Number

Title

1204

VHA HSR&D (46KB, MSWord)
This Directive contains policy and guidance for programs in HSR&D.

1204.01

Scientific Research and Development Projects (106KB, PDF)
This Handbook provides procedures on support for scientific research and development projects, and clarifies specific information about funding programs in HSR&D.

1204.03

Health Services Research and Development (HSR&D) Centers (44KB, PDF)
This Veterans Health Administration (VHA) Handbook defines Health Services Research and Development Service’s (HSR&D) procedures that establish and govern HSR&D Centers and conference support.

1204.04

Under Secretary Award for Outstanding Achievement in Health Services Research (29KB, PDF)
This Veterans Health Administration (VHA) Handbook provides procedures related to nomination and selection for the “Under Secretary’s Award for Outstanding Achievement in Health Services Research.”

1204.05

Operational Procedures for Activities Sponsored by HSR&D (68KB, PDF)
This Veterans Health Administration (VHA) Handbook provides specific guidance for activities sponsored by Health Services Research and Development (HSR&D) Service including policies and procedures related to: communication with Department of Veterans Affairs (VA) Central Office; financial operations, including funding decisions and investigator travel; investigator eligibility; monitoring of HSR&D projects and programs; investigators’ reporting obligations and requests for modifications to approved projects. NOTE: This Handbook supplements VHA Handbook 1200.2.

1204.5a

Modification of Projects Funded by HSR&D (43 KB, MSWord)
. Health Services Research and Development (HSR&D) Service expects all research projects it sponsors to be carried out according to the plan presented in the approved proposal. Once funding has started, investigators must obtain formal approval from the Director, HSR&D, for any significant change in objectives, methods, budget, time, key personnel, or location. Requests for changes must be submitted in writing by the medical center Director, through the Associate Chief of Staff (ACOS) for Research and Development (R&D) and the Principal Investigator of the HSR&D COE (if one) to the Director, HSR&D (124), in conformance with the following procedures. A project that is changed without prior approval is at risk of termination.

1204.1a

02/20/03 Section 7 Revision (30KB, MSWord)
This is intended to clarify Section 7 of the handbook, and applies to all applications seeking support of developmental work through HSR&D's Investigator-Initiated Research (IIR) program.

1204.1b

08/18/03 Memo 1 - Policy Change - Proposal Limit, Final Reports (29KB, PDF)
HSR&D has implemented changes in the proposal submission limit per review cycle and Institutional Review Board Approval process effective immediately. The principal changes clarify and incorporate additional information on Investigator Initiated Research (IIR) proposal submission and Final Report requirements.

1204.1c

08/18/03 Memo 2 - Policy Change - Implementation/Dissemination (118KB, PDF)
HSR&D has added application and final report requirements on Dissemination/Implementation, added a Dissemination/Implementation application, and changed Final Report submission requirements effective immediately.

1204.3

HSR&D Centers and Conferences (47 KB, MSWord)
This Handbook defines procedures that apply to HSR&D programs that are designed to strengthen health services research in the VA by enhancing opportunities for intellectual exchange.

Number

Title

1058.2

Research Misconduct (136 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes the procedures and other requirements for handling allegations of misconduct in Department of Veterans Affairs (VA) research. Note: This document rescinds VHA Manual M-3, Part I, Chapter 15; Misconduct in Scientific Research.

1108.4

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.

1200

Veterans Health Administration Research and Development Program (120 KB, PDF)
This Veterans Health Administration (VHA) Directive provides an overview of Research and Development policies and procedures.

1200.05

Requirements for the Protection of Human Subjects in Research (196KB, PDF)
This Handbook prescribes procedures for the protection of human subjects in Department of Veterans Affairs (VA) research.

1200.09

Inclusion of Women and Minorities in Research (31 KB, PDF)
This VHA Handbook provides information regarding the requirement for the inclusion of women and minorities in the Department of Veterans Affairs (VA) sponsored research.

1200.1

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.

1200.2

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.

1200.3

Centralized Positions of Research Scientists, GS-14 and Above (150 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.

1200.4

NEW! 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.

1200.6

Control of Hazardous Agents in VA Research Laboratories (412 KB, PDF)
This Veterans Health Administration (VHA) Handbook establishes policy and guidance related to select agents and toxins and the prevention and/or detection of terrorist events occurring in or originating from the Department of Veterans Affairs (VA) research laboratories. NOTE: The policies contained in this Handbook apply to all Research and Development (R&D) laboratories located within VA facilities, including leased space, and to space within a VA facility leased to a private entity. VA research laboratories located in approved off-site facilities such as affiliate universities are expected to comply with all VA and other Federal laws and regulations regarding security of both research laboratory facilities and select agents and toxins.

1200.7

Use of Animals in Research (842 KB, PDF)
This VHA Handbook sets forth the principles and procedures that govern research, testing, and teaching activities involving laboratory animals in the VA.

1200.8

Safety of Personnel Engaged in Research (541KB, PDF)
This Handbook establishes policies for ensuring the safety of personnel engaged in research. [Replaces VHA Handbook 1200.11 dated Aug. 22, 1997.]

1200.13

Financial Conflicts of Interest in Research Handbook (rescinded) (452, PDF)
This Handbook establishes policy and procedures to enable all VA medical centers to develop comprehensive programs regarding financial conflicts of interest in research, and to enable investigators to comply with applicable VA and other Federal and state regulations regarding conflicts of interest in research.

1200.13-Memo

New! Memo from CRADO – Financial Conflicts of Interest in Research (176 KB, PDF)
Official memorandum from the Chief Research and Development Officer, Joel Kupersmith, MD, regarding financial conflicts of interest in VA research.

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).

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.

1200.16-Template

Partial Offsite Waiver Request Template (60 KB, MSWord)
Template document for Partial Offsite Waiver requests.

1200.17

VA Research And Education Corporations (330KB, PDF)
This Handbook provides policies, procedures, and instructions governing non-profit Research and Education Corporations created pursuant to sections 7361 through 7368, United States Code.

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).

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.

1201

Overview of VHA Research Programs (35KB, MS Word)
This Directive provides an overview of Research and Development (R&D) research initiatives.

2003-031

Establishment of a Facility Human Protections Program (132KB, PDF)
This establishes a new policy for the establishment of a Facility Human Protections Program (FHPP) to help Department of Veterans Affairs (VA) medical centers fully cover costs associated with human subjects protection. This policy applies to all newly funded and VA approved industry-funded studies conducted at VA facilities.

2003-065

Accreditation of Human Research Protection Programs (27KB, PDF)
This Directive establishes policy requiring all VHA facilities conducting human subjects research to obtain accreditation of their Human Research Protection Program (HRPP) by an organization approved by VHA to perform this function. NOTE: It describes the accreditation process for a VHA facility using an Institutional Review Board (IRB) that is administered by an affiliated academic institution.

2004-064

Use of Non-contract Implantable Pacemakers and Implantable Defibrillators in VA-Approved Research (139 KB, PDF)
This VHA Directive provides policy for use of implantable pacemakers and implantable defibrillators that are not covered by the current national contract for research purposes.

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.

2005-050

Requirements for Conducting VA-Approved International Research Involving Human Subjects, Human Biological Specimens, or Human Data (30 KB, PDF)
This VHA Directive provides policy that requires permission be granted by the Chief Research and Development Officer (CRADO), or designee, prior to initiating or conducting VA-approved international research involving human subjects, human biological specimens, or human data.

2005-050-Instructions

Instructions for Requesting Permission to Conduct International Research as required by VHA Directive 2005-050 (66 KB, PDF)
Permission to conduct international research involving human subjects or human biological specimens must be obtained prior to initiating the research as required by VHA Directive 2005-050 “Requirements for Conducting VA-Approved International Research Involving Human Subjects, Human Biological Specimens, or Human Data.”

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.

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).

2008-064

Research Compliance Officers and The Auditing Of VHA Human Subjects Research To Determine Compliance With Applicable Laws, Regulations, And Policies (30 KB, PDF)
This Veterans Health Administration (VHA) Directive establishes policy requiring the appointment of a Research Compliance Officer (RCO) and the periodic auditing of Department of Veterans Affairs (VA)-approved human subjects research to assess compliance with all applicable laws, regulations, and policies including those related to privacy, confidentiality, and information security requirements. The effectiveness of this Directive in assuring the highest level of human subjects protections will be evaluated in a year.

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.

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.

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...