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 Institute of
Mental Health (NIMH) (http://www.nimh.nih.gov)
Title: Novel
NeuroAIDS Therapies: Integrated Preclinical/Clinical Program (IPCP) (U19)
Announcement Type
New
Request For Applications (RFA) Number:
RFA-MH-09-040
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release Date: July 15, 2008
Letters of Intent Receipt Date: August
12, 2008
Application Receipt Date: September 12,
2008
Peer Review Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 2009
Additional
Information To Be Available Date (Url Activation Date): N/A
Expiration Date: September 13, 2008
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 National Institute of Mental Health (NIMH) invites applications from single institutions and consortia of institutions to participate in the Novel NeuroAIDS Therapies: Integrated Preclinical/Clinical Program (IPCP) for the development and evaluation of innovative therapies to ameliorate the CNS complications of HIV infection. This Funding Opportunity Announcement (FOA) is designed to assist researchers interested in therapeutics development for the neurological complications of HIV disease, to assemble the diverse scientific expertise and resources needed to translate basic and laboratory discoveries to applied entities. In the preclinical area, the FOA seeks research on: (1) the development/validation of new therapeutic targets; and (2) the development and evaluation of small molecule inhibitors of viral or cellular proteins or pathways critical to HIV replication and/or persistence with an emphasis on compounds having immunomodulatory and/or neurobehavioral implications. The inclusion of animal studies is encouraged. In the clinical area, the focus is on iterative bench to bedside research to optimize new therapeutic approaches. Pilot clinical studies (10-30 subjects) will provide the means for demonstrating proof-of concept.
Background
This funding opportunity AI-06-009,
was originally issued jointly with NIAID and NIMH. This FOA MH-09-040
only includes NIMH. NIAID has a separate announcement: AI-08-018.
Earlier drug discovery efforts concentrated on a relatively small number of viral targets; however, basic research on the virus and host interactions is yielding new targets that can be evaluated in the clinic. NIMH originally co-sponsored this program to ensure that researchers studied the consequences of HIV on the central nervous system (CNS) in order to foster the development of treatments specifically directed toward HIV-related CNS complications. While highly active antiretroviral therapies (HAART) have reduced the incidence of severe HIV-associated dementia, the prevalence of milder forms of HIV-related CNS complications is reportedly increasing as individuals live longer with multiple insults on the brain including inflammation associated with viral proteins or recrudescence, normal brain-related aging processes, chronic anti-retroviral (ARV) treatments and their associated toxicities on the nervous system, and many medical comorbidities including depression.
NeuroAIDS research to date indicates that searching for new targets and treatments having immunomodulatory and neuroprotective properties is a promising endeavor. The NIMH proposes to foster the Novel NeuroAIDS Therapies: IPCP to support new treatment concepts that can be translated to clinical practice and/or to open a new research direction.
Research Objectives and Scope
The objectives of the Novel NeuroAIDS Therapies: Integrated Preclinical/Clinical Program (IPCP) are to support: (1) innovative preclinical studies to develop new HIV therapeutics for CNS indications, and (2) the translation of innovative treatment concepts from the preclinical arena to pilot clinical proof-of-concept studies (10-30 subjects). Successful programs will develop a new treatment concept that can be translated to clinical practice and/or open a new research direction. Applicants may propose: (1) preclinical research exclusively; (2) preclinical research that transitions to clinical research during the award period. Each application must be composed of a minimum of 3 research projects.
Examples of research responsive to this FOA include, but are not limited to, the following:
Applications proposing research in any of the following areas will be deemed non-responsive and will not be reviewed.
Partnerships
A key component of this initiative is the formation of partnerships between academia and the private sector. For the purpose of this FOA, the term “private sector” comprises large and small, domestic and foreign, for-profit and non-profit pharmaceutical, biotechnology, bioengineering, and chemical companies. Each application must be composed of a minimum of three interrelated research projects and an Administrative Core; one or more Scientific Cores may be proposed. At least one research project must be contributed by the private sector partner if the applicant institution is from academia; conversely, at least one research project must be contributed by an academic partner if the applicant institution is from the private sector. Applications not meeting the above described requirements, with regard to number and types of projects/cores, will be considered non-responsive and the application will not be reviewed.
The private sector partner must propose a research plan that contributes materially and intellectually to the overall goals and objectives of the program. The requirement for a private sector component is not met by entities providing only research resources for the project, such as reagents and novel experimental therapeutics, or service-type activities as described below under Scientific Cores. Projects from a private sector partner proposing to provide only resources or services, even if unique, will be deemed non-responsive, and the application will not be reviewed.
Applicants are encouraged to reach early consensus with any proposed partners regarding intellectual property, data sharing, and other legal matters that may arise during the project. In addition, applicants are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole Act to promote the utilization, commercialization and availability of U.S. Government-funded inventions for public benefit. Finally, applicants are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to NIMH.
Scientific Cores
One or more scientific cores may be proposed. A scientific core is a resource to the multi-project grant as a whole and must support at least two of the proposed research projects. The application must indicate the specific projects to be served by the scientific core(s). Typically a core performs a service-type activity rather than hypothesis-driven research. Examples of services that could be provided by such cores include: routine in vitro assays, cell processing and preparation, standard pharmacology and toxicology tests. The placing of clinical trials or other significant clinical activity in a core is not appropriate; applications structured in this manner will be deemed as non-responsive and will not be reviewed.
Scientific Advisory Panel
The PI will constitute a Scientific Advisory Panel (SAP) of 2-3 investigators not affiliated with any of the institutions comprising the group within six months of the award. The SAP will attend the awardee’s annual meeting to review program activities and evaluate progress, adherence to the milestones and timelines, and the continued relevance of each project and core to the overall goals. The SAP will recommend new directions as appropriate and will provide the PI and NIMH with a comprehensive written evaluation of the group’s activities following each annual meeting.
NOTE: The SAP may NOT be constituted prior to award and names of potential members are NOT to be provided in the application.
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 Multi-project Cooperative
Agreement (U19) 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
The estimated
amount of funds available for support of 1-2 projects awarded as a
result of this announcement is $2-3 million for fiscal year 2009. Future year
amounts will depend on annual appropriations.
An applicant may request a project period of up to five years and a budget for direct costs that respects the following limits: for applicants proposing exclusively preclinical research throughout the 5 year term, $675,000 direct costs for the first year; for applicants proposing the use of large animals (e.g., non human primates), up to $800,000 direct costs in any year(s) that such large animals will be needed; and for applicants proposing clinical studies, up to $1.3 million direct costs in any year(s) in which clinical studies are being conducted
Applicants are encouraged to develop plans to use existing infrastructure and organizational support to complement the award [including NIH-sponsored General Clinical Research Centers (GCRC, http://www.ncrr.nih.gov/clinical/cr_gcrc.asp), Institutional Clinical and Translational Science Awards (CTSA, http://www.ncrr.nih.gov/clinical discipline.asp), and Centers for AIDS Research (CFAR, http://www3.niaid.nih.gov/research/cfar/)]. These plans, and supporting documentation, should be included in the application.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of the IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and administrative costs requested by
consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible
to apply:
Foreign institutions are not eligible to apply as the primary applicant, but may enter into a consortium with a domestic institution serving as the primary applicant for one of the proposed research projects or scientific cores.
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.
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
Applicants
may not submit a resubmission application.
Renewal applications will not be permitted for this FOA.
Applicants may submit more than one application, provided each application is scientifically distinct.
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: [email protected].
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.
Foreign Organizations (Non-domestic (non-U.S.) Entity)
Foreign institutions/organizations are not eligible to apply as the primary applicant, but may enter into a consortium with a domestic [U.S.] institution/organization and participate as a component (project or scientific core).
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.
3. Submission Dates and Times
Applications must be received on or before the receipt
date described below (Section IV.3.A).
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: August 12, 2008
Application Receipt Date: September 12, 2008
Peer Review Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date(s): April 2009
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:
Jeymohan Joseph, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health
6001 Executive Boulevard, Room 6202,
MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-3012
FAX: (301) 443-9719
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:
Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
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 or renewal award
if such costs: 1) are necessary to conduct the project, and 2) would be
allowable under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm)
The
release of funds for any clinical study will be contingent upon compliance with
NIH, NIMH policies and procedures for clinical research and those of applicable
institutional and regulatory bodies [Institutional Review Board (IRB),
Institutional Biohazard Committee (IBC), Food and Drug Administration (FDA),
Recombinant DNA Advisory Committee (RAC)]. See Section VI.2.A.1.c
6. Other Submission Requirements and Information
Development/implementation plan: A plan outlining the short and long term goals of the multi-project IPCP should be articulated, with a time table for achieving them and milestones for assessing progress. For project with a proposed clinical component, decisions to proceed to the clinical phase, or any changes in the protocol design after the clinical phase has been initiated, will be made in consultation with NIMH and may involve the Scientific Advisory Panel and/or other consultants identified by NIMH, and will be based on preclinical data generated to support the clinical study, the clinical protocol, and the budget.
Clinical study plan, if applicable (Place in appropriate research project): Applicants must address the following elements: study design, rationale for the design, study objectives, study population, statistical design and analysis, management and quality control of data, receipt and storage of human samples, proposed clinical sites and investigators. Recognizing that the details of the study will change as a result of scientific progress and as a function of review by various institutional and Governmental bodies, a formal protocol is not requested. However, applicants must address all NIH-required human subjects issues, including protection against research risks and gender, minority, and child representation in the human subjects section of the application as described in the PHS 398 application instructions.
Applications that do not include a development plan and a clinical study plan (if applicable) will be deemed non-responsive and will not be reviewed.
Additional requirements for the applicants are stated below (Section VI.2.A. Cooperative Agreement Terms and Conditions of Award).
Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A. “Award Administration Information”.
Supplemental Instructions for the Preparing Multi-Project Applications
The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research grant (R01) applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.
The supplemental instructions below are divided as follows:
A. General Instructions – addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.
B. Specific Instructions for Individual Projects – describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.
C. Specific Instructions for Core Units – Cores must provide services or resources to support at least two research projects. Instructions describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.
A. General Instructions
All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.
1. Form Page 1 - Face Page
Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.
2. Form Page 2
Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.
3. Form Page 3 - Table of Contents
Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.
Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."
4. Composite Budget
Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)
SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support
Component |
Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
All Years |
Project 1. Invest. |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 2. Study |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 3. Develop. |
100,000 |
104,000 |
108,160 |
112,486 |
116,985 |
541,631 |
Core A. Admin. Core. |
50,000 |
52,000 |
54,080 |
56,243 |
58,493 |
270,816 |
Core B. DNA |
25,000 |
50,000 |
52,000 |
54,080 |
56,243 |
237,323 |
Totals |
425,000 |
466,000 |
484,640 |
504,025 |
524,185 |
2,403,850 |
5. Form Page 5
Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.
6. Biographical Sketch Format Page
Biographical sketches of all professional personnel for all components should be placed after the last core section (see below) with the Principal Investigator first, followed by those of any other key personnel in alphabetical order.
7. Other Support Format Page
Do not complete. (Any required information will be requested from successful applicants prior to grant award.)
8. Resources Format Page
Do not complete. Essential information is to be presented in the individual research project and core sections of the application.
9. Program Overview (Research Objectives and Strategic Plan)
This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.
10. Checklist
One Checklist, placed at the end of the overall application, is to be submitted for the entire application.
11. Resource Sharing Plan
One Resource Sharing Plan, placed after the biosketches, near the end of the overall application, is to be submitted for the entire application.
B. Specific Instructions for Individual Research Projects
1. Cover Page
The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a
"Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):
Project Number and Title: (e.g., 1. Preclinical Evaluation of HIV Microbicides)
Name of Project Leader: (e.g., Jones, Roberta A.)
Human Subjects: (Yes or No)
If Yes, exemption number:
(or)
IRB Approval Date: (e.g., 12/13/2006,or "Pending")
(and)
Federal-wide Assurance (FWA) number:
Vertebrate Animals: (Yes or No)
If Yes, IACUC Approval Date: (e.g., 11/17/2006, or Pending)
(and)
Animal welfare assurance number:
Proposed Period of Support:
From: (mmddyyyy - e.g., 07/01/2007)
To: (mmddyyyy - e.g., 06/30/2112)
Costs Requested for Initial Budget Period: (e.g., 07/01/2007-06/30/2008)
Direct Costs: (e.g., $ 150,000)
Total Costs: (e.g., $162,000)
Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2112)
Direct Costs: $700,000
Applicant Organization:
(full address)
2. Form Page 2
Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.
3. Form Page 3
Prepare a Table of contents for the research project using Form Page 3 of the PHS 398.
4. Biographical Sketches
Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
5. Research Plan (Items 2-5 cannot exceed 25 pages)
6. Appendix. Do not create an appendix for an individual project. (See Section IV.6 for appendix instructions for overall application)
7. Resource Sharing Plan. Do not create a resource sharing plan for an individual project.
For all other items in the individual research project application, follow the usual PHS 398 instructions.
C. Specific Instructions for Cores
All Cores
Cover Page. The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:
Core Letter and Core Title
(e.g., A. Monoclonal Antibody Production Core)
Name of Core Leader
(e.g., Smith, Robert A.)
Human Subjects (Yes or No)
If Yes, Exemption Number
(or)
IRB Approval Date (e.g., 5/14/2008, or Pending)
(and)
Federal Wide Assurance (FWA) number
Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/2008, or Pending)
(and) Animal welfare assurance number
Proposed Period of Support
From: (mmddyyyy, e.g., 07/01/2008)
To: (mmddyyyy, e.g., 06/30/2013)
Costs Requested for Initial Budget Period
(e.g., Direct Costs: $50,000)
(e.g., Total Costs: $70,000)
Costs Requested for the Entire Budget Period
(e.g., Direct Costs: $212,323)
(e.g., Total Costs: $297,252)
Applicant Organization
(full address)
Form Page 2. Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.
Form Page 3. Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.
Biographical Sketches. Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).
Core Research Plan (Items 2-5 cannot exceed 25 pages)
Appendix. Do not create an appendix for a core. (See Section IV.6 for appendix instructions for overall application)
Resource Sharing Plan. Do not create a resource sharing plan for a core.
For all other items in the individual core application, follow the usual PHS 398 instructions.
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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
One appendix may be submitted for the whole application. The appendix may contain 3 publications per project/core. Clearly cross-reference any material that relate to a project or core.
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: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be
considered in the review process.
2. Review and Selection Process
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 NIMH 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 goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a meritorious priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Review Criteria for the Overall Application
The following items will be considered in the determination of overall scientific merit and priority score for the entire application.
Overall score: a single numerical priority score will be assigned to the whole application after consideration of all of the elements. The overall score for the application will be based primarily on the scientific merit of the individual components, with additional consideration of the overall synergy and integration of the components, the overall program organization, and the capabilities of the associated personnel.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Review Criteria for Individual Research Projects
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Review Criteria for Individual Cores
Administrative Core
Scientific Research Cores
Private sector partner. Did the private sector partner propose a research plan that contributes materially and intellectually to the overall goals and objectives of the program? Is it committed to the development of the proposed therapeutic entity or modality? Will it provide expertise and/or resources not generally available in academia?
Groups proposing exclusively preclinical
research. Is it likely that the proposed target/strategy can be advanced
toward clinical evaluation during the award period?
Groups proposing clinical research. Is the timeline for initiating the
clinical studies realistic? Has the group provided milestones that can be
used to assess their readiness to begin human studies? Have they provided
a short and long term development plan?
2.A. Additional Review Criteria
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
rating:
Protection of Human
Subjects from Research Risk: The
involvement of human subjects and protections from research risk relating to
their participation in the proposed research will be assessed (see the Research
Plan section on Human Subjects in the PHS 398 instructions).
Inclusion of Women,
Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated (see the Research Plan section on Human
Subjects in the PHS 398 instructions).
Care and Use of Vertebrate
Animals in Research: If vertebrate
animals are to be used in the project, the five points described in the
Vertebrate Animals section of the Research Plan will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget: The
reasonableness of the proposed budget and the requested period of support in
relation to the proposed research. The priority score should not be affected by
the evaluation of the budget.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
3.
Anticipated Announcement and Award Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be generated
via email notification from the awarding component to the grantee business
official (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 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 will have the primary responsibility for:
a) Annual Meeting: The Principal Investigator (PI) will be responsible for scheduling the time and place of an annual meeting of the group (PI, Project and Core Leaders), the Scientific Advisory Panel, and NIMH Project Scientist (PS) to review progress, plan and design research activities, and establish priorities.
b) Scientific Advisory Panel: The PI will designate a Scientific Advisory Panel of 2-3 investigators, not affiliated with any of the institutions comprising the Group, within six months of the award. The Panel will review progress and make recommendations as appropriate. The Panel will provide the PI with a comprehensive written evaluation of the group's activities after each meeting; a copy of the Panel's report will be sent by the PI to the NIMH PS within thirty (30) days of each annual meeting. For awards involving a clinical study, the Panel, at the discretion of NIMH, may be called upon to help determine the readiness of the group to initiate the study.
c) Communication: The PI will communicate with the NIMH PS on a regular basis regarding the status of the ongoing research. Importantly, the PI will communicate with the NIMH PS regarding the conduct of any clinical activity (enrollment, adverse events, interactions with the FDA, problems and resolutions of the same, changes of personnel, protocol amendments, etc.).
d) Intellectual Property:
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.
e) Annual progress report: The PI will submit an annual progress report including results of the activities of all components of the grant (projects and cores); a summary outlining interactions among group members and with NIMH; and a complete, cumulative list of all publications authored by group members.
f)
Presentations or publications: The PI is responsible for the timely
presentation/publication of work supported in part or in whole by this
Cooperative agreement. Appropriate acknowledgement of NIMH support under
the IPCP is required.
2. A.2. NIH Responsibilities
An NIMH PS will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below. The NIMH PS and the PI will communicate on a regular basis
regarding the status of the ongoing research, particularly regarding the
conduct of clinical activity. During the performance of the award, the PS
may provide assistance, advice, and guidance as needed, and may facilitate
communication between the awardee and other experts or groups when
necessary. The NIMH PS may engage other scientific experts to provide
guidance as deemed necessary. In addition, the NIMH Program Official (PO) 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
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. The three members are: 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.
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:
Jeymohan Joseph, Ph.D.
Division of AIDS and
Health and Behavior Research
National Institute of
Mental Health
6001 Executive Boulevard,
Room 6202, MSC 9619
Bethesda, MD 20892-9619
Telephone: (301) 443-3012
FAX: (301) 443-9719
Email: [email protected]
2. Peer Review Contacts:
David Armstrong, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9609
Bethesda, MD 20892-9609
Telephone: (301) 443-3534
Email: [email protected]
3.
Financial or Grants Management Contacts:
Rita Sisco
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
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. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the 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 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-02-005.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. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy Requirement:
In accordance with
the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must
submit or have submitted for them their final, peer-reviewed manuscripts that
arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/),
to be made publicly available no later than 12 months after publication. As of
May 27, 2008, investigators must include the PubMed Central reference number
when citing an article in NIH applications, proposals, and progress reports
that fall under the policy, and was authored or co-authored by the investigator
or arose from the investigator’s NIH award. For more information,
see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described
in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authorization of Sections 301 and 405 of the Public Health Service
Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement
can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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