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: Clinical
Coordinating Center for the Severe Asthma Research Program (SARP) (U10)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: May 26, 2010
Letters of
Intent Receipt Date: September
15, 2010
Application Receipt Date: October 15, 2010
Peer Review
Date: March 2011
Council Review
Date: May 2011
Earliest
Anticipated Start Date: July 1, 2011
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: October 16, 2010
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
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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution 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
Asthma affects 22 million
people in the United States. Although most patients have mild-to-moderate
asthma that responds well to treatment, 5-10% exhibit severe disease. These
account for more than half of the estimated $19.7 billion annual costs of
asthma, which is the 5th most costly chronic disease. Severe asthma is an
escalating public health problem world-wide. Severe in contrast to
mild-moderate asthma is characterized by continuous rather than episodic
symptoms, frequent exacerbations, progressive decline in lung function and
limitations to physical activity despite aggressive therapy, including
high-dose inhaled and systemic corticosteroids. These patients suffer higher
morbidity and mortality, are largely insensitive to available therapies, and
endure serious side effects from their intensive yet modestly effective
treatments. Current understanding of these complex processes and attendant
interactions is limited, thus improvements in care remain elusive.
Accumulating evidence suggests that severe asthma is heterogeneous in several dimensions including age of onset, sex, allergic response, comorbidities, patterns of inflammation, and response to treatment. Recognizing that severe asthma consists of groups of patients with distinct underlying phenotypes has important implications for how to target therapies, but the understanding thus far primarily derives from cross-sectional data. SARP will develop a new paradigm for the understanding of severe asthma and its sub-phenotypes, in children and adults, by defining disease at the molecular and cellular level longitudinally. There is a paucity of information on the evolution of pathobiology and disease presentation over time that makes it difficult to predict clinical course and optimal treatment. Disease definition will be characterized through identification and validation of phenotypic traits that are based on underlying pathobiology and pathophysiology rather than clinical manifestations which can lead to an oversimplified approach to diagnosis and treatment. Definition and phenotyping at the cellular and molecular level over time will provide a comprehensive understanding of the evolution of disease and serve as a rational basis for the design of mechanism-based diagnostic, prognostic and treatment strategies for severe asthma in children and adults.
The purpose of this new phase of the Severe Asthma Research Program (SARP) is to promote collaborative, multidisciplinary research using a mechanistic-based temporal approach to achieve the following objectives:
Central to success of the new Severe Asthma Research Program will be the establishment of a Clinical Coordinating Center (CCC). Applicants for the CCC should be familiar with RFA-HL-11-018, announcing an open competition to participate as a Clinical Center in SARP, to learn more about the scientific objectives and operational structure of SARP. The CCC Principal Investigator is expected to share in the scientific leadership and strategic planning of the SARP collaboration through the Steering Committee. In addition to activities presented below, it is anticipated that the CCC will enable the performance and productivity of SARP by identifying synergies and points of leverage with other federally sponsored projects (e.g., CTSA, SCCOR, PPG, R01). For example, applicant could present a plan to utilize CTSA expertise and resources to address the scientific objectives of SARP with greater efficiency and success than otherwise might be achievable. The CCC is expected to provide the methodological, analytical, managerial, website, computer systems, logistical and administrative expertise for the following activities:
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 a cooperative agreement award mechanism. 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 SARP for six years. It is expected that mechanistic studies and longitudinal protocol will be completed within the 6-year time period. Plans beyond the current funding period are indefinite.
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).
This funding opportunity will use a cooperative agreement award mechanism. 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".
2. Funds Available
The total amount of funding
that NHLBI expects to award for SARP (for up to six clinical centers and one
CCC) is $31.5 million for a project period of 6-years. Designated funding
levels are subject to change at any time prior to award, due to unforeseen
budgetary, administrative, or scientific developments.
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 program support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Principal Investigator must possess a doctoral degree in a relevant field such as biostatistics, clinical epidemiology, biomedical informatics or other relevant area. The PI must have experience in multicenter interventional clinical research and statistical expertise.
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. Applicants
may submit more than one application, provided they are scientifically
distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Awards will not be made with the same person serving as Principal Investigator on a Clinical Center and on a Clinical Coordinating Center to ensure that data analyses and data acquisition are fully independent.
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 and 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.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
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
Letter of Intent Receipt Date: September 15,
2010
Application Receipt Date: October 15,
2010
Peer
Review Date: March 2011
Council
Review Date: May 2011
Earliest Anticipated Start Date: July 1, 2011
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:
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC7924
Bethesda, MD 20892-7924 (Express mail zip: 20817)
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:
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC7924
Bethesda, MD 20892-7924 (Express mail zip: 20817)
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
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information.".
Applicants should describe qualifications and experience in the appropriate narrative sections of the application and in biosketches. Principal Investigator must possess a doctoral degree in a relevant field such as biostatistics, clinical epidemiology, biomedical informatics or other relevant area. The Principal Investigator must have experience in multicenter interventional clinical research and statistical expertise.
Budget Information: Applicants should consider the following guidance in preparing the PHS 398 budget page forms. All costs in the proposed budget should include appropriate justification. For budget planning assume that during the first year a shared longitudinal protocol will be initiated within six months. A detailed description of potential research approaches, questions/topics and organizational structure for SARP are presented in the FOA for Clinical Centers (see RFA-HL-11-018). The budget for each year should include direct costs among (1) Operational Costs and (2) Clinical Research Costs as described below. Present each budget with separate PHS 398 forms. The cumulative direct costs for Operational Costs and Clinical Research Costs should not exceed direct costs of $350,000 in the first year, and $395,000 direct costs for years 2-6.
Operational Costs include funds to support SARP activities not directly related to clinical research, including:
Clinical Research Costs include (1) Longitudinal Protocol Initiation Costs and (2) Longitudinal Protocol Execution and Close-out Costs at the CCC. For budget planning, assume that 750 children and adults (125 participants per clinical center) will be enrolled across six clinical centers in the shared longitudinal protocol during each of the first three years (N=2250) of the project period. Approximately 3500 data items per participant will be collected over 36- to 48-months of rolling accrual. Accrual should begin within six-months of award.
Longitudinal Protocol Initiation Costs may include:
Longitudinal Protocol Execution and Close-out Costs may include:
Protocol funds ($4,000,000) to develop and execute a shared longitudinal protocol will be part of the Clinical Coordinating Center grant and will be distributed by the CCC to the Clinical Centers in accordance with budget approved by the Steering Committee and NHLBI. The CCC should request Longitudinal Protocol Costs (Protocol Costs) in total cost amounts of $450,000, $700,000, $800,000, $800,000, $600,000 and $600,000 for years 1, 2, 3, 4, 5 and 6 in the project period, respectively.
Applicants should modify the Research Plan section of PHS 398 Table of Contents with the following items (1 5), in order, with a maximum of 12 pages to provide evidence of skills and ability to:
1. Scientific Leadership and Scholarship. Participate in the scientific leadership and strategic planning of the SARP collaboration through the Steering Committee. Assume a lead role in concept development, feasibility, clinical research design and data analyses. Applicants are encouraged to describe special or unique strengths that may be relevant to SARP research. These can include state-of-the art informatics systems (e.g., innovative tools; methods and algorithms; computational approaches that integrate molecular and clinical phenotyping). Applicants should provide evidence of scholarship as Principal Investigator of a Clinical Coordinating Center (or equivalent activity) in previous or ongoing clinical trials, especially those of a cooperative or multicenter design.
2. Performance Leadership. Enhance performance and cost effective productivity of SARP by identifying and capitalizing on synergies and points of leverage with other federally sponsored projects (e.g., CTSA, SCCOR, PPG, R01). For example, applicant could present a plan to utilize CTSA expertise and resources to address the scientific objectives of SARP with greater efficiency and success than otherwise might be achievable.
3. Operations Management. Provide management/coordination of research and administrative support of SARP activities. Develop Manual of Operating Procedures (e.g., sputum induction, spirometry), data collection forms, study manuals, and data entry and collection systems. Applicants should provide evidence of data management and program support capabilities by describing the plan for data collection, management, analysis, data security and backup, privacy protections, and quality control. Plan should include approach to (1) monitoring patient safety, protocol execution quality, data entry quality, and participant accrual in shared protocol; (2) providing relevant reports to NHLBI, Steering Committee (SC) and Data and Safety Monitoring Board (DSMB); and (3) training and competence certification of research staff at the Clinical Centers.
4. Logistical and Communication Support. Plan, arrange for, and support meetings and teleconferences of the SC and its subcommittees, DSMB and other meetings as required by SARP. Facilitate communication among CCC staff and other components of SARP. Plan should include support of electronic mail and a Website. The Website should have password-protected access and provide secure distribution of study documents, forms, and metrics of study progress and performance. Plan should include an open-access web site that communicates information about SARP to the public and prospective research participants.
5. Distribute Funds for Shared Longitudinal Protocol. Manage and distribute funds to the Clinical Centers for conducting the longitudinal protocol. Applicant should present a plan for distribution of funds to conduct the shared longitudinal protocol.
Applicants should modify the Research Plan section of PHS 398 Table of Contents with the following standard items to provide information according to the instructions accompanying the PHS 398 form.
6. Bibliography and References Cited/Progress Report Publication List.
7. Human Subjects (Guidance suggestion: Check Yes for Item 4 of the PHS 398 application Face Page and in this section include a paragraph stating that as CCC, you will not interact directly with research subjects and that you acknowledge your responsibility to (1) coordinate inclusion of women, children and minorities among clinical centers according to NIH policies; (2) monitor recruitment; (3) assure current IRB approval among clinical centers and CCC; and (4) coordinate protection of human subjects according to NIH policies and through coordination of DSMB activities.)
8. Consortium/Contractual Arrangements.
9. Letters of Support.
10. Resource Sharing Plan.
11. Plan for Dissemination of Research Findings (for guidance see below).
Application is expected to include a plan for dissemination of research findings and should include:
PHS398 Research Plan Sections
All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:
Budget
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
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.. 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/.
Applicants should include a plan for sharing research data and submitting Genome-Wide Association Studies data to the NIH-designated GWAS data repository. All Clinical Center applicants in response to the SARP Clinical Centers FOA should indicate here their willingness to participate in data sharing and submitting Genome-Wide Association Studies (GWAS) data to the NIH-designated GWAS data repository. The precise content of the data-sharing plan ultimately developed by the Clinical Coordinating Center will vary, depending on the data being collected and how the investigators in the Steering Committee are planning to share the data.
It is expected that SARP research resources such as Manual of Operating Procedures, study manuals, case-report forms, phenotype ascertainment tools, and data will be made available to the public after publication of study findings (e.g., through the National Technical Information Service, see http://www.ntis.gov/index.asp). The Clinical Coordinating Center applicants will include a plan for sharing these resources in response to RFA-HL-08-011. Clinical Center applicants in response to this FOA should indicate here their willingness to cooperate with this resource sharing.
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 and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 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. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does applicant demonstrate ability to participate as an intellectual collaborator and science/technology enabling partner? What is the experience of the proposed CCC team, as a whole, in supporting multisite, collaborative clinical research?
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? Does the
applicant propose adequate plans to:
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? Is there evidence of experience with multicenter clinical research and datasets (not necessarily in asthma), and of the availability of an infrastructure to support the appropriate storage, management, and analyses of data generated, including genetic and omics datasets? What is the quality of the organizational and administrative structure, including the capacity to assure quality control of data, data entry, confidentiality of data, distribution of shared longitudinal protocol funds to Clinical Centers and proposed plans for day-to-day coordination? What is the quality of the Institutional commitment to support the CCC proposed program?
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. Resubmission applications are not permitted in response to this FOA.
Renewal Applications. Renewal applications are not permitted in response to this FOA.
Revision Applications. Not applicable to this FOA.
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); (3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html; and (4) Applicant will prepare public-use files for sharing research resources, such as methods of procedures, study manuals, case-report form templates, patient-centric diary templates and phenotype ascertainment instruments (e.g., National Technical Information Service -- http://www.ntis.gov/). The reasonableness of the data-sharing plan proposed by the Clinical Coordinating Center applicants will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
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
The following will be considered in making funding decisions:
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.
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.
Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award
costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All
NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
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 Clinical Coordinating Center Principal Investigator will be responsible for the overall function of the CCC, which is to coordinate, administer, and support all SARP research activities. The CCC PI will be responsible for oversight of longitudinal protocol development, data collection, data safety and confidentiality, quality assurance, data analysis, coordination of data distribution, and implementation of all data sharing plans. The CCC PI will be responsible for the distribution of longitudinal protocol funds to the Clinical Centers (see Funds Available in Section II. 2.). The CCC PI will be responsible for coordination of the activities of the Steering Committee and Data and Safety Monitoring Board and for coordinating manuscript preparation.
The Clinical Center Principal Investigator will have the primary responsibility for: all aspects of the research plan, including participating in overall development of protocol and budget in collaboration with the Steering Committee, modifying protocol if indicated, recruiting protocol participants, executing the longitudinal protocol, assuring quality of protocol participant care and protocol adherence, assuring the accurate and timely transmission of data collected in conjunction with the CCC, analyzing and interpreting data, preparing publications, and working with the CCC and NHLBI to disseminate research findings. Clinical Center PIs also will be responsible for working with the Steering Committee to (1) to develop common guidelines and Methods of Operations for all SARP studies; (2) identify core constructs (e.g., asthma severity, control, responsiveness to therapy) for developing clinical asthma history and phenotype ascertainment tools, standardized procedures and outcome measures, and when possible harmonize phenotypes that apply uniformly to children and adults where appropriate; and (3) promote collaboration across SARP to develop a comprehensive framework for evaluating the effectiveness of SARP, and for defining indicators (metrics) that SARP is achieving proposed goals.
Support
or other involvement of industry or any other third party in the SARP protocol
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. Awardees must follow NHLBI
policy concerning third party agreements (http://www.nhlbi.nih.gov/funding/policies/thirdparty.htm).
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
An
NIH Project Scientist will have substantial programmatic involvement that is
above and beyond the normal stewardship role in awards, as described below.
Additionally,
an agency program official or IC 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 the NIH
Project Scientist. SARP will have an NIH Project Scientists who will also serve as program
director; he/she will share participation in overall Steering Committee
activities. Several procedures are in place to manage potential conflict of
interest by project scientist (PS) administering the cooperative agreement.
These include: the PS adhere to stringent NIH ethics rules and financial
disclosure reporting to eliminate overt and perceived conflict of interest; PS
is prohibited from observing scientific review of competing applications from
an investigator with whom they have published in the last three years;
recommendations from PS about budgetary requests (e.g., carryover,
administrative supplements, no-cost extensions) are reviewed and approved by
supervisors (e.g., Branch Chiefs, Division Director, and Institute Director);
recruitment progress is reviewed by study independent staff (quarterly within
the Division; quarterly or semi-annually by the DSMB and supervisory staff; PS
may be asked to leave the room during DSMB reviews of studies; recommendations
made by PS in annual progress reports are reviewed by grant specialists with a
separate Division (Office of Grants Management); PS will not seek co-authorship of
primary publications and will obtain approval by Branch Chief to participate in
secondary publications.
The NHLBI
Project Scientist may work with awardees on issues coming before the Steering
Committee and, as appropriate, other committees (e.g., recruitment,
intervention, follow-up, quality control, adherence to protocol, assessment of
problems affecting the study and potential changes in the protocol, data and
safety monitoring, final data analysis and interpretation, preparation of
publications, and development of solutions to major problems such as
insufficient participant enrollment). 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.
The NHLBI reserves the right to terminate or curtail any SARP study (or an
individual award) in the event of (1) failure to develop or implement mutually
agreeable collaborative longitudinal protocol; (2) substantial shortfall in
participant recruitment, follow-up, data reporting, or quality control; (3)
major breach of a protocol or substantive changes in the agreed-upon protocol
with which NHLBI cannot concur; (4) attaining of a major study endpoint before
schedule with persuasive statistical significance, or (5) human subject ethical
issues that may dictate a premature termination.
Annual
continuation and level of funding for each Clinical Center will be based on
NHLBI review of accrual, scientific progress and overall performance,
determined as part of the NHLBI review of the annual non-competing continuation
grant progress reports submitted by awardees.
2.A.3. Collaborative Responsibilities
Awardees agree to the governance of studies through a
Steering Committee (SC). All Principal Investigators, an NHLBI representative,
and a Chairperson, to be appointed by the NHLBI, will comprise the SC. All
major scientific decisions will be determined by majority vote of the SC. Each Clinical Center, the Clinical Coordinating Center, and the NHLBI Project Scientist will have
one vote; the Chair will have one vote in case of a tie. It is anticipated that
SC meetings will be held twice a month by conference call and six times a year
in person.
A Data and Safety Monitoring Board (DSMB) will be appointed by the Director,
NHLBI to provide overall monitoring of study performance, interim data, and
safety issues. The Steering Committee may nominate members for the DSMB. DSMB
meetings will ordinarily be held in Bethesda. An NHLBI scientist, other than
the NHLBI Project Scientist, shall serve as Executive Secretary to the DSMB.
Each
full member will have one vote. Awardee members of the Steering Committee will
be required to accept and implement policies approved by the Steering
Committee.
2.A.4.
Dispute Resolution 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 Dispute
Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter 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:
Robert Smith, Ph.D.
Division
of Lung Diseases
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive
Bethesda, MD 20892-7952
Telephone:
(301) 435-0202
Email: [email protected]
2. Peer Review Contacts:
Director, Office of
Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC7924
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: (301) 435-0270
FAX: 301-480-0730
Email: [email protected]
3. Financial or Grants Management Contacts:
Dianna Jessee
Office of
Grants Management
Division
of Extramural Research Activities
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive
Room 7170,
MSC 7926
Bethesda, MD 20816-7926
Telephone:
301-435-0154
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.
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-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 PA is related to one or more
of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements
of Executive Order 12372. 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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