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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. Purpose.

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Fourth Annual Medical Research SummitApril 21-23, 2004Evolution 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


Purpose
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)


Lessons learned
Lessons Learned

Key Issues to Consider In Setting Up Program


What are your objectives
What Are Your Objectives?

  • Quality Assurance

  • Quality Improvement

  • QA and QI


What standards will you use
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
Who Oversees the Program?

  • Internal to IRB Office

  • External to IRB

  • Combination


Who assesses findings
Who Assesses Findings?

  • IRB

  • QI – QA Staff

  • PI

  • ?


What shapes decisions
What Shapes Decisions?

  • Objectives

  • Existing Organization

  • Resources



96 97 uk objectives
’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
’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


96 97 program1
‘96-’97 Program

  • Random Selection Protocol

  • On-Site Review/Chair/Staff

  • Inspect Corresponding IRB Files/Minutes Etc.

  • Compare with Sponsored Project File


Lessons learned1
Lessons Learned

  • Labor Intensive

  • Necessary Expertise


98 2002 uk
’98-2002 UK

  • Used 3 of 4 Original Objectives

  • Hired 1 Full Time Staff

  • Broadened Standards


Goal

Improve Programs


Good news bad news
Good News/Bad News

  • IRB Loved the Program

  • IRB Loved the Program


Lessons learned2
Lessons Learned

  • QI vs. QA

  • Set Policy Through Noncompliance

  • Labor Intensive

  • Necessary Expertise


2003 objectives
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
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
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.


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