# Collaborative Opportunities for Multidisciplinary, Bold, and Innovative Neuroscience (COMBINE) (RM1 Clinical Trial Optional)

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A team science approach expands our ability to pursue challenging problems in neuroscience research in a comprehensive, interdisciplinary, rigorous, and mechanistic manner.

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The next application receipt date is October 8, 2024. Only COMBINE RM1 applications that are fully within the NINDS mission will be accepted and considered for funding by NINDS. To determine if your proposal fits the NINDS mission and RM1 mechanism, please provide the following information****in a **one-page word/PDF**to your NINDS Program Official or to NINDSTeamScience@nih.gov as soon as possible. 
- Title
- Team Composition  (Names, Title, Affiliation, 1-3 expertise keywords)
- Planned Goal  (Describe the single focused goal and its transformative nature)
- Approach  (Briefly describe the research strategy and the need for an interdisciplinary and integrated approach)
- Budget  (Estimated total costs with broad categorizations (personnel, equipment, travel, F&A, etc.))

The COMBINE RM1 has fixed and limited budget commitments, so funding priorities will include considerations where the research might better fit special funding programs like the NIHBRAIN initiative, HEAL Initiative, ADRD, and other active programs. 

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## Overview

Download the slides**(pdf, 2954 KB)

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## Key Features

              - Transformative  5-year goal	                 - Bold, impactful, and challenging
                - Single focused goal only achievable through interdisciplinary team science
                - Multiple aims are non-responsive
              - 3-6 MPIs integrating distinct viewpoints/expertise 	                 - At least 2.4 cal months effort each
                - Subject to  SCR policy
              - Sufficient scope and complexity to warrant a team approach (as opposed to a Multi-PI R01)
              - Anticipated direct costs/year are $500K - $1.5M. 

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## Application Specifics (Section IV of RFA)****

**Specific Aims and 15-page Research Strategy:**
              - Overall, address **how will the project challenge existing paradigms, overcome long-standing roadblocks to progress, and/or develop new synergies between different scientific fields?**
              - Specific Aims Page is structured differently (see Section IV). Multiple aims are inappropriate as the research plan must be focused on pursuing a single focused goal.
              - Research strategy (15-page max). Teams should use the following subheading to structure the Research Strategy: "Importance of the Research and Appropriateness for the NINDS COMBINE program" and "Approach and Experimental Design".
              - Highlight activities, planned outcomes, and/or frameworks that will integrate and combine efforts across disciplines and team members. Single set of specific aims organized to address the overall objective rather than by individual or parallel PI contributions.
              - The COMBINE program will assume some degree of risk and are in general more ambitious and innovative than traditional NIH applications. Because feasibility will be assessed, applicants should carefully manage any risk in the premise and/or approach.

**Other Attachments:**The success of team science also hinges on well-managed team interactions, clear timelines and benchmarks for success, and evidence of commitment to diverse perspectives. As such, three additional attachments are required: 
              -                  - Team Management Plan  (3-pages max): Address how the entire group will function to accomplish program objectives and vision A helpful reference is the  NCI’s Field Guide to Collaboration and Team Science . Whereas, the “Multiple PD/PI Leadership Plan” focuses on leadership and interactions across the PD/PIs, the “Team Management Plan” focuses on management of the whole team/key personnel.
                - Timeline and Benchmarks for Success  (2-pages max): 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. Highlight specific activities and/or planned outcomes that act as “glues”, serving to combine and integrate efforts across disciplines and team members.
                - Plan for Enhancing Diverse Perspectives  (PEDP, 1-page max): Includes 1)  a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity, (2) timeline and milestones for the PEDP, (3) approaches to assessing progress towards meeting the PEDP defined goals.  Please see the  NINDS COMBINE PEDP page  for more information. 

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## Is My Project a Good Fit?

Only COMBINE RM1 applications that are fully within the NINDS mission will be accepted and considered for funding by NINDS. Non-responsive applications will be withdrawn. 

### Please note these topics and features that are not responsive to this program: 

              - Applications with multiple aims or without a single, focused goal
              - Applications in which the goal is not well-defined or has a low likelihood of being completed within 5 years
              - Applications in which the primary goal is to create, maintain, expand, and/or disseminate resources or infrastructure
              - Applications that lack a minimum of three PD/PIs or that exceed the maximum of six PD/PIs
              - Research that is not fully within the NINDS mission 
              - Applications that propose to discover and develop a small molecule, biologic therapeutic, or therapeutic device to treat neurological and/or neuromuscular disorders (covered by NINDS Division of Translational Research Programs). 
              - Development and validation of biomarkers for use in clinical trials or in clinical practice. These types of applications are already covered by the NINDS Biomarker Program funding opportunities (PAR-22-089 and PARs-21-056, 057, 058, and 059), see: NINDS: Focus On Biomarkers Research.
              - Clinical trials designed to answer specific questions about safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions (e.g., phase I, phase II, phase III, or pivotal clinical trials). Such designs should be submitted to an NINDS clinical trial-specific funding announcement (see NINDS: Clinical Research). If planning a clinical trial, this NOFO will only accept mechanistic or BESH (Basic Experimental Studies Involving Humans) types of clinical trials. Understanding the distinction between mechanistic, BESH, and efficacy trials can be difficult. PIs are strongly encouraged to discuss any planned clinical trial in consideration for this opportunity with the scientific program contact to avoid errors in interpretation. 
              - Clinical research projects with an inherently team science approach (e.g., applications in which the primary goal is multi-site clinical epidemiological or observational studies, genetic studies, or comparative effectiveness research). NINDS will continue to consider these large projects as a separate, unsolicited independent investigator-initiated projects (i.e., R01/U01 applications). For comparative effectiveness research projects, see: PAR-22-076: Prospective Observational Comparative Effectiveness Research in Clinical Neurosciences (UG3/UH3 Clinical Trial Not Allowed). 

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For inquiries related to responsiveness of your neuroscience topic, contact the relevant NINDS Program Official.

For inquiries related to the COMBINE RM1 program or NOFO, contact the NINDS Team Science Group at: NINDSteamscience@nih.gov

> Related Topics
NINDS COMBINE RM1 (RFA-NS-23-027)

NINDS COMBINE RM1 Informational Webinar for Applicants (RFA-NS-23-027)

Frequently Asked Questions (FAQs) for the NINDS COMBINE RM1 (RFA-NS-23-027) 

Plan For Enhancing Diverse Perspective (PEDP) for the NINDS COMBINE RM1 (RFA-NS-23-027)