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Policy & Guidance

• VHA Handbook 1058.1 – Reporting Adverse Events in Research to the Office of Research Oversight
• VHA Handbook 1058.2 – Research Misconduct
• VHA Handbook 1108.04 – Investigational Drugs and Supplies
• VHA Handbook 1200.1 - The Research and Development (R&D) Committee
• VHA Handbook 1200.5 - 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 1605.1 - Privacy and Release of Information
• VHA Handbook 1605.2 - Minimum Necessary Standard for Protected Health Information
• VA Handbook 5011/5 - Human Resource Management policy regarding flexible work arrangements (telework)
• Handbook 6102 - Regarding internet and intranet services
• Handbook 6502.1 and Handbook 6502.2 - Regarding the privacy program, One VA Privacy Violation Tracking System (PVTS), and Privacy Impact Assessment (PIA)

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• VHA Directive 2000-043 - Banking of Human Research Subjects’ Specimens (11/6/00)
• Clarification, Banking of Human Research Subjects’ Specimens (3/28/01) (75 KB, PDF)
• VHA Directive 2001-028 - Research Involving Children
• VHA Directive 2001-071 - RR&D Service, Data Safety Monitoring Board
• VHA Directive 2003-031 - Establishment of a Facility Human Protections Program
• VHA Directive 2003-065 - Accreditation of Human Research Protection Programs
• VA Directive- 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)
• VA Directive 6504 - restrictions on transmission, transportation and use of, and access to, VA data outside VA facilities
• VHA Directive 2004-002 - regarding commercial or external web hosting services

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Federal Regulations

• 45CFR46 The Common Rule (HHS - Protection of Human Subjects)
• 38CFR16 (VA - Protection of Human Subjects)
• 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)

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• Guidance for Industry E-6 (261 KB, PDF)
• Comparison of FDA and DHHS Human Subject Protection Regulations

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• The Belmont Report
• The Nuremberg Code
• World Medical Association Declaration of Helsinki

Other

• 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)
• Stand Down- Materials from the 90-day National VA R&D Stand Down, March 10-June 6, 2003

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