[]{#_top .anchor}**Number range CHAPTERQUESTIONS AND ANSWERS ABOUT**

**THE UPDATED**

**NIH CRITERIA FOR EVALUATING RESEARCH GRANT APPLICATIONS**

**OCTOBER 5, 2004**

1\. [Have the NIH Criteria for evaluating grant applications been
replaced with new
criteria?](#have-the-nih-criteria-for-evaluating-grant-applications-been-replaced-with-new-criteria)

2\. [What was the perceived rationale for updating of the
criteria?](#what-was-the-perceived-rationale-for-updating-of-the-criteria)

3\. [What was the formal process for adopting the updated
criteria?](#what-was-the-formal-process-for-adopting-the-updated-criteria)

4\. [What aims guided the process of updating
criteria?](#what-aims-guided-the-process-of-updating-criteria)

5\. [What portions of the application review criteria were
updated?](#what-portions-of-the-application-review-criteria-were-updated)

6\. [What are the updates to the Significance
criterion?](#what-are-the-updates-to-the-significance-criterion)

7\. [What are the updates to the Approach
criterion?](#what-are-the-updates-to-the-approach-criterion)

8\. [What are the updates to the Innovation
criterion?](#what-are-the-updates-to-the-innovation-criterion)

9\. [What are the updates to the Investigators
criterion?](#what-are-the-updates-to-the-investigators-criterion)

10\. [What are the updates to the Environment
criterion?](#what-are-the-updates-to-the-environment-criterion)

11\. [What are the updates to the Overall Evaluation
paragraph?](#what-are-the-updates-to-the-overall-evaluation-paragraph)

12\. [What are the updates to the overall score
instructions?](#what-are-the-updates-to-the-overall-score-instructions)

13\. [When do the updated grant application evaluation criteria take
effect?](#when-do-the-updated-grant-application-evaluation-criteria-take-effect)

14\. [How will peer reviewers be instructed to use the updated
criteria?](#how-will-peer-reviewers-be-instructed-to-use-the-updated-criteria)

15\. [Where can get more
information?](#where-can-i-get-more-information)

16\. [How can I provide feedback on the updated
criteria?](#how-can-i-provide-feedback-on-the-updated-criteria)

17\. [To whom can I talk about the updated
criteria?](#to-whom-can-i-talk-about-the-updated-criteria)

# 

# 1. Have the NIH Criteria for evaluating grant applications been replaced with new criteria? 

No. The original NIH criteria, first described in 1997 (see
<http://grants.nih.gov/grants/guide/notice-files/not97-010.html>) have
been updated to include information relevant to clinical, translational,
and interdisciplinary studies.

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# 2. What was the perceived rationale for updating of the criteria? 

Number range CHAPTERIn the course of consultation with the extramural
community regarding development of the NIH Roadmap-- aimed at
strengthening basic, interdisciplinary, and clinical research--the
perception was widespread that the existing NIH criteria for evaluating
grant applications did not sufficiently address the salient points of
all projects.

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# 3. What was the formal process for adopting the updated criteria? 

The Roadmap Trans-NIH Clinical Research Workforce Committee proposed a
set of initial changes, which were fully developed through extensive
discussions of NIH staff, NIH committees and chairs of Scientific Review
Groups (i.e. peer review study sections). The updated review criteria
were adopted at the August 5, 2004 meeting of Institute and Centers
Directors committee.

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# 4. What aims guided the process of updating criteria? 

The overriding aim was to ensure a rigorous and fair evaluation of all
grant applications. The updates were incorporated into a single set of
criteria intended for use with all research grant applications. The
updates consisted of the addition of words and phrases that addressed
the needs of clinical, translational, and interdisciplinary research.
The additions were kept to a minimum, Number range CHAPTERand were
closely evaluated to ensure completeness and clarity.

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# 5. What portions of the application review criteria were updated? 

A side-by-side comparison of the updated review criteria and the
previous criteria is available on the [Office of Extramural Review Peer
Review Policy and Issues](http://grants1.nih.gov/grants/peer/peer.htm)
website (<http://grants1.nih.gov/grants/peer/peer.htm> ). The specific
changes to the criteria are presented and discussed below in items 6
thru 10.

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# 6. What are the updates to the Significance criterion? 

Two portions of the significance criterion were changed. "*Clinical
practice*" was added to the sentence "*If the aims of the application
are achieved, how will scientific knowledge or clinical practice by
advanced.*" This clarification instructs reviewers to consider the
importance of the practical applicability of the results in changing
clinical practice (the practice of medicine). Examples of such changes,
including treatments, services, or prevention interventions have been
added to the last sentence of the criteria. The last sentence has also
been expanded to include technologies, because of the role of technology
as an engine to drive NIH discovery research.

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# 7. What are the updates to the Approach criterion? 

The phrases "*Clinical*" and "*well reasoned*" were added to the first
sentence (*are the conceptual or clinical frameworks \... well reasoned
\... and appropriate to the aims of the project*) to instruct the
reviewers to consider the overall clinical framework of the project. For
example, does the project fit correctly into what is already known in
the area, or is it unnecessarily duplicative? Is it the 'natural'
correct next step to perform at this time? Number range CHAPTERFor
example, an operational case definition of disease and natural history
studies are needed early in a research area to define the course of a
disorder. However, after sufficient natural history information has been
accrued, it may be time for an area to substantively move on, to
consider pathophysiological studies and/or treatment and preventive
studies.

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# 8. What are the updates to the Innovation criterion? 

The innovative criterion was changed extensively. The criterion begins
with a question "Is the project original and innovative?" which asks the
reviewers to consider the entire project, not the individual aims. The
criterion then gives a number of examples for how "*original and
innovative*" should be interpreted. "*Does the project challenge \....
clinical practice?*" asks the reviewer to consider if the project, if
successful, will upset an important scientific paradigm, or lead to a
new way of diagnosing, preventing or treating clinical disease.

Number range CHAPTERThe inquiry "*\[Does the project\] address a \...
critical barrier to progress in the field?*" asks the reviewer Number
range CHAPTER to consider whether the proposed project might open up a
particular field to new inquiry, or break through a significant barrier
that has heretofore stalled progress.

The question "*Does the project employ \... For this area?*" instructs
the reviewer that innovation comprises "*first ever*" projects and
"*first to use*" projects that carefully and correctly use existing
concepts, approaches, methodologies, tools or technologies for the first
time in a particular area. For example, epidemiologic studies or
randomized clinical trials may not be novel experimental approaches, but
may be completely appropriate to use at a certain stage of investigation
in a particular area.

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# 9. What are the updates to the Investigators criterion? 

Many research projects are now carried out by a multi- or
inter-disciplinary research team of investigators. The criterion has
been cast in plural, and a sentence added \[*Does the investigative team
bring complementary and integrated expertise to the project (if
applicable)?*\] to instruct reviewers to consider the expertise and
contributions of the team members.

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# 10. What are the updates to the Environment criterion? 

The previously used "*experiments*" has been changed to "*studies*" to
more appropriately describe clinical studies. Reviewers are also
instructed to consider the research benefits that might accrue from the
inclusion of unique subject populations as proposed by the applicant.

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# 11. What are the updates to the Overall Evaluation paragraph? 

The phrase "*or improve clinical decisions or outcomes*" was added to
the last sentence to instruct reviewers that grants that support certain
types of clinical studies that aim to improve clinical care may not be
highly innovative, but still may be essential to move a field forward.
For example, a large adequately powered randomized clinical trial
comparing the blood pressure control of two different types of
anti-hypertensive compounds may not employ a novel design, but the
results will improve clinical decision making regardless of the outcome.

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# 12. What are the updates to the overall score instructions? 

As before, the score should reflect the overall impact that the project
could have on the field based on consideration of the review criteria.
The updated criteria emphasize that the relative weight of each
criterion may vary from one application to another and that an
application need not be strong in all categories to be judged likely to
have a major scientific impact. This was emphasized because of the
widespread belief that certain types of research are not innovative yet
may propel a field forward.

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# 13. When do the updated grant application evaluation criteria take effect? 

Number range CHAPTERThe updated review criteria will be effective for
all investigator initiated research grant applications submitted for
receipt dates on or after January 10, 2005 (including those responding
to a Program Announcement (PA)). Applications responding to a Request
for Applications (RFA) will continue to follow the criteria published in
the specific RFA. Review committees will begin using the updated review
criteria for investigator initiated grant applications during the summer
of 2005.

Beginning with the announcement of the updated criteria on October 12,
2004, all NIH PAs will begin to use the updated review criteria.
Similarly, all NIH RFAs will begin to use the updated criteria as a
framework for constructing review criteria specific to that RFA.

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# 14. How will peer reviewers be instructed to use the updated criteria? 

The Scientific Review Administrators will introduce the updates to
reviewers who serve on Scientific Review Groups at the February/March
meetings, and will explain how the changes will be applied.

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# 15. Where can I get more information? 

More information, including a side by side listing of the changes is
available on the [Office of Extramural Review Peer Review Policy and
Issues](http://grants1.nih.gov/grants/peer/peer.htm) website
(<http://grants1.nih.gov/grants/peer/peer.htm> ).

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# 16. How can I provide feedback on the updated criteria? 

Feedback and comments regarding the criteria may be sent to
<grantsinfo@nih.gov>.

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# 17. To whom can I talk about the updated criteria?

Inquiries regarding the updated peer review criteria may be directed to:

> Dr. Anthony M. Coelho, Jr.
>
> Office of Extramural Programs
>
> Office of Extramural Research
>
> National Institutes of Health
>
> 6701 Rockledge Drive, Room 3533
>
> Bethesda, MD 20892
>
> Telephone: (301) 402-7543
>
> Email: CoelhoA@nih.gov

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