NOT OD 15 102 - Guidance
NOT OD 15 102 - Guidance
NOT OD 15 102 - Guidance
1
This
document
serves
as
a
companion
reference
to
NIH
Guide
Notice
NOT-‐OD-‐15-‐102.
2
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
3
Collins
FS,
Tabak
LA.
Policy:
NIH
plans
to
enhance
reproducibility.
Nature.
2014
Jan
30;505
(7485):
612-‐613.
http://www.nature.com/news/policy-‐nih-‐plans-‐to-‐enhance-‐reproducibility-‐1.14586
4
https://www.iom.edu/Reports/2001/Exploring-‐the-‐Biological-‐Contributions-‐to-‐Human-‐Health-‐Does-‐Sex-‐Matter.aspx
1
Literature
review.
Consider
and
describe
how
sex
and
gender
may
influence
the
research
question(s)
at
hand.
Conduct
a
review
of
the
human
clinical
literature
and
any
relevant
preclinical
literature.5
If
there
are
differences
between
males
and
females
in
previous
preclinical
or
clinical
studies,
this
would
provide
a
strong
rationale
for
building
consideration
of
sex
into
the
research
design
and
analyses
of
data.
The
absence
of
previous
study
data
in
an
area
of
research
does
not,
by
itself,
constitute
strong
justification
to
study
only
one
sex.
Research
design,
data
analysis,
and
reporting.
Choice
of
research
design
depends
on
a
variety
of
considerations,
including
preliminary
data,
past
studies,
scientific
literature
review,
scope
of
the
work,
and
specific
questions
and
hypotheses
to
be
addressed.
Appropriate
strategies
that
consider
sex
as
a
biological
variable
depend
on
the
context
of
the
research
question,
existing
knowledge
about
male
and
female
biology
and
behavior
in
a
given
area
of
research,
as
well
as
available
methodology.
Where
little
or
no
sex-‐
specific
data
is
available,
sex-‐specific
hypotheses
may
not
be
possible,
whereas
previously
observed
sex
differences
may
prompt
sex-‐specific
hypotheses.
Experimental
design
should
include
consideration
of
effect
size
and
power
calculations
to
determine
the
number
of
samples/subjects
in
the
study,
if
applicable.
Researchers
working
with
animal
models
should
consider
if
and
how
the
female
estrous
cycle
is
relevant
for
experimental
design
and
analysis;
it
may
be
relevant
for
some
research
questions
and
not
others.6
For
studies
using
both
sexes,
develop
a
data
analysis
plan
prospectively
that,
at
a
minimum,
provides
for
the
collection
of
data
disaggregated
by
sex.
Acknowledge
limitations
in
the
applicability
of
findings
that
may
arise
from
the
samples,
methods,
and
analyses
used,
in
the
research
plan
as
well
as
in
progress
reports
and
publications.
In
progress
reports
and
publications,
provide
the
sex
of
research
subjects
and/or
materials,
when
possible.
Report
when
sex
differences
are,
or
are
not,
detected
in
analyses,
which
may
be
valuable
for
future
research
and
meta-‐analysis.
Single-‐sex
studies.
Applicants
must
provide
strong
justification
for
applications
proposing
to
study
only
one
sex.
Such
justification
may
include
the
study
of
sex-‐specific
conditions
or
phenomena
(e.g.,
ovarian
or
prostate
cancer),
acutely
scarce
resources
(e.g.,
non-‐human
primates),
or
investigations
in
which
the
study
of
one
sex
is
scientifically
appropriate.
The
absence
of
evidence
regarding
sex
differences
in
an
area
of
research
does
not
constitute
strong
justification
to
study
only
one
sex.
Further
Resources
Additional
resources
that
may
provide
a
starting
point
regarding
sex
as
a
biological
variable
in
biomedical
research
are
located
on
the
NIH
Office
of
Research
on
Women’s
Health
web
site,
Studying
Sex
to
5
For
literature
review
tools
and
resources,
see
references
below
for
Jenkins
&
Wilson
(2012)
and
Oertelt-‐Prigione,
Gohlke,
Dunkel,
Preissner,
&
Regitz-‐Zagrosek
(2014).
6
Prendergast,
BJ,
Onishi
KO,
Zucker
I.
Female
mice
liberated
for
inclusion
in
neuroscience
and
biomedical
research.
Neurosci
Biobehav
Rev.
2014;40:1–5.
2
Strengthen
Science7;
these
include
research
and
training
materials8
such
as
online
courses,
resources
on
methods
and
techniques,
and
scientific
reports.
The
site
also
includes
research
summaries9
on
specific
topical
areas
with
known
sex/gender
differences.
The
following
articles
and
web
site
may
provide
useful
resources
related
to
the
consideration
of
sex
as
a
biological
variable:
1. Becker
JB,
Arnold
AP,
Berkley
KJ,
Blaustein
JD,
et
al.
Strategies
and
methods
for
research
on
sex
differences
in
brain
and
behavior.
Endocrinology.
2005;
146:1650-‐73.
2. Holdcroft
A.
Integrating
the
dimensions
of
sex
and
gender
into
basic
life
sciences
research:
methodologic
and
ethical
issues.
Gend
Med.
2007;
4
Suppl
B:S64-‐74.
3. Hughes,
RN.
Sex
does
matter:
comments
on
the
prevalence
of
male-‐only
investigations
of
drug
effects
on
rodent
behavior.
Behav
Pharmacol.
2007;18:
583-‐589.
4. McCarthy
MM,
Arnold
AP,
Ball
GF,
Blaustein
JD,
et
al.
Sex
differences
in
the
brain:
the
not
so
inconvenient
truth.
J
Neurosci.
2012;
32:2241-‐7.
5. Nieuwenhoven
L,
&
Klinge
I.
Scientific
excellence
in
applying
sex-‐
and
gender-‐sensitive
methods
in
biomedical
and
health
research.
J
Women’s
Health.
2010;
19:
313-‐321.
6. Prendergast,
BJ,
Onishi
KO,
Zucker
I.
Female
mice
liberated
for
inclusion
in
neuroscience
and
biomedical
research.
Neurosci
Biobehav
Rev.
2014;40:1–5.
7. Ritz
SA,
Antle
DM,
Côté
J,
Deroy
K,
et
al.
First
steps
for
integrating
sex
and
gender
considerations
into
basic
experimental
biomedical
research.
FASEB
J.
2014;
28:4-‐13.
8. Gendered
Innovations
web
resources:
http://genderedinnovations.stanford.edu/methods-‐sex-‐and-‐
gender-‐analysis.html
Accessed
May
15,
2015.
The
following
may
provide
useful
literature
review
tools
and
resources
related
to
the
consideration
of
sex
as
a
biological
variable:
1. Jenkins
M
&
Wilson
J.
(2012).
Finding
the
Evidence:
A
Sex-‐
and
Gender-‐Specific
Medicine
(SGSM)
PubMed
Search
Engine
Tool.
Lubbock:
Texas
Tech
University
School
of
Medicine
Health
Sciences
Center.
(Instructions
for
accessing
the
database
can
be
found
here:
http://genderedinnovations.stanford.edu/methods/Workshop_B_LWBSHI_Search_Engine.pdf).
2. Oertelt-‐Prigione
S,
Gohlke
BO,
Dunkel
M,
Preissner
R,
Regitz-‐Zagrosek
V.
GenderMedDB:
an
interactive
database
of
sex
and
gender-‐specific
medical
literature.
Biol
Sex
Differ.
2014;
5:7.
3. What
a
Difference
Sex
and
Gender
Make:
A
Gender,
Sex
and
Health
Research
Casebook,
(Canadian
Institutes
of
Health
Research,
Institute
of
Gender
and
Health)
http://www.cihr-‐irsc.gc.ca/e/44734.html
7
http://orwh.od.nih.gov/sexinscience/index.asp
8
http://orwh.od.nih.gov/sexinscience/researchtrainingresources/index.asp
9
http://orwh.od.nih.gov/resources/sexgenderhealth/
3