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 Institute of General Medical Sciences
(NIGMS) (http://www.nigms.nih.gov)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/) (Removed per NOT-OD-12-095)
Title: Centers
of Biomedical Research Excellence (COBRE) Phase III: Transitional Centers [P30]
Announcement Type
This is a reissue of RFA-RR-09-005.
Update: The following update relating to this announcement has been issued:
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-10-196
Catalog of Federal Domestic
Assistance Number(s)
93.859
Key Dates
Release
Date: May 11, 2010
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Dates(s): July 20, 2010, July 20, 2011. and July 20, 2012
Peer
Review Date(s): October/November 2010, October/November 2011, October/November 2012
Council Review Date(s): January 2011, January
2012, January 2013
Earliest Anticipated Start Date: April
2011, April 2012, April 2013
Additional Information To Be
Available Date (Url Activation Date): Not Applicable
Expiration Date: July 21, 2012
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
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
Background
The Institutional Development Award (IDeA) Program at the National Center for Research Resources of the NIH has endeavored to stimulate research at institutions that traditionally have not received significant levels of competitive research funding from the NIH. The IDeA Program was established for the purpose of broadening the geographic distribution of NIH funding for biomedical and behavioral research by enhancing the competitiveness for research funding of institutions located in states in which the aggregate success rate for grant applications to the NIH historically has been low. The Centers of Biomedical Research Excellence (COBRE) program launched in fiscal year 2000 in IDeA-eligible states seeks to augment and strengthen institutional biomedical research capacity. This is accomplished by expanding and developing biomedical faculty research capability and enhancing research infrastructure, including the establishment of core facilities needed to carry out the objectives of a multidisciplinary, collaborative program.
COBRE support consists of two sequential five-year phases. Phase I focuses on developing research infrastructure and providing junior investigators with formal mentoring and research project funding to help them acquire preliminary data and successfully compete for independent research grant support. Phase II is intended to strengthen the center through further improvements in research infrastructure and continuing development and support of a critical mass of investigators with shared scientific interests. After ten years of COBRE support, the centers are expected to be able to compete successfully for other sources of research funding, such as program project or center grants from other NIH Institutes and Centers. The objectives of this FOA (COBRE phase III), are to (1) provide support for maintaining COBRE research cores developed during phases I and II that are essential for the continuing conduct of basic, clinical, translational research, and/or community based research at the institution, and (2) sustain a collaborative, multidisciplinary research environment by providing support for research pilot projects and mentoring and training components.
Program
In addition to providing core services to meet the needs of center research activities, the COBRE Transitional Center support should encourage and facilitate collaborative research supported by the IDeA program and other research programs at the applicant institution and, where applicable, at consortium sites. The center will provide support to:
Funds cannot be used at collaborative institutions in non-IDeA states. However, funds may be used in other IDeA and non-IDeA states for fee-for-service activities that include activities such as learning new techniques, sample and data analysis, workshops etc. It is the responsibility of the PD/PI to define an effective partnership and collaboration. Funds cannot be used for alteration and renovation.
Overall Center Organization and Management Plan: Accomplishments during the past ten years of support and how requested cores will sustain the center must be described. Each application must describe an overall strategic plan to identify the significant scientific opportunities that the center intends to pursue in the next five years. A summary of the proposed research of the center participants and the anticipated scientific and core facility needs of each individual project must be included in the Organization and Management Plan narrative as needed to describe the programs, but also summarized in a table. Applications must describe an administrative core with detailed plans for coordinating and facilitating research and training activities that are to be supported by the COBRE cores.
Administrative core: The administrative core should be led by the PD/PI of the center. The components of the core should identify a program coordinator, an internal steering committee consisting of the core directors and other faculty to provide ongoing assessment and evaluation of the progress of the center, and an external advisory committee (EAC) consisting of 3-4 members to provide external review of progress and assure collaboration and/or partnership between investigators within an institution, and among institutions in a state and regionally. The administrative core should provide a clear plan as to how the Administrative Core intends to implement and accomplish these functions, including,
Although the COBRE transitional center awards do not require non-Federal matching funds, applications must include clear evidence of institutional commitment. The level of institutional commitment may vary across applicant institutions depending on the availability of institutional resources. At a minimum, a letter of support from a senior institutional official (e.g., President or Dean) must outline the commitment of resources and facilities to support the core center. A strategic plan as to how the cores can be sustained beyond the requested period of grant support must be provided.
Qualifications and Responsibilities of the PD/PI: The PD/PI must be an established biomedical or behavioral research scientist with demonstrated administrative leadership skills. The PD/PI is responsible for overall direction and development of the center to support collaborative research efforts within and across institutions. The PD/PI will resolve disputes arising in the priority of usage of the core facilities and will be responsible for final budget decisions with the assistance of the program coordinator. Multiple PDs/PIs are not allowed. The PD/PI should devote at least 1.2 person months to this effort. A maximum of 2.4 person months effort may be supported.
Qualifications and Responsibilities of Program Coordinator: A program coordinator may be designated to provide day-to-day operational and administrative oversight of the core facilities, help core directors set work priorities, and coordinate recommendations for major purchases of supplies, equipment upgrades, technical support staff, and other budget issues with the core directors and the PD/PI. The program coordinator should have a broad knowledge of core resources and their management and application to the projects supported by the Center. He/She should have the ability to assist the PD/PI to oversee, coordinate and support the Center’s research efforts. The program coordinator may devote up to 2.4 person months to this effort.
Qualifications and Responsibilities of Core Directors: The core director must be a scientist with expertise in the specific area of service that the core provides. The core director will be responsible for meeting with research investigators, determining which research projects are qualified to use the core, and set priorities for core usage. The core director also should provide guidance or training to investigators in the complex core techniques and methodologies to ensure that the core facilities are appropriately used. Core directors are responsible for maintaining state-of-the-art techniques and for recommending updated and/or replacement equipment, as needed, to the Program Coordinator and PD/PI. Each Core Director may devote up to 1.2 person months to the cores.
Research Core Facilities: The applicant must demonstrate that each core proposed for support will serve the scientific needs of biomedical research projects; how each core will benefit investigators and users; and how the Cores serve and/or improve the research infrastructure of the institution. Each core description should indicate the qualifications of personnel selected to manage the core facility and/or plans to recruit personnel to operate the core, if needed. Furthermore, the PD/PI should indicate any institutional commitment to support and maintain the proposed facilities. The applicant should describe the operating procedures of each core, how state-of-the-art techniques will be maintained, how quality control will be managed, how disputes concerning core usage will be resolved, and how research investigators will be trained in the capabilities of the core and the techniques required best served by the core. As appropriate to the core, applicants should describe plans for protections of human subjects from research risks, including data security and privacy protection issues; inclusion of women, minorities, and children; care and welfare of vertebrate animals, and management of biohazards.
Sharing research resources among IDeA programs is strongly encouraged. Applicants should seek to utilize existing equipment and instrumentation supported by COBRE or IDeA Networks of Biomedical Research Excellence (INBRE) awards. A table summarizing the existing core equipment must be included in the application. Requests that appear to be duplicative of existing equipment or instrumentation, including computational facilities and related bioinformatics resources, must be appropriately justified. Core facilities supported through this FOA must not duplicate currently available facilities at the institution.
It is expected that investigators outside of the applicant’s institution that utilize the core will provide service fees to the core. The service fees will offset some of the costs for the specific service provided. Waivers of the fee-for-service charge may be granted by the PD/PI in appropriately justified instances.
Research pilot project program: Applicants may request support for a pilot project program that 1) allows junior or senior investigators to generate preliminary data for submission of grant applications; 2) develops new technologies; or 3) achieves other goals, as defined by the PD/PI that will better position the institution to conduct basic and clinical research. The proposed pilot project(s) must not overlap with the ongoing funded project(s). Research plans for the individual research projects should not be included in the application. Up to $250,000 annually can be used to support the pilot project program. If such a program is proposed, the description of the pilot project program should include:
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 NIH center core grant
(P30) award
mechanism. The PD/PI 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 $10 million to support this activity, contingent upon the availability of funds. An applicant must request a project period of five years and may request direct costs up to, but no more than, $750,000 per year.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Eligibility is restricted to (1) institutions awarded a COBRE grant in response to NIH Notice RR-04-008, (http://grants.nih.gov/grants/guide/notice-files/NOT-RR-04-008.html), but not awarded a COBRE Phase III award in response to RFA-RR-09-005 (http://grants.nih.gov/grants/guide/rfa-files/RFA-RR-09-005.html); (2) institutions awarded a COBRE grant in response to NIH Notice RR-05-007, (http://grants.nih.gov/grants/guide/notice-files/NOT-RR-05-007.html).
The following types of organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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. Institutions/organizations may submit only one application per COBRE center 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). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) are permitted only a single amendment (A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new applications that were submitted prior to January 25, 2009 are 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 are not permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The current 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
Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
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
Applications must be received on or before the receipt date described below (Section IV.3.A.).
3.A. Receipt, Review and Anticipated Start Dates
Letter of
Intent Receipt Date(s): Not
Applicable
Application Receipt Date(s): July 20, 2010, July 20, 2011, July 20, 2012.
Peer Review Date(s): October-November
2010, October-November 2011, October-November 2012
Council Review Date(s): January
2011, January 2012, January 2013
Earliest Anticipated Start Date(s): April
2011, April 2012, April 2013
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
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 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]
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.
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 new 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
new 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 phase III must include the following sections and follow the page limits.
Overall Center Organization and Management Plan (12 pages):
Administrative core (12 pages):
Research cores (12 pages for each core)
Research pilot project program (12 pages):
The page limitation designated above includes tables, graphs, figures, diagrams, and charts.
Application Organization:
Application Organization
Applicants should follow the order of content described in the current PHS 398 document instructions and indicated on the Table of Contents page unless noted otherwise below:
Applicants submitting a revised application must include an Introduction that summarizes the substanitial additions, deletions, and changes. The Introduction must include responses to the criticisms and issues raised in the Summary Statement. The Introduction is limited to one page for each section. Each research core comprises a separate section. Insert the Introduction just before the very beginning of the Research Strategy. Identify within the Research Strategy 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.
Appendix Materials
No appendix material is allowed.
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
Review Process
Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NCRR and 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:
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 scored review criteria, and additional review criteria (as applicable for the project proposed).
Scored 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 core. 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?
Do the existing core resources and facilities serve the scientific needs of the research projects? For requests of new core facilities: is the request well justified in terms of the need for the core?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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?
Leadership: Does the PD/PI have the ability to provide scientific and administrative leadership and direction? Has the PD/PI shown effective leadership and judgment in the selection of research cores in terms of the cores being related to and consistent with the overall goals of the center? Has the PD/PI presented a plan to develop and maintain core laboratories as state-of-the-art through the selection of appropriate Core Directors?
Program coordinator/manager: Does the program coordinator manager have knowledge of core resources and their application to the projects supported by the Center? Has he/she demonstrated an ability to oversee and coordinate research activities?
Core Directors and Core Personnel: Do the core laboratory directors have the scientific and technical experience to manage their core facility? Has he/she demonstrated expertise in the core technologies by specific training and/or publications using such methods and equipment? Has he/she demonstrated the capability to work with many investigators across departments and institutions? Does he/she have experience in mentoring and research training for the career development of investigators who use the cores? Are the personnel who manage the core facilities as well as the technical staff well qualified?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and benchmarks
for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly
risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Administrative Core: Is the administrative core adequate to coordinate and facilitate the research, mentoring, and training supported by the COBRE cores? Are there adequate plans describing the routine daily operation of the core facility and the quality control methods for the facility? Are plans in place to ensure adequate methods for resolution of disputes of core usage and for methods to maintain the core as a state-of-the art facility? Are plans adequate to prioritize and evaluate requests for replacement or upgrade of core equipment? Are there adequate plans for training of research investigators and their staff in the techniques appropriate for optimal use of the core facility? Is the plan adequate to identify the internal steering committee, and external advisory committee (EAC), to provide ongoing assessment and evaluation of the operations of the cores? Is there an adequate plan in place to evaluate core performance?
Pilot Project Program: Are there adequate institutional plans and procedures to solicit proposals, prioritize the projects, assure compliance with applicable federal policies and guidelines for research and research protections, and to review their methodology?
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?
Has the PD/PI obtained institutional commitment ensuring the resources and facilities required to sustain the cores during and after the period of support by this program?
Overall Center Organization and Management Plan: Does the overall plan justify continued support of the proposed cores for the COBRE for an additional five years? 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?
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 PD/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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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.
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. Renewal applications are not permitted for this FOA.
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.
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/priority score.
Applications from Foreign Organizations. Foreign applications are not permitted for this FOA.
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).
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).
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.
Selection Process
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:
NIH considers the following in evaluating Center grant applications:
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.
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.
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:
J. Rafael Gorospe M.D. Ph.D.
Medical Officer
Division of Research Infrastructure
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd. Rm 941
Bethesda MD 20892
Tel No. 301-435-0832
Fax No. 301-480-3770 (Email PDFs preferred)
Email: [email protected]
2. Peer Review Contacts:
Steven
Birken, Ph.D.
Office of Review
National Center for Research Resources
National
Institutes of Health
6701
Democracy Boulevard
Bethesda,
MD 20892-4874
Bethesda,
MD 20817-4874 (for express/courier service)
Telephone:
(301) 435-0811
FAX: (301)
480-3660
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Gavin
Wilkom, M.I.M.
Office of
Grants Management
National
Center for Research Resources
National
Institutes of Health
6701
Democracy Boulevard
Bethesda,
MD 20892
Telephone:
(301) 435-0964
FAX:
301-480-3777
Email: [email protected]
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.
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 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-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 investigator’s 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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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