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: Pediatric Heart Network Clinical Centers (U10)
Announcement Type
New
Related Notices
Request For Applications (RFA) Number: RFA-HL-11-010
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 Dates: October 29, 2010
Peer Review Dates: 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 Funding Opportunity
Announcement (FOA) is to support the Clinical Centers in 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 multicenter 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. There is a
separate FOA for the PHN Data Coordinating Center ( RFA-HL-11-027).
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
The purpose of this FOA is to invite applications to
participate as a Clinical Center in the Pediatric Heart Network (PHN)
whose mission it is 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 through multi center clinical research.
This is a one-time solicitation to support Clinical Centers
in the PHN for a 5-year project period. For the PHN Data Coordinating
Center FOA, please see (HL-11-027).
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 at between one and 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. Since 2001, the PHN has provided the infrastructure for collaborative studies, 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 for 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 available 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.
Types of Research Being Sought to Achieve the Objectives
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 considers each proposed protocol, and prioritizes them along with other research ideas. Proposals that receive a high priority are developed into full protocols. The exact number of protocols supported will depend on the nature and extent of the investigations prioritized by the PHN leadership and the availability of funds. Protocols may be selected from the studies proposed by the successful applicants in response to this FOA, but a decision to fund a particular Clinical Center will not commit the PHN to develop that applicant’s specific protocol. All Clinical Centers are expected to participate in all protocols.
The 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.
Examples of Research Topics
Some examples of research topic areas appropriate for this FOA include, but are not limited to, those outlined below. Please keep in mind that we are looking for research topics that address key diagnostic, therapeutic, and other management problems. In addition, proposed research can, but is not required to, include a health economics or other health services research component as appropriate:
THESE ARE EXAMPLES ONLY. APPLICANTS SHOULD NOT FEEL LIMITED TO THE TOPICS MENTIONED ABOVE AND ARE ENCOURAGED TO SUBMIT OTHER TOPICS PERTINENT TO THE OBJECTIVES OF THE FOA.
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 will 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 Program Scientists. The Executive Committee has primary responsibility for the general organization of the PHN, approval of clinical protocols and protocol changes, the conduct and monitoring of studies, and 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.
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). Foreign Institutions must submit a non-modular budget for all mechanisms. (See also Section IV.6. Other Submission Requirements and Information.)
2. Funds Available
Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of the IC(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation; see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
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 Clinical Center 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.
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. Box 1, Title
of the Project should state Pediatric Heart Network [name of institution].
Foreign
Organizations (Non-domestic
(non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
All applicants are highly encouraged to propose multiple PDs/PIs in their applications.
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, a new 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: October 29, 2010
Peer Review Dates: February-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 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: [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 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: [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 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 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
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 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).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
Qualifications and experience
This is an open competition; therefore, Clinical Center applicants are not required to be current PHN clinical sites. Applicants for Clinical Centers must demonstrate experience and expertise in the conduct of complex multi-center clinical studies in congenital cardiac disease and acquired pediatric heart disease. Prospective Clinical Centers must have an established research program in the scientific areas of interest, an established infrastructure that supports multi-center clinical trials, and demonstrated access to a sufficient number of patients to accomplish their portion of the proposed protocols.
Application to participate in the PHN should not be undertaken lightly, as it entails a significant commitment in terms of time, organizational skills, and administrative ability. Applicants should indicate their willingness to attend all Steering Committee meetings, which may include conference calls twice a month and in-person meetings at least twice a year, as well as participation in other aspects of the PHN (study, writing, finance, ancillary studies, etc., committees).
Collaboration
Applicants should state their general support of collaborative research and interaction with other Clinical Centers, the NHLBI, and the Data Coordinating Center through this Network concept.
Applicants can propose consortia of two or more sites. For sites with more than one clinical center, collaboration and interaction among institutions should be clearly documented in the application including the investigator responsible at the collaborating site(s). Management plans including supervision, training, in-service, certification, data handling, quality assurance, cost effective management, and communication are required for centers with more than one clinical site.
Departmental and Institutional Commitment
Letters of institutional and departmental support for participation in the PHN are requested, which should include assurances that in the case of studies competing for the same patient population, NHLBI-funded studies will take priority. Applicants should discuss their willingness, and that of their institutions involved, to accept fee for service reimbursement from the Data Coordinating Center for patient care costs as approved by the SC and NHLBI for each protocol.
Applications from institutions that have a Clinical and Translational Science Award (CTSA) funded by NIH should identify the resources that could be available to support the proposed Clinical Center, commenting particularly on those aspects that will enhance their programmatic and scientific efficiency. In such a case, a description of the CTSA and how the applicant proposes interacting with it should be included, as well as letter of agreement from either the CTSA Program Director or PI. This information should be included in the Resources section of the 398 Form.
Research Team
The Principal Investigator or another member of the physician investigative team is expected to be readily available to respond directly to questions about PHN matters on a daily basis, preferably through e-mail, and should indicate this in the application. 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 pediatric cardiologists, pediatric cardiothoracic surgeons, nurses, and other related subspecialists. While the multiple PI leadership strategy is highly encouraged, in the case of a single PI, an alternate PI must be designated to serve in the absence of the PI.
Nurse coordinators, study coordinators and other research staff should be available, as many protocols require patient recruitment at night and on weekends. Plans for availability of staff must be included in the application. The individual staff training, experience, qualifications, and prior involvement in clinical research should be described in the Personal Statement section of the Biosketch.
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 annual administrative review.
Study Population
Clinical Center applicants should have sufficient patients to support recruitment in a variety of studies in the PHN. Applications should include a table in the Resources section of the 398 Form with the following information for each of the past three years:
As a rough guide and in order to have sufficient patients to participate in PHN protocols, it is estimated that a minimum of 200-250 open surgical cases per year with a significant proportion of local patients would be necessary. Each Clinical Center applicant is expected to contribute patients equally to all protocols.
Patient access may be accomplished by establishing collaborations with other groups in addition to the applicant’s institution. If this is planned, there must be a well-described plan for the coordination of PHN activities among the linked entities.
Budget Plans
Clinical Centers must submit budgets for core budget costs as well as for patient care costs to conduct the protocol proposed. Core budgets should be included in the Detailed Budget for Initial Budget Period and Budget for the Entire Proposed Project Period forms. Core budget requests must be well justified and may not exceed $300,000 in direct costs. Core budgets are expected to vary somewhat due to differential costs in different geographic locations and other factors. Core budgets should include:
A patient care budget should be developed that reflects the expenses of conducting the protocol that are not covered by the Clinical Center Core Budgets. This budget will be considered as part of peer review, but the final budget for any protocol conducted by the PHN will be developed through standard PHN processes. During the grant cycle covered by this FOA, all patient care dollars will be awarded to the DCC. The DCC distributes patient-related funds to the Clinical Centers according to established schedules for each protocol.
Patient care costs include expenses associated with the conduct of a specific protocol, such as:
Research Plan and Table of Contents: Each applicant should follow the directions for the Table of Contents and Research Plan contained in the PHS 398 Application Guide: (http://grants.nih.gov/grants/funding/phs398/phs398.html).
Research Plan: Applicants must propose a research plan that includes a single protocol or series of related protocols that require the Network environment and could be conducted in a three-to-five year time frame. The research plan should demonstrate detailed knowledge of the conduct of multi-center clinical studies in the field of pediatric cardiology and should involve sufficient subjects to require the use of a Network with multi-center participation. Inclusion of a registry to monitor patient outcomes within a protocol is acceptable, provided that the registry falls within the time constraints of the FOA.
Research Strategy: (maximum 12 pages)
The Research Strategy should include three key components: significance, innovation and research approach. Begin with a one-page overview of the proposed investigation that presents the key research objective(s) and why they are important, and a diagram depicting the initiation and duration over a five-year period; a description of the protocol that includes the background and rationale, hypothesis being tested, specific research aims, and primary and secondary endpoint or outcome measures.
The study approach should include:
Protection of Human Subjects: In the Form 398 section on Human Subjects, the data and safety monitoring plan requirements can be addressed as follows:
For applications from current PHN Clinical Centers, applicants should include the most recent Site Assessment Report completed by the DCC in the Protection of Human Subjects section. This report contains:
For other Clinical Center applicants, the Protection of Human Subjects section should include the following information, based on prior experience with clinical studies:
Appendix
Materials
All applicants should describe their
plan to provide a link to the Pediatric
Heart Network and the Children
and Clinical Studies websites at their respective institutions.
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/.
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
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? 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
Potential for Collaboration: Would the project proposed benefit from collaborative interactions with the Network? Will the investigators bring valuable areas of expertise to the Network that will maximize flexibility for the program? Does the application describe prior successful collaborative research?
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.
Reviewers will be evaluating Clinical Center applications on the basis of the specific research protocol, as well as the overall ability to participate in a multi-center Network. In addition to the above criteria, in accordance with NHLBI policy, all Clinical Center applications will also be reviewed with respect to the following:
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. Renewals are not allowed for this FOA.
Revision Applications. Revisions are not allowed for 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. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 Notice of Award 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 Center Principal Investigators will have the primary responsibility in all aspects of PHN studies, including proposing protocols, participating in their overall development, preparing protocol budgets in collaboration with the DCC, modifying proposals if indicated, recruiting study participants, conducting the research, assuring quality of study participant care and protocol adherence, assuring the accurate and timely transmission of data collected in conjunction with the DCC, analyzing and interpreting data, preparing publications, and working with the DCC and NHLBI to disseminate research findings. Clinical Center PIs will also be responsible for working with the DCC to develop common definitions and standardization across protocols wherever appropriate. Awardees must agree to the governance of the study through a Steering Committee.
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.
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 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.
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, established by the NHLBI, will provide peer review for each
network protocol. A Data and Safety Monitoring Board will be appointed by
the Director, NHLBI to provide overall monitoring of interim data and safety
issues. 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.
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, M.D., Sc.D.
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: [email protected]
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: [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
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
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: [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 public
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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