National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
U24 Resource-Related Research Projects – Cooperative Agreements
NOT-NS-22-034 - Notice of Intent to Publish a Funding Opportunity Announcement for Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection - Testing Laboratories (U01 Clinical Trial Not Allowed)
NOT-NS-22-035 - Notice of Intent to Publish a Funding Opportunity Announcement for Limited Competition: Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection - Coordinating Center (U24 Clinical Trial Not Allowed)
NOT-NS-22-036 - Notice of Intent to Publish a Funding Opportunity Announcement for Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies For Acute Cerebroprotection - Interventions (U01 CT Not Allowed)
NOT-NS-22-037 - Notice of Intent to Publish a Funding Opportunity Announcement for Stroke Preclinical Assessment Network (SPAN) to Support Translational Studies for Acute Cerebroprotection - Interventions from Small Businesses (U44 CT Not Allowed)
RFA-NS-22-032 , U01 Research Project (Cooperative Agreements)
RFA-NS-22-033 , U44 Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II
The purpose of this funding opportunity announcement (FOA) is to invite applications for the Coordinating Center (CC) for the NIH Stroke Preclinical Assessment Network (SPAN). SPAN will facilitate testing of up to 8 promising cerebroprotective drugs or interventions to be given prior to or at the time of reperfusion in experimental models of ischemic stroke (e.g., transient middle cerebral artery occlusion, tMCAo). The CC will work with the awarded SPAN testing laboratories (RFA-NS-22-003) and intervention contributors (RFA-NS-22-032, RFA-NS-22-033) to provide centralized administrative oversight and coordination of all aspects of the network. If successful, the SPAN network will accelerate the identification of the most promising cerebroprotective therapies for future pivotal clinical trials and span the gap between preclinical and clinical testing, in a cost-and-time-effective fashion.
This limited competition FOA solicits applications for the Coordinating Center (CC) for SPAN. Separate FOAs are issued to solicit applications for the testing laboratories (RFA-NS-22-003) and cerebroprotective intervention research projects (RFA-NS-22-032, RFA-NS-22-033).
30 days prior to application due date.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| March 14, 2022 | Not Applicable | Not Applicable | July 2022 | October 2022 | December 2022 |
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.
Purpose
The purpose of this funding opportunity announcement (FOA) is to solicit an application for the Coordinating Center (CC) for the Stroke Preclinical Assessment Network (SPAN) as it enters its second three-year funding cycle. SPAN will support late-stage preclinical studies of putative cerebroprotectants to be given prior to or at the time of reperfusion in rodent models of transient middle cerebral artery occlusion (tMCAo), with clinically relevant long-term outcomes and in models of comorbidities. Each testing laboratory (RFA-NS-22-003) will be responsible for the parallel testing of up to 8 selected cerebroprotective interventions that will be chosen from among well-scoring applications submitted under the companion SPAN intervention FOAs (RFA-NS-22-032, RFA-NS-22-033). The overall goal is to determine whether such interventions can significantly improve outcome compared to reperfusion alone and/or extend the therapeutic window for reperfusion, in the hopes of guiding the selection of the best agent(s) to transition to future Phase II clinical trials (to be conducted through StrokeNet). SPAN will consist of one Coordinating Center (CC) and up to 8 testing laboratories, which will assess up to 8 interventions. The SPAN program will not support any human subjects research.
Background
Until 2015, intravenous recombinant tissue-type plasminogen activator (rt-PA) was the only FDA-approved therapy for acute ischemic stroke. Despite its overall efficacy and safety, rt-PA presents some limitations, such as an increased risk of hemorrhagic transformation, a narrow time window of a few hours from stroke onset, and a low success rate in lysing large clots. Over the past few years, acute endovascular therapy (EVT) with stent-retriever devices and access to advanced imaging modalities have transformed the standard of care for ischemic stroke, offering the opportunity to significantly improve clinical outcomes in selected patients that have salvageable tissue treated as late as 24 hours after their stroke. Unfortunately, despite the success of EVT in clinical trials, many patients still experience neurological deficits following therapy. Thus, there is a critical need to develop adjunctive approaches to improve long-term outcomes after ischemic stroke. These recent advances in stroke treatment such as EVT now offer a new and timely opportunity to further evaluate the potential benefit of cerebrovascular protective agents in the context of mechanical revascularization. Indeed, a cerebroprotectant that can stabilize the stroke penumbra or reduce the rate of infarct core expansion may offer significant benefits if administered as early as possible in a stroke’s evolution.
In 2018, the NINDS launched the Stroke Preclinical Assessment Network (SPAN), the first iteration of which consisted of one coordinating center (CC) and six study sites, each of which proposed a promising cerebroprotective modality, all selected following rigorous NIH peer review. The network was designed to perform highly rigorous and reliable preclinical testing with a timeline and resources that would not be possible for a single laboratory, while at the same time allowing a blinded head-to-head comparison of each putative cerebroprotective therapy. It also developed a rigorous data analysis pipeline that involves deposition of all raw experimental data from each site into a centralized, secure database followed by randomized assignment of the de-identified data to blinded reviewers at each of the six sites for analysis. During the first funding cycle, the SPAN network successfully demonstrated its ability to test interventions in a time and cost-effective manner. As a result, the NINDS now wishes to build on this momentum by further expanding the network to include more testing sites and promising cerebroprotective interventions.
Research Objectives
The overall goal of this program is to support a preclinical stroke network to conduct late-stage preclinical studies of potential cerebrovascular protective strategies to be given prior to or at the time of reperfusion.SPAN will test in parallel up to 8 compounds/interventions in animal models of transient cerebral ischemia following the same rigor and methodology characteristic of clinical trials. The parallel testing of multiple interventions, including an adaptive experimental design that will eliminate compounds that do not demonstrate significant efficacy compared to the others, will allow the identification of the most promising candidates to advance to clinical testing. Only drugs/interventions that are supported by robust and rigorous preliminary data and are likely to be ready for clinical testing by the end of the award will be eligible to be tested through the SPAN network.
The SPAN CC will contribute to these objectives by providing scientific and organizational leadership for implementation of preclinical protocols to be conducted within the testing laboratories. The CC will promote high quality and efficiency in study execution and provide a central resource for protocol development, drug acquisition, formulation and distribution, study administration, data management, and statistical analysis. The CC additionally organizes the SPAN governance committees and oversees quality assurance for network performance. The CC is encouraged to be innovative in improving research efficiency and quality.
SPAN Organization
The Coordinating Center (CC) provides scientific and organizational leadership to SPAN to achieve both efficiency and excellence in the implementation and performance of cerebroprotective intervention testing protocols. The CC will work collaboratively with the testing sites, intervention contributors, and the NINDS to provide overall study coordination, including animal enrollment, oversight of study protocols, monitoring of the individual sites, data analysis, data management, data sharing, and reporting. Additionally, the CC will be responsible for the acquisition, formulation, and distribution of active and control compounds.
Up to 8 selected cerebroprotective interventions will be tested in parallel in SPAN in a controlled, randomized, and blinded fashion. Such interventions may be proposed by academic, small business, or industry investigators. The proposed interventions should be mature enough to potentially rapidly advance to a clinical trial at the end of the testing phase. All selected interventions will be assessed by the testing laboratories following standard protocols and procedures, under the direction and leadership of the CC. Candidate compounds/interventions for the network will be proposed through the companion FOAs RFA-NS-22-032 and RFA-NS-22-033 (SBIR) and selected following peer review.
SPAN testing laboratories will conduct tests of selected cerebroprotective interventions that will be chosen from well-scoring applications submitted under the companion intervention RFAs. It is expected that SPAN sites will be academic or other preclinical research laboratories with documented expertise in the tMCAo model of ischemic stroke and relevant comorbidities (e.g., aging, hypertension, diabetes, hyperlipidemia, obesity, etc.). In addition, laboratories must demonstrate expertise in the assessment of clinically relevant, long-term functional outcome measures, with a particular emphasis on small rodent neuroimaging and behavioral testing. It is an absolute requirement that laboratories have extensive access to animal MRI facilities. All applicants must also agree to test multiple interventions in collaboration with the other testing laboratories in a randomized and blinded fashion, as directed by the SPAN CC. Testing laboratories for the network will be proposed through the companion FOA RFA-NS-22-003 and selected following peer review.
The governing body of the network is the SPAN Steering Committee which will consist of the PD/PI of the CC, the PD/PI of each of the network’s testing laboratories, the PD/PI of each selected intervention, and NINDS Program staff. The CC will be responsible for managing the logistics of committee activities, such as scheduling, soliciting agenda items, finalizing and distributing agendas, arranging and leading monthly teleconferences, preparing minutes, and making logistic and financial arrangements for annual in person SPAN meetings, including meeting space, accommodation, travel, per diem reimbursement, etc. The NINDS Director has the right to supersede any decision by the network at any time.
Finally, there is also an independent External Advisory Board, appointed by and reporting to NINDS, which includes basic and clinician scientists with expertise in cerebroprotection, representatives from pharmaceutical and biotech industry, experts in regulatory affairs, statistics, and clinical trial design, and representatives from the NINDS Stroke Clinical Trials Network (StrokeNet) Steering Committee (to facilitate a potential transition to clinical trials to be conducted in the future, if the intervention is successful in SPAN).
Expectations of the SPAN Coordinating Center
The CC provides scientific and organizational leadership to facilitate the conduct of preclinical studies within SPAN.The CC is the administrative center of the network, with responsibility for maintaining the network’s infrastructure in accordance with best practices routinely used in clinical trials. The CC is required to have strong expertise in stroke research, as well as data management; statistical analysis, including adaptive trial design; drug formulation; complex project coordination; randomization; and blinding. In addition, the CC leads and manages the SPAN Steering Committee (described below). While specific activities could be performed through subcontracts, these additional activities and the facilities involved would need to be clearly described in the application.
Examples of responsibilities of the CC include the following:
- Providing scientific leadership and regular communication to SPAN testing laboratories and intervention contributors regarding protocols and study progression.
- Overseeing multiple concurrent protocols.
- Managing ongoing operational issues, such as subcontracts, protocol-specific site training, and site monitoring.
- Developing and implementing investigator and staff training programs.
- Organizing and implementing investigator meetings, including an annual in-person meeting to enable the exchange of data and enhance synergy across the network.
- Overseeing drug/intervention and placebo control acquisition and distribution, on an as needed basis.
- Developing operational guidelines and assuring compliance with protocols and reporting.
- Developing a plan for conflict resolution.
- Coordinating editorial and manuscript preparation.
- Managing data and resource sharing activities.
- Analyzing data and adjustment of protocols/interventions to be performed at each site, based on the adaptive experimental design.
- Monitoring compliance with milestones to be determined at the time of the award.
The CC is expected to coordinate with the testing laboratories and intervention contributors to ensure that the testing of the selected drugs/interventions will start no later than 1 year after the award start date and will be completed in the remaining 2 years of the award.
Other significant responsibilities of the CC include the following:
- SPAN Website. This is an important tool for increasing awareness of SPAN and managing communication about and within the SPAN network.It should continue to have a public section describing SPAN, giving instructions regarding selected interventions and procedures, and providing ready access to public information such as press releases and publications.The website should also have a private section accessible only to SPAN PIs and personnel to facilitate communication about, though not limited to, SPAN committee meetings, metrics, and procedures.The CC is responsible for design implementation and maintenance of the SPAN Website.
- Protocol development. The CC is charged with creating, negotiating and maintaining network protocols and procedures for all stroke modeling and the testing of the interventions conducted in SPAN.
- Animal Enrollment. The CC is charged with the oversight of animal enrollment for each of the interventions at the SPAN testing laboratories, with attention to adequate sex, age, and comorbidities inclusion to assure that a robust analysis may be conducted at the conclusion of the testing.The CC, working with the testing laboratory PI, should implement corrective actions if a testing laboratory is not meeting enrollment expectations.
- Quality Assurance.The CC has specific responsibility for quality assurance in SPAN through the creation and monitoring of specific, quantifiable performance metrics for itself and the testing laboratories. Innovative approaches to quality assessment and improvement are encouraged.
CC roles and responsibilities in terms of leadership and SPAN organization include, but are not limited to:
- Providing scientific leadership for the network.
- Coordinating and supporting all SPAN Steering Committee activities including, but not limited to, scheduling teleconferences and in-person meetings; arranging accommodations, transportation, and facilities for in-person meetings; and creating and maintaining documentation such as meeting agendas and minutes.
- Developing SPAN Standard Operating Procedures (SOPs) that address implementation of all aspects of stroke modeling and testing of the selected interventions, animal recruitment and enrollment, and quality assurance.
- Providing instruction and training to testing laboratories regarding Good Laboratory Practices (GLP) and SPAN processes, procedures, and metrics.
- Providing a mechanism (e.g., call center, hot line, web chat) for promptly addressing procedural queries from testing laboratories, both for general SPAN processes and for processes specific to each of the selected interventions.
- Coordinating study drug management, including but not limited to drug and placebo control acquisition, delivery planning for bulk drug, secondary packaging/labeling/distribution/storage, coordinating stability testing and accommodating expiration timelines, and drug accountability, if required to do so.
- Proposing innovative methods and leveraging existing local research resources to enhance programmatic efficiency.
The Responsibilities of the SPAN CC in relation to preclinical trials include, but are not limited to:
- Rapid initiation of testing of the interventions.
- Supervision and tracking of all aspects of animal recruitment, enrollment, retention, and disposition.
- Financial management.
- Supporting the clinical trial PD/PI and testing laboratories investigators in finalization of the protocols, detailed animal recruitment plan, with attention to adequate sex, age and comorbidities representation.
- Finalizing study drug packaging and labeling and distributing drugs to the testing laboratories.
- Holding investigator meetings and ensuring initial study personnel training for GLP and protocol adherence.
- Ensuring appropriate protocol implementation, protocol adherence and Good Laboratory Practices (GLP) compliance.
- Answering queries from the centers (e.g., application of inclusion and exclusion criteria, drug dose adjustments, handling adverse events, procedures for premature withdrawals).
- Conducting testing laboratory visits, as needed.
- Coordinating activities with other networks or institutions, if applicable.
- Publishing the primary and, if applicable, secondary manuscripts, in collaboration with the SPAN Steering Committee and the PIs of the tested interventions.
SPAN Governance Committees
The success of SPAN requires collaboration and cooperation among its component parts and members. Therefore, participation in the SPAN governance committees is an important responsibility.
The SPAN Steering Committee (SSC) will be the main governing body. The responsibilities of the SSC are to: 1) provide scientific leadership in SPAN; 2) promote awareness of SPAN throughout the stroke research community; and 3) systematically assess the needs and goals for the network. SSC meetings may include other ad hoc participants.
The SSC may establish SSC working groups or SSC subcommittees on an as-needed basis for specific functions, such as: 1) support of CCC functions (e.g., developing study budgets; assuring quality control; monitoring conflicts of interest; developing data sharing policies); 2) development of core competencies and technologies (e.g., imaging, data analysis, educational materials); 3) subject area working groups; 4) special topics (publication plans, training/education materials).
The SPAN External Advisory Board (EAB) advises the NINDS regarding all operational and scientific aspects of the network.
National Institute of Neurological Disorders and Stroke
The NINDS will be responsible for organizing and providing overall support for the SPAN network. NINDS Program and Grants Management staff will be responsible for the overall management of the SPAN network. In addition to regular grant stewardship, a NINDS Project Scientist will be involved substantially with the awardees as a NINDS partner, consistent with the Cooperative Agreement mechanism.
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.
Need help determining whether you are doing a clinical trial?
The number of awards is continigent upon NIH appropriations and the merit of the applications. NINDS intends to commit $600,000 in direct costs per year to fund one award for up to three years.
Application budgets may not exceed a maximum of $600,000 in direct costs per year but need to reflect the actual needs of the proposed project.
The maximum project period cannot exceed 3 years, but the actual funded project period is dependent upon reaching specific performance milestones (see Cooperative Agreement Terms and Conditions of Award).
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
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 not 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.
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)
To avoid a conflict of interest, the Institution being awarded a SPAN CC U24 cannot be awarded a testing laboratory (RFA-NS-22-003) or research project/intervention (RFA-NS-22-032, RFA-NS-22-033) U01/U44.
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.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:
[email protected]
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.
The PD/PI(s) should have technical resources and documented experience in:
- Successfully designing and implementing multicenter preclinical trials.
- Successfully working in a highly collaborative setting.
- Managing a multi-site geographically dispersed consortium or network.
- Statistical analysis and adaptive trial design, drug formulation, data monitoring, data sharing, randomization, blinding and other rigorous procedures that are routinely used in clinical trials and are adopted in the SPAN preclinical network.
- Significantly contributing to Steering Committees and other governance committees.
The PD/PI should be willing to commit a minimum of 3 person months effort and have documented expertise in leading multiple complex projects in parallel. It is critical to the success of the SPAN Network that the CC interacts effectively with the testing laboratories, intervention contributors, and the NINDS. Therefore, in addition to the required strong leadership and staff with highly specialized expertise, the CC must include 1 full-time dedicated staff member as key personnel who will be the point of contact for all network sites, is highly motivated, has excellent communication skills, and has significant training and experience with information technology and biological data management.
The qualifications and experience of key personnel must be described, specifically documenting their respective abilities to organize and manage a CC.
Applicants are strongly encouraged to name an experienced research team. The applicants are encouraged to assemble a diverse team, that includes women and minorities. The applicants are also encouraged to include junior investigators, if appropriate. Members of the CC research team are determined by the applicant, but typically might include:
- Experienced study coordinators and/or project managers.
- Experienced financial coordinator or manager.
- Site Support Manager or comparable staff for training of all testing laboratories.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The budget submitted for this FOA should reflect baseline costs needed to initiate, organize and maintain the CC ready for rapid implementation of protocols and testing of the selected interventions. Salary support for the PD/PI and research team members should only include time spent on SPAN activities, which may include organizational/administrative tasks, support of individual testing laboratories, and participation in SPAN governance and committee activities.
The budget should include travel costs for 1) PD/PI and two CC team members to attend in person SPAN annual meetings, 2) other travel related to SPAN operations.
The budget should not include tasks specific to testing laboratories since these will be awarded separately.
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:
Specific Aims: State the specific aims to outline a clear strategy for implementing the goals of this FOA.
Research Strategy: The Research Strategy must include all of the below sections.
A) Background and Experience
The applicant should include a description of current and completed SPAN multicenter testing. Present specific performance metrics, including but not limited to:
- The number and location of sites (US and/or other countries).
- The number of animals enrolled.
- Time to first animal screened.
- Time to first animal randomized.
- Overall recruitment rate.
- Proportion of animals lost.
- Proportion of animals missing data on primary or secondary efficacy measures.
- Type and frequency of protocol deviations.
- Time from database lock to completion of statistical analyses.
- Time from statistical analyses available until final draft of primary manuscript.
B) Leadership Plan
Demonstration of leadership capability is required for the SPAN CC PD(s)/PI(s). It is also expected that, in order to successfully lead SPAN, the PD/PI already plays a leadership role in some capacity in the stroke research community, which should be described in the application.
- Leadership derives not only from the CC PD/PI, but also from members of the CC research team. A brief leadership plan should be presented which identifies and describes the roles of CC personnel, along with how they will contribute to the success of SPAN in the next funding cycle.
- The brief leadership plan should include a succession plan with identification of a substitute/back-up PD/PI candidate, if possible, to assure programmatic continuity.
- Applicants should state their general support of collaborative research and their willingness to participate in a collaborative and interactive manner in all aspects of SPAN. Applicants are encouraged to present prior examples of leadership in a comparably collaborative setting.
- Applicants should comment on any special expertise or unique strengths they can offer to leadership or collaboration within SPAN.
C) Administration and Organization
- The duties of proposed personnel responsible for day-to-day administration and operations at the CC should be described. The organizational structure should be described with attention to how the structure will support optimal execution of the tasks in the CC: Roles and Responsibilities. If there is prior experience operating as a team, this should be described.
- The applicant should indicate how potential investigators (from academia, military or industry) will be supported to work with SPAN in the feasibility phase and integrated into the network in the planning and implementation phases.
- Success of SPAN will require strong communication and close collaboration. The application should include a communication plan, which discusses:
- Communication with the testing laboratories and interventions PIs, and any experience with working in a CC structure.
- General site training on SPAN processes; 2) intervention-specific training; 3) mechanism for answering questions from sites; 4) mechanism(s).
- The applicant is encouraged to be specific. For example, a plan for testing laboratories training might include, though not be limited to, some of the following: 1) face to face and virtual venues for training (e.g., investigator meetings, steering committees meetings, site visits, webinars, teleconferences, newsletters); 2) potential topics of general importance; 3) when or how certification or other means of training verification might be used; 4) training new site personnel when there is staff turnover; 5) whether and how training should be repeated periodically.
- The SPAN Committees are key venues for organization and communication. The CC PI chairs the SPAN Steering Committee and organizes and facilitates all SPAN meetings. The application should discuss how the applicant proposes to optimally use these resources to generate a coherent network identity, stimulate enthusiasm and ideas, provide a forum for communication and education, and to execute tasks related to SPAN management and testing execution.
- The applicant may propose changes to the committee membership or meeting frequency from that outlined in this FOA, with explanation of why these would be more effective.
- The personnel responsible and existing support materials (e.g., templates, SOPs) should be identified. Relevant SOPs may be included in an appendix.
- The SPAN website may be an integral component of the communication plan and means for organizational management. The applicant should discuss a plan for the continued maintenance and optimal use of the SPAN website, along with other communication and organizational tools. The website plan should include design, contents, capabilities, and integration into the larger organizational management plan. The plan should also include logistical basics relevant to the maintenance of the website, such as availability and access to individuals with appropriate IT expertise and to required computer equipment.
D) Operations
- The application should describe the CC's standard operating procedures (SOPs) for conducting the testing and for administering and coordinating a network.
- The ability of the proposed CC research team to work in a collaborative and interactive manner with the testing laboratories, the PIs of the proposed interventions, and NINDS Program Staff should be discussed.
E) SPAN Financial Management
- The application should provide a summary of the experience managing the financial aspects of SPAN.
- Plans for negotiating, establishing and maintaining agreements with each testing laboratory.
- Consideration should be given to tools that may simplify procedures involving interaction with the sites, such as dedicated portals on the SPAN website or on-line budget calculators.
- The financial plan should also include CC central management approaches, such as tracking and archiving, reconciliation, error checks and planned audits, if any.
- The applicant should discuss their existing approach to financial management, including software, SOPs, templates or other tools.
F) Recruitment and Animal Enrollment
The PI should review prior SPAN experience and future plans which address specifics such as 1) mechanisms for performance of recruitment feasibility assessments; 2) creation of intervention-specific recruitment plans; 3) tracking enrollment accurately in real-time during testing; 4) creating corrective action plans if needed.
- Plans should be described for interaction with the testing laboratories in terms of data collection, and identification, and intervention at sites lagging in enrollment.
- Plans for collaboration and incorporation of the intervention proposing PI should be outlined.
- Describe any particular tools or software that will be used or developed for recruitment, enrollment, and/or feasibility.
- Describe the personnel responsible for recruitment and how their unique experiences and skills will increase successful enrollment in SPAN testing.
- Present examples of corrective actions for inadequate enrollment.
G) SPAN Quality Assurance
- The applicant should review experience with quality assurance and improvement over the last funding period, including the design and implementation of quality improvement programs. The application should identify CC personnel responsible for quality assurance and the means by which testing laboratories and interventions PIs or personnel will be integrated into the quality process. Additional resources for quality assurance expertise should be identified.
- The application should include a quality assurance plan, which has identifiable portions for the CC alone and for SPAN testing laboratories. This plan should include, though not be limited to: 1) specific, quantifiable metrics; 2) means of collecting this data; 3) performance and communication of findings of annual quality review; 4) proposed quality assurance besides the annual review (e.g., for cause site audits, on-going quality monitoring); 5) creation, communication, performance and verification of improvement plans; 6) creating incentives and enthusiasm for participation and compliance with quality assurance activities.
Significance: The Significance section should describe how the proposed CC infrastructure and organization will address the primary goal of rapid identification of neuroprotective interventions as adjunctive therapies to recanalization. This section should provide justification and rationale indicating that the proposed team and plan can fulfill the role of the CC as the network’s information, data, and administrative hub, and will work closely, collaboratively and effectively with the individual projects’ PIs and their teams, the NINDS/NIH Program staff and the Steering Committee and External Advisory Board.
Innovation: Describe the leading and innovative tools and approaches that the proposed CC offers to the network in terms of data management, communication strategies, information technology, approaches to organization of meetings and conference calls, drug development and distribution, and other activities under the purview of the CC.
Approach: The approach should address administrative commitment, resources, and ability to carry out the duties of the CC. The application must describe the current and/or planned organizational structure under which it proposes to operate. If the CC has more than one component/affiliate institution, describe the relationship of component(s)/affiliate(s) to each other and to the CC. Include the distance between these institutions (including administrative offices and shared resources) and location of proposed personnel.
Relevant Accomplishments: Describe the group’s accomplishments relative to implementing protocol and procedures used in SPAN, and the progress made during the previous funding cycle.
Milestone Plan: The application must include a yearly well-defined Milestone Plan in the approach section with a timeline for establishing the CC to full functionality within the expectations indicated below. Milestones should be unambiguous, quantifiable, and justified. The final milestone plan is subject to concurrence by the CC and NINDS. The timeline and milestones will be used to evaluate applications both in peer-review and for funding of non-competing award years. See the section below on Cooperative Agreement Terms and Conditions of Award for specific guidance on content and timing of Milestones. The final Milestone plan is subject to approval by NINDS.
- Initiate calls to organize the Steering Committee by 1 month after Notice of Grant Award.
- Organize the SPAN Kickoff Meeting to be held within 4 months of receiving a Notice of Grant Award.
- Organize Annual meetings (1 per year within a month of annual date of original Notice of Grant Award) and monthly meetings.
- Test the CC’s information technology infrastructure for receiving real-time data entry from multiple remote locations (including imaging data) by two months from the notice of grant award.
- Timely distribution of the drugs/ interventions to the testing laboratories
- Coordinate and implement the experimental plan for each of the testing labs (e.g., number of surgeries sex and age of the animals, use of comorbidities, imaging, behavioral assessments, etc.).
- Statistical analysis, quality control, and data management
The application should describe the strategy used by the PD/PI and Institutional official to delegate leadership responsibility and how the responsibility is delegated among key/senior individuals. The qualifications, experience, and proposed duties of all proposed support personnel should be described.
Letters of Support: A statement of commitment from each participating institution or organization must be provided. At least one letter of support from the applicant's institution must be included in the application. This letter should address how the general institutional commitment was previously established and sustained, how the institution maintains accountability for promoting scientific excellence, and how the SPAN effort was given a high priority within the institution (relative to other research efforts and non-NIH supported programs). The institutional commitment may be in the form of support for recruitment of scientific talent, provision of discretionary resources to the CC director, assignment of specialized research space, cost-sharing of resources, and/or other ways proposed by the applicant institution.If the Institution has committed facilities or resources to create, maintain or support SPAN activities, these should be presented in detail. There may be multiple letters of support from the institution or its components, particularly if the institution is providing support of collaboration for specific CC responsibilities. At least one letter confirming institutional support should come from a high-level institution official(s) (e.g., Dean of the School of Medicine, and Vice President for Research). If the application includes subcontracts or subawards for particular components of the CC’s operational structure, it should include letters of support from consultants and/or sub awardees detailing the required expertise and available infrastructure. If an application plans to utilize the infrastructure or resources of existing projects, whether funded by the NINDS, other governmental or non-governmental entities, letters of support detailing the terms of collaboration and data sharing must be included and must be from the appropriate authority/ies (e.g. institutional/foundation official, funding sponsor, and/or lead PI of the parent activity). Any conflicts with any known entities should be revealed and discussed. .
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan. The sharing infrastructure and protocols mustbe able to facilitate sharing within the network and with scientists outside of the network (after projects are completed).
- Applications must include a clear administrative and institutional commitment to data sharing, including strategies and ability to share raw data, images, and protocols both within the network as well as with other investigators.
The following items are recommended for inclusion in the Appendix:
- Sample documents that illustrate the CC's expertise, such as existing SPAN policies, SOPs, etc.
- One sample study SOP describing regulatory document collection, IRB approvals, study drug management, procedures to minimize bias and maintain blinding, recruitment plans, data sharing plans, etc.
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 NINDS, NIH. Applications that are incomplete, non-compliant and/or non-responsive 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 proposed CC address the needs of the research network that it will coordinate? Is the scope of activities proposed for the CC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?
Has the CC demonstrated its ability to conduct safe, efficient, and rigorous testing of cerebrovascular protective interventions within SPAN during the last funding period?
Has the CC outlined ways to meet or exceed its prior performance in the proposed funding period?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to their roles in the CC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing complex cooperative multi-site network or consortium projects? Do the investigators demonstrate significant experience with coordinating collaborative preclinical research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the CC? Does the applicant have experience overseeing selection and management of subawards, if needed?
Do the PD(s)/PI(s), collaborators, and the overall research team have expertise in drug acquisition, formulation, and distribution?
Do the PD(s)/PI(s) have the required expertise in implementing procedures routinely used in clinical trials, such as randomization, blinding, inclusion/exclusion criteria, pre-registration, monitoring of the sites that are applicable to the SPAN network? Do the PD(s)/PI(s) have adequate expertise in statistical analysis, including sample size determination and adaptive trial design?
Does the application identify a dedicated staff member as key personnel to be the point of contact who has high motivation, excellent communication skills, significant training and experience with information technology and biological data management?
To what extent do the performance metrics from past funding cycle support that the applicant would form an exemplary CC? Does the evidence support the ability to carry out the tasks enumerated under CC: Roles and Responsibilities?
Innovation
Does this application demonstrate that the proposed CC has successfully managed concepts, innovative tools and approaches for data management, communication, information technology, instrumentation, organization of meetings and conference calls, and other activities under its purview? Is there evidence that they will continue so to do?
Does the application provide evidence to suggest that the PD/PI or other members of the proposed research team could institute novel and innovative procedures that would increase efficiency and/or quality of testing conducted in SPAN?
Approach
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?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the CC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for workflow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals?
Does the application provide assurance that the proposed CC will provide strong organizational focus for the CC itself and for SPAN?
Does the application present a communication plan that promotes collaboration and information sharing: 1) with the testing laboratories; 2) with the interventions’ PIs? In what ways does the communication plan provide assurance that the CC will continue to provide sufficient procedural training and will provide rapid, accurate resolution of questions/issues?
If the CC has more than one component/affiliate institution, are the relationship and distance of component(s)/affiliate(s) to each other and to the CC reasonable to allow efficient communication and operation?
Is the plan for drug formulation and distribution appropriate?
Does the application include well-described conflict resolution plan? Does it include a feasible and appropriate description of how the CC will organize, coordinate and administratively drive network-specific activities including establishing the Steering Committee; logistical components of committee activities including, for example, scheduling, soliciting agenda items, finalizing and distributing agendas, arranging calls including conference calls, minutes (drafting, editing based on input, and finalizing); all logistic and financial requirements for in-person network meetings including meeting space, accommodation, travel, per diem reimbursement, etc.; required sharing activities?
Is the description of how the CC will work with multiple and de-centralized investigators and schedule large (dozens of participants) interactive conference calls including with visual support feasible and appropriate?
Is it described how the CC will manage real-time electronic data entry, to collect, curate for quality (e.g. accuracy, completeness, and internal consistency), display, house, and distribute data, including all relevant control data (within the network and with external scientists after appropriate publication) and how the CC will facilitate efficient and accurate incorporation of new and/or extant data via electronic data entry from remote locations? Is it described how the CC will assist in developing and building into its infrastructure the core set of de-identified data elements agreed upon by the network and how the CC will receive in real-time, and by remote electronic submission, data from up to 10 testing laboratories, and distribute data to approximately the same number of sites? Does the application explain how the CC will harmonize compatible but not identically coded extant data across platforms for sharing and meta-analyses? Is the plan to monitor performance and collect data from the individual project sites included and appropriate?
Assurance of quality is a joint responsibility of the CC and the individual project sites.
Is there a clear scientific, administrative, and institutional commitment to collaborate with other funded network project investigators/sites to maximize time- and cost-efficiency of testing in parallel up to 8 cerebroprotective interventions?
Is the Milestone Plan appropriate and feasible, with a timeline for establishing the CC to full functionality?
Does the application present a plan for animal enrollment, including feasibility assessments, intervention-specific recruitment plans and other components outlined in Research Plan, F, which will contribute to the success of SPAN?
Does the application evince strong concern for and adherence to high quality standards? Does the application propose a plan for quality assurance and quality improvement for the CC itself and for the SPAN infrastructure which will produce an exemplary and successful network?
To what extent does the application demonstrate that the proposed CC will meet the challenges of flexibility and scalability required to meet the needs of the different interventions to be tested in SPAN?
How well does the Data Sharing Plan provide a summary of the shared data, a description of the data standards, a plan for the data archiving, and a timeline for data submission to the archive and sharing data with the research community?
Environment
Will the institutional environment in which the CC will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the CC proposed? Will the CC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
In the letters of support and commitment, are the level and extent of commitment from the institution for the PI (may be expressed as additional protected time, departmental research leadership position, facilities, space, or resources) adequate? How have these been demonstrated in the past funding cycle?
Does the application include a clear administrative and institutional commitment to data sharing, including strategies and ability to share raw data, images, and protocols both within the network as well as with other investigators?
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
Generally not applicable. Reviewers will bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
Generally not applicable. Reviewers will bring any concerns to the attention of the Scientific Review Officer.
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) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For networks 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
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.
- Compliance with data and resource sharing policies and the collaborative structure of the network.
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.htmlandhttps://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 75.205and 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 recipientsis 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 recipientsfor the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
- Organizing and managing SPAN infrastructure including establishment of protocols and procedures, managing SPAN steering committee, implementing testing of the selected interventions, overseeing enrollment, overseeing quality), and collaboratively working with the testing laboratories, the interventions PIs and NINDS Program staff.
- The CC PI is expected to chair the SPAN Steering Committee and to participate in other SPAN committee meetings as appropriate.
- Designing, leading, and implementing all aspects of the SPAN CC as described in this FOA;
- Setting milestones, subject to the concurrence of the CC Program Director;
- Reporting to NINDS regarding timeline and milestone achievement and annual progress reports;
- Ensuring adherence to all applicable NIH/NINDS policies including for data sharing and reporting and assisting sites with development of standard protocols involving vertebrate animals;
- Analyzing and publishing results, interpretations, and conclusions of the studies, in collaboration with the network PIs, and providing overall scientific and administrative leadership for the research projects;
- Coordinating and monitoring all projects within the SPAN Network;
- Scheduling and participating in all network teleconferences and investigator meetings, including Kickoff and Annual in-person SPAN network meetings;
- Coordinating and facilitating development and implementation of network-specific protocols and policies (e.g. regarding pre-registration, randomization, blinding, publication, sharing, etc., as applicable);
- Providing appropriate guidance to network sites/PIs;
- Providing quality assurance monitoring.
- Recipientswill 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 DHHS, PHS, and NIH policies.
NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- The NINDS staff will work with the SPAN investigators to develop performance milestones for the CC. Failure to meet the agreed-upon milestones may result in reduced funding or early termination of the cooperative agreement.
- An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
- Cooperation or coordination with, or assistance to, recipients in performing project activities, e.g., development of research protocols; data collection, analyses, and interpretations; re-establishment of objectives during the course of a project;
- Contribute to developing final milestones for the study;
- Serve as a liaison between the recipients, the NINDS Advisory Council and the larger scientific community;
- Establish the External Advisory Board Committee;
- Serve on committees of the SPAN network as appropriate;
- Assist in promoting the availability of data and resources developed during the project to the scientific community at large;
- Assist recipients in the development, if needed, of policies for dealing with situations that require coordinated action;
- Assistance with the selection of contractors or sub-recipients and in the selection of key project personnel other than PD/PI;
- Technical monitoring to permit the specific direction of the project, including recommending approval of changes in technical approaches;
- Participation on committees as a voting member or in other functions responsible for helping to guide the course of SPAN; and
- Participation in the presentation of research results, including publications from the project.
- In addition to the Project Scientist, an NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice.
- Retain the option to recommend the withholding or reduction of support from any cooperative agreement that either substantially fails to achieve its goals agreed to at the time of award, fails to maintain state-of-the-art capabilities, or fails to comply with the Terms and Conditions of the award including biospecimen and data sharing requirements
Areas of Joint Responsibility include:
- Participation on SPAN committees, specifically the SPAN Steering Committee and its working groups and subcommittees.
- Clarifying, negotiating, and finalizing the milestones and timelines.
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. It will have three members: 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: [email protected]
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
?Telephone: 301-496-9223
?Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52, and 45 CFR Part 75.
and Human Services (HHS)
