VCU IRB Written Policies & Procedures


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VCU IRB Written Policies and Procedures

(Red Text Indicates Recent Updates as of 11-30-09)

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) 6-30-07
Section XIV: Prisoners as Research Participants
XIV-1 Prisoners As Research Participants (Special Protections) 6-21-06
Section XV: Children as Research Participants
XV-1 Permissible Categories (Children) 10-15-07
XV-2 Assent/Informed Consent Considerations 1-15-08
XV-3 Wards and Emancipated Minors 10-15-07
Section XVI: FDA Regulated Products
XVI-1 Review of Devices - IDE Requirements (SR vs. NSR Determination) 2-5-07
XVI-2 Humanitarian Use Devices (HUD) 2-15-08
XVI-3 Emergency Use of a Investigational Drug, Device, or Biologic 2-5-07
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-1 Research Subjects with Limited English Proficiency (LEP) 9-4-09
XVII-2 Subject Recruitment and Compensation 11-30-09
XVII-4 Research Involving Data Registrics and Specimen Banks 9-4-09
XVII-5 Genetic Research (DNA) 6-21-06
XVII-6 Involving Non-VCU Institutions in Human Subjects Research 12-4-08
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 6-1-08
XVII-11 Involving Foreign Institutions/Sites in VCU Human Research 12-4-08
XVII-12 Additional Department of Defense (DoD) - Department of the Navy (DoN) Requirements for Human Subject Protection 2-15-09
XVII-15 Involving Independent Investigators in Human Research 12-4-08
XVII-16 Planned Emergency Research, Exception from Informed Consent, and Waiver of Applicability of Informed Consent 6-15-10