and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institute of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Heart, Lung, and Blood
Institute (NHLBI) (http://www.nhlbi.nih.gov)
Title: Heart
Failure Clinical Research Network Regional Clinical Centers (U10)
Announcement Type
This is a new announcement for RFA-HL-12-001, which is a
reissue of one portion (the Regional Clinical Centers) of RFA-HL-05-003.
This announcement is made in conjunction with RFA-HL-12-002 for the Network Coordinating Center.
Update: The following update relating to this announcement has been issued:
Catalog of Federal Domestic Assistance Number(s)
93.837
Key Dates
Release
Date: June 4, 2010
Letters of
Intent Receipt Date: November
1, 2010
Application Receipt Date: December 1, 2010
Peer Review
Date(s): June-July 2011
Council
Review Date: October 2011
Earliest
Anticipated Start Date: January 1, 2012
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: December
2, 2010
Due Dates
for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated
Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
Terms and Conditions of Award
1. Principal
Investigator Rights and Responsibilities
2. NIH
Responsibilities
3.
Collaborative Responsibilities
4. Dispute
Resolution Process
3.
Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Nature of the Research
Opportunity:
The purpose of this solicitation is to request applications for participation in the continuation of the Heart Failure Clinical Research Network as a Regional Clinical Center (RCC). A separate solicitation (RFA-HL-12-002) seeks applications for the combined Data Coordinating Center/Clinical Coordinating Center (CC).
The original Network was established to provide a mechanism to expedite clinical research that evaluates strategies to diagnose, manage and treat all forms of heart failure (HF). The renewal program will continue to provide support to develop, coordinate, and conduct multiple, collaborative, proof of concept clinical trials to improve HF outcomes. The solicitation is structured to support concurrent, small to intermediate-sized randomized clinical trials (RCTs) that can be completed within 2-5 years and is not designed to fund large, Phase III definitive studies. Proposed studies should provide clinically relevant pathophysiologic information and move the field of HF treatment forward.
RCCs will provide scientific leadership in the collaborative development of the Network’s scientific agenda and design, implementation and conduct of its protocols. RCCs may propose an infrastructure that includes geographically or organizationally linked partners or satellites for efficient trial implementation and patient recruitment. The solicitation is open to new and currently participating centers.
Background:
Heart Failure is a common syndrome and, in contrast to other cardiovascular diseases, is responsible for an increasing number of hospitalizations and deaths each year in the U.S. HF is expected to be an even more important cause of morbidity with the aging of the U.S. population. Although survival after the onset of heart failure has improved, modern therapies are not curative, and the syndrome is progressive in many patients despite optimal modern therapy. The health care costs related to HF have been estimated to be as high as $35 billion annually.
In response to this clinical problem and with the guidance of two Working Groups, the National Heart, Lung, and Blood Institute, issued RFA-HL-05-003 to form the Heart Failure Clinical Research Network. A network structure allows for efficiency in conducting multiple concurrent trials and enables a team of investigators to plan and execute serial trials based on earlier results. The Network has been successful in conducting up to three concurrent randomized clinical trials to advance the treatment of patients with acute and chronic heart failure. One clinical trial has been completed, two additional trials are expected to be completed in the initial funding period and the Network has received approval to begin two additional trials in the current project. Due to the success of the program, the NHLBI plans to continue the Network for an additional seven years, through this and the companion RFA-HL-12-002 for the Coordinating Center.
Scientific Knowledge to be Achieved Through Research Supported:
The primary goal of the Network is to conduct multiple Network-wide randomized clinical trials to evaluate treatments and strategies for the management of acute and chronic HF. The scientific agenda will be developed through collaborative decision making of the Steering Committee, consisting of the program’s Coordinating Center (CC) and RCC PIs, the NHLBI-appointed Study Chair, and NHLBI representatives. All protocols must be approved by both the NHLBI-appointed Protocol Review Committee and Data and Safety Monitoring Board. During the first funding period, the Network’s agenda included addressing practical questions in the day-to-day management of HF, such as the optimal way of administering diuretics during acute decompensation without worsening renal function and testing new therapies for HF with preserved systolic function. The Network renewal will continue its tradition of answering practical clinical questions as well as potentially testing new therapies and hypotheses formulated from the first round of studies or other advances in the field of HF research.
Objectives:
The primary goal of the Network is to improve the treatment of HF by rigorous testing, through randomized clinical trials, interventions that aid in diagnosis, therapy, management of HF and prevention of the syndrome or its associated morbidity.
Secondary objectives of the Network are to:
Types of research and experimental approaches that are being sought:
The emphasis will be on early phase small to intermediate-sized randomized clinical trials that help identify optimal diagnosis, evaluation, and therapy to improve ventricular function and structure. Proposed studies should provide clinically relevant pathophysiologic information and move the field of HF treatment forward. Trials may involve investigational drugs or other interventions or new strategies for currently used interventions. Proposed trials should make use of the Network model. Proposed interventions to be tested should be implementable at most, if not all, Network RCCs and/or satellites. For acute HF, endpoints can be measured over shorter durations. For both acute and chronic HF, meaningful composite endpoints can be chosen that accommodate trials with sample sizes of fewer than a thousand patients. The Network is expected to be able to concurrently successfully perform three or four trials and should be able to complete two or three waves of trials in the seven-year period.
Examples of Research Topics:
Potential research protocols might include, but are not limited to, RCTs that:
Trials that involve techniques, procedures, or biologic agents that cannot be disseminated for implementation in a Network model will be considered non-responsive. Large Phase III RCTs, epidemiologic or other observational studies, and protocols based on behavioral and lifestyle intervention will be considered non-responsive to this solicitation.
Project Organization:
The Heart Failure Clinical Research Network will be funded as a cooperative agreement and consist of up to nine RCCs, a single combined Coordinating Center performing Data and Clinical Coordination, an NHLBI-appointed Network Study Chair and the NHLBI. Applications for the Coordinating Center are solicited through RFA-HL-12-002.
Committees:
Steering Committee (SC)
The SC will be the main governing body of the HF Network and is expected to meet on a bi-monthly basis by teleconference. Members will include the Study Chair, the CC and RCC PIs, and NHLBI program staff. The Study Chair will be appointed by the NHLBI and will be responsible for oversight of the scientific agenda and progress of the Network in achieving its scientific goals. The responsibilities of the SC will include, but are not limited to: (1) ensuring compliance with Network policies and procedures, (2) identifying and prioritizing topics for investigation, (3) evaluating and developing protocols proposed by RCCs or others outside the Network for Network implantation, (4) ensuring that studies are appropriately carried out, (5) ensuring that data are appropriately analyzed and interpreted; and (6) ensuring that study results are published in a timely fashion. Other governance committees may be continued or developed such as the Executive Committee, Publications Committee, and Ancillary Studies Committee. The separate charges for these committees will be maintained in an actively updated Manual of Operations for Network activities.
Protocol Review Committee (PRC)
An independent PRC will be appointed by the NHLBI and will meet as needed to review protocols. It will consist of a chairperson and scientists with expertise in HF research, clinical trial design, biostatistics, and other areas of expertise as needed. The PRC will evaluate protocols proposed by the SC based on the following criteria: (1) the scientific merit of the experimental design and approach, (2) the feasibility, and (3) the appropriateness of the protocol for the Network and the consistency with the mission of the NHLBI. All new study protocols performed by the Network must be approved by the PRC before referral to the DSMB. Minor protocol amendments or low burden ancillary studies or secondary analyses of approved trials may be directly referred to the Data and Safety Monitoring Board for consideration.
Data and Safety Monitoring Board (DSMB)
The NHLBI will appoint a
DSMB in accordance with established policies to ensure data quality and
participant safety. All Network protocols must be approved and monitored by the
DSMB, generally after their approval by the PRC (except in the case of minor
protocol amendments, low burden ancillary studies or secondary analyses of
approved trials). The DSMB will be responsible for providing independent
advice to the NHLBI regarding the progress of each trial and the
appropriateness of continuing each study. The DSMB will meet approximately
every 6 to 12 months with interim meetings or calls as necessary.
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 U10 award mechanism(s).
The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."
2. Funds Available
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH program support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://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 not submit more than one application.
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.
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
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the NoA.
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: November
1, 2010
Application Receipt
Date: December 1, 2010
Peer Review Date(s): June-July 2011
Council
Review Date: October
2011
Earliest
Anticipated Start Date: January
1, 2012
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
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
3.B. Sending an
Application to the NIH
Applications
must be prepared using the forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
3.C. Application
Processing
Applications must be received
on or before the application receipt date described above (Section
IV.3.A.). If
an application is received after that date, the application may be delayed in
the review process or not reviewed. Upon receipt, applications will be
evaluated for completeness by the CSR and for responsiveness by the reviewing
Institute. Incomplete and/or non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy
Statement can be found at NIH Grants Policy
Statement.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: 1) are necessary to conduct the project,
and 2) would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain NIH approval before incurring the cost. NIH prior approval
is required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements
The U10 mechanism is a Cooperative Agreement. Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."
Scientific and Performance Requirements for RCCs:
The primary goal of the Network is to conduct multiple concurrent and collaborative small to intermediate-sized randomized clinical trials to evaluate strategies to improve the diagnosis, management, and treatment of all forms of HF. RCCs will be evaluated on the strength of their scientific application as well as their record of success in previous HF clinical trials, especially enrollment and proper trial conduct.
Scientific Requirements:
RCC applications should include a research protocol for a RCT furthering the understanding of the diagnosis, management, or treatment of HF that could potentially be implemented in the Network. Protocols that feature a small to intermediate-sized RCT that can be completed within 2-5 years and that can be conducted across a Network structure will be considered responsive. Proposed studies should provide clinically relevant pathophysiologic information and move the field of HF treatment forward. A description of the protocol should include the objectives, rationale, research aims, outcome measures, study design, description of the patient population with an estimate of the expected distribution of minority and female patients and ages. The applicant must also indicate how many patients are available in the applicant’s RCC (including any partners or satellites) and how many will be required from the Network.
The PI of the RCC is expected to have demonstrated scientific leadership in the conduct of HF clinical research and a demonstrated ability to contribute to the conduct of clinical HF RCTs.
Performance Requirements:
The RCC must demonstrate both clinical science excellence and specialized expertise in HF management, a strong background in HF research, and a proven ability to recruit HF patients that include patients from various racial and ethnic groups. RCCs will propose, develop, and conduct protocols, recruit patients, and disseminate research findings. Each RCC will be expected to take part in multiple (3-5) concurrent protocols. All individual RCCs will be required to participate in a cooperative and interactive manner with one another and with the CC. Awards may be restricted at sites unable to successfully participate in Network protocols, including adequate patient enrollment.
RCCs may choose to include geographically or organizationally linked partners or satellite sites, such as other academic centers and/or private and community hospitals and clinics. Such satellite sites could be venues for additional patient enrollment or might provide access to patient populations not traditionally cared for at the RCC. The RCC will be responsible for providing scientific leadership and regular communication to satellite sites regarding protocols and study progress and for providing administrative and budget support for protocol initiation. The Coordinating Center will manage ongoing operational issues, such as subcontracts for capitated payments, protocol-specific site training, and site monitoring. The productivity of the partners and satellites will be considered part of the RCC’s contribution to the HF Network.
Enrollment productivity will form the basis for enhanced reimbursement from Protocol Funds for patient recruitment. RCCs and their satellites will be compensated according to a two-tiered payment structure, with enrollment beyond a threshold number of patients compensated with a higher reimbursement per patient.
The Principal Investigator (PI) at each RCC will be responsible for proposing and developing protocols, estimating their costs, conducting the research, assuring quality of patient care and protocol adherence, and ensuring the accurate and timely transmission of collected data to the CC.
RCC applicants should submit benchmark data from 3 HF trials conducted at the site in the past five years. The benchmark data should include information (compared to the overall trial average) on: 1) the number of patients recruited, 2) timeliness of enrollment (time from site activation to first enrollment), 3) endpoint completion (submission of primary and secondary endpoint data), 4) patient retention (subjects completing final study visit, and 5) data quality and timeliness. Such information should be verified as much as possible by the DCC of the trial.
The Research Strategy, and scientific and performance requirements must follow the instructions in the PHS 398 application form, http://grants.nih.gov/grants/funding/phs398/phs398.htmland should not exceed 12 pages total.
Clinical Research Skills Development Core:
The Clinical Research Skills Development Core is designed to assist RCCs in training and developing young clinical investigators. The NHLBI will award up to 4 RCCs up to $100,000 in direct costs per year for mentoring and educational activities, including travel to scientific meetings and research rotations at other Network sites. This award will be in addition to the direct costs budget for the RCCs. A Clinical Research Skills Development Core application is not required and will have no effect on the overall score of the RCC application.
The objective of the Clinical Research Development Core is to support activities that develop new clinical investigators by providing an environment to enhance their research skills. The Clinical Research Development Core application will be evaluated based on the quality of the following required elements: (1) the educational environment, including access to databases, exposure to grant writing and the ethical conduct of research, and contact with statisticians, project leaders and other individuals involved in clinical research; (2) specific programs designed to develop young investigators, such as seminars, coursework, or external rotations; and (3) a detailed mentoring plan identifying specific mentors and mentees, including a discussion on how the mentoring will advance the careers of the junior investigators. In addition, the Clinical Research Development Core should be directed by an investigator with strong educational and mentoring credentials who will devote a minimum of 5% effort as the leader of the program.
The Clinical Research Development Core program is intended for staff investigators with limited clinical research experience, including fellows and junior faculty members. Investigators who have received a K award are not eligible to participate. However, individuals with an active K grant are eligible until the end of the award period for the K grant, but may not receive salary on the Core grant.
The scientific and performance requirements must follow the requirements listed above and the instructions in the PHS 398 application Continuation Format Page form http://grants.nih.gov/grants/funding/phs398/phs398.html#fp3. aThe total length of the Research Skills Development section should not exceed 4 pages. These pages will not be counted against the 12 page Research Strategy limit and should not be included in the Research Strategy Section of the application. Rather this optional Research Skills Development Core component section should be placed immediately before the Checklist in the application and pages must be numbered sequentially with the rest of the application. The presence of a Research Skills Development Core must be noted at the beginning of the Abstract.
If an RCC application includes an application for a Clinical Research Skills Development Core, then this should be mentioned in the Abstract. Up to four additional pages may be used to describe the proposed plan for the Clinical Research Development Core. These pages will not be counted against the 12 page Research Strategy limit.
HF Network and Clinical and Translational Award (CTSA) Organizations:
The NHLBI encourages academic centers participating in the Heart Failure Clinical Research Network to partner with the CTSA if one exists at the applicant institution to enhance the scientific and operational aspects of the Network.
There are many potential ways that a HF Network RCC could interface with a CTSA structure. Specific examples include utilizing some of the educational and mentoring programs within the CTSA organization to enhance a Clinical Research Skills Development Core. Since one of the goals of the CTSA network is to establish strong and interactive relationships with local communities and clinics, there may be potential for enhanced recruitment of clinically and ethnically diverse patient populations through the CTSA. RCCs might partner with translational investigators in the CTSA to create state-of-the art mechanistic and translational sub-studies that could be conducted within the Network’s clinical protocols.
Specific Budget Requirements:
The RCC budget is expected to maintain the infrastructure required to perform multiple clinical trials. For each year of the grant, each RCC should request non-protocol budget costs only not to exceed $230,000 Direct Costs per year. These costs should include: 1) up to 1 FTE for an investigator, with a required minimum of at least 0.25 FTE for the PDs/PIs 2) a minimum of one FTE for a study coordinator or coordinators; and, 3) appropriate administrative support. RCCs utilizing geographically or organizationally linked satellites should consider how best to apportion FTEs to facilitate trial implementation, patient recruitment and enrollment at the constituent sites. Costs not directly linked to patient enrollment at any satellite sites must be budgeted in the RCC application. Ongoing monitoring, training and contract management of clinical trials at any satellite sites will be performed by the Coordinating Center and need not be budgeted by the RCC.
Appropriate effort for other key personnel, Institutional Review Board costs, and travel costs for two or more people to attend SC meetings and other travel related to Network operations should be included with appropriate justification.
It is expected that actively enrolling sites will use per-patient protocol-specific payments to supplement the RCC budget for the support of additional personnel and activities. These payments should not be included in the application budget.
Estimated protocol implementation costs should also not be included in the application budget although the proposed trial should be feasible for implementation in the described Network structure. Proposed protocols which will test or use patented pharmaceuticals or devices should include plans for in-kind industry support. Applications should clearly identify the potential source for any drugs or substances being considered for clinical protocols that are currently unavailable commercially. It should be noted that funds will not be provided for the purchase of expensive medical equipment, such as echocardiographic, cardiopulmonary exercise testing, magnetic resonance imaging or ultrafiltration systems
If any of the protocols proposed by RCC applicants include obtaining blood or tissue samples, the applicant should delineate how such specimens will be handled and analyzed. If a central laboratory is required to analyze specimens, the RCCs will be responsible for obtaining the sample and the cost of obtaining and shipping them will be part of the per patient payments.
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.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
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.
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? Does the application provide evidence of a record of excellence in carrying out HF clinical trials?
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.
Review Criteria for Clinical Research Skills Development Cores:
The Clinical Research Skills Development Core will receive an impact/priority score based on the review criteria below, but the impact/priority score will be recorded separately and will not enter into consideration of the overall Network application impact/priority score. The Clinical Research Skills Development Core will be reviewed for its effectiveness in developing the skills and clinical research capabilities of new investigators. This will include an evaluation of the:
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
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy
Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative
and National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and
Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific
Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms
and Conditions of Award
The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when state and local governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this concept,
the dominant role and prime responsibility resides with the awardees for the
project as a whole, although specific tasks and activities may be shared among
the awardees and the NIH as defined below.
2.
A.1. Principal Investigator Rights and Responsibilities
The
Principal Investigator (PI) at each RCC will be responsible for proposing
protocols, estimating their costs, participating in their overall development,
conducting the research, assuring quality of patient care and protocol
adherence, assuring the accurate and timely transmission of data collected,
participating in data analysis and interpretation and preparation of
publications in collaboration with other investigators from the Network. If
partners or satellites are included as part of a proposed Regional Clinical
Center, the RCC PI will provide scientific leadership for the consortium and
assist with resources for study initiation at the satellites.
Awardees will retain
custody of and have primary rights to the data and software developed under
these awards, subject to Government rights of access consistent with current
HHS, PHS, and NIH policies.
2.
A.2. NIH Responsibilities
The NHLBI Project Scientist
and staff will work closely with the Study Chair, CC, and RCCs to ensure proper
conduct of the Network. The NHLBI Project Scientist will be responsible for:
(1) overseeing the activities of the Network along with the Study Chair to
ensure that studies are properly conducted and completed in a timely fashion;
(2) providing advice and guidance to ensure that the Network runs in accordance
with NHLBI policies and procedures, and is consistent with the mission of the
NHLBI to improve public health; and (3) serving as a point of contact for
investigators with the NHLBI, disseminating information from the Institute and
communicating with Institute leadership to ensure that the Network operates
smoothly.
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
See Section
I.1, Project Organization and Committees.
2.A.4.
Dispute Resolution Process
Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
Dispute Resolution. A Dispute Resolution Panel composed of three members will
be convened. It will have three members: a designee of the Steering Committee
chosen without NIH staff voting, one NIH designee, and a third designee with
expertise in the relevant area who is chosen by the other two; in the case of
individual disagreement, the first member may be chosen by the individual
awardee. This special dispute resolution procedure does not alter the awardee's
right to appeal an adverse action that is otherwise appealable in accordance
with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part
16.
3. Reporting
Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We encourage
your inquiries concerning this funding opportunity and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:
1. Scientific/Research Contacts:
Monica R. Shah, MD, MHS, MSJ
Division of
Cardiovascular Sciences
National Heart, Lung,
and Blood Institute
National Institutes of
Health
6701 Rockledge Drive,
Room 8173
Bethesda, MD 20892-7956
Telephone: (301) 594
4629
FAX: (301) 480 7404
E-mail: [email protected]
2. Peer Review Contacts:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
3. Financial or Grants Management Contacts:
Anthony Agresti
NHLBI/Office of Grants Management
6701 Rockledge Drive
Room 7158
Rockledge II
Bethesda, MD 20892
Phone: 301-435-0186
Fax: 301-451-5462
Email:[email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of
PHS support for activities involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health
Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal
Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human
Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and
Safety Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, state and federal
laws and regulations, including the Privacy Rule.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/.
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to
place data collected under this funding opportunity in a public archive, which
can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH
recognizes the rights of grantees and contractors to elect and retain title to
subject inventions developed with Federal funding pursuant to the Bayh Dole Act
(see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators
submitting an NIH application or contract proposal, beginning with the October
1, 2004, receipt date, are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
Inclusion of Women
And Minorities in Clinical Research:
It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the
updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy
incorporates: the use of an NIH definition of clinical research; updated racial
and ethnic categories in compliance with the new OMB standards; clarification
of language governing NIH-defined Phase III clinical trials consistent with the
new PHS Form 398; and updated roles and responsibilities of NIH staff and the
extramural community. The policy continues to require for all NIH-defined Phase
III clinical trials that: (a) all applications or proposals and/or protocols
must provide a description of plans to conduct analyses, as appropriate, to
address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and (b) investigators must report annual accrual and progress
in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic
group differences.
Inclusion of
Children as Participants in Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
All investigators
proposing research involving human subjects should read the "NIH Policy
and Guidelines" on the inclusion of children as participants in research
involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education
on the Protection of Human Subject Participants:
NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem
Cells (hESC):
Criteria for federal
funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC
lines that are registered in the NIH Human Embryonic Stem Cell Registry will be
eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research.
NIH Public Access
Policy Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008, to PubMed Central (http://www.pubmedcentral.nih.gov/), to be
made publicly available no later than 12 months after publication. As of May
27, 2008, investigators must include the PubMed Central reference number when
citing an article in NIH applications, proposals, and progress reports that
fall under the policy, and was authored or co-authored by the investigator or
arose from the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information," the "Privacy Rule," on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible online 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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