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: Phase II Clinical Trials of Novel Therapies for Lung Diseases
(U01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Request For Applications (RFA) Number: RFA-HL-10-003
Catalog of Federal Domestic Assistance Number(s)
93.838, 93.233
Key Dates
Release Date: February 23, 2009
Letters of
Intent Receipt Date(s): May 18,
2009, December 30, 2009, and August 15, 2010
Application
Receipt Dates(s): June 18, 2009, January 29, 2010, September 15, 2010
Peer Review
Date(s): October 2009,
June 2010, and January 2011
Council Review
Date(s): January 2010,
August 2010, and May 2011
Earliest
Anticipated Start Date: April 2010,
September 2010, and July 2011
Additional Information To Be Available Date (Url
Activation Date): N/A
Expiration Date: September 16, 2010
Due Dates
for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2.
NIH Responsibilities
3.
Collaborative Responsibilities
4.
Arbitration Process
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of
Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The purpose of this FOA is to solicit research grant applications to conduct Phase II clinical therapeutic trials that have the potential to advance development of novel therapies for a lung disease or a cardiopulmonary disorder of sleep. Each application will propose one Phase II interventional trial that will most likely use physiological or biochemical rather than clinical endpoints along with at least one smaller basic ancillary research study that is tightly related to the clinical question. Although definitive Phase III trials will not be supported, the proposed studies must provide proof of concept for a novel intervention that has high potential for modifying current treatments and could be disease modifying.
Background
Acute and chronic lung diseases are a significant cause of mortality and morbidity in the United States, greatly affecting quality of life, as well as longevity. Many lung diseases are managed by controlling symptoms and lack proven pharmacologic or immuno-modulating treatments. Current treatments are often based on reducing inflammation or preventing cell proliferation with cytotoxic agents that have modest therapeutic efficacy and in most cases have substantial toxicities. Similarly, insufficient sleep and sleep disorders may contribute to cardiopulmonary diseases.
Novel and innovative treatments need testing in lung diseases and sleep disorders. Basic research studies in cells, tissues, and animal models, investigations of biomarkers and functional genomics have led to a better understanding of the pathogenesis of several of these diseases and suggest new ideas for treatment targets. Mechanistic insights into lung disorders suggest that already approved agents effective in other diseases (e.g., rheumatoid arthritis, diabetes, systemic lupus erythematosus) could be appropriate for treating lung diseases. Combinations of common drugs with low toxicities could be tested. Studies supported by this FOA are unlikely to be conducted by industry because of relatively small market shares, or changed or competing company priorities.
Despite the substantial progress made on identifying molecular mechanisms underlying lung diseases, there is little research supported by NHLBI for proof-of-concept, mechanistically-driven small clinical trials. These are important as they are key in translating basic research advances into clinical research, provide the foundation for larger efficacy trials, and can assist in the understanding of disease processes and perhaps disease sub-groups.
Research objectives
This program enhances opportunities for translational research with the central emphasis on clinical studies. Research conducted would provide high quality data that could lead to efficacy or Phase III trials in networks or investigator-initiated trials. Furthermore, this research will provide important pathogenetic understanding of responses to treatments. Close interaction between clinical and basic researchers required in this program should promote translation of basic science ideas into the clinical setting and expand on ideas from clinical observations that can be pursued in the basic laboratory.
Each application must propose one Phase II clinical treatment trial. In this context, Phase II trials are proof of concept studies that will most likely employ (surrogate) physiological (which can include imaging methods) or biochemical endpoints rather than mortality or major clinical endpoints. The trials should include data collection on well-characterized subjects. Novel clinical trial designs are encouraged.
Each application must also include at least one but no more than two tightly-related ancillary studies that will provide mechanistic understanding of the clinical question. The basic ancillary study can be bench-to-bedside or bedside-to-bench and will have budget restrictions (see Section II 2: Funds Available). The application must be led by the Principal Investigator of the clinical study. A separate investigator will lead each ancillary study. Co-principal investigators are encouraged in order to maximize the interaction and idea exchange. The ancillary study may be conducted by an investigator at a separate institution through a consortium agreement.
Consortia with other sites that will assist with patient recruitment are highly recommended.
Research topics: Clinical studies must include trials of novel drugs, devices, or management practices for treatment of lung diseases that will provide proof of concept or early testing for efficacy that have the potential to change clinical practice and modify disease. Where possible, the clinical trial will be a double-blinded placebo-controlled design. Given the scope of this FOA, it is most likely that appropriate physiological or biochemical endpoints rather than clinical endpoints will be used. Some examples that may or may not be feasible include but are not limited to those listed below:
Examples of ancillary studies:
Examples of research that would NOT be responsive to this FOA:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the cooperative agreement (U01) award mechanism.
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." There is no
intention to renew these awards.
2. Funds Available
Future year awards will depend on annual appropriations. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. The clinical study budget is expected to be a majority of the budget. An ancillary study may not exceed $150,000 direct costs/year and the sum of two ancillary studies cannot exceed $250,000 direct costs/year. Although the financial plan of NHLBI provides 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. There will be a rigorous administrative evaluation of recruitment and scientific progress before non-competing renewals are awarded. In addition, NHLBI intends to establish a translational oversight committee who will review progress. The metrics for success and continued funding will be based on achievement of research milestones. Completion of the proposed clinical studies, new insights into disease mechanism or treatment efficacy, and progression to Phase III efficacy will constitute ultimate success of this program.
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,are encouraged. 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.
The PI of the application must be the leader of the clinical trial. This individual should have demonstrated experience in design and recruiting into clinical studies or trials. Each ancillary study must be led by a separate individual who may be either a Co-Investigator or a Co-Principal Investigator on the the application for the phase II clinical trial network. This individual should have demonstrated expertise in the proposed field of basic science. Multiple PD/PIs are encouraged.
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
Resubmissions. Applicants may submit one revised application (resubmission); revised applications must include a one page introduction that addresses issues raised in the previous review (Summary Statement).
Renewals. Renewal applications are not permitted in response to this FOA.
Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.
Applications from foreign institutions are not eligible for this program.
Section IV. Application and Submission Information
1. Address to
Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866)
705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form, and the YES box must be checked.
SPECIAL
INSTRUCTIONS
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.
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
Letters
of Intent Receipt Date(s): May 18,
2009, December 30, 2009, August 15, 2010.
Application
Receipt Dates(s): June
18, 2009, January 29, 2010, September 15, 2010.
Peer Review
Date(s): October 2009,
June 2010, and January 2010.
Council Review
Date(s): January 2010,
August 2010, and May 2011.
Earliest
Anticipated Start Date: April 2010,
September 2010, and July 2011.
3.A.1. Letter of
Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
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 NIH staff
to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent
should be sent to:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3.B. Sending an
Application to the NIH
Applications
must be prepared using the forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Chief, Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3.C. Application
Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time(of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon
receipt, applications will be evaluated for completeness by the Center for
Scientific Review, NIH. Incomplete applications will not be reviewed.
There will
be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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.
The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
6. Other Submission Requirements and Information
Qualifications and Experience. The PI must have the necessary experience and expertise to conduct clinical studies in patients and have access to infrastructure (e.g., research coordinator, statistical support, etc.) to conduct the trial. Previous participation in clinical trials for lung diseases or sleep disorders should be detailed including name of study, role in study and number of patients recruited; participation in studies where recruitment was unsuccessful should also be included. The leader of the ancillary studies should have demonstrated expertise and publications in the field of study. The ancillary study can be conducted through a consortium arrangement with a collaborating institution.
An appropriate time commitment is expected from the principal investigators and co-investigators. The Principal Investigator(s) must commit at least 20 percent effort to the clinical project and management of the program; investigators that lead the ancillary studies must devote at least 10 percent effort. A plan to ensure interaction among all investigators and the communication of ideas and results should be described. Multiple PD/PIs are strongly encouraged.
Study Population. Applicants should demonstrate access to a sufficient number of patients to accomplish the protocol by providing specific, objective sources of data on the size of the available population. This can include documentation of participation in previous clinical trials of similar patients.
Patient access may be
accomplished by establishing links with other groups in addition to the
applicants institution.It is strongly recommended that at least
two recruiting centers be included in each trial. If links with
other groups are anticipated,the application should include a plan with
appropriate letters of support that describes (1) how the applicant will link
to and operate with the other groups and (2) how the PI will monitor the
quality of the other groups performance (recruitment and data quality).
Links with NIH Clinical and Translational Science Award (CTSA) Centers.Applications
from institutions that have a CTSA funded by the NIH National Center for Research Resources should identify the resources that would be available to support
the proposed research. Examples of resources include cost sharing,
in-kind support of personnel or facilities, assay performance,
statistical or regulatory support, etc. 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 participating
PI. Research Plan. Applicants should submit a research plan with
the following subsections: Overview, Clinical Research Protocol Plan and
Budget, Basic Ancillary study research project(s) and Budget.
Overview (limited to one page): The overview will describe the significance and rationale of the proposed clinical intervention study and describe the relationship of the ancillary study(s) to the clinical project. The potential for substantially changing clinical management must be addressed.
Clinical Protocol (maximum total 12 pages): The proposal should generally follow the instructions in the PHS 398 application form (revised 11/2007; http://grants.nih.gov/grants/forms.htm) and should include a rationale (i.e., scientific and clinical practice justification for the proposed research), research aims, outcome measures (indicating appropriate objective and patient-centered measures of primary and secondary outcomes), study design (including a sound statistical plan, including power analysis, interim reviews, and stopping rules, and timetable).It is expected that all protocols will be performed in a manner consistent with NIH clinical research policies and the United States Food and Drug Administration (FDA) guidelines.Evidence of FDA approval, or a plan for obtaining FDA approval should be provided and will be required at the time of award.
A budget should be presented using the PHS 398 budget page forms; the budget pages are not included in the page limit.
Basic Ancillary Study(s) (maximum 6 pages each): At least one but not more than two mechanistic studies that elucidate the biology or mechanism of the intervention must be included in the application. This proposal should generally follow the instructions in PHS 398 and include rationale, including relationship to main clinical trial, research aims, methods, and expected results.
A budget for each study should be presented separately, using the PHS 398 budget page forms; the budget pages are not included in the page limit.
There will be separate budget pages for the clinical study and the ancillary study(ies).
This FOA solicits translational research programs that include a clinical trial and at least one but no more than two related ancillary studies. An ancillary study cannot exceed $150,000 in direct costs; and, if two are proposed, the total requested for the ancillaries cannot exceed $250,000 in direct costs. Each ancillary study will be scored separately after discussion and scoring of the clinical trial. The clinical trial must be meritorious to receive funding. If any or all of the ancillary projects are not found to be highly meritorious, the meritorious clinical project may still be funded without the ancillary study(ies). Conversely, an ancillary study will not be funded without the clinical study.
Feasibility is an important aspect of these applications. Applicants must demonstrate the ability to enroll the required numbers of patients. Patient availability at consortia proposed to assist with enrollment must also be documented. Additional recruiting site(s) are highly recommended.
If an IDE or IND is required, applicants will be required to provide evidence of FDA approval at the time of award. Evidence of FDA approval or communication will be considered a plus.
A detailed time line for milestones in the study must be provided. This time line must account for IRB and DSMB approval, realistic goals for patient recruitment and follow up, and data analysis and preparation. Progress will be administratively assessed annually before non-competing awards are made. It is expected that no more than six months from the funding date will be required before patient recruitment begins.
Communication: Communication in this translational program is essential. Applicants must propose a plan for or describe how communication and interactions will be maintained between clinical sites and basic project leaders and study personnel. If projects or recruitment sites reside at a separate institution, any costs for meetings and teleconferences should be included in the budget.
Responsiveness: This FOA is intended to stimulate novel clinical research that has the potential to significantly change clinical management of lung diseases and sleep disorders. Applications that propose Phase I (safety) or dose-response studies will be considered not responsive. Large Scale Phase III efficacy studies will be considered not responsive. Applications may not propose work that has significant overlap with currently funded programs. Applications may not compare two agents within a same class of currently used drugs.
Funding Priorities: This FOA is intended to support study of novel approaches to treatment of lung diseases and sleep disorders. Priority ranking of the application will be heavily dependent on the novelty, feasibility, and potential to significantly alter the treatment of the disorder or lead to a larger Phase III efficacy trial. The emphasis is on clinical research, with a strong connection to basic research.
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."
Research Strategy Page Limitations
The Research Strategy for the clinical study is limited to a maximum of 12 pages.
Each ancillary study Research Strategy is limited to a maximum of 6 pages and will include a background indicating relationship to clinical study, specific aims, preliminary studies, research design.
There will be separate budget pages for the clinical study and the ancillary study(ies).
Budget pages are not included in the page limitation.
Applications received that exceed these page limitations will not be reviewed.
Appendix Materials
Each application must include the complete protocol and consent form(s) as appendices.
All paper PHS 398 applications 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 one-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHLBI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The 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 core review criteria, and additional review criteria (as applicable for the project proposed).
Core 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. The ancillary study and the clinical projects will be evaluated separately according to the criteria below. 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? What is the potential of the clinical trial to affect clinical practice or progress to a phase III testing? Does the clinical project answer an important question that could potentially change clinical practice or lead to testing in larger trials?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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? Is there an appropriate plan for inclusion of personnel to prepare confidential reports of interim data reports and safety monitoring on site? If a Research Coordinator is proposed, are the qualifications of that individual appropriate?
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) Protections for Human Subjects, 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? Is the statistical plan sound,
including power analysis, interim reviews, and stopping rules? Is the
primary endpoint meaningful? If required by the research, has FDA
approval been obtained or, is there a plan to obtain FDA approval? Is
there a realistic plan to recruit the required number of patients?
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
Review Criteria for the Ancillary Studies
The Ancillary Studies will receive a score based on the review criteria below, but the score will be separate from and will not enter into the overall Clinical application impact/priority score. The Ancillary Studies will be evaluated for their effectiveness in addressing the mechanistic, pathophysiological basis of the clinical study. This will include an evaluation of:
Significance. Do the studies address an important mechanistic problem? Does the ancillary study complement the clinical study? 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 conducting the ancillary studies well suited to the project? If Early Stage Investigators or New Investigators, 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?
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?
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, the proposed clinical study, or collaborative arrangements?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
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.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.
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).
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.
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).
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 ofAward (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official (designated in
item 12 on the Application Face Page). If a grantee is not email enabled, a
hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the Notice ofAward. 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).
2.A. Cooperative
Agreement Terms and Conditions of Award
The following
special terms of award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration regulations
at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and local
governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.
2.
A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for all aspects of the clinical study and coordination with the ancillary study(s). For the clinical study, these responsibilities include recruiting study participants, conducting the research in an ethical and safe manner, assuring quality of study participant care and protocol adherence, assuring the accurate and timely transmission of data collected, supervision or preparation of adverse event reporting, supervision of preparation of confidential interim reports, analyzing and interpreting data, preparing publications, and dissemination of research findings. The principal investigator of the ancillary study may be a co-PI (encouraged) or a co-investigator and will be responsible for all aspects of the research proposed. A coordination plan between clinical and basic investigators must be presented.
Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.
2.
A.2. NIH Responsibilities
An NHLBI program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as the NIH Project Scientist.
The project scientist (PS) adheres to stringent NIH ethics rules and financial disclosure reporting to eliminate overt and perceived conflict of interest; PS are prohibited from observing scientific review of competing applications from an investigator with whom they have published in the last three years; recommendations from PS about budgetary requests (e.g., carryover, administrative supplements, no-cost extensions) are reviewed and approved by supervisors (e.g., Branch Chiefs, Division Director, and, Institute Director); recruitment progress is reviewed by study independent staff (quarterly within the Division; semi-annually or quarterly by the DSMB and supervisory staff; PS may be asked to leave the room during DSMB reviews of studies; recommendations made by PS in annual progress reports are reviewed by grant specialists with a separate Division (Office of Grants Management); PS will not seek lead authorship of primary publications and will obtain approval by Branch Chief to participate in secondary publications.
Progress will be administratively reviewed prior to issuance of non-competing award. In addition, NHLBI intends to establish a translational oversight committee who will also review progress. NHLBI reserves the right to terminate or curtail an individual award) in the event of (1) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (3) major breach of a protocol or substantive changes in the agreed-upon protocol with which NHLBI cannot concur; (4) attaining of a major study endpoint before schedule with persuasive statistical significance; or (5) human subject ethical issues that may dictate a premature termination.
Annual continuation and level of funding for each Clinical Center will be based on NHLBI review of actual recruitment and overall performance, determined as part of the NHLBI review of the annual non-competing continuation grant progress reports submitted by awardees.
2.A.4. Arbitration Process
Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
Awardees will be
required to submit the Non-Competing Continuation Grant
Progress Report (PHS 2590) annually and financial statements as
required in the NIH Grants Policy Statement.
Patient recruitment reports will be required semi-annually. Serious Adverse events and annual adverse events must be reported in accordance with NHLBI guidelines.
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:
Andrea L.
Harabin, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda, MD 20892-7952
Telephone: (301) 435-0222
Email: harabina@nhlbi.nih.gov
2. Peer Review Contacts:
Chief, Review
Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Room 7214, MSC 7924
Bethesda, MD 20892-7924 (Express zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
3. Financial or Grants Management Contacts:
Ryan Cherise
Lombardi, M.S.M.
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Room 7154, MSC 7926
6701 Rockledge Drive
Bethesda, MD 20892-7926
Telephone: (301) 435-0144
FAX: (301) 451-5462
Email: lombardr@nhlbi.nih.gov
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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). The DSMB may be an
institutional DSMB or NHLBI may decide to operate the DSMB depending on the
research proposed.
Sharing
Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, state and federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of the
scientific merit or the impact/priority score.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this policy,
a genome-wide association study is defined as any study of genetic variation
across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/
Access
to Research Data through the Freedom of Information Act:
The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women, Minorities, and Children:
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 investigators 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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