## Memorandum

Date: February 20, 2003

To: General Distribution

From: John Demakis, MD Director of HSR&D

Subject: HSR&D Funding for "Development"

It has been brought to my attention that the policy of the Health
Services Research & Development Service (HDR&D) regarding developmental
projects is not clear. In addition, staff reports that some
developmental proposals may have had difficulty successfully completing
the review process due to efforts to attach ("shoehorn") a clinical
trial onto a developmental study. In review of our policy, I suspect
this may have resulted from investigators trying to comply with VHA
Handbook 1204.01 (subpara. 7.a.4.c): "All developmental work...is
expected to...Constitute a relatively small portion of the total time
and budget requested for the completed project (i.e., development plus
evaluation)."

Subparagraph 7.a.4.c of the Handbook was intended for non-appropriate
developmental projects (especially software development, algorithms,
etc.) where exceptions may be made when the extent of the development is
minor when compared to the entirety of the project (such as tweaking
developed software or an algorithm to fit a study). It was not intended
to prevent or limit the scope of appropriate developmental projects.

In an effort to clarify our policy and reaffirm HSR&D's support for
developmental research, I have attached a revised version of Section 7
of the Handbook. I ask that investigators use this revised policy to
guide their decisions regarding submitting developmental projects and
that reviewers consider this policy during review of letters of intent
and proposals.

#### **VHA HANDBOOK 1204.01**

(Revised 2/20/02003)

# **7. HSR&D FUNDING FOR "DEVELOPMENT"**

**NOTE:** This policy applies to all applications seeking support of
developmental work through Health Services Research & Development's
(HSR&D) Investigator-Initiated Research (IIR) program. To the extent
possible, determinations of eligibility for HSR&D-IIR funding will be
made at the stage of Letter of Intent review, and applicants will be
notified promptly if their request is deemed inappropriate.

a\. **[Scope.]{.underline}** The mission of the HSR&D Service includes
the support of scientifically meritorious and VA-relevant research and
development. Scientific activity that yields new knowledge (research)
and work resulting in new products (development) are often
interdependent; and HSR&D receives proposals that include elements of
both. This mission statement clarifies the nature and extent of
"developmental" work that may be supported with HSR&D funds.

(1) HSR&D-IIR funding support is appropriate for either developing new
    methods and tools for conducting research or for evaluating existing
    methods and tools where efficacy has not been determined. Funding
    for development is limited to methods and tools, not efficacy trials
    of clinical interventions.

(2) All development work supported through HSR&D's IIR program is
    expected to:

    a.  Meet established standards of scientific peer review and
        applicable review criteria.

    b.  Be submitted with a well-developed evaluation plan.

b\. **[Appropriate HSR&D IIR Support]{.underline}**. HSR&D IIR support
is appropriate for, but not limited to, development of the following.

(1) Measures of quality of care

(2) Measures of functional status

(3) Measures of cognitive status

(4) Methods for risk adjustment

(5) Methods for measuring or estimating costs

# 

# Methods to elicit patient preferences 

c\. **Non-appropriate HSR&D IIR Support**. HSR&D-IIR support is not
appropriate for development of the following:

(1) Clinical practice guidelines

# Computer algorithms or reminder systems

(2) Databases or registries

(3) Computer software

(4) Clinical or surgical techniques

(5) Diagnostic tests

(6) Drugs

(7) Educational materials (for patients or providers)

#### Equipment

###### Medical devices

**Note:** Products such as those listed in the preceding become
appropriate subjects of HSR&D-IIR research once they are developed and
there is some evidence of their efficacy or validity. For example, IIR
research might focus on implementation of clinical practice guidelines,
evaluation of outcomes related to a new drug, or adaptation of a
computerized reminder system for use in VA.

d\. **Exceptions**

(1) Development that normally would not be funded but constitutes a
    relatively small portion of the total time and budget requested for
    the entire project may also be appropriate for HSR&D funding (i.e.,
    minor development with the primary focus on evaluation).

(2) Developmental work that is not appropriate under HSR&D's IIR program
    may be appropriate for support by HSR&D through the Service-Directed
    Research (SDR) program or when the Director, HSR&D, identifies a
    specific need and issues a call for proposals.