Clinical Research Center Grants (P50)

Clinical Research Center Grants (P50) is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-13-062: NIDCD Clinical Research Center Grant (P50) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute on Deafness and Other Communication Funding Opportunity Title NIDCD Clinical Research Center Grant July 19, 2013 - This PAR has been expired and reissued as PAR-13-277. Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for Clinical Research Center Grants designed to advance the diagnosis, prevention, treatment, and amelioration of human communication disorders.

For this announcement, Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder. Examples of such research include but are not limited to, studies of the prevention, pathogenesis, pathophysiology, diagnosis, treatment, management or epidemiology of a disease or disorder of hearing, balance, smell, taste, voice, speech, or language.

Letter of Intent Due Date(s) January 22, 2013; April 30, 2013; September 1, 2013; December 30, 2013; May 2, 2014; September 1, 2014; January 2, 2015; May 1, February, 22, 2013; May 30, 2013; October 1, 2013; January 30, 2014; June 2, 2014; October 1, 2014; February 2, 2015; June 6, 2015; AIDS Application Due Date(s) (Now Expired July 19, 2013 per issuance of PAR-13-277 ), Originally October 2, 2015 Required Application Instructions It is critical that applicants follow the instructions in Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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. Looking ahead : NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs.

NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website . Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH) invites new or competing applications for Clinical Research Center Grants (P50). This Funding Opportunity Announcement (FOA) targets applicant institutions with demonstrated ability to conduct clinical research in human communication disorders.

Applications are encouraged in the seven scientific programs of the NIDCD: hearing, balance, smell, taste, voice, speech and language. The Clinical Research Center Grant (P50) supports an investigator-initiated research program in which a multidisciplinary team of investigators works in a clearly defined central theme of mutual scientific interest.

This mechanism facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating cooperation among clinical investigators whose projects are directed toward a common goal. For this announcement, Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder.

Examples include (but are not limited to) studies of prevention, pathogenesis, pathophysiology, detection, diagnoses or epidemiology of a communication disorders or disease.

Center must be an identifiable organizational unit with an administrative structure and clear lines of authority in order to facilitate coordination among Center personnel and to assure maximum accountability and efficiency in has identified a number of research priority areas. Priority areas 3 and 4 are in the domain of clinical research.

Investigators are encouraged to study topics in these priority areas such as improving outcomes for human communication, community based participatory research, implementation and dissemination research and other areas of clinical research. NIDCD P50 must meet 4 essential criteria listed below: 1. The research to be conducted must be clinical as 2.

The P50 must have a well-defined central unifying theme consisting of three or more research subprojects with 1-2 supporting cores as appropriate; one core must be an administrative core. 3. Each research subproject must be unambiguously related to the central unifying theme.

Synergistic and substantial interactions among the subprojects should be evident. 4. The overall P50 must provide multidisciplinary approaches to the central theme, defined as having research subprojects representing different disciplines, approaches and expertise.

Studies with normal human subjects (e.g., those without a communication disorder) may be included in the research only when data from normal controls are essential for interpretation of the results. Non-human research will be allowed on an NIDCD P50 grant on rare occasions. Non-human research is limited to one subproject and only if translational or serves as a platform for translational research.

Core support can be requested as part of a P50 application to provide essential resources required by multiple subprojects, for example, patient management or speech processing technical support etc. Requests must be carefully justified and not be used to acquire additional support that duplicates existing resources already at the institution. Section II.

Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed Glossary and the PHS 398 Application Guide provide details on these application Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Budgets for new P50 applications are limited to $1,500,000/year direct cost (DC). Competing renewals (type 2) P50 grant applications may request budgets (DC) that are no greater than 10% above the budget of the last year of the existing grant or $2,000,000 whichever is less. Annual budget increases should not exceed more than NIH allowances at the time of submission of the application.

Salary levels in all years are limited to the NIH maximum rate. Competitive revision (supplemental) applications requesting an additional research component to an existing P50 are allowed, but may not exceed the terms of the parent award or the budgetary caps as described above.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The maximum period is 5 years.

Although the financial plans of the NIDCD provide support for this program, awards pursuant to this funding opportunity are contingent upon the described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations. Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually.

Use the Sam. gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.

gov for additional information. All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be completed by the application due date.

Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date. Eligible Individuals (Program Director/Principal 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 PHS 398 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

Section IV. Application and Submission Information Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 2. Content and Form of Application Submission It is critical that applicants follow the instructions in 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 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 research 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: Division of Scientific Programs National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd; EPS 400C Telephone: (301) 496-5061 Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail) Bethesda, MD 20817 (for express/courier service; non-USPS service) At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to: Melissa J.

Stick, Ph. D. , M.

P. H.

Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd, EPS 400C Telephone: (301) 496-8683 All page limitations described in the PHS 398 Application Page Limits must be followed, with the following exceptions or additional The Clinical Research Center Overview has a 12 page limit for the Each Research Subproject has a 12 page limit for the Research The Administrative Core and any additional Scientific Cores each have a 12 page limit for the Research Strategy.

Typically, the Administrative Core requires much fewer pages. For Resubmission applications, an Introduction section is required:a separate 1-page Introduction is allowed for the Research Center Overview section as well as for each subproject and core. Supplemental Instruction for the Preparation of Multi-Component The NIDCD P50 Research Center Program requires a multi-component application.

It must consist of at least 4 components (3 research subprojects and one administrative core). Each research subproject may be a "stand alone" research project. The NIDCD P50 requires that the subprojects be inter-related creating a synergistic comprehensive center.

The interrelationship among the subprojects does not mean that they depend on one another. Scientific cores are optional components. An individual research subproject is typically comparable to an R01 application.

A PD/PI must serve as director of the Administrative Core. If appropriate, scientific core(s) may be included in the P50 application. Core components are shared research resources that provide Center investigators with techniques, instrumentation, services, or resources that will enhance NIDCD mission related research to accomplish the common goals of the Center.

A core component is a laboratory, facility, service, or other resource that provides support for at least two scientific research subprojects of the Center. Cores should be used primarily to support projects which are part of the Center Grant award. New research experiments or projects may not be proposed in the Cores, they must be contained in the Research Subprojects.

Each core component is directed by an investigator with established expertise relevant to the support or service to be provided. Each shared scientific resource component should be clearly described in terms of the services and resources to be provided to investigators. Applications: A comprehensive progress report is required for renewal applications.

A statement describing the progress made by the Center as a regional or national research resource should be included.

Each component (Overall, Scientific Subprojects, Administrative Core, and Scientific Cores) should follow PHS 398 instructions as appropriate for that section of All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: The application should be assembled as follows: Face Page - describes the entire application.

As the title, include the words Clinical Research Center , adding a few descriptive words (e.g., Voice Disorders and Management" etc.). Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS 398 Form Page 2) - prepare one form to describe the overall application. Table of Contents - describes the entire application.

Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the research subprojects first and the administrative core followed by any other core(s) last. Identify each research subproject by title; assign each research subproject a number and each core a capital letter that reflects the order in which the research subprojects and core(s) are presented in the application.

Provide the name(s) of the responsible investigator(s) for each component (research subproject or core). Number the pages consecutively. Indicate the beginning page numbers for each research subproject, core and their respective budget.

Detailed Budget for Initial Budget Period, and Budget for Entire Proposed Period of Support- Include budget pages for the overall budget, each subproject, and each core. All budgets (overall, subproject, core, and consortium/contractual) will be in this one section, placed in the same order that the subproject and cores are listed in the table of contents, and paginated accordingly.

Person months distribution table: As an aid to reviewers, the information on the person month distribution of personnel among subprojects/cores should be presented in tabular format.

Biographical Sketches: include biographical sketches for all personnel, beginning with the PD/PI Resources - describes the entire application Research Plan - prepare a research plan for the overall component Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (PHS 398 Form Page 2) - prepare one form for each individual Research Subproject, Administrative Core, and Scientific Core (optional).

Follow each Form Page 2 with the appropriate Research Plan. Research Plan - prepare a research plan for each of the individual subprojects/cores, as described below and in the PHS 398 Application Guide, with special instructions for the Research Strategy section of each component. Appendix for each Research Subproject and Scientific Core.

Appendix materials should be organized and labeled based on the Subproject(s)/Core(s) to which they pertain. Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application GuideChecklist - describes the entire Research Plan Overall Component Provide an overview of the entire research program and describe the defined central theme and goals of the Clinical Research Center (P50). Provide the rationale for the proposed research program.

Include potential impact, any areas of special interest, and any research ideas, disease entities, and target populations to be studied. Explain the research plan for achieving the objective(s) of the overall research program and how each research subproject and core relates to that overall plan.

Explain how this Clinical Research Center Grant (P50) application supports an investigator-initiated research program in which a multidisciplinary team of investigators works in a clearly defined central theme of mutual scientific interest.

Describe how this effort facilitates economy of effort, space, and equipment, and accelerates the acquisition of knowledge by stimulating cooperation among clinical investigators whose projects are directed toward a common goal. Describe how this overall Research Center will provide a whole that will have an impact beyond simply the sum of its parts.

Describe how the research focuses on individuals with communication disorders or data/tissues from individuals with a communication disorder.

Indicate any prior collaborative arrangements between investigators in the group; emphasizing the events that led to the current application; predict the anticipated advantages that would be gained by including the research in the proposed program; describe the overall theme of the Center and how research subprojects are related to the theme; and describe the multidisciplinary nature of the proposed research.

For renewal applications, collaborative activities if any, with other NIDCD funded Research programs should be described along with a list of joint accomplishments. In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal.

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Research Plan Research Subprojects Research Subprojects are individual scientific research subprojects, comparable to R01s. Each proposed research subproject should provide a clear description of its major goals, objectives, and how it integrates with the other research components in relation to the overall Center program’s central theme.

The hypotheses to be tested should be focused and The design and procedures should describe the strategies proposed to accomplish the specific aims and the innovative aspects of the approach should be highlighted.

A description of the resources and working arrangements required to implement and conduct the proposed research should be fully elaborated with particular attention to a description of necessary resources, subjects, clinical populations, tissue resources, biological models, existing data sets, etc., which will be involved in the proposed studies. If core facilities are utilized, information on their use should be provided.

Each subproject should describe the Significance, Approach, and Innovation in sufficient detail for evaluation by reviewers. For renewal applications, collaborative activities if any, with other NIDCD funded Research programs should be described along with a list of joint accomplishments.

In addition, for each research component of the existing Center grant, a succinct account of its published and unpublished results must be provided, indicating progress toward achieving aims regardless of whether the component has been submitted for renewal.

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Research Plan - Administrative Core Describe how the Administrative Core administration will coordinate and manage activities across the components of the Research Center. Describe the organizational framework for the management, direction, and coordination of the Center to ensure that all proposed components and related activities will function in an optimal and synergistic manner.

Include information on how this core will facilitate administration of the budget. This core should be described in sufficient detail to assure that all proposed components and related activities will function optimally. In addition, day-to-day operations involving procurement, finances, personnel, planning, and budgeting should be detailed in the description of this core.

Describe how the administration of the overall Administrative Core will enhance the overall P50 research, including the required significance, innovation, and approach. The PD/PI provides scientific and administrative leadership for the Center, so the PD/PI must have a demonstrated ability to coordinate, integrate, and provide guidance in establishing multi-faceted research programs.

Describe the administrative framework to manage the Research Center and each core, including the roles of the Research Center/Administrative Core Director and Research Subprojects and Scientific Core Directors, the lines of authority and relationship to appropriate institutional officials, how access and utilization of services will be prioritized, how potential disputes will be resolved, and how periodic evaluations will be used to improve the services.

Describe how the proposed Administrative Core will foster close interactions among the various component Directors and other appropriate institutional administrative personnel.

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Research Plan Scientific Cores (optional) Concisely describe how this Scientific Core will provide services to the various components in the Clinical Research Center. Describe how the scientific core will increase effectiveness by sharing expertise or centralizing labor-intensive tasks, how it will encourage and facilitate collaborative work, or promote public health advances.

Describe the services and resources to be provided to investigators. The description should include a discussion of the core's contributions to the research objectives of the Center. Relevant aspects of cost effectiveness, timesaving, and increased efficiency attributable to the existence of the cores should also be addressed.

A core component should support two or more of the Center’s scientific research components. Describe how the Scientific Cores facilities or services will enhance research activities of the Clinical Research Center using this core, and add benefits to the research accomplishments; include the required significance, innovation and approach.

Include how the Scientific Core will provide increased or innovative capabilities; facilitate increased productivity or effectiveness through sharing expertise or centralizing labor-intensive tasks; and/or foster collaborative or new research directions or attracting new investigators into an area.

Describe each proposed technique or service in the Scientific Core, and its current status of staffing, space and equipment, should be described in enough detail to allow a comprehensive evaluation. Describe briefly existing methodologies already in use at the institution; describe in more detail methodologies new to the institution with strategies for their successful implementation.

Include any developmental methods for research or training, if proposed. If applicable, include sections on quality control. The ability to articulate user benefit is a critical Include plans for administration, organization and proposed management of the individual Scientific Core.

Include plans to implement core services, to prioritize investigator use among projects competing for core use, and to resolve potential disputes.

If the core is used to train investigators in special techniques, describe the nature and extent of this training and the qualifications of core personnel to provide and oversee Discuss the potential for budgetary overlap, whether minimal or extensive, between the Research Subprojects and the Scientific Core, including personnel effort as well as other categories. If appropriate, provide a strategy for reimbursement of core services.

Describe the investigator and his/her established expertise relevant to the support or Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modifications: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Part I. Overview Information contains information about Key Dates. Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Applicants may track the status of the application in the eRA Commons , NIH’s electronic system for grants Intergovernmental Review (E.

O. 12372) This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Pre-award costs are allowable only as described in the NIH Grants Requirements and Information Applications must be received on or before the due dates in Part I. Overview Information .

If an application is received after that date, it will not be reviewed. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff 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 PHS 398 Application Guide.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 . Section V. Application Review Information Only the review criteria described below will be considered in the review process.

As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer For this particular announcement, note the following: Clinical Research is defined as research involving individuals with communication disorders or data/tissues from individuals with a communication disorder.

The NIDCD P50 Research Center Program requires a well-defined central unifying theme. It must consist of at least four or more components (three research subprojects and one administrative core). The overall P50 must provide multidisciplinary approaches to the central theme, defined as having subprojects representing different disciplines, approaches and expertise.

Each subproject will be scored individually.

The overall P50 score is an overall evaluation, and not an average of the individual subprojects scores; the IRG will evaluate the relationship and contributions of the combined subprojects and cores to the overall theme of the Clinical Research 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 Scored Review Criteria - Overall 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. Does the project address an important problem or a critical barrier to progress in the field?

If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research to be conducted involving individuals with communication disorders or data/tissues from individuals with a communication disorder?

Is the project clearly related to the central unifying theme? To what extent is there synergy and substantial interaction between this project and all the other components? Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?

If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the level of effort proposed for the PI/PD and other key personnel adequate? Are communication plans, the process for making decisions on scientific direction and procedures for resolving conflicts clearly presented?

Are the roles of the PD(s)/PI(s) and other collaborators and other administrative, technical and scientific responsibilities clearly delineated? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the overall strategy, methodology, and analyses well-reasoned