Department of Health and Human Services
Participating Organizations
National Institutes
of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Allergy and Infectious Disease (NIAID), (www.niaid.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (www.niddk.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (www.niams.nih.gov)
Office of
Research on Women's Health (ORWH), Office of the Director, (http://orwh.od.nih.gov/)
National
Institute of Neurological Disorders and Stroke (NINDS), (http://ninds.nih.gov)
Title: Autoimmunity Centers of Excellence (U19)
Announcement Type
This is a
reissue of RFA-AI-02-006,
which was previously released May 13, 2002.
Update: The following update relating to this announcement has been issued:
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research
Objectives
Section
II. Award Information
1. Mechanism(s) of
Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible
Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2.Cost Sharing or
Matching
3. Other - Special
Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request
Application Information
2. Content and Form
of Application Submission
3. Submission Dates
and Times
A.
Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
D. Application Assignment
4. Intergovernmental
Review
5. Funding
Restrictions
6. Other Submission
Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and
Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Resource Sharing Plan(s)
3. Anticipated
Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative
and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting
Section
VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer Review
Contact(s)
3. Financial/ Grants
Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Research on Women's Health (ORWH) invite applications for the Autoimmunity Centers of Excellence (ACE) program. This cooperative research program seeks to:
Background
Autoimmune diseases result from an immune response directed against the body's own tissues. The most common autoimmune diseases include systemic lupus erythematosus, multiple sclerosis, type 1 diabetes mellitus, and rheumatoid arthritis. Autoimmune responses can affect many organs, resulting in a wide variety of diseases, including autoimmune myositis, thyroid disease, hepatitis, hemolytic anemia, inflammatory bowel disease, pemphigus, alopecia, and many others. Although many individual autoimmune diseases are rare, autoimmune diseases as a group afflict millions of Americans. Women are disproportionately affected. The costs of these diseases are enormous, including hospitalizations, outpatient visits, lost productivity, and reduced quality of life for patients and their families.
Clinically divergent autoimmune diseases are likely to have common as well as unique immune aspects. For example, self-reactive T and B lymphocytes probably initiate, exacerbate, or modulate different diseases. The number, activity, and specificity of these cells are determined by many different molecules, cells, and processes. These include: the frequency and affinity of specific antigen receptors on lymphocytes; the binding of antigen to the molecules of the major histocompatibility complex (MHC, HLA in humans) and presentation by different cell types; the presence of co-stimulatory molecules; the activity of regulatory T cells; the concentration of extracellular mediators including cytokines and chemokines; and the relative strengths of intracellular signaling pathways leading to activation, anergy, or apoptosis (programmed cell death). Strategies to modify the immune response at any of these steps could prevent or reduce autoimmune disease. Agents that block co-stimulatory signals or cytokines, interrupt or alter binding of antigen to MHC molecules, or modulate the appearance and activity of regulatory cells have been evaluated for treatment of multiple autoimmune diseases. Approaches currently under evaluation target molecules in many pathways, including CD3, CD11a (LFA-1), CD19, CD20, CD22, CD25 (IL-2Ra), CD40 ligand (CD154), CD52 IgE, Fc Receptors (including CD23), and CTLA-4. The mechanisms of therapeutic action of treatments proven to be effective, such as transient ablation of mature B cells with anti-CD20 (Rituximab), remain unclear and would likely be highly informative if better understood.
Understanding how current and new therapies work can guide development of the next generation of more effective and targeted therapies. Mechanisms of action are best defined by basic studies performed in parallel with clinical testing of immune interventions. Currently, autoimmune diseases are treated by multiple clinical specialists because the affected organ systems vary and overlap. Thus, multiple sclerosis is treated by neurologists; type 1 diabetes, Graves' disease, and Hashimoto's thyroiditis by endocrinologists; systemic lupus erythematosus, rheumatoid arthritis, and scleroderma by rheumatologists; pemphigus by dermatologists; and inflammatory bowel disease by gastroenterologists. A cooperative group of scientists who are able to evaluate new therapeutic agents in several autoimmune diseases offers many advantages. By working together in planning, performance, and evaluation of clinical trials/studies, clinical specialists, clinical scientists, and basic scientists can accelerate the evaluation of new therapies and improve our understanding of their underlying mechanisms of action.
Research Objectives and ScopeThe major goal of this program is to support an integrated basic and clinical research program focused on tolerance induction and immune modulation to prevent or treat autoimmune disease. Basic researchers and clinicians, working together, can accelerate the translation of advances from the laboratory to the clinic and better utilize patient materials for testing mechanisms of action. NIAID, NIDDK, NIAMS, NINDS, and ORWH seek multidisciplinary centers with scientists who have new ideas, take novel approaches, and use state of the art technology to improve our understanding of the basic mechanisms of autoimmunity and self tolerance and the translation of that knowledge to design and evaluate clinical interventions to prevent or treat autoimmune diseases. The Clinical Components of the Autoimmunity Centers of Excellence will perform early clinical trials, typically phase I and phase II, and mechanistic studies, hereafter designated clinical trials/mechanistic studies, in patients with autoimmune disease(s) to test, evaluate, develop, or determine mechanism of action of agents or interventions to prevent or treat autoimmune disease by induction of tolerance or immune modulation. While industry has supported some translational activities, industry-supported trials have generally not focused on the basic mechanisms of action of these agents. Collaboration of the Autoimmunity Centers of Excellence with industry in performance of clinical trials/mechanistic studies and autoimmune disease research is encouraged.
Specific areas of interest include, but are not limited to:
The ACE Program will NOT support:
ACE Program Components
Each ACE application must include the components described below:
1. a Clinical Component, incorporating clinical specialists in several autoimmune diseases to conduct clinical trials and associated mechanistic studies that have been developed by the Center and approved by the ACE Steering Committee (see below);
2. a Research Component, consisting of two or more individual research projects investigating the mechanisms of autoimmunity, self tolerance, or immune modulation;
3. a Pilot Research Project with discrete benchmarks of short duration and limited funding; and
4. one or more Cores that support the work within and among the Centers.
1. Clinical Component (required)
The Clinical Component will be responsible for the implementation and execution of single- and multi-site clinical trials and associated mechanistic studies. The description of the Clinical Component should contain sufficient detail to permit an assessment of the ability of the Center to successfully design, develop, and execute single- or multi-site clinical trials. Specialists in at least 3 different disciplines (e.g., dermatology, endocrinology, gastroenterology, neurology, ophthalmology, rheumatology, etc.) must participate. Within each specialty, applicants must identify one or more autoimmune disease(s) on which the Center will focus.
The description of the Clinical Component must include (a) demonstrated evidence of the capability of the Center to perform clinical trials, and (b) two clinical trial concepts.
a) Clinical Trial Capability
Applicants must provide evidence of the ability of the Center to lead or participate in clinical trials and associated mechanistic studies, including the availability of an appropriate patient population and clinical infrastructure support at the applicant institution. See Section IV.2.B. below for additional application submission information.
b) Clinical Trial Concepts
Applicants must propose two potential phase 1 or phase 2 single- or multi-site clinical trials in different autoimmune diseases that the Center could lead. The trial concepts should balance feasibility and innovation. The trial concepts should be reasonable candidates for implementation within the 5 year program. Applicants who propose multi-site trials may assume that other Centers within the ACE network will be able to enroll patients in numbers similar to those of the proposing site. Each clinical trial concept must be described in the form of a protocol synopsis and must be accompanied by mechanistic studies designed to expand our understanding of the mechanism of action of the agent or intervention (see Section IV.2.B. below for additional application submission information). The protocol synopsis should contain sufficient detail to permit an assessment of the ability of the Center to successfully design, develop, and execute the proposed single- or multi-site clinical trial. Methods of data analysis and sample size justification must be included. Applicants must not submit a detailed, final clinical protocol. A final clinical protocol will be developed prior to study initiation, as indicated in the NIAID Clinical Terms of Award (see Section VI.2.A.1. Cooperative Agreement Terms and Conditions of Award – “Principal Investigator Rights and Responsibilities”).
No budgetary support for the Clinical Component should be requested in the application. After award, additional resources to support the development and implementation of clinical trials and associated mechanistic studies may be requested from the ACE Steering Committee and paid from the ACE Discretionary Fund (see Section VI.2.A.3.a).
Statistical, Data Management, Pharmacy, and Clinical Trial Operations Support
NIAID will provide statistical, data collection and management, pharmacy, and clinical trial operations support through a separately-funded Statistical and Clinical Coordinating Center for Autoimmune Diseases Clinical Trials (SACCC-ADCT) contract. Each participating institution will be responsible for providing primary study data to the SACCC-ADCT. Timeliness and accuracy of submitted data will be monitored by the SACCC-ADCT and evaluated by the Steering Committee. SACCC-ADCT responsibilities are further described under Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award – “Collaborative Responsibilities.”
2. Research Component (minimum 2 research projects required)
Applicants must propose a robust research component describing at least two research projects with up to 5 year research plans and strongly supported by preliminary studies.
All projects must focus on human autoimmune diseases. Applicants may propose to study disease in animals only if the animal is a highly relevant model of human autoimmune disease with a clear potential to translate findings to the clinic.
3. Pilot Research Project (required)
Applicants must describe one pilot research project with a 2 year research plan with scope and aims consistent with the goals of the ACE. The pilot research project should emphasize innovation and need not be supported by preliminary studies. Benchmarks to be achieved at 18 months must be stated. These benchmarks will be used by the ACE Steering Committee to measure progress. The Steering Committee will review the progress of the pilot research projects after 18 months. Based upon the ACE Steering Committee review, additional support may be provided by the ACE Discretionary Fund to continue the successful pilot research project beyond the initial 2 years. To be eligible to receive additional discretionary funds, the Pilot Research Project Leader will be required to provide the ACE Steering Committee with an updated research plan for continued support. Leaders of successful pilot research projects will be encouraged to apply for NIH unsolicited R01 support.
Support for the pilot research project will be provided from the ACE Discretionary Fund. Funds requested for the pilot research project should NOT be included in the overall budget of the application. However, a budget for the pilot research project should be included.
The pilot research project will be of least consideration in the overall score for the Center’s application.
4. Core Components
a. Administrative Core (required)
The Administrative Core is responsible for coordinating the Center’s efforts and may sponsor activities to advance the Center’s integration.
NOTE: Applications without the above required components will be considered non-responsive and will not be reviewed.
b. Scientific Cores (optional)
One or more Scientific Cores may be proposed. Each Scientific Core must be used by at least 2 research projects. Applicants may indicate whether the Scientific Core will support the studies associated with the clinical component. However this will not substitute for the requirement that Scientific Cores support 2 research projects.
Scientific cores are limited to providing standard assays, reagents, technologies, or other available services to ACE investigators. Scientific Cores must be well justified and clearly non-duplicative of other services or facilities available to ACE investigators. If during the funding period the use of a Scientific Core is significantly changed through the modification, deletion, or addition of pilot research projects and clinical trials/mechanistic studies, funds may be re-budgeted within the ACE after approval by NIAID. Scientific Cores may include clinical, technical (e.g., flow cytometry, microarray, microdissection), informatics, or other non-administrative activities that directly support the research program.
If appropriate to the particular ACE, repositories for cells, tissues, reagents, or large data sets may be proposed as Scientific Core activities. In this case, applications should include methods to obtain, protect, and archive relevant clinical information or family history. In addition, appropriate informatics capability should be provided to track data and link to other data sets. A plan for the distribution of samples, reagents, data, and other resources should be included and conform to the NIH policies on data and resource sharing (see Section IV.6. Other Submission Requirements and Information).
Applications proposing Scientific Cores must indicate the specific projects to be served by that Core and explain why those Core resources are not otherwise available at the applicant institution or through other grant mechanisms, for example, NIH-funded centers programs or clinical networks. The apportionment of dollars, or percentage of dollars, that will be required to support each Research Project and Pilot research project should also be presented.
c. Discretionary Fund Management (DFM) Core (optional):
Applicants proposing to manage the ACE Discretionary Fund (DF) must include in the application a detailed plan to support the responsibilities associated with the disbursement, administration and reporting on the use of the funds. This Core is optional and will not be considered in the overall evaluation of the application. Such applications must include a plan for the DFM Core describing:
(1) an administrative structure that should include a full-time administrator;
(2) methods/procedures to support the Steering Committee in soliciting, evaluating, prioritizing, selecting, and monitoring the progress of projects supported by the DF;
(3) plans for interacting with investigators, both within and outside the ACE network, who are applying for, or in receipt of DFs;
(4) the experience/qualifications of the DFM core leader and all proposed DFM Core staff;
(5) proposed procedures, format and timing for reporting on the status of DF use;
(6) documentation of institutional commitment to the administration of the DF.
A separate budget for the DFM Core must be provided and is not to be included in the total budget of the Center. The DFM Core will be evaluated by the review panel, but will not influence the overall score of the application.
Center External Advisory Board (Center EAB)
Applicants may propose a Center External Advisory Board (EAB). Applicants should not contact nor identify individuals who might be invited to serve on the advisory board for their ACE. Applicants may describe the expertise required for individuals to serve on the advisory board. For competing renewal applications, if an advisory board exists already, the names of current advisory board members should be provided so that conflicts may be efficiently managed. An individual may serve on two different Center EABs. Investigators participating in one ACE may serve as a Center EAB member on another ACE.
ACE Clinical and Research Representatives
A Clinical Representative and a Research Representative must be identified among the Key Personnel in each Center. The PD/PI must serve as the Clinical Representative or the Research Representative. For multiple PDs/PIs, one PD/PI must be selected to serve as the Clinical Representative, and a different PD/PI must be selected to serve as the Research Representative. One individual may not serve as both Representatives.
The clinical and research components of all Centers will work cooperatively to select, design, and perform the clinical trials and the adjunct mechanistic studies as well as collaborative basic and translational research projects.
Steering Committee
A Steering Committee will be established to direct the collaborative work of the Centers and approve use of ACE discretionary funds. All major scientific and budgetary decisions will be made by the majority of the voting members of the Steering Committee. To permit comprehensive reporting and discussion by the entire Committee, the formation of subcommittees or working groups and the delegation to them of discrete responsibilities and authorities is strongly encouraged. The Clinical Representative and Research Representative from each ACE will serve as voting members of the Steering Committee. Other voting members will include one NIAID Representative and one representative from the SACCC-ADCT supporting the ACE network. See Section VI.2.A.3. for a full description of Steering Committee responsibilities.
Discretionary Fund
NIAID plans to set aside approximately $4.9 million in total costs per year in a Discretionary Fund (DF) to support clinical trials and mechanistic studies, pilot research projects, and other group activities such as working groups or subcommittees formed by the Steering Committee with narrow focus and short duration (e.g., establishing immunocompetence criteria or comparing measurements of regulatory T cells). Members of the Steering Committee may apply for DF support, and they may sponsor proposals from investigators either at their institution or at other institutions. The ACE Steering Committee will establish the goals, priorities, and evaluation criteria for the use of the DF. Management of the Discretionary Fund will be awarded to a single ACE institution from among successful ACE applicants who proposed acceptable DFM Cores.
Annual ACE Plenary Meetings
The NIAID will hold an annual two-day plenary meeting to share recent findings and encourage collaborations. All key personnel are expected to attend and participate. Funds for travel and accommodations should be included in the budget request for the Administrative Core. The research aims and status of all projects from all Centers will be presented in brief talks. The highlights from each Center’s recent findings should also be presented. All annual ACE plenary meetings will be held in the Bethesda, Maryland area. The initial plenary meeting will be held in Bethesda, Maryland within 2 months of award.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This
funding opportunity will use the NIH Multi-project Cooperative
Agreement (U19) award mechanism. The Project Director/Principal
Investigator (PD/PI) will be solely responsible for planning, directing, and
executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
At this time, the NIAID has not determined whether or how this
solicitation will be continued beyond the present FOA.
2. Funds Available
NIAID, NIDDK, NIAMS, NINDS, and ORWH intend
to commit approximately $12.1 million in FY 2009 to fund up to 9 new and/or competing
renewal grants in response to this FOA. An applicant may request a project
period of up to 5 years and a budget for direct
costs up to $450,000 per year. Of the $12.1million total, approximately $4.9 million per year
will be available in a Discretionary Fund to support clinical trials including
associated mechanistic studies, pilot research projects, and other group
activities.
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. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as
described in the NIH
Grants Policy Statement will apply to the applications submitted and awards
made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The
following organizations/institutions are eligible to apply:
Foreign Institutions are not eligible to apply as the primary applicant but they may enter into collaborations with a domestic institution that is the primary applicant.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Note that multiple Project Leaders or Core Leaders are not allowed for individual Research Projects, the Pilot Research Project, or the Scientific Cores. The Core Leader(s) of the Administrative Core will be the PD/PI(s) of the overall application.
2. Cost Sharing or Matching
This program does not
require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special
Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
The
PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.
Applicants must use the currently approved version of the PHS 398. For further
assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application Submission
Applications
must be prepared using the most current PHS 398 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.
The title and number
of this funding opportunity must be typed in item (box) 2 only of the face page
of the application form and the YES box must be checked.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PD/PIs. NIH requires one PD/PI be designated as the "contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PI may be changed during the project period. The contact PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project (see below under Supplemental Instructions for the Preparation of Multi-project Applications).
Supplemental Instructions for the Preparation of Multi-Project Applications
The following section supplements the instructions found in the PHS Form 398 for preparing multi-project grant applications that will be submitted in paper format. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.
The supplemental instructions below are divided as follows:
A. General Instructions – address collaborative efforts among research projects, the administrative and organizational structure, as well as the overall facilities and environment, and the overall budget.
B. Specific Instructions for the Clinical Component – describe modifications to PHS Form 398 instructions on selected items to address specific requirements for this component.
C. Specific Instructions for the Research Component Projects and Pilot Research Project – describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.
D. Specific Instructions for Core Units – describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.
A. General Instructions
All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.
Note that pages in excess of the allowed limits will be removed from the application and will not be reviewed.
The order of presentation should be as follows:
1. Form Page 1 - Face Page
Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.
When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs. The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued.
Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the PDs/PIs of the multi-project application, followed by the Clinical and Research Representatives, Project and Core Leaders of the research component projects, pilot research project, and cores, other key personnel, and then other significant contributors.
When multiple PDs/PIs are proposed, list the Contact PI first, then all additional PDs/PIs in alphabetical order. Then list all Key Personnel, giving name and organization.
3. Form Page 3 - Table of Contents
Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.
Prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."
4. Composite Budget
Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)
Do not include the budget for the Clinical Component, the Pilot Research Project, or the (optional) DFM Core in the Composite Budget. The clinical trials/studies and pilot research project will be supported through the ACE Discretionary Fund.
SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support
Component |
Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
All Years |
Project 1. Invest. |
150,000 |
150,000 |
150,000 |
150,000 |
150,000 |
750,000 |
Project 2. Study |
175,000 |
175,000 |
175,000 |
175,000 |
175,000 |
875,000 |
Core A. Admin. Core. |
50,000 |
50,000 |
50,000 |
50,000 |
50,000 |
250,000 |
Core B. DNA |
25,000 |
25,000 |
25,000 |
25,000 |
25,000 |
125,000 |
Totals |
400,000 |
400,000 |
400,000 |
400,000 |
400,000 |
2,000,000 |
5. Form Page 5
Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below).
6. Biographical Sketch Format Page
Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PD/PI(s) first, followed by those of other key personnel in alphabetical order.
7. Resources Format Page
Do not complete. Essential information is to be presented in the individual research project and core sections of the application.
8. Program Overview (Research Objectives and Strategic Plan)
This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.
Within this overview, applicants must:
If the application is a competing renewal of a prior ACE, this section should also highlight the major accomplishments from the prior funding period. In addition to discussing results from individual projects and clinical trials/studies, describe the synergy and collaborations that occurred. For individual projects that will be continued, additional details should be provided in the Progress Report section of the Research Plan within the application for the Research Component (see below Section IV.2.C.7.). Other points to include are: the numbers and quality of publications; whether any patents were filed; if researchers were brought into the study of autoimmune diseases; and how the ACE was managed.
9. Leadership Plan for Multiple PDs/PIs (required, if applicable)
For applications designating multiple PDs/PIs, a Leadership Plan must be included and is limited to 3 pages (see item 14 of the PHS 398 Research Plan for additional guidance). The governance and organizational structure of the leadership team and their relationship with the overall ACE should be described, including communication plans, process for making decisions on scientific direction, intellectual property issues, and procedures for resolving conflicts. The roles and shared administrative, technical, and scientific responsibilities for the program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
10. Checklist
One Checklist, placed at the end of the application, is to be submitted for the entire application.
11. Appendix
A change in policy limiting Appendix materials began with receipt dates on or after January 3, 2007 (NOT-OD-07-018). http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html .
For each project or core in the multi-project application, 3 publications (see below) plus other approved material are allowed. The Appendix may not be used to circumvent the page limitations of the Research Plan. The Appendix material should be collated as one body of material and submitted on CD only, as indicated below. Each document file must include header information clearly indicating the project or core to which it applies.
Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.
Note: Include the URL or PMC submission identification numbers along with the full reference in the Literature Cited section, the Progress Report for Competing Renewals section, and/or the Biographical Sketch section.
Beginning May 25, 2008 and for all subsequent due dates, all paper PHS 398 applications must provide appendix material on CD only, and include five (5) identical CDs in the same package with the application. (See NOT-OD-08-031; http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html)
Please note that a summary listing of the items included in the appendix is encouraged but not required. When including a summary it should be the first file on the CD.
When preparing CDs:
For materials that cannot be submitted electronically or materials that cannot be converted to PDF format; (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Officer (SRO) for instructions following notification of assignment of the application to a study section.
B. Specific Instructions for the Clinical Component
Except for the requirements below, follow the PHS 398 instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing the Clinical Component.
The Clinical Component portion of the application must include:
Note: Budgets pages should be omitted.
1. Cover Page
The Face Page of the PHS 398 Form should not be used as a cover page for the Clinical Component within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about the Clinical Component. A Cover Page must demarcate the Clinical Center Description and each Clinical Trial Concept, and should contain the following information items:
Project Number and Title: (e.g., Clinical Trial Concept 1. “Rituxan, Tolerance, and Lupus”)
Name of Project Leader: (e.g., Jones, Roberta A.)
Proposed Period of Support:
From: (mm/dd/yyyy - e.g., 07/01/2009)
To: (mm/dd/yyyy - e.g., 06/30/2112)
Applicant Organization:
(full address)
2. Form Page 2
Provide an abstract of the Clinical Component according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should describe how the Clinical Component will contribute towards attainment of the multi-project program objectives.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Clinical Representative, the Research Representative, and the Project Leaders for each of the clinical trial concepts, followed by other key personnel, and then other significant contributors.
3. Form Page 3
Prepare a Table of Contents using Form Page 3 of the PHS 398.
4. Biographical Sketches
Do not place biographical sketches here; they are placed together at the end of the overall application.
5A. Clinical Center Description (maximum 25 pages)
Clinical Center Capability: Applications must provide evidence of the capability of the Center to conduct clinical trials and associated mechanistic studies. This section of the Clinical Component should include the following:
a. Experience in performing clinical trials.
b. Information on the potential participants in clinical trials for each of the autoimmune diseases identified:
c. Information on resources available to assist in conducting clinical trials:
d. Examples of successful collaborations among basic scientists and clinical scientists.
5B. Clinical Trial Concepts (2 required, each 10 pages maximum)
Each Clinical Trial Concept must include a protocol synopsis and a brief description of the mechanistic studies that would accompany the trial.
a. Protocol Synopsis: include the following information (maximum 5 pages):
b. Mechanistic Studies: include the following information (maximum 5 pages):
6. Appendix
Do not place a separate appendix for the Clinical Component here. All appendix materials should be collated as one body of material at the end of the application as described above.
C. Specific Instructions for the Research Component Projects and Pilot Research Project
Except for the requirements below, follow the PHS 398 instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each individual Research Project and the Pilot Research Project.
Each individual Research Project and Pilot Research Project must include:
1. Cover Page
The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing specific information about each Research Project and the Pilot Research Project. Demarcate each project with a cover page containing the following items (these constitute a subset of the information provided on a PHS 398 Face Page):
Project Number and Title: (e.g., Research Project 1. Preclinical Evaluation of HIV Microbicides)
Name of Project Leader: (e.g., Jones, Roberta A.)
Human Subjects: (Yes or No)
If Yes, exemption number:
(or)
IRB Approval Date: (e.g., 12/13/2007,or "Pending")
(and)
Federalwide Assurance (FWA) number:
Vertebrate Animals: (Yes or No)
If Yes, IACUC Approval Date: (e.g., 11/17/2007, or Pending)
(and)
Animal welfare assurance number:
Proposed Period of Support:
From: (mm/dd/yyyy - e.g., 04/01/2009)
To: (mm/dd/yyyy - e.g., 03/31/2114)
Costs Requested for Initial Budget Period: (e.g. 04/01/2009-03/31/2010)
Direct Costs: (e.g., $ 150,000)
Total Costs: (e.g., $162,000)
Note: Pilot Research Project budget request must not exceed $100,000 per year in direct costs.
Costs Requested for the Entire Budget Period: (e.g., 04/01/2009-03/31/2014)
Direct Costs: (e.g., $700,000)
Applicant Organization:
(full address)
2. Form Page 2
Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.
3. Form Page 3
Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.
4. Budget pages (PHS 398 Form Pages 4 and 5)
Provide a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.
5. Biographical Sketches
Do not place biographical sketches here; they are placed together at the end of the overall application.
6. Resources Format Page
Provide information on resources available for the project.
7. Research Plan (Items 2-5 cannot exceed 25 pages for each Research project and 15 pages for the Pilot Research Project)
Item 2 -- Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the project's relationship to the multi-project program goals and how it relates to other projects or cores. This section is typically one page.
Item 3 -- Background and Significance: Use this section to describe how the proposed research will contribute to meeting the program's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.
Item 4 – Preliminary Studies/Progress Report:
A list of publications, manuscripts accepted for publication, patents, and other printed materials will be included elsewhere; do not include that information here.
Item 5 – Research Design and Methods
Describe the research design conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 17 of the Research Plan, describe how the data will be collected, analyzed, and interpreted, as well as the data-sharing plan as appropriate. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.
Although no specific number of pages is recommended for the Research Design and Methods section, be as succinct as possible. There is no requirement to use all pages allotted for items 2-5.
8. Appendix
Do not place a separate appendix here. All appendix materials should be collated as one body of material at the end of the application as described above.
D. Specific Instructions for Cores
Except for the requirements below, follow the PHS 398 instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.
Each Core must include:
1. Cover Page
The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:
Core Letter and Core Title: (e.g., A. Monoclonal Antibody Production Core)
Name of Core Leader: (e.g., Smith, Robert A.)
Human Subjects (Yes or No)
If Yes, Exemption Number
(or)
IRB Approval Date (e.g., 5/14/06, or Pending)
(and)
Federalwide Assurance (FWA) number
Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending)
(and) Animal welfare assurance number
Proposed Period of Support
From: (mmddyy, e.g., 07/01/2007)
To: (mmddyy, e.g., 06/30/2012)
Costs Requested for Initial Budget Period
(e.g., Direct Costs: $50,000)
(e.g., Total Costs: $70,000)
Costs Requested for the Entire Budget Period
(e.g., Direct Costs: $212,323)
(e.g., Total Costs: $297,252)
Applicant Organization
(full address)
2. Form Page 2
Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.
List the performance sites where the core activities and services will be conducted.
Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.
3. Form Page 3
Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.
4. Budget Pages (PHS 398 Form Pages 4 and 5)
Prepare a detailed budget and justification for the core Form Pages 4 and 5 of the PHS 398
5. Biographical Sketches
Do not place biographical sketches here; they are placed together at the end of the overall application.
6. Resources Format Page
Provide information on resources available for the core.
7. Core Research Plan (Items 2-5 cannot exceed 5 pages for the Administrative Core, 10 pages for each Scientific Core, and 10 pages for the [optional] Discretionary Fund Management Core.)
8. Appendix
Do not place a separate appendix here. All appendix materials should be collated as one body of material at the end of the application as described above.
3. Submission Dates and Times
Applications
must be received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date: June 16, 2008
Application Receipt Date: July 15, 2008
Peer
Review Date: November, 2008
Council
Review Date: January, 2009
Earliest
Anticipated Start Date: April, 2009
3.A.1. Letter of
Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
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.
The letter of intent is to
be sent by the date listed In Section IV.3.A.
The letter of intent
should be sent to:
Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular
mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-9369
FAX: (301) 480-2408
E-Mail: pmehrotra@niaid.nih.gov
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms found in the PHS 398 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)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular
mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 435-9369
FAX: (301) 480-2408
E-Mail: pmehrotra@niaid.nih.gov
3.C. Application
Processing
Applications must be received
on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date,
the application may be delayed in the review process or not reviewed. Upon
receipt, applications will be evaluated for completeness by the CSR and
responsiveness by the reviewing institute.. Incomplete and/or
non-responsive applications will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.
Information on the
status of an application should be checked by the Principal Investigator in the
eRA Commons at: https://commons.era.nih.gov/commons/.
4.
Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants
Policy Statement.
Pre-award costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing renewal award if such
costs: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing renewal award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements and Information
Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A. “Award Administration Information”.
Research Plan Page Limitations
See Section IV.2. ”Content and Form of Application Submission” for Research Plan page limitations for the individual ACE components.Resource Sharing Plan(s)
NIH considers the
sharing of unique research resources developed through NIH-sponsored research
an important means to enhance the value of, and advance research. When
resources have been developed with NIH funds and the associated research
findings published or provided to NIH, it is important that they be made
readily available for research purposes to qualified individuals within the
scientific community. If
the final data/resources are not amenable to sharing, this must be explained in
Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1.
Criteria
Only
the review criteria described below will be considered in the review process.
2. Review
and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NIAID in
accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/)
using the review criteria stated below.
As
part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Review
Criteria for the Overall Application
The following items will be considered in the determination of overall scientific merit and priority score for the entire application:
Overall score: a single numerical priority score will be assigned to the whole application after consideration of all of the elements. The overall score for the application will be based primarily on the scientific merit of the individual components, with additional consideration of the overall synergy and integration of all the components, the overall program organization, and the capabilities of the associated personnel. The overall score will depend on the perceived ability of the proposed work to advance development of therapies for autoimmune diseases. The clarity and completeness of the application’s combined components with regard to specific goals, proposed feasibility, and progress towards stated goals are critical.
An application with fewer than 2 scored required Research Projects and the required Clinical Component will be considered "not recommended for further consideration" (NRFC).
Review criteria for the overall application:
Review Criteria for the Clinical Component, Individual Research Projects, and the Pilot Research Project
Significance: Does this study address an important
problem? If the aims of the application are achieved, how will scientific
knowledge or clinical practice be advanced? What will be the effect of these
studies on the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field? What
is the likelihood that the results of the proposed mechanistic research study
will be translated into new approaches for treatment and prevention of
autoimmune disease?
Approach: Are the conceptual or clinical
framework, design, methods, and analyses adequately developed, well integrated,
well reasoned, and appropriate to the aims of the project? Does the applicant
acknowledge potential problem areas and consider alternative tactics? Is there a focus on human
autoimmune disease? If animal studies are proposed to study human autoimmune
disease, is that animal disease an excellent model for human disease? Are
there clear paths to translating findings from animal studies to humans? For
clinical studies involving human samples, is the rationale for the relevance of
the proposed clinical study to human autoimmune disease sound and with high
impact?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the
investigators appropriately trained and well suited to carry out this work? Is
the work proposed appropriate to the experience level of the principal
investigator and other researchers? Does the investigative team bring
complementary and integrated expertise to the project?
Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
In addition to the above criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.
Clinical Component: Is there evidence of ability to perform and participate in clinical trials and associated mechanistic studies? Have potential participants for clinical trials for selected autoimmune diseases been appropriately identified? Are adequate resources available to assist in the conduct of clinical trials, including availability of dedicated clinics, established clinical trial units, or other clinical infrastructure support? Have successful collaborations among basic and clinical scientists been established to facilitate the translation and interpretation of basic and applied scientific knowledge of autoimmune disease into sound clinical trials? Are the rationale and scientific merit of the proposed clinical trials sound and with high scientific merit? Is there potential for the clinical trial to advance the treatment or prevention of autoimmune disease?
Pilot Research Project: Are the plans to monitor success of the Pilot Research Project adequate? Is it feasible to achieve the research goals in 18 months?
The Pilot Research Project will be of least consideration in the overall score for the Center’s application.
Review Criteria for Cores
Administrative Core
Scientific Cores (if applicable)
2.A. Additional