. May 2002; Vol. 2, No.5.

References Wolf, Delia and Pearl O’Rourke. “Improving the Quality of Clinical Research: Recognizing Common Areas of Noncompliance and Providing Quality Assurance and Quality Improvement Tips for Investigators.” Clinical Researcher. October 2002; Vol. 2, No.10.