and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Center for
Research Resources (NCRR), (http://www.ncrr.nih.gov/)
Title: Competitive Continuation of Centers of Biomedical Research Excellence (COBRE)[P20]
Announcement Type
This is a modification of RFA-RR-05-002, which was previously released June 30, 2005 as a Letter RFA.
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-RR-06-001
Catalog of Federal Domestic Assistance Number(s)
93.389
Key Dates
Release
Date: March 24, 2006
Application
Receipt Date(s): August 10, 2006
Peer Review Date(s): November/December
2006
Council
Review Date(s): January 18, 2007
Earliest
Anticipated Start Date: July 1, 2007
Expiration Date: August 11,
2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1.
Research Objectives
Section
II. Award Information
1. Mechanism(s)
of Support
2. Funds
Available
Section
III. Eligibility Information
1.
Eligible Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2.Cost
Sharing or Matching
3. Other
- Special Eligibility Criteria
Section
IV. Application and Submission Information
1.
Address to Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Sending an Application 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 Contact(s)
1.
Scientific/Research Contact(s)
2. Peer
Review Contact(s)
3.
Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The purpose of this Request
for Applications (RFA) is to allow institutions holding eligible Centers of
Biomedical Research Excellence (COBRE) grants to compete for continuation
support to promote the development of thematic, multi-disciplinary centers.
Progress must be commensurate with previous support and must substantiate the
merit of continued NIH research funding. It must be demonstrated that previous
support has allowed centers to achieve specific benchmarks, which include the
acquisition of independent status by the investigators and evidence that the
competitiveness of these investigators for other complementary NIH, Federal or
non-Federal external peer-reviewed research grant support has been enhanced.
Furthermore, evidence that a critical mass of investigators has been (or is
being) established must be shown. These benchmarks are a measure of successful
mentoring and scientific leadership by the Principal Investigator and the established
biomedical research faculty. Leadership is also demonstrated 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 were established
through COBRE support.
The objectives of the 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 complementary NIH individual research grants or other external peer-reviewed support. It is emphasized that a significant part of the COBRE program is to build and develop thematic multi-disciplinary research centers. 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 center's investigators collectively competing for individual investigator-initiated research support.
See Section VIII, Other Information
- Required Federal Citations, for policies related to this announcement.
Overall Research Plan
Each application must describe an overall research plan that justifies continued support of a thematic multi-disciplinary center for an additional five years. A description of the unique research opportunities that have been and will continue to be provided to the investigators and to the institution must be provided. The efforts and ongoing research of all center investigators should be described in the context of developing an independent and sustainable multi-disciplinary program. Ideally, it is recommended that the research plan contain the descriptions of at least three and up to five individual research projects. However, the research plan cannot contain fewer than three individual research projects. In addition, support for core facilities necessary to carry out the objectives of the center may be proposed.
The leadership and direction of the COBRE is provided by the Principal Investigator (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 PI may continue to serve in this role or a new PI may be appointed. In either case, the PI must be an established biomedical or behavioral research scientist who will ensure that high-quality research be performed and who has the experience and qualifications to effectively administer and integrate all components of the program. A minimum time commitment of 25-percent is required for this individual. However, up to 50-percent effort 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 clearly documented. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among 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 period of funding and to maintain these resources beyond the period of grant support.
The institutional environment and resources that are available to investigators must be briefly described. Evidence of how prior support has improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, geographic distributions of space and personnel) should be indicated. If support for instrumentation either to augment current or establish new core facilities is requested, the relationship of each component research project to the core(s) should be identified.
Individual Research Projects
Each COBRE program should ideally include three to five individual research projects that stand alone, but share a common thematic scientific focus. Each program must propose a minimum of three individual research projects. 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. The design principles supporting the research or the hypotheses to be tested should be delineated. Preliminary studies are not required for COBRE applications, but applicants with preliminary results should describe them. In the absence of preliminary results, applicants should describe the rationale and scientific basis for the proposed research. Furthermore, each research project should describe the area of multi-disciplinary research that is the focus of the COBRE and critically assess the existing knowledge and approaches that have been or are being directed in the area with an emphasis on specifically how the multi-disciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research to the specific aims should be concisely stated.
Mentoring and development of investigators not yet established is a significant part 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 and is strongly encouraged. 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 a Federal or non-Federal source that names that individual as the PI. This RFA also includes continued mentoring of and support for qualified early career investigators to promote the success and integrity of the research center. Furthermore, this RFA encourages the recruitment and/or support of qualified, more senior investigators to facilitate the growth and independence of the center. Qualified investigators must demonstrate a record of productivity. Taken together, these efforts will promote the development of an independent and successful research center. To this end, any qualified investigator is eligible to participate as a project principal investigator.
Junior investigators must claim an initial minimum commitment of 50-percent effort. Established investigators must claim an initial commitment of at least 25-percent effort. 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 efforts. Investigators should consult with NCRR Program staff regarding appropriate reductions. Investigators should indicate in the Biographical Sketch their current and previous history of peer-reviewed research support.
Investigators must hold a faculty appointment (or equivalent at research institutes) at the time that the award is made. Moreover, a clear commitment to support this faculty appointment independent of the outcome of this application must be demonstrated from the institution by a letter(s) from the appropriate senior institutional official(s). Postdoctoral fellows or other positions that do not carry independent faculty status will disqualify that individual and his/her research project from further consideration.
The 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 support must be discontinued if it is significantly similar to or overlaps with the newly funded project. Conversely, COBRE support can be continued if there are sufficient differences between the COBRE and non-COBRE supported projects, since the investigator is obligated to complete his/her COBRE project.
Development and Mentoring Plan
A clear plan for the transition to and attainment of independent status for junior investigators and for the continued development for early career investigators must be included. This plan should detail the long-term goals regarding how the institution intends to make the transition from the research support of multi-disciplinary COBRE projects to competitive grant support through applications submitted by its faculty members to relevant NIH Institutes and Centers or to other appropriate Federal or non-Federal agencies or organizations. All project investigators, regardless of their career status, must submit investigator-initiated RPG applications by the end of two years of support to maintain continued funding through the COBRE award.
The development plan must include both formative and summative evaluation strategies with specific milestones. 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; see Other-Special Eligibility Criteria below), and coordinated management of all of these individuals by the PI of the COBRE program. Additional oversight may be augmented through the use of an internal advisory committee, but this committee should not act as a substitute for the EAC.
Each junior investigator must have at least one mentor. Additionally, mentoring of early career investigators is strongly encouraged. The mentor must be an established investigator who has demonstrated the ability to advise others through 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. Mentors may be provided 10 to 15-percent effort and should be listed in the Administrative Core's budget section of the application and not in the individual projects' budget sections. 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 receipt of a RPG may continue to participate as a project investigator by proposing a new research project that does not overlap with his/her new award. New projects must be reviewed by the PI and the EAC. The PI must communicate the EAC's recommendation to the NCRR for Programmatic Review. Alternatively, an investigator who has acquired an RPG may direct a 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.
An investigator who no longer supervises a research project may be replaced by a new investigator. Replacement research projects and new investigators must be reviewed by the PI and the EAC. The PI must communicate the EAC's recommendation to the NCRR for Programmatic Review.
In some instances, an investigator may be placed on probation or 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, to submit an investigator-initiated RPG application by the end of two years of COBRE support.
Core Facilities
Funds may be requested to maintain or establish core facilities. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed. Alteration & Renovation of core facilities cannot be proposed, nor can funds be used to support renovations. 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. Furthermore, the PI should indicate any institutional commitment to support and maintain the proposed facilities.
1. Mechanism(s) of Support
This funding opportunity will use the P20 award mechanism.
As an applicant, you will be solely responsible for
planning, directing, and executing the proposed project.
This funding
opportunity uses the just-in-time budget concepts. It also uses the non-modular
budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A
detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds Available
The NCRR intends to commit
approximately $18 million dollars in FY 2007 to fund up to 10 competing
continuation grants in response to this RFA. An applicant must request a
project period of five years and a budget for direct costs up to $1.5 million
dollars per year.
Individual research projects and core facilities that are proposed to begin in the first year should have corresponding individual budgets. Although the applicant can propose research projects and/or support for core facilities to begin in later years, each year's budget should include costs for those projects or cores that will be active in that year only.
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. The PI must communicate plans for the expenditure of funds for recruitment purposes to the NCRR for Programmatic Review.
Alteration & Renovation of laboratory facilities should not be proposed and will not be supported.
When a grant application includes research activities that involve institutions other than the grantee institution, it is considered a consortium effort. Such activities may be included in the COBRE grant application, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. In addition, the thematic scientific focus of the COBRE must be evident in applications that include consortia arrangements. Applicants for COBRE grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution because synergism and cohesiveness can be diminished when projects are located outside of the parent institution.
Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-04-040.
Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size of each award will also vary.
Although the financial plans of the NCRR provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You
may submit (an) application(s) if your organization has any of the following
characteristics:
Eligibility is restricted 1) to institutions awarded a COBRE grant in response to the Request for Applications (RFA) RR-02-003, (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-02-003.html), 2) to institutions awarded a COBRE grant in response to (RFA) RR-00-006, (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-00-006.html), but not awarded a competitive continuation in response to Notice (NOT) RR-05-007, (http://grants.nih.gov/grants/guide/notice-files/NOT-RR-05-007.html), and 3) to institutions awarded a COBRE grant in response to (RFA) RR-00-003, (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-00-003.html), but not awarded a competitive continuation in response to Notice (NOT) RR-05-007, (http://grants.nih.gov/grants/guide/notice-files/NOT-RR-05-007.html).
1.B. Eligible Individuals
Either the current PI or a new PI with the skills, knowledge, and resources necessary to carry out the proposed research may be selected by the institution to develop an application for continuation support. The PI of the COBRE application must be an established biomedical or behavioral research scientist who has demonstrated the administrative abilities to effectively carry out the objectives of the COBRE program and meet its goals. The qualifications of the PI have been previously described.
2. Cost Sharing or Matching
This
program does not require cost sharing. The most current Grants Policy
Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Investigators may submit
only one application in response to this RFA.
Annual Meetings for Principal Investigators
Principal Investigators (PIs) of the Centers funded through this RFA should budget and will be expected to attend an annual two-day meeting in Bethesda, Maryland with NCRR staff.
External Advisory Committees
Each COBRE application must include an External Advisory Committee (EAC) comprised of scientists with national scientific reputations in their field; their expertise must be directly relevant to the scientific theme of the COBRE. The PI must name in the application all EAC members and must confirm their participation in the EAC by including a letter of acceptance and a current biographical sketch of each member. Ideally, an EAC consists of at least three, but no more than five scientists, although it is understood that in some cases additional members may have been added after the original award was made to reflect the development of the center. The PI may recruit additional members or remove members to the EAC after an award is made. The PI must communicate the selection of additional EAC members or removal of members to the NCRR for Programmatic Review.
The EAC critiques the scientific progress of the COBRE and also offers advice on scientific matters to the COBRE 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 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 candidates for replacement/substitute projects and investigators, as required, before such requests are forwarded to the NCRR 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 NCRR.
Section IV. Application and Submission Information
1. Address to Request Application Information
The
PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.
The title and number
of this funding opportunity must be typed on line 2 of the face page of the
application form and the YES box must be checked.
3. Submission Dates and Times
Applications
must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A.
Receipt, Review and Anticipated Start Dates
Application
Receipt Date(s): August 10,
2006
Peer
Review Date: November/December 2006
Council Review Date: January 18, 2007
Earliest
Anticipated Start Date: July 1, 2007
3.A.1. Letter of Intent
Not applicable.
3.B. Sending an
Application to the NIH
Applications must be prepared
using the research grant applications found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three signed photocopies in
one package to:
Center
for Scientific Review
National Institutes
of Health
6701 Rockledge
Drive, Room 1040, MSC 7710
Bethesda, MD
20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817
(for express/courier service; non-USPS service)
Personal
deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all copies
of the appendix material must be sent to:
Dr. Carol Lambert
Office of
Review
National Center for Research Resources
National
Institutes of Health
6701
Democracy Boulevard, Room 1076
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone:
(301) 435-0811
FAX:
(301) 480-3660
E-mail: Lambert@mail.nih.gov
Using
the RFA Label: The RFA label available in the PHS
398 application instructions must be affixed to the bottom of the face page of
the application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title and
number must be typed on line 2 of the face page of the application form and the
YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be evaluated for completeness by the CSR and
responsiveness by the NCRR. Incomplete
and non-responsive applications will not be reviewed.
The NIH will not accept any application in response to
this funding opportunity that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The NIH will
not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of a substantial revision of an
application already reviewed, but such application must include an Introduction
addressing the previous critique.
Information
on the status of an application should be checked by the Principal Investigator
in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award
Costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
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 continuation award.
The
incurrence of pre-award costs in anticipation of a competing or non-competing
award imposes no obligation on NIH either to make the award or to increase the
amount of the approved budget if an award is made for less than the amount
anticipated and is inadequate to cover the pre-award costs incurred. NIH
expects the grantee to be fully aware that pre-award costs result in borrowing
against future support and that such borrowing must not impair the grantee's
ability to accomplish the project objectives in the approved time frame or in
any way adversely affect the conduct of the project. See NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
An application for a COBRE
award must include the following:
A clear and full explanation of the necessary administrative, fiscal, and scientific aspects of the proposed COBRE.
A research plan for five years that describes the organization and component functions of the COBRE. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to developing and maintaining a significant and productive research program.
A description of and justification for the proposed individual research projects and core service facilities that collectively will contribute to the center. Applicants should ideally propose at least three and up to five meritorious individual research projects and must describe the nature and scope of any scientific research collaborations.
A description of the research and research training or career development goals and capabilities of the proposed COBRE.
A description of the infrastructure for conducting studies aimed at developing a nationally competitive biomedical research program.
The Research Plan section of the application describing the center, but not including the individual investigators' research projects and core facilities, is limited to no more than 25-pages, including all text, tables, graphs, figures, diagrams and charts. The Research Plans for the investigators' research projects and core descriptions are limited to no more than 10-pages each. These limitations do not include the sections describing Human Subject Research, Vertebrate Animals, Literature Cited, Consortium/Contractual Arrangements, Consultants, and/or supporting letters. Each Biographical Sketch is limited to no more than four pages. If not specifically cited in the PHS 398 document instructions, no page limit is in place for any other section. However, applicants are strongly urged to be succinct.
Applicants should follow the order of content described in the PHS 398 document instructions and indicated on the Table of Contents page. With respect to specific sections, the Budget section should begin with the summary or composite budget for the center, followed by the individual budgets for all projects, cores, consortia and contractual arrangements. Do not separate the individual project budgets into each project section. All Biographical Sketches should be grouped together with the PI's biographical sketch presented first followed by all other sketches in alphabetical order. Do not separate the biographical sketches into each project section. The Research Plan for the center should be followed with letters indicating institutional commitment and any letters of support for the proposed center (if applicable). Do not place these letters in the Appendix. The Research Plan for the center (including letters) should be followed by the core descriptions and individual investigator Research Plans. Although a PHS 398 face page should not be used for each individual research project , a cover page should be included that indicates the project title, the name of the investigator supervising the project, the name of the mentor(s) if applicable, whether human subject/human subject materials will be used in the project, and whether vertebrate animals will be used in the project. A Description page that provides an Abstract of the proposed project is required and should immediately precede each project's Research Plan. As necessary, each project section can be concluded with letters of commitment from mentors and, as needed, letters of commitment from collaborators and/or consultants. Do not place these letters in the Appendix. Consecutively number the pages throughout the application. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b, etc.
Applicants submitting a revised application should follow the instructions for revised applications described in the PHS 398 document instructions. The revision must include an Introduction of not more than three pages that summarizes the substantial additions, deletions, and changes. The Introduction must include responses to the criticisms and issues raised in the Summary Statement. Insert the Introduction just before the very beginning of the Research Plan. Identify within the Research Plan the changes made by clearly bracketing, indenting, or changing typography, unless the changes are so extensive as to include most of the text. This exception should be explained in the Introduction. Do not underline or shade changes.
Individual projects that are retained in the revision may each include a separate section of not more than one page titled Response to Previous Review that summarizes the substantial additions, deletions, and changes from the project that was originally submitted with the prior COBRE application. Insert the Response to Previous Review just before the very beginning of the individual project s Research Plan section. Revised text should be marked as described above.
The Preliminary Studies/Progress Report sections for the overall center and for revised individual projects should incorporate any work done since the prior version was submitted.
The main body of the application should be self contained and the Appendix must not be used to circumvent page limitations. Applicants must adhere to the guidelines described in the PHS 398 document instructions regarding the preparation and presentation of materials that can be included in the Appendix.
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 website, 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 must
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 requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only the
review criteria described below will be considered in the review process.
The following will be considered in making funding decisions:
In addition, the final selection of awards will depend upon the National Advisory Research Resources Council, geographic distribution, program balance, and the enhancement of the research competitiveness of the institution.
2. Review and Selection Process
Applications that are complete and responsive to the RFA
will be evaluated for scientific and technical merit by an appropriate peer
review group convened by the NCRR in accordance with the review
criteria stated below.
As part of the
initial merit review, all applications will:
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?
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?
Innovation. Is the project original
and innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators. Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment. Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review
Criteria:
A COBRE application s
review involves an evaluation of the qualifications of the PI to provide both
scientific and administrative leadership and on the feasibility and potential
for investigators and the center as a whole to become competitive for
independent funding. Specifically, has the PI demonstrated the
administrative leadership and overall potential for developing and sustaining
an independent, multi-disciplinary center; has he/she shown effective
leadership in mentoring, developing and promoting investigators to independent
status; and do the investigators of the individual biomedical/behavioral
research projects show career development potential and/or ability to achieve
independent status.
Has the PI shown effective administrative leadership and overall potential for developing and sustaining an independent, multi-disciplinary center? Has he/she shown the ability to lead, develop and direct the COBRE, and to establish thematic collaborative research efforts? Does the PI provide evidence that he/she can continue to provide effective leadership? Has the PI provided the necessary oversight to establish and maintain the necessary core resources and laboratory facilities to carry out the objectives of the application? Has the PI obtained institutional commitments commensurate to ensure that the resources and facilities required to sustain the center are present? Do the core resources and facilities serve the scientific needs of the individual research projects?
Has the PI shown effective leadership in directing and managing the mentoring required to move the investigators toward independent status? Has he/she been able to ensure that all research projects produce results of high quality and significance? Has he/she made sure that investigators publish their work in a timely manner and seek investigator-initiated research support? Has the mentoring provided to the junior investigators promoted their development toward independent status? Does the PI present a plan for the continued development of investigators to independent status? If the PI has recruited new investigators to the center, have these efforts been successful in increasing the biomedical research capacity of the institution? If the PI plans to recruit new investigators in the future, are these plans consistent with effective growth of the center?
Has the PI shown effective leadership and judgment in the selection of research projects? Are these projects related to and consistent with the overall goals of center?
Has the PI selected appropriate and suitable evaluation strategies and specific milestones to measure progress toward attaining long-range goals? Has the PI demonstrate how prior support has helped achieve these milestones, and described the strategies and milestones that will be applied in the future? Has the PI selected a suitable External Advisory Committee and has he/she made effective use of this committee to achieve the objectives of the center?
Do the individual research project investigators show the potential and/or ability to achieve independent status? Do the project investigators demonstrate the ability to compete successfully for investigator-initiated support?
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
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 Research Plan, Section E on Human
Subjects in the PHS Form 398).
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 Research Plan, Section E on Human
Subjects in the PHS Form 398).
Care
and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under Section F of the PHS Form 398 research grant application instructions
will be assessed.
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: The
reasonableness of the proposed budget and the requested period of support in
relation to the proposed research. 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 requires that grant awardee 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html).
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 will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. 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.
3. Anticipated Announcement and Award Dates
Not applicable.
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 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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 (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the NoA will be mailed to the 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 Also 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
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.
Section
VII. Agency Contacts
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 Contacts:
Dr. Lawrence N. Yager
Division
of Research Infrastructure
National Center for Research Resources
National
Institutes of Health
6701
Democracy Boulevard, Room 930
Bethesda, MD 20892-4874
Telephone:
(301) 435-0760
FAX:
(301) 480-3770
E-mail: yagerL@mail.nih.gov
2. Peer Review Contacts:
Dr. Carol Lambert
Office of
Review
National Center for Research Resources
National
Institutes of Health
6701
Democracy Boulevard, Room 1076
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone:
(301) 435-0811
FAX:
(301) 480-3660
E-mail: Lambert@mail.nih.gov
3. Financial or Grants Management Contacts:
Ms. Alice Chi
Office of
Grants Management
National Center for Research Resources
National
Institutes of Health
6701
Democracy Boulevard, Room 1040
Bethesda, MD 20892-4874
Telephone:
(301) 435-0844
FAX:
(301) 480-3777
E-mail: chia@mail.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 (45CFR46) 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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, 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 new PHS Form 398; 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 (http://publicaccess.nih.gov/publicaccess_Manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The
Department of Health and Human Services (DHHS) 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 DHHS
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. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
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 PA 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 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
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
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