Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Nursing Research (NINR)

Funding Opportunity Title

Chronic Wounds: Advancing the Science from Prevention to Healing (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 16, 2014 - See Notice NOT-OD-14-091. Piloting Modified NIH Biosketches.

Funding Opportunity Announcement (FOA) Number

RFA-NR-15-001

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.361

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) seeks to stimulate research that will increase the understanding of biological and psychosocial factors associated with development, progression, and repair of chronic wounds (e.g., diabetic ulcers, pressure ulcers, venous and arterial ulcers) and associated adverse outcomes, and to develop and test interventions aimed at preventing the onset of chronic wounds, expediting the healing process, or alleviating wound-related symptoms. It is anticipated that the findings from this research will expand the body of knowledge needed to identify individuals at the highest risk for developing chronic wounds and to inform the search for tailored treatments to improve outcomes and quality of life for millions of persons at risk for or suffering from chronic wounds. 

Key Dates
Posted Date

May 6, 2014

Open Date (Earliest Submission Date)

June 24, 2014

Letter of Intent Due Date(s)

June 24, 2014

Application Due Date(s)

July 24, 2014, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2014

Advisory Council Review

January 2015

Earliest Start Date

April 2015

Expiration Date

July 25, 2014

Due Dates for E.O. 12372

Not Applicable

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. This FOA is part of an NIH pilot to enhance reproducibility and transparency of research findings. See Section IV 2. below for additional instructions under “SF424(R&R) Senior/Key Person Profile” and “PHS 398 Research Plan” related to information to be included in Biographical Sketches and the Research Strategy.



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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Chronic wounds (wounds that have not proceeded through a reparative process in three months) affect over five million Americans each year, resulting in over $20 billion in health care costs. Individuals with disabilities and diabetes, as well as the elderly, have the highest risk of developing chronic wounds. Patients afflicted with chronic wounds suffer from physical pain and disabilities in addition to psychological and emotional stresses and poor quality of life. Current treatments for chronic wounds include cleansing, debridement, maintaining a moist tissue environment, and when possible, eliminating the underlying pathology or factors that contributed to poor wound healing. In advanced cases, amputation may become necessary. Death, especially in elderly patients, may result from sepsis that can be associated with chronic wounds.

Recent scientific advances have helped delineate the underlying mechanisms associated with the development and trajectory of chronic wounds. For example, candidate gene studies have revealed single nucleotide polymorphisms (SNPs) that are specific to certain types of venous ulcers. Genes involved with inflammation and repair were shown to be differentially expressed over the course of wound healing, and the roles of epigenetic modifications and non-coding RNAs in wound repair have been described. Molecular-based methods (such as sequencing of the bacterial 16S ribosomal RNA gene) have been shown to be superior to culture-based strategies for identification of bacteria that may be colonizing a chronic wound. Other types of biomarkers (e.g., cytokines, growth factors) have provided insight to the cellular events associated with wound healing, and have the potential to be used to predict the healing capacity of a chronic wound. Technological innovations, such as sensors capable of non-invasively assessing wound parameters (e.g., moisture, temperature, pH) in real time, may someday markedly change the wound care paradigm.

It is important to note, however, that despite these and other advances, chronic wound management remains complex and multidimensional, and as such, an effective wound management strategy must include a holistic approach that addresses the patient as a whole, rather than focusing only on the repair of the skin and underlying tissues and addressing infection.  Factors such as co-morbidities, in addition to environmental, behavioral, and sociodemographic influences, may impact the ability to heal. Pain and other symptoms (such as swelling, burning, itching) are well-documented in patients with chronic wounds, and it is not uncommon for patients to experience multiple symptoms concurrently.  These symptoms, which may further impact the patient’s quality of life, are often inadequately addressed as part of a wound care regimen. Additionally, patients that experience pain after the wound has healed (including those with no reported pain at baseline) may be more susceptible to wound recurrence, but the cause for this, as well as the best course of treatment for these patients, is not well-understood. Moreover, physical symptoms are not only debilitating but can also lead to psychological symptoms (such as depression, stress, and anxiety) in addition to psychosocial stressors such as low self-esteem, social isolation, and financial and employment insecurity.  These in turn may compromise the immune system, further impairing the healing process. A better understanding of biological and psychosocial influences and associated mechanisms, including this reciprocal relationship, is needed to advance wound care practice. It is also important to address palliative wound care strategies in individuals with wounds that may not have the capacity to heal. For these individuals, the primary objective may shift from wound healing to symptom relief and improved quality of life, and should be aligned with patient- and family-directed goals, needs, and priorities.

Research Objectives

For this FOA, NINR is primarily interested in applications focusing on clinical research (including studies that develop and/or test clinical interventions), but recognizes that certain studies may be restricted to animal models at present because appropriate human research models are not available, or human studies are otherwise not feasible. Applications that include animal studies should provide a rationale for why the use of the animal model is essential for the research proposed.

Research projects of interest include, but are not limited to, those that address:

  • Biomarkers (e.g., genomic, proteomic, metabolomic) and mechanisms associated with chronic wound risk, development, progression, and healing
  • Contribution of co-morbidities, behavioral or lifestyle factors (e.g., nutrition, physical activity), sociodemographic influences (e.g., age, ethnicity, gender, education, socioeconomic status), or the built environment to the prevention or trajectory of chronic wounds, including (but not limited to) the impact of these factors on biological mechanisms or the expression/activity of biomarkers
  • Bacterial colonization of chronic wounds; impact of bioburden and biofilms on wound repair processes; role of contributing factors (e.g., age of patient, nutritional status, underlying health status or comorbid conditions, obesity, duration of wound) that further compromise the ability to effectively address infection
  • Estimation of an individual’s risk for development/recurrence of chronic wounds or potential for poor healing outcomes
  • Non- or minimally-invasive technologies that facilitate wound management or healing
  • Symptoms (e.g., pain,  fatigue) and symptom clusters associated with chronic wounds; management of chronic wound-induced symptoms; impact of symptoms on clinical outcomes (e.g., poor wound healing), disability, or quality of life; relationship between pain (or other symptoms) at time of healing and risk for recurrence of chronic wounds
  • Interventions that:
    • Prevent the occurrence/recurrence of chronic wounds or expedite the healing process
    • Incorporate an individual’s biological information and environmental, behavioral, and/or psychosocial factors/influences into wound management strategies
    • Alleviate or manage pain or other symptoms associated with chronic wounds, including symptoms that persist following wound healing or in the absence of wound manipulations (e.g., dressing changes)
    • Modify the wound environment (e.g., wound fluid composition, wound biofilms) to promote healing
    • Use self-management strategies to restore or enhance the ability to carry out activities of daily living, improve physical or emotional health and well-being, or attain other positive outcomes in individuals with chronic wounds
    • Can be implemented in community settings by patients, families, informal caregivers, or others in the community, particularly (but not limited to) interventions that target/take into account factors such as patient experiences, lifestyle, health behaviors, social support, the built environment, etc. 
    • Incorporate wound palliation

This FOA focuses on non-pharmacological interventions only. Additionally, alternative interventions such as acupuncture, hypnosis, and natural products (such as herbal medicines, dietary supplements, and probiotics) will not be considered under this FOA.

Interdisciplinary collaborations that include nurse scientists in the project team are strongly encouraged. Additionally, applicants should consider engaging the resources and expertise of nearby or otherwise available Clinical and Translational Science Award grant sites (CTSAs) and/or federally funded research centers where possible.  

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NINR intends to commit $3,000,000 in FY 2015 for up to six awards in response to this FOA.

Award Budget

Application budgets are limited to $350,000 in direct costs in any year, not including consortium F&A costs.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • 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)
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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Yujing Liu, Ph.D, Chief, Office of Review
National Institute of Nursing Research (NINR)
Telephone: (301) 451-5152
Email: yujing_liu@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following modification:

  • The Biographical Sketch for each Senior/Key Person may not exceed five pages.
Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed, with the following modifications.

Biographical Sketch: NINR is piloting a proposed change to the SF424 (R&R) Biographical Sketch to allow applicants to this FOA to include a description of up to five contributions to their scientific field(s). The intent is for applicants to be evaluated on the basis of better information than can be conveyed by a simple list of publications. The Biographical Sketch Format page for the pilot is available at http://grants.nih.gov/grants/funding/424/index.htm.

Following the education section of the Biographical Sketch, complete sections A, B, C and D as indicated below:

NOTE: Applicants must follow the formats and instructions below.

A. Personal Statement: Briefly describe why you are well-suited for your role in the project described in this application. The relevant factors may include aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and your past performance in this or related fields (you may mention specific contributions to science that are not included in Section C).   Also, you may identify up to four peer reviewed publications that specifically highlight your experience and qualifications for this project, provided that those publications do not appear in Section C.   If you wish to explain impediments to your past productivity, you may include a description of factors such as family care responsibilities, illness, disability, and active duty military service.

B. Positions and Honors:  List in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee.

C. Contributions to Science:  Briefly describe up to five of your most significant contributions to science.   For each contribution, indicate the historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology; and your specific role in the described work.   For each of these contributions, reference up to four peer-reviewed publications that are relevant to that contribution.   The description of each contribution should be no longer than one half page including any figures.  Please also provide a link to a full list of your published work as found in a publicly available digital data base such as PubMed, myBibliography, or SciENcv all of which are maintained by the National Library of Medicine.

D. Research Support:  List both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs.

All other components of the Biographical Sketch remain as described in the SF424 (R&R) Instruction Guide.

R&R or Modular Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Application Submission Information to Enhance Reproducibility and Transparency of Research

Reproducibility, control of bias, and transparency of reporting are important for all research, and can significantly affect the quality of studies that provide the basis for large-scale clinical trials. For this reason, investigators should consider the following points in explaining the background justification for their work, proposed study design and data analysis, and to address those aspects as appropriate for their application:

Experimental design:

  • Include discussion of the background literature and preliminary data—include literature that may contradict your proposed work;
  • Outline the conceptual framework for the proposed study;
  • Address the use of the controls/control groups;
  • Clearly explain the route & timing of intervention delivery / dosing;
  • Provide clear justification of sample size(s), including power calculation(s).

Minimizing bias:

  • Describe methods of masking (allocation concealment and masked assessment of outcome);
  • Include strategies for randomization and/or stratification;
  • Explain how missing data, such as due to attrition or exclusion, would be addressed;
  • Include a plan for reporting of all results (negative and positive);
  • Indicate if there will be an independent validation/replication;
  • Describe plan to ensure robustness and reproducibility of all experimental data.

Interpretation of results:

  • Explain the statistical methods to be used in data analysis and interpretation of  results;
  • Explain possible alternative interpretations of the experimental data;
  • Clarify methods for handling missing data;
  • Cite relevant literature in support or in disagreement with the potential results.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

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.

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.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the National Institute of Nursing Research, NIH.  Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the discussions of background literature and preliminary data appropriate to this project? Is the conceptual framework well-reasoned for the proposed study? Are the sample size, power analysis and controls well justified? Are there strategies for randomization and/or stratification, masking, and reporting results? Are there plans for independent validation/replication of observed results? Are statistical methods for data analysis/interpretation and handling missing data appropriate to this project? Are possible alternative interpretations of data and theory presented?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?     

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

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.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Nursing Research in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Institute of Nursing Research. 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

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Lois Tully, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-594-5968
Email:  tullyla@mail.nih.gov


Peer Review Contact(s)

Yujing Liu, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-451-5152
Email: yujing_liu@nih.gov

Financial/Grants Management Contact(s)

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: Freundlichr@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

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