The National Institute of Diabetes & Digestive & Kidney Diseases

NIDDK Collaborative, Interdisciplinary Team Science (R24) Guidelines

These guidelines and Frequently Asked Questions (FAQs) pertain to applications in response to PAR-11-221.

TABLE OF CONTENTS

I. Description
    Background
    Examples

III. Preparation of Application
    Form
    Teams and Shared Resources
    Rationale
    Approach
    Administrative Structure
    Budget Categories

IV. Review Process and Criteria

V. Frequently Asked Questions (FAQs)

• The NIDDK-supported R24 grant mechanism is designed to apply the flexibility of the Research Resource Project Grant mechanism (R24) to provide a mechanism for addressing complex challenges in biomedical research relevant to the National Institute of Diabetes and Digestive and Kidney Diseases when multiple levels of expertise are needed.
  
  
• Multidisciplinary, integrative and/or paradigm shifting approaches should be applied to a complex problem. This complex problem can take many forms including discovery-based or resource-generating and be hypothesis-driven or hypothesis-generating science.
  
  
• Information regarding the mission of NIDDK and its constituent Extramural Scientific Divisions, including Diabetes, Endocrinology and Metabolic Diseases (DEM), Digestive Diseases and Nutrition (DDN), and Kidney, Urology and Hematologic Diseases (KUH) may be found at: http://www2.niddk.nih.gov.
  
  
• All three divisions support this R24 mechanism. In addition, KUH provides a “Seeding R24” which allows applications for funding to support the formation of teams. For details of this mechanism, follow this link to the KUH webpage (http://www2.niddk.nih.gov/KUH/KUHHome/default.htm).
  

1. Background
   The complexity and pace of biomedical science often require input and expertise from a group of investigators working together. Currently support for collaborative research takes the form of a large R01 with one Principal Investigator (PI) and one or more key personnel, a multi-PD/PI R01, or a Program Project Grant (P01) with 3 or more individual and independent projects and cores centered on a common theme, or a Center supporting a focused set of activities. Other large research mechanisms often utilize cooperative agreements that also entail significant involvement of the NIH in the planning and execution of research objectives. In large collaborative studies synergies are built out of the interactions between and among the projects and investigators of these focused efforts. It is becoming clear that mechanism(s) to support collaborative (team) science in ways not amenable to the R01, P01, or Center are needed to address complex challenges in biomedical science that require multiple and often different expertise. The use of the Research Resource Project Grant mechanism (R24) by NIDDK is designed to provide resources for challenges where multiple levels of expertise are needed to focus on a single complex problem in biomedical research relevant to the mission of NIDDK. The use of the R24 is not intended to support more traditional investigator-initiated and highly focused studies best supported by the R01 or P01. Nor is it intended to supplement the budgets of existing R01-type efforts by providing core type services or to support the interactions of members of the same department or institution who already normally interact. Rather the flexible nature of the R24 grant mechanism allows for the assembly of teams of investigators from diverse disciplines with the intent of providing support for innovative approaches and paradigm-shifting studies. One example is that such teams could support integrated basic or transformative studies that have a potential to significantly advance the knowledge in a given field. Teams may also support integrated basic and clinical studies with the intent of moving forward the NIH agenda on translation of basic science to the clinic. NIDDK expects investigators forming collaborative teams to already be funded and productive investigators who now wish to integrate their interests and efforts to facilitate a synergistic approach to the challenge not possible through other grants mechanisms. Support for resource development, generation, or utilization can be included to enhance the catalytic and transformative nature of the proposed studies.
   
   
2. Examples
   The intent of the R24 is to define a complex and important problem relevant to NIDDK and then assemble a collaborative team around this central problem with members based on the expertise and discipline needed to answer the complex question. In such a team individual creativity is preserved while taking advantage of the synergy of collaborative approaches. Such collaborative teams would include members based on the needs of the problem and need not all be based at the same institution. The team science concept should foster a sense of connectivity between and among the investigators comprising the team. The collaborative nature of the team required to address the complex question would require experienced investigators. Teams structured around funded and productive investigators will be better suited for the task than untested, new investigators. The following provides two examples of R24 projects:
   
   
   • The use of siRNA mediated gene silencing as a novel strategy for developing the next generation of therapeutics for human disease has been limited by the lack of safe and effective delivery methods. A physiologist, an immunologist and an engineer bring their collective expertise to bear on the question: Can you achieve effective oral delivery of siRNA in mice to silence genes in specific selected target tissues?
     
     
   • A central repository contains information-rich sequential and reciprocal RNA, protein and metabolite comparisons between humans with different complications of diabetes. A clinician, a basic scientist and a bioinformatics expert form a collaborative team to answer the question: Can a systems biology approach be used to discover the essential cellular pathways involved in the pathogenesis of diabetic complications?

• To be eligible for an R24, a potential applicant should be an independent, funded investigator who has been productive in their field of research, as evidenced by peer-reviewed publications. The applicant should develop a team of such investigators, with expertise in the relevant areas to address the problem of interest to the mission of NIDDK (http://www2.niddk.nih.gov), The problem chosen should be one that would benefit from a team science approach where a collaborative, interdisciplinary team would be best suited to attack the problem.
  
  
  1. Communication with NIDDK Staff
     Early communication between the potential applicant(s) and an NIDDK program director is critical for the development of a successful R24 application. These discussions should start at a minimum of 6 months and as early as 9 months prior to the projected receipt date and should include the choice of funding mechanism, relevance of the topic to the NIDDK mission, and the scope and approach of the project.
     
     
  2. Approval Process in Order to Submit an R24 Application
     Specific Instructions for Applications Requesting $500,000 (direct costs) or more per year are defined by the NIH: (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html). The applicant must obtain agreement from the NIDDK staff that the Institute will accept your application for consideration for award. Given the large budgetary commitment to an R24 project, the NIDDK reviews these requests based on their relevance to high priority areas within the Institute.
     
     A written “request for preapproval” is due at least 3 months prior to the application receipt date. This request should contain:
     
     
     1. Statement of the complex problem
     2. Importance and relevance to NIDDK
     3. Need for an R24 as opposed to any other granting mechanism
     4. Significance and impact of the question
     5. Nature and composition of the collaborative team and the role(s) that each member will play
     6. Bio sketches for all members of the team
     7. First year budget (indicate whether DC will exceed $1M in any of the out years)
        
        
     Initial consideration of the suitability of a prospective application will be made by a trans-DK group of Extramural Scientific Program Officers who will make a recommendation to the appropriate Division Directors. If accepted, the contact PI will be informed by phone or email in sufficient time to allow for preparation and submission of a full application. Due to the broad nature of possible responses, not all requests will be accepted for submission of a full R24 application. The purpose of this process is to establish communication between the potential applicant group and NIDDK staff. It is not part of the peer review material. Upon receipt of a request, the appropriate NIDDK program director may contact the prospective principal investigator to assist in a number of areas that include scientific content and objectives, organization, and clarification of intent. However, applicants should not construe advice given by the NIDDK staff as assurance of favorable review of the request. The staff will not evaluate or discuss the merit of the scientific aspects of the proposal.

III. PREPARATION OF APPLICATION

1. Form
   
   1. Applications must be prepared using the most current PHS research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/  . The D&B number should be entered on line 11 of the face page of the PHS 398 form.
      
      
   2. When the R24 grant mechanism transitions to electronic submission (SF424) a new set of instructions will be issued.
      
      
   3. The title and number of this funding opportunity announcement must be typed on line 2 of the face page of the application form and the YES box must be checked.
      
      
   4. Applicants may also consult with NIDDK staff concerning the technical aspects of preparing the application. The most recent policies from the NIH regarding page limits and application forms must be used (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html).
      
      
2. Teams and Shared Resources
   
   1. The Principal Investigator of an R24 grant may be located at one institution while other members of the collaborative team may be located at the same, affiliated, or other institutions. It is anticipated that members of the team may not already be interacting on this, or other problems.
      
      
   2. A clear plan of operation should be provided for the administrative structure and proposed interactions among the investigators. Research related to any resources that are needed to enhance the capabilities of the team should be clearly articulated.
      
      
   3. An important part of the application will be the description of the collaborative team aspect of the work proposed including the requirements and roles to be played by each member of the team. Lines of communication and exchange of data should be clearly established. The coordinated use of shared resources that could increase the efficiency of the entire team, as well as facilitate the use of new technologies and the pursuit of new lines of investigation should be defined.
      
      
   4. The plan for development and use of resources should help to promote the interdisciplinary and collaborative research around which the team has formed. Shared research resources and activities can include services (e.g., cell isolations, patient recruitment, statistical support); equipment (e.g., confocal microscope, scanning electron microscope); or other resources (e.g., use of transgenic facilities, access to batch preparation of reagents, clinical research resources), as needed by the collaborative team.
      
      
   5. Since the overall goal of the R24 is to bring together investigators from varied disciplines to attack a complex problem in a coherent fashion, the justification for drawing investigators from varied disciplines (e.g. chemistry, physics, biological computation, imaging, molecular biology, physiology, etc) should be well defined. The role(s) for each member of the team and how this will provide the requisite synergies for answering the complex problem should be clearly articulated. These activities should significantly enhance the investigators' existing capabilities and introduce new approaches to the research aims of the objective of the collaborative team.
      
      
   6. This mechanism is not intended to support core facilities. It also is not designed to support groups of investigators at the same institution who would normally interact and collaborate in the absence of a collaborative grant. The collaborative research plan must facilitate a synthesis of information that would not be possible otherwise.
      
      
3. Rationale
   
   1. The application must include sufficient detail to enable an assessment of the degree to which the R24 grant would facilitate collaborative and integrative approaches to the shared research problem.
      
      
   2. The application should also contain a rationale for why this group of investigators was selected, and why the R24 is the appropriate grant mechanism for support as well as why it is likely to significantly enhance progress on the shared research problem, beyond what could be accomplished with the individual investigators' research grant support.
      
      
   3. If some of the participating investigators are at the same institution, a rationale must be provided explaining how this R24 grant will enhance integration and collaboration amongst those participants, beyond what would normally be expected of a group of investigators with shared interests at the same institution.
      
      
   4. Impact and significance should be clear, particularly with respect to why and how the collaborative team approach to the research question is likely to lead to paradigm-shifting outcomes.
      
      
4. Approach
   
   The approach should contain a description of how the team will accomplish its objectives. The lead principal investigator should describe how the activities will be coordinated and made accessible to all participating consortium members. Applicants also should include specific plans for sharing data and materials that may be generated through the R24 grant.
   
   
5. Administrative Structure
   
   1. The final administrative structure of the R24 will be left largely to the discretion of the applicant institution (subject to review by NIH peer review mechanisms). However, NIH's experience has demonstrated that the effective development of a collaborative, interdisciplinary team such as this requires close interaction between the PI, collaborating investigators, and appropriate institutional administrative personnel, the staff of the awarding agency, and the members of the community in which the Center is located. It is expected that the PI would provide a plan for the organization of collaborating investigators and institutions, including the need for electronic communication and/or travel.
      
      
   2. Depending on how the R24 is structured, the PI might need to develop policies and procedures for the operations of project resources. Resources should address the issue of allocation of resources to development of new technologies in comparison to provision of services with existing technologies. Although facilities available should be described for each element of the application, a more general description of overall facilities and a statement regarding institutional commitment to the Center should also be included here.
      
      
6. Budget Categories
   
   1. Professional Personnel: This category may include support for salaries of key personnel within the Collaborative team. The salaries derived from the R24 grant will depend on the effort provided and institutional salary as well as existing NIH policies; however, current NIDDK practice limits annual increments to 3 percent. It is recommended that the lead PI devote at least 25% of his/her efforts to the project. The R24 application should include salaries for individual principal investigators only to the extent that they provide an essential function of the collaborative team. No overlap of time or effort between the R24 and separately-funded projects is permitted.
      
      
   2. Technical and Support Personnel: This category may include salaries and fringe benefits for support of personnel directly involved with the execution of the R24 Specific Aims.
      
      
   3. Equipment: It is anticipated that the research environment available to each team member will be sufficient to support the proposed work. However, requests for essential equipment must include documentation of similar equipment already available at the institution and provide a clear justification in terms of need and service to collaborative team investigators. General purpose equipment needs should be included only after surveying the availability of such items within the institution.
      
      
   4. Supplies: Consumable supplies related to the operation of the collaborative team are allowed and include office materials, as well as scientific supplies.
      
      
   5. Research Patient Care Costs: Research patient care costs (both in-patient and out-patient expenses) will be considered in the context of other existing institutional clinical resources. Attempts should be made by the applicant institution to utilize existing clinical facilities, such as CTSAs. Costs relating to the clinical research efforts of R24 investigators may be funded through the R24, provided there is no overlap of funding. The R24 is not intended to be a facility for health care delivery; thus, only those patient costs directly related to research activities may be charged to the grant.
      
      
   6. Travel: Domestic and foreign travel of project personnel directly related to the collaborative team activities of the R24 is allowable. Travel of collaborative team members for attendance at annual meetings is allowable.
      
      
   7. Consultants: Consultants and any associated costs (consultant fees, per diem, travel) may be included when their services are required within the R24.
      
      

• Upon receipt, applications will be reviewed by NIH staff for completeness. For purposes of evaluating the suitability for the R24 and the strengths of a collaborative team science approach to the central problem, the following criteria will apply:
  
  
• Team Science: Does the team that has been assembled have the appropriate mix of expertise necessary to achieve the objectives of the work proposed?
  
  Synergy: Does the team apply appropriate and state-of-the-art approaches to the problem in such a way as to create a level of synergy that will significantly enhance the outcomes?
  
  Administrative organization: Coordination of ongoing research; establishment and maintenance of internal communication and cooperation among investigators; mechanisms for prioritizing usage of shares resources.
  
  Budget: An additional review consideration is the appropriateness of the budgets for the proposed and approved work to be done; as well as the institutional commitment to the program, including lines of accountability regarding management of the R24 grant.
  
  

1. How is an R24, as used by NIDDK, different from a regular R01 or a Program Project?
   NIDDK uses the Resource Research Grant mechanism (R24) for collaborative, team science projects that require multi- or trans-disciplinary teams of investigators to answer complex questions relevant to our mission. The approach may involve discovery based, as well as hypothesis-generating and –testing approaches. An R01 between collaborating investigators is ordinarily focused on a specific hypothesis which is tested and may involve collaborations between and among investigators with relevant expertise. A Program Project involves 3 or more R01-like projects addressing a common theme and requiring a core(s) resource to foster synergy between and among the individual projects.
   
   
2. Who is eligible to apply for an R24?
   As used by NIDDK the stipulation is that experienced, funded, and productive investigators should form the core of a collaborative team. The R24 should not be used as a vehicle for Early Stage Investigators to obtain their first R01 funding.
   
   
3. Can early stage investigators be PIs on an R24? Co-PIs?
   The collaborative nature of the team required to address the complex question would require experienced investigators. Teams structured around funded and productive investigators will be better suited for the task than untested, new investigators.
   
   
4. Are cores allowed?
   While it is understood that the development of research resources may be important to an R24 project, cores, per se, are defined components of the program project grant mechanism. The program project format consists of individual R01-like projects and cores that provide support service while an R24 is a collaborative and multi-disciplinary team science approach to solving a complex central question. Individual members of the team may contribute to the collaborative attack on the problem by applying specific and required expertise in order to assist the team as a whole to make progress. Such resource needs should be included in the overall approach to the research plan.
   
   
5. What are the budget limits on full R24 applications?
   Budgets of $500,000 represent the minimal starting point and therefore triggers the need to obtain prior approval from NIDDK for submission of an application. Prior review helps both NIDDK and the applicants determine whether a project is deemed appropriate for the R24 grant mechanism. While no firm upper limit has been set, R24 applications are often considered similar in scope to Program Project applications which have direct costs limits of $5,000,000 over 5 years (new projects) and $6,250,000 over 5 years (competing continuation projects).
   
   
6. What are the areas of science relevant to NIDDK that could be investigated using an R24?
   Prospective applicants are encouraged to contact relevant Program Officers of the three extramural science divisions of NIDDK: Diabetes, Endocrinology and Metabolic Diseases (DEM), Kidney, Urologic and Hematologic Diseases (KUH), and Digestive Diseases and Nutrition (DDN): http://www2.niddk.nih.gov. Contacts should be initiated early in the planning process to obtain guidance about the R24 concept.
   
   
7. How are R24s reviewed?
   Applications undergo a first level of review by a multi-disciplinary group of scientific experts convened by the NIDDK Review Branch in accordance with NIH peer review procedures and using review criteria outlined in the FOA. Applications will be reviewed in a special study section using an editorial-board method, and those applications with the highest merit will be discussed, using significance, innovation, and potential impact as primary determinants of scientific merit. Reviewers will be looking for applications that 1) address a question that represents a major gap in our knowledge; 2) are paradigm shifting and of great impact; 3) creates synergies; and 4) is a departure from ongoing work.