and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of General Medical Sciences (NIGMS) |
|
Funding Opportunity Title |
Renewal of Centers of Biomedical Research Excellence [COBRE](P20) |
Activity Code |
P20 Exploratory Grants |
Announcement Type |
Reissue of PAR-12-224 |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-243 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.859 |
Funding Opportunity Purpose |
The National Institute of General Medical Sciences (NIGMS) invites renewal applications from eligible Centers of Biomedical Research Excellence (COBRE). The objective of the COBRE initiative is to strengthen an institution's biomedical research infrastructure through the establishment of a thematic, multi-disciplinary center and to enhance the ability of investigators to compete independently for National Institutes of Health (NIH) individual research grants or other external peer-reviewed support. COBRE awards are supported through the Institutional Development Award (IDeA) Program, which aims to foster health-related research by increasing the competitiveness of investigators at institutions located in IDeA states. |
Posted Date |
June 7, 2013 |
Open Date (Earliest Submission Date) |
August 25, 2013 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
September 25, 2013; September 25, 2014; and September 25, 2015, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
January/February 2014, January/February 2015, and January/February 2016 |
Advisory Council Review |
May 2014, May 2015, and May 2016 |
Earliest Start Date |
July 2014, July 2015, and July 2016 |
Expiration Date |
September 26, 2015 |
Due Dates for E.O. 12372 |
Not Applicable |
NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The goals of the Centers of Biomedical Research Excellence (COBRE) program are (1) to strengthen an institution's biomedical research infrastructure through the establishment of a thematic multi-disciplinary center and (2) to enhance the ability of investigators to compete independently for NIH individual research grants or other external peer-reviewed support. COBRE support consists of three sequential five-year phases. Phase I focuses on developing research infrastructure and providing junior investigators with formal mentoring and research project funding to help them acquire preliminary data and successfully compete for independent research grant support. Phase II, which is the focus of this FOA, is intended to strengthen the center through further improvements in research infrastructure and to continue development and support of a critical mass of investigators with shared scientific interests. It is therefore expected that progress will have been made toward establishing centers that can compete independently for external peer-reviewed center or program project grant support. In some instances centers may be more effectively maintained by the centers investigators competing for individual investigator-initiated research support. Phase III provides support for maintaining COBRE research cores developed during phases I and II.
1. Accomplishments and Center Organization and Management Plan
A. Program Accomplishments
A description of the major progress and accomplishments made in COBRE Phase I in the following areas:
B. Center Organization and Management Plan
2. Administrative Core
3. Research Core
If the research core(s) is proposed, the following information should be provided in Research Core component:
4. Research Projects
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
Renewal The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
The annual budgets must not exceed $1.5 million in direct costs. |
Award Project Period |
Five years |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Applications will be accepted from institutions that are in IDeA states and currently hold a Phase I COBRE award.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s)) and
component Project Leads that are not yet registered in eRA Commons must work
with their institutional officials to register. Also, institutional officials
at the applicant organization should ensure that the eRA Commons account for
the contact PD/PI is affiliated with their organization.
eRA Commons accounts are necessary to use ASSIST to prepare and submit
applications.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged to
apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Component Types |
Research Strategy/Program Plan Page Limits |
Overall (Program Accomplishments and Center Organization and Management Plan |
12 |
Admin Core |
12 |
Core |
12 |
Project |
12 |
Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits must be followed.
The following section supplements the instructions found in the SF 424 Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
Overall (Program Accomplishments and Center Organization and Management Plan): Required
Administrative Core: Required
Research Core: Optional
Research Project: Required; minimum of 3, maximum of 5
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall)
Complete entire form.
PHS 398 Cover Page Supplement (Overall)
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall)
Follow standard instructions.
Project/Performance Site Location(s) (Overall)
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research & Related Senior/Key Person Profile (Overall)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall)
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
An applicant may request a budget for total direct costs no more than $1.5 million per year, excluding facilities and administrative (F&A) costs on consortium arrangements. If items are requested as direct costs that are normally treated as F&A costs (for example, computers and general office supplies), the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated project.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall)
Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.
Research Strategy:
Program Accomplishments
The purpose of this FOA is to allow institutions holding COBRE Phase I grants to compete for continuation support of thematic, multi-disciplinary centers. Thus progress must be commensurate with previous support and must demonstrate the merit of continued NIH research funding. It must provide evidence that previous support has allowed the center to achieve specific benchmarks, including 1) acquisition of independent status by the junior investigators; 2) enhancement of competitiveness of these investigators for NIH, other Federal or non-Federal peer-reviewed research grants; and 3) a critical mass of investigators has been established. These benchmarks are a measure of successful mentoring and scientific leadership by the program director/principal investigator (PD/PI) and the established biomedical research faculty. Leadership is also demonstrated by showing that the infrastructure necessary for the continued functioning of the center (facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) is in place, and that the institution is committed to maintain the resources and infrastructure that have been established through prior COBRE support.
Center Organization and Management Plan
Applications must describe an overall center organization and management plan that justifies continued support of a thematic multi-disciplinary center for COBRE Phase II, and a description of the unique research opportunities that have been and will continue to be provided to the investigators and to the institution. The efforts and ongoing research of all center investigators should be described in the context of developing an independent and sustainable multi-disciplinary program. The research plan must contain the descriptions of at least three and no more than five individual research projects. An administrative core with a detailed development and mentoring plan must be included. In addition, support for research core facilities necessary to carry out the objectives of the center may be proposed.
The leadership and direction of the COBRE are provided by the PD/PI. He/she has the primary responsibility for administering the program and overseeing the development of the center and its associated core facilities. The current PD/PI may continue to serve in this role or a new PD/PI may be appointed. In either case, the PD/PI must be an established biomedical or behavioral research scientist who will ensure that high-quality research is performed, and who has the experience and qualifications to effectively administer and integrate all program components of the program. A minimum time commitment of 3 person months is required for this individual. However, up to 6 person months will be supported for mentoring and administrative oversight of the center.
No non-Federal matching funds are required for these applications. However, evidence of institutional commitment must be included and explicitly described and/or documented. The level of institutional commitment may differ across applicant institutions because of the variability of resources available at those institutions. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) should outline the commitment of resources and facilities to sustain and support the COBRE throughout the funding period and plans to maintain these resources beyond the period of grant support.
Applications must briefly describe the institutional environment and resources available to investigators, and indicate how prior COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel). If support for instrumentation to augment existing or establish new core facilities is requested, the application should identify the needs of each component research project for the core(s) and how this instrumentation will facilitate the center’s research.
Progress Report Publication List:
A list of publications produced from COBRE phase I should be included.
Letters of Support:
Letters indicating institutional commitment and any letter of support for the proposed center should be included.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Admin Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Administrative Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Administrative Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Administrative Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Administrative Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Administrative Core)
Budget (Administrative Core)
The PD/PI of the COBRE is not eligible for research project support from the COBRE award, nor can he/she use COBRE funds to supplement research activities within his/her laboratory. Mentors may be compensated for up to 1 person month of effort and should be listed in the Administrative Core's budget section of the application and not in the individual research projects' budget sections. Mentors from non-IDeA states can be compensated as a consultant or fee for service.
A minimum time commitment of 3 person months is required for PD/PI. However, up to 6 person months will be supported for mentoring and administrative oversight of the center.
Funds may be used to recruit additional faculty who complement the scope of the proposed program. Recruitment funds are limited to $200,000 per year for each position and may be used to recruit either junior or established senior investigators. These funds may be used for salary, supplies, and/or equipment costs.
PD/PIs of the Centers funded through this FOA should budget for and will be expected to attend biennial two-day meetings in Bethesda, Maryland with NIGMS staff.
Funds for alteration & renovation of laboratory facilities should not be proposed and will not be supported.
Funds cannot be used at collaborative institutions in non-IDeA states. However, funds may be used in other IDeA and non-IDeA states for fee-for-service activities that include activities such as learning new techniques, sample and data analysis, workshops etc.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Administrative Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement andsummarize the substantial additions, deletions, and changes.
Specific Aims: The SF424 application Guide must be followed.
Research Strategy: A clear plan for the transition to and attainment of independent status for junior investigators and for the continued development of early career investigators must be included. This plan should also describe how the center as a whole intends to make the transition from support of multi-disciplinary COBRE research projects to competitive grant support obtained through applications submitted by its faculty members to relevant NIH Institutes and Centers or other appropriate Federal or non-Federal agencies or organizations. All project investigators, regardless of their career status, must submit independent investigator-initiated RPG applications by the end of two years of COBRE phase II support to be eligible for continued COBRE funding.
The mentoring plan must include both formative and summative evaluation strategies detailing specific milestones, including, but not limited to, the acquisition of independent status by the investigators; competition for NIH, Federal or non-Federal external peer-reviewed research grant support; and publications in peer-reviewed journals. Faculty development should include a mentoring plan that involves oversight by established senior faculty members assigned as mentors, constructive evaluations by members of the External Advisory Committee (EAC, detailed requirements are described below), and coordinated management of all of these individuals by the PD/PI of the COBRE program. Additional oversight may be augmented through the use of an internal advisory committee.
Each junior investigator must have at least one mentor. The mentor must be an established investigator who has demonstrated the ability to advise others on the acquisition of external support and the maintenance of an independent research laboratory. In some instances a suitable mentor may not be available within the applicant's institution and it is therefore acceptable to enlist appropriate mentors from outside institutions, including institutions in non-IDeA states. Mentors may be compensated for up to 1.2 person months of effort and should be listed in the Administrative Core's budget section of the application and not in the individual research projects' budget sections. Mentors from non-IDeA states can be compensated as a consultant or fee for service. Investigators should clearly designate in the text the identity of their mentors and describe their qualifications, both scientific and advisory, that make them appropriate to assist in the oversight of the project.
An investigator who has acquired independent status through the award of an RPG may continue to participate as a COBRE research project investigator by proposing a new project that does not overlap with his/her other award(s). New COBRE projects must be reviewed by the PD/PI and the EAC. The PD/PI must communicate the EAC recommendation to the NIGMS for their programmatic and administrative review. An investigator who has acquired independent RPG support may direct a COBRE core facility or serve as a mentor. In either case, investigators should not be excluded from center activities and should be encouraged to participate in collaborative research efforts. In some instances, a project leader may be considered for removal from the COBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project or, as noted above, failure to submit an investigator-initiated RPG application by the end of two years of COBRE support.
Each COBRE application must include an EAC comprised of 3-5 scientists with national scientific reputations in their fields. Their expertise must be directly relevant to the scientific theme of the COBRE. The EAC critiques the scientific progress of the COBRE and also offers advice on scientific and administrative matters to the COBRE PD/PI. The EAC activities include developing and planning concepts and programs, encouraging and assisting faculty development and mentoring, identifying resources, evaluating the development of the center, evaluating the progress of the individual research projects, and evaluating the junior investigators' progress toward acquiring independent status. The PD/PI will share the advice and critiques provided by the EAC with other COBRE investigators at the center. The EAC also will review and recommend candidate investigators for replacement/substitute projects, as required, before such requests are forwarded to the NIGMS for programmatic review. The EAC must meet at least twice per year. Video-, teleconferencing or other means may be used in situations where it would be difficult to hold an in-person meeting. A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.
A pilot project program may be proposed. The description of a pilot project must include a plan for the solicitation of proposals, their review and funding prioritization, oversight and evaluation procedures, and assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards. The pilot project(s) must be reviewed by EAC. The recommendation from EAC must be submitted to NIGMS for programmatic review. Research plans for individual pilot research projects should not be included in the application.
Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed administrative core should be included.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Research Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Research Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Research Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Research Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Research Core)
Budget (Research Core)
Funds may be requested to maintain and/or establish core facilities. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed. Alteration and Renovation (A&R) of core facilities cannot be proposed, nor can funds be used to support A&R.
Core facilities should have a detailed budget for the entire proposed project period (5 years). Although the applicant can propose support for core facilities to begin in later years, each year's budget should include costs for only cores that will be active in that year.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Research Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.
Specific Aims: The SF424 application Guide must be followed.
Research Strategy: The applicant must demonstrate that each core will serve the scientific needs of the individual research projects and must show how each core will impact the development and sustainability of the center. Although the COBRE award is not intended to replace support for ongoing investigator-initiated research projects, all center participants, including the mentors, as well as other non-center investigators at the institution, may use these facilities. Additional justification may be offered by showing how a core facility will benefit these individuals and improve the research infrastructure of the institution. Each core description should indicate the qualifications of personnel selected to manage the facility and/or plans to recruit personnel to operate the core, if needed, and the proposed business plan for operation of the core including prioritization of the service requests, charge back fees for non-COBRE users. Furthermore, the PD/PI should indicate any institutional commitment to support and maintain the proposed facilities.
Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed research core should be included.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Project.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Research Project)
Complete only the following fields:
PHS 398 Cover Page Supplement (Research Project)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Research Project)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Research Project)
List all performance sites that apply to the specific component.
Research & Related Senior/Key Person Profile (Research Project)
Budget (Research Project)
Individual research projects should have a detailed budget for the entire proposed project period (5 years). Although the applicant can propose research projects to begin in later years, each year's budget should include costs for only those projects or cores that will be active in that year.
Junior investigators must make an initial minimum commitment of 6 person months annually. Established investigators must make an initial commitment of at least 3 person months annually. It is recognized that during the development of an investigator's career (for example, the acquisition of other research support) it may be necessary to reduce these levels of commitment. PD/PIs should consult with NIGMS program staff regarding appropriate reductions. Each project investigator should indicate in the Biographical Sketch his/her current and previous history of peer-reviewed research support.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Research Project)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component. The Introduction must include responses to the criticisms and issues raised in the prior Summary Statement andsummarize the substantial additions, deletions, and changes.
Specific Aims: The SF424 application Guide must be followed.
Research Strategy: The COBRE center must contain at least three and up to five individual research projects. The individual research projects should stand alone but share a common thematic scientific focus. Each research project should be supervised by a single investigator who is responsible for ensuring that the specific aims of that project are met. Each individual research project should describe the specific aims in the selected area of research and the goals for the long term, and delineate the design principles supporting the research or the hypotheses to be tested. Preliminary studies are not required for COBRE applications, but they are encouraged. In the absence of preliminary results, applicants should describe the rationale and scientific basis for the proposed research. Each research project should describe its relationship to the area of multi-disciplinary research that is the focus of the COBRE. It should also critically assess the existing knowledge and approaches that have been, or are being, directed in the area with a specific emphasis on how the multi-disciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research should be concisely stated.
Mentoring and development of investigators who are not yet established are significant parts of the creation and establishment of the critical mass of successful investigators necessary to make up a research center. The participation of junior investigators is integral to this concept. A junior investigator is defined as an individual who does not have, or has not previously had external, peer-reviewed Research Project Grant (RPG) or Program Project Grant (PPG) support from either Federal or non-Federal sources for which the individual is named as the PD/PI. A junior investigator who is supported by IDeA Networks of Biomedical Research Excellence (INBRE) is not eligible to receive research support from COBRE. A junior investigator is not allowed to receive research support from multiple COBREs simultaneously. This FOA also includes continued mentoring of and support for early career investigators to promote the success and integrity of the research center. Furthermore, this FOA encourages the recruitment and/or support of more senior investigators to facilitate the growth and independence of the center. Investigators must demonstrate a record of productivity. Taken together, these efforts are intended to promote the development of an independent and successful research center. To this end, any investigator is eligible to participate as a project investigator in the center.
Junior investigators must make an initial minimum commitment of 6 person months annually. Established investigators must make an initial commitment of at least 3 person months annually. It is recognized that during the development of an investigator's career (for example, the acquisition of other research support) it may be necessary to reduce these levels of commitment. PD/PIs should consult with NIGMS program staff regarding appropriate reductions. Each project investigator should indicate in the Biographical Sketch his/her current and previous history of peer-reviewed research support.
Investigators must hold a faculty appointment (or equivalent at research institutes) at the time the award is made. Moreover, the applicant institution must demonstrate, in a letter(s) from the appropriate senior institutional official(s), a clear commitment to support this faculty appointment independent of the outcome of the COBRE grant application. Individuals holding postdoctoral fellowships or other positions that lack independent faculty status are not eligible to lead COBRE research projects. The PD/PI of the COBRE is not eligible for research project support nor can he/she use COBRE funds to supplement research activities within his/her laboratory.
COBRE support cannot be provided for a project that overlaps with or is significantly similar to an investigator-initiated research program that is already funded from another source. Furthermore, if a COBRE supported investigator obtains additional external support, COBRE supported project must be discontinued if it is significantly similar to, or overlaps with, the newly funded project. Conversely, COBRE support must be continued if there are sufficient differences between the COBRE and non-COBRE supported projects.
Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed research project should be included.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
In order to expedite review, applicants are requested to notify the NIGMS Office of Scientific Review by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Program Accomplishments
Has previous support allowed the center to achieve specific benchmarks, which include the acquisition of independent status by the junior investigators, publishing data in peer-reviewed journals, and evidence that the competitiveness of these investigators for other NIH, Federal or non-Federal external peer-reviewed research grant support has been enhanced?
Is there evidence that a critical mass of investigators has been (or is being) established?
Have new investigators been recruited to the center and have these efforts been successful in increasing the biomedical or behavioral research capacity of the institution?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the PD/PI demonstrate leadership by showing that the infrastructure necessary for the continued functioning of the center (e.g., facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) is in place, and that the institution is committed to maintain the resources and infrastructure that have been established through prior COBRE support?
Has the PD/PI shown the ability to lead, develop, and direct the COBRE to establish thematic collaborative research efforts? Has the PD/PI shown effective leadership and judgment in the selection of research projects in terms of research projects being of high quality and significance? Has the PD/PI shown effective leadership in directing and managing the mentoring plan required to move the investigators toward independent status? Does the PD/PI present a plan for the continued development of investigators to independent status?
If a new PD/PI has been selected, has the new PD/PI provided evidence of successfully mentoring graduate students, postdoctoral fellows and junior investigators as well as leading a large research group?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Center Organization and Management Plan
Does the overall plan provide confidence that a productive, thematic multi-disciplinary center can (or will) continue for an additional five years?
Are the efforts and ongoing research of all center investigators described in the context of developing an independent and sustainable multi-disciplinary program? Are the proposed projects related to and consistent with the overall goals of center?
If the PD/PI plans to recruit new investigators in the future, are these plans consistent with the thematic focus of the center? Are the senior investigators research projects related to, and do they advance, the thematic focus of the COBRE?
If support for instrumentation to augment existing or establish new core facilities is requested, does the application identify the needs of each component research project for the core(s) and how this instrumentation will facilitate the center’s research?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Does the application describe the institutional environment and resources available to investigators, and indicate how prior COBRE support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel)?
Reviewers will score each core based on the criteria provided.
Administrative Core
Does the administrative core include a clear plan for the transition to and attainment of independent status for junior investigators and for the continued development of early career investigators and describe how the center as a whole intends to make the transition from support of multi-disciplinary COBRE research projects to competitive grant support?
Does the development plan include a mentoring plan that involves oversight by established senior faculty members assigned as mentors, and constructive evaluations by members of the External Advisory Committee? Is there coordinated management of all of these individuals by the PD/PI of the COBRE program?
Milestones and Evaluation: Has the PD/PI selected appropriate and suitable evaluation strategies? Does the development plan include both formative and summative evaluation strategies detailing specific milestones for the acquisition of independent status by the investigators? Are specific milestones identified and supported to measure progress toward attaining long-range goals?
Has the PD/PI described the strategies and milestones that will be applied in the future, describing what has worked and what needs to be improved in terms of milestones?
Is the External Advisory Committee properly constituted with the scientific expertise to critique the scientific progress of the COBRE and offer advice on scientific matters to the COBRE PD/PI?
If a pilot project program is proposed, is there an adequate plan to solicit proposals, prioritize the projects and review their methodology and research performance? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections?
Research Cores
Has the PD/PI provided the necessary oversight to establish and maintain the necessary core resources and laboratory facilities to carry out the objectives of the application?
Do the core resources and facilities serve the scientific needs of the individual research projects?
Are the personnel who direct the core facility as well as the technical staff who operate the core facility well qualified?
Has the PD/PI obtained institutional commitments sufficient to ensure that the resources and facilities required to sustain the center are present?
For requests of new core facilities: is the request justified in terms of the need for the core as it relates to the COBRE thematic research focus?
For each research project, reviewers will consider each of the review criteria below in determination of scientific and technical merit and provide an overall impact/priority score, but will not give separate scores for the individual criteria.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Are the strengths, academic qualifications and biomedical expertise of the project investigator appropriate and sufficient for research productivity? Does the project investigator have the potential and ability to achieve independent status? Does the investigator demonstrate the ability to compete successfully for investigator-initiated support? Does the investigator publish his/her work in a timely manner? For project investigators new to the COBRE, do they show career development potential and/or an ability to achieve independent status?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
If this project involves community engagement and outreach research, are there clear and detailed plans for identifying a health issue that fits community priorities and academic capacity to respond? Are there plans for developing a coalition of community and academic stakeholders and for implementing evaluation strategies for the proposed projects? Is the research characterized by substantial community input in the development of the proposed study? Are community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community s health, full participants in each phase of the research, including conception, design, conduct, analysis, interpretation, drawing of conclusions and communication of results?
Can this project stand alone?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the cores and projects proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to NIGMS. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the NIGMS Advisory Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
Awardee-selected projects require prior approval by NIH prior to initiation (see the NIH Grants Policy Statement 8.1.3 Requests for Prior Approval for instructions on submitting a request). The awardee institution will provide NIH with following documents for administrative review:
Clinical Research
Clinical Trial
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Telephone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Yanping Liu, MD., PhD.
National Institute of General Medical Sciences
Telephone: (301) 451-4217
Email: [email protected]
Helen R. Sunshine, PhD
National Institute of General Medical Sciences
Telephone: (301) 594-2881
Email: [email protected]
Ms. Christy Leake
National Institute of General Medical Sciences
Telephone: (301) 594-7706
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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