OFFICE OF OFFICE OF RESEARCH COMPLIANCE: RESEARCH COMPLIANCE:

Progress ReportProgress Report

Camille A. McWhirter, J.D.Camille A. McWhirter, J.D.DirectorDirector

May 11, 2007May 11, 2007Office of Research, Graduate and Office of Research, Graduate and

Postdoctoral AffairsPostdoctoral AffairsStaff MeetingStaff Meeting

COI/Compliance Committee COI/Compliance Committee Management GridManagement Grid

Committee Committee RepresentationRepresentation

Broaden, Diversify,Broaden, Diversify,

FormalizeFormalize

AccessibilityAccessibility

Website, GuidanceWebsite, Guidance

NoncomplianceNoncompliance

Subcommittee, Subcommittee, Policy DevelopmentPolicy Development

Member/StaffMember/Staff

EducationEducationDisclosure Review, Disclosure Review, Application of Application of Federal Regulations Federal Regulations & Industry Guidance& Industry Guidance

Record-KeepingRecord-Keeping

Database,Database,

Filing SystemFiling System

Feedback/Feedback/

AccountabilityAccountability

How are we doing? Efficiency, Effectiveness

Operating Operating ProceduresProceduresOperations, Intake/ Operations, Intake/ Distribution, Records Distribution, Records

OutreachOutreach

Education, Education, Research Research Compliance MattersCompliance Matters

ImprovementImprovementIncorporate Incorporate feedback, establish feedback, establish standards and goalsstandards and goals

COI Committee: Committee COI Committee: Committee MembershipMembership

Include members from each college of USF Include members from each college of USF Health and a college of arts & sciences Health and a college of arts & sciences membermember

Include both basic and clinical researchersInclude both basic and clinical researchers Include a community memberInclude a community member Include ex-officio representation from all Include ex-officio representation from all

compliance offices dealing with COIcompliance offices dealing with COI Include alternatesInclude alternates Formalize terms of membershipFormalize terms of membership

Goal Achieved: October 2006Goal Achieved: October 2006

COI Committee: Member EducationCOI Committee: Member Education

Members must be familiar with the Members must be familiar with the regulations that govern COIregulations that govern COI

Members must be familiar with the Members must be familiar with the industry guidance interpreting the industry guidance interpreting the regulationsregulations

Members must be able to apply the Members must be able to apply the “rules” to the disclosures reviewed“rules” to the disclosures reviewed

Goal Achieved: October 2006Goal Achieved: October 2006

COI Committee: Operating COI Committee: Operating ProceduresProcedures

Procedures for the operation of the Committee Procedures for the operation of the Committee (scope, charge, expedited review procedures, (scope, charge, expedited review procedures, conduct of meeting, etc.)conduct of meeting, etc.)

Distribution and intake procedures for staff to Distribution and intake procedures for staff to process, distribute and maintain documents process, distribute and maintain documents

Covers all Committee and staff operations Covers all Committee and staff operations from the time a document is received to the from the time a document is received to the review and distribution of the document review and distribution of the document

Goal (Substantially) Achieved: Goal (Substantially) Achieved: April 2006April 2006

COI Committee: AccessibilityCOI Committee: Accessibility

If someone is looking for your program, If someone is looking for your program, will they be able to find it?will they be able to find it?

Website : Website :

http://health.usf.edu/research/compliance/index.hhttp://health.usf.edu/research/compliance/index.htmtm

Specific program information (policies, Specific program information (policies, processes, forms, Committee roster & processes, forms, Committee roster & schedule, deadlines)schedule, deadlines)

ProceduresProcedures

Goal Achieved: November 2006Goal Achieved: November 2006

COI Committee: Record-KeepingCOI Committee: Record-Keeping

Records should be accessible and Records should be accessible and searchablesearchable

Database for financial interest Database for financial interest disclosures and management plansdisclosures and management plans

Goal: June 2007Goal: June 2007

COI Committee: OutreachCOI Committee: Outreach

Awareness of program by end-usersAwareness of program by end-users Foundation of compliance is Foundation of compliance is

educationeducation Not enough that users can find you, Not enough that users can find you,

must take the message on the road must take the message on the road to the end userto the end user

Goal: May/June 2007Goal: May/June 2007

COI Committee: NoncomplianceCOI Committee: Noncompliance

Every compliance committee must Every compliance committee must address the issue of how noncompliance address the issue of how noncompliance will be handledwill be handled

Need policies/procedures for identifying Need policies/procedures for identifying and managing noncompliance—both and managing noncompliance—both intentional and unintentionalintentional and unintentional

Issues are complex enough to require Issues are complex enough to require subcommittee to address: first meeting subcommittee to address: first meeting was May 7, 2007was May 7, 2007

Goal: May/June 2007Goal: May/June 2007

COI Committee: Feedback & COI Committee: Feedback & AccountabilityAccountability

FeedbackFeedback: Website/e-mail survey to solicit feedback : Website/e-mail survey to solicit feedback from users of the program to confirm customer from users of the program to confirm customer satisfactionsatisfaction

AccountabilityAccountability: COI Office has established standards : COI Office has established standards for program operations, efficiency and effectivenessfor program operations, efficiency and effectiveness

Quarterly Reports on the website to document Quarterly Reports on the website to document achievement of performance standards. achievement of performance standards. Weblinks:Weblinks:

Fall 2006Fall 2006 Winter 2007Winter 2007

ORC: Contracting FunctionORC: Contracting Function

Website content for sponsor Website content for sponsor educationeducation

Assist with pending contracts Assist with pending contracts Review contract language Review contract language

ORC: Ombudsman FunctionORC: Ombudsman Function

IRBIRB Outside Activity ProcessOutside Activity Process Public Records RequestsPublic Records Requests Contracting ProcessContracting Process Research Misconduct InvestigationsResearch Misconduct Investigations ““We don’t have a policy for this.”We don’t have a policy for this.”

ORC: EducationORC: Education

Responsible Conduct of Research: Core CurriculumResponsible Conduct of Research: Core Curriculum Research Compliance EducationResearch Compliance Education

Newsletter: Newsletter: Research Compliance MattersResearch Compliance Matters Live Presentations Live Presentations

15 minute compliance update15 minute compliance update Specific topics to address specific compliance Specific topics to address specific compliance

needs/questionsneeds/questions One-on-One CounselingOne-on-One Counseling

Assist with OCR course in clinical researchAssist with OCR course in clinical research Assist with course for research administratorsAssist with course for research administrators

Goal: Summer/Fall 2007Goal: Summer/Fall 2007