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.

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

In 2003, NIH issued a Funding Opportunity Announcement (FOA) to advance scientific understanding on the plausible causal pathways that explain the widely accepted, but poorly understood positive association between education and health. Based on a competitive peer review process, 13 grants were awarded by OBSSR. The scientific contribution of this programmatic effort produced an impressive bibliography of several dozen original peer reviewed publications. Both a brief history and listing of the resulting publications of the 2003 FOA can be read here: https://obssr.od.nih.gov/scientific-initiatives/health-and-education/

From an NIH perspective, the findings built on previous research by formalizing how education is clearly linked to a variety of specific and important health behaviors and conditions, therefore bringing the science closer to a mechanistic understanding of the causal pathways. For instance, some researchers found a moderate to strong association between educational attainment and several different biological risk factors, such as markers of inflammation, higher/lower cardiovascular risks, and hypercholesterolemia. Other researchers focused on a wide variety of specific illnesses and health problems, including diabetes, depression, and mental well-being. Still others examined how education is linked to positive and negative health behaviors, such as smoking cigarettes, drug and alcohol abuse, and utilization of medical screening programs.

As is often the case in science, these advances in our understanding also raised new questions.

For instance, many of these studies didn't specifically study the education process, per se, making it difficult to parse out the contributions of education from overall socioeconomic status (SES). Additionally, due to data limitations, many of the studies utilized very limited measurements of education, such as high school completion verses not completed, or cognitive performance and IQ as surrogates for education. Although this is not an unreasonable empirical strategy when faced with data limitations, these approaches limit our ability to determine which specific features of the educational experience are linked to improved health. For example, what types of skills and knowledge are relevant to speci?c positive health outcomes, and how does schooling lead to the acquisition of these skills and knowledge?

Related, are there critical periods in the life course during which education has a greater impact on the trajectory of an individual’s health than at other times for example, during pre-school, adolescence, or college? Are health benefits associated with adult education and occupational training or continuing education later in life? Are the health benefits of additional years of schooling constant no matter what the baseline level of education? Does it matter what kind of education you get: private, public, home-school, or for higher level education; technical/vocational or liberal arts; online or in a traditional setting? Does the quality of education matter, and if so, which aspects of quality? How do you measure 'quality'? How does the role of the teacher versus the family affect the linkage to positive or negative health outcomes?

The goals of this FOA are to further elucidate the pathways involved in the relationship between education and health outcomes and in doing so to carefully identify the specific aspects and qualities of education that are responsible for this relationship and what the mediating factors are that affect the nature of the causal relationship.

In June 2014, OBSSR convened a workshop that brought together clinicians and researchers in education and health in order to identify opportunities and gaps in the field as well as to develop strategies to ensure that education and health research remains a national priority. A summary of the meeting can be read here: https://obssr.od.nih.gov/wp-content/uploads/2016/07/OBSSR_Education_and_Health_REV_8-22-2014_FINAL_RLA.pdf

Areas of research that were emphasized included: developing better measures of health outcomes (including cognitive function, subjective well-being, etc.), improving study designs, identifying mechanisms underlying the relationship between education and health, and considering contextual issues. Additionally, it was noted that there must also be attention to longitudinal research to understand long-term implications of early interventions and replication of studies to verify results. Themes evident throughout the meeting included the nature of the causal relationship between education and health, contextual issues, the need for more and better data, and interventions in education and health.

A number of private foundations have current initiatives which examine the links between health and education. The William T. Grant Foundation has recently examined the infrastructure to improve the use and usefulness of research in education (http://blog.wtgrantfoundation.org/). The Robert Wood Johnson Foundation is exploring education and health within its series on the social determinants of health (http://www.rwjf.org/en/how-we-work/grants/programs-and-initiatives.html). Their work examines the interrelated pathways through which educational attainment is linked to health outcomes, including through employment and income, and social and psychological factors. The W. K. Kellogg Foundation is addressing the health and well-being of children and families from interrelated fronts, including nutrition and education (http://www.wkkf.org/grantseekers). The Open Society Foundation is committed to supporting quality education across the globe, imagining education as a key to civic participation and healthy lives (http://www.opensocietyfoundations.org/). This FOA seeks to supplement the work of these foundations by promoting an examination of the specific mechanisms through which educational experiences and activities are linked to health outcomes, elucidate pathways and inform causal models that can inform more targeted interventions.

Recent contemporary work on educational attainment and adult health has demonstrated that the treatment of health is multi-dimensional and the treatment of education is not limited to a simple operationalization. Both health and education need to be examined in complex ways, using novel methodological tools and datasets, as well as situating analyses across diverse global spaces and within specific historical time periods to better understand the macro mechanisms which link educational attainment with health outcomes.

For this FOA, education refers to the comprehensive formal instruction that spans the human experience, from early childhood programs to pre-school, elementary and secondary schooling, college and adult learning programs. It includes the social and behavioral processes that are combined with formal instruction in educational environments. A better scientific understanding of the mechanisms linking education and health could lead to additional and improved prevention and therapeutic intervention strategies for important health problems. NOTE: This FOA is not directed at studies which limit their focus to the impact of specific health education courses or programs on health behaviors; rather, the focus is on the impact of more general education experiences.

In order to better understand these pathways, it will be necessary to explore which components or dimensions of education are important to health. The association or pathway between formal education and important health behaviors or diseases may not be causal. Instead it may reflect the influence of confounding or co-existing determinants or bi-directionality. Appropriate research topics for this FOA may involve pilot studies, new analyses of existing data, longitudinal studies, or a balance of approaches tailored for the study hypotheses. It is strongly encouraged that an application involve new teams of multidisciplinary researchers with expertise in both health and education domains.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 activity code. For example, long-term projects, or projects designed to increase knowledge in a well-established area, are not appropriate for R21 awards. Applications submitted to this FOA should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

To achieve the goal of a more comprehensive understanding of the mechanisms linking education and health outcomes, this FOA encourages the exploration of research perspectives and themes described below. The NIH believes these approaches may move current research efforts to the next level of accomplishment. Applicants are not required to incorporate all of the themes below into their research applications; however, applicants should explicitly address at least one.

Education and Health Across the Age Spectrum

Formal education often occurs at the stage of the life cycle when significant formation of health behaviors is also occurring; these specific formal educational experiences as well as the social context provided by the school and the behavior and norms of the other students may either directly or indirectly influence the development of health behaviors. Education may improve health by laying the foundation for the individual's integration in to society, not only in terms of the content of the curriculum, but also in terms of social competencies and the ability to function in hierarchical, structured settings (i.e., universities and colleges, employment settings, civic society, etc.). Because of the critical need for additional information on the pathways that link education with a variety of diseases and health risk factors, researchers are encouraged, but not required, to include in any research project objectives directed at both (1) better understanding the relationship between education and a specific disease or important macro- and/or micro- health risk factor and (2) better understanding the relationship between one or more pathways that explain the association between education and general health and wellbeing. Examples of possible relevant topics might include the following (but are in no way limited to this suggested list):

- Through which biological pathways (including neurological, inflammatory, and endocrinological

networks) does education affect health?

- What is the effect(s) of education on the function or structure of the brain (eg. prefrontal cortex,

temporal lobe, etc.), during the period of formal education; is there the evidence of the persistence

of these alterations into adulthood?

- What mechanisms account for the impact of education on the risk of neurological diseases later in

life such as mild cognitive impairment, Alzheimer's disease, or cancer-related cognitive impairment?

- How does sleep moderate or mediate the relationship between education and health?

- How might education buffer against the acute and chronic effects of physiological and psychological

stress in adulthood? Does education have its effect by an enhancement of coping resources or

strategies?

- What impacts do the demands of various educational programs (at all levels) have on students

stress levels and subsequent health outcomes, both in the short and long term? Do stress

management programs moderate these effects?

- How does education affect mental health outcomes, including depression and other mental

disorders?

- What is the effect of education and moderating factors such as peer/group effects and/or social

context formation provided by the school on the development of health behaviors?

- The effect of education and educational outcomes on the initiation, maintenance, and/or cessation

of risky behaviors such as substance abuse. Compare/contrast trajectories of risky behavior with

initiation, maintenance, and/or cessation of healthy behaviors. Also, how do these risky/healthy

behaviors support or interfere with the pursuit of education?

- How do specific formal education experiences (e.g. public, private, charter, homeschooling, online,

etc.) influence health outcomes and behaviors?

- Do changes in educational policies and requirements at the local, state, tribal, and national level

result in changes in educational outcomes, attitudes towards education, and health outcomes?

- How does the timing of education, (e.g. Education obtained in adulthood versus the more traditional

educational trajectory of grade school and high school) affect health outcomes?

- How do parental inputs, including parental educational status and attitudes towards education,

influence educational outcomes? How do the influences of educational trajectories and health

outcomes of siblings and other household members alter this relationship?

- Research on the sensitive periods in prenatal, early and middle childhood development (e.g. small

class sizes in kindergarten through 3rd grade, early childhood interventions) and their impact on

education and health outcomes.

- How does the changing distribution of mental health diagnoses (e.g., how conditions are defined

such as of LD, ADHD, etc.) and how this changes the perception of the link between education and

health? Is this different over time and what are the mechanisms?

- Are the behavioral, psychological, and neurobiological risk factors associated with poor early

educational experiences plastic or malleable in mid-life? Can we identify targets for intervention in

mid-late life that might compensate for or remediate deficits associated with these risk factors?

- Research on the mechanisms that account for links between personality and other non-cognitive

skills and capacities to educational attainment, and the associated pathways linking these individual

difference factors to health outcomes in later life.

- How malleable are personality and non-cognitive skills and capacities throughout the lifespan? Do

these factors have an impact on the effectiveness of educational programs at any life stage?

- Research on the supported education for individuals with mental illness or with autism spectrum

disorders (ASD) in all levels of formal education including post-secondary and its effects on health

and quality of life measures, including longer term functioning and employment outcomes.

Innovative Data and Methodologies
Particular school-based studies have included the collection of health data, and allow for potentially important research on the links between education and health. For instance, both the Early Childhood Longitudinal Study-Birth Cohort (ECLS-B; birth through kindergarten) and the Early Childhood Longitudinal Study-Kindergarten (ECLS-K; kindergarten through eighth grade) include data on children’s cognitive, physical, social, and emotional development in the home, childcare, and school settings. The National Center for Education Statistics (NCES) High School and Beyond includes data on general health, access to health care, and health insurance status. It is the intention of this FOA to inspire collaborative work across disciplines, and through innovative methodologies to explore the mechanisms linking health outcomes to educational experiences.

Examples of possible relevant topics may include the following (but are in no way limited to this list):

- How can we more accurately or completely characterize or measure education (including teacher-

student interaction in a more formal education setting, but also non-formal social forms of

education, e.g., tribal, church, scouts, musical instruction, school clubs etc.), beyond simply as

years of education without regard to the characteristics or nature of the educational experience?

- How do we measure quality of education, such as the relationship between teacher instructional

styles and quality of teaching and health outcomes?

- Equivalently, are there innovations in metrics of resilience/personality, either on the individual or

structural supports (e.g., family, church, other) that may confer some protection from risk and may

help predict why someone in a poor quality education institution can do well later in life?

- In what ways do education quality, content, and/or appropriateness of the curriculum moderate the

association between educational attainment and health?

- Cross-national comparisons of education’s effects on health behaviors.

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.

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)
• Eligible Agencies of the Federal Government
• 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
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are 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.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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).

Applicants must obtain 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.

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.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed

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.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

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.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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.

Applicants are required to follow our Post Submission Application Materials policy.

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 R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

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).

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.

Does the project address an important problem or a critical 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? Field(s) is defined by either or both a health related science and educational sciences.

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? Does it include an expert in both the health sciences and educational sciences?

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? Innovation can be either in the health sciences, educational sciences, or both.

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?

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?

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?

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.

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.

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.

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.

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.

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.

Not Applicable

Not Applicable

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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 Data Sharing Plan (GDS).

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.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually 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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Michael Spittel, PhD.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-451-4286
Email: [email protected]

OBSSR does not award grants. Please contact one of the IC program contacts listed below for questions regarding funding interest.

Georgeanne Patmios, PhD
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: [email protected]

Todd Horowitz, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6963
Email: [email protected]

Heather Kimmel, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-8769
Email: [email protected]

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9849
Email: [email protected]

Gabriel Fosu, PhD.
Center for Scientific Review (CSR)
Telephone: 301-435-3562
Email: [email protected]

Jaclyn Crouch, MPA
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-451-3975
Email: [email protected]

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: [email protected]

Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Crystal Wolfrey
National Cancer institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Jen Schermerhorn
National institute on Drug Abuse (NIDA)
Telephone: 240-631-2090
Email: [email protected]

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.

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.