VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

7.9. Recruitment & Payment ................................................................................................................16 7.10. Required Certification ...................................................................................................................16 8. RECORD KEEPING..........................................................................................................................16 8.1. Voting ............................................................................................................................................17 8.2. Member Recusal ............................................................................................................................17 8.3. Principal Investigator Attendance .................................................................................................17 9. TYPES OF REVIEW .........................................................................................................................18 9.1. Exempt...........................................................................................................................................18 9.2. Expedited .......................................................................................................................................18 9.3. Full Board ......................................................................................................................................18 9.4. Continuing .....................................................................................................................................18 9.5. Modification ..................................................................................................................................19 9.6. Review by Institution ....................................................................................................................20 9.7. Outside IRB Authorization............................................................................................................20 10. ACTIONS FOLLOWING REVIEW ............................................................................................20 10.1. Approval of Research ....................................................................................................................20 10.2. Minor Modifications or Clarifications Required ...........................................................................20 10.3. Deferral..........................................................................................................................................20 10.4. Disapproval ...................................................................................................................................21 10.5. Suspension and Termination .........................................................................................................21 10.6. Notification of IRB Actions ..........................................................................................................21 10.7. Appeal of IRB Decisions...............................................................................................................21 11. STUDY CLOSURE OR COMPLETION .....................................................................................22 11.1. Voluntary Completion ...................................................................................................................22 11.2. Termination by the IRB.................................................................................................................22 11.3. Expiration of Approved Period .....................................................................................................22 12. ADVERSE EVENTS & UNANTICIPATED PROBLEMS ........................................................22 12.1. Adverse Event Written Report ......................................................................................................23 12.2. Data and Safety Monitoring Plans.................................................................................................23 12.3. IRB Responsibilities ......................................................................................................................23 13. CONFIDENTIALITY ....................................................................................................................24 14. INFORMED CONSENT ................................................................................................................24 14.1. General Requirements ...................................................................................................................24 14.2. Documentation ..............................................................................................................................27 14.3. VCOM Consent Form Templates..................................................................................................28 14.4. Assent by Children & Parental Permission ...................................................................................28 14.5. Stored Samples & Genetic Testing................................................................................................29 14.6. Record Retention ...........................................................................................................................30 15. HIPAA & IRB REVIEW................................................................................................................30 15.1. HIPAA Authorization and Informed Consent ...............................................................................30 15.2. HIPAA Waiver of Authorization: .................................................................................................31 16. RECRUITMENT & INCENTIVES ..............................................................................................31

VCOM Institutional Review Board Policies and Procedures

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