VCU IRB Written Policies and Procedures

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

Part III: Special Requirements
Section XIII: Pregnant Women, Fetuses, and Neonates as Research Participants
XIII-1 Pregnant Women, Human Fetuses, and Neonates (Special Protections) 9-24-14

Section XIV: Prisoners as Research Participants
XIV-1 Prisoners As Research Participants (Special Protections) 9-24-14

Section XV: Children as Research Participants
XV-1 Permissible Categories (Children) 9-24-14
XV-2 Assent and Parental/Guardian Permission Considerations 9-24-14
XV-3 Children in Court-Appointed or State Custody and Emancipated Minors 5-22-14

Section XVI: FDA Regulated Products
XVI-1 Review of Devices - IDE Requirements (SR vs. NSR Determination) 8-12-14
XVI-2 Humanitarian Use Devices (HUD) 4-22-14
XVI-3 Emergency Use of a Investigational Drug, Device, or Biologic 8-12-14
XVI-5 Non-Research Uses (Treatment Use, Single Pt. Use, Parallel Track) 6-21-06
XVI-6 Review of Drugs - IND Requirements 2-5-07
XVI-7 Control of Investigational Drugs, Devices, and Biologics 2-28-10

Section XVII: Special Requirements and Guidance for Investigators
XVII-2 Subject Recruitment and Compensation 9-24-14
XVII-3 Research Involving Genomic Data Sharing 8-15-16
XVII-4 Research Involving Data Registries and Specimen Banks 9-4-09
XVII-5 Genetic (DNA) Research 4-22-14
XVII-6 Involving Non-VCU Institutions in Human Subjects Research 9-24-14
XVII-7 Evaluating Consent/Persons with Limited Decision-making Capacity 1-30-08
XVII-8 Equitable Subject Selection 6-21-06
XVII-9 Use of the Internet for Recruitment and Research Data Collection 6-21-06
XVII-10 Research Participant Inquiries/Concerns 9-24-14
XVII-11 Involving Foreign Institutions/Sites in VCU Human Research 8-6-14
XVII-12 Additional Department of Defense (DoD) - Department of the Navy (DoN) Requirements for Human Subject Protection 7-30-14
XVII-15 Involving Independent Investigators in Human Research 6-21-06
XVII-16 Planned Emergency Research, Exception from Informed Consent, and Waiver of Applicability of Informed Consent 9-24-14
XVII-17 Additional Department of Education (DoEd) and National Institute on Disability and Rehabilitation Research Requirements (NIDRR) for Human Subject Protection 9-24-14
XVII-18 Additional Requirements for Human Subject Protection in Research Funded by the Department of Justice (DoJ) including the National Institute of Justice 9-24-14
XVII-19 Additional Requirements for Research Conducted Within the Federal Bureau of Prisons 7-29-14