Policy and Guidance
Handy references to research policy and guidance
- VHA Handbook 1200.17 - VA Research And Education Corporations (330 KB, PDF)
- VHA Handbook 1200.2 - Research Business Operations (224 KB, PDF)
- Reportable Events (30 KB, Word)
Other
- Issue Brief: A133 Audits
- Issue Brief: Generally Accepted Auditing Standards (GAAS)
- Statement on Auditing Standards (SAS) 112
- Establishing NPCs
VHA Handbooks
- VHA Handbook 1058.01 – Research Compliance Reporting Requirements
- VHA Handbook 1058.2 – Research Misconduct
- VHA Handbook 1058.03 – Assurance of Protection for Human Subjects in Research
- VHA Handbook 1108.04 – Investigational Drugs and Supplies
- VHA Handbook 1100.19 - Credentialing and Privileging
- VHA Handbook 1200.01 - Research and Development (R&D) Committee
- VHA Handbook 1200.05 - Requirements for the Protection of Human Subjects in Research
- Clarification on IRB Arrangements (9/23/04)
- VHA Handbook 1200.9 - Inclusion of Women and Minorities in Research
- VHA Handbook 1200.12 - Use of Data and Data Repositories in VHA Research
- VHA Handbook 1200.16 - Off-Site Research
- VHA Handbook 1605.1 - Privacy and Release of Information
- VHA Handbook 1605.2 - Minimum Necessary Standard for Protected Health Information
- VHA Handbook 1605.03 - Privacy Compliance Assurance Program and Privacy Compliance Monitoring
- VHA Handbook 1907.01 - Health Information Management and Health Records
- VA Handbook 5005, Part I, Chapter 3, Section C - Temporary Assignment of Employees Under the Intergovernmental Personnel Act (IPA)
- VA Handbook 5011/5 - Human Resource Management policy regarding flexible work arrangements (telework)
- VA Handbook 6102 - Regarding internet and intranet services
- VA Handbook 6502.1 and VA Handbook 6502.2 - Regarding the privacy program, One VA Privacy Violation Tracking System (PVTS), and Privacy Impact Assessment (PIA)
VHA Directives
- VHA Directive 1200 - Veterans Health Administrative Research and Development Program (July 9, 2009)
- Clarification, Banking of Human Research Subjects' Specimens (3/28/01) (75 KB, PDF)
- NEW! VHA Directive 2009-054- Credentialing of Unlicensed Research Staff (November 2, 2009)
- NEW! VHA Directive 2009-061 - Establishing A New Nonprofit Corporation (November 20, 2009)
- VHA Directive 2008-072 - Research Personnel Notification of Pharmacy Benefits Management
- VHA Directive 2008-064 - Research Compliance Officers and The Auditing Of VHA Human Subjects Research To Determine Compliance With Applicable Laws, Regulations, And Policies
- VHA Directive 2007-040 - Appointment of Facility Information Security Officer (ISO) and Privacy Officer to the Institutional Review Board (IRB) or the Research and Development (R&D) Committee.
- VHA Directive 2001-028 - Research Involving Children
- VHA Directive 2003-031 - Establishment of a Facility Human Protections Program
- VHA Directive 2003-065 - Accreditation of Human Research Protection Programs
- VA Directive 6102- regarding internet and intranet services
- VA IT Directive 06-2 - Safeguarding Confidential and Privacy Act-Protected Data at Alternative Work Locations
- VHA Directive 6210 - regarding automated information systems security
- VA Directive 6212 - Security of External Electronic Connections
- VA Directive 6502- regarding the privacy program, One VA Privacy Violation Tracking System (PVTS), and Privacy Impact Assessment (PIA)
- VHA Directive 2004-002 - regarding commercial or external web hosting services
Federal Regulations
- 45CFR46 The Common Rule (HHS - Protection of Human Subjects)
- 38CFR16 (VA - Protection of Human Subjects)
- 38 CFR 17 VA - Medical
- 21CFR11 (FDA - Electronic Records and Signatures)
- 21CFR50 (FDA - Protection of Human Subjects)
- 21CFR56 (FDA - Institutional Review Boards)
- 21CFR312 (FDA - Investigational New Drug Application)
- 21CFR812 (FDA - Investigational Device Exemptions)
- 32CFR219 (DOD - Protection of Human Subjects) (40 KB, PDF)