Participating Organization(s)
National Institutes of Health (NIH)
Components
of Participating Organizations
National Institute on Minority Health and Health
Disparities (NIMHD)
Funding Opportunity Title
NIMHD Social, Behavioral, Health
Services, and Policy Research on Minority Health and Health Disparities (R01)
Activity Code
R01 Research Project Grant
Related Notices
- July 10, 2014 - Notice of Expiration of RFA-MD-14-004. See Notice NOT-MD-14-004.
-
June 4, 2014 -
Notice NOT-14-074
supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The purpose of this Funding Opportunity Announcement (FOA)
is to solicit innovative social, behavioral, health services, and policy
research that can directly and demonstrably contribute to the elimination of
health disparities. Projects may involve primary data collection or secondary
analysis of existing datasets. Projects that examine understudied health
conditions; examine the effectiveness of interventions, services, or policies
for multiple health disparity populations; and/or directly measure the impact
of project activities on levels of health disparities are particularly
encouraged.
Open Date (Earliest Submission Date)
Letter of Intent Due Date(s)
Application Due Date(s)
August 28, 2014, by 5:00 PM local time of applicant
organization.
Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.
AIDS Application Due Date(s)
August 28, 2014, by 5:00 PM local time of applicant
organization.
Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.
Expiration Date
Now July 14, 2014 per NOT-MD-14-004. (Originally August 29, 2014)
Required Application Instructions
It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.
Table of Contents
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Part 2.
Full Text of Announcement
Section I. Funding Opportunity Description
Although scientific and technological discoveries have
improved the health of the US population overall, racial/ethnic minority
populations, socioeconomically disadvantaged populations, and rural populations
continue to experience a disproportionate burden of disease. Increased
morbidity, mortality, incidence of disease, disability, and adverse outcomes in
cancer, cardiovascular disease, diabetes, HIV/AIDS, infant mortality, and other
conditions are well documented in the scientific literature. Moreover, there
are a range of health conditions that have yet to be studied adequately in
these health disparity populations.
As the Nation’s steward of biomedical and behavioral
research, NIH has devoted considerable resources to characterize the root causes
of health disparities. As a result of these efforts, a complex and
multi-factorial web of interconnected and overlapping factors (i.e.,
biological, behavioral, environmental, and societal) has emerged. As an
important next step, research is needed that capitalizes upon this knowledge
about causal pathways to directly and demonstrably contribute to the
elimination of health disparities.
Research Objectives
Investigators who conduct original and innovative social,
behavioral, clinical, health services or policy research directed toward
eliminating health disparities are invited to apply to this FOA. Projects must
include a focus on one or more health disparities populations, which include
Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives,
Asian Americans, Native Hawaiians and other Pacific Islanders,
socioeconomically disadvantaged populations, and rural populations. This
focus can be on health disparity populations as a whole, a single health
disparity population, or a subgroup within a health disparity population.
Projects addressing the improvement of health in racial/ethnic minority
populations (without a specific emphasis on disparities relative to other
groups) are also accepted under this FOA. Projects may include observational/descriptive
studies as well as interventional studies and may involve primary data
collection or secondary analysis of existing datasets.
Applications will be considered non-responsive to this FOA
if they merely focus on diseases or conditions that happen to be more prevalent
or associated with greater morbidity/mortality in one or more disparity
populations, without the proposed work itself being directly focused on
improving minority health or health disparities (i.e., specific risk/protective
factors, disease progression, treatment response, or health outcomes for a
particular health condition in one or more health disparity populations).
Applications with foreign components that involve data
collection at foreign sites must state how this activity will improve minority
health or health disparities in the United States. Applications that do not
include this information will be considered non-responsive to this FOA.
Specific Areas of Research Interest
Areas of research interest for this initiative are divided
into three areas, social and behavioral research, health services research, and
policy research, for the sake of simplicity. It is recognized that these
categories are not exclusive and it is expected that many projects will address
more than one topic area; it is not required that investigators identify a
single area as the focus of their application.
Social
and Behavioral Research
The importance of social, cultural, and environmental
factors in driving or sustaining health disparities is increasingly recognized.
More work is needed to understand how these factors can be addressed to achieve
meaningful and lasting changes in health and health behavior at the individual
and community level. Research topics of specific interest include but are
not limited to:
- Social, behavioral, cultural, or environmental risk and
protective factors related to the development of health conditions.
- Individual- and family-level strategies to cope with disability.
- The impact of racism, discrimination, and segregation on health
and health behavior and strategies to ameliorate these effects.
- The promotion of health literacy at the community level.
- The use of health information technologies and/or social media to
promote health.
- Strategies to promote greater participation of health disparity
populations in health research and clinical trials.
- Preventive or health improvement interventions in non-medical
organizational settings, such as schools or the workplace.
- Preventive or health improvement interventions at the family,
neighborhood, or community level.
NIMHD has supported a number of phase-II clinical trials for
a range of health conditions that involve individual lifestyle/behavioral
interventions culturally tailored for a particular health disparity population.
Therefore, for lifestyle/behavioral intervention projects, those tailored for
more than one health disparity population and/or that intervene at the group
level (i.e., where groups, such as families, peer groups, or neighborhoods,
work together to achieve collective outcomes) rather than the individual level
are strongly encouraged for this FOA.
Health
Services Research
Disparities in healthcare are a clear contributor to
disparities in health outcomes. Differences in utilization patterns and quality
of care indicators between health disparity populations and the general
population have been well documented. More work is needed to understand how to
best eliminate these inequities. Research topics of specific interest include
but are not limited to:
- Potential for health information technologies to improve or
broaden access to existing services.
- Interventions to improve cultural competence of providers that
demonstrate a clear link to improvement in patient outcomes.
- Initiatives to increase the supply of healthcare practitioners in
medically underserved areas.
- The use of paraprofessionals or peer-led health services to
supplement existing healthcare services.
- The use of alternative or complementary medicine in conjunction
with formal healthcare services.
- Strategies to organize, manage, finance, and deliver quality
healthcare.
- Patient-provider communication patterns that contribute to or
minimize health disparities.
- The feasibility and/or effectiveness of healthcare delivery in
non-medical settings, such as schools or the workplace.
- Patient preferences regarding help-seeking, treatment options,
and adherence.
Because NIMHD has supported numerous projects examining the
impact of patient navigation on screening, diagnosis, and initial help-seeking
for a variety of health conditions, these topic areas are not targeted for
support under this FOA. Projects examining other uses of patient navigation
(for example, to promote treatment adherence, use of follow-up care, or patient
health outcomes) should very clearly articulate how the work fills a unique gap
in the literature.
Policy
Research
Public and private-sector policies have great potential to
influence minority health and health disparities, in both positive and negative
directions. Research advances identifying successful strategies to reduce
health disparities are unlikely to have a sustained or widespread impact unless
they can directly inform and shape policy. At the same time, the impact of new
or existing policies on minority health and health disparities may not be
evident in the absence of rigorous research evaluation. Research topics of
specific interest include but are not limited to:
- Analysis of local, state, or national health policies that
increase or reduce health disparities, such as those related to insurance
coverage or reimbursement, organization of government-run or -funded healthcare
services, or regulation of environmental hazards.
- Analysis of local, state, or national policies not specifically
related to health that increase or reduce health disparities, including those
related to zoning or housing, government entitlements, public education,
immigration, and criminal justice.
- Analysis of workplace policies in the public or private sector
that impact health.
- Identification of geographic, political, and socio-cultural
factors that predict the success or impact of policy initiatives to reduce
health disparities in different settings or regions.
Note:
NIH grantees may not use Federal funds to attempt to directly influence
deliberations or actions by Federal, state, or local legislative or executive
branches. Further, NIH grantees may not use Federal funds for grassroots
lobbying activity directed at inducing members of the public to contact their
elected representatives to urge support of, or opposition to, proposed or
pending legislation or appropriations or any regulation, administrative action,
or order issued by the executive branch of any Federal, state or local
government (see http://grants.nih.gov/grants/lobbying_guidance.htm for more information). Applications
that include prohibited policy lobbying or advocacy activities will be
considered non-responsive to this FOA.
Special
Program Priorities across Research Areas
Across specific topic areas, projects that address the
following are strongly encouraged:
- Health conditions in which disparities exist but have not been
adequately studied in health disparity populations (e.g., focal segmental
glomerulosclerosis, scleroderma and other autoimmune disorders, pancreatic
disorders, and traumatic brain injury).
- The inclusion or examination of multiple health disparity
populations. This refers both to the inclusion of separate health disparity
populations as well as the inclusion of groups that belong to one or more
health disparity population.
- Direct measurement of the impact of particular social/behavioral
risk factors, social/behavioral interventions, health services, or policies on
actual levels of health disparities. This refers to both intervention studies
(i.e., the impact of the intervention on existing disparities) and descriptive
studies (i.e., the contribution of the phenomenon being studied in explaining
disparities).
Section II. Award Information
Funding Instrument
Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
New
Resubmission
The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.
Funds Available and Anticipated Number of Awards
NIMHD intends to commit an estimated $3.0 million for 7-9
awards in FY 2015.
Award Budget
Although the size of awards may vary with the scope of the
project, direct costs are limited to $250,000 annually.
Award Project Period
The scope of the proposed project should determine the
project period. The maximum period is 5 years.
NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.
Section III. Eligibility
Information
1. Eligible Applicants
Eligible Organizations
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:
- Hispanic-serving
Institutions
- Historically
Black Colleges and Universities (HBCUs)
- Tribally
Controlled Colleges and Universities (TCCUs)
- Alaska
Native and Native Hawaiian Serving Institutions
- Asian
American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of
Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions
of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally
Recognized)
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally
recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Foreign Institutions
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.
Applicant
Organizations
Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.
- Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the initial
registration. SAM registration includes the assignment of a Commercial and
Government Entity (CAGE) Code for domestic organizations which have not already
been assigned a CAGE Code.
- NATO Commercial and
Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE
code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.
- Grants.gov Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.
Program
Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.
Eligible Individuals (Program Director/Principal
Investigator)
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH
Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an
Application Package
Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the Apply for Grant
Electronically button in this FOA or following the directions provided at Grants.gov.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.
For information on Application Submission and Receipt, visit Frequently
Asked Questions Application Guide, Electronic Submission of Grant
Applications.
Letter of Intent
Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.
By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Maryline Laude-Sharpe, PhD
National Institute on Minority Health & Health Disparities
6707 Democracy Blvd., Suite 800, MSC 5465
Bethesda, MD 20892-5465
Telephone: 301-451-9536
Fax: 301-480-4049
Email: [email protected]
Page Limitations
All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.
Required and Optional Components
The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some components
marked optional in the application package are required for submission of
applications for this FOA. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate optional components.
Instructions for Application Submission
The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide
must be followed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide
must be followed.
Modular Budget
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide
must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:
Specific
Aims: The Specific Aims section should include a summary of the
expected outcome(s) as they relate to the improvement of minority health and/or
contribute to the elimination of health disparities.
Research
Strategy: Applications should articulate how the proposed work
will specifically impact minority health or minimize health gaps between health
disparity population(s) and the general population.
Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide.
Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.
Planned Enrollment Report
When conducting clinical research, follow all instructions
for completing Planned Enrollment Reports as described in the SF424 (R&R)
Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report
When conducting clinical research, follow all instructions
for completing Cumulative Inclusion Enrollment Report
as described in the SF424 (R&R) Application Guide.
3. Submission Dates and
Times
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.
Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.
Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.
4. Intergovernmental Review
(E.O. 12372)
This initiative is not subject to intergovernmental
review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
6. Other Submission
Requirements and Information
Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations
before the application due date. Section
III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are
incomplete and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.
Section V. Application Review Information
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
Overall Impact
Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.
Significance
Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? To what extent will the project have a
direct and sizable effect on minority health and/or the elimination of health
disparities?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research
risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender,
race, and ethnicity, as well as the inclusion or exclusion of children,
justified in terms of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and
Children
When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of
children to determine if it is justified in terms of the scientific goals and
research strategy proposed. For additional information on review of the
Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.
Renewals
Not Applicable
Revisions
Not Applicable
Additional Review Considerations
As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.
Applications from Foreign
Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following
Resource Sharing Plans, or the rationale for not sharing the following types of
resources, are reasonable: 1) Data
Sharing Plan; 2) Sharing
Model Organisms; and 3) Genome Wide
Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.
2. Review and Selection
Process
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIMHD, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.
As part of the scientific peer review, all applications:
- May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.
- Will receive a written critique.
Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.
Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the National Advisory Council on Minority Health and Health
Disparities. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as
determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- Geographic distribution of the awardees.
3. Anticipated Announcement
and Award Dates
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.
Information regarding the disposition of applications is
available in the NIH Grants
Policy Statement.
Section VI. Award
Administration Information
1. Award Notices
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants
Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
Specific Types of Grants, Grantees, and Activities. More information is
provided at Award
Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
3. Reporting
When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH Grants
Policy Statement.
A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.
The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Scientific/Research Contact(s)
Jennifer Alvidrez, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9567
Email: [email protected]
Peer Review Contact(s)
Maryline Laude-Sharpe, PhD
National Institute on Minority Health & Health
Disparities (NIMHD)
Telephone: 301-451-9536 Email: [email protected]
Financial/Grants Management Contact(s)
Priscilla Grant, JD
National Institute on Minority Health & Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]
Section VIII. Other
Information
Recently issued trans-NIH policy
notices may affect your application submission. A full list of policy
notices published by NIH is provided in the NIH
Guide for Grants and Contracts. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement.
Authority and Regulations
Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health®