Perspectives from the NIH Study Section Keith C. Norris, MD, FASN, FACP Professor and Executive VP for Research and Health Affairs, Charles R. Drew University Assistant Dean for Clinical and Translational Science, UCLA

1. Keith
C.
Norris,
MD,
FASN,
FACP
Professor
and
Execu<ve
VP
for
Research
and
Health
Affairs,
Charles
R.
Drew
University
Assistant
Dean
for
Clinical
and
Transla<onal
Science,
Geffen
School
of
Medicine,
UCLA
Perspec<ves
from
the
NIH
Study
Sec<on
UCLA
CTSI
K
Award
Workshop

2. Perspec<ves
from
the
NIH
Study
Sec<on
NIH
Career
Award
(K)
Programs
UCLA
CTSI
K
Award
Workshop
Keith
C.
Norris,
MD,
FASN,
FACP
Professor
and
Execu<ve
VP
for
Research
and
Health
Affairs,
Charles
R.
Drew
University
Assistant
Dean
for
Clinical
and
Transla<onal
Science,
Geffen
School
of
Medicine,
UCLA

3. • Overview
of
K
Awards
• The
Review
of
K
awards
• General
NIH
Reviewer
Guidelines
NIH
Career
Award
(K)
Programs

4. • Support
mechanisms
that
provide
mentored
research
experiences
to
gain
addi<onal
exper0se
in
a
new
research
area
or
in
an
area
that
will
significantly
enhance
research
capabili0es.
Mentored
K
Awards:
What
are
they?

5. • It
is
expected
that
the
mentored
research
and
career
development
experience
will
lead
to
an
independent
and
produc0ve
research
career
Mentored
K
Awards:
Objec@ve

6. • K01:
Mentored
Research
Scien<st
Development
Award
• K08:
Mentored
Clinical
Scien<st
Development
Award
• K23:
Mentored
Pa<ent-­‐Oriented
Research
Development
Award
• K99/R00:
NIH
Pathway
to
Independence
(PI)
Award
• K12:
Ins0tu0onal
Mentored
Research
Scien0st
Development
Program
Mentored
K
Awards:
Which
One?

7. Common
K
Award
Features
• Must
have
a
full-­‐<me
appointment
at
applicant
organiza<on
• Dura<on:
three,
four,
or
five
years
• Salary
–
legisla<ve
cap
*
• Research/development
–
usually
25K
*Amounts
vary
by
par<cipa<ng
NIH
Ins<tute

8.
Common
K
Award
Features
(cont’d)
• Level
of
Effort:
• generally
>75
percent
toward
K12
ac<vi<es
and
the
remainder
toward
other
clinical
and
teaching
pursuits
consonant
with
the
award
objec<ves.
• In
final
2
years
may
now
reduce
effort
on
K
if
replaced
by
effort
as
a
PD/PI
or
subproject
PD/PI
provided
they
remain
in
mentored
situa<on.
hdp://grants.nih.gov/grants/guide/no<ce-­‐files/NOT-­‐OD-­‐04-­‐007.html

9. K12:
Op@ons
for
Ins@tu@ons
• K12:
Ins<tu<onal
Mentored
Research
Scien<st
Development
Program
• Enhance
research
career
development
for
individuals,
selected
by
the
ins@tu@on,
who
are
training
for
careers
in
specified
research
areas
• Provides
ins<tu<ons
with
a
greater
capacity
for
mentoring
junior
inves<gators
• Not
transferable
to
another
ins<tu<on
• Usually
solicited
by
a
Funding
Opportunity
Announcement
(FOA)

10. Mentored
Clinical
Research
Scholar
Program
Award
(K12)
• Train
and
retain
clinicians
in
clinical
research
inves<ga<on
• Provide
clinicians
with
both
didac0c
experience
and
supervised
research
training
in
more
than
one
discipline
• Accommodate
candidates
with
varying
levels
of
research
experience
• Allow
clinicians
engaged
in
pa<ent-­‐based
or
basic
biomedical
research
to
bring
a
clinical
dimension
to
the
research
enterprise

11.  Candidate
 Mentor
 Career
Development
Plan
 Research
Plan
 Ins<tu<onal
Environment
Mentored
K
Awards:
Review

12. Mentored
K
Awards:
Review
 Candidate
 Prior
Research
Experiences
• Poten<al
for
conduc<ng
research.
• Evidence
of
originality
 Publica<ons
(first-­‐author);
produc<vity
 Likelihood
of
research
independence
 Jus<fica<on
of
need
for
addi<onal
research
mentoring
 Leders
of
Reference

13.  Mentor
 Track
record
in
mentoring
 Appropriate
scien<fic
exper<se
 Research
funding
and
publica<ons
 Commitment
to
mentoring
candidate
(leder
of
support)
Mentored
K
Awards:
Review

14.  Ins<tu<onal
Environment
 Necessary
resources
for
proposed
research
and
career
development
 Interac<ons
with
other
inves<gators
 Detail
opportuni<es
for
research
and
career
development
 Ins<tu<onal
commitment
to
candidate
 assurances
that
the
ins<tu<on
intends
the
candidate
to
be
an
integral
part
of
its
research
program
 commitment
to
protect
at
least
75%
of
the
candidate’s
effort
for
proposed
career
development
ac<vi<es
Mentored
K
Awards:
Review

15.  Career
Development
Plan
 Ac0vi0es
other
than
research
alone
that
will
facilitate
transi0on
to
independence
 Addi<onal
coursework
to
fill-­‐in
gaps?
 Grant-­‐wri<ng
workshops?
 Seminars,
journal
clubs
 Par<cipa<on
in
K30
program?
Mentored
K
Awards:
Review

16.  Research
Plan
 Should
include
new
research
training
 Hypothesis-­‐
vs.
discovery-­‐driven
 Provide
a
logical
path
to
research
independence
(away
from
mentor)
 Detailed
experimental
plan
with
poten0al
piDalls,
expected
outcomes,
alterna0ve
approaches
 (K99/R00:dis<nct
research
phases)
Mentored
K
Awards:
Review

17. Helping
Candidates
Develop
a
Strong
Career
Development
Training
Plan
• Understand
the
intent
of
the
mentored
K
award
is
to
help
new
inves0gators
achieve
independence
(i.e.,
R01-­‐level
funding).
• Preparing
for
the
R01
grant
applica<on
that
the
candidate
will
submit
at
the
end
of
the
K
award
should
be
the
organizing
principle
of
the
K
grant
applica<on,
which
includes
both
a
training
plan
and
a
research
plan.

18. Career
Development
Training
Plans
• Make
a
compelling
argument
why
the
mentee
needs
a
K
award.
• Iden<fy
cri<cal
gaps
or
deficiencies
in
the
mentee’s
knowledge
or
skills.
• Explain
how
addi<onal
training
or
mentored
research
experience
in
these
areas
will
enable
the
mentee
to
compete
successfully
for
R01
funding.
• Be
specific;
provide
examples.

19. Career
Development
Training
Plans
• Develop
a
career
development
training
plan
that
is
uniquely
suited
to
the
mentee.
• Given
their
previous
training
and
research
experience,
mentees
should
propose
a
mix
of
didac<c
training
and
hands-­‐on
research
experience
that
address
the
gaps
or
deficiencies
in
their
knowledge
or
skills.
• Fully
exploit
the
training
opportuni<es
available.
• The
training
plan
should
be
as
carefully
thought
out
and
presented
as
the
research
plan.

20. Helping
Candidates
Develop
a
K
Award
Research
Plan
• The
research
plan
is
a
training
vehicle.
Should
be
well
integrated
with
the
candidate’s
training
plan
and
provide
an
opportunity
to
acquire
new
skills
• The
research
plan
is
a
means
to
achieve
independence.
Should
be
viewed
as
a
precursor
for
the
next
state
of
research
–
ideally,
an
R01.
• Mentored
K
awards
provide
limited
funding.
The
scope
needs
to
be
appropriate
and
feasible
($25K-­‐
$50K/year).

21. General
NIH
Reviewer
Guidelines

22. Significance
• Does
this
study
address
an
important
problem?
Do
you
make
a
compelling
case?
• If
the
aims
of
the
applica<on
are
achieved,
how
will
scien0fic
knowledge
be
advanced??
• What
will
be
the
effect
of
these
studies
on
the
concepts
or
methods
that
drive
this
field?
How
might
this
change
the
field?
Be
convincing!!!

23. Approach
• Are
the
conceptual
framework,
design,
methods,
and
analyses
adequately
developed,
well-­‐
integrated,
and
appropriate
to
the
aims?
• Does
the
applicant
acknowledge
poten0al
problem
areas
and
consider
alterna0ve
tac0cs?
• Is
there
an
appropriate
work
plan
included?
• Does
the
project
include
plans
to
measure
progress
toward
achieving
the
stated
objec<ves?
How
will
you
know
when
you
are
half
way
there?

24. Innova@on
• Does
the
project
employ
novel
concepts,
approaches
or
methods?
• Are
the
aims
original
and
innova<ve?
• Does
the
project
challenge
or
advance
exis<ng
paradigms
or
develop
new
methodologies
or
technologies?

25. Inves@gator
• Is
the
inves<gator
appropriately
trained
and
well
suited
to
carry
out
this
work?
• Is
the
work
proposed
appropriate
to
the
experience
level
of
the
principal
inves<gator
and
other
significant
inves<gator
par<cipants?
• Is
there
a
prior
history
of
conduc<ng
(fill
in
area)
research?
Does
not
fund
empty
aspira0ons!

26. Environment
• Does
the
scien<fic
environment
contribute
to
the
probability
of
success?
• Do
the
proposed
experiments
take
advantage
of
unique
features
of
the
scien0fic
environment
or
employ
useful
collabora0ve
arrangements?
• Is
there
evidence
of
ins<tu<onal
support?
• Is
there
an
appropriate
degree
of
commitment
and
coopera<on
of
other
interested
par<es
as
evidence
by
leOers
detailing
the
nature
and
extent
of
the
involvement?

27. Budget
• Are
all
requests
jus<fied
scien<fically
• Do
special
items
have
quotes
• Is
the
project
feasible
with
the
given
budget
• Low
budget
omen
viewed
worse
than
high
budget,
• Low
budget
-­‐
applicant
does
not
understand
what
is
need
to
do
the
work
-­‐
may
worsen
the
score
• -­‐High
budget
-­‐:
will
get
cut
but
usually
not
worsen
score,
unless
really
high

28. Other
Key
areas
• Protection of human subjects (closely
reviewed)
• HIPAA plan
• data and safety monitoring plan
• inclusion of women, minorities & children
• recruitment plan
• evidence (not plan) of proposed partnerships
• Animal welfare
• Biohazards
• Evaluation

29. NIH
grant
applica<on
scoring
system
• 9-­‐point
ra<ng
for
the
impact/priority
score
with
1
=
Excep<onal
and
9
=
Poor.
• Ra<ngs
in
whole
numbers
only
(no
decimal).

30. Helpful
Hints
for
K
Awards
• Read
the
FOA;
contact
program
staff
to
discuss
your
eligibility
and
proposed
plan!
• Read
the
Instruc@ons
in
the
PHS
398
applica@on
kit!
• Observe
page
limita<ons
• Give
yourself
and
your
mentor
enough
<me
• Give
references
and
leders
of
support
enough
<me
• Career
Development
Plan
should
be
appropriate
considering
previous
experience
• Capable
and
experienced
mentor?
Co-­‐mentor?
• Project
should
have
merit
as
research
and
as
career
development
mechanism
• Arrange
for
pre-­‐review

31. K
Award
Success

32. "The
greatest
obstacle
to
discovery
is
not
ignorance
–

33. Career
Development
Programs
• K
Kiosk
at:
hdp://grants.nih.gov/training/
careerdevelopmentawards.htm
• Career
Award
Wizard
at:
hdp://grants.nih.gov/training/kwizard/index.htm