and Human Services (HHS)
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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: Pediatric
Heart Network (U10) Limited Competition for the Data Coordinating Center
Announcement Type
New
Related Notices
Request For Applications (RFA) Number: RFA-HL-11-027
Catalog of Federal Domestic Assistance Number(s)
93.837
Key Dates
Release Date: July 19, 2010
Letters
of Intent Receipt Date: September
29, 2010
Application Receipt Date(s): October 29, 2010
Peer
Review Date(s): February-March
2011
Council
Review Date: May 2011
Earliest Anticipated Start Date: July 1, 2011
Additional Information To Be
Available Date (Url Activation Date):
Expiration
Date: October 30, 2010
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
The primary objective of this limited Funding Opportunity
Announcement (FOA) is to support the Data Coordinating Center for the Pediatric Heart Network (PHN).
The mission of the PHN is to improve the health and quality of life for
children, adolescents, and young adults with congenital and acquired heart
disease through multicenter collaborative clinical research. The PHN provides
an infrastructure to permit multi-center evaluation of medical, interventional
and surgical therapies; to serve as a training platform for fellows, junior
faculty and nurses; and to disseminate results of studies to improve the
scientific basis for the care of affected individuals. A separate FOA for
the PHN Clinical Centers (HL-11-010)
has been issued.
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
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. 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
Purpose
This funding opportunity announcement (FOA) issued by the National Heart, Lung, and Blood Institute (NHLBI) is a component of the Pediatric Heart Network (PHN). The reissued PHN focuses on research to improve the health of children and adults with structural congenital heart defects, as well as children with inflammatory heart disease, heart muscle disease, and arrhythmias. Clinical Centers will be funded through a companion FOA (HL-11-010).
This FOA is a limited competition solicitation to continue the operation of the PHN Data Coordinating Center. Only the current PHN Data Coordinating Center awardee is eligible to apply in response to this FOA. (Note that the companion FOA for PHN Clinical Center awards HL-11-010 solicits applications from all qualified applicants.)
Background
Congenital cardiovascular malformations affect approximately 40,000 infants in the United States each year and are one of the leading causes of infant mortality. Improved medical and surgical management in the past 20 years has produced a growing number of adults with congenital heart disease, whose numbers are now estimated between one to two million. In addition, a significant number of children suffer from acquired heart disease due to inflammatory cardiac conditions, primary cardiac muscle disease, and arrhythmias. Affected individuals experience morbidity and mortality that generate health and economic consequences out of proportion to their numbers.
The major barriers to clinical studies in pediatric heart disease include the heterogeneity of conditions, the small numbers of individuals with a particular malformation or condition at any one center, differences in treatment approaches to particular problems between centers, and the absence of systematic centralized databases. The PHN has, since 2001, provided the infrastructure for nine collaborative studies, and trained nearly 300 investigators and study coordinators, and has demonstrated the efficiency of conducting research through a common infrastructure for recruiting, monitoring, and following patients whose conditions can be characterized in a standard fashion. More information about the PHN, including current and completed studies, can be found at the Pediatric Heart Network website.
Treatment of congenital and acquired pediatric heart disease involves a complex array of medical, surgical, and catheter-based approaches. Great strides have been made in diagnosing and treating congenital and acquired heart disease, but important clinical questions remain unanswered. Few therapies now used as "standard therapy" in the treatment of pediatric heart disease have been tested in randomized controlled trials.
Program Objectives
The primary mission of the PHN is to address important clinical management questions in congenital heart disease in children or adults, and inflammatory cardiovascular disease, cardiac muscle disease, or arrhythmias in childhood, through multi-center collaborative clinical research. The objectives of the PHN are to provide an infrastructure this research and to evaluate diagnostic, medical, interventional, and surgical therapies. Results of Network studies are expected to be widely disseminated and to improve the scientific basis of care for affected individuals.
Equipping pediatric cardiovascular researchers with the skills and experience needed to conduct multi-center clinical trials is essential to carrying out the aims of the PHN. The PHN Executive Committee will conduct a needs assessment to determine how to allocate the designated funds to support research training at the Clinical Centers. This could include providing support to fellows and junior faculty for developing writing topics and secondary analyses of PHN data, travel to attend PHN or professional meetings to present research results or to support ancillary studies conducted within the Network.
Organization of the Pediatric Heart Network (PHN)
The PHN is a cooperative Network of Clinical Centers, a Data Coordinating Center, a Network Chair, and NHLBI Project Scientists.
Clinical Centers are responsible for proposing and developing protocols, recruiting study subjects, entering data into the web-based data collection system, other aspects of conducting the research, training junior investigators, and disseminating research findings. All individual Clinical Centers are required to participate in a cooperative and interactive manner with one another and with the Data Coordinating Center.
The Data Coordinating Center supports protocol development; provides sample size calculations, statistical advice, common questionnaires, and data analysis; supports manuscript preparation; and provides overall study coordination and quality assurance, including coordination of the activities of the Data and Safety Monitoring Board (DSMB), the Protocol Review Committee (PRC), the Steering Committee, and other standing committees. Funds to support execution of the protocols at the Clinical Centers will be part of the Data Coordinating Center grant award and be distributed to the Clinical Centers by the Data Coordinating Center on a per patient basis and according to the approved protocol budgets.
The Executive Committee is the main governing body of the PHN. The Executive Committee is composed of the Principal Investigators of the Clinical Centers and the Data Coordinating Center, the Network Chair, and NHLBI staff. The Executive Committee has primary responsibility for the general organization of the PHN, the approval of clinical protocols and protocol changes, the conduct and monitoring of studies, and the expeditious reporting of study results. All major scientific and administrative decisions are determined by majority vote of the Executive Committee, which meets quarterly, and reports to the PHN Steering Committee.
The Steering Committee consists of all PHN investigators from the Clinical Centers and auxiliary sites, staff members from the DCC and NHLBI, and the PHN Chair. The Network Chairperson is named by NHLBI to oversee and guide Executive and Steering Committee activities. PHN investigators, study coordinators, Data Coordinating Center statisticians and staff, and NHLBI staff meet in person an average of twice a year and by teleconference on a monthly basis. Subcommittees are established as necessary and membership includes physician and nurse investigators from the Clinical Centers, representatives from the Data Coordinating Center, and ex officio members from NHLBI.
NHLBI is responsible for organizing and providing overall support for the PHN. The NHLBI Program Office and Office of Grants Management are responsible for the overall management. In addition to regular grant stewardship, the NHLBI Project Scientists will be involved substantially with the awardees as a partner, consistent with the Cooperative Agreement mechanism. The NHLBI will appoint the Protocol Review Committee, the Data Safety and Monitoring Board, and the Study Chair.
An independent Protocol Review Committee (PRC), established by the NHLBI, provides scientific peer review for each protocol. The PRC will provide a written critique of each proposal and a final recommendation to the NHLBI.
A Data Safety and Monitoring Board (DSMB), also established by the NHLBI, monitors patient safety and reviews performance of each study. As a part of its monitoring responsibility, the DSMB submits recommendations to the NHLBI regarding the conduct and continuation of each protocol.
Specific Research Objectives and Requirements for the PHN Data Coordinating Center
The PHN conducts clinical research with multiple studies active at any given time. During this grant cycle, the emphasis will continue to be on research that is based on a thorough evaluation of the most important problems facing affected children and young adults. Studies proposed should require the collaborative infrastructure of the PHN, and should be able to be completed in a three-to-five year time frame.
Once the Clinical Centers are convened in the new grant cycle, the PHN Steering Committee and Executive Committee consider each proposed protocol, and prioritize them along with other research ideas. Protocols are developed collectively by a study committee with membership from all Clinical Centers, the Data Coordinating Center, and NHLBI. Protocols undergo peer review by an independent PHN Protocol Review Committee.
The PHN DCC plays an important role in study design, conduct, and analysis as well as overseeing the broad scope of PHN research and integrating the efforts of individual PHN Clinical Centers (HL-11-010). The DCC also has substantial responsibility for the continued evaluation of PHN clinical center awardees and evaluation of the entire PHN. To fulfill these roles, the DCC applicant team must have prior experience in the design and analysis of multi-center pediatric cardiovascular trials, coordinating large multi-center pediatric cardiology research programs, providing logistic infrastructure and support for such programs, evaluating complex programs, and planning/implementing research results dissemination programs.
The DCC will be expected to provide intellectual, scientific leadership as well as logistic support for the Network and will work to bring together expertise and data relevant to the funded research. The DCC should be able to connect available resources and serve as a research data management center. The PHN DCC will be expected to integrate activities of all of the awarded PHN Clinical Centers to minimize resources/effort duplication and utilize existing resources available and will have substantial responsibility for the continued evaluation of PHN awardees and the evaluation of the entire PHN.
The applicants must have appropriate professional expertise and experience in the areas defined above. The applicant institution must have the necessary facilities to meet the special requirements mentioned in the FOA.
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 Cooperative Agreement (U10) 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." Plans beyond the
current funding opportunity 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).
2. Funds Available
NHLBI intends to commit approximately $64 million to fund eight awards for Clinical Centers and one award for a Data Coordinating Center for a five-year period.
It is anticipated that the FY 2011 award for the Data Coordinating Center will be approximately $2,500,000 direct costs plus $3,530,880 direct costs in patient care funds. All patient care funds will be awarded to the Data Coordinating Center for subsequent distribution to the Clinical Centers as recruitment in protocols proceeds. Future year amounts will depend on annual appropriations. Funds to support clinical research skills training and development will be set aside in the DCC budget at $400,000 direct costs per year.
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
Only the current PHN Data Coordinating Center
awardee institution is eligible to apply in response to this FOA.
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://grants.nih.gov/grants/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.
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 only submit one application in response to this
FOA.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The current PHS 398
application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
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. Box 1, Title of the
Project should state Pediatric Heart Network DCC.
Qualifications and experience
The DCC must demonstrate experience leading and coordinating complex multi-center clinical pediatric cardiology studies, including activities such as:
The DCC must have the ability to provide online resources for collaborative writing and communicating, must outline a plan for obtaining robust regulatory consultation and must demonstrate the ability to apply for and hold any Investigational New Drug applications (INDs) required for new studies.
Applicants must agree, if awarded, to accept the Cooperative Agreement Terms and Conditions of Award in Section VI. 2. A. Award Administration Information. Awards will be subject to administrative review annually.
Budget Plans
Budgets should be prepared for five 12-month periods. The budget justification for each year should include a table that apportions the direct costs among the following categories: patient care costs, core lab costs, auxiliary site subcontracts, and infrastructure. The DCC applicant should assume that three to four protocols will be active in the first year (continuing from the current grant period), and that at least three protocols will be developed and begin active recruitment during the grant period covered by this FOA. Studies begun in this grant period will not necessarily be concluded by the end of the grant period. The budget should include, but is not limited to:
Research Strategy and Table of Contents: Each applicant should follow the directions for the Table of Contents and Research Strategy contained in the PHS 398 Application Guide: (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Research Strategy: The research plan should demonstrate knowledge of the conduct of multi-center clinical studies in the field of pediatric cardiology. It should include the following components:
Research Team
The Principal Investigator(s) must have a demonstrated track record of successful leadership of a multi-disciplinary team, including the ability to communicate with and ensure collaboration among all PHN entities. The major strengths and critical expertise of the DCC team members should be described in sufficient detail to demonstrate the ability to manage multiple studies at various stages of study design, management and closeout as outlined in the section below.
Study design and management
The applicant should describe their experience with representative studies from the PHN as a means of discussing their approach to key scientific aspects of study design and conduct, such as outcome measures, methods of randomization, sample size and power calculations, and protection of vulnerable subjects.
The applicant should describe proposed administrative and quality assurance approaches for PHN clinical research, including methods for and frequency of data collection and entry; monitoring accuracy of data collection; quality control procedures including training and certification for multiple protocols occurring simultaneously; and labeling and handling of blood samples or other specimens.
The applicant should describe plans for administrative management of the PHN, including the DSMB, the Protocol Review Committee, the Executive and Steering Committees, and associated subcommittees.
A plan should be described for web-based protocol training, web-based annual Good Clinical Practice training, and financial oversight of the PHN. A plan should be included for the ongoing management of both public and secure web sites that includes information for families and investigators.
Most PHN protocols require central laboratories for uniform interpretation of key study data, such as laboratory samples or imaging studies. The specific central lab(s) needed will depend on the protocols ultimately selected. The applicant should describe the process for identifying and securing the necessary central lab(s) once specific protocols are approved. The applicant should describe the operation of a central lab for echocardiography. The processes for shipping, tracking, and storage of blood or tissue specimens should also be described.
The applicant should describe plans for drug acquisition and distribution when required for protocols.
The applicant should describe the process for developing study budgets, and distributing study funds to the Clinical Centers.
The applicant should describe plans for the continued development of the PHN Bioinformatics Grid, focusing on implementation of common nomenclature and image processing.
The applicant should describe plans for efficient dissemination of study results to the scientific community and study participants.
Protection of Human Subjects: In the Form 398 section on Human Subjects, the data and safety monitoring plan requirements can be addressed as follows:
Applications with Multiple PDs/PIs
The DCC applicant institution is highly encouraged to propose multiple PDs/PIs in its application.
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.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
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 29, 2010
Application Receipt Date(s): October 29 2010
Peer Review Date(s): February-March
2011
Council Review Date: May
2011
Earliest
Anticipated Start Date(s): 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 Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Two Rockledge Centre, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
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 Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Two Rockledge Centre, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
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 NHLBI. 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 or renewal award if such costs: 1) are necessary to conduct the
project, and 2) would be allowable under the grant, if awarded, without NIH
prior approval. If specific expenditures would otherwise require prior
approval, the grantee must obtain NIH approval before incurring the cost. NIH
prior approval is required for any costs to be incurred more than 90 days
before the beginning date of the initial budget period of a new or renewal award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements
For cooperative agreements, awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."
PHS398 Research Plan Sections
All application instructions outlined in the PHS398 Application Guide 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 should 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
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 the National Heart, Lung, and Blood Institute 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? What
is the quality of the statistical
and administrative capabilities of the investigators and staff? What is the
quality of the experience of the investigators in administering collaborative
research and clinical networks? 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?
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?
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?
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. Resubmissions are not allowed for this FOA.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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 are not allowed.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research; (2) the registration status of all entities where Select Agent(s) will be used; (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s); and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); (2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
The following will be considered in making funding decisions:
NIH considers the following in evaluating Center grant applications:
3. Anticipated Announcement and Award
Dates
Not
Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
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
Identify terms and conditions/requirements that the awards
include, so that potential applicants may identify any with which compliance
would be difficult (e.g., if human subjects are involved or if there are
special terms on intellectual property, data sharing, or security
requirements). See also VIII-Other Information for required Federal Citations
and provide additional instruction here, as appropriate; and subsection IV.5.
Funding Restrictions.
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 DCC Principal Investigator(s) will be responsible for the overall function of the DCC, which is to coordinate, administer, and support all PHN research and training activities. The DCC PI(s) will be responsible for oversight of protocol development, drug acquisition and distribution, data collection, data safety and confidentiality, quality assurance, data analysis, coordination of data distribution, and implementation of all data sharing plans. The DCC PI(s) will be responsible for the distribution of protocol funds to the Clinical Centers. The DCC PI(s) will be responsible for the editorial and meeting coordination for manuscript preparation, coordination of the activities of the Steering and Executive Committees, Study Committees, other Subcommittees established for the PHN, the Protocol Review Committee, and the Data and Safety Monitoring Board.
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.
Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study in accordance with study protocols and governance. For applicable studies, 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, within three years of the end of the period of NHLBI support, provided such release is consistent with the study protocol and governance.
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
NIH Project Scientists
will have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below.
The NHLBI Project Scientists will monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and ensure adherence to NHLBI policies. NHLBI will appoint the Network Chair, all members of the Protocol Review Committee (PRC), and the Data and Safety Monitoring Board (DSMB). The Network Chair will be responsible for ensuring that there are well-documented policies, procedures, and bylaws to guide all aspects of Network activities and operations.
The NHLBI Project Scientists will serve on the Steering Committee and other study committees, when appropriate, and will have one vote. The NHLBI Project Scientists 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 possible changes in protocol, interim 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 reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol; (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (c) major breach of the protocol or substantive changes in the agreed-upon protocol with which NHLBI cannot concur; (d) attaining of a major study endpoint before schedule with persuasive statistical significance; or (e) human subject ethical issues that may dictate a premature termination.
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.
2.A.3.
Collaborative Responsibilities
Awardee(s) agree to the governance of the study through a
Steering Committee. The Steering Committee will have primary
responsibility for the conduct of protocols and the preparation of
publications. Steering Committee voting membership shall consist of all
Principal Investigators (i.e., cooperative agreement awardees), one NHLBI
Project Scientist, and the Chairperson. 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.
An independent Protocol
Review Committee will provide peer review for each network protocol. A
Data and Safety Monitoring Board will provide overall monitoring of interim
data and safety issues. Both are appointed by the Director, NHLBI. An
NHLBI scientist, other than the NHLBI Project Scientist, shall serve as
Executive Secretary to the Boards. Because the Boards serve as
independent groups advisory to the NHLBI, study investigators will not
communicate with Board members regarding study issues, except as authorized by
the Board’s Executive Secretary.
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.
NHLBI policy requires that the Data
Coordinating Center report quarterly on recruitment in all Network Studies that
propose to enroll more than 150 patients.
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:
Gail Pearson, MD, ScD
Division
of Heart and Vascular Sciences
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 8104
Bethesda,
MD 20892-7940
Telephone:
(301) 435-0510
FAX:
(301) 480-2858
Email: Pearsong@mail.nih.gov
Victoria
Pemberton, RNC, MS, CCRC
Division of Heart and Vascular Sciences
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive, Room 8102
Bethesda,
MD 20892-7940
Telephone:
(301) 435-0510
FAX:
(301) 480-2858
Email: Pembertonv@mail.nih.gov
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
Bethesda,
MD 20892-7924 (Express zip: 20817)
Telephone:
(301) 435-0270
FAX:
(301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3. Financial or Grants Management
Contacts:
Ms. Mary Baylor
Division
of Extramural Research Activities
National
Heart, Lung, and Blood Institute
6701
Rockledge Drive
Room 7133,
MSC 7926
Bethesda,
MD 20892-7926 (Express 20817)
Telephone:
(301) 435-0166
Fax:
(301) 480-3310
Email: mary.baylor@nhlbi.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human
Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, state and federal
laws and regulations, including the Privacy Rule.
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 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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