NIH NEW REVIEW WORKSHOP
J. Michael Hardin, Ph.D.
John C. Higginbotham, Ph.D., M.P.H.
Always READ the Instructions
A French Airbus:
Untrained Arab Flight Crew:
Unread Operating Manual:
$200,000,000
$300,000 Yearly Salary
$300
Alignment of Applications & Review Criteria

Enhanced review criteria*
Significance
 Investigator(s)
 Innovation
 Approach
 Environment


Necessitated changes to three parts of
application:
Biographical sketch
 Research Plan
 Resources and Facilities

Biographical Sketch

Personal Statement added
 Briefly
describe why your experience and
qualifications make you particularly wellsuited for your role in the project

Publications to be limited to 15
 Make
selections based on recency,
importance to the field, and/or relevance
to the application
Restructured Research Plan








Introduction
Specific Aims
Background and Significance
Preliminary Studies/Progress Report
Research Design and Methods
Inclusion Enrollment Report
Progress Report / Publication List
Human Subjects Sections….


Protections (5 review criteria, women/minorities, enrollment,
children
Other Research Plan Sections….


Research
Strategy
animals, select agent, MPI, consortium, support, sharing
Appendix
Restructured Research Plan
Former Application
New Application
Background and Significance
Research Strategy
Preliminary Studies/Progress
Report
a. Significance
Research Design and Methods
b. Innovation
c. Approach
Summary Results of Alignment
Core Review Criteria
Addressed in these
sections of the Application
Significance
Research Strategy
a. Significance
Investigator(s)
Biosketch
Personal Statement
Innovation
Research Strategy
b. Innovation
Approach
Research Strategy
c. Approach
BUT REMEMBER …
In the words of
Environment
Johnny Cash… I’ve
been everywhere man,
I’ve been everywhere
Resources
Environment
Specific Aims
Review Criteria

Significance
 If
the aims of the project are achieved, how will
scientific knowledge, technological advances, technical
capability, clinical practice, and/or health be
improved?
 How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?
Review Criteria

Investigator(s)
 Are
the PD/PIs, Community Research Associates,
collaborators, and other researchers well suited to
address the aims of the project?
Review Criteria

Innovation
 Do
the aims of the application challenge and seek to
shift current research or clinical practice paradigms by
utilizing novel theoretical concepts, approaches or
methodologies, instrumentation, or interventions?
 Is a refinement, improvement, or new application of
theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed (i.e., in the
specific aims)?
Review Criteria

Approach
 Are
the overall strategy, methodology, and analyses
well reasoned and appropriate to accomplish the
specific aims of the project?
Review Criteria

Environment
 Will
the scientific environment in which the work will be
done contribute to the probability of success (i.e.,
achievement of specific aims)?
 Are the institutional support, equipment and other
physical resources available to the investigators
adequate for the project proposed (i.e., the specific
aims)?
Specific Aims

Necessary Elements
A
clear statement of the problem
 Background material, to provide context
 Public health significance
 What you plan to do
 Basics
of design
 Primary outcomes,
 Study conditions
 Specific
Aims