Frequently Asked Questions for NINDS Interdisciplinary Team Science (RM1 Clinical Trial Optional) (RM1; RFA-NS-22-036)

Funding Opportunity Description

What is the NINDS Interdisciplinary Team Science RM1 and what is its purpose?

The new NINDS Interdisciplinary Team Science RM1 funding opportunity announcement (FOA) (RFA-NS-22-036) encourages interdisciplinary teams of experts that seek to cross technical and conceptual boundaries through collaboration to achieve ambitious goals for basic, translational, and clinical research questions within the mission of NINDS. We invite teams to challenge existing paradigms, overcome long-standing roadblocks to progress, and/or develop new synergies across different scientific fields.

What distinguishes the RM1 from traditional NIH programs?

This program is distinct from the NINDS P01 in that it will support a cohesive, single, well-integrated research plan with a singular focus, one set of aims, and a budget without subprojects. This program also requires a Multi-PI (MPI) structure with a minimum of three PD/PIs (up to six) who will each bring a distinct scientific viewpoint or expertise necessary to pursue the interdisciplinary approach.  Applications for smaller projects with one or two PD/PIs should consider submitting a multi-PD/PI application to the "NIH Research Project Grant (Parent R01)" FOA (see the Parent Announcement website for the current issuance of this FOA).

How can I decide if the RM1 is right for my circumstances?

First, the research topic must be fully within the NINDS mission. Second, the RM1 best fits team science efforts by 3-6 multiple PD/PIs that are integrated and cohesive and with a single common goal that is achievable within 5-years. Applications that propose extrapolations of a single line of research or propose parallel but independent advancement of different areas are not appropriate for this FOA. The RM1’s single set of aims is distinct from the P01’s multi-component structure of projects and cores.  

We recommend that potential applicants contact NINDS program staff  or NINDSTeamScience@nih.gov about mission relevance, research aims, and anticipated budget very early in the planning stage and a minimum of 8 weeks before submission of an application is anticipated. Applications that are not responsive to the FOA will not proceed to review and will be withdrawn. Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

How can I determine if my proposal is within the mission of NINDS? 

Check the NINDS website for information on areas of research. The full scope of the application must be within the mission of NINDS, to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people. You can use the NIH Matchmaker tool available in NIH RePORTER to find which institutes fund research related to your proposed area. We strongly encourage applicants to contact NINDS program staff or NINDSTeamScience@nih.gov to seek advice. However, no final decisions can be made until the complete application is received. 

What scientific areas of research are appropriate for support by the RM1?

Any research area within the mission of NINDS is eligible for support using the RM1 award.  However, some types of research might be more suitably supported through a traditional R01 or other grant mechanism that requires more specific methodological detail or programmatic oversight (e.g., clinical trials, advanced translational research). NINDS strongly encourages applicants to speak with NINDS program staff to help determine if a different mechanism is better suited to the proposed research area. The RM1 is neither appropriate for the support of clinical trials designed to answer specific questions about the safety, tolerability, efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions nor is it appropriate for research that has been traditionally supported by another NIH Institute or Center, even when combined as part of a larger research program.

Is the NINDS Interdisciplinary Team Science (RM1 Clinical Trial Optional) appropriate for clinical trials?

Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For this funding announcement, only the following types of clinical trials will be supported: 
Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., how an intervention works, but not if it works or is safe).
Basic Experimental Studies with Humans (BESH), defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena.

Is the NINDS Interdisciplinary Team Science (RM1 Clinical Trial Optional) appropriate for projects proposing to develop therapeutics? 

Applications that propose a systematic, team-based plan to discover and develop a small molecule or biologic therapeutic to treat neurological and/or neuromuscular disorders should consider PAR-20-122, PAR-21-163, RFA-21-010 and small business SBIR/STTR funding opportunities.

Should I consult with program staff prior to submission? 

Only applications that fall within the scientific mission of the NINDS will be accepted and considered for funding by NINDS. Thus we strongly recommended that potential applicants contact NINDS program staff or NINDSTeamScience@nih.gov about mission relevance, research aims, and anticipated budget very early in the planning stage and a minimum of 8 weeks before submission of an application is anticipated. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed project does not meet the programmatic needs of this FOA, applicants will be strongly encouraged to consider other funding opportunities. Prior approval is needed if proposing a budget above $500,000; please follow the Policy on the Acceptance for Review of Unsolicited Applications that Request or More in Direct Costs as described in the SF424 (R&R) Application Guide. 

Application

What are the application page limits? 

Specific Aims = 1 page 
Research Strategy = 15 pages 
Team Management Plan = 3 pages 
Timeline and Benchmarks for Success = 2 pages 
Plan for Enhancing Diverse Perspectives (PEDP) = 1 page   

Because these are scorable components, we recommend reading through the instructions on Section IV and the review criteria on Section V.  

Where should the Team Management Plan, Timeline and Benchmarks for Success, and the Plan for Enhancing Diverse Perspectives be placed in the application? 

These 3 attachments, with different page limits and instructions (see Section IV of the FOA), should be included as separate “Other Attachments”. Applications that are missing these components and/or do not follow the page limits will be withdrawn.  

Why are both an MPI Plan and a Team Management Plan required? 

The “Multiple PI Plan” and the “Team Management Plan” ask for somewhat different information. Whereas the “Multiple PD/PI Leadership Plan” focuses on leadership by and interactions across the PD/PIs, the “Team Management Plan” focuses on management of the whole team/key personnel.  

Beyond a description of MPI responsibilities, the Team Management Plan should describe the entire team structure and composition; shared leadership, decision making, conflict resolution, contributions and distributed responsibility; resource allocation; plans for professional development; professional credit; evaluation of investigator progress; and replacement of key personnel and PD/PI’s if needed. technical and administrative roles; scientific responsibilities, including human subjects and vertebrate animals. In preparing the Team Management Plan, applicants are encouraged to consult resources to aid in developing effective team-based programs (see e.g., the NCI Collaboration and Team Science Field Guide). 

What should be included in the "Timeline and Benchmarks for Success”? 

As an "Other Attachment" entitled “Timeline_Benchmarks.pdf”, applicants should include a project timeline in the form of a Gantt chart/table (or similar) that includes all major tasks to be performed during the project as well as critical benchmarks for success. The chart should also include estimated start and completion dates for those tasks and should identify the contributions expected from each PD/PI toward accomplishing each task. For a truly integrated collaborative project, it is expected that most or all of the scientific aims will require substantial contributions from more than one PD/PI. This chart will aid reviewers in assessing the feasibility and likelihood that the work plan is adequate for achieving project objectives within the funding period. It will also aid in assessing the degree of integration and collaboration, and the availability of appropriate intellectual and technical expertise for each aim. 

What should be included in the “Plan for Enhancing Diverse Perspectives”? 

For more information on the PEDP, please see the Overview, Key Elements and Examples, and FAQs. You can also email NINDSTeamScience@nih.gov. In an "Other Attachment" entitled "PEDP.pdf", all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to: 

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). 

  • Description of any planned partnerships that may enhance geographic and regional diversity. 

  • Plan to enhance recruitment of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce. 

  • Proposed monitoring activities to identify and measure PEDP progress benchmarks. 

  • Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers. 

  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds. 

  • Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s). 

  • Publication plan that enumerates planned manuscripts and proposed lead authorship. 

  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds. 

Is an established collaborative team necessary? 

This program supports highly integrated teams that are either new collaborators or established teams of investigators.  

What can be included in the budget?  

PD/PIs should submit a single integrated budget that is not limited but must cover all costs and reflect the actual needs of the proposed project. PDs/PIs are encouraged to discuss their proposed budgets / projects with NINDS program staff prior to submission and should provide detailed evidence supporting their proposed request in the budget justification section. 

To be successful, programs of this level of complexity are expected to require significant effort from all PDs/PIs involved. Generally, each PD/PI should devote at least 2.4 person months (i.e., the equivalent of 20% effort on a full-year appointment, 26.7% on a 9-month appointment, or 40% on a 6-month appointment) throughout the duration of the award. 

Other costs that can be included: 

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. 

It is strongly recommended that potential applicants contact NINDS while they are still in the process of developing conceptual plans for an RM1 and at least 8 weeks before submitting. After applicants have obtained agreement from the NINDS to accept the application, the PD/PI should include a cover letter with the application that identifies the NINDS staff member who agreed to accept assignment of the application. 

Are amended (resubmitted) applications permitted? 

No. NINDS will not accept resubmissions of RM1 applications. The same or a similar team of investigators may submit a new application on the same or a similar topic.  

Investigators

Is there an expected level of effort from the PIs?  

To be successful, programs of this level of complexity are expected to require significant effort from all PDs/PIs involved. Generally, each PD/PI should devote at least 2.4 person months (i.e., the equivalent of 20% effort on a full-year appointment, 26.7% on a 9-month appointment, or 40% on a 6-month appointment) throughout the duration of the award. 

Is it appropriate to include Early-Stage Investigators (ESIs) in the MPI team?

Team composition should be based on the background and expertise necessary to address the proposed scientific problem. We welcome teams that are inclusive of diverse backgrounds, including early career investigators. ESIs will lose their ESI status if they are an MPI in the RM1 application. 

Are scientists in the NIH intramural research program eligible to apply?  

Yes. The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.    
    
If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.    
    
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above. 

Are individuals who have support from sources other than NINDS eligible to apply?  

Yes. Individuals may have support from NINDS, other NIH components or from other sources, provided they meet all other eligibility requirements and are able to generally devote at least 2.4 person months (i.e., the equivalent of 20% effort on a full-year appointment, 26.7% on a 9-month appointment, or 40% on a 6-month appointment) throughout the duration of the award. Multiple PD/PI projects will be subject to the NINDS Special Review Council policy if one or more of the PD/PIs has NIH research support exceeding the threshold put forth in the SCR Policy. 

Are Howard Hughes Medical Institute investigators eligible to apply for RM1? What about individuals with other types of substantial, unrestricted research support?  

Yes. HHMI investigators are eligible to apply for RM1, provided they are able to generally devote at least 2.4 person months (i.e., the equivalent of 20% effort on a full-year appointment, 26.7% on a 9-month appointment, or 40% on a 6-month appointment) throughout the duration of the award. The relationship between the work supported by another organization and the work to be supported by NINDS must be distinct, and it must be clearly explained how the funding provided by the RM1 will impact your research program. Multiple PD/PI projects will be subject to the NINDS Special Review Council policy if one or more of the PD/PIs has NIH research support exceeding the threshold put forth in the SCR Policy. 

Can an R35 awardee serve as one of the Multiple Principal Investigators (MPI) in the RM1 award? 

No. Instead of serving as a PI, NINDS R35 awardees can participate as a collaborator of the RM1 and may not receive additional funds from this award.  

Is participation of scientists at non-domestic institutions permitted? 

Foreign components are allowed. If foreign investigators are involved, it should be described how they are uniquely qualified to participate in the team and/or provide unique resources that are not otherwise available. 

 

Review

How are applications evaluated for appropriateness to the NINDS mission? 

Applications are considered by the most relevant program directors. Applications judged not to fit within the NINDS mission will be withdrawn without review.  

How are applications reviewed? 

All applications for a given Council round will be reviewed by a single Special Emphasis Panel organized by the NINDS Scientific Review Branch, with members representing the breadth of applications under review. The name and contact information for the scientific review official assigned to the application will be posted in the Commons.  

Will the reviewers have expertise in the subject area of my application?  

Yes. NINDS will ensure that reviewers have the relevant expertise to review the application, bearing in mind that RM1 is intended to support a broad program of research and the breadth of research areas that are encompassed by the NINDS mission. Thus, reviewers will be expected to bring a broad perspective rather than detailed expertise. 

How are applications scored? 

Applications will be scored according to the NIH priority score system. Reviewers provide initial reviews and scores. Only those applications judged in the upper half are discussed at the meeting and assigned a priority score. Investigators will receive a summary statement with the reviewer critiques regardless of the score. Applications will not be percentiled. 

How do the review criteria differ from those for a regular R01 research grant application? 

Review criteria that are specific to the RM1 can be found under Section V of the FOA. 

How will the study section arrive at a budget recommendation? 

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

Can I appeal the review of my RPA application? 

No. Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

If my application for the RM1 is not funded, will I be able to prepare a resubmission? 

No, but you may be eligible to submit a new application to the next deadline. 

How does the NIH Special Council Review policy apply to the RM1? 

Multiple PD/PI projects will be subject to the NINDS Special Review Council policy if one or more of the PD/PIs has NIH research support exceeding the limit of the SCR policy. 

Do applications submitted to this FOA qualify for the Continuous Submission Policy? 

No. Continuous Submission only applies to applications submitted to an FOA using Standard Due Dates. Since this FOA (RFA-NS-22-036) does not use Standard Submission Due Dates, applications in response to this FOA are not eligible for this policy. Late submissions may be accepted per NOT-OD-15-039.  

Funding

How many RM1s does NINDS expect to award? 

NINDS intends to commit up to $10M per fiscal year to fund 4-6 awards for up to five years of support.  

When will funding decisions be made? 

Applications will be accepted once per year for three years (October 7th, 2022, October 11th, 2023, and October 8th, 2024). Applications will be reviewed and presented at the NINDS Advisory Council the following May/June. Funding decisions for all applications will be made after the Council meeting.  

Are RM1 applications subject to the NINDS Council Review and Oversight Policy? 

NINDS will look carefully at scientific and budgetary overlap between the RM1 application and all existing and pending sources of support for the investigators and their laboratories. Multiple PD/PI projects will be subject to the NINDS Special Review Council policy if one or more of the PD/PIs has NIH research support exceeding the SCR policy limit.  

What, if anything, will be different about the annual reporting required for RM1? 

Annual reports will be required using the Research Performance Progress Report (RPPR). Additional FOA specific requirements, such as teleconferences at a specified interval, will be indicated in the Notice of Award. 

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