All ORD
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1058.01 |
Research Compliance Reporting Requirements
(143 KB, PDF)
This Veterans Health Administration (VHA) Handbook sets forth the requirements for reporting certain research events to facility research oversight committees and to the Office of Research Oversight (ORO)(10R). NOTE: This Handbook does not preempt or otherwise alter any other applicable research reporting requirements, whether within the Department of Veterans Affairs (VA) or to other Federal or state agencies or commercial sponsors.
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1058.05 |
VHA Operations Activities That May Constitute Research (SEE ALSO: VHA Handbook 1058.05 Teleconference archive)
(64 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes procedures for determining whether a VHA operations activity constitutes research. It also establishes procedures for verifying and documenting the non-research status of certain operations activities prior to publication of findings outside the Department of Veterans Affairs (VA).
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1100.19 |
Credentialing and Privileging
(327 KB, PDF)
This Veterans Health Administration (VHA) Handbook provides VHA procedures regarding credentialing and privileging of all health care professionals who are permitted by law and the facility to practice independently. NOTE: This Handbook does not apply to residents, except those who function outside the scope of their training program; i.e., Admitting Officer of the Day.
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1108.04 |
Investigational Drugs and Supplies
(165 KB, PDF)
This Veterans Health Administration (VHA) Handbook provides specific procedures related to the appropriate handling of investigational drugs and supplies.
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1200 |
Veterans Health Administration Research and Development Program
(65 KB, PDF)
This Veterans Health Administration (VHA) Directive provides an overview of Research and Development policies and procedures.
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1200.01 |
Research and Development Committee Handbook
(119 KB, PDF)
This Handbook is a major revision to the current VHA procedures governing the Research and Development’s responsibilities and operations. It also addresses emerging issues and recent concerns related to research including information security, and credentialing and privileging of physicians and other applicable research employees. The provisions of the Handbook must be implemented no later than July 31, 2007.
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1200.02 |
Research Business Operations
(224KB, PDF)
This Handbook establishes standards and requirements for the proper and efficient operation of research offices with regard to formal communications, financial operations, and personnel.
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1200.03 |
Centralized Positions of Research Scientists, GS-14 and Above (SEE ALSO: Guidance for Classifying PD Not Covered by 1200.03)
(30 KB, PDF)
This VHA Handbook defines the information required by the Office of Research and Development (ORD) to evaluate research scientist positions and other professional positions funded by ORD for classification at General Schedule (GS)-14 and above.
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1200.04 |
Research Career Development Program
(61 KB, PDF)
The Research Career Development Program is an award series under which both clinically and non-clinically trained post-doctoral researchers may gain mentored research time intended to advance awardees toward independence as funded Department of Veterans Affairs (VA) scientists. The program is designed to attract, develop, and retain talented VA researchers in areas of particular importance to VA. This Handbook provides the structure and procedures of this Office of Research and Development (ORD) program.
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1200.05 |
Requirements for the Protection of Human Subjects in Research
(478 KB, PDF)
o The Department of Veterans Affairs (VA) is one of seventeen Federal departments and agencies that have agreed to follow the Federal Policy for the Protection of Human Subjects (Common Rule), effective June 18, 1991 (56 Federal Register (FR) 28001). This policy is incorporated in title 38 Code of Federal Regulations (CFR) Part 16. This Veterans Health Administration (VHA) Handbook defines the procedures for implementing 38 CFR Part 16 and other applicable Federal requirements for the protection of human subjects, and defines changes to the Human Research Protection Program accreditation policy.
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1200.06 |
Control of Hazardous Agents in VA Research Laboratories
(412 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes policy and procedures related to select agents and toxins.
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1200.07 |
Use of Animals in Research
(418 KB, PDF)
This VHA Handbook sets forth the principles and procedures that govern research, testing, and teaching activities involving laboratory animals in the VA.
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1200.08 |
Safety of Personnel Engaged in Research
(201KB, PDF)
This Handbook establishes
policies for ensuring the safety of personnel engaged in research. [Replaces VHA Handbook 1200.11 dated Aug. 22, 1997.]
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1200.09 |
Inclusion of Women and Minorities in Research
(31 KB, PDF)
This Veterans Health Administration (VHA) Handbook defines the requirements regarding the inclusion of women and minorities in Department of Veterans Affairs (VA) research.
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1200.12 |
Use of Data and Data Repositories in VHA Research
(185 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes the procedures for the use of data for VHA research purposes, the storage of VHA research data, and the development of VHA research data repositories.
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1200.15 |
Eligibility for VA Research Support
(278 KB, PDF)
This Handbook defines the criteria for eligibility to receive research support from the Office of Research and Development (ORD).
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1200.16 |
VA Off-site Research Handbook
(194 KB, PDF)
This Handbook clarifies the
scope of the Office of Research and Development (ORD) on the performance of VA-funded research in sites other than VA medical centers and VA-leased space.
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1200.16-Template |
Partial Offsite Waiver Request Template
(60 KB, MSWord)
Template document for Partial Offsite Waiver requests.
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1200.17 |
VA Nonprofit Research and Education Corporations
(111KB, PDF)
This Veterans Health Administration (VHA) Handbook provides procedures and instructions governing Nonprofit Research and Education Corporations (NPC) created pursuant to title 38 §§ 7361 through 7366, United States Code (U.S.C.).
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1200.18 |
Intellectual Property
(204KB, PDF)
This Handbook provides revised guidance and instruction regarding intellectual property (inventions) and the transfer of new scientific discoveries to benefit the public good (technology transfer).
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1200.19 |
Presentation of Research Results
(112KB, PDF)
This Handbook establishes
procedures, assigns responsibilities, and specifies authority for ensuring that the contributions of
the VA to research are appropriately acknowledged and publicly disclosed. This Handbook applies to all research results where either direct or indirect support for the research emanated from VA, either in the form of research funding, resources
(e.g., facilities or patients), or as a result of the investigator’s full-time, part-time, or without
compensation (WOC) appointment. The policies herein extend to all forms of research results,
including publications, presentations, media interviews, and other professional activities.
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1201 |
Overview of VHA Research Programs
(35KB, MS Word)
This Directive provides an overview of Research and Development (R&D) research initiatives.
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1400.06 |
Foreign Travel
(79.25 KB, PDF)
This VHA Handbook revises procedures associated with VHA staff foreign travel in order to increase the efficiency of the approval processes, as well as, maintaining and improving oversight and accountability. NOTE: In today's sensitive international environment, foreign travel carries the potential for personal, financial and institutional risk. In an effort to reduce risk and streamline the approval process, the VHA Foreign Travel Handbook has been revised.
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1605.01 |
Privacy and Release of Information
(806 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes guidance on privacy practices and provides procedures for the use and disclosure of individually-identifiable information and individual’s rights in regards to VHA data. This Handbook covers the responsibilities and requirements for compliance with all Federal confidentiality and privacy laws and regulations. When using or disclosing VHA information, all applicable laws and regulations must be reviewed and applied simultaneously to the request. This Handbook is the reference to be used to document and facilitate the appropriate use and disclosure of information residing under the care of VHA.
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1605.02 |
Minimum Necessary Standard for Protected Health Information
(378 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes guidance on the procedures for determining the minimum necessary amount of access to protected health information. This document describes the minimum necessary policies in compliance with the provisions of the Standards for Privacy of Individually-identifiable Health Information, Title 45 Code of Federal Regulation (CFR) Parts 160 and 164.
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1605.03 |
Privacy Compliance Assurance Program and Privacy Compliance Monitoring
(171 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes the Privacy Compliance Assurance Program and the required activities and procedures to monitor and validate compliance within VHA with Federal privacy laws, regulations and Department of Veterans Affairs (VA)-VHA privacy policy.
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1907.01 |
Health Information Management and Health Records
(581 KB, PDF)
This Veterans Health Administration (VHA) Handbook is issued to provide basic health information procedures for managing the patient health record. Procedures have been revised to delineate new and additional specificity for health record documentation requirements, management of the health record, and management of health information.
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2005-003 |
Requirements for Submittal and Approval of Biosafety Level-3 (BSL-3) Research Laboratory Construction and Renovation
(40 KB, PDF)
This VHA Directive provides policy on how to obtain approval for the construction of new Biosafety Level 3 (BSL-3) research laboratories and approval for planning a major renovation of space for a BSL-3 research laboratory, including the renovation of an existing BSL-3 research laboratory. NOTE: VHA does not permit the construction or operation of Biosafety Level-4 laboratories.
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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
(29 KB, PDF)
Appointing the VHA facility ISO and Privacy Officer as non-voting members to each facility's IRB(s) of record or to the facility's R&D Committee of record helps ensure appropriate review of research practices to maintain confidentiality and security of identifiable data obtained from human research subjects or from other sources, such as administrative or clinical databases.
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2007-044 |
Use of a Cooperative Research and Development Agreement (CRADA)
(25 KB, PDF)
This Veterans Health Administration (VHA) Directive provides policy on mandatory use of Cooperative Research and Development Agreements (CRADAs).
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2008-072 |
Research Personnel Notification of Pharmacy Benefits Management
(51 KB, PDF)
This Veterans Health Administration (VHA) Directive establishes policy and procedures that will ensure that the investigators, Associate Chiefs of Staff for Research and Development (ACOS for R&D), Administrative Officers for Research and Development (AO for R&D), and Institutional Review Boards (IRBs) are notified as soon as possible about all Department of Veterans Affairs (VA) Pharmacy Benefits Management (PBM) Services alerts. These alerts include safety issues and adverse events related to Food and Drug Administration (FDA) approved medications and biologics used in human research projects conducted by VA. This early notification of the ACOS for R&D, AO for R&D, investigator, and Chiefs of Pharmacy Services will allow for a timely assessment of risks to research subjects and, when indicated, modifications in research protocols, informed consent, and prompt notification of research participants to ensure the highest level of protections for these research subjects. It will also serve to alert investigators to the need for the reporting, monitoring, and surveillance of adverse drug events (ADEs), whether they were observed Adverse Drug Reactions (ADR) or historical ADRs from FDA approved investigational drugs. This notification will ensure timely inclusion of patient or research subject information to the national VA Adverse Drug Event Reporting System (VA ADERS), the newly formed VA ADERS Advisory Committee (VA ADERS AC), and the FDA MedWatch System.
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2008-10.1 |
Interim Guidance Usual Care Research
(63 KB, MSWord)
Clinical and health services research involving "usual care" is common in the Department of Veterans Affairs (VA). Subjects in such research receive the same "usual" interventions for their conditions as patients at their VA facility who are not involved in research.
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2008-10.2 |
Interim Guidance on Special Safeguards
(58 KB, MSWord)
In approving research, Department of Veterans Affairs (VA) regulations and the Federal Policy (Common Rule) for the Protection of Human Subjects at Title 38 Code of Federal Regulations Part 16 (38 CFR 16) require that Institutional Review Boards (IRBs) determine the following...
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2012.07 |
Rescission of VHA DIrective 2003-31, Establishment of a Facility Human Protections Program
(12 KB, PDF)
By direction of the Under Secretary for Health, Veterans Health Administration (VHA), Directive 2003-031, Establishment of a Facility Human Protections Program (FHPP), dated June 13, 2003, is rescinded. This Directive is being rescinded because the requirement for an FHPP has been incorporated into VHA Handbook 1200.05. In addition the new Cooperative Research and Development Agreements (CRADA) have incorporated components that will ensure the appropriate costs of administering an FHPP will be reimbursed by the entity entering into a CRADA with the Department of Veterans Affairs.
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5011.05 |
Human Resource Management policy regarding flexible work arrangements (telework)
(377 KB, PDF)
To revise Department of Veterans Affairs (VA) policies and procedures for
the approval of alternative workplace arrangements (telework). “Telework” means to work from an
alternative worksite other than the traditional office setting. Alternative worksite locations may include
work-at-home, community-based telecenters and/or satellite centers, and virtual employment
arrangements.
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6102.00 |
Regarding internet and intranet services
(509 KB, PDF)
This Handbook revises Department-wide procedures for the
establishment and administration of Department of Veterans Affairs (VA) Internet/Intranet
sites, and sites operating on behalf of VA, and non-VA entities contracted to operate for VA,
and/or related services. This Handbook implements the policies contained in VA Directive
6102, Internet/Intranet Services.
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6502.01 |
Privacy Event Tracking
(65 KB, PDF)
This handbook revises Department-wide procedures for the OneVA tracking of complaints and privacy incidents, and implements the policies set forth in Department of Veterans Affairs (VA) Directive 6502, VA Enterprise Privacy Program, and VA Handbook 6500.2, Management of Security and Privacy Incidents.
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6508.01 |
Privacy Impact Assessment (PIA)
(169 KB, PDF)
This handbook establishes Department-wide procedures for conducting Privacy Impact Assessments (PIA), and implements the policies pertaining to PIAs that are set forth in Department of Veterans Affairs (VA) Directive 6502, VA Enterprise Privacy Program. In accordance with the provisions of VA Directive 6502, and in order to comply with the requirements of the E-Government Act of 2002 (Pub. L.107-347), the VA Privacy Servicehas been established as the central VA office for compliance with the Federal requirements for PIAs.
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