Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Heart, Lung, and Blood Institute (NHLBI)
Reissue of RFA-HL-16-024
RFA-HL-20-012, R35 Emerging Investigator Award
The purpose of the NHLBI Outstanding Investigator Award (OIA) 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 demonstrates their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The OIA 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 OIA will support the research program of NHLBI-funded investigators for up to seven years. The OIA 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 OIA must be within the scope of the NHLBI mission (https://www.nhlbi.nih.gov/about/mission-statement).
It is anticipated that the OIA will:January 25, 2019
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.
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.
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 Outstanding Investigator Award (OIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Director/Principal Investigators (PD/PIs) who are currently PD/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrates their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The OIA 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 OIA will support the research program of NHLBI-funded investigators for up to seven years. The OIA 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 time frame. Research supported by the OIA must be within the scope of the NHLBI mission (http://www.nhlbi.nih.gov/about/org/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 OIA will:
An OIA 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 OIA must be related to HLBS research as described within the scope of the NHLBI mission (https://www.nhlbi.nih.gov/about/mission-statement).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 OIA 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 OIA 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 OIA 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. Phase I, II, III, and T4 clinical trials are not permitted under this FOA. 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."
The amount of an OIA 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 the NIH $1,000,000 total direct cost Special Council Review policy in considering all sources of investigator support (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html).
Investigators should consider the pros and cons of the OIA award when deciding to apply. Benefits include:
It is anticipated that the OIA will be highly competitive. To prevent a lapse in funding, a PD/PI can submit an R01 application and an OIA 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 OIA awardee during the OIA 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 OIA is intended to provide the primary, and most likely sole, source of NHLBI funding on individual grant awards. The OIA does not eliminate the eligibility of the PD/PI for the following separate sources of NHLBI funding:
Research Not Supported by the NHLBI OIA
The following types of projects are not responsive to this FOA and will not proceed to review:
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.
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 $17 million per year in total costs for new awards in in Fiscal Years 2020, 2021, and 2022.
The NHLBI intends to fund up to 17 new awards per year in Fiscal Years 2020, 2021, and 2022.
Applications may request up to $600,000 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.
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
Governments
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.
PD/PIs with effort on other NIH grants will be expected to provide, as part of the Just-in-Time information, a detailed explanation describing how effort on other NIH grants will be adjusted, if necessary, to permit 50% effort (i.e., a minimum of six person months) on the OIA.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Buttons to access the online ASSIST system or to download application forms 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924 or Bethesda, MD 20817 (express mail)
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov
Biographical Sketch: The OIA 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 OIA, including flexibility and adaptability to new research opportunities. Explicitly address intellectual and technical contributions to any publications 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.
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.
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 OIA.
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:
The following modifications also apply:
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.
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. Carryover of an unobligated balance from budget period to another budget period will require NHLBI Grants Management Office prior approval.
2. Awards funded under this FOA are not subject to Streamlined Non-Competing Award Process authorities; annual financial reporting is required.
3. All funds must be expended within the approved project period.
4. 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.
5. Change of PD/PI will not be allowed under the OIA.
6. Change of grantee institution will be allowable if the original grantee institution agrees to relinquish the OIA and the receiving institution agrees to all of the required OIA terms.
7. It is expected that the OIA 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 50% research effort (i.e., a minimum of six person months) is required on the OIA.
8. It is expected that the PD/PI will renegotiate effort on other NIH grants, if necessary, to permit the required effort on the OIA. Applicants with administrative responsibilities or other duties inconsistent with this time commitment must reduce those other commitments to accommodate the OIA time and effort.
9. 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.
10. The NHLBI will not consider funding future individual or multiple PD/PI research grants from an OIA awardee during the OIA project period, except for applications included under the list of exempted awards in Part 2, Section I of this FOA.
11. Transfer of an OIA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration requires prior approval; however, OIA 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In an NHLBI OIA 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 OIA 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.
Only the review criteria described below will be considered in the review process. Applications submitted 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 OIA is meant to support an individual PD/PI's research program focused on HLBS research within the scope of the NHLBI mission ( https://www.nhlbi.nih.gov/about/mission-statement).
The OIA 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.
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 program 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 program 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 program that by its nature is not innovative may be essential to advance a field.
Does the program 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 program rigorous? If the aims of the program 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 to be addressed and why is this important? Is the proposed research program adequately broad and ambitious? How likely is the research program to be groundbreaking and provide future direction for 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 program? 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 program 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 program ?
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? Has the PD/PI provided evidence of mentoring undergraduate and graduate students, postdoctoral or clinical fellows, medical students, or junior faculty? Does the PD/PI provide evidence of 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 program, 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 program ? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed program ? 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 program 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?
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 is 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?
If the program 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?
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 program proposed? Will the program 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:
I f 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?
Study Timeline
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 program 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)?
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.
Individuals Across the Lifespan
When the proposed program 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the program 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.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For programs involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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.
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.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Research involving human subjects is permitted under this FOA. Specifically, mechanistic trials and/or fundamental or basic experimental studies with humans (BESH) are permitted. Phase I, II, III, and T4 clinical trials are not permitted under this FOA. 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."
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: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
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.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The instructions are hereby amended as follows:
a) Under Section 6.2 B.1 What are the major goals of the project? Note that the goals of the program of research supported by the OIA are broader than the specific aims of a single project and should be appropriately described. If the goals of the OIA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and further contributions to the field, and an explanation of how the research continues to fit within NHLBI mission interests.
b) Under Section B.2, in addition to the instructions, emphasize how the work continues to be innovative and of high impact.
c) Under section D.2.c. additional information, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of the relationship of the new awards to the activities supported by the OIA.
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.
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.
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 processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Division of Cardiovascular Sciences
Narasimhan Danthi, Ph.D.
Telephone: 301-451-5170
Email: ndanthi@nhlbi.nih.gov
Division of Lung Diseases
Lisa Postow, Ph.D.
Telephone: 301-827-7843
Email: postowl@mail.nih.gov
Division of Blood Diseases and Resources
Andrei Kindzelski, M.D., Ph.D.
Telephone: 301-827-8275
Email: kindzelskial@mail.nih.gov
Center for Translation Research and Implementation Science
Rebecca Roper, M.S., M.P.H.
Telephone: 301-496-1051
Email: rebecca.roper@nih.gov
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov
Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8014
Email: agrestia@nhlbi.nih.gov