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: Renewal
of Centers of Biomedical Research Excellence (COBRE) [P20]
Announcement Type
This is a reissue of RFA-RR-08-007.
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PAR-09-180
Catalog of Federal Domestic
Assistance Number(s)
93.389
Key Dates
Release
Date: may 1, 2009
Letters of Intent Receipt Date(s): Not applicable.
Application Receipt Date(s): September 22, 2009, September 22, 2010, September 22, 2011
Peer
Review Date(s): January/February
2010, January/February 2011, January/February
2012.
Council Review Date(s): May 2010, May 2011,
May 2012.
Earliest Anticipated Start Date(s): July
2010, July 2011, July 2012
Expiration Date: September
23, 2011
Due
Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. 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. Resource Sharing Plan(s)
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section
VII. Agency 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 Funding Opportunity Announcement (FOA) 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 the center to achieve specific
benchmarks, which include the acquisition of independent status by the junior
investigators and evidence that the competitiveness of these investigators for
other 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 principle
investigator (PI) 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 have been established through prior 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 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 centers investigators competing for individual investigator-initiated research support.
Overall 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 an additional five years, 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 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 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 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 will 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, geographic distribution of 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 centers research.
Administrative Core
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 support to be eligible for continued COBRE funding.
The development 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; 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 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. Mentors may be compensated for up to 1.8 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. 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 PI and the EAC. The PI must communicate the EAC recommendation to the NCRR for their programmatic 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.
A project leader 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, 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.
Research 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 and Renovation (A&R) of core
facilities cannot be proposed, nor can funds be used to support A&R. 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.
Individual Research Projects
Each COBRE program must include three to five individual research projects that stand alone but share a common thematic scientific focus. Applications must describe a minimum of three individual research projects and no more than five. 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 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. 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 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 Federal or non-Federal sources for which the individual is named as the PI. A junior investigator who is supported by IDeA Networks of Biomedical Research Excellence (INBRE) is not eligible to receive research support from COBRE. This FOA also includes continued mentoring of and support for qualified early career investigators to promote the success and integrity of the research center. Furthermore, this FOA 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 are intended to promote the development of an independent and successful research center. To this end, any qualified 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. PIs should consult with NCRR 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 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 of the project 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.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding
opportunity announcement (FOA) will use the P20 award mechanism. The applicant will be solely responsible for planning,
directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
The NCRR intends to commit approximately $20 million dollars in FY 2010 to fund up to 9 renewal (competing continuation) grants in response to this FOA. Applicants may request up to a project period of five years and may request up to $1.5 million dollars per year in direct costs.
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 only those projects or cores that will be active in that year.
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.
Funds for 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.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation noted above, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
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 as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number
of Applications: Investigators may submit only one
application in response to this FOA.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Renewal applications submitted in year 2009 are restricted to COBRE grants awarded in 2005 in response to Request for Applications (RFA) RR-04-007 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-04-007.html). Applications will also be accepted for renewal of a COBRE grant awarded in response to RFA RR-03-014, (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-03-014.html) and RR-02-007 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-02-007.html).
Renewal applications submitted in year 2010 are restricted 1) to COBRE grants awarded in 2005 and 2006 in response to Request for Applications (RFA) RR-04-007 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-04-007.html). Application will also be accepted for renewal of a COBRE grant awarded in response to RFA RR-03-014 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-03-014.html ).
Renewal applications submitted in year 2011 are restricted 1) to COBRE grants awarded in response to Request for Applications (RFA) RR-06-002 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-06-002.html). Applications will also be accepted for renewal of a COBRE grant awarded in 2006 in response to RFA RR-04-007 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-04-007.html).
Annual Meetings for Principal Investigators
PIs of the Centers funded through this FOA should budget for 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. In the application the PI must name 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: [email protected].
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 in item (box) 2 only
of the face page of the application form and the YES box must be checked.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Receipt, Review and Anticipated
Start Dates
Application
Receipt Date(s): September
22, 2009, September 22, 2010, September 22, 2011
Peer
Review Date(s): January/February
2010, January/February 2011, January/February 2012.
Council Review
Date(s): May 2010, May
2011, May 2012.
Earliest
Anticipated Start Date: July 2010, July 2011, July
2012
3.A.1. Letter of Intent
Not
applicable.
3.B. Sending an
Application to the NIH
Applications
must be prepared using the research grant application forms 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 CDs of
the appendix materials must be sent to:
Steven
Birken, PhD
Office of
Review
National
Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard,
Room 1078
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0815
FAX: (301) 480-3660
E-mail: [email protected]
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 not
be reviewed.
Upon receipt
applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. However, the
NIH will accept a resubmission application, but such application must include
an Introduction addressing the critique from the previous review.
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.
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 renewal award if such costs: 1) are
necessary to conduct the project, and 2) 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 renewal award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see 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:
Center Organization and Management Plan:
The Center Organization and Management Plan is limited to no more than 30 pages, including all text, tables, graphs, figures, diagrams, and charts. This page limit does not include the letters of commitment/support, core facilities or the individual investigators' research projects,
Letters of Commitment and Support:
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. No page limit on this section.
Cores and Projects:
The Research Plan for the center (including letters) should be followed by the core descriptions and individual investigator Research Plans. The Research Plans for the investigators' research projects and core facilities descriptions are limited to no more than 12 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.
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 project investigator, the name of the mentor(s) and/or collaborators, as applicable, whether human subjects/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.
Applicants should follow the order of content described in the PHS 398 document instructions and indicated on the Table of Contents page; a customized Table of Contents page is encouraged to indicate the start pages for major sections of the application. 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. Each Biographical Sketch is limited to no more than four pages, using the NIH format. 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. . Consecutively number the pages throughout the application. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b, etc. Adhere to NIH format described in the PHS 398 instructions for font, line spacing and margins.
Resubmission Applications
Applicants submitting a resubmission (formerly revised/amended) application should follow the instructions for resubmission applications described in the PHS 398 document instructions. The resubmission 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 and core descriptions that are retained in the resubmission 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 projects Research Plan section. Revised text should be marked as described above. As in other NIH resubmission applications, Introduction sections do not count against the page limit for the Research Strategy.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not put materials in the Appendix that are required as part of the application. . For any special file formats or other information needed regarding the Appendix, contact the Scientific Review Officer. Extensive appendix materials generally are not in the best interest of the applicant. An application that does not observe the requirements will not be reviewed.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1.
Criteria
Only the review criteria
described below will be considered in the review process.
2. Review and Selection
Process
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by NCRR in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority 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 five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 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, 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?
Principal Investigator(s): Does the Principal Investigator demonstrate that previous support has allowed the center to achieve specific benchmarks, which include the acquisition of independent status by the junior investigators and evidence that the competitiveness of these investigators for other NIH, Federal or non-Federal external peer-reviewed research grant support has been enhanced? Does the Principal Investigator provide evidence that a critical mass of investigators has been (or is being) established?
Does the 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 PI shown the ability to lead, develop, and direct the COBRE to establish thematic collaborative research efforts? Has the PI shown effective leadership in directing and managing the mentoring plan required to move the investigators toward independent status? Does the PI present a plan for the continued development of investigators to independent status?
Has the PI recruited new investigators to the center and have these efforts been successful in increasing the biomedical or behavioral research capacity of the institution? If the 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 advance, the thematic focus of the COBRE?
If a new PI has been selected, has the new PI provided evidence of successfully mentoring graduate students, postdoctoral fellows and junior investigators as well as leading a large research group?
Project Investigator(s): Do the project investigators demonstrate the ability to compete successfully for investigator-initiated support? Do project investigators publish their 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) Protections for Human Subjects, 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?
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?
Core Facilities: 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, constructive evaluations by members of the External Advisory Committee? Is there coordinated management of all of these individuals by the PI of the COBRE program?
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 PI?
Research Core Facilities: 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?
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 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 related to the COBRE thematic research focus?
COBRE Research Projects: The projects themselves are reviewed using the standard NIH review criteria, Significance, Investigator, Approach, Innovation, and Environment.
Milestones and Evaluation: Has the 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 PI demonstrated how prior support has helped achieve these milestones, such as junior investigators reaching independent status, successfully obtaining complementary NIH, Federal, or non-Federal external peer-reviewed research grant support, and publishing data in peer-reviewed journals?
Has the 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?
Overall Center Organization and Management Plan: Does the overall plan justify continued support of a thematic multi-disciplinary center 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? Has the PI shown effective leadership and judgment in the selection of research projects in terms of research projects being of high quality and significance? Are these projects related to and consistent with the overall goals of center?
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, geographic distribution of space and personnel)?
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 centers research?
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?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.
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.
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.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents 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).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
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.
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.
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.
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
When multiple years are
involved, awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Yanping
Liu, MD, PhD.
Division of Research Infrastructure
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard,
Room 930
Bethesda, MD 20892-4874
Telephone: (301) 451-4217
FAX: (301) 480-3770
E-mail: [email protected]
2. Peer Review Contacts:
Steven
Birken, PhD
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard,
Room 1078
Bethesda, MD 20892-4874
Bethesda, MD 20817-4874 (for express/courier service)
Telephone: (301) 435-0815
FAX: (301) 480-3660
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Mr
Gavin Wilkom
Office of Grants Management
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard,
Room 1048
Bethesda, MD 20892-4874
Telephone: (301) 435-0964
FAX: (301) 480-3777
E-mail: [email protected]
Section
VIII. Other Information
Required
Federal Citations
Vertebrate Animals:
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 impact/priority score.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
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.
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.
Inclusion of Women, Minorities, and Children:
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-09-116.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.
NIH
Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigators NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. 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/.
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NIH Funding Opportunities and Notices
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