VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

Edward Via College of Osteopathic Medicine

Policy Order No.: R004 Effective Date: May 5, 2003 Revised: August 1, 2021

Signature on File __________________________ Dixie Tooke-Rawlins, D.O. President and Provost

VCOM Institutional Review Board Policies ___________________________________________________________________________________

1. SIGNIFICANCE ...................................................................................................................................3 2. STATEMENT OF PRINCIPLES........................................................................................................4 2.1. The Belmont Report ........................................................................................................................4 2.2. 45 CFR 46 ........................................................................................................................................6 2.3. 21 CFR 50 AND 21 CFR 56 ..............................................................................................................6 3. DEFINITIONS ......................................................................................................................................6 4. THE BOARD.......................................................................................................................................10 4.1. Membership ...................................................................................................................................10 4.2. Appointments ................................................................................................................................10 4.3. Terms .............................................................................................................................................11 4.4. Schedule ........................................................................................................................................11 5. AUTHORITY OF THE IRB..............................................................................................................11 5.1. Authorities of Review ...................................................................................................................12 6. RESPONSIBILITIES OF THE IRB.................................................................................................12 6.1. Duties of the Members to the IRB.................................................................................................12 6.2. Duties of the Chairperson ..............................................................................................................13 6.3. Duties of the IRB Coordinator ......................................................................................................13 7. CRITERIA FOR IRB APPROVAL..................................................................................................14 7.1. Risks ..............................................................................................................................................14 7.2. Benefits..........................................................................................................................................14 7.3. Selection of Subjects .....................................................................................................................14 7.4. Informed Consent Review & Documentation ...............................................................................15 7.5. Safety Monitoring .......................................................................................................................... 15 7.6. Privacy and Confidentiality...........................................................................................................15 7.7. Vulnerable Subjects Safeguards ....................................................................................................16 7.8. Continuing Review........................................................................................................................16

VCOM Institutional Review Board Policies and Procedures

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