+--------------------------------+-------------------------------------+
| # **De                         | # **VHA DIRECTIVE 1204**            |
| partment of Veterans Affairs** |                                     |
+--------------------------------+-------------------------------------+
| ###                            | ###                                 |
| Veterans Health Administration |                                     |
+--------------------------------+-------------------------------------+
| **Washington, DC 20420**       | **April 15, 2002**                  |
+--------------------------------+-------------------------------------+

VETERANS HEALTH ADMINISTRATION

**HEALTH SERVICES RESEARCH AND DEVELOPMENT**

**1. REASON FOR ISSUE:** This Veterans Health Administration (VHA)
directive defines HSR&D policy.

**2. SUMMARY OF MAJOR CHANGES**: This document clarifies content and
incorporates additional information previously contained in VHA Manual
M-3, Part III, Chapter 1.

**3. RELATED DIRECTIVES:** VHA Handbooks 1204.1 through 1204.5.

**4. RESPONSIBLE OFFICE:** The Health Services Research and Development
Service (124) is responsible for the contents of this Directive.
Questions may be referred to (202) 273-8287, or by facsimile at (202)
273-9007.

**5. RESCISSION:** This VHA Directive rescinds VHA Manual M-3, Part III,
dated November 12, 1985.

**6. RECERTIFICATION:** This document is scheduled for recertification
on or before the last working day of April 2007.

  ------------------------------- ---------------------------------------
                                  

                                  Robert H. Roswell, M.D.

                                  Under Secretary for Health
  ------------------------------- ---------------------------------------

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  DISTRIBUTION:   CO:     E-mailed 4/16/2002

                  FLD:    VISN, MA, DO, OC, OCRO, and 200 -- E-mailed
                          4/16/2002
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### 

### 

VETERANS HEALTH ADMINISTRATION

**HEALTH SERVICES RESEARCH AND DEVELOPMENT**

**1. PURPOSE**

This Veterans Health Administration (VHA) Directive provides policy and
guidance for Health Services Research and Development (HSR&D) Service
programs and serves as a guide to additional sources for
program-specific information and procedures. ***NOTE:*** *HSR&D program
documents are updated as necessary and are available electronically, at
[www.va.gov/resdev]{.underline}.*

**2. BACKGROUND**

a\. **[Scope of HSR&D-Sponsored Development]{.underline}**. In addition
to research, HSR&D also supports certain kinds of scientific
"development." Most of this work focuses on the development of new
measures or analytic techniques for use in health services research, or
on the refinement, testing, or translation of existing research tools.
Selectively, HSR&D also supports the development of certain other
products, such as computer software, patient registries, research
databases, and educational materials, although all development projects
are bound by restrictions on the use of Department of Veterans Affairs
(VA) research funds for clinical equipment. All development work
sponsored by HSR&D includes a plan for scientific evaluation (see VHA
Handbook 1204.1).

b\. **[Scope of HSR&D-Sponsored Health Services Research]{.underline}**

\(1\) Health services research is a multidisciplinary field concerned
with the effects of social factors, financing systems, organizational
structures and processes, technology, and human behavior on health care
access, quality, costs, and outcomes. In VA, health services research
focuses on understanding how to organize, deliver, and finance health
care that is effective and cost effective, in order to meet the needs of
veterans and to ensure that their health care system is sound and
consistently excellent. It emphasizes research that has practical
applications and that can assist patients, health care providers,
managers, and policymakers.

\(2\) HSR&D funding support is primarily for studies about health care
services and health care delivery models that are available or feasible
in regular clinical settings. The "laboratory" for health services
research studies is the real world of clinical practice, where
variations among patients, physicians, and other factors that affect
health care cannot be fully controlled (and may themselves be the focus
of research). ***NOTE:** In general, studies involving treatments that
are still regarded as experimental are not in the domain of health
services research.*

\(3\) HSR&D's research agenda is further shaped by the Designated
Research Areas and Designated Research Elements adopted by VA's Office
of Research and Development (ORD) as a conceptual framework for
organizing all VA research. Advice regarding appropriate research
priorities and emerging issues in health services research is provided
by the HSR&D Subcommittee of the National Research Advisory Council and
by a joint committee of HSR&D and Veterans Integrated Service Network
(VISN) leadership.

**3. POLICY:** It is VHA policy that HSR&D's mission is to advance
knowledge and promote innovations that improve the health and care of
veterans. This mission is carried out through the support of
scientifically meritorious and VA-relevant research and development.

**4. ACTION:** The Director, HSR&D**,** VHA Central Office is
responsible for the overall policy, planning, coordination, and
direction of HSR&D activities.

**5.** **DEFINITIONS**

a\. **[Programs Managed By HSR&D.]{.underline}** HSR&D programs are
initiated and directed by VA Central Office staff and coordinated with
VA Research and Development (R&D) offices throughout the system, in
accordance with established policies and procedures. HSR&D programs are
of three main types: programs that directly support scientific research
and development, programs that build health services research capacity
within VA, and programs that strengthen VA's health services research
infrastructure. In addition, HSR&D manages some R&D-wide programs for
ORD and other entities within VA.

###  (1) HSR&D Programs

\(a\) [Merit-Reviewed Research]{.underline}. In HSR&D, direct support
for scientific research and development is provided through two main
categories of merit-reviewed research, the Investigator-Initiated
Research (IIR) program and the Service-Directed Research (SDR) program.
Adhering to the same general principles and procedures for scientific
merit review, the IIR and SDR programs provide a flexible framework for
support of research addressing a very wide range of topics and employing
a range of approaches to address important health services research
questions. Projects supported through the IIR mechanism include research
on VA-relevant topics identified by the investigators or developed in
response to one of HSR&D's program announcements highlighting current
research priorities. SDR projects are responses to specific research or
development needs identified by HSR&D, ORD, or other offices within VHA,
to strengthen or complement VA's health services research enterprise.

\(b\) [Capacity Building]{.underline}. Recognizing the need to maintain
and build a strong pool of investigators, HSR&D makes a significant
investment in the operation of programs to build health services
research capacity within VA. Largest are the Career Development program
and the Research Career Scientist programs, which provide protected
research time, respectively, for talented VA clinicians and
non-clinicians who are dedicated to health services research. The
Associate Investigator program provides opportunities for junior
investigators to work on HSR&D research projects under the mentorship of
an experienced Principal Investigator (PI). The newest program for HSR&D
is the Research Enhancement Award Program (REAP), which targets sites
where the presence of a small number (but at least three) funded HSR&D
investigators signals potential growth. REAP awards provide
infrastructure support, including costs for some personnel, supplies and
equipment, and for pilot projects. In addition, the Nursing Research
Initiative (NRI) is another capacity-building program managed by HSR&D
for all the services within ORD.

\(c\) [Centers and Conferences]{.underline}. Two types of HSR&D programs
are designed to strengthen health services research in VA by enhancing
opportunities for intellectual exchange. First, HSR&D supports several
types of research centers located throughout the country. Second,
through support of conferences, including an annual national research
conference and occasional special-purpose conferences, HSR&D facilitates
communication, collaboration, and rapid dissemination of research
findings.

[1]{.underline}. HSR&D's Centers of Excellence (CoE) are large,
multidisciplinary teams of investigators with the intellectual resources
and logistical support to develop and pursue long-term programs of
research and to nurture young investigators. Awarded and renewed based
on competitive, merit-review, each of HSR&D's CoEs has unique strengths
and research foci. CoE staff constitutes a strong national pool of
clinician- and non-clinician researchers, available both as potential
collaborators or consultants to other researchers in VA and throughout
the health services research community, and as advisers to HSR&D Central
Office.

[2]{.underline}. HSR&D's Resource Centers provide technical assistance
and consultation services to VA researchers and others in Central Office
and the field. Each of these Centers (three in fiscal year (FY) 2001)
fills a specific need. Current Resource Centers strengthen VA health
services research through their expertise and activities in
organizational and management issues, the use of VA databases in
research, and economic analysis. HSR&D's extensive research
dissemination program is also managed at one of these Centers.
***NOTE:** Core support from HSR&D helps to stabilize and nurture the
expertise based at these Centers.*

[3]{.underline}. A third set of HSR&D Centers supports work of the
Quality Enhancement Research Initiative (QuERI). The QuERI Coordinating
Centers are responsible for the implementation, program coordination,
and ongoing management of all phases of QuERI work.

[4]{.underline}. HSR&D's 2-day national scientific meeting, held every
year since 1983, is an important forum for exchange of health services
research information, and is attended by VA managers and policymakers as
well as VA and non-VA researchers. In conjunction with this conference,
HSR&D sponsors a day-long meeting for its Career Development and
Research Career Scientist awardees. ***NOTE:** In addition to these
annual opportunities for presentation and dissemination of
HSR&D-sponsored research, HSR&D may decide to sponsor or co-sponsor
selected other conferences or workshops that address current
priorities.*

\(2\) **Programs Managed by HSR&D for VHA**

\(a\) [QuERI.]{.underline} QuERI is a systematic, national effort to
translate research findings into improved patient outcomes and system
improvements. Led and managed by HSR&D, QuERI relies on the
collaboration of various divisions within VHA Central Office and between
Central Office and field operations. HSR&D's key QuERI partners include
the Offices of Quality and Performance and Patient Care Services. QuERI
activity is organized around a set of clinical conditions; for each
clinical area, QuERI promotes a systematic approach for identifying best
practices, systematizing their use, and providing feedback to promote
ongoing improvement and sustain positive change. ***NOTE*:** *HSR&D
supports QuERI researchers through its established programs, especially
IIR and SDR support for individual research projects, and support of the
QuERI infrastructure.*

\(b\) [Nursing Research Initiative (NRI).]{.underline} Designed to
encourage research pertaining to nursing topics and to expand the pool
of nurse investigators within VA, NRI is a ORD program, implemented in
collaboration with VA's Nursing Strategic Healthcare Group (SHG), and
managed by HSR&D. Through NRI, new nurse investigators work with
experienced investigators or preceptors. NRI supports research pertinent
to the mission of each of three services within ORD (i.e., HSR&D,
Medical Research Service (MRS), or Rehabilitation Research & Development
(RR&D). ***NOTE:** Funded projects cover a wide range of important
topics for VA patients, with particular emphasis on patient-centered
care.*

b\. The following VHA Handbooks address policies and programs that are
unique in HSR&D as well as HSR&D programs that are implemented
differently than their counterparts in other parts of ORD.

#  (1) **[Support for Scientific Research and Development Projects \-- Investigator --]{.underline}**

**[Initiated Research Program (IIR), Service-Directed Research Program
(SDR), and Nursing Research Initiative (NRI)]{.underline} (VHA Handbook
1204.1).** IIR is HSR&D's mechanism for supporting projects designed by
independent VA investigators. SDR is the mechanism for supporting
projects that respond to special needs identified by HSR&D, ORD, or VHA
leadership. NRI is a mentored research program for VA nurse
investigators, managed by HSR&D for ORD. A handbook entitled, "Overview
of Support for Scientific Research and Development Projects," and its
appendices present information related to submitting a Letter of Intent,
full research proposal, and scientific ("merit") review. ***NOTE:***
*Except as specifically indicated, VHA Handbook 1204.1, and VHA Handbook
1204.5, apply to all IIR (including IIR supported through QuERI), NRI,
and SDR projects.*

\(2\) **Capacity-Building Programs (VHA Handbook 1204.2).** Four
distinct programs to increase the number and diversity of VA
investigators, by providing support for protected time for research
and/or mentoring. Handbook entitled "Overview of Capacity-Building for
Health Services Research" and its appendices describe HSR&D's Career
Development, Research Career Scientist, Associate Investigator, and
Research Enhancement Award programs.

\(3\) **Centers and Conferences (VHA Handbook 1204.3).** Programs
designed to help ensure the continuing vitality of health services
research in VA by providing stable support for certain ongoing needs,
and by promoting active information exchange. VHA Handbook 1204.3
describes three types of HSR&D Centers (CoEs, Resource Centers, QUERI
Coordinating Centers), and HSR&D conference support.

\(4\) **Under Secretary's Award for Outstanding Achievement in Health
Services**

**Research (VHA Handbook 1204.4).** HSR&D's highest honor, awarded
annually to an investigator who exemplifies the highest achievement as
researcher, mentor, and role model is described in VHA Handbook 1204.4.

\(5\) **Operational Guidelines (VHA Handbook 1204.5).** In addition to
the operational guidelines that apply to all ORD activities, specific
requirements applicable to HSR&D-sponsored activities are contained in
VHA Handbook 1204.5.