Policy & Guidance
ATTENTION: The new, revised VHA Handbook 1200.05, "Requirements for the Protection of Human Subjects in Research" was signed by the Under Secretary for Health, October 15, 2010. The provisions of this handbook must be implemented by March 31, 2011.
Access guidance PowerPoint slides here.
If you have specific questions regarding this policy, please send them to VHACO120005Q@va.gov.
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