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 Heart, Lung, and
Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)
Title: NHLBI
Progenitor Cell Biology Consortium Administrative Coordinating Center (U01)
Announcement
Type
New
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: January 30, 2009
Letters of Intent Receipt Date: April 1, 2009
Application Receipt
Dates: May 1, 2009
Peer Review
Date: July-August,
2009
Council Review Date: August
2009
Earliest
Anticipated Start Date: September 30, 2009
Additional Information To Be Available Date (URL
Activation Date): January 12, 2009
Expiration Date: May
2, 2009
Due Dates for E.O. 12372
Not
Applicable
Additional Overview Content
Executive
Summary
Table of Contents
Part
I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
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
A. Cooperative Agreement
Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Collaborative Responsibilities
4.
Arbitration Process
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
Purpose
The National Heart, Lung, and Blood Institute (NHLBI) invites applications to participate as the Administrative Coordinating Center for the NHLBI Progenitor Cell Biology Consortium (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-004.html). The goal of the Consortium is to identify and characterize progenitor cell lineages, to direct the differentiation of stem and progenitor cells to desired cell fates, and to develop new strategies to address the unique challenges presented by the transplantation of these cells. The Consortium will assemble multiple independent research projects, each with a multi-disciplinary team of Principal Investigators, core research support facilities, and skills development components to establish synergistic virtual hubs focused on progenitor cell biology.
At present, a number of promising discoveries, technologies, and reagents are poised to have a catalytic effect on the field of regenerative biology and medicine. The aim of this initiative is to markedly accelerate progress by forming a coordinated Consortium that includes leading scientists in the field of cardiovascular, pulmonary, and hematopoietic cell biology, working closely with experts in the general field of progenitor cell biology. Additional expertise in areas such as immunology, developmental biology, bioengineering, animal model development, and imaging will also be required to develop and translate these technologies. The goal of the Consortium will be to harness advances in stem cell and progenitor cell biology to improve the understanding and treatment of cardiovascular, lung, and blood diseases. Areas of emphasis are expected to include lineages derived from murine and human embryonic stem cells, progenitor cells, somatic stem cells, and induced pluripotent stem (iPS) cells (somatic cells reprogrammed to become pluripotent), which are all included in the progenitor cell biology Consortium described in this FOA. In addition, the derivation of iPS cells from patients with genetic diseases, and differentiation of these cells to specific cell types, is expected to give unique mechanistic insight into disease processes. The development of allogeneic cell lines offers the promise of faster, simpler, and cheaper regenerative therapies, but brings new challenges in understanding immune tolerance and therapy to prevent rejection. The generation of publicly available molecular, epigenetic, and functional databases on specific embryonic stem cell lines, induced pluripotent cells, and progenitor lineages will also be a priority. Participants in the Consortium will be expected to share data and resources with the Consortium rapidly in order to promote the goals of the Consortium.
The research emphasis within the Consortium will vary depending upon the status of stem and progenitor cell science. NHLBI recognizes that fundamental knowledge of cardiovascular and pulmonary stem and progenitor cell biology, including progenitor cell lineages, lags behind the level of understanding in the hematopoietic field. Therefore, an area of emphasis is the generation of well-characterized cardiovascular and lung progenitor cell fate maps, integrated with specific approaches to identify, purify, renew, and direct the differentiation of specific lineages of interest. Another important focus will be regional and/or developmental differences in cell origin and lineage, for example proximal versus distal lung versus upper respiratory tract, and the identification of appropriate phenotypic markers to facilitate these studies. For hematopoietic studies, the de novo generation of hematopoietic stem cells (HSC) will be a key objective, taking advantage of established stem cell markers, models and reagents. Accomplishment of this goal has clear clinical implications given the uses of HSC for transplantation. The combination of cardiovascular, pulmonary, and hematopoietic cell biology within the Consortium is seen as a clear advantage anticipated to accelerate progress in all three areas. The Consortium is expected to foster innovative new technologies, reagents, strategies, and protocols that will have a major impact on scientific, translational, and clinical utility of cardiovascular, lung, and hematopoietic progenitor cell lineages.
Program Structure
The Consortium will consist of multiple virtual Research Hubs funded through an additional FOA http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-004.html, and an Administrative Coordinating Center (ACC) supporting the Consortium funded through this FOA. The ACC will also administer funds to support cores and pilot studies.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1.
Mechanism of Support
This funding
opportunity will use the Research
Project Cooperative Agreement (U01) award
mechanism(s). In the cooperative agreement
mechanism, the Project Director/Principal Investigator (PD/PI) retains the
primary responsibility and dominant role for planning, directing, and executing
the proposed project, with NIH staff being substantially involved as a partner
with the Principal Investigator, as described under the Section
VI. 2. Administrative Requirements, "Cooperative Agreement Terms and
Conditions of Award." This is a one-time solicitation to fund the Progenitor Cell Biology Consortium Administrative Coordinating Center for seven
years. The Consortium will undergo a mid-course review by the External
Advisory Committee during the fourth year of funding to determine how well the
Consortium is meeting its goals. Metrics to be assessed during the review
of the ACC will include the quality, accessibility and security of databases
established; success in facilitating interactions between Consortium research
and skills development groups through in person meetings, teleconferences and
other communication methods; quality of logistical support for meetings and
communications with the External Advisory Committee members; logistical support
for solicitation, peer review and oversight of cores, ancillary and
collaborative studies, and pilot projects; and quality of public and private
websites established. Continued funding for the ACC, and progenitor cell
biology research projects funded through FOA http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-004.html,
will be contingent on the outcomes of this review. Continuation of this
program at the end of the seven years will depend on evaluations conducted by the External Advisory Committee,
NHLBI strategic priorities, and available funds.
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
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 and the receipt of a sufficient number of meritorious
applications.
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
The following 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 as the PD/PI 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. Investigators
may submit only one application and in addition may not be included in any
application to FOA HL-09-004, NHLBI Progenitor Cell Biology Consortium (U01).
Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
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.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and
Anticipated Start Dates
Letters of Intent Receipt Date: April 1, 2009
Application Receipt Date: May 1, 2009
Peer Review Date: July-August 2009
Council Review Date: August 2009
Earliest
Anticipated Start Date: September
30, 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The
letter of intent should be sent to:
Chief,
Review Branch
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
FAX: 301-480-0730
Email: [email protected]
3.B.
Sending an Application to the NIH
Applications
must be prepared using the 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 copies of the appendix material must be sent to:
Chief,
Review Branch
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
FAX: 301-480-0730
Email: [email protected]
3.C.
Application Processing
Applications
must be received
on or before the application receipt date described above (Section IV.3.A.). If an application is received after
that date, the application may be delayed in the review process or not
reviewed. Upon receipt, applications will be evaluated for completeness
by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or
non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy
Statement can be found at 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 and Information
Awards will also be made under the Cooperative Agreement Terms and Conditions of Award noted in Section VI. 2. A
ACC Principal Investigators will be required to declare a minimum effort of 2.4 calendar months, and will be required to participate on the Consortium Steering Committees and the Coordinating Committee, as described in the companion FOAs.
Research Plan Page Limitations
In lieu of a research plan, the following items should be addressed satisfactorily by the applicant, within a maximum 25 pages.
Expertise and Experience in Logistical and Other Support Services: The ACC provides arrangements for logistical support associated with meetings and conference calls for the Consortium Steering Committee, the External Advisory Committee, the Skills Development Committee, and other meetings as required by the Consortium. The application should demonstrate substantial experience with organizing, supporting, and conducting in-person and teleconference meetings, and with the preparation of minutes and other related reports. The application should demonstrate successful experience arranging logistical services for multi-center translational or clinical research, such as overseeing selection of technical laboratories.
Capacity and Ability to Manage and Distribute Consortium Funds: The ACC will receive and disburse funds for Consortium Cores, ancillary and collaborative studies, and pilot studies for the Progenitor Cell Biology Consortium. The application should demonstrate experience with similar financial arrangements, and detail how the funds will be managed.
Electronic Information and Data Systems: The ACC will be required to oversee and coordinate communications in this complex Consortium, and will also be expected to take a leadership role in communicating with individuals and groups beyond the Consortium. Accordingly, the application should detail prior experience with these activities, including systems for management and archiving of email traffic and electronic reports, development of standard operating procedures, development of databases, and ensuring data safety and confidentiality. The ACC will be expected to develop a secure website for sharing of data, protocols and other research materials among Consortium members. In addition, the ACC will be expected to develop a public web site for the Consortium, with input from investigators and NHLBI staff. The application should demonstrate successful experience with web site development for similar programs.
Particular Strengths of PI or Institution: Applicants are encouraged to describe special or unique strengths that may be relevant to Consortium infrastructure and research. Examples, could include significant previous experience coordinating research related to progenitor cell biology, prior participation in research funded by an NIH cooperative agreement, prior development of award-winning media programs to disseminate information about research to the public, or state-of-the art biomedical or research informatics systems (e.g., innovative tools, methods and algorithms), which may be shared or may be available to develop and expand scientific productivity of the Consortium.
Willingness to Collaborate: The application should include a statement indicating willingness to engage in collaborative activities across the Consortium, in partnership with NHLBI staff, to support the goals of the NHLBI progenitor cell biology Consortium, and to accelerate translation of study findings to the scientific community and clinical practice.
Additional submission requirements for the preparation of the Detailed Budget
The ACC applicant may ask for a maximum allowable direct cost of $600,000 per year for ACC operations. In addition, the applicant should request a budget for cores and pilot studies (including subcontract F&A costs) and should request the following amounts for that support: Yrs 1&7=$1.5 million; Yrs 2&5 =$3.25 million; Yrs 3-5=$5 million.
The budget for the first year, which is a planning year, should include a minimum of 2.4 calendar months for the PI, and sufficient additional staff support to accomplish the tasks required. There will be two Steering Committee meetings in Bethesda, MD, during the first year; therefore, the budget should include funds for travel for two two-day trips to Bethesda for the ACC PI and at least one other staff member, as well as the costs associated with the meetings. Travel for the Research Hub PIs and other staff is included in the Research Hub grants. The budget should also provide for quarterly Steering Committee conference calls in the first year, as well as 6-8 additional conference calls as needs arise. It is expected that most materials for meetings and calls will be in electronic form. During the first year, the ACC should establish all communication and related processes, and begin development of the internal and public web sites.
The budgets for Years 2-7 should provide for continuing logistical support of the Consortium, quarterly calls and up to two meetings per year for the Steering Committees, as well as the selection process for Cores, and the distribution process for ancillary and collaborative study and pilot study funds to investigators within or outside the Consortium.
Annual Grantee Meeting: Upon initiation of the program, the ACC on behalf of the NHLBI will arrange annual meetings to encourage the exchange of information among the investigators who participate in this program. The annual meeting will be held in Bethesda, MD, before or after one of the Steering Committee meetings. The budget for the ACC should include funds for this meeting. Hub grantees will budget for their travel to the meeting.
The External Advisory Committee (EAC) will be selected by NHLBI, but support for their activities will be provided by the ACC. The EAC is expected to include five members, will meet in person in Bethesda approximately once a year, beginning in Year 1, and may have one or more additional conference calls each year. The ACC budget should include travel funds for EAC members, an honorarium of $200 per day for meetings and calls, and funds for the preparation of meeting and call materials.
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 use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
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: Regardless of the amount requested, investigators 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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI 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 following will be considered in making funding decisions:
The goals of NIH
supported research are to advance our understanding of biological systems, to
improve the control of disease, and to enhance health. In their written
critiques, reviewers will be asked to comment on each of the following criteria
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as appropriate
for each application. Note that an application does not need to be strong in
all categories to be judged likely to have major scientific impact and thus
deserve a meritorious priority score. For example, an investigator may propose
to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does
this study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Do the investigators have experience with coordinating basic and translational research, particularly in the areas related to progenitor cell biology?
Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.
Potential for Collaboration: Does the applicant demonstrate the ability to work as part of a multi-disciplinary team through significant prior experience in coordinating collaborative scientific research?
Coordination: Does the applicant demonstrate significant experience coordinating complex research efforts, including logistical support for meetings and calls, data management systems, and the development and archiving of reports and other documents?
Communication: Does the applicant demonstrate significant experience in development of web sites for research programs, in communication of research results to other scientists, and in communicating scientific principles to the lay public?
2.A. Additional
Review Criteria:
In addition to
the above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan section on Human Subjects in the PHS 398 instructions).
Inclusion of
Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research will be assessed. Plans for the
recruitment and retention of subjects will also be evaluated (see the Research
Plan section on Human Subjects in the PHS 398 instructions).
Care and Use
of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five points described in
the Vertebrate Animals section of the Research Plan will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3. Anticipated Announcement and Award Dates
N/A
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.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2.
Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the No A. 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).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A.
Cooperative Agreement Terms and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when state and local governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.
2.
A.1. Principal Investigator Rights and Responsibilities
The
Principal Investigator will have the primary responsibility for the overall function of the ACC. This includes the
coordination of the activities of the of the Steering Committees, External
Advisory Panel, and Consortium annual meeting; designing and maintaining
written materials and websites to support the Consortium; and allocating funds
to the Cores. The ACC will also oversee pilot study funds for the
Consortium (see Funds Available in Section II).
Awardee(s) agree to the governance of the study through a Steering Committee. Steering Committee voting membership shall consist of the Principal Investigators (i.e., cooperative agreement awardees), the NHLBI Project Scientist, and the Chairperson. Meetings of the Steering Committee will ordinarily be held by telephone conference call or in the Metropolitan Washington Area.
Study investigators are strongly encouraged to share data within the Consortium prior to publication, and to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and governance. Within three years of the end of the period of NHLBI support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance. In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NHLBI immediately upon completion of the three year period following the end of the period of NHLBI support.
Upon completion of the project, awardees are expected to put their intervention materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NHLBI, for the conduct of research at no charge other than the costs of reproduction and distribution.
Awardees will retain custody of and have primary rights to their data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The collaborative protocol and governance policies will call for the continued submission of data centrally to the coordinating center for a collaborative database; the submittal of copies of the collaborative datasets to each Principal Investigator upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NHLBI Project Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee.
Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.
2.
A.2. NIH Responsibilities
The NHLBI Project
Scientist will have substantial programmatic involvement that is above and
beyond the normal stewardship role in awards, as described below.
The NHLBI Project Scientist will serve on the Steering Committee; he/she or other NHLBI scientists may serve on other study committees, when appropriate. The NHLBI Project Scientist (and other NHLBI scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., data sharing and database development, quality control, adherence to protocol, core development.
The NHLBI reserves the right to withhold funding or curtail the study (or an individual award) in the event of (a) substantive changes in the agreed-upon workscope with which NHLBI cannot concur, (b) human subject ethical issues that may dictate a premature termination.
Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NHLBI support; or special access to study results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI.
Additionally, an agency program official or NIH program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.
2.A.3.
Collaborative Responsibilities
Awardees agree to the governance of the Consortium through
the Steering Committee. Membership will include, at a minimum, the
Consortium PIs, the PI of the Administrative Coordinating Center, and the NHLBI
Project Scientist. The Steering Committee Chair will be appointed by
NHLBI. Additional members may be added by majority vote of the Steering
Committee.
Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.
2.A.4. Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3.
Reporting
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:
Denis
Buxton, Ph.D.
Division of
Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Rockledge 2, Room 8216
6701
Rockledge Dr, MSC 7940
Bethesda,
MD 20892
Telephone:
(301) 435-0513
Email: [email protected]
2. Peer
Review Contacts:
Chief,
Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
3.
Financial or Grants Management Contacts:
Ron
Caulder
NHLBI/Office of Grants Management
Rockledge II
6701 Rockledge Drive,
Room 7162
Bethesda, MD 20892
Phone: 301-435-0166
Fax: 301-451-5462
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. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the 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/
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of
Model Organisms:
NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of
Women And Minorities in Clinical Research:
It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy continues
to require for all NIH-defined Phase III clinical trials that: (a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and (b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required
Education on the Protection of Human Subject Participants:
NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic
Stem Cells (hESC):
Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy 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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