EXPIRED
Department of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of
Participating Organizations
National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
Title: Ancillary Studies to Large
Ongoing Clinical Projects (R21)
Announcement Type
New
Request for Applications (RFA) Number: RFA-AR-10-011
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.846
Key Dates
Release/Posted Date: April 29, 2009
Opening Date: July
3, 2009 (Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): July 3, 2009; November 3, 2009; March 1, 2010
NOTE: On-time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization).
Application Due Date(s): August
3, 2009; December 3, 2009; April 1, 2010
Peer Review
Date(s): October/November 2009; February/March
2010; June/July 2010
Council Review Date(s): January 2010; May 2010; August 2010
Earliest Anticipated Start Date(s): January 2010; May
2010; September 2010
Additional
Information To Be Available Date (Activation Date): Not Applicable
Expiration
Date: April 2, 2010
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
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 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. 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. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
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
3.
Reporting
Section
VII. Agency Contacts
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
This FOA solicits grant applications that propose to conduct time-sensitive studies ancillary to privately or publicly funded large ongoing clinical projects. The ancillary studies can address any new research questions related to the mission of NIAMS for which an ongoing clinical trial, observational study or disease registry can provide a sufficient cohort of well-characterized patients, infrastructure, data, or biological samples. The purpose is to provide a flexible mechanism to facilitate the development of meritorious ancillary studies to leverage the established resources offered by the already-funded parent projects and maximize the return on the existing investments in these large clinical studies. Successful ancillary studies will enhance the scientific content and value of the parent projects, improve the understanding of underlying mechanism of a disease or organ system in the NIAMS portfolio, and thus identify novel targets for diagnosis, treatment, and prevention of disease.
This FOA uses the NIH Exploratory/Developmental Research Grant (R21) award mechanism. Applications in response to this announcement will support innovative, ground breaking projects with potential for significant impact. Such projects may also develop novel technology or tools that have the potential to significantly accelerate research fields; or may apply methods, technologies or approaches from outside this field of research in a novel way to conduct an important ancillary study. Projects not suitable for this program are ones specifically to develop preliminary data for longer-term projects in a well established research area, or pilot projects that are less than highly innovative. Projects of limited time and scope that do not meet these characteristics of innovative, ground breaking research should consider applying for a small Research Project Grant (R01) instead, through the accompanying FOA for NIAMS R01 grants for ancillary studies (RFA AR-10-010). The R21 is not a starter grant for new investigators, and such investigators may be better served by applying for an R01 (for the definition of new investigators and additional information on point please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-013.html ). Potential applicants are strongly encouraged to contact the appropriate NIAMS Program Director prior to application to determine the suitability of the project for the R21 mechanism. Preference in funding decisions will be given to projects within NIAMS mission areas that are especially innovative, ground breaking and have a high potential impact on the relevant fields of research.
Background
Clinical studies, whether they are clinical trials, observational studies, or disease registries, often represent a substantial financial commitment from the sponsors and enormous effort from the investigators who establish an infrastructure for patient recruitment, examination, and follow-up. These large clinical projects, particularly clinical trials, offer unique experimental windows to human disease that are largely under-exploited. Additional studies that go beyond the core activities of the original clinical project can explore the research opportunities offered in the established cohorts and generate new information to enhance the scientific content of the original project. Such studies that are not part of the original parent project are referred to as ancillary studies.
Participants at the NIAMS 2008 Scientific Planning Retreat recommended that NIAMS consider strategies to fully explore opportunities to enhance or facilitate the use of ancillary studies in its mission areas. For instance, an ancillary study may begin at any time during the course of the parent project, but ideally should begin in the early stages of the parent project, at least before the recruitment is completed. Once a parent projects clinical protocol is finalized, its investigators often are ready to begin recruiting patients as soon as they obtain Institutional Review Board approval. This time-sensitive feature demands a robust administrative system within NIAMS that is compatible with the timeline of the parent project to avoid any missed research opportunities; an accelerated review and award process would allow the initiation of ancillary studies in a timely fashion to take advantage of the unique resources and well-characterized cohorts being established in the parent project.
Objectives
This FOA will provide support for time-sensitive ancillary studies related to the NIAMS mission that will be conducted in conjunction with privately or publicly funded large ongoing clinical projects. These large ongoing parent projects can be clinical trials, observational studies or disease registries that can provide sufficient cohorts of well-characterized patients, infrastructure, data, and biological samples. The parent projects must be independently funded, by the NIAMS, other NIH institutes or government agencies, or private sponsors. They will not receive support from this FOA. Unlike those of the ancillary studies, the objectives of the parent study need not relate to the NIAMS mission, so long as the parent study provides an appropriate venue for the proposed ancillary study. Information about clinical trials currently supported by a variety of public and private entities can be obtained from http://www.clinicaltrials.gov/.
The ancillary studies supported under this FOA should focus on areas that are not studied in the parent project and address new research questions that are related to the mission of NIAMS (http://www.niams.nih.gov/About_Us/Mission_and_Purpose/mission.asp) in the venue of a parent project. The parent project can provide existing resources to facilitate the research and make it more efficient than initiating the same research de novo. Any applications dealing with mechanistic studies in clinical trials of immunomodulatory interventions for immune-mediated diseases should submit to the NIAID Hyperaccelerated Award Program for Ancillary Studies in Immunomodulation Clinical Trials (RFA-AI-08-011) in which NIAMS is a participating institute.
The following are examples of research that might be proposed under this FOA. These are only examples and are not meant to be inclusive:
Ancillary studies must document permission from the parent project to use the patient cohorts, data and biological materials. Ancillary studies must not interfere with the parent project or unduly burden participants. Applicants must document that proper informed consent to conduct ancillary studies has been or will be obtained, and must agree to follow the procedures and policies established by the parent project. Ancillary studies may involve the entire cohort of participants in a parent study or selected subsets, depending on the scientific questions posed and the sample size required to answer them. The ancillary studies may also draw patients from two or more parent projects if they are able to obtain approval from these parent projects and if their research plan is feasible. In general, this FOA will not support the recruitment of patients who are not already enrolled in the parent study or studies; however, recruitment of a small number of normal controls is acceptable provided that the cost is minimal (e.g., no more than one budget module).
Applications submitted to this FOA will use a modified application process and be subject to an accelerated peer review and award process. Each application must include a timeline to demonstrate that the parent project has adequate time left to carry out the proposed ancillary study. Each application must justify the time-sensitive nature of the ancillary study and clearly explain why an expedited review and award process is essential to its feasibility. Examples of characteristics that would support the case for time-sensitivity include (1) the need for support to collect samples or data prior to end of recruitment, (2) the need to perform analysis on soon-to-be-collected fresh specimens, or (3) the need for collecting post-intervention data in a trial that will end soon. If the proposed research does not need to be concurrent with the parent project (e.g., secondary analysis of existing datasets), the application will be determined as non-responsive to this FOA. Investigators who could complete the same work using the standard application process should not apply to this FOA.
This FOA encourages collaboration between basic and clinical investigators and partnership with private entities. In addition, this FOA encourages junior investigators to take a leading role in clinical research with the support and collaboration of senior investigators. The prospective applicants are not necessarily investigators in the parent study. However, collaborations in which a senior investigator from the parent study mentors a junior investigator on an ancillary study are encouraged.
Prior to award, the Principal Investigator of the ancillary study must provide the NIAMS with a memorandum of understanding (MOU) co-signed by the Principal Investigator of the parent project and representatives of the applicant institution and the institution sponsoring the parent project. The MOU must outline agreed procedures in the following areas:
The MOU also state that no funds from the ancillary study will be received by the parent grant for the purposes of extending the recruitment phase of the parent grant.
This MOU is in addition to the approval letter from the parent projects organization/leadership, documenting that patients, samples, data and/or materials are available to the proposed ancillary study from the parent project.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
This FOA will use the NIH Exploratory/Developmental Grant (R21) 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 (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
2.
Funds Available
The NIAMS
expects to commit approximately $1.5 million total costs in FY2010 to support a
total of four to six new awards combined from the two parallel FOAs for R01s
(RFA-AR-10-010) and R21s (RFA-AR-10-011). Under this FOA, an application may
request a budget for a total project period of two years. Direct costs are
limited to $275,000 over the two-year period, with no more than $200,000 in
direct costs allowed in any single year.
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.
Facilities
and Administrative (F&A) 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:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.
More than one PD/PI (i.e., 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 and 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 electronic Research Administration (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 grant 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. When considering the multiple PD/PI option, 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.
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
All ancillary study applications MUST include a letter or statement from one of the parent study leadership committees (i.e., Steering Committee, Scientific Advisory Board, Data and Safety Monitoring Board or Observational Study Monitoring Board, or other equivalent oversight committees) documenting its approval of the proposed ancillary study. This letter of approval must explicitly indicate that the required patients, samples, data, and materials from the parent project are accessible to the ancillary study. The letter should also provide the details of any agreement reached between the parent and ancillary study if there are requirements for limited data access and distribution. It must provide assurance that there is adequate time left in the parent study to carry out the ancillary study. This letter should be included as an upload in Item 14 of the PHS398 Components Letters of Support. Applications missing such documentation will be considered non-responsive to this FOA. Applications in which the critical time lines for the parent study and ancillary study are incompatible or ambiguous may be returned as non-responsive.
All ancillary study applications must include a paragraph with the heading Time-Sensitivity under Approach to explicitly justify the time-sensitive nature of the proposed ancillary study. The intent of this FOA is to fund applications that require an expedited review and award. Applications will be considered responsive only if they demonstrate the need for expedited review and award in order to complete the proposed work. Investigators who could complete the same work using the regular submission process should not apply to this FOA.
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement) ). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).
Renewals. Renewal applications are not permitted in response to this FOA.
Section IV. Application and Submission Information
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).
To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for
Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to
a specific FOA can be used. You will not be able to use any other SF424
(R&R) forms (e.g., sample forms, forms from another FOA), although
some of the "Attachment" files may be useable for more than one
FOA.
For further
assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: [email protected].
Telecommunications
for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover
component)
Research & Related
Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related
Budget, as
appropriate (See Section IV.6., Special Instructions, regarding appropriate
required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or 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 (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: July 3, 2009 (Earliest
date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): July 3, 2009; November 3, 2009; March 1, 2010
Application Due
Date(s): August 3, 2009; December 3, 2009; April
1, 2010
Peer Review
Date(s): October/November 2009; February/March 2010; June/July 2010
Council Review
Date(s): January 2010; May 2010; August 2010
Earliest
Anticipated Start Date(s): January
2010; May 2010; September 2010
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:
Anna Nicholson
Clinical
Coordinator, Extramural Program
National Institute of Arthritis and Musculoskeletal
and Skin Diseases
One Democracy Plaza, Suite 800
6701
Democracy Blvd.
Bethesda, MD 20892-4872
Telephone:
(301) 451-6513
Fax:
(301) 480-4543
Email: [email protected]
3.B.
Submitting an Application Electronically to the NIH
To submit an
application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the Scientific Review Branch at NIAMS by email [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local
time(of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for
all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.