1. 1 April 21 – 23, 2004 Baltimore, Maryland John Arnaldi, Ph.D. Coordinator of Education USF Research Compliance Barry Bercu, M.D. Chair, USF Biomedical IRB Professor of Pediatrics, Biochemistry and Molecular Biology, Pharmacology and Therapeutics USF College of Medicine Investigator Education: Training for Accountability in Human Research Programs

2. 2 Elements of Institutional Policy Elements of Institutional Policy Typical Course Content Typical Course Content Formats for Education Formats for Education Outcome Measures Outcome Measures Tracking and Enforcement Tracking and Enforcement Pearls for Developing a Successful Program Pearls for Developing a Successful Program Overview

3. 3 Target Groups Target Groups Elements of Policy Education is required for all faculty, staff, and students directly involved in research with human subjects, including anyone who: Collects data from or about human subjects Collects data from or about human subjects Conducts study procedures or interventions with human subjects Conducts study procedures or interventions with human subjects Uses or has access to private data that can be linked to identifiable persons Uses or has access to private data that can be linked to identifiable persons

4. 4 Requirements – Basic & CE Requirements – Basic & CE Approved Courses – Previously Identified Approved Courses – Previously Identified Renewal Period – Annual by 12-31 Renewal Period – Annual by 12-31 Submission Procedures – Because of Demands on IRB Staff Time, Try to Transfer More Responsibility for Documentation from IRB Staff to PIs Submission Procedures – Because of Demands on IRB Staff Time, Try to Transfer More Responsibility for Documentation from IRB Staff to PIs Elements of Policy (cont.)

5. 5 Changes & Transition from Previous Policy – Updates and Mechanisms to Publicize Policy Changes via: Changes & Transition from Previous Policy – Updates and Mechanisms to Publicize Policy Changes via: Newsletter Newsletter Web Site Web Site E-Mail Blasts E-Mail Blasts Failure to Comply – Need Consistent and Fair Policy; Final Decision Referred to Full Board Elements of Policy (cont.)

6. 6 Definitions of Research and Human Subjects Definitions of Research and Human Subjects Background History of Human Subject Protections as Basis for IRB of 2004 Background History of Human Subject Protections as Basis for IRB of 2004 Ethical Foundations - Belmont Report Ethical Foundations - Belmont Report Legislative Mandates for Oversight Legislative Mandates for Oversight Types of IRB Review Types of IRB Review Criteria for IRB Approval Criteria for IRB Approval Typical Course Content

7. 7 Informed Consent Informed Consent Recruitment & Selection of Subjects Recruitment & Selection of Subjects Vulnerable Populations Vulnerable Populations Specific Institutional Policies & Procedures Specific Institutional Policies & Procedures Adverse Events Adverse Events Conflict of Interest Conflict of Interest Special Topics – e.g., Current Hot Topics Course Content (cont.)

8. 8 Seminars & Workshops –Keep to 1 Hour Seminars & Workshops –Keep to 1 Hour On-Line (Web-Based) & Computer-Based (CD) On-Line (Web-Based) & Computer-Based (CD) Conferences (National, Regional, Local) Conferences (National, Regional, Local) Videos & Audio/Video Conferences Videos & Audio/Video Conferences Workbook with Test Workbook with Test Brown-Bag Lunches & Networking Meetings Brown-Bag Lunches & Networking Meetings Web Site Newsletters and E-Mail News Newsletters and E-Mail News Formats for Educational Programs

9. 9 Quizzes/Tests – After Each Module Quizzes/Tests – After Each Module Attendance Sign-In Sheets Attendance Sign-In Sheets Certificates of Completion Certificates of Completion Signature to Certify Completion of Reading Material Signature to Certify Completion of Reading Material Outcome Measures

10. 10 Develop Database Develop Database Issue Certificates of Completion Issue Certificates of Completion Maintain Database & Investigator Files Maintain Database & Investigator Files Send Renewal Notices Send Renewal Notices Generate Non-Compliance Reports Generate Non-Compliance Reports Send Non-Compliance Letters Send Non-Compliance Letters Refer Non-Compliant Investigators to IRB Tracking & Enforcement

11. 11 Include stakeholders in policy development Include stakeholders in policy development Keep policy simple & consistent – no exceptions Keep policy simple & consistent – no exceptions Publicize constantly – educate about education Schedule courses for a variety of times & locations Schedule courses for a variety of times & locations Pearls

12. 12 Require Online RSVP to make it easy for IRB staff to give out pre-printed CME certificates (thereby avoid having to mail certificates) Require Online RSVP to make it easy for IRB staff to give out pre-printed CME certificates (thereby avoid having to mail certificates) Balance collegiality with accountability Balance collegiality with accountability Keep database up to date Keep database up to date Transfer responsibility for documentation from IRB Staff to PIs, as much as possible Yet remain user friendly Pearls

13. 13 Elements for Successful Program Reviewed Elements for Successful Program Reviewed Emphasis on Partnership Among Investigators, Coordinators, IRB Staff, and IRB Chair Emphasis on Partnership Among Investigators, Coordinators, IRB Staff, and IRB Chair Need for Dedicated Individual as Educator/Trainer, Dependent on Size of Program Need for Dedicated Individual as Educator/Trainer, Dependent on Size of Program Summary

14. 14 Web site:http://www.research.usf.edu/cs/ Phone:(813) 974-5638 Mail:USF Division of Research Compliance 12901 Bruce B. Downs Blvd., MDC 035 Tampa, FL 33612-4799 Division of Research Compliance Contacts

15. 15 Division of Research Compliance Contacts (cont.) John Arnaldi, Ph.D. Coordinator of Education USF Research Compliance (813) 974-7363 jarnaldi@research.usf.edu Barry Bercu, M.D. Chair, USF Biomedical IRB Professor of Pediatrics, Biochemistry and Molecular Biology, Pharmacology and Therapeutics USF College of Medicine (813) 974-5638 bbercu@research.usf.edu