and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Allergy and Infectious Diseases (NIAID) |
|
Funding Opportunity Title |
Autoimmunity Centers of Excellence, Clinical Research Program (UM1) |
Activity Code |
UM1 Multi-Component Research Project Cooperative Agreements |
Announcement Type |
Reissue of RFA-AI-08-010 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-AI-12-059 |
Companion Funding Opportunity |
RFA-AI-12-060, Autoimmunity Centers of Excellence, Basic Research Program (U19) |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.855, 93.856 |
Funding Opportunity Purpose |
This FOA solicits applications to participate in the Autoimmunity Centers of Excellence (ACE) program, a cooperative network intended to improve the understanding and treatment of autoimmune diseases (www.autoimmunitycenters.org). The ACE program was founded on the premise that collaboration among basic and clinical scientists can accelerate both fundamental and applied research. For this reissued, the formerly integrated Centers are divided into Basic and Clinical research programs. This FOA solicits applications for the Clinical research program; a companion FOA solicits applications for the Basic research program. The members of the Basic and Clinical ACE will work together to design and conduct studies of mechanisms of action of immune-modulating agents tested in clinical trials. A program director/principal investigator (PD/PI) may NOT apply to both this ACE Clinical program FOA and the companion Basic program FOA. |
Posted Date |
January 15, 2013 |
Letter of Intent Due Date(s) |
May 13, 2013 |
Application Due Date(s) |
June 13, 2013 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
October, 2013 |
Advisory Council Review |
January, 2014 |
Earliest Start Date |
May, 2014 |
Expiration Date |
June 14, 2013 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS 398 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
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The ACE was founded in 1999, recompeted and expanded in 2004, and revised and recompeted in 2009. The ACE fosters collaborations among basic and clinical scientists with the goal of advancing our understanding of autoimmunity and accelerating the development of improved therapies for autoimmune diseases. Such collaborations have been productive but they are also difficult to create. This reissued FOA divides the ACE program into 2 components -- Basic and Clinical -- to better align grant awards with responsibilities. The Basic research program will provide a solid scientific foundation and will conduct advanced investigations into human immunology. The Clinical research program will develop and conduct Clinical Projects: clinical trials with integrated mechanistic studies. The members of the Basic and Clinical programs will work closely together to fully develop and conduct Clinical Projects.
Clinical trials with integrated mechanistic studies that are designed to "utilize materials and data from clinical trials to elucidate underlying mechanisms of drug activity and immune response" were advocated in the 2005 Autoimmune Diseases Research Plan by the Trans-NIH Autoimmune Diseases Coordinating Committee. The Plan also acknowledged that clinical trials are lengthy, risky, and expensive, conceding "many agents that show promising results in preclinical studies do not advance to clinical trials" and noting that new treatments are sometimes discovered "when practitioners identify new uses for medications originally approved for other conditions". The importance of informative clinical trials in developing new therapies and evaluating existing therapies was also emphasized by expert panels convened by the Institute of Medicine, most recently by a panel convened in November 2011 ("Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020" pre- publication Clinical Trials Workshop Summary). Well-designed clinical studies of immune modulating agents can be fundamentally informative whether or not an investigational agent ultimately advances to licensure and clinical practice.
The purpose of this FOA is to solicit applications for the reissuance of the Autoimmunity Centers of Excellence (ACE) program. The goal of the ACE is to conduct insightful analyses of human immunology within and among collaborative Centers and especially in the context of Clinical Projects, i.e., clinical trials with integrated mechanistic studies. For this reissuanc, the formerly integrated Centers are divided into Basic and Clinical research programs. This FOA solicits applications for the Clinical research program; a companion FOA (RFA-AI-12-060) solicits applications for the Basic research Program. The members of the Basic and Clinical ACE will work together after award to design, fully develop, and conduct studies of mechanisms of action of the immune-modulating agents being tested in clinical trials with integrated mechanistic studies.
A Clinical ACE possesses the following Components:
Center Research Agenda (Program Overview): Applicants must set forth their perspectives on the fields of autoimmune disease research and therapy in a Center Research Agenda. This should include the theme and goals of the Center, the most important questions to be answered, and a description of how the work of the Center will answer these questions. Also the applicants should discuss how the Projects proposed within this application relate to the Center’s Research Agenda, how they would receive benefit from the ACE collaboration, and how they would benefit the ACE.
Clinical Projects: Each applicant must propose two Clinical Projects (clinical trials with integrated mechanistic studies) designed to advance our understanding of autoimmune disease in humans. "Clinical trial" is defined for this FOA as a medical research study in humans to evaluate the effects of one or more interventions for treatment of an autoimmune disease. Mechanistic studies are supplements to clinical trials and are designed to improve the understanding of the mechanism of action of the intervention. In addition to assessing practical questions about the intervention, such as whether the targeted cell or molecule has been affected, these studies should also be designed to address fundamental questions about human immunology. These Projects should not be fully developed in the application but must be ready to be fully developed by the entire ACE after award. The Clinical Projects will consist of:
a. Primary Clinical Project: The Primary Clinical Project must be ready to enter into full development soon after award.
b. Alternate Clinical Project: The Alternate Clinical Project must be ready to enter into full development within a year of award.
Collaborative Project (optional): An applicant to the Clinical program may propose a single Collaborative Project to test at least one specific hypothesis on the nature of human autoimmunity, exploit particular strengths of the applicant, and be designed to engage other members of the ACE after award. The Aims should exceed the reach of a single investigator and produce a greater-than-additive return. It is recognized that applicants will NOT know in advance with whom they will be collaborating because the members of the ACE will not be known before award; therefore, applicants should make reasonable assumptions as to the types of collaborations that will be available and build some flexibility into their research plans. The Collaborative Project must include a 5 year research plan with scope and Specific Aims consistent with the goals of the ACE and annual benchmarks for evaluating progress. The ACE will fully develop the Collaborative Projects after award and they will become part of the ACE Research Agenda (see below).
Administrative Core: The Administrative Core should include the following information: a Staffing and Administrative Plan to facilitate the objectives of the proposed Center; the managaement experience, level of commitment, and availability of the PD(s)/PI(s), and Project and Core Leaders; the plans for coordination, problem identification and resolution and the establishment of a strong collaborative environment; timelines, milestones and performance objectives for the overall Center; and a management plan for fiscal accountability and communication within the Program.
Applicants must request funds and justify their use to coordinate the Center activities.
ACE Funds Management Core (optional): The ACE program will be awarded a Clinical Project Fund (CPF) for support of the Clinical Projects, and an Opportunity Fund (OF) for support of the Collaborative Projects and additional studies required for achieving the aims of the ACE Research Agenda. Applicants may propose an ACE Funds Management Core to administer the CPF and OF on behalf of the entire group.
The ACE will coordinate its activities through a Steering Committee, which will formulate an ACE Research Agenda and manage resources to complete the Agenda. These elements are described below.
ACE Program: The ACE Clinical and Basic programs will interact through the following elements:
Steering Committee: The work of the ACE will be coordinated by a Steering Committee formed with the PDs/PIs of the Basic and Clinical programs. The Steering Committee will, within 6 months of award, collaboratively formulate the ACE Research Agenda and post it on the public website (www.autoimmunitycenters.org). The Steering Committee will execute the Agenda by fully developing and conducting Clinical Projects and Collaborative Projects and managing resources, including reviewing applications to the Clinical Projects Fund and Opportunity Fund. The Steering Committee will monitor work and post on the public website an annual report on the progress toward the goals of the Agenda.
ACE Research Agenda: The Steering Committee will formulate an ACE Research Agenda that includes overarching themes, goals, and approaches for the period of award. The Agenda should incorporate the best ideas from the individual Centers' Research Agendas as well as the Collaborative Projects and the Clinical Projects.
Plenary Meeting: The ACE will convene an annual plenary meeting to develop collaborations among the investigators. The aims and status and highlights of all projects from all Centers will be presented in brief talks. All key personnel, including project leaders, are expected to attend and participate. The initial plenary meeting will be held in Bethesda, Maryland soon after award.
These elements will help enable, coordinate, and direct collaborations among the Centers and Projects.
The objectives of the ACE are to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases. The ACE approaches these objectives by conducting cooperative basic, clinical, and mechanistic studies, fostering intellectual and material collaborations among basic and clinical scientists, and facilitating the study of clinical samples by basic research scientists. These approaches are expected to identify common and distinct mechanisms in the pathogenesis of autoimmune diseases.
Research Scope: All projects must investigate autoimmune disease in humans.
Clinical Projects: Clinical Projects developed by the ACE must be innovative and propose clear, testable hypotheses on underlying mechanisms. Mechanisms of interest include the intervention, the disease, and immunity in general. The proposed Clinical Projects may aim to generate initial evidence of efficacy and mechanism, using resources appropriate to the scope of the ACE network.
Types of trials that may be proposed include but are not limited to the following:
Clinical Projects of particular interest to the ACE include but are not limited to the following:
The ACE Clinical Projects will NOT support:
Note: Applications that propose research in these areas are nonresponsive and will not be reviewed.
Collaborative Project (optional): The Collaborative Project may use samples from previously completed clinical trials but they may not support a clinical trial. For these Projects, specific areas of interest include, but are not limited to:
The ACE Collaborative Projects will NOT support:
Note: Applications that propose research in these areas are nonresponsive and will not be reviewed.
Statistical, Data Management, Pharmacy, and 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 Cooperative Agreement Terms and Conditions of Award Collaborative Responsibilities.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the PHS 398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
NIAID anticipates awarding up to $1.2 million in direct costs in FY 2014 to fund up to 4 new or renewal grants within the ACE Clinical program. Additional funds will be awarded to support the Clinical Project Fund and an Opportunity Fund. Future year amounts will depend on annual appropriations. |
Award Budget |
Applicants to the ACE Clinical program can request up to $700,000 (direct costs) each per year for the Primary and Alternate Clinical Projects. It is anticipated that this FOA will fund successful applicants up to $50,000 per year direct costs for planning further development of successful Clinical Trial Projects. It is anticipated that Funds for implementing the full Clinical Trial Projects will be provided by the ACE Funds Management Core. In addition, applicants can request up to $50,000 per year in direct costs for the Administrative Core. Applications containing an optional Collaborative Project may request up to $250,000 per year in additional direct costs. Support for the optional ACE Funds Management Core is limited to $250,000 per year in direct costs. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 5 years. |
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not 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.
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 least 6 weeks prior to the application due date.
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 Application Guide.
Each individual Project and Core must be led by a single Project or Core Leader. Multiple PDs/PIs for projects and cores are not allowed.
An individual may serve as PD/PI on an application to either this ACE Clinical program FOA or the companion Basic program FOA but not both. PD(s)/PI(s) should commit at least 2.4 person months effort (total for multiple PDs/PIs). A PD/PI may lead no more than one of the proposed Projects. The PD/PI (or one of the PDs/PIs if multiple PDs/PIs) should also lead the Administrative Core.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. The same institution may also apply to the companion FOA. A single PD/PI, and PDs/PIs on a multiple-PD/PI application, may NOT also serve as PDs/PIs on an application to the companion FOA.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS 398 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 plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Priti Mehrotra, M. Sc., Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
(NIAID)
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Telephone: 301-435-9369, 301-496-2550
Fax: 301-480-2408
Email: [email protected]
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:
All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, with the following limitations to the Research Strategy section of each component of the application:
The following section supplements the instructions found in Form PHS 398 for preparing a multi-project grant application. Additional instructions are required because the Form PHS 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 multi-component grant application should be assembled and paginated as one complete document in the following order:
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
Form Page 1 - Face Page (Center Research Agenda)
Complete items 1 14 as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.
Form Page 2. Summary, Relevance, Project/Performance Site, Senior/Key Personnel, Other Significant Contributor, and Human Embryonic Stem Cells (Center Research Agenda)
Description: Using PHS 398 Form Page 2; provide a succinct but accurate description (abstract) of the OVERALL multi-component application addressing the major, common theme of the program. Do not exceed the space provided.
Project/Performance Site: List the performance sites where the research will be conducted.
Senior/ Key Personnel: Under "Key Personnel", list the PD/PI(s) of the application, followed by the Leaders of the Projects and Cores, and co-investigators.
Form Page 3 - Table of Contents (Center Research Agenda)
Do NOT use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.
Bearing in mind that the application will be scientifically reviewed component by component, 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 research project and core. Further, each component should be identified by number (e.g. Component 1), title, and responsible Leader. Provide the page numbers for the budgets of each component. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."
ITEMS (in order of appearance in application) |
Application Package Cover Letter (optional). The cover letter is not provided to reviewers. |
Face Page (use PHS 398 Form Page 1). This is the first numbered page of the application; number all succeeding pages consecutively. |
Program Description (use PHS 398 Form Page 2) Project/Performance Sites, Senior Key Personnel and Key Personnel, Other Significant Contributors, Human Embryonic Stem Cell statement if applicable. |
Table of Contents (do NOT use PHS 398 Form Page 3; Instead, use a Continuation Format Page and follow instructions above) |
Composite Budget for Entire Proposed Project Period (do NOT use PHS 398 Form Page 4). Instead, use a Continuation page. See example and follow instructions below. |
Center Research Agenda (Program Overview) including progress report for renewal applications) |
Note: For each Project and Core below, include a Cover Page (described below) and other information as described below under specific headings. |
Primary Clinical Project |
Alternate Clinical Project |
Collaborative Project (optional) |
Administrative Core |
Funds Management Core (optional) |
Appendix |
Biographical Sketches (Biographical Sketch Format Page). Provide biographical sketches of all senior/key professional personnel here. Place PD/PI biographical sketch(es) first, followed by those of other senior/key personnel in alphabetical order. |
Checklist (Checklist Form Page, last page of application) |
PHS 398 Form Page 4 and 5 Composite
Budget (Center Research Agenda)
Do NOT use PHS 398 Form Page 4. Instead, use the suggested format presented below to prepare a Composite Budget for All Proposed Years of Support. (Justification for budget items should NOT be presented here but instead in the individual budgets of the projects and cores.)
SAMPLE: Consolidated Budget; Direct Costs for All Proposed Years of Support. Add additional Cores as appropriate to this FOA.
Cost Categories |
Yr 1 |
Yr 2 |
Yr 3 |
Yr 4 |
Yr 5 |
All Years |
Primary Clinical Project |
$700,000 |
$700,000 |
$700,000 |
$700,000 |
$700,000 |
$3,500,000 |
Alternate Clinical Project |
$700,000 |
$700,000 |
$700,000 |
$700,000 |
$700,000 |
$3,500,000 |
Collaborative Project (optional) |
$200,000 |
$200,000 |
$200,000 |
$200,000 |
$200,000 |
$1,000,000 |
Administrative Core |
$50,000 |
$50,000 |
$50,000 |
$50,000 |
$50,000 |
$250,000 |
Total |
$1,650,000 |
$1,650,000 |
$1,650,000 |
$1,650,000 |
$1,650,000 |
$8,250,000 |
Notes:
The Center Research Agenda, does not have its own budget. If an ACE Funds
Management Core, the (optional) Funds Management Core B, is proposed, provide
the budget only within its description (see below), not here.
Biographical Sketch Format Page (Center Research Agenda)
Do not include here. Biographical sketches of all professional personnel for all components should be placed together at the end of the application with the PD/PI first, followed by those of other key personnel in alphabetical order.
Resources Format Page (Center Research Agenda)
Do not include here. Essential information is to be presented in the individual research project and core sections of the application as applicable.
Research Plan (Center Research Agenda)
Specific Aims: List the Specific Aims of the Center focusing on the overall research agenda and strategic plan.
Research Strategy: This narrative section summarizes the overall research plan for the multi-project application and explains how the proposed Program satisfies the purpose and all objectives of this FOA as outlined in Section I. Set forth your perspectives on autoimmune disease research and therapy. State the most important questions to be answered, and explain how the work of their proposed Center would answer these questions. Also describe how the projects proposed within this application would receive benefit from the ACE collaboration and how they would benefit the ACE. The Center Research Agendas will become parts of the ACE Research Agenda.
Applicants should describe the central theme of the proposed Program and explain how the proposed Principal, Pilot, and Collaborative Projects fit under the overarching Program theme. Summarize the special features in the environment and/or resources that make this application strong or unique. If possible, provide evidence that the investigators have experience in developing and conducting collaborative clinical trials with integrated mechanistic studies, highlight accomplishments in the field and describe the synergy and collaborations that occurred.
Applicants should also describe the plans and processes for setting scientific priorities and integrating new opportunities. Also discuss the standards, criteria, processes and timelines for evaluating and funding research projects, assessing productivity/continued relevance, discontinuing projects when necessary, and reallocating research funds. Provide plans and metrics for evaluating overall Center performance and productivity.
Progress Report: (Required for renewal applications; not applicable for new applications.)
If the application is a renewal, this section should also highlight past performance and the major accomplishments from the prior funding period as described in the PHS 398 Instructions. In addition to discussing results from individual projects, describe the synergy and collaborations that occurred within the Program. For individual research projects and cores that will be continued as part of a renewal application, additional details should be provided in the progress report section of the Research Strategy within each research project and core
Advisory Committee: (optional) If the application proposes to appoint an advisory committee, describe the expertise and responsibilities of the potential committee members. For a new application, do NOT contact, recruit, or name potential members. For a renewal application, provide the names of current and former members.
Leadership Succession Plan: Provide a brief plan in the case the PD/PI moves to a different institution or is for any reason unable to continue as leader of the program.
Resource Sharing Plan
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 modification:
Checklist (Center Research Agenda)
One checklist, placed at the end of the application, is to be submitted for the entire application.
Repeat this section for each of the two required Clinical Projects and the optional Collaborative Project. Except for the requirements below, follow the PHS 398 Specific Instructions in preparing each research project.
Cover Page (Clinical and Collaborative Projects)
The Face Page of the 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 selected data about each individual project (do NOT use the PHS 398 Face Page Form). This Cover Page will demarcate each project and should contain the following information items:
Project Number and Title: (e.g., Project 1. Immune modulators in Lupus )
Name of Project Leader: (e.g., Jones, Roberta A.);
Human Subjects: (Yes or No) If Yes: Exemption number, -or- IRB Approval Date (e.g., 12/13/2012,or "Pending"), and Federalwide Assurance (FWA) number;
Vertebrate Animals: (Yes or No) If Yes: IACUC Approval Date (e.g., 11/17/2012, or Pending) and Animal welfare assurance number
Proposed Period of Support:
Costs Requested for Initial Budget Period: (e.g. 09/01/2014-08/30/2015)
Costs Requested for the Entire Budget Period: (e.g., 09/01/2014-08/30/2019)
Applicant Organization (Organization name; Street address; City, State, Zip code)
Form Page 2. Summary, Relevance, Project/Performance Site, Senior/Key Personnel, Other Significant Contributor, and Human Embryonic Stem Cells (Clinical and Collaborative Projects)
Description: Provide a brief Description (abstract) of the individual component according to the instructions on Form Page 2 of PHS Form 398. The abstract should explain how the individual research components will contribute towards attainment of the multi-project Program objectives.
Project/Performance Sites: List the performance sites where the research will be conducted.
Key Personnel: Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.
Form Page 3 Table of Contents (Clinical and Collaborative Projects)
Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.
Form Page 4 and 5. Detailed Budget for Initial Budget Period (Clinical and Collaborative Projects)
Prepare a detailed budget and justification for the project using Form Pages 4 and 5 of the PHS 398. Follow the Project-specific budget instructions below.
Clinical Projects (Primary and Alternate): The costs of developing and performing clinical trials and integrated mechanistic studies must be estimated and provided in the application. Applicants may request up to $50,000 in direct costs for core funds to support the initial development of the Primary Clinical Project; after year 1, these funds should be used either to offset costs of an active Clinical Project or to support the initial development of subsequent Clinical Projects. The full costs of the Clinical Projects approved for development will be paid by the Clinical Project Fund that will be awarded separately. Clinical projects may propose budgets averaging up to $700,000 direct costs per year. Prepare a detailed budget and justification using Form Pages 4 and 5 of the PHS 398. Budgets should be based on per patient costs and include the other costs of performing the trial (clinical research tests, coordinator and PD/PI time, drug costs if applicable, pharmacy costs, mechanistic study costs, etc.). The costs for data collection and management, statistical support and monitoring and other costs associated with trial management will be covered by the Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) as detailed below. Full development will begin soon after award, with the involvement of the other ACE grantees and the help of NIAID staff and SACCC. After award, additional funds to support the development and implementation of clinical trials and associated mechanistic studies may be requested from the ACE Steering Committee and provided by Clinical Project Fund (see Section VI).
Collaborative Project: Applicants may request up to $250,000 direct costs to support an optional Collaborative Project. The budget should reflect the anticipated costs of the proposed collaborations. A direct award will be made but the final budget for the collaborative project will be decided after the ACE Research Agenda has been developed. Additional funding will be determined post-award and will be guided by the final form of the ACE Research Agenda.
Research Plan (Clinical and Collaborative Projects)
Primary and Alternate Clinical Projects
This section describes the required Primary and Alternate Clinical Projects.
Keep in mind that both Clinical Projects should be ready for full development. Development of the Primary Clinical Project will begin as soon as possible after award and involve the entire ACE in the design and performance of the clinical trial and the mechanistic studies. The timing of the development of the Alternate Clinical Project will depend in part on the progress and scope of the Primary Clinical Project.
The two Clinical Projects must have different leaders and they must address different diseases, though they may be within one clinical specialty. The Clinical Projects will be phased for development by the Steering Committee.
Specific Aims: List in priority order, the broad, long-range objectives and goals of the Clinical Project. Concisely and realistically describe the hypothesis or hypotheses to be tested.
Research Strategy: Use this section to describe how the proposed research will contribute to meeting the Program goals and explain the approach and rationale for selecting the methods to achieve 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.
Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new projects must be included as part of the approach section, and must be contained within the page limits of the Research Strategy section.
For each Specific Aim, provide details about the approach, the planned experiments, anticipated results and alternative approaches. Explain how the results will be interpreted (e.g., what would support your hypothesis? What would disprove it?). This section should include:
Clinical Trial: Separately, for both the Primary and Alternate clinical trials, include a detailed discussion of the rationale and methods for objectives that are primarily clinical. The proposed studies must not exceed the clinical and scientific resources of the applicant’s team of institutions (e.g., the applicant group must be able to recruit the required number of study subjects from within their collaborating institutions) and must not exceed 5 years in duration.
The Clinical Trial studies must include the following information:
Study title
Hypothesis
Study objectives (primary, secondary; include mechanistic objectives)
Population
Study eligibility criteria
Intervention(s) and comparators
Clinical study design
Feasibility Assessment:
The Clinical Trial studies should be presented in sufficient detail to allow reviewers to judge significance, approach, innovation and environment. Do not submit a detailed, final clinical protocol because it will be developed collaboratively within the ACE post-award.
To help overcome enrollment challenges, applicants are encouraged to adopt recommendations of the Institute of Medicine expert panels (Clinical Trials Workshop Summary), including:
Collaborative Project
This section describes the option Collaborative Project.
Specific Aims: List 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 individual research project's relationship to the Program’s goals and how it relates to other projects or cores. The Collaborative Project should propose Specific Aims that test at least one hypothesis on the nature of human autoimmunity.
Research Strategy: 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.
Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.3. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. Preliminary Studies for projects should be included as part of the approach section, and must be contained within the page limits of the Research Strategy section.
The Collaborative Project must be closely related to the overarching theme of the applicant's proposed Center. Applicants should provide a research plan that exploits not only the applicant's strengths but will also benefit from the expertise of members of the network. It is recognized that applicants will NOT know in advance with whom they will be collaborating because the members of the ACE will not be known before award; therefore, applicants should make reasonable assumptions as to the types of collaborations that will be available and build flexibility into their research plans. For example, applicants may start from their own specific expertise and disease focus and seek to generalize observations and mechanisms to other autoimmune diseases. This could be accomplished with collaborators who have complementary strengths and skills. The Collaborative Project must be coherent but it may lack some details if they can be reasonably developed with additional ACE collaborators after award.
Applicants should provide evidence of their success in previous collaborations (publications, patents, etc.) in the form of an annotated bibliography.
The Collaborative Projects will be fully developed after award and conducted with other members of the ACE. They will be integrated into an ACE Research Agenda. The Collaborative Project should include:
Letters of Support: Documentation of availability of interventional agent. A letter of collaboration from a pharmaceutical company to assure the company’s interest in participation from a business as well as a medical perspective is recommended. The letter of collaboration should include a statement of willingness (1) to share the Investigator’s Brochure and (2) to write a cross-reference letter for the IND submission.
Resource Sharing Plan
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 modification:
Resources Format Page (Clinical and Collaborative Projects)
Provide information on resources available for the project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site.
Describe any special facilities used for working with biohazards or other potentially dangerous substances in the US and at non-US sites.
Biographical Sketch Format Page (Clinical and Collaborative Projects)
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
Appendix
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 Guide, with the following modification:
The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual. For all other items in the core application, follow the usual PHS 398 instructions.
Cover Page (Administrative and ACE Funds Management Cores)
The Face Page of the 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the 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 (which are a subset of the information provided on a Face Page - see PHS 398):
Core Letter and Core Title: (e.g., Core A. Administrative )
Name of Core Leader: (e.g., Smith, Robert A.)
Human Subjects (Yes or No) If Yes, Exemption Number, -or-IRB Approval Date (e.g., 5/14/12, or Pending), and Federalwide Assurance (FWA) number;
Vertebrate Animals (Yes or No) If Yes, IACUC Approval Date (e.g., 4/15/12, or Pending), and Animal welfare assurance number;
Proposed Period of Support
Costs Requested for Initial Budget Period
Costs Requested for the Entire Budget Period
Applicant Organization (Organization name; Street address; City, State, Zip code)
Form Page 2. Summary, Relevance, Project/Performance Site, Senior/Key Personnel, Other Significant Contributor, and Human Embryonic Stem Cells (Administrative and ACE Funds Management Cores)
Description: Provide a brief Description (abstract) of the core according to the instructions on Form Page 2 of PHS Form 398. The abstract should explain how the core will contribute towards attainment of the multi-project Program objectives.
Project/Performance Sites: List the performance sites where the core activities and services will be conducted.
Key Personnel: Under "Key Personnel", list the Core Leader, followed by other key project personnel, and then other significant contributors.
Form Page 3. Table of Contents (Administrative and ACE Funds Management Cores)
Prepare a Table of Contents for the core using page 3 of Form PHS 398.
Form Page 4 and 5. Budget Pages (Administrative and ACE Funds Management Cores)
Provide a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.
See below for Core-specific instructions.
Administrative Core: Applicants must request at least 1.2 person months effort by the PI(s). Clinical ACE applicants may request up to $50,000 direct total costs for supporting key personnel, including those required to coordinate development of Clinical Projects. Additional effort will be budgeted as required after award during Clinical Project development and paid by the Clinical Project Fund. Funds should also be budgeted for attending the twice-yearly Steering Committee face-to-face meetings, one of which will overlap with the annual ACE plenary meeting held in the Bethesda MD area.
ACE Funds Management Core (optional): Applicants may also request support for a Funds Management Core to administer the Clinical Project Fund and Opportunity Fund. This Core should be headed by a Leader committing at least 1.2 person months effort. The budget for this Core must be entirely separate from the other elements. The plans and budget should be scaled to administer 60 contracts with 30 different sites amounting to $5M annually. In the proposed budget for the Funds Management, please include the Facilities and Administrative (F&A) costs that will be incurred by the institution to administer each consortium agreement in accordance with the Institution s negotiated F&A Rate Agreement. The proposed budget for the FM Core must be provided and is not to be included in the total budget of the Center.
Research Plan (Administrative and ACE Funds Management Cores)
Administrative Core
This section describes the required Administrative Core.
Specific Aims: List in priority order the broad, long-range objectives and goals of the Administrative Core. In addition, state the Core's relationship to the Program’s goals and how it relates to assisting the other elements in the application.
Research Strategy: Organize the Administrative Plan in the specified order as stated in the PHS 398 Instructions, Section 5.5.
ACE Funds Management Core (optional)
This section describes the optional ACE Funds Management Core.
Specific Aims: An annual award will be made to a single Center to support an ACE Clinical Projects Fund (CPF) and an Opportunity Fund (OF), both administered by an ACE Funds Management (FM) Core at the Center. List in priority order the broad, long-range objectives and goals of the Funds Management Core. In addition, state the Core's relationship to the goals of the ACE.
Research Strategy: Applicants proposing a Funds Management Core must submit a plan to fulfill the responsibilities associated with the disbursement, administration and reporting on the use of the funds, including but not limited to the following:
In addition,
Describe the experience of the proposed Funds core managers and environment, including:
Resource Sharing Plan
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 modification:
Resources Format Page (Administrative and ACE Funds Management Cores)
Provide information on resources available for the core. Describe how the scientific and/or administrative environment in which the work will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) For Early Stage Investigators, describe institutional investment in the success of the investigator. If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.
Biographical Sketch Format Page (Administrative and ACE Funds Management Cores)
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
Appendix
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 Guide, with the following modification:
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
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
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 and responsiveness by NIAID, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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
review system.
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 project proposed).
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 Center that by its nature is not innovative may be essential to advance a field.
Significance
Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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 Center’s Research Agenda as a whole scientifically compelling? Are the Center’s overall goals, as articulated in the Center Research Agenda, significant and how well do they address key roadblocks to the development of treatment for two different autoimmune diseases? Does the application have a high likelihood of developing critical new knowledge about autoimmunity in humans, as well as underlying mechanisms and therapeutic effect for multiple diseases?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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? Do the applicants and collaborators have appropriate experience developing and conducting clinical research projects? Have the applicants provided evidence of any successful prior collaborations? Does the PD/PI have documented experience in directing large, complex, integrated and multifaceted clinical research activities and will the PD(s)/PI(s) devote adequate time and effort to the program? Are the qualifications, competence, and key clinical, scientific and technical personnel appropriate?
Innovation
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?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the Center involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Are the plans and processes for setting scientific priorities and integrating new opportunities sound, appropriate and feasible? Are there sound, appropriate and feasible standards, criteria, processes and timelines for evaluating and funding research projects, assessing productivity/continued relevance, discontinuing projects when necessary, and reallocating research funds? Are plans and metrics for evaluating overall Center performance and productivity sound, appropriate and meaningful? Are plans for the overall operation, succession planning, management and coordination of the Center appropriate?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Reviewers will consider the review criteria below for each Component in the determination of scientific merit, and give a separate score for each Component.
Center Research Agenda
Clinical Projects (Primary & Alternate)
Significance of the clinical trial
Adequacy of the experimental design of the trial and mechanistic studies:
Plans for Patient Recruitment/Retention
Investigators
Collaborative Project (if proposed)
Administrative Core
As applicable for the Center, Project, or Core proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed Center, Project, or Core involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
For Renewals, the committee will consider the progress made in the last funding period. .
Revisions
Not Applicable.
As applicable for the Center Research Agenda, Project, or Core proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Fund Management Component (if proposed)
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIAID, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted response to this FOA..
Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council . The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
The following special terms of award are in addition to, and not in lieu of, other applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The NIAID reserves the right to terminate or curtail a study or any individual award in the event of: (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol; (b) substantive changes in the consensus protocol to which the NIAID does not agree; (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance; or (d) human subject ethical or safety issues that may dictate a premature termination.
An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist. The program official will monitor program progress, approve changes, and have access to data generated under these awards. NIAID staff may use the information for the preparation of internal reports on the activities of the group.
The PD(s)/PI(s) will have the primary responsibility for:
Federally Mandated Regulatory Requirements for Clinical Trials
Each institution participating in a clinical trial is required to meet DHHS regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include:
Data Sharing
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees are expected to be committed to making the biological samples, diagnostic products, and other research tools, methods, data, and materials that are developed under the ACE awards available to other members of the ACE and to the research community. For data sharing information, see: NIH Data Sharing Policy.
Intellectual Property
The awardee is solely responsible for the timely acquisition of all appropriate propriety rights, including intellectual property rights, and all materials needed for the awardee to perform the project.
Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any propriety rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act). Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID, or other mechanisms.
Clinical Trial Development Fund & Opportunity Fund Management
Clinical Trial Development & Opportunity funds will be awarded to one ACE institution that will be responsible for managing the Funds. This institution must agree to take responsibility for managing the funds, including the disbursement, administration, and reporting on the use of Opportunity funds as approved by the Steering Committee. Fund expenditures will be restricted until a process for the prioritization, solicitation, review and evaluation of projects and the disbursement of funds is established and agreed upon in writing by the Steering Committee. Once this process is established, funds will be available for distribution.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NIAID staff assistance will be provided by a DAIT Program Official and Project Scientists along with other NIH staff. These staff will be identified at the time of award and their roles and responsibilities will be addressed in the NoA. These staff members will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond the normal program stewardship role for grants, including but not limited to the following:
Trial Sponsorship. NIAID staff will have the option to independently file an IND on investigational agents or an IDE on investigational devices evaluated in NIAID-supported clinical studies. NIAID will advise the investigators on the specific regulatory requirements for IND sponsorship. In situations where NIAID is the IND sponsor, NIAID through its contractors will also assemble, review, and submit the required regulatory documents to the FDA. When holding an IND or IDE, NIAID has responsibility for the reporting of safety information in accordance with FDA requirements and preferences. In order to provide for consistent reporting of serious adverse experiences across the NIAID-supported clinical trial Networks, NIAID will provide current policies and procedures that govern the reporting of adverse events in NIAID-supported trials. Final disposition of serious adverse event (SAE) reports will be decided by NIAID staff for all IND studies held by NIAID.
Trial Monitoring. NIAID staff oversees external clinical site monitoring that evaluates GCP, regulatory compliance, protocol implementation, internal quality assurance, and test article accountability at the Network clinical sites. The monitoring contractor, with or without accompanying NIAID staff, will visit ACE clinical sites periodically to review selected protocols, provide training on general protocol conduct, review internal QA/QC plans, and audit pharmacies.
Training. NIAID staff will provide a variety of training activities to appropriate ACE personnel to help ensure that consistent standards for protection of human subjects and clinical trial conduct and documentation are achieved across the NIAID-supported Networks. Training areas include, but are not limited to, regulatory requirements, GCP, adverse event reporting, human subject protections, informed consent, and NIAID and NIH policies and procedures.
Protocol review. NIAID staff will review all protocols and approval is required for initiation. The Program Officer or designee will return comments and recommendations to the ACE protocol team after review. The protocol team must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by NIAID to the satisfaction of NIAID before participant enrollment can begin. If a protocol is disapproved, NIAID will not provide investigational products or permit expenditure of NIH funds for the proposed investigation. If a protocol is not initiated within twelve months of NIAID approval, re-review and approval by NIAID will be required.
Safety Monitoring. NIAID staff will participate in the development of appropriate safety monitoring plans for all planned clinical trials and must approve the plan for all trials involving investigational drugs, devices, biologics, or other clinical interventions. The frequency and intensity of safety monitoring will be based on individual study characteristics and past experience with study products and may require review by an Independent Safety Monitor, Safety Monitoring Committee (SMC) or Data and Safety Monitoring Board (DSMB). NIAID Medical Officers will be part of the organized protocol safety review teams to monitor the safety and efficacy of the intervention(s) for ongoing studies, and will be provided with appropriate reports. Approval of the final monitoring plan, including the composition of the review committee, by NIAID is required prior to study initiation. NIAID independently supports Data and Safety Monitoring Boards (DSMB) that oversee clinical trials at the discretion of NIAID.
Study Termination. NIAID staff reserves the right to terminate or curtail a clinical study for any reason. Examples include, but are not limited to, risks to subject safety, failure to achieve recruitment goals, and reaching a major study endpoint substantially before schedule with persuasive statistical significance
Data Access. NIH has the right of access to all data generated (raw and analyzed) and may periodically review it. This includes data as recorded on the case report forms and in the central databases, and external checking against the original source documentation as required by federal regulation and NIAID as the IND sponsor. NIAID staff may request from ACE protocol teams specific data analysis needed for programmatic activities or for issues related to NIAID plans with other partners. The NIH requires public access to selected data sets generated with the use of public funds within a reasonable time.
Areas of Joint Responsibility include:
Steering Committee
A Steering Committee will be established to coordinate and direct the collaborative work of the ACE. The Steering Committee will formulate an ACE Research Agenda and determine the use of the Clinical Project Fund and Opportunity Fund. The PDs/PIs of the ACE basic and clinical awards, along with a representative of NIAID and a representative of the SACCC-ADCT will be permanent, voting members of the Steering Committee. NIAID may appoint ad-hoc voting members to the SC in order to provide scientific balance. An award with multiple PDs/PIs will share a single vote; a grantee, i.e. institution, with both Clinical and Basic awards would have a vote for each award (2 votes). A Chair of the Steering Committee will be elected by majority vote from among the PIs during the first meeting, which will be convened by the NIAID representative. All major scientific and budgetary decisions will be made by the Steering Committee. To permit comprehensive reporting and informed discussion by the entire Committee, the formation of subcommittees and the delegation to them of discrete responsibilities and authorities is encouraged.
The Steering Committee will meet twice each year in person and monthly by teleconference. Use of internet-enabled collaborative tools, including websites, email, conferencing, web logs (blogs), and community-moderated discussions are encouraged. A public website for the ACE (www.autoimmunitycenters.org) and a password-protected secure site will be maintained by the SACCC-ADCT.
The Steering Committee will:
The Basic research and Clinical translation programs must be willing to work cooperatively and collaboratively both within their ACE and with other members. Clinical Projects will proceed into the implementation stage only with the concurrence of the Steering Committee and the NIAID Project Scientist.
Annual ACE Plenary Meetings
The ACE will hold an annual two-day plenary meeting to share recent findings and facilitate 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. The initial plenary meeting will be held in Bethesda, Maryland soon after award.
Data Coordination and Management
Each awardee will be responsible for providing the NIAID with all clinical trial/study data for management, quality control and analysis, using procedures and standards determined by the Steering Committee. Specific analysis to be performed by NIAID will be directed by the Steering Committee or its designee. The awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS and NIH policies.
The Steering Committee will determine how data from multiple Centers collaborating on a study will be analyzed. Centers wishing to perform their own analysis of local data or of single site studies must obtain approval for the planned analysis from the Steering Committee.
Publication and Presentation of Findings from Clinical Trials, Mechanistic Studies, and Collaborative Projects
The Steering Committee will establish procedures for the publication and oral presentation of results or data collected within the Centers network. The results of any collaborative work must be approved by the Steering Committee before it is made public. Publications and oral presentations of work performed under this agreement should acknowledge support by the Autoimmunity Centers of Excellence and NIAID.
Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the External Advisory Group chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Progress reports should briefly describe the status of pilot projects (awardee-selected projects involving new clinical trials and mechanistic studies), including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
David Johnson, Ph.D.
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-496-7104
Email: [email protected]
Priti Mehrotra, M. Sc., Ph.D.
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-435-9369
Email: [email protected]
John A. Villella
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 301-451-2677
Email: [email protected]
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Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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