NPPO Policy and Guidance

Handy references to research policy and guidance

• Guidance Documents and Forms Related to VHA Directive 1200.17
• 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

The following Handbooks are available on the VHA Publications site at https://www.va.gov/vhapublications/publications.cfm?Pub=2.

• VHA Handbook 1058.01 – Research Compliance Reporting Requirements
• VHA Handbook 1058. – 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 1200.2 - Research Business Operations (224 KB, PDF)
• 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 1200.17 - VA Research And Education Corporations (330 KB, PDF)
• 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

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VHA Directives

The following Directives are available on the VHA Publications site at https://www.va.gov/vhapublications/publications.cfm?Pub=1.

• 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 2009-061 - Establishing A New Nonprofit Corporation (November 20, 2009)
• VHA Directive 2008-072 - Research Personnel Notification of Pharmacy Benefits Management
• 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.
• 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)

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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)