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Ada Sue Selwitz, M.A. Director, Office of Research Integrity Adjunct Associate Professor,

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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Ada Sue Selwitz, M.A. Director, Office of Research Integrity Adjunct Associate Professor,

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  1. 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

  2. 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)

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

  4. What Are Your Objectives? • Quality Assurance • Quality Improvement • QA and QI

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

  6. Who Oversees the Program? • Internal to IRB Office • External to IRB • Combination

  7. Who Assesses Findings? • IRB • QI – QA Staff • PI • ?

  8. What Shapes Decisions? • Objectives • Existing Organization • Resources

  9. IRB QA – QI at UK

  10. ’96-’97 UK Objectives • Determine if Study Implemented as Approved • Evaluate IRB/ORI Procedures/Ethical Decisions • Identify Issues for Education • Examine Informed Consent Process

  11. ’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

  12. ‘96-’97 Program • Random Selection Protocol • On-Site Review/Chair/Staff • Inspect Corresponding IRB Files/Minutes Etc. • Compare with Sponsored Project File

  13. Lessons Learned • Labor Intensive • Necessary Expertise

  14. ’98-2002 UK • Used 3 of 4 Original Objectives • Hired 1 Full Time Staff • Broadened Standards

  15. Goal Improve Programs

  16. Good News/Bad News • IRB Loved the Program • IRB Loved the Program

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

  18. 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

  19. 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

  20. 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)

  21. 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.

  22. 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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