Research Compliance Auditing Barry Bercu, M.D. Chair, USF Biomedical IRB Professor of Pediatrics, Biochemistry and Molecular Biology, Pharmacology and Therapeutics College of Medicine Caroline Fultz-Carver, Ph.D., M.H.A Quality Assurance Program Assistant Director USF Research Compliance April 21 23, 2004 Baltimore, Maryland 1
Overview Overview of USF IRB History of USF Human Subject Protections Program USF Auditing Program Recommendations for a Successful Program Pearls for Developing a Robust, Credible Audit Program 2
Average Active Protocols (n=1500) Biomedical Studies (n>800) Weekly Biomedical IRB Meetings IRB Professional Support (20 FTEs) Assistant Directors-IRB and Quality Assurance (n=2) Coordinators-Biosafety Biosafety,, IRB, HIPAA, and Education (n=4) Senior Grant Specialists (n=8) Grant Assistants (n=2) Program Assistants (n=4) Human Subject Protections Program Budget $1,300,000 3
History of USF Audit Program Established in March 2002 with 1 FTE (currently 2 FTEs) Completed Audits to Date (n=9) Common Deficiencies/Findings Informed Consent (IC) Documentation Missing pages, signatures, dates Subject consented with wrong version Subject Organization No documentation to demonstrate adherence to IRB-approved protocol Research Organization 4
USF Audit Program Plans for Next year Increase Number Audits Completed Annually For-Cause (average 4/year) Randomly-Selected (4/year) 5
6 USF Audit Process Summary USF Audit Process Summary Subject Subject Selection Selection Pre Pre- Interview Interview Approval Approval Period Period Continuing Continuing IC IC Document Document IC Process IC Process Protocol Protocol Adherence Adherence Research Research Adverse Adverse Events Events Preparation Preparation Dissemination Dissemination Pre Pre- Post Post-
Pre- Interviews and IRB File Pre- Interview Meeting with Principal Investigator (PI) and coordinator to review auditing process and schedule Subject Selection Random selection of subject records based on randomization algorithm Approval Period of IRB approval letters to ensure no lapses in IRB approval and ensure no subjects enrolled during lapses in IRB approval Continuing of continuing review (CR) applications to ensure PI compliance with CR submissions policies 7
On-Site IC Process Interview with PI and coordinator to review informed consent process IC Document of informed consent documentation for completeness (all pages present, appropriately signed and dated) Protocol Adherence of subject records (subject binders, case report forms, medical records, etc.) for evidence of adherence to the IRB-approved protocol 8
On-Site (cont d) Adverse Events Research of adverse events reports to IRB to ensure reporting policies met and, if still enrolling subjects, ICF contact information valid of informed consent documentation for completeness (all pages present, appropriately signed and dated) 9
Post- Preparation and Dissemination Preparation Summation of audit findings and, when needed, clarification of specific issues with PI of audit findings with PI, includes time for PI response and any necessary updates/corrections to report Dissemination Distribution to PI and followed by discussion and vote by IRB 10
11 USF Audit Process Summary USF Audit Process Summary Subject Subject Selection Selection Pre Pre- Interview Interview Approval Approval Period Period Continuing Continuing IC IC Document Document IC Process IC Process Protocol Protocol Adherence Adherence Research Research Adverse Adverse Events Events Preparation Preparation Dissemination Dissemination Pre Pre- Post Post-
Recommendations for a Successful Program Audit Program Implementation and Management Clear Communication with Stakeholders Documentation requirements Audit process/timetable Process Objectivity Investigators Complete for Each Enrolled Subject Organize (Chronological by Study Number) Open Communication with Auditors to Ensure Understanding of Record-Keeping Expectations 12
Pearls Effective communication with stakeholders critical: PI, IRB members, University officials, and, when applicable, Affiliate Institutions Balancing collegiality with accountability 13
Summary Elements for Successful Program ed Emphasis on Partnership Among Investigators, Coordinators, IRB Staff, and IRB Chair Need for Dedicated Individuals to Address Audit Volume (For-Cause and Randomly- Selected) 14
Contacts Division of Research Compliance Web site: http://www.research.usf usf.edu/cs/ Phone: (813) 974-5638 Mail: USF Division of Research Compliance 12901 Bruce B. Downs Blvd., MDC 035 Tampa, FL 33612-4799 15
Contacts (cont.) Division of Research Compliance Barry Bercu, M.D. Chair, USF Biomedical IRB Professor of Pediatrics, Biochemistry and Molecular Biology, Pharmacology and Therapeutics College of Medicine (813) 974-5638 bbercu@research. research.usf.edu Caroline Fultz-Carver, Ph.D., M.H.A Quality Assurance Program Assistant Director USF Research Compliance (813) 974-9312 9312 cfcarver@research. @research.usf.edu 16