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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
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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 2009-061
- 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)
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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)