Considering Inclusion in

NIH Grant Applications and

Contract Proposals

Dawn Corbett, MPH

NIH Inclusion Policy Officer
Office of Extramural Research
Introduction
Goals for this session:
• Lea rn how NIH inclus ion policies a re a ddres s ed when a pplying for or
propos ing NIH clinica l res ea rch
• Unders ta nd how peer review eva lua tes pla ns for inclus ion
• Recognize requirements for reporting a nd monitoring inclus ion in clinica l
res ea rch

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 NIH Inclus ion P olicie s
• Inclusion of women and minorities in all NIH funded
or supported clinical research is mandated by law
• Additional requirements for NIH -defined Phase III
clinical trials to consider whether the study can be
expected to identify potential differences by
sex/gender, race, and/or ethnicity
• NIH policy requires recipients include individuals
across the lifespan when conducting clinical
research, unless there is a scientific or ethical
reason for their exclusion.
• Goal of policies to ensure individuals are included in
clinical research in a manner appropriate to the
scientific question under study.
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 Wha t’s Re quire d for Inclus ion Whe n
Applying for NIH Funding?
• Plans for inclusion of women and minorities
• If proposing an NIH-defined Phase III clinical trial, address
plans for valid analysis of differences in effect by
sex/gender, race, and/or ethnicity.
• Inclusion enrollment report
• Data on sex/gender, race, and ethnicity of the sample
• Planned and/or Cumulative (actual) depending on the
study design
• Plans for inclusion of individuals across the lifespan
• Age limits (if applicable) and justification

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Inclus ion Enrollm e nt Re port

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 P e e r Re vie w of Inclus ion
• Each reviewer will assess
the inclusion plans
• Peer review group will
determine overall rating of
“acceptable” or
“unacceptable”
• Projects considered Picture courtesy of the NIH Center for Scientific
“Unacceptable” may not be Review

funded until resolved!

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Com m on Inclus ion Conce rns
• Inadequate information describing the sex/gender, race, ethnicity,
and/or age(s) of the sample

• Inadequate justification for proposed sample

• Sex/gender, race, ethnicity, and/or age(s) breakdown not
appropriate for the scientific goals of the study or not adequately
justified

• Unrealistic sampling
• Appropriate from scientific perspective but not realistic
• Collaborations and outreach plans may help
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Afte r Funding…Now Wha t?

• Investigators/recipients provide actual inclusion enrollment data

in progres s reports
• For NIH-defined Phas e III Clinical Trials – report status/results of
analyses by s ex/ gender, race, and ethnicity
• For applicable NIH-defined Phas e III Clinical Trials , report
res ults by s ex/ gender and/ or race/ ethnicity in Clinicaltrials .gov
within 1 year of primary completion date
• Inclus ion enrollment progres s (or challenges ) reviewed at leas t
annually by NIH s taff
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 Individua l- le ve l P a rticipa nt Da ta
• De-identified individual-level participant data on sex/gender, race, ethnicity, and
age at enrollment required in progress reports for applications submitted for due
dates January 25, 2019, contract solicitations issued after that date, and
intramural studies initiated after that date

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 Inclus ion Re s ource s

• Inclusion of Women and Minorities

https://grants.nih.gov/grants/funding/women_min/women_mi
n.htm

• Inclusion Across the Lifespan

https://grants.nih.gov/grants/funding/lifespan/lifespan.htm

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Sum m a ry
• NIH applicants/offerors proposing clinical research
must include plans to address inclusion of women,
minorities, and individuals across the lifespan
• Inclusion plans are evaluated by peer review and
determined to be “acceptable” or “unacceptable”
• After funding, recipients report progress of
enrollment by sex/gender, race, ethnicity, and age at
least annually

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Que s tions
1. If peer review finds inclus ion pla ns to be una ccepta ble, the
concerns mus t be res olved prior to NIH funding
TRUE

2. If funded, NIH recipients will need to provide da ta on

pa rticipa nt ra ce, ethnicity, s ex/ gender, a nd da te of birth
FALSE

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