Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
R35 Outstanding Investigator Award
The purpose of the NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PD/PIs) who are currently PD/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrate their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The EIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards.
The EIA will support the research program of NHLBI-funded investigators for up to seven years. The EIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PD/PIs to take greater risks and to pursue research that requires a longer timeframe. Research supported by the EIA must be within the scope of the NHLBI mission.
It is anticipated that the EIA will:
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| February 15, 2022 | Not Applicable | April 25, 2022 | July 2022 | October 2022 | December 2022 |
| February 15, 2023 | Not Applicable | April 25, 2023 | July 2023 | October 2023 | December 2023 |
| February 15, 2024 | Not Applicable | April 25, 2024 | July 2024 | October 2024 | December 2024 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
The purpose of the NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PD/PIs) who are currently PD/PIs on at least two NHLBI R01-equivalent awards, of which one must be an NHLBI-funded NIH Early Stage Investigator R01 award, and whose outstanding record of research demonstrate their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The EIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding.
The EIA will support the research program of NHLBI-funded investigators for up to seven years. The EIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PD/PIs to take greater risks and to pursue research that requires a longer timeframe. Research supported by the EIA must be within the scope of the NHLBI mission.
Applicants are strongly encouraged to review the NHLBI R35 Program Frequently Asked Questions (FAQs) and consult with the appropriate scientific research contacts.
Overview
This FOA is intended for established investigators who have the potential to conduct outstanding, innovative research. For this reason, eligibility is limited. Please refer to Section III. Eligibility Information for specific details.
It is anticipated that the NHLBI EIA will:
An EIA is intended to be the primary, and in most cases, sole support for all of the NHLBI-related research conducted by an investigator. Research supported through the EIA must be related to HLBS research as described within the scope of the NHLBI mission. Within these bounds, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research. Work involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component requires prior approval of NHLBI according to existing policies and procedures.
It is expected that the EIA will replace current NHLBI funding on other NHLBI individual research grants, as described below. NHLBI investigators with additional NIH support from other NIH Institutes or Centers (ICs) are welcome to apply, however funds cannot be requested through the EIA for activities supported by another IC, federal or state agency, or private foundation. PD/PIs will be expected to renegotiate their time and effort on other (non-NHLBI) NIH grants in order to accommodate the required EIA level of effort.
Research involving human subjects is permitted under this FOA. Specifically, mechanistic trials and/or fundamental or basic experimental studies with humans (BESH) are permitted. NIH defines a mechanistic study as a study "designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention." NIH defines basic research consistent with the definition of basic research in federal code, "the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena or of observable facts without specific applications towards processes or products in mind." However, Phase I, II, III, and T4 clinical trials are not permitted under this FOA.
The amount of an EIA will be determined by NHLBI, based on the recommendations of the study section, the National Heart, Lung, and Blood Advisory Council (NHLBAC), and evaluation of the needs, expected productivity, and impact of the proposed research program. NHLBI will continue to implement NOT-OD-12-140, "Notice of NIH Special Council Review of Research Applications from PDs/PIs with More than $1.0 Million Direct Costs in Annual NIH Support" in considering all sources of investigator support.
Investigators should consider the following features of the EIA award when deciding to apply. Benefits include:
It is anticipated that the EIA will be highly competitive. To prevent a lapse in funding, a PD/PI can submit an R01 application and an EIA application in parallel. Should both applications be selected for funding, the PD/PI will be permitted to accept only one of the awards. The NHLBI will not consider funding future individual PD/PI research grants from an EIA awardee during the EIA project period, except for applications included under the list of exempted awards below. To clarify which awards are exempted from this policy, applicants are strongly encouraged to contact NHLBI staff.
The EIA is intended to provide the primary, and most likely sole, source of NHLBI funding on individual grant awards. The EIA does not eliminate the eligibility of the PD/PI for the following separate sources of NHLBI funding:
Research Not Supported by the NHLBI EIA
The following types of projects are not responsive to this FOA and will not proceed to review:
Please see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts for a list of all available FOAs in which NHLBI participates, including those that support clinical trials.
Diversity Statement
Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The NHLBI intends to commit up to $20 million in total costs for new awards in Fiscal Years 2023, 2024, and 2025.
The NHLBI intends to fund up to 20 new R35 awards per year in Fiscal Years 2023, 2024, and 2025.
Applications may request up to $700,000 direct costs per year. Investigators are encouraged to request what is well-justified for their research program. The award amount will be determined by the NHLBI and commensurate with current NHLBI support of the PD/PI.
Applications may request a maximum project period of up to seven (7) years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted. Applications that do not meet eligibility requirements will not be reviewed.
Eligibility is determined by NHLBI after the receipt of applications on the intended application due date. Eligibility to apply to this FOA is limited to PD/PIs who meet all of the following criteria:
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
It is anticipated that the EIA will be highly competitive. To prevent a lapse in funding, a PD/PI can submit an R01 application and an EIA application in parallel.
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
Biographical Sketch: The NHLBI EIA is intended for investigators with track records of creativity, consistent productivity, and significant scientific impact. The PD/PI should, in the Biographical Sketch, address these considerations and demonstrate a history of conducting rigorous and reproducible research and reporting it in a transparent fashion. In addition, the PD/PI should demonstrate their suitability for funding through the NHLBI EIA, including flexibility and adaptability to new research opportunities. Explicitly address intellectual and technical contributions to any publications with former mentors and highlight contributions since becoming an independent investigator. Include experience as a mentor of undergraduate and graduate students, postdoctoral or clinical fellows, medical students, or junior faculty.
Current & Pending Support: Use the SF424 R&R Current and Pending Support instructions and attach this information to the Senior/Key Personnel Form. List NHLBI grants first, followed by other NIH grants, followed by other sources of support.
Provide a list of all current and pending support for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications, regardless of source of support (e.g., Federal, private, non-profit). Show the total award amount for the entire award period (including indirect costs) as well as the number of person months per year to be devoted to the project by the senior/key person. Provide current and pending research support information at time of application using the format typically used for Just-in-Time information. Be sure to distinguish the direct costs per year that support research in the investigator's laboratory from support that goes to other investigators. Concurrent submission of an application to other organizations that are not components of NIH or the Public Health Service will not prejudice its review.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 7 years of support.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Do not use. Specific Aims are not required and should not be submitted.
Research Strategy: The Research Strategy should include the following information:
1. Background regarding the area(s) of research proposed and key gaps in our understanding or challenges that need to be addressed relevant to HLBS research. Describe the potential for the identified area(s) of research to be groundbreaking or paradigm-shifting. Describe future impact on HLBS research.
2. Describe the overall vision, conceptual framework, and general strategies for furthering and sustaining the proposed research program, including plans for building on prior accomplishments to formulate a highly innovative program for advancing and transforming the research field.
3. Discuss the importance of the research question and how the research could impact the current understanding of the problem being addressed and/or advance the field of study. Describe how the research program could evolve as the work is being performed and how the risks and challenges will be addressed. Explain how the proposed research program is in an area that will continue to be important and generate significant new discoveries within the mission of the NHLBI (e.g., describe how the research program will result in new opportunities, explore new areas of scientific inquiry, and develop new systems and strategies, if applicable).
The proposed research can be either a continuation of the PD/PI's previous or current work, or involve a new line of investigation. If the planned research diverges significantly from past/current work, explain the rationale for the changes and describe the PD/PI's ability to undertake this new direction. A detailed experimental plan is not expected. Preliminary data are not required, but limited information may be included if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published. Although the proposed direction of the research program will be considered in review, if new opportunities or directions arise during the course of the research, the PD/PI will have the flexibility to change course and pursue them. Explain how the proposed research program will benefit from the flexibility, level of effort, and the longer-term funding offered by the EIA.
Letters of Support: The application must include a Letter of Support from the institution’s Authorized Organizational Official (AOR). Applications that are missing a Letter of Support will not be reviewed.
In two pages or less, the Letter of Support should include:
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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
It is anticipated that the terms of award will include, but not be limited to, the following:
1. Awards funded under this FOA are not subject to Streamlined Non-Competing Award Process authorities; annual financial reporting is required.
2. All funds must be expended within the approved project period.
3. Awards funded under this FOA will not be provided the authority to extend the final budget period of the previously approved project period one time for up to 12 months beyond the original expiration date shown in the Notice of Grant Award, as outlined in the NIH Standard Award Terms and Conditions. All extensions, including the first extension, will require NIH prior approval.
4. Change of PD/PI will not be allowed under the EIA.
5. Change of grantee institution will be allowable if the original grantee institution agrees to relinquish the EIA and the receiving institution agrees to all of the required EIA terms.
6. It is expected that the EIA will replace all funded NHLBI single project/single PD/PI grants (see exceptions in Part 2, Section I of this FOA). NHLBI-funded multiple PD/PI and multiple project grants as well as other NIH funding will be excluded; however, effort on those grants will need to be accommodated outside the requirement for six person months (i.e., the equivalent of 50% effort on a full-year appointment, 66.67% on a 9-month appointment, or 100% on a 6-month appointment) is required on the EIA.
7. It is expected that the PD/PI will renegotiate effort on other NIH grants, if necessary, to permit the required effort on the EIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment must reduce those other commitments to accommodate the EIA time and effort.
8. There must be continued evidence of a clear and substantial institutional commitment to the PD/PI (e.g., 20% salary support, access to resources, protected time, space, etc.) for the duration of the award.
9. The NHLBI will not consider funding future individual or multiple PD/PI research grants from an EIA awardee during the EIA project period, except for applications included under the list of exempted awards in Part 2, Section I of this FOA.
10. Transfer of an EIA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration requires prior approval; however, EIA grant funds may not be used to support this component.
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In an NHLBI EIA application, applicants should not propose research that is currently funded by, and that fits appropriately within the mission of, other NIH Institutes and Centers (ICs) . PDs/PIs are encouraged to contact NHLBI Scientific/Research staff prior to submission of an NHLBI EIA application to discuss whether their application is relevant to the NHLBI mission and whether it overlaps with awards from other NIH ICs or independent funding entities.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The EIA is meant to support an individual PDs/PI's research program focused on HLBS research within the scope of the NHLBI mission (https://www.nhlbi.nih.gov/about/mission-statement).
The EIA is intended to promote scientific productivity and innovation by providing stable and flexible funding. Applicants are expected to provide an overview of the research program, the scientific questions they currently plan to address, and a general description of possible strategies. Experimental details and preliminary data are not expected, but limited information may be included if it is critical for assessing the feasibility of new avenues of research or critical methodologies about which the PD/PI has not yet published.
Accordingly, in addition to the criteria below, reviewers will emphasize the following:
1. Evidence of important previous contributions made by the PD/PI to their field (outstanding research quality; continuous record of publications in peer-reviewed journals; landmark publications, honors and awards received; professional service; etc.);
2. PD/PI's demonstrated outstanding HLBS research productivity of the highest quality;
3. Potential that the PD/PI will continue to impact and influence HLBS research at the same high caliber level in the future.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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 the prior research that serves as the key support for the proposed project rigorous? 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?
Specific to this FOA:
What is the heart, lung, blood or sleep (HLBS) scientific challenge being addressed? How substantially would the proposed research program increase the overall scientific knowledge in this field? Is the proposed research program adequately broad and ambitious? How likely is the research program to be groundbreaking and paradigm-shifting in HLBS research? Is the proposed research program substantive in scope?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
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?
Specific to this FOA:
How has the PD/PI demonstrated outstanding research productivity of the highest quality? How has the PD/PI's past research contributed to HLBS research? What is the potential for the PD/PI’s research productivity and influence to continue at the same high caliber level? Does the PD/PI show promise as a mentor of undergraduate and graduate students, postdoctoral or clinical fellows, medical students, or junior faculty? Does the PD/PI demonstrate the potential to establish a record of professional service? Does the PD/PI have a record of conducting rigorous research and reporting it transparently? Has the PD/PI provided evidence of the program’s novelty in HLBS research?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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?
Specific to this FOA:
How likely is it that the proposed program will result in new opportunities, explore new areas of scientific inquiry, and/or develop new systems and strategies?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
Does the application indicate appropriate commitment of time and effort for the proposed work? Does the PD/PI provide strong evidence that the research program will evolve appropriately as the work in performed? How likely is the proposed research to be performed rigorously and the results carefully interpreted?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
Specific to this FOA:
Does the required letter of support assure appropriate commitment and effort by the PD/PI, and adequate institutional commitment to the PD/PI for the duration of the award?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHLBI, 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 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 NHLBI. 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 Heart, Lung, and Blood Advisory Council. Final award decisions will be based on a variety of criteria relevant to scientific merit, program balance, and NHLBI strategic priorities including:
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 recipient'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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Division of Cardiovascular Sciences
Narasimhan Danthi, Ph.D.
Telephone: 301-451-5170
Email: [email protected]
Division of Lung Diseases
Lisa Postow, Ph.D.
Telephone: 301-827-7843
Email: [email protected]
Division of Blood Diseases and Resources
Andrei Kindzelski, M.D., Ph.D.
Telephone: 301-827-8275
Email: [email protected]
Center for Translation Research and Implementation Science
Desir e L. Salazar, PhD
Telephone: 301-480-4177
Email: [email protected]
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]
Gayle Jones
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8010
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.