This FOA calls for research on the health of lesbian, gay,
bisexual, transgender, intersex, and related populations. In reference to
LGBTI health, an Institute
of Medicine (IOM) Report (March 2011) stated that the "existing body
of evidence is sparse and that substantial research is needed." Despite
improvements, there remains a need for further research on the health of these
populations. Applicants are urged to read the IOM report, which delineates
numerous extant research gaps.
SGM populations encompass several partially overlapping groups,
which are defined in the March 2011 IOM report as follows:
Following recent usage, the term Sexual and Gender Minority
[SGM] is used to designate both these populations overall and the individuals
within these populations. Applicants may adopt other classification frameworks
and terminologies as appropriate for their proposed research.
Recent data from national health surveys and targeted
studies suggest that prevalence rates for some health conditions are higher
among SGM populations than for the general population. This FOA encourages
research that will enrich scientific understanding of how sexual orientation
and gender identity influence health, perceptions and expectations about
health, health behaviors, and barriers and access to health-related services.
This FOA encourages research that describes the biological,
clinical, behavioral, and social processes that affect the health and
development of SGM populations and individuals and their families, and that
leads to the development of acceptable and appropriate health interventions and
health service delivery methods that will enhance health and development of
these populations. Research submitted to this FOA should focus on clearly
defined health outcomes, rather than on general measures of "well-being" or
"adjustment." This FOA encourages researchers to investigate new research
questions related to the health and development of SGM populations and
individuals and their families and to develop and/or apply innovative
methodologies to improve understanding of mechanisms affecting their health and
development.
This FOA encourages four main types of research.
Research should be designed so that it is readily
discernable whether the findings from the study sample can be generalized to
other populations. Applicants should provide a precise description of the
target population and of the sampling methods to be employed, paying attention
not only to sexual behavior, identity, orientation, and gender characteristics,
but to such variables as age, generational cohort, race/ethnicity, culture,
geography, socioeconomic status, and physical and psychological qualities.
Given the diversity of SGM populations, and their unknown distribution in the
general population, it is expected that most projects will focus on one or a
few well-defined groups.
Proposed research may draw from the full range of approaches
within biological, clinical, behavioral, and social sciences, including both
quantitative and qualitative approaches. Applicants are encouraged to build on
and/or incorporate approaches and findings from research on other types of
health disparities and from research on the influences of sex and gender in
biological and behavioral functioning. Proposed research projects must consider
the potential risks to and vulnerability of research participants and must
ensure their confidentiality and protection. The ethical and legal implications
of the proposed research on SGM populations must be considered. While the
primary domain of interest is populations within the United States, research
with non-U.S. populations is acceptable if the applicant can demonstrate the
proposed work will contribute to scientific understanding of U.S. SGM
populations.
Examples of research areas include but are not limited to
the following and combinations of these approaches:
Socio-Demographic Characteristics and Human Development,
cross-sectional and longitudinal
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
Renewals
Revisions
The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.
Award Budget
Applicants may request a maximum of $300,000 total direct
costs plus applicable Facilities & Administrative (F&A) for the
entire project period of up to three years. When a consortium is involved,
the $300,000 direct cost limit is exclusive of consortium F&A
costs. These can be requested in addition to the $300,000 direct costs
limit.
Award Project Period
The scope of the proposed project should determine the
project period. The maximum project period is 3 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)
In addition, all organizations must meet the following two
criteria:
-
The applicant organization must offer baccalaureate or advanced
degrees in biomedical or behavioral sciences
-
The applicant organization may not receive research support from
the NIH totaling more than $6 million per year (in both direct and
F&A/indirect costs) in each of 4 of the last 7 years.
Note that the following activity codes are excluded:
C06, S10, and all activity codes starting with a G.
Institutions
with Multiple Schools or Colleges
For institutions composed of multiple schools or colleges,
the criterion of financial eligibility is based on the amount of NIH research
grant monies received, not by the institution (university or college) as a
whole, but by the individual school/college or aggregation of "other
academic components" (as defined in this section) where the PD/PI has an
appointment (e.g., School of Medicine, College of Nursing, etc.). Thus, each of
the following should be considered independently when determining the financial
eligibility of the applicant organization.
-
Health professional school/college: Accredited public or
non-profit private school that provides a terminal degree related to the health
sciences granted by that school (e.g., PhD, MD, DDS, MPT, DC, ND, BSN). The
term "accredited" means a school or program that is accredited by a
recognized body or bodies approved for such purpose by the Secretary of
Education.
-
Includes schools or colleges of medicine, dentistry, osteopathy,
pharmacy, nursing, veterinary medicine, public health, optometry, allied
health, chiropractic, naturopathy and podiatry.
-
Other academic component: Once the health professional schools
have been excluded, "other academic components" refers to all remaining
schools, colleges, and free-standing institutes of the institution taken as a single
component.
Additional Eligibility Guidance
To determine the eligibility of an institution, applicants
should consult the list of
ineligible institutions on the AREA program website. If the name of the
school does not appear on the list, it is likely eligible to apply for AREA
grants. Applicants should check with their own institutions if unsure.
An AREA grant is permitted to have a subcontract to a
non-AREA-eligible institution. However, applicants should keep the goals of the
AREA program in mind when preparing the application, which include
strengthening the research environment of the institution and exposing students
to research.
Although foreign institutions are not eligible, applications
may include a foreign collaboration, component, or consortium.
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.
To be eligible for an AREA grant, the PD(s)/PI(s) must meet
the following additional criteria:
-
The PD(s)/PI(s) must have a primary appointment at an AREA
eligible institution.
-
The PD(s)/PI(s) may not be the PD(s)/PI(s) of an active NIH
research grant, including another AREA grant, at the time of award of an AREA
grant (although he or she may be one of the project personnel for an active NIH
grant held by another PD/PI).
-
The PD(s)/PI(s) may not be awarded more than one AREA grant at a
time (although he or she may hold successive new or grants
Note: These eligibility criteria only apply to the
PD(s)/PI(s) of the application, not to other key personnel such as
collaborators and consultants.)
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.
The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:
-
A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.
-
A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.
-
An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).
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, including Supplemental
Grant Application Instructions 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.
Page Limitations
All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.
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. , with the following additional instructions:
Facilities
and Other Resources
-
A profile of the students of the applicant institution/ academic
component and any information or estimate of the number who have obtained a
baccalaureate degree and gone on to obtain an academic or professional doctoral
degree in the health-related sciences during the last five years.
-
A description of the special characteristics of the institution/
academic component that make it appropriate for an AREA grant, where the goals
of the AREA program are to: (1) provide support for meritorious research; (2)
strengthen the research environment of schools that have not been major
recipients of NIH support; and (3) expose available undergraduate and/or
graduate students in such environments to research. Include a description of
the likely impact of an AREA grant on the PD(s)/PI(s) and the research
environment of the institution/academic component.
-
Although it is expected that the majority of the research will be
directed by the applicant investigator and conducted at the grantee
institution, limited use of special facilities or equipment at another
institution is permitted. For any proposed research sites other than the
applicant institution, provide a brief description of the resources.
-
If relevant, a statement of institutional support for the
proposed research project (e.g., equipment, laboratory space, release time,
matching funds, etc.).
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide
must be followed with the following additional instructions:
Biographical
Sketch: The PD(s)/PI(s) should include a summary of his or her
previous and/or current experience in supervising students in research in the
Personal Statement. The PD(s)/PI(s) should indicate which peer-reviewed
publications involved students under his or her supervision.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide
must be followed , with the following additional instructions:
The total budget for all years of the proposed project must
be requested in Budget Period 1. Do not complete Budget Periods 2 or 3. They are not required
and will not be accepted with the application.
Complete only Budget Period 1 of either the PHS 398 Modular
Budget component or the R&R Budget component.
-
Applicants submitting an application with direct costs of
$250,000 or less (total for all years, excluding consortium Facilities and
Administrative [F&A] costs) must use the PHS 398 Modular Budget component.
-
Applicants submitting an application with direct costs of
$250,001 - $300,000 (total for all years) must use the Research & Related
(R&R) Budget component.
PHS 398 Modular Budget (direct costs
of $250,000 or less):
Follow all instructions in the SF424 (R&R)
Application Guide, noting the following specifications for R15 applications.
Budget
Period 1: Direct Costs
- Direct Costs less Consortium
F&A: Select the appropriate dollar amount from the drop-down
list. This number must NOT EXCEED $250,000.
- Consortium F&A: If
applicable, enter the actual consortium F&A (e.g., $3,271).
- Total Direct Costs: This
field auto-calculates so no data entry is required.
Budget
Period 1: Indirect Costs:
- If the
F&A rate agreement has been established, indicate the type of agreement and
the date. All appropriate exclusions must be applied in the calculation of the
F&A costs.
- If the
F&A rate has not been established, enter "None-will negotiate" and include
information for a proposed rate. Use the budget justification if
additional space is needed.
Budget
Justification: Attach the Personnel Justification and
Consortium Justification. If the requested budget requires any additional
justification, attach an Additional Narrative Justification.
- Personnel Justification: Follow all instructions in the SF424 (R&R) Application Guide. Since a
primary objective of the AREA program is to expose students to meritorious
research, PD(s)/PI(s) must include undergraduate (preferably, if available)
and/or graduate students in the proposed research. Indicate aspects of the
proposed research in which students will participate. If participating students
have not yet been individually identified, the number and academic level of
those to be involved should be provided. If there are any Collaborators or
Consultants for the project, provide their names, organizational affiliations,
and the services they will perform.
- Consortium Justification: Follow all instructions in the SF424 (R&R) Application Guide, but note that
the Letter of Intent to establish a consortium must also be included in the
Consortium Justification attachment.
R&R Budget direct costs of
$250,001 to $300,000):
Follow all instructions in the SF424 (R&R)
Application Guide, noting the following specifications for R15 applications.
Budget
Period 1: Direct Costs
- Total Direct Costs less Consortium
F&A: This number must NOT EXCEED $300,000.
- Consortium F&A: If
applicable, enter the actual consortium F&A (e.g., $3,271).
Budget
Period 1: Indirect Costs:
- If the
F&A rate agreement has been established, indicate the type of agreement.
All appropriate exclusions must be applied in the calculation of the F&A
costs.
- If the
F&A rate has not been established, enter "None-will negotiate" and include
information for a proposed rate. Use the budget justification if
additional space is needed.
Budget
Justification: Follow all instructions in the SF424 (R&R)
Application Guide. Since a primary objective of the AREA program is to expose
students to meritorious research, PD(s)/PI(s) must include undergraduate
(preferably, if available) and/or graduate students in the proposed research.
Indicate aspects of the proposed research in which students will participate.
If participating students have not yet been individually identified, the number
and academic level of those to be involved should be provided. If there are any
Collaborators or Consultants for the project, provide their names,
organizational affiliations, and the services they will perform.
R&R Subaward 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:
Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans 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.
PHS Human Subjects and Clinical Trials Information
When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a delayed onset study record.
Study Record: PHS Human Subjects and Clinical Trials Information: All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
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. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues.
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 and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.
Post Submission Materials
Applicants are required to follow our Post Submission Application Materials policy.
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.
For this particular announcement, note the following:
The objectives of the R15 program
are to (1) provide support for meritorious research, (2) strengthen the
research environment of schools that have not been major recipients of NIH
support, and (3) expose available undergraduate and graduate students in such
environments to meritorious research. Preliminary data are not required for an
R15 application; however, they may be included if available.
Overall Impact
Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to make an important
scientific contribution to the research field(s) involved, to provide research
opportunities to students, and to strengthen the research environment of the
institution, in consideration of the following review criteria and additional
review criteria (as applicable for the project proposed).
For this particular announcement, note the following: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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 barrier to progress in the field?
Is there a strong scientific premise for the project? 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? If funded, will the AREA
award have a substantial effect on the school/academic component in terms of
strengthening the research environment and exposing students to research?
In addition, for applications proposing clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?
Investigator(s)
Are the PD(s)/PI(s), collaborators,
and other researchers well suited to the project? If Early Stage Investigators
or those 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? Do the
PD(s)/PI(s) have suitable experience in supervising students in research?
In addition, for applications proposing clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
In addition, for applications proposing clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Does the application provide sufficient evidence that
the project can stimulate the interests of students so that they consider a
career in the biomedical or behavioral sciences?
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?
In addition, for applications proposing clinical trials: Does the application adequately address the following, if applicable:
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
Are the institutional support, equipment and other
physical resources available to the investigators adequate for the project
proposed? Does the application demonstrate the likely availability of
well-qualified students to participate in the research project? Does the
application provide sufficient evidence that students have in the past or are
likely to pursue careers in the biomedical or behavioral sciences?
In addition, for applications proposing clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Study Timeline
Specific to applications proposing clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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
For Renewals, the committee will
consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider
the appropriateness of the proposed expansion of the scope of the project. If
the Revision application relates to a specific line of investigation presented
in the original application that was not recommended for approval by the
committee, then the committee will consider whether the responses to comments
from the previous scientific review group are adequate and whether substantial
changes are clearly evident.
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) Genomic Wide Association Studies
(GWAS) /Genomic Data Sharing Plan.
Authentication of Key Biological and/or Chemical Resources
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 the Center
for Scientific Review, 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.
Applications will be assigned on the basis of established
PHS referral guidelines 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 appropriate national Advisory
Council or Board. 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.
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
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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials by law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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
Progress reports for multi-year funded awards are due
annually on or before the anniversary of the budget/project period start date
of award. The reporting period for multi-year funded award progress report is
the calendar year preceding the anniversary date of the award. Information on
the content of the progress report and instructions on how to submit the report
using the RPPR are posted at https://grants.nih.gov/grants/policy/myf.htm.
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 Service Desk (Questions regarding ASSIST, 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: https://grants.nih.gov/support/index.html
Email: [email protected]
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Scientific/Research Contact(s)
Della Brown White, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-2712
Email: [email protected]
Liz Perruccio, PhD
National Cancer Institute (NCI)
Telephone: (240) 276-6178
Email: [email protected]
Robert Freeman
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-433-8820
Email: [email protected]
Philip O. Renzullo, PhD
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301 451-2764
Email: [email protected]
Jeffrey Schulden, MD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-1526
Email: [email protected]
Lana Shekim, PhD
National Institute on Deafness and Other Communication
Disorders (NIDCD)
Telephone: 301-496-5061
Email: [email protected]
Melissa Riddle, PhD
National Institute of Dental and Craniofacial Research
(NIDCR)
Telephone: 301-451-3888
Email: [email protected]
Catherine Roca, MD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: [email protected]
Jennifer Alvidrez
National Institute on Minority Health and Health Disparities
(NIMHD)
Telephone: 301-594-9567
Email: [email protected]
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and
contact information (information appears two weeks after the submission due
date).
Financial/Grants Management Contact(s)
Bryan S. Clark,
MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]
Liz Perruccio, PhD
National Cancer Institute (NCI)
Telephone: (240) 276-6178
Email: [email protected]
Ann White Devine
National Institute on Allergy and Infectious Disease (NIAID)
Telephone: 301-402-5601
Email: [email protected]
Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-6710
Email: [email protected]
Chris Myers
National Institute on Deafness and Other Communication
Disorders (NIDCD)
Telephone: 301-435-0713
Email: [email protected]
Diana Rutberg
National Institute of Dental and Craniofacial Research
(NIDCR)
Telephone: 301-594-4798
Email: [email protected]
Tamara Kees
National Institute on Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]
Priscilla Grant
National Institute on Minority Health and 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 Part 75.
Department of Health
and Human Services (HHS)
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