VCU IRB Written Policies and Procedures

Part I: Human Research Protection Program Overview
Part II: IRB Operations
Part III: Special Requirements

Part II: IRB Operations
Section VII: General Operations
VII-1 Authority of the IRB and Scope of Review 8-6-14
VII-2 Activities of the Full Board 9-24-14
VII-3 Records, Minutes and Communications 9-24-14
VII-4 Reporting to Regulatory Agencies 6-23-15
VII-5 Appeal of IRB Decisions 7-22-14
VII-6 Required Reporting of Unanticipated Problems Involving Risk 5-13-14

Section VIII: Review Types
VIII-1 Initial Review - Exempt 9-24-14
VIII-2 Initial Review - Expedited 9-24-14
VIII-3 Initial Review - Full Board 9-24-14
VIII-4 Continuing Review 9-24-14
VIII-5 Review of Modification to Research 9-24-14
VIII-6 Review of Revisions Prior to Final Approval and Calculation of Approval/Expiration Dates 5-13-14
VIII-7 Review of Grant Applications 5-13-14
VIII-8 Suspensions and Terminations of Previously Approved Research 4-22-14
VIII-9 Investigations of General, Serious or Continuing Noncompliance 6-23-15
VIII-10 Evaluating and Managing Investigator Conflicts of Interest 09-29-16

Section IX: Principal Investigator Requirements
IX-1 Principal Investigator Eligibility and Statement of Responsibilities 9-24-14
IX-2 Principal Investigator Absences 5-14-14
IX-3 Personnel Qualifications 7-30-14

Section X: Monitoring Activities
X-1 Terms of Approval 9-24-14
X-2 Data and Safety Monitoring Plan Requirements 5-14-14
X-3 Post Approval Monitoring and Quality Improvement Program (PAMQuIP) 10-22-13
X-4 Closure of Study from VCU IRB Oversight 4-22-14

Section XI: Informed Consent
XI-1 Consent Process, Elements, Waiver of Element(s), and Modification 5-13-14
XI-2 Informed Consent Documentation, Waiver of Documentation, and Required Signatures 3-28-16
XI-3 Legally Authorized Representative (Inclusion in Consent Process)
See also WPP#XV-2 Assent/Informed Consent Considerations
5-13-14
XI-4 Consideration of Research Involving Third Parties as Human Subjects 05-13-14
XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP) 03-24-15

Section XII: Safeguarding Confidentiality and Records
XII-1 General Safeguards and Investigator Records Retention 5-14-14
XII-2 Certificates of Confidentiality 5-14-14
XII-3 Health Insurance Portability and Accountability Act (HIPAA) Information and the Conduct of Research 9-25-13
XII-4 Identification and Recruitment of Research Participants 5-14-14