Policy & Guidance
Additional VHA Handbooks, Directives, Manuals, Memorandums, Information Letters, and Notices are listed in VHA Publications located at http://www1.va.gov/vhapublications/index.cfm
VHA Handbooks
- VHA Handbook 1058.01 – Research Compliance Reporting Requirements
- Decision Chart for Reporting of Noncompliance in VA Human Research (32 KB, PDF)
- Decision Chart for Reporting SAEs and Problems Involving Risk in Research (28 KB, PDF)
- PowerPoint Presentation that highlights and outlines new requirements found in VHA Handbook 1058.01
- 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 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 6508.1 - 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)
- VHA Directive 2009-054- Credentialing of Unlicensed Research Staff (November 2, 2009)
- 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 (35 KB, Word)
- 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
- VA Directive 6500 - Information Security Program rescinds Directive and Handbook 6210 and 6212
- VA Directive 6502- regarding the privacy program, One VA Privacy Violation Tracking System (PVTS), and Privacy Impact Assessment (PIA)
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)
Good Clinical Practice
- Guidance for Industry E-6 (260 KB, PDF)
- Comparison of FDA and DHHS Human Subject Protection Regulations
Guiding Principles
Other
- Office of Research and Development Guidance: The RCOs Role on Research Review Committees (June 7, 2010; 63 KB, PDF)
- ORD and ORO Guidance on IRB Approval of Changes in Protocol Study Teams (June 7, 2010; 38 KB, PDF)
- Guidance on Informed Consent Form Modifications Addressing VA Record Retention Requirements (July 23, 2009)
- Case Report Guidance (20 KB, PDF; December 2009)
- Interim Guidance on Protecting the Rights and Welfare of Human Subjects in Research Involving "Usual Care" (October 10, 2008)
- Interim Guidance On Research Warranting Special Safeguards To Protect The Rights And Welfare Of Human Subjects (20 KB, PDF)
- Should Veterans with a Diagnosis of Post-Traumatic Stress Disorder Be Considered a Vulnerable Population for the Purpose of Applying Guidelines for the Protection of Human Subjects in Research? Report of a Work Group Convened by the National Center for Ethics in Health Care of the Veterans Health Administration on Behalf of the Secretary of Veterans Affairs - October 2008 (928 KB, PDF)
- ORD Guidance on Pregnancy in Human Subject Research- June 2009 (21 KB, PDF)
- Checklist for use in developing a Memorandum of Understanding (MOU) between a VA facility and an Affiliated IRB: Memo (177 KB, PDF) | MOU (153 KB, PDF)
- VA Technology Transfer Program