National Institutes of Health (NIH)
U01 Research Project – Cooperative Agreements
NOT-HL-21-006 - Notice of Intent to Publish a Funding Opportunity Announcement for the ARDS, Pneumonia, and Sepsis Phenotyping Consortium Coordinating Center (U01)
NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available
NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients
NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022
NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements
NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel
This funding opportunity annoucement (FOA) seeks applications for a Coordinating Center that will support the activities of a cooperative multi-site Acute Respiratory Distress Syndrome (ARDS), Pneumonia, and Sepsis Phenotyping Consortium (APS Consortium). The APS Consortium will seek to understand the heterogeneity and underlying mechanisms of critical illness syndromes and recovery, specifically in adults with ARDS, pneumonia, and/or sepsis, as well as the relationship and biological overlap among these syndromes. This will be accomplished through a prospective, longitudinal observational study with common data and biospecimen collection of 5,000 hospitalized adults with one or more of the following diagnoses: ARDS, pneumonia, or sepsis. It is expected that approximately half of the participants discharged from the hospital will have follow-up at 3, 6, and 12 months to facilitate understanding of long-term outcomes, including biological and physiological resolution of ARDS, pneumonia, and sepsis. Throughout the program’s funding period, data (including imaging data) and biospecimens collected will be made available as a resource to the broader research community as rapidly and simply as possible.
The Coordinating Center will be expected to have expertise in statistics, longitudinal cohort studies, informatics, data management (including imaging data), and biospecimen management, and to have demonstrable interest in developing proactive policies for sharing.
This FOA runs in parallel with the APS Consortium Clinical Centers (see RFA-HL-23-001).
May 17, 2022
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| June 17, 2022 | Not Applicable | Not Applicable | November 2022 | January 2023 | April 2023 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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.
Background
ARDS, pneumonia, and sepsis are common critical illness syndromes with significant associated morbidity and mortality, both during the acute phase and long-term. There is substantial heterogeneity in these critical illness syndromes, and the mechanisms of injury and recovery in these syndromes are not well understood. The presence of significant heterogeneity within each syndrome, combined with the overlapping phenotypes among syndromes, suggests that study of common critical illness syndromes in an interrelated manner may improve the understanding of mechanisms that dictate short- and long-term outcomes and enhance the identification of sub-phenotypes across syndromes. To address this need and begin to move toward precision-based therapies, the ARDS, Pneumonia, and Sepsis Phenotyping Consortium (APS Consortium) will conduct a longitudinal cohort study of 5,000 participants hospitalized in the U.S. with ARDS, pneumonia, or sepsis, and collect multidimensional data for up to one year from the time of hospitalization to allow for rigorous phenotyping. Data and biospecimen collection for proactive sharing for future research purposes is an additional goal of the APS Consortium.
Purpose and Objectives
This funding opportunity announcement (FOA) is intended to support the Coordinating Center that will facilitate the organization and conduct of all shared research activities within the APS Consortium. The APS Consortium will bring together five Clinical Centers (each made up of one main site and 1-3 subsites, funded under the companion RFA-HL-23-001) and the Coordinating Center to form a cooperative research platform to conduct a Consortium-wide longitudinal cohort study, and facilitate Clinical Center-specific scientific projects, focused on ARDS, pneumonia, and sepsis. The APS Consortium will also be supported by project scientists from the NHLBI and NIGMS, as well as an NHLBI-appointed independent Protocol Review Committee (PRC) and Observational Study Monitoring Board (OSMB).
It is anticipated that each Clinical Center will enroll 40 participants in year 1 and 240 participants/year in years 2-5 for a total of 1000 participants over the project period. Enrollment of participants early in their hospital course is encouraged. Approximately half of the participants discharged from the hospital will have in-person follow-up at 3, 6, and 12 months; data (including core outcome measures of quality of life, cognition, and mental health as recommended by Needham et al Am J Resp Crit Care Med 2017 or similar), imaging, and biospecimens will be collected at the follow-up visits to facilitate understanding of biological/physiological resolution of ARDS, pneumonia, and sepsis. Methods for passive follow-up of participants (e.g., National Death Index) or telephone/virtual follow-up of participants not followed in-person may also be considered. Participant follow-up, analysis, and close out activities will occur during year 6.
The Consortium-wide longitudinal cohort study protocol will be determined by a Steering Committee comprised of the Clinical Center and Coordinating Center PIs and NIH program staff during the first year of the program. Each Clinical Center application will be expected to propose a Clinical Center-specific scientific project that addresses hypothesis-driven scientific questions that can be assessed through data, imaging, and/or biospecimens collected through the Consortium-wide longitudinal cohort study protocol. Scientific questions may be focused on the hospital and/or post-hospital period. The questions should be focused on ARDS, pneumonia, sepsis, or the combination of or interrelatedness among these critical illness syndromes.
This Consortium will generate key information about the heterogeneity (including clinical, physiological, and biological heterogeneity), underlying mechanisms, and interrelatedness of critical illness syndromes and recovery, and yield a collection of well-phenotyped clinical data, imaging, and biospecimens. Throughout the program’s funding period, data (including imaging data) and biospecimens collected will be made available as a resource to the broader research community as rapidly as possible. Data and biospecimens will be collected with forward-looking data sharing policies compatible with broad consent in order to enable future research studies by others, both within and outside of the Consortium. The process for sharing data and biospecimens throughout the program’s funding period with the broader research community will be developed in the first year of the program, with input and approval from NIH staff. Data and biospecimens are expected to be shared as rapidly as possible, with processes that are simple and achievable. Wherever possible, the consortium will not hold data or biospecimens for its exclusive use or for the exclusive use of one of its components, and will endeavor to make samples (including information about how the samples were obtained and processed) and data available to the broader research community. Data will be deposited into NHLBI’s repositories (anticipated to be BioData Catalyst and BioLINCC) and made available for use by the research community annually and at the end of the program. Biospecimens will be deposited into NHLBI's repository (anticipated to be BioLINCC) and made available for continued use by the research community at the end of the program.
Program Structure
Is it anticipated that the APS Consortium will be a cooperative network comprised of up to five Clinical Centers (funded through the companion RFA-HL-23-001), one Coordinating Center (funded through this FOA), a Steering Committee chair, and program staff from the NHLBI and NIGMS. The APS Consortium participants will participate in a cooperative and interactive manner with one another, develop and implement a Consortium-wide longitudinal cohort study, and share data (including imaging data) and biospecimens collected throughout the program's funding period with researchers both within and outside of the APS Consortium.
Coordinating Center: The Coordinating Center will collaborate with the Clinical Centers and coordinate, administer, and support all APS Consortium administrative, governance, clinical research, regulatory, analysis, reporting, dissemination, and data/biospecimen sharing activities. The Coordinating Center Principal Investigator(s) is (are) expected to share in the scientific leadership of the APS Consortium through the Steering Committee. The Coordinating Center is expected to provide the methodological, analytical, managerial, website, computer systems, logistical, and administrative expertise to support research and operational activities of the APS Consortium including: (1) collaborate in the design and analytic plans for a Consortium-wide longitudinal cohort protocol to be executed by all Clinical Centers; (2) manage and distribute protocol funds (anticipated to be $19,500,000 total costs) to Clinical Centers to conduct the Consortium-wide longitudinal cohort protocol on a per-enrollee basis and according to the Steering Committee and NHLBI approved protocol budget; (3) provide support that is flexible to enable operations, administration and research activities; (4) manage and evaluate quality of data received from Clinical Centers and provide relevant reports to the Steering Committee and OSMB; (5) monitor and evaluate Consortium-wide longitudinal cohort protocol execution and subject accrual and provide relevant reports to NHLBI, the Steering Committee, and the OSMB; (6) develop a manual of procedures for quality control, training and certification, case report forms, data management, and regulatory compliance; (7) provide logistical support for meetings (may be virtual) and video/teleconferences of the Steering Committee and its subcommittees, the PRC and OSMB; (8) provide support for preparing and submitting collaborative presentations and manuscripts; (9) provide statistical advice and data analysis; (10) storage, maintenance, and analysis of data (including imaging data) and biospecimens as needed for the Consortium-wide protocol; (11) oversee and facilitate data (including imaging data) and biospecimen sharing among Clinical Centers and investigators outside the Consortium; (12) create and maintain an outward facing website that is updated regularly and includes study documents (e.g., Consortium-wide protocol, informed consent forms) and information about available data and biospecimens and the process for requesting data and biospecimens during the APS Consortium funding period; (13) transfer the data, imaging, and biospecimens to NHLBI's repositories annually (for data) and at the conclusion of the program; (14) oversee a skills development core that will provide skills development opportunities in the conducts of ARDS, pneumonia, and/or sepsis research, contributing to the development of the next generation of researchers; (15) utilize the capabilities in the Clinical Centers to the maximum benefit of the entire Consortium; and (16) track progress of publications, including PubMed Central reference number, and presentations of findings. Additional details regarding these areas of responsibility are described below:
Consortium-wide Longitudinal Cohort Study Protocol Development, Study Design, and Analysis
Lending study design, statistical and biomedical scientific writing expertise to the Protocol Development, including assisting in the determination of study endpoints and analytical approaches. Use of established Common Data Elements is encouraged. Facilitation of Protocol Development Committee meetings/teleconferences to ensure that the protocol is developed and executed within specified APS Consortium timelines, and review of the Consortium-wide longitudinal cohort study protocol through the Steering Committee, PRC, and OSMB processes. The Coordinating Center will also oversee data (including imaging data) and biospecimen-related document development and finalization. It is anticipated that the biospecimens collected and processing methods under the common protocol may include, but are not limited to, blood, urine, and lung specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage fluid), and that chest x-ray or other medical images will be collected. Coordinating Center applicants should plan for coordinating the prospective enrollment of 5,000 U.S. participants overall (200 in Year 1 and 1,200 per year in Years 2-5). This timeline is intended to provide adequate time for protocol development in Year 1, enrollment and follow-up of half of discharged participants for 12 months, and the completion of data analysis, manuscripts, and study closeout by the end of Year 6.
Data Management and Analysis
Development, maintenance, and/or refinement of data dictionaries and a 21CRF Part 11-compliant electronic data capture (EDC) system for clinical research studies conducted by the APS Consortium, assuring high data quality through edit/validation checks; serving as a central repository for study data including imaging data and a central biorepository for biospecimens during the Consortium lifetime. Additional Coordinating Center responsibilities are expected to include overseeing secure data and biospecimen collection, storage, and, when appropriate, transfer of study-generated data and biospecimens; preparing confidential data analyses and reports as requested by the NHLBI, the Steering Committee, the OSMB, and regulatory agencies; and coordinating data analysis, reporting, and publishing of APS Consortium research in high-quality peer-reviewed journals, as they relate to the Consortium-wide longitudinal cohort study protocol.
Biorepository Establishment and Management
Establishment of a centralized Biorepository with necessary personnel, equipment, and protocols. Establishments of procedures for transfer of biospecimens from the enrolling sites to the centralized biorepository, to core facilities/laboratories as needed for analysis in a timely manner, to investigators approved to obtain biospecimens during the project period, and to the NHLBI repository at the end of the project period. The Coordinating Center will also develop standardized protocols for the collection, preparation, processing, storage, and shipment of biospecimens (e.g. blood, urine, lung specimens) into and out of the biorepository, provide training of Clinical Center personnel on the proper collection, preparation, processing, and storage of biospecimens as needed, and will maintain accurate inventories of what is available in the biorepository.
Data and Biospecimen Sharing
Development of a plan to make data (including imaging data) and biospecimens collected through the Consortium-wide longitudinal study available to Clinical Center investigators for Clinical Center-specific projects as rapidly as possible. Development of a plan to make data and biospecimens collected through the Consortium-wide longitudinal study available as a resource to the broader research community as rapidly as possible. Data and biospecimens will be collected with forward-looking data sharing policies compatible with broad consent in order to enable future research studies by others, both within and outside of the Consortium. Develop a process for sharing clinical and research data (including imaging) and biospecimens throughout the program’s funding period with the broader research community during the first year of the program, with input and approval from NIH staff. Create and maintain an outward facing website that is updated regularly and includes information about available data and biospecimens and the process for requesting data and biospecimens during the APS Consortium funding period. Data and biospecimens are expected to be shared as rapidly as possible, with processes that are simple and achievable. Wherever possible, the consortium will not hold data or biospecimens for its exclusive use or for the exclusive use of one of its components, and will endeavor to make samples (including information about how the samples were obtained and processed) and data available to the broader research community. Data will be deposited into NHLBI’s repositories (anticipated to be BioData Catalyst and BioLINCC) and made available for use by the research community annually and at the end of the program. Biospecimens will be deposited into NHLBI's repository (anticipated to be BioLINCC) and made available for continued use by the research community at the end of the program.
Clinical Center Reimbursement
Administration of five Clinical Center site subcontracts and other agreements as necessary to facilitate reimbursement for enrollment in the Consortium-wide longitudinal cohort study protocol after it has been approved by the PRC and OSMB and the NHLBI has approved the funds for distribution. Establishment and tracking of site enrollment targets. Additionally, the NHLBI anticipates the Coordinating Center will prepare, distribute for review, finalize, and then disseminate the approved protocol, protocol amendments, manual of procedures, and other materials necessary for Consortium-wide study conduct. The Coordinating Center will provide protocol training including sample collection and specialized preparation methods upon initial approval, following significant amendments, and otherwise as needed. Applicants should note that only research-related costs above those incurred as part of usual clinical care are eligible to be covered by grant funds and/or reimbursement via protocol costs from the Coordinating Center.
Human Subjects Protection
Overseeing the preparation of informed consent templates, recruitment brochures, and other Consortium-wide longitudinal cohort study-related patient materials; ensuring that all Coordinating Center and Clinical Center personnel are trained on necessary human subjects procedures including the informed consent process, APS Consortium policies, applicable regulations, and Good Clinical Practice (GCP). Additional Coordinating Center responsibilities in this area include routine tracking and reporting of adverse events and unanticipated problems to NHLBI, the OSMB, and other regulatory agencies as appropriate. Monitoring study execution at Clinical Centers to assure compliance with the common protocol, manual of procedures, APS Consortium policies, applicable regulations and guidelines throughout the duration of the program. The Coordinating Center will be expected to identify any study-related issues at the Clinical Centers as early as possible, develop corrective and preventative action plans in consultation with the NHLBI, and oversee the implementation of the corrective and preventative action plans.
Regulatory Affairs and Compliance
Assuring compliance with the Health Insurance Portability and Accountability Act (HIPAA) within the APS Consortium in accordance with 45 CFR Parts 160, 162, and 164; Implementation and supervision of the revised Common Rule (45 Part 46) within the APS Consortium, including the use of a single-IRB review for federally-funded, multi-institutional studies conducted in the United States. Clinical Centers must agree to use of the single Institutional Review Board (sIRB) selected by the Coordinating Center for all APS Consortium studies, consistent with NIH policies regarding multi-site studies involving human subjects.
Skills Development Core
Direct and coordinate skills development core activities that will contribute to the development of the next generation of ARDS, pneumonia, and/or sepsis researchers.
Given these numerous duties, the NHLBI encourages multi-PD/PI applications with at least two PDs/PIs; one a senior statistician with demonstrated experience in coordinating large multi-site clinical research studies and another senior investigator with extensive clinical research experience and expertise in the areas of ARDS, pneumonia, and/or sepsis. Familiarity with and support for data and biospecimen collection for sharing purposes is desirable. Applications for the Coordinating Center may be submitted by individuals at the same institution as an applicant for a Clinical Center grant under this FOA, but an individual may not be the PI of both a Clinical Center and the Coordinating Center.
Clinical Centers: The Clinical Centers will enroll participants hospitalized in the U.S. in the Consortium-wide longitudinal cohort study, and each Clinical Center will conduct a Clinical Center-specific study utilizing data, imaging, and/or biospecimens collected through the Consortium-wide study. Applicants should anticipate that the Steering Committee will combine their proposed Consortium-wide longitudinal cohort study strategy with longitudinal cohort study strategies proposed by successful Clinical Center applicants into the final protocol during the first year of the program. The final Consortium-wide longitudinal protocol and methods for biospecimen collection will be developed or adapted by the Steering Committee during the first year of the program from the protocols and methods for biospecimen collection proposed by the successful Clinical Center applicants. Each Clinical Center will be expected to enroll 40 participants in year 1 and 240 participants/year in years 2-5, for a total of 1,000 participants over the program period, and to conduct in-person follow-up of approximately half of the participants discharged from the hospital at 3, 6, and 12 months. Across all Clinical Centers, total enrollment of 5,000 participants with ARDS, pneumonia, or sepsis is expected, with at least 1,000 participants with ARDS, 2,000 with pneumonia, and 2,000 with sepsis. Investigators must agree to use common guidelines and a manual of procedures developed by the Steering Committee for all APS Consortium studies.
The Clinical Centers will be responsible for collecting and transferring data and biospecimens collected for the Consortium-wide longitudinal cohort study protocol to the Coordinating Center for management and collation. The Clinical Centers will be reimbursed for patient care costs for the Consortium-wide longitudinal cohort study via subcontract by the Coordinating Center. The Clinical Centers will be responsible for distributing the funds to their subsites. It is anticipated that $19,500,000 total costs in patient care funds will be included in the Coordinating Center award and made available for reimbursement to the Clinical Centers for enrollment in the Consortium-wide longitudinal cohort study. Clinical Centers, in coordination with the Coordinating Center, are expected to (1) ensure that all participating sites are trained on APS Consortium policies, applicable regulations, and GCP; (2) be responsible for ensuring that study execution is compliant with the APS Consortium protocols, manual of procedures, APS Consortium policies, and applicable regulations and guidelines throughout the duration of the program; and (3) routine tracking and reporting of adverse events and unanticipated problems, monitoring enrollment and data quality, and identifying and addressing any study-related issues through development of corrective and preventative action plans in consultation with the NHLBI.
NIH: NHLBI will be responsible for overall support, direction and oversight of the APS Consortium. The NHLBI Program Office and Office of Grants Management will oversee the overall direction and progress of the APS Consortium. In addition to regular grant stewardship, the NHLBI Project Scientist will be involved substantially with the awardees as a voting member of the Steering Committee, consistent with the Cooperative Agreement mechanism. The NHLBI will appoint an independent PRC, an OSMB, and the Steering Committee chair. An NIGMS representative will serve as a non-voting member of the Steering Committee, and will provide input to the NHLBI representative on items presented to the Steering Committee for a vote.
A Steering Committee composed of the principal investigators of the Clinical Centers and the Coordinating Center, a Steering Committee chair, and NHLBI and NIGMS representatives will be the core governing body of the APS Consortium. The NHLBI will appoint a Steering Committee chair to preside over Steering Committee meetings and serve as the Steering Committee representative. The Steering Committee chair will be compensated for their effort and travel (in the case of non-virtual meetings) by subcontract from the Coordinating Center. All major scientific decisions will be determined by majority vote of the Steering Committee. Each Clinical Center (independent of multiple PIs), the Coordinating Center, and the NHLBI will have one vote; the Steering Committee chair will have a vote in case of a tie vote among the other Steering Committee members. An NIGMS representative will serve on the steering committee as a non-voting member, and will provide input to the NHLBI representative on selection of the Steering Committee chair and any items presented to the Steering Committee for a vote. It is anticipated that the Steering Committee will meet two times a month by conference call and by in-person meetings three times in year 1 and two times/year in years 2-6 (with virtual meetings as an option/alternative if necessary). The Steering Committee has primary responsibility for the general organization of the APS Consortium, approval of the Consortium-wide longitudinal cohort study protocol and budget, including protocol revisions, before review by the PRC and OSMB, the conduct and monitoring of APS Consortium studies, the expeditious reporting of study results, and the rapid sharing agreements for APS Consortium data and biospecimens. Subcommittees of the Steering Committee will be established to oversee specific functions such as Protocol Development and Oversight, Publications, Biorepository, and Data and Biospecimen Sharing. The Steering Committee will monitor disclosures of financial interests and potential conflicts of interest among investigators, but such monitoring will not preclude investigators’ responsibility to report their financial disclosures to their respective grantee institutions. Grantee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
During the first award year, the Steering Committee in conjunction with the Coordinating Center will be responsible for developing the Consortium-wide longitudinal cohort protocol that outlines standardized procedures for enrolling participants and procedures and methods for the collection of data, images, and biospecimens across all participating sites within the APS Consortium. It is expected that the Consortium-wide protocol may be refined iteratively over the course of the project period as new data become available. The protocol, and any subsequent changes to that protocol, will be voted on and must be approved by majority vote of the Steering Committee in order to be implemented. Steering Committee-approved protocol studies that have not previously been peer reviewed will be referred to an independent PRC and an OSMB for review and approval.
An independent Protocol Review Committee (PRC) will be appointed by and advisory to the NHLBI. It will consist of a chairperson, clinicians and scientists with expertise in ARDS, pneumonia, and sepsis, observational study design, outcome measures, biostatistics, ethics, biospecimen collection, and other areas of expertise as needed. The PRC will review and, if deemed appropriate, approve APS Consortium studies put forth by the Steering Committee. The PRC will evaluate proposed protocols for studies on the basis of the significance of the questions to be addressed, scientific merit, innovation of the experimental design and approach, feasibility, appropriateness in the context of the APS Consortium program goals, and consistency with NHLBI’s and NIGMS's mission and policies.
An independent Observational Study Monitoring Board (OSMB) will be appointed by and advisory to the NHLBI. The OSMB will be responsible for providing independent advice to the NHLBI regarding study safety and related ethical considerations, the progress of the study, and the appropriateness of continuing the studies performed by the APS Consortium. The OSMB will also review and, if deemed appropriate, concur with the implementation of the Consortium-wide protocol and associated studies approved by the PRC. The OSMB will meet approximately every six months, with interim meetings as necessary.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
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The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NHLBI and NIGMS intend to commit total costs of up to $2,340,000 in fiscal year 2023 to fund one award.
Application budgets are limited to $975,000 in year 1 and $1,275,000/year in years 2-6 in direct costs, but should reflect the actual needs of the project.
In addition, patient care funds of $780,000 in year 1 and $4,680,000/year in years 2-5 will be included in the Coordinating Center award and will be distributed to Clinical Centers in accordance with the Steering Committee and NHLBI-approved budget for the Consortium-wide longitudinal cohort study.
The maximum project period is six years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.
- System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
NHLBI encourages multi-PD/PI applications with at least two PDs/PIs; one a senior statistician with demonstrated experience in coordinating large multi-site clinical research studies and another senior investigator with extensive clinical research experience and expertise in the areas of ARDS, pneumonia, and/or sepsis. Familiarity with and support for data and biospecimen collection for sharing purposes is desirable.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
1. Requesting an Application Package
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.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
In addition, and without duplicating information in the biosketches, the PDs/PIs should describe any prior experience working productively in collaborative multi-center programs.
The NHLBI strongly recommends that the Key Personnel include:
- A senior PD/PI with biostatistical expertise and demonstrated experience in coordinating large multi-site clinical research studies.
- A senior PD/PI with extensive clinical research experience and expertise in the areas of ARDS, pneumonia, and/or sepsis.
- A PD/PI experienced with and supportive of data and biospecimen collection and processing for proactive sharing purposes with the broader scientific community.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Application budgets should plan for the following:
- Suggest at least a cumulative 4.8 person-months among the PD(s)/PI(s)
- For other Investigators/Staff, the person-months should be commensurate with the effort required for the proposed personnel activities. This should include biostatistical support staff with demonstrated experience in the oversight of large clinical research studies to manage the Coordinating Center's day-to-day activities involving data management and statistical analysis, clinical research support staff with demonstrated clinical research experience to facilitate the day-to-day clinical study operations of the Coordinating Center including: managing collaborations with other clinical research coordinators; receipt, processing, and storage of human biospecimens; management of data (including imaging data); a comprehensive knowledge of GCP study conduct; development of study enrollment accrual benchmarks; generation of case report forms; administration of agreements with clinical centers and other research collaborators.
- Expenses related to the development and implementation of the Consortium-wide protocol, including use of established Common Data Elements; designing case report forms, informed consent documents, a manual of procedures, methods for timely safety monitoring and reporting of adverse events to the appropriate entities, study monitoring reports to track patient accrual, follow-up rates, adherence to protocol, and data quality. Applicants should assume that each awarded Clinical Center will enroll 40 U.S. participants each in year 1 (i.e., 200 participants total) and 240 U.S. participants (i.e., 1200 participants total) each year during years 2-5 into the Consortium-wide protocol beginning in Q4 in Year 1 through Year 5 of the project period (i.e., 5000 total U.S. participants).
- Support for the Steering Committee Chair at 1.2 person-months.
- Expenses related to managing the Steering Committee to include travel expenses (or virtual meetings, if necessary) for four Coordinating Center representatives to attend three meetings in Year 1 and two meetings/year in years 2-6, in-person in Bethesda, Maryland, and other meetings occurring twice per month by conference call.
- Expenses related to managing the OSMB to include remuneration for services provided and travel expenses for approximately five members to attend a one-day meeting occurring in-person in Bethesda, Maryland, during the first year and additional meetings by conference call on an as-needed basis but no less frequently than every 6 months thereafter.
- Expenses related to managing the PRC to include remuneration for services provided and travel expenses for approximately five members to attend one meeting occurring in-person in Bethesda, Maryland, during the first year and additional meetings on an as-needed basis by conference call.
- Site monitoring activities that will be conducted via centralized monitoring to the extent possible, but provisions for site visits to improve training and site performance as needed.
- Expenses associated with contracting and the day to day oversight and operational management of five Clinical Centers (each with 1-3 subsites, for a total of up to 20 individual sites) for training on GCP, the implementation of the Consortium-wide protocol and related data (including imaging) and biospecimen collection, processing, and storage, including expenses related to training new Clinical Center staff that join throughout the project period.
- Expenses associated with the day to day operations of a centralized biorepository: to include the expenses associated with collection containers, procurement, storage, and shipping of biospecimens collected as part of the Consortium-wide protocol from the Clinical Center sites to the Coordinating Center, training site coordinators and other study personnel to obtain the data and biospecimens for the protocols in a uniform manner, and instituting quality control measures. It is anticipated that the biospecimens collected may include, but are not limited to, blood, urine, and lung specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage fluid). The biorepository budget should include sufficient labor to establish procedures that meet quality standards of the NHLBI Biorepository (BioLINCC). Expenses should include plans for facilitating data and biospecimen analyses on Consortium-wide protocol biospecimens, shipping containers and shipping costs for the Clinical Centers, costs for storage at the Coordinating Center biorepository during the project period, costs to facilitate sharing of biospecimens with approved investigators within and outside the Consortium during the project period, and costs for final shipping to the NHLBI biorepository upon study completion. It is anticipated that Clinical Centers will ship collected biospecimens collected as part of the Consortium-wide protocol to the Coordinating Center biorepository at regular intervals throughout the project period to facilitate sharing of samples both within and outside of the Consortium. Costs for routine biospecimen quality assurance should be included and described. The biospecimen collection plan will be finalized by the Steering Committee, but the Coordinating Center should present a vision and budget for the biospecimen collection. A subcontract may be proposed for the biorepository.
- Expenses associated with creating and maintaining an outward facing website that includes information about available data (including imaging data) and biospecimens and the process for requesting data and biospecimens, data/biospecimen request review meeting costs, data transfer costs, biospecimen shipping/aliquoting costs, and a biospecimen coordinator.
- Expenses associated with providing statistical support to the Clinical Centers and analysis of aggregate Consortium-wide protocol data, including the development and maintenance of systems for data entry, transmission, quality control, and analysis.
- Expenses associated with the creation and maintenance of a secure data access portal with project management dashboards to coordinate efficient workflow, assessment of progress, and enable open access of study data to APS Consortium investigators, as well as related costs to ensure compliance with the NIH Data Management and Sharing Policy.
- Expenses associated with creation and maintenance of a secure portal for imaging data, including plans for managing imaging data deposition, tracking, access, and sharing.
- Costs related to the design and maintenance of an APS Consortium website.
- Costs to engage a sIRB for all APS Consortium studies.
- Applications must plan for $50,000 in direct costs for skills development activities each year. Allowable costs include salary support for the skills development core director and other senior investigators and staff participating in mentoring activities; travel costs for junior investigators; supplies and equipment to support developmental activities; and costs for courses, seminars, workshops, and other activities directly related to the APS Consortium skills development core. All costs requested should be justified with respect to developmental activities and may not be used to supplement the costs of research proposed in the rest of the APS Consortium application. Salary support for the junior investigators is neither needed nor allowable, since the the APS Consortium skills development core is intended to serve new clinical investigators who occupy positions and receive salary support from other sources.
- Other expenses related to Coordinating Center core activities as appropriate.
- Patient care funds ($780,000 total costs in year 1 and $4,680,000/year total costs in years 2-5) for the Consortium-wide longitudinal cohort protocol will be part of the Coordinating Center award and will be distributed by the Coordinating Center to the five Clinical Centers in accordance with the budget approved by the Steering Committee and NHLBI. As such, the Coordinating Center should request a line item for Patient Care Costs in total cost amounts of $780,000 in year 1 and $4,680,000/year in years 2-5 of the project period. These funds will be restricted for this use only. Only research-related costs above those incurred as part of usual clinical care are eligible to be covered by reimbursement via protocol costs from the Coordinating Center. Costs for reimbursement will be in the form of capitated payments to the sites on a per patient basis.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: The research strategy must describe the following:
Plans for leading and coordinating a complex multi-center observational study of patients hospitalized with ARDS, pneumonia, or sepsis and in-person follow-up at 3, 6, and 12 months post-hospitalization of approximately half of participants discharged from the hospital. Plans for data and biospecimen collection for proactive sharing for future research purposes beyond the APS Consortium should also be described.
- Discuss experience with prior relevant studies as a means of justifying the proposed approach to overseeing the design and conduct of a multi-center observational study for data and biospecimen collection, ways to maximize recruitment and retention, and minimize logistical, operational, and regulatory issues. Include a description of novel clinical research approaches to enhance data and biospecimen collection, analysis, and dissemination in order to maximize scientific output from the APS Consortium.
- Discuss the approach to operations management by providing evidence of data management and program support capabilities and describing the plan for data collection, management, analysis, data security and backup, privacy protections, and quality control. The plan should include an approach to monitoring patient safety, protocol execution quality, data entry quality, and participant accrual; providing relevant reports to NHLBI, the Steering Committee and the OSMB; and training and competence certification of research staff conducting the protocol at the participating Clinical Centers.
- Discuss the timeline and plans for how the Coordinating Center will cooperate and interact within the Coordinating Center and across the Clinical Centers to achieve coordination of all APS Consortium activities during the project period: include strategies to manage and support electronic and other communications; support regulatory affairs and compliance, human subjects protections, data monitoring, clinical operations and administrative activities; inform study design; provide support for data collection, management, and statistical analysis; and reporting of results in a timely manner.
- Provisions for logistical and communications support to the Clinical Centers within the APS Consortium, and to the broader research and patient communities. Web resources and data management systems should provide secure distribution of study documents, forms, and metrics of study progress and performance. Plans should also include an open-access web site that communicates information about the APS Consortium to the public, prospective research participants, and the broader research community.
- Describe a plan to share data (including imaging data) and biospecimens throughout the funding period with the broader research community, including plans for inclusion of forward-looking data sharing policies compatible with broad consent, processes to allow sharing as rapidly as possible, and plans for an outward facing website that includes information about available data and biospecimens and the process for requesting data and biospecimens.
- Plans for developing and managing, as well as distributing patient care funds to the individual Clinical Centers for conducting the Consortium-wide observational study. This should include a vision for how the Protocol Development Committee will function, as well as plans for facilitating efficient review and approval of the study by the Steering Committee, independent PRC, and OSMB. Applicants should assume that each awarded Clinical Center will enroll 40 U.S. participants each in year 1 (i.e., 200 participants total) and 240 U.S. participants (i.e., 1200 participants total) each year during years 2-5 into the Consortium-wide protocol beginning in Q4 in Year 1 through Year 5 of the project period (i.e., 5000 total participants). It is anticipated that the biospecimens collected under the protocol may include, but are not limited to, blood, urine, and lung samples (e.g., sputum, tracheal aspirate, bronchoalveolar lavage fluid) as well as radiographic or other medical images, and the applicant should discuss special considerations for the collection and storage of these sample and imaging types. These plans should also include how the Coordinating Center plans to facilitate a timeline that includes protocol development in year 1, enrollment through Year 5, follow-up through Year 6, and the completion of data analysis, manuscripts, and study closeout by the end of Year 6.
- Plans for engaging a centralized sIRB to oversee the APS Consortium studies.
- Plans for directing and coordinating skills development core activities. The skills development core is intended to foster the next generation of researchers at the APS Consortium sites, including fellows and junior faculty members, so that they are versed in ARDS, pneumonia, and/or sepsis research. Include a plan to recruit high quality participants, including recruitment of women and minorities, and a description of the experience level of potential participants. Describe the needs or gaps for junior investigators this core will address, plans for skill development of participants (including didactic preparation) that will promote progress to more independent research status, the nature and extent of mentoring, and a plan for coordinating activities and progress of participants across sites. Partnership and collaborations with professional societies or foundations, or leveraging other resources such as CTSA infrastructure, are encouraged.
Research Team
- Provide an overview of the overall organization of personnel in the proposed Coordinating Center's research team and describe the ability and commitment of the investigators to function as a coordinated research team, to work efficiently and expeditiously with, and to enhance the research goals of, the APS Consortium.
- A sound rationale should be provided as to why the research team is the most appropriate, and likely to generate an exceptionally high impact protocol and maximize scientific output/study results from the consortium if successful. Provide an overview of the Coordinating Center team member roles and responsibilities.
- Describe how the research team is poised to provide scientific leadership and scholarship to the APS Consortium through collaboration with the Clinical Centers, the Steering Committee, and NIH partners.
Letters of Support:
A letter of support is required from the submitting organization that indicates institutional willingness to participate in all aspects of the APS Consortium studies and related activities, including engaging a sIRB to oversee the APS Consortium studies.
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.
- All applications, regardless of the amount of direct costs requested for any one year, should address a Resources and Data Management and Sharing Plan. Data Management and Sharing Plans should comply with the guidelines and requirements set forth in NOT-OD-21-013 and related Notices that establish the NIH-wide Data Management and Sharing Policy that goes into effect January 25, 2023. Data Management and Sharing Plans that do not conform to these requirements will not be considered adequate. This plan should be as forward-looking and proactive as possible to rapidly share data (including imaging data) and biospecimens collected in the APS Consortium, as well as materials and methods, in order to enable future research studies by the broader research community.
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.
Delayed Onset Study
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.
3. Unique Entity Identifier and System for Award Management (SAM)
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.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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.
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.
1. Criteria
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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? 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:
How compelling is the experience from presented representative research studies and related support activities, and how well does this experience predict the ability of the proposed Coordinating Center to successfully coordinate high-impact collaborative observational studies in ARDS, pneumonia, and sepsis? What will be the impact of the proposed plans to manage biospecimens and clinical and research data storage and proactive sharing?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA:
How likely is it that the investigators have sufficient expertise to manage and operate the Coordinating Center as proposed, notably in the oversight of the development and execution of Consortium-wide observational research protocol and related data and biospecimen acquisition and storage across multiple sites? To what extent are the PD/PIs and any key personnel likely to be able to accomplish all the objectives in a highly collaborative, fair, and flexible manner, appropriate to the roles and responsibilities of the Coordinating Center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA:
To what extent does the proposed project consider unique challenges to conducting large multi-center clinical research studies involving ARDS, pneumonia, and sepsis patients, and how likely are the proposed plans to address these challenges to yield impactful results and achieve the stated public health goals of the APS Consortium? To what degree are novel organizational concepts and analytical approaches, including innovative statistical methodologies, data management strategies, and/or electronic and information technologies, proposed to support rapid and efficient integration of disparate data types derived from clinical research, and how likely are these to succeed? To what extent are innovative and useful approaches to project coordination and logistical support that are likely to work in the setting of ARDS, pneumonia, and sepsis research proposed? How innovative and cost-effective are the proposed approaches to study design, data and biospecimen collection, staff training, Clinical Center oversight, and data and biospecimen sharing?
Approach
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?
Specifc to this FOA:
To what extent does the approach indicate that the Coordinating Center will be successful in the administrative oversight and management of scientific activities across a large multi-site Consortium conducting a Consortium-wide observational study? How efficient are the proposed means of communication within the Coordinating Center and among Clinical Centers? How sufficient are the plans for establishing dedicated data and biospecimen repositories for samples derived from the performance of the study across many sites, and how likely are they to result in high-quality data and biospecimen acquisition, storage, and dissemination? How adequate are the proposed statistical support and data management plans, including the development and maintenance of a secure website?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specifc to this FOA:
How adequate are the currently available or proposed novel resources for secure data and biospecimen storage and distribution on the scale appropriate for the multi-site observational protocol activities? Does the required letter of support indicate a sufficient level of institutional support and commitment to participation in all activities expected of the APS Consortium Coordinating Center?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the 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
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.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by theNational Heart, Lung, and Blood Institute, 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.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The Coordinating Center PD(s)/PI(s) play an important role in all aspects of APS Consortium studies, including participating in Consortium-wide protocol development, monitoring recruitment of study participants, assuring the quality of study participant protocol adherence, assuring the accurate and timely transmission of data, analyzing and interpreting data, preparing publications, and working with the Clinical Centers and NHLBI to disseminate research findings. The Coordinating Center will also be responsible for working with the Clinical Centers PDs/PIs, Steering Committee Chair, and NIH Project Scientists to develop the Consortium-wide longitudinal cohort study protocol. Recipients must agree to the governance of the study through a Steering Committee. Investigators will be required to project patient enrollment for the Consortium-wide protocol during a specified time frame as specified in the FOA; continuation and level of funding will in part be based on actual recruitment and the Coordinating Center will monitor this in collaboration with the NHLBI.
Support or other involvement of any other third party in the study (e.g., participation by the third party) may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI.
PIs are encouraged to publish and disseminate results and other products of the study in accordance with study protocols and governance, and the recipient's data management and sharing plan.. . The Clinical Centers, in concert with the Coordinating Center, are expected to facilitate the sharing of data and biospecimens promptly among the APS Consortium participants and as rapidly as possible with the broader research community during the project period and via deposition into publicly available resources including the NHLBI biorepositories (BioLINCC and BioData Catalyst) and in accordance with the NHLBI Data Sharing Policy. Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NHLBI will appoint the Steering Committee Chair, the independent PRC, and the independent OSMB.
An NHLBI Project Scientist will assist with the development of the Consortium-wide protocol, monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and ensure adherence to NHLBI policies. An NIGMS Project Scientist will assess and informally advise the development of plans for biospecimen collection, preparation, and distribution and plans for clinical and research data sharing. An NHLBI Project Scientist and NIGMS Project Scientist will serve on the Steering Committee and other study committees, when appropriate, and the NHLBI Project Scientist will have a single vote on the Steering Committee. The NHLBI and NIGMS Project Scientists may work with recipients on issues coming before the Steering Committee and as appropriate, other committees, such as: development of the Consortium-wide protocol, recruitment intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, biospecimen and clinical and research data collection and distribution, final data analysis and interpretation, preparation of publications and development of solutions to major problems such as insufficient participant enrollment.
In addition to the Project Scientist, an NHLBI Program Official will be responsible for the normal program stewardship of the cooperative agreement and will be named in the Notice of Award. NHLBI may elect to have a dual-role approach where a single individual may act as an NHLBI Project Scientist and the Program Official. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the dual-role Project Scientist/Program Official. The responsibility for final decision making may reside with Senior Institute management, separate organizational components and/or oversight committees. In the event that a Project Scientist/Program Official participates in activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication, other staff members such as direct line supervisors and/or other Senior NHLBI Program management staff who are also not a named Project Scientist will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award for a period of no less than three years from the time of co-publication.
The NHLBI reserves the right to phase-out or curtail the study (or an individual award) in the event of (a) failure to develop or implement mutually agreeable collaborative protocols; (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (c) major breach of the protocols or substantive changes in the agreed-upon protocols with which NHLBI cannot concur; (d) human subject ethical issues that may dictate a premature termination.
Areas of Joint Responsibility include:
Recipient(s) agree to the governance of the study through a Steering Committee. The Steering Committee will have primary responsibility for the identification of priority areas for research and the conduct of studies related to the common protocol, methods for biospecimen collection, data analysis and the preparation of publications and dissemination products. Steering Committee voting membership shall consist of one representative from each Clinical Center award, one representative from the Coordinating Center award, one NHLBI-appointed independent Steering Committee Chair, and one NHLBI Project Scientist. Each of these full members of the Steering Committee will have one vote. Recipientmembers of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
An independent PRC will provide peer review for the Consortium-wide longitudinal cohort protocol. The PRC may be involved in reviewing and prioritizing protocol ideas for significance. The PRC will be appointed by and be advisory to the NHLBI. It will consist of a chairperson, and Executive Secretary who is an NHLBI scientist other than the NHLBI Program Scientist or Program Official, and scientists with expertise in clinical study design, ARDS, pneumonia, sepsis, biostatistics, ethics, biospecimens, and other areas of expertise as needed. Because the PRC serves as an independent group advisory to the NHLBI, study investigators will not communicate with PRC members regarding study issues, except as authorized by the PRC Executive Secretary. The PRC will evaluate the Consortium-wide longitudinal cohort protocol put forth by the APS Consortium based on the significance of the questions to be addressed, scientific merit and innovation of the experimental design and approach, feasibility, appropriateness for the APS Consortium and consistency with NHLBI missions and policies. The PRC will provide a written critique of each proposal and a final recommendation to the NHLBI. The protocol will be recommended by the PRC and approved by the NHLBI before initiation.
An OSMB will be appointed by the Director, NHLBI to provide overall monitoring of interim data and safety issues. An NHLBI scientist, other than the NHLBI Project Scientist or Program Official, shall serve as Executive Secretary to the OSMB. Because the OSMB serves as an independent group advisory to the NHLBI, study investigators will not communicate with OSMB members regarding study issues, except as authorized by the Board’s Executive Secretary. All local Clinical Center site-specific and Consortium-wide protocols performed within the APS Consortium will be recommended by the OSMB and approved by the NHLBI before initiation.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. Members will include: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulations 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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)
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Lora Reineck, MD, MS
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7845
Email: lora.reineck@nih.gov
Xiaoli Zhao, Ph.D.
National Institute Of General Medical Sciences (NIGMS)
E-mail: xiaoli.zhao@nih.gov
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
Telephone: 301-435-0270
Email: NHLBIChiefReviewBranch@nhlbi.nih.gov
Louis Velasco
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: (301) 827-7977
Email: louis.velasco@nih.gov
Grace Olascoaga
National Institute Of General Medical Sciences (NIGMS)
E-mail: olascoag@nigms.nih.gov
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 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.
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