Department
of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov)
Title: Support
of Competitive Research (SCORE) Research Continuance Award (SC3)
Announcement Type
This is a conversion of PAR-06-493, which was
released on July 20, 2006.
Update: The following update relating to this announcement has been issued:
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 weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-08-028
Catalog of Federal Domestic Assistance Number(s)
Key Dates
Release/Posted Date: November 16, 2007
Opening Date: December 25, 2007 (Earliest date an application may be
submitted to Grants.gov
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 Submission Dates: Standard dates
for SC3 applications apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for
details.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward .
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
guidance on dates.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for
guidance on dates.
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: September 8, 1011
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(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, 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. Sharing Research Data
D. Sharing Research Resources
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
In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical and behavioral research. In response to the Act, starting in 1996 the Minority Biomedical Research Support (MBRS) Branch of the Minority Opportunities in Research Division (MORE) of NIGMS offered institutional grants under the Support of Competitive Research (SCORE) program. The objective of the SCORE program is to foster the development of faculty at minority serving institutions (MSIs) in order to increase their research competitiveness and promote their transition to non-SCORE external sources of funding. This objective is expected to translate into an increase in the number of individuals from groups underrepresented in biomedical and behavioral research professionally engaged in these areas of research, and an enhancement of an institution’s research base. SCORE SC grants are offered to eligible MSIs. For the purposes of this program, eligible MSIs are those with more than 50% student enrollment of individuals from groups underrepresented in biomedical and behavioral research.
MSIs have significantly contributed to the scientific training of students from underrepresented groups, i.e., African Americans, Hispanic Americans, Native Americans, and natives of the U.S. Pacific Islands. Faculty members at these institutions, who are involved in underrepresented student training, often engage in competitive research projects. Such investigator-initiated research contributes to basic knowledge in the biomedical and behavioral sciences, allows faculty to stay at the cutting edge of their disciplines, and improves the quality of their teaching.
Because of the mixture in the individual focus of scholarly research at MSIs, the SCORE program offers several support mechanisms for individual investigator-initiated biomedical or behavioral research projects of different scope. This support allows faculty at MSIs to conduct high-quality research and to increase their research competitiveness by progressively enhancing the pace and productivity of their projects. It is the intent of the SCORE Program that the more productive SCORE PIs will transition to non-SCORE sources of external support.
The SCORE mechanisms available to investigators according to their experience/track records are:
The SC3 mechanism allows investigators who are at intermediate stages of development to continue to engage in meritorious research projects of limited scope in a given biomedical/behavioral area within the NIH mission. It is expected that the SC3 award will increase the PI’s research productivity and peer-reviewed publications. Moreover, the SCORE SC3 initiative seeks to expand the national research base, particularly at MSIs, advance the knowledge base in biomedical and behavioral areas, and broaden the exposure of students to the excitement of science and the conduct of biomedical research.
SC3 PIs are encouraged to establish meaningful collaborations with R01-funded investigators in the U.S. particularly outside of the applicant’s institution that will increase the progress and productivity of the project. These collaborators or consultants must be recognized experts in a field and must have their own research support, i.e., SC3 funds may not be used to support a consultant’s or collaborator’s research project. Collaborators, who may be from the applicant institution or another institution, generally provide expertise in a very specific aspect of the execution of the proposed project in which the PI has little or no experience. Collaborators from the applicant institution may be paid for the limited time, not to exceed a total of 2 person months, devoted to a specific area of the project. Consultants from domestic or foreign institutions other than the applicant institution are individuals who have committed to contributing intellectually to the scientific project development or execution but are not committing any specified measurable effort (in person months) to the project or conducting any part of the project. These consultants may be paid a reasonable fee commensurate with their limited involvement in a project. The specific role of a consultant/collaborator in a project must be described clearly in the application (see special instructions below).
SC3 projects are renewable but cannot be held in conjunction with any other SCORE investigator-initiated mechanism. SC3 new or renewal applications may request a maximum of four years of support. Although there is no limit to the number of SC3 renewals, a progressive development of the PI’s research trajectory as indicated by an increase in the number and quality of publications should follow each renewal application. Since SC3 is a developmental award multiple PIs, co-PIs or co-Investigators are not allowed.
SC3 PIs whose research productivity is significantly enhanced may apply for SC1 awards as well as other non-SCORE support. PIs who have received SC3 awards may apply for an SC2 award only if they intend to change research fields and develop a different line of research from that in which they have been engaged and published in, and have no other active external research support.
SCORE investigator-initiated research projects are limited to the NIH mission. SCORE PIs are strongly encouraged to visit the NIH website, http://www.nih.gov, to search the NIH archives for all past and currently funded NIH grants and research areas. Specifically searches of abstracts of funded grants using specific key words could be done using the Computer Retrieval of Information on Scientific Projects (CRISP) at, http://crisp.cit.nih.gov/.
Applicants are strongly advised to review the SCORE Answers to Frequently Asked Questions section in the NIGMS website, http://www.nigms.nih.gov/Minority/MBRS before they consider applying for any SCORE individual award.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This Funding
Opportunity Announcement (FOA) will use the SC3 grant award mechanism.
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses the modular budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm).
2.
Funds Available
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 Institutes and Centers (ICs) provide support for
this program, awards pursuant to this funding opportunity are contingent upon
the availability of funds and the submission of a sufficient number of meritorious
applications.
The participating organization National Institute of General Medical Sciences intends to commit approximately:
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.
F&A costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You may submit an application(s) if your
institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Typically the PI of a SCORE application possesses a Ph.D. or M.D./Ph.D. degree. He/she must also have a full-time regular faculty appointment at the applicant institution and be eligible to apply for an NIH R01 research grant. Postdoctoral fellows, research instructors, research assistant professors, research scientists, other research appointments or appointments contingent on an individual securing his/her salary from grants, and part-time or adjunct faculty are not eligible to apply for SCORE individual awards. Emeritus/retired investigators/professors as well as individuals with a track record of R01 or equivalent research grant awards are considered to be fully developed and may not apply for this award. Investigators who have developmental award support are ineligible to apply for SCORE individual awards, i.e., SCORE awards are not intended to duplicate other individual or institutional developmental awards; these include K awards and awards given as part of institutional centers or program projects. An applicant may not be the PI of an S06 subproject (under the previous S06 program project) or any other SCORE investigator initiated research grant at the time an SC3 award is made. Concurrent or duplicate application to any of the SCORE mechanisms (SC1, SC2, or SC3) by a single PI is not allowed. A PI may only apply for/receive one SC award at a time.
SC3 awards may not be transferred from one PI to another. If an SC3 PI moves to another SCORE eligible institution, his/her award may be transferred to the new institution provided that all transfer requirements as per NIH policy are fulfilled and the maximum number (25) of individual SCORE awards/applications and, if applicable, S06 subprojects from this institution has not been met.
All PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
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
Institutions receiving a new or renewal S06 award after January, 2006 may submit individual SC1, SC2 or SC3 (not S06) applications to a combined maximum of 25 total S06 subprojects and SCORE SC1, SC2 or SC3 individual investigator applications/awards. However, in this case, individual investigator-initiated SC1, SC2, or SC3 applications may only be submitted by PIs who are not already receiving S06 support (see I.B. Eligible Individuals).
Institutions that have an S06 grant in place prior to January, 2006 are not eligible to apply for any of the new SCORE individual awards until the last year of the S06 award. Note that these applications have special instructions, see section IV.2 subheading “Renewal Applications.”
Section IV. Application and Submission Information
To download a SF424
(R&R) Application Package and SF424 (R&R) Application Guide for
completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization 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) Principal Investigator (PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different from any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
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
301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
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. There are fields within the SF424 (R&R) application components that, 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 PI’s 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
SPECIAL INSTRUCTIONS
Applicants are advised to follow carefully the instructions given for electronic submission and the use of the SF424 (R&R) form at http://era.nih.gov/ElectronicReceipt/. Below are special instructions for this FOA describing the information that must be included in the required components mentioned above. Incomplete and non-compliant applications will be withdrawn and will not be reviewed.
PHS 398 Research Plan. The Research Plan should be prepared following PHS 398 (4/2006 revision) instructions. The Research Plan is divided into several categories (Introduction, Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Designs and Methods) and should be labeled accordingly. There is a 15-page limit for the Research Plan, which includes figures, charts, tables, and diagrams.
Institutional Data - limited to one page (counted as part of the 15-page limit) and should have the following information:
a. The total student enrollment at the institution and the number and percent of underrepresented minorities (e.g., Native American, African American, Hispanic American, natives of the U.S. Pacific Islands) in the total student population;
b. Number and percent of underrepresented minority students (undergraduate and graduate) enrolled in the sciences relevant to biomedical and behavioral research;
c. Number and percent of total and underrepresented minority faculty in the sciences relevant to biomedical and behavioral research and the total number of faculty and of underrepresented minority faculty from these departments participating in funded research.
Preliminary Studies/Progress Report - any PI who has previously received SCORE support (under an SC or earlier S06 subproject) must include a progress report indicating the extent to which the proposed objectives were accomplished. The Progress Report, which does count toward the Research Plan page limit, must be clearly indicated in a subheading separate from the Preliminary Data. PIs who have had a gap in funding must still include a report of the research accomplishments that they have achieved with SCORE support. This section is required, even though, for the purposes of electronic submission to Grants.gov, the application must be designated on the face page as “New.”
Research Design and Methods - in
addition to the experimental design and methodology to be used in the proposed
project, the PI’s Developmental Plan should be indicated as a separate
subheading (“Developmental Plan and Timeline”) within this section. The developmental plan must show how
and when the PI’s SC3 and research career goals will be achieved as a logical
progression from the candidate’s current support to SC3 support. The plan must
justify the need for development, provide an explanation of how the proposed
project and the time devoted to it will help the PI further his/her research
competitiveness, and describe how the proposed research will significantly
improve his/her productivity and consequently progress to the next step in
his/her research career.
Accomplishments for each
funding cycle should be used to present a developmental plan that indicates how
the PI ’s research competitiveness and productivity will improve, and if
applicable, how SC3 support has or will assist the PI in obtaining other
support. This should be limited to one
page and is included in the 15-page limit for the Research Plan.
Other Research Plan Sections
Renewal Applications
As described above, a detailed progress report (refer to SF424 (R&R) instructions) and a list of peer-reviewed publications resulting from SCORE support must be submitted by PIs who have previously received SCORE (i.e., S06 subproject or SC) support and are submitting a first SC3 application or by PIs submitting renewal applications. Information on the level of funding (dollars per year) during the previous grant period and on the number of technical personnel (technicians, research assistants, etc.) who participated in the project (whether or not paid with SCORE funds) must be included in the progress report. The progress report section must be placed immediately after the section on background and significance as described in SF424 (R&R). Applications lacking a progress report are considered non-compliant and will not be reviewed.
S06 subproject investigators may apply for support to continue their work by the SC3 mechanism if the S06 is in its last year. Since this is a different support mechanism, the application face page should indicate that this is a NEW application (box 8); previous support and progress should be described in the text of the application. Designating the SC3 as a RENEWAL may cause the application to be rejected by Grants.gov.
Resubmission Applications
Resubmissions (previously called revised application) of SC3 applications may be submitted. Resubmissions must include an Introduction not to exceed one page that addresses fully the questions/issues raised by the reviewers of the previous application. In addition, the body of the application must indicate, by changes in font or other means, the revised sections, unless the changes are so extensive as to include most of the text. Do not underline or shade changes (see SF424 (R&R) instructions). A revision of an application previously submitted as an S06 subproject under the old SCORE Program is considered a new application. .
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: December 25, 2007(Earliest date an application may be submitted
to Grants.gov) Application Submission Dates: Standard dates for SC3
applications apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for guidance on dates.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
Earliest Anticipated Start Date: Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for guidance on dates.
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
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.
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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5.
Funding Restrictions
All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants
Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
(See also Section
VI.2 Award Administration Information).
Pre-award costs are allowable.
A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or renewal (formerly “competing
continuation”) award if such costs: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing renewal award.
The incurrence of pre-award costs in anticipation of a competing or
non-competing award imposes no obligation on NIH either to make the award or to
increase the amount of the approved budget if an award is made for less than
the amount anticipated and is inadequate to cover the pre-award costs incurred.
NIH expects the grantee to be fully aware that pre-award costs result in
borrowing against future support and that such borrowing must not impair the
grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project. See the NIH Grants
Policy Statement.
SCORE SC3 awards include restrictions as to how the funds may be used. The following account summarizes allowable and non-allowable costs under the SCORE SC3 mechanism.
Allowable Costs
Unallowable Costs
6. Other Submission
Requirements
PI Credential (e.g., Agency Login)
The NIH requires the PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
PHS398 Research Plan Component Sections
Items 2-5 of the PHS398 Research Plan component are limited to 15 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
Applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.
Policies in limiting appendix materials are found in the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
All applicants are
expected to include a plan for sharing research data in their application. The
data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH
policy expects that grant recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
“Reporting.”
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIGMS in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If
the aims of the application are achieved, how will scientific knowledge or
clinical practice be advanced? What will be the effect of these studies on the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? What is the likelihood that the proposed
research will increase the PI’s productivity and lead to peer-reviewed
publications?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Are the PI’s developmental objectives reasonable and what
is the likelihood that they will be accomplished?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Is the PI and other key personnel appropriately trained and well suited to carry out this work? Is the proposed work appropriate to the experience level of the principal investigator and other researchers?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there sufficient access to resources? Is there evidence of institutional support?
Overall Evaluation: Summarize the major factors from the five review criteria above that contribute to or detract from scientific merit. In addition, evaluate whether the proposed project and specifically the PI’s developmental objectives and plan address the intent of the SCORE SC3 mechanism, which is to increase the competitiveness of investigators from MSIs at intermediate stages of their research careers so that they can increase their research productivity and peer-reviewed publications.
2.A.
Additional Review Criteria
In addition to the above criteria, the
following items will continue to be considered in the determination of
scientific merit and the priority score:
Progress Report (for competing renewal applications only): Progress achieved from the previous funding cycle will weigh heavily on the funding of subsequent renewal applications. Has significant progress been achieved toward each of the originally proposed objectives? Has the investigator’s productivity been commensurate with the support received? Will the research data support the continuity or enhance the PI’s research line? Were the PI’s developmental objectives achieved or was there significant progress in the PI’s developmental plan?
Resubmission Application (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. The priority score should not be
affected by the evaluation of the budget.
2.C.
Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH policy expects that grant
recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3., “Reporting.”
Model Organism Sharing Plan: Reviewers are
asked to assess the sharing plan in an administrative note. The sharing plan
itself should be discussed after the application is scored. Whether a sharing
plan is reasonable can be determined by the reviewers on a case-by-case basis,
taking into consideration the organism, the timeline, the applicant's decision
to distribute the resource or deposit it in a repository, and other relevant
considerations.
3.
Anticipated Announcement and Award Dates
Earliest possible dates when awards will be made will be January for
applications reviewed at the September Council meeting, April for applications
reviewed at the January Council meeting and July for applications reviewed at
the May Council meeting.
Section VI. Award Administration Information
1.
Award Notices
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 NIH eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
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. See Section
IV.5., “Funding Restrictions.”
2. Administrative and National Policy Requirements
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.
3.
Reporting
Awardees
will be required to submit the PHS Non-Competing Grant Progress Report, Form
2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and
financial statements as required in the NIH Grants
Policy Statement.
The annual progress (refer to PHS 2590) must detail the progress accomplished towards each specific aim and provide a list of peer-reviewed publications resulting from SCORE support. Information on the level of funding (dollars per year) during the previous grant period and on the number of technical personnel (technicians, postdoctoral research associates, and other research associates) who participated in the project (whether or not paid with SCORE funds) must be included in the progress report.
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1.
Scientific/Research Contact(s):
Hinda Zlotnik, Ph.D.
Minority Opportunities in Research Division
National
Institute of General Medical Sciences, NIH
45
Center Drive
Room
2AS.37, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-3900
Fax:
(301) 480-2753
Email:
hollanda@nigms.nih.gov
2.
Peer Review Contact(s):
Helen R. Sunshine, Ph.D.
Office
of Scientific Review
National
Institute of General Medical Sciences, NIH
45
Center Drive
Room
3AN.12F, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-2881
Fax:
(301) 480-8506
Email:
sunshinh@nigms.nih.gov
3. Financial/Grants Management Contact(s):
Antoinette Holland
Division
of Extramural Activities
National
Institute of General Medical Sciences, NIH
45
Center Drive
Room
2AN.50B, MSC 6200
Bethesda, MD 20892-6200
Telephone:
(301) 594-5132
Fax: (301) 480-2554
Email:
hollanda@nigms.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided guidance
at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of
Women And Minorities in Clinical Research:
It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research should
read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects
in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required
Education on the Protection of Human Subject Participants:
NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human
Embryonic Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov/) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is
requesting that authors submit manuscripts resulting from 1) currently funded
NIH research projects or 2) previously supported NIH research projects if they
are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more
information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for
NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
Healthy
People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. 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. See also
Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive
Order 12900, Educational Excellence for Hispanic Americans February 22, 1994,
Executive Order 12876, Historically Black Colleges and Universities, November
1, 1993, and Executive Order 13021, October 21, 1996 and Outline of Work Plan,
August 18, 1998, White House Initiative on Tribal Colleges and Universities.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants
Policy Statement.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files. |