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April 21 – 23, 2004April 21 – 23, 2004Baltimore, MarylandBaltimore, Maryland

John Arnaldi, Ph.D.John Arnaldi, Ph.D.Coordinator of EducationCoordinator of EducationUSF Research ComplianceUSF Research Compliance

Barry Bercu, M.D.Barry Bercu, M.D.Chair, USF Biomedical IRBChair, USF Biomedical IRB

Professor of Pediatrics,Professor of Pediatrics,Biochemistry and Molecular Biology, Biochemistry and Molecular Biology,

Pharmacology and TherapeuticsPharmacology and TherapeuticsUSF College of MedicineUSF College of Medicine

Investigator Education: Training for AccountabilityInvestigator Education: Training for Accountabilityin Human Research Programsin Human Research Programs

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• • Elements of Institutional Elements of Institutional PolicyPolicy

• • Typical Course ContentTypical Course Content

• • Formats for EducationFormats for Education

• • Outcome MeasuresOutcome Measures

• • Tracking and EnforcementTracking and Enforcement

• • Pearls for Developing aPearls for Developing a Successful Program Successful Program

OverviewOverview

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• • Target GroupsTarget Groups

Elements of PolicyElements of Policy

Education is required for all faculty, Education is required for all faculty, staff, and students directly involved staff, and students directly involved in research with human subjects, in research with human subjects, including anyone who:including anyone who:

• Collects data from or aboutCollects data from or about human subjects human subjects• Conducts study procedures orConducts study procedures or interventions with human interventions with human subjectssubjects• Uses or has access to private Uses or has access to private data thatdata that can be linked to identifiable can be linked to identifiable personspersons

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• • Requirements – Basic & CERequirements – Basic & CE

• • Approved Courses – Previously IdentifiedApproved Courses – Previously Identified

• • Renewal Period – Annual by 12-31Renewal Period – Annual by 12-31

• • Submission Procedures – Because ofSubmission Procedures – Because of Demands on IRB Staff Time, Try to Demands on IRB Staff Time, Try to

TransferTransfer More Responsibility for Documentation More Responsibility for Documentation

fromfrom IRB Staff to PIs IRB Staff to PIs

Elements of Policy Elements of Policy (cont.)(cont.)

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• • Changes & Transition from Previous Changes & Transition from Previous Policy – Policy –

Updates and Mechanisms to Publicize Updates and Mechanisms to Publicize Policy Changes via: Policy Changes via:

• NewsletterNewsletter

• Web SiteWeb Site

• E-Mail BlastsE-Mail Blasts

•• Failure to Comply – Need Consistent andFailure to Comply – Need Consistent and Fair Policy; Final Decision Referred to Fair Policy; Final Decision Referred to

FullFull Board Board

Elements of Policy Elements of Policy (cont.)(cont.)

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• • Definitions of Research and Human Definitions of Research and Human Subjects Subjects

• • Background History of Human SubjectBackground History of Human Subject Protections as Basis for IRB of 2004 Protections as Basis for IRB of 2004

• • Ethical Foundations - Belmont ReportEthical Foundations - Belmont Report

• • Legislative Mandates for OversightLegislative Mandates for Oversight

• • Types of IRB ReviewTypes of IRB Review

• • Criteria for IRB ApprovalCriteria for IRB Approval

Typical Course ContentTypical Course Content

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• • Informed ConsentInformed Consent

• • Recruitment & Selection of SubjectsRecruitment & Selection of Subjects

• • Vulnerable PopulationsVulnerable Populations

• • Specific Institutional Policies &Specific Institutional Policies & Procedures Procedures

• • Adverse EventsAdverse Events

• • Conflict of InterestConflict of Interest

•• Special Topics – e.g., Current Hot Special Topics – e.g., Current Hot TopicsTopics

Course Content Course Content (cont.)(cont.)

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• • Seminars & Workshops –Keep to 1 HourSeminars & Workshops –Keep to 1 Hour

• • On-Line (Web-Based) & Computer-Based On-Line (Web-Based) & Computer-Based (CD)(CD)

• • Conferences (National, Regional, Local)Conferences (National, Regional, Local)

• • Videos & Audio/Video ConferencesVideos & Audio/Video Conferences

• • Workbook with TestWorkbook with Test

• • Brown-Bag Lunches & Networking Brown-Bag Lunches & Networking MeetingsMeetings

•• Web SiteWeb Site

• • Newsletters and E-Mail NewsNewsletters and E-Mail News

Formats for Educational Formats for Educational ProgramsPrograms

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• • Quizzes/Tests – After Each Quizzes/Tests – After Each ModuleModule

• • Attendance Sign-In SheetsAttendance Sign-In Sheets

• • Certificates of CompletionCertificates of Completion

• • Signature to Certify Completion Signature to Certify Completion of of Reading Material Reading Material

Outcome MeasuresOutcome Measures

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• • Develop DatabaseDevelop Database

• • Issue Certificates of CompletionIssue Certificates of Completion

• • Maintain Database & Investigator FilesMaintain Database & Investigator Files

• • Send Renewal NoticesSend Renewal Notices

• • Generate Non-Compliance ReportsGenerate Non-Compliance Reports

• • Send Non-Compliance LettersSend Non-Compliance Letters

•• Refer Non-Compliant Investigators to IRB Refer Non-Compliant Investigators to IRB

Tracking & EnforcementTracking & Enforcement

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• • Include stakeholders in policy developmentInclude stakeholders in policy development

• • Keep policy simple & consistent – no Keep policy simple & consistent – no exceptionsexceptions

•• Publicize constantly – educate about Publicize constantly – educate about educationeducation

• • Schedule courses for a variety of times & Schedule courses for a variety of times & locationslocations

PearlsPearls

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• • Require Online RSVP to make it easy for IRBRequire Online RSVP to make it easy for IRB staff to give out pre-printed CME certificates staff to give out pre-printed CME certificates (thereby avoid having to mail certificates) (thereby avoid having to mail certificates)

• • Balance collegiality with accountabilityBalance collegiality with accountability

• • Keep database up to date Keep database up to date

•• Transfer responsibility for documentation Transfer responsibility for documentation fromfrom

IRB Staff to PIs, as much as possible IRB Staff to PIs, as much as possible

•• Yet remain user friendlyYet remain user friendly

PearlsPearls

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• • Elements for Successful Program Elements for Successful Program ReviewedReviewed

• • Emphasis on Partnership Among Emphasis on Partnership Among Investigators, Coordinators, IRB Investigators, Coordinators, IRB

Staff,Staff, and IRB Chair and IRB Chair

• • Need for Dedicated Individual as Need for Dedicated Individual as Educator/Trainer, Dependent on Educator/Trainer, Dependent on

Size ofSize of Program Program

SummarySummary

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Web site:Web site: http://www.research.usf.edu/cs/http://www.research.usf.edu/cs/

Phone:Phone: (813) 974-5638(813) 974-5638

Mail:Mail: USF Division of Research USF Division of Research ComplianceCompliance

12901 Bruce B. Downs Blvd., MDC 12901 Bruce B. Downs Blvd., MDC 035035

Tampa, FL 33612-4799Tampa, FL 33612-4799

Division of Research ComplianceDivision of Research Compliance

ContactsContacts

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Division of Research ComplianceDivision of Research Compliance

Contacts Contacts (cont.)(cont.)

John Arnaldi, Ph.D.John Arnaldi, Ph.D.Coordinator of EducationCoordinator of EducationUSF Research ComplianceUSF Research Compliance

(813) 974-7363(813) 974-7363jarnaldi@research.usf.edujarnaldi@research.usf.edu

Barry Bercu, M.D.Barry Bercu, M.D.Chair, USF Biomedical IRBChair, USF Biomedical IRB

Professor of Pediatrics,Professor of Pediatrics,Biochemistry and Molecular Biology, Biochemistry and Molecular Biology,

Pharmacology and TherapeuticsPharmacology and TherapeuticsUSF College of MedicineUSF College of Medicine

(813) 974-5638(813) 974-5638bbercu@research.usf.edubbercu@research.usf.edu