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 Allergy and Infectious
Diseases (NIAID), (http://www.niaid.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
Title: Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) (U19)
Announcement Type
This
is a re-issuance, with modifications, of RFA-AI-07-001 and RFA-AI-08-006.
Update: The following update relating to this announcement has been issued:
Request for Applications (RFA) Number: RFA-AI-08-057
Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856, 93.242
Key Dates
Release
Date: Novembeer 28, 2008
Letters
of Intent Receipt Date: February 13, 2009
Application Receipt Date: March 13, 2009
Peer
Review Date: June 2009
Council
Review Date: August 2009
Earliest
Anticipated Start Date: December, 2009
Additional
Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration
Date: March 14, 2009
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 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. 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.
Application Processing
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 Contacts
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 Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) invite applications from single institutions and consortia of institutions to participate in the Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) for the advancement of novel single and combination safe, effective and acceptable microbicides and microbicide strategies to prevent sexual transmission of HIV. The types of microbicide research that will be supported by the IPCP-HTM include basic microbicide science, focused preclinical development and exploratory small scale clinical trials hereinafter referred to as pre-Phase I clinical trials. The IPCP-HTM is specifically designed to serve as a platform for microbicide development through support for integrated and iterative research projects and activities including but not limited to: microbicide-relevant basic science; drug discovery-driven development of microbicides; preclinical virologic and toxicologic assessment of lead candidates; development and validation of Good Laboratory Practice (GLP)-compliant analytical assays; and Good Manufacturing Practice (GMP)-manufacturing activities in support of pre-Phase I clinical trials. Applications may include any combination of these activities. The proposed research is not required to include all activities that might constitute the complete development path from discovery to a pre-Phase I clinical trial.
NOTE: While pre-Phase I clinical trials may be supported under the IPCP-HTM, this FOA will NOT support Phase I, II, or III clinical trials.
Background
With current global HIV infection estimates exceeding 42 million people, the development of a safe, effective, and acceptable topical microbicide to prevent the sexual transmission of HIV could play a major role in world-wide reduction of the over 9,000 new HIV infections per day, and potentially save millions of lives. Topical microbicides are agents which when applied vaginally and/or rectally can result in inhibition of the transmission of HIV and/or other sexually transmitted infections (STIs) that may be co-factors in HIV transmission. Progress has been made in the field of microbicides as evidenced by the proof-of-concept studies of the effectiveness and safety of multiple microbicides in non-human primates and the initiation of large-scale effectiveness trials. Although the identification of an effective microbicide candidate has yet to be achieved, the results of Phase III trials for Nonxynol-9, Savvy , Cellulose Sulphate and Carraguard have already provided critical information and informed the development of topical microbicides. NIAID has sponsored and continues to sponsor Phase II and IIB topical microbicide clinical trials. These include:
Completed: Phase II safety trial of daily and coitally-associated use of tenofovir gel in HIV negative women (HPTN059, http://www.hptn.org/research_studies/hptn059.asp).
Ongoing and to be completed in the next year: Phase II/IIB safety and effectiveness trial of BufferGel and PRO2000/5 gel (http://www.hptn.org/research_studies/hptn035.asp).
Planned: 5 arm Microbicide Trials Network trial (MTN003/VOICE) (http://mtnstopshiv.org/node/70) that will assess the use of tenofovir topical and placebo gel and oral tenofovir, oral Truvada or oral placebo in HIV negative women.
The IPCP-HTM Program has been integral in supporting the transition of topical microbicide candidates from early discovery to initial clinical testing. The program began with the release of the Microbicide Preclinical Development Program (RFA HD-00-018, http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-00-018.html) on November 7, 2000. In 2003 this program evolved into the IPCP-HTM program with the release of PAR-03-137 (http://grants.nih.gov/grants/guide/pa-files/PAR-03-137.html) on June 9, 2003. The IPCP-HTM Program has continued with the release of RFA AI-07-001 (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-07-001.html, September 29, 2006) and RFA AI-08-006 (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-08-006.html, March 4, 2008). Although IPCP-HTM grants have promoted significant development of single and combination topical microbicides and the first clinical testing of rectal microbicides, the microbicide field still faces significant challenges in the following areas:
Central to developing a rational approach to these many challenges is the development of collaborative platforms for the integration of the diverse scientific disciplines required to discover and advance microbicide candidates toward general use and distribution. The IPCP-HTM program was initiated to provide a platform to support the establishment and implementation of integrated and interactive research projects for identifying and advancing novel single microbicides and combination strategies from the basic/preclinical stage to pre-Phase I clinical trials. NIAID is currently supporting fourteen IPCP-HTM awards. Current projects include development of microbicide candidates covering potential targets from vericidal activity on cell-free virus, inhibition of entry (gp120, Co receptor, gp41) to reverse transcriptase as single or combination microbicides for vaginal and/or rectal use. Currently supported microbicide candidate studies include small chemically-defined molecules to a wide range of microbicide-relevant targets, peptides, proteins, siRNA strategies and bioengineered Lactobacilli expressing a variety of protein-based microbicides. In addition to iterative development of candidates, the IPCP-HTM Program supports basic and developmental programs designed to advance our understanding of the mechanism(s) of sexual transmission of HIV and to provide new technologies and markers for microbicide candidate analysis, safety, efficacy and acceptability. Integral to accomplishing the goals of each IPCP-HTM is the inclusion of milestones and industry partners in planning and executing projects.
Milestones
Milestones will be used to measure the progress of the individual projects and scientific cores as well as the whole IPCP-HTM as a whole. Milestones should identify research outcomes by providing measures of success within specified timelines. In addition to providing a quantifiable measurement of program outcome, it is expected that milestones will facilitate tracking of the successes and failures of individual activities within the IPCP-HTM. Assigned NIAID staff, through the Cooperative Agreement grant mechanism, will monitor progress toward achieving milestones and work with the IPCP-HTM PI to adjust or modify established milestones as needed to adapt to changes that are supported by strong scientific rationale.
Industry Partnerships
A key component of this initiative is the development of partnerships with industry. For the purposes of this FOA industry is defined as for-profit or not-for-profit pharmaceutical, biotechnology, bioengineering, or chemical companies that are large or small, domestic or foreign. Because academic organizations and investigators are often the source of new candidates for future products, this RFA supports and requires partnerships with industry in an effort to help insure the efficient and effective development of such potential products. Although industry applicants are not required to involve collaborators from academic or non-profit research organizations, they are encouraged to include members of these organizations when appropriate to the scope and focus of the application.
Industrial partners are expected to contribute in a positive and significant way to the overall scientific agenda of the IPCP-HTM. Incorporation of Contract Research Organizations (CROs) into IPCP-HTM for the purpose of providing required resources, services, or strategy for advancing a microbicide candidate on a fee-for-service basis without a demonstrable level of scientific involvement in the IPCP-HTM development process is not considered to meet the requirement. Industry partners should participate as significant collaborators in the application, fulfilling roles such as Project or Core PI, Co-PI, or act as key personnel with appropriate time commitment to a Project or Core.
The applicant PI may be affiliated with industry, an academic institution or a non-profit organization.
Research Objectives and Scope
The objectives of the IPCP-HTM are to:
(1) Integration of behavioral research into the early stages of microbicide development
(2) Modulation of innate and adaptive vaginal defenses in order to promote microbicide use that is associated with coitus
(3) Validation of models and surrogate markers for safety, efficacy, and acceptability.
A minimum of two research projects and an Administrative Core must be proposed. Scientific cores may also be proposed; each core must support two or more research projects.
The scope of microbicide strategies eligible for support includes strategies developed around a novel single microbicide and/or combination microbicides incorporating optimized mixtures of two or more compounds that may:
(1) Block virus entry
(2) Inhibit virus replication
(3) Modulate adaptive and/or innate immunity, and/or
(4) Prevent HIV transmission through a novel target(s) that is compatible with the concept of a microbicide.
Transmission-inhibitory strategies should be focused on microbicides as the primary mode of inhibition; however the microbicide candidates/strategies may also (1) inhibit STIs associated with HIV acquisition in addition to HIV, while maintaining anti-HIV activity, and (2) be composed of complex strategies incorporating other modes of prevention in support of the microbicide component (single or combination), where the microbicide strategy is the dominant mode of prevention being developed within the IPCP-HTM.
The IPCP-HTM supports the innovative development of single and combination microbicides and microbicide strategies in the context of the global need for a microbicide to prevent HIV transmission. Innovation may be realized through incremental advancement of a microbicide or strategy. Thus, innovation in those cases will consist of the value added to the field of microbicides by the individual research projects and scientific cores, as well as the integration of the overall program.
The IPCP-HTM, through the value-added aspect of the integrated multi-project environment, will support research and development projects in the following three main areas of microbicide science:
1. Basic Science: Although the overarching goal of the IPCP-HTM is to advance novel microbicides toward clinical studies, a basic science program integrated with microbicide development may be proposed to address hypotheses essential to the understanding and development of safe, effective, and acceptable microbicides. All basic science projects must be carried out in the context of an identifiable microbicide candidate(s) or strategy and the outcomes of the research should directly support preclinical and/or clinical projects that further advance the microbicide or strategy forming the thematic basis of the application. Examples of responsive basic science projects include: the role of the vaginal microenvironment; the role of biofilms and hormone fluxes in HIV acquisition; the role of adaptive and/or innate immunity in promotion and/or inhibition of HIV acquisition; the development of new technologies that directly support microbicide development, i.e. novel formulation strategies, safety techniques; and the investigation of the mechanism of cell-free and/or cell-associated HIV transmission in the presence of vaginal and seminal plasma factors.
2. Preclinical Development: Projects that focus on preclinical development of a microbicide candidate or microbicide strategy should incorporate activities that (1) prove the feasibility of a microbicide candidate/strategy, and (2) meet minimal requirements for preclinical virology as identified by the Food and Drug Administration (FDA) (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0183-gdl0002-01.pdf).
Feasibility of a microbicide candidate is defined as the demonstration of attributes compatible with:
Preclinical studies are expected to be incremental and iterative in nature, resulting in the optimization of the microbicide candidate. The proposed studies should be developed such that a strong scientific rationale can be established for its use as a vaginal, rectal, and/or penile microbicide. Applicants are encouraged to include preliminary studies that assess toxicity (acute and/or chronic vaginal, rectal or penile), immunotoxicity (for drug- protein- or peptide-based microbicides), pre-formulation and formulation of candidates, including stability and release of the microbicide from the proposed gel or device, and genotoxicity and/or systemic absorption in animal models. In all cases projects must work toward defined milestones that specify the predicted range and magnitude of potency and/or antiviral activity of the microbicide and/or strategy to be developed.
Preclinical studies also may include the FDA-required applications associated with preparing for clinical testing, such as Investigational New Drug (IND), Investigational Device Evaluation (IDE) and/or New Device Exception (NDE) applications. Studies to address the FDA requirements could include acute and chronic toxicology, pharmacokinetic [absorption, distribution, metabolism and excretion (ADME)] and pharmacodynamic studies, reproductive toxicology, analytical methods development, and limited GMP manufacturing (provision of investigational product for proposed pre-Phase I clinical trials). Given the nature and complexity of FDA-required preclinical activities, applicants are encouraged to seek in-kind support for specialized facilities and resources required to carry out these preclinical studies. In addition, applicants are encouraged to incorporate pre-IND meetings/conference calls with the FDA early in their development plans and incorporate such meetings/conference calls and IND filings as milestones.
3. Exploratory Clinical Development: Inclusion of pre-Phase I clinical trials allow the pursuit of microbicide-derived clinical hypotheses that are critical to the advancement of a specific microbicide and/or are broadly applicable to microbicide development. Proposed trials should follow the FDA Guidance for Exploratory IND Studies found at: http://www.fda.gov/cder/guidance/7086fnl.htm. Under these guidelines pre-Phase I studies are (i) to be conducted early in Phase I prior to traditional dose-escalation, safety, and tolerance studies that ordinarily initiate a clinical drug development program; (ii) involve very limited human exposure; and (iii) have no therapeutic or diagnostic intent (e.g., vaginal absorption studies, screening studies, micro-dose and gel distribution studies). The number of participants should be commensurate with the intent of the pre-Phase I clinical trial concept and the scope of the secondary and tertiary objectives. It is not the intent of pre-Phase I clinical trials to provide powered statistical assessments of the proposed hypothesis or a microbicide candidate or strategy, but rather to be an initial determination of whether additional (more adequately powered) trials are needed. It is intended that these larger trials be performed outside the framework of the IPCP-HTM. Phase I, II or III trials WILL NOT BE supported under this FOA. Examples of responsive clinical projects include:
Clinical projects may start as early as year 1 but no later than year 4 of the project period. Applicants are encouraged to coordinate with, or use clinical trial sites affiliated with the NIAID HIV/AIDS Clinical Trials Networks when possible (http://www3.niaid.nih.gov/news/newsreleases/2006/leadership.htm). Applicants should not propose or depend upon the NIAID DAIDS-supported clinical trial networks to perform or provide all support for a proposed clinical activity. All interactions with the NIAID HIV/AIDS Clinical Trials Networks should be collaborative in nature and provide iterative and supportive development of the proposed microbicide for future clinical evaluations.
Responsive Areas of Research
Examples of the types of research projects that are responsive to the IPCP-HTM Program include:
Non-responsive Areas of Research
Applications focusing on the following areas will not be considered responsive and will not be reviewed:
Applicants are strongly encouraged to discuss applications with Program staff to determine if the approach, concept or strategy could be considered non-responsive based on the information provided.
IPCP-HTM Scientific Cores
Scientific cores to support research and development projects may be proposed if they will be utilized by at least two of the proposed projects. Such cores should provide services and/or facilities that are either new or can not be funded through other means. The services rendered should be well justified within the description of the proposed scientific core and also within each relevant project description. Examples of scientific cores include defined and routine in vitro and in vivo screening/testing, statistical, data management, and regulatory support for pre-Phase I clinical trials, product manufacturing, and product formulation services/facilities. Scientific cores should not be solely concerned with coordinating contractual activities to support preclinical development of a microbicide, such as those associated with fee-for-service support, i.e. GLP toxicology, GMP manufacturing, etc. The required administrative core is not considered a scientific core and should not incorporate scientific activities, but may coordinate fee-for-service services for the overall program.
NOTE: Pre-Phase I clinical trial(s) should be conducted as a research project and not as a scientific core.
IPCP-HTM Scientific Advisory Panel
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 NIH multi-project Cooperative Agreement (U19) award mechanism. The Project Director/Principal Investigator 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 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the Initial Budget Period and the Entire Proposed Period of Support is to be submitted with the application.
This funding opportunity will use the NIH U19 cooperative agreement award mechanism. In the cooperative agreement mechanism the Principal Investigator (PI) retain(s) 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 PI, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
At this time the NIAID has not determined whether this funding opportunity will be reissued.
2. Funds Available
The NIAID and NIMH intend to commit approximately $5 million ($4.5 million NIAID and $0.5 million NIMH) dollars in FY 2010 to
fund 2-3 new applications in response to this FOA. An applicant may request a
project period of up to 4 years for an application that does not include a
pre-Phase 1 clinical trial, and up to 5 years for an
application that includes a
pre-Phase 1 clinical trial. The budget should reflect the proposed research
activity.
Budget requests may not exceed the stated Direct Cost upper limits for each of the categories below.
The total annual direct costs for current IPCP HTM awards with the following activities range from:
Applications with budget requests in excess of the stated direct cost upper limits in any year will be considered non-responsive and will not be reviewed.
The anticipated start date for awards is December 1, 2009.
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.
Facilities
and Administrative (F&A) 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(s) with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her organization 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
An individual may apply as the PI on only one IPCP-HTM application; but may serve as a Project Leader and/or Scientific Core Leader on one or more other applications, provided there is no scientific overlap with the application submitted by the PI.
Renewals (formerly competing continuation ) submitted in response to this FOA or competitive supplements to existing IPCP-HTM awards will not be accepted. Recipients of previous IPCP-HTM awards may reapply with a new IPCP-HTM application; however, the scope and specific aims of the new application must differ substantially from the previous award. Applications proposing the next step in development subsequent to a previous award will not be considered different from the previous award and, therefore, will be deemed unresponsive by NIAID Program staff and will not be reviewed. NIAID defines substantially different as the pursuit of new molecular entities, mechanisms/targets of action or strategies. Development of a combination microbicide or complex strategy that incorporates a molecule from a previous award may be considered responsive. Interaction with the Program contact, listed in Section VII. Agency Contacts, will be crucial in determining whether the new application is sufficiently different to be responsive.
Resubmissions (formerly revisions/amendments") of a previously reviewed IPCP-HTM grant application may be submitted.
PIs, Project Leaders, and Administrative and Scientific Core Leaders are requested to commit substantial time and effort to ensure success of the complex IPCP-HTM Program. It is recommended that these individuals devote a minimum of 2.4 calendar months per year effort to the Program. This level of commitment can be all in one project/scientific core or a total effort across several projects/scientific cores within a single application. However, if the effort is derived from multiple scientific cores and/or individual research projects, the level of effort is expected to be commensurate with the direct involvement necessary to ensure successful implementation and management.
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 on line 2 of the face page of the
application form and the YES box must be checked.
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy
Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
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 PHS Form 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. Detailed budgets are required within
the descriptions of each project and core (see below).
6. Biographical Sketch Format
Page
Biographical sketches of all professional personnel
for all components should be placed at the end of the
application with the Principal Investigator first, followed by those of other
key personnel in alphabetical order.
7. Resources Format Page
Do not complete. Essential information is
to be presented in the individual research project
and core sections of the application.
8. 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.
9. Checklist
One Checklist, placed at the end of the application, is to be submitted for the entire application.
B. Specific Instructions for Individual Research Projects
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.
Each individual Research Project must include:
1. Cover Page
The Face Page of the 398 Form should not be
used as a cover page for individual research projects within a multi-project
application. Instead, a "Cover Page" containing selected data about
each individual research project should be prepared. A Cover Page 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 Rectal 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)
Federalwide 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: (mmddyy - e.g., 07/01/2007)
To: (mmddyy - 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 PHS Form 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.
3. Form Page 3
Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.
4. Budget Pages (PHS 398 Form Pages 4 and 5)
Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.
5. 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).
6. Resources Format Page
Provide information on resources available for the project.
7. Research Plan (Items 2-5 cannot exceed 25 pages)
Item 2 -- Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the project's relationship to the multi-project program goals and how it relates to other projects or cores. This section is typically one page.
Item 3 -- Background and Significance: Use this section to describe how the proposed research will contribute to meeting the program's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.
8. Appendix
All appendix material should be collated as one body of material and submitted on CD as described above.
C. Specific Instructions for Core Units
Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.
Each Core must include:
1. Cover Page.
The Face Page of the 398 Form should not be used as a cover page for cores
within a multi-project application. Instead, use the
398 continuation page to create a "Cover Page" containing selected
data about each individual core. This cover page will demarcate each core. A
Cover Page should contain the following information items (which are a subset
of the information provided on a Face Page - see PHS
398):
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., 5/14/02, or Pending)
(and)
Federalwide Assurance (FWA) number
Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/07, or
Pending)
(and) Animal welfare assurance number
Proposed Period of Support
From: (mmddyy, e.g., 07/01/2007)
To: (mmddyy, e.g.,
06/30/2012)
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
(ABC University
111 Main Street
Anywhere, Else 99999)
The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual. For all other items in the core application, follow the usual PHS 398 instructions.
2. Form Page 2.
Provide a Description (abstract) of the Core activities and services according
to the instructions on Form Page 2 of PHS Form 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.
3. Form Page 3.
Prepare a Table of Contents for the core using page 3 of Form PHS 398. Since
the biographical sketches of all participating investigators will be located at
the end of the overall application (and therefore
should be referenced in the Overall Table of Contents), it is not necessary to
repeat these pages.
4. Budget Pages (PHS 398 Form Pages 4 and 5)
Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.
5. 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).
6. Resources Format Page
Provide information on resources available for the core.
7. Core Research Plan (Items 2-5 cannot exceed 25 pages)
Item 2 - Specific Aims: List in priority order the broad, long-range objectives of the proposed core. In addition, state the core's relationship to the multi-project program goals and how it relates to the research projects or other cores in the application.
Item 3 - Background and Significance: Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. In addition, this section should indicate the relevance of the core to the primary theme of the multi-project grant.
8. Appendix
All appendix materials should be collated as one body of material and submitted on CD as described above.
For all other items in the individual core section of the application, follow the usual PHS 398 instructions.
1. Administrative Core
Each application must provide for an Administrative
Core headed by the Principal Investigator or other senior investigator who is
responsible for the overall management, coordination and supervision of the
IPCP-HTM. Provide an administrative plan that
includes a discussion of the structure and roles of administrative staff,
including the training and experience of proposed staff and the functions to be
performed; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated;
and how research related travel and training will be budgeted.
Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here.
2. Scientific Cores
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). This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific Core Leader and each of the key participants. The apportionment of dollars or percentage of dollars that will be required to support each component research project that will utilize each scientific core should also be presented.
D. Instructions for resubmissions
The resubmission must include an Introduction of not more than three pages that summarizes the substantial additions, deletions, and changes for the overall application and for each project and core resubmitted. The Introduction for the overall application should summarize and address significant changes in the proposed IPCP-HTM, i.e. Projects or Cores eliminated or significantly modified. The Introduction to Projects and Cores should address the specific criticisms of the component and how the changes improve the overall integration of the Project or Core in the overall IPCP-HTM. The Introduction must also include responses to the criticisms and issues raised in the Summary Statement. Insert the Introduction just before the very beginning of the Research Plan.
A resubmission application must include substantial changes in the Research plan. Identify the changes in the Research Plan clearly by bracketing, indenting, or changing typography, unless the changes are so extensive as to include most of the text. This exception should be explained in the Introduction. Do not underline or shade changes.
3. Submission Dates and Times
Applications
must be received on or before the receipt date described below See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: February 13, 2009
Application Receipt Date: March 13, 2009
Peer
Review Date: June 2009
Council
Review Date: August 2009
Earliest
Anticipated Start Date: December, 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:
Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (express mail zip 20817)
Telephone: (301) 496-8426
Fax: (301) 496-2310
Email: [email protected]
3.B. Sending an Application to
the NIH
Applications must be prepared using the research grant
applications 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:
Peter R. Jackson,
Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (express mail zip 20817)
Telephone: (301) 496-8426
Fax: (301) 496-2310
Email: [email protected]
3.C. Application Processing
Applications must be received
on or before the application receipt date described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review. Upon receipt, applications will be
evaluated for completeness by the CSR and responsiveness by NIAID. Incomplete
and non-responsive applications will not be reviewed.
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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
Resubmissions (formerly revisions/amendments") of a previously reviewed IPCP-HTM grant application may be submitted.
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.
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 the NIH
Grants Policy Statement).
6. Other Submission Requirements and Information
Supplemental Instruction for the Preparation of Multi-Project Applications
The following section supplements the instructions found in Form PHS 398 for preparing the multi-project grant application. Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research grant (R01) applications, and have 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
address 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 describe
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 scientific cores must provide
services or resources to support at least two research projects. Describe
modifications to PHS Form 398 instructions on
selected items to address the collaborative or interactive role of the project.
D. Specific Instructions for Resubmissions - describes the requirements for resubmission.
A. General Instructions
All applications must be
submitted on Form PHS 398. The
multi-project grant application should be assembled and paginated as one
complete document.
1. Form Page 1 - Face Page
Items 1 - 15: 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 Page 2 of Form 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, and
then by other key personnel.
Special requirements of this FOA include:
All applications must include:
1. IPCP-HTM PROGRAM OVERVIEW
An overview of the proposed IPCP-HTM is required and should be placed ahead of the discussion of individual research projects, the Administrative Core and any proposed scientific cores. It should be labeled IPCP-HTM Program Overview . The overview will address the entire IPCP-HTM application and include:
The IPCP-HTM Program Overview must not exceed 25 pages. The Research Design and Methods section of the Program Overview should address the overall design of the IPCP-HTM program, and how it will accomplish its stated objectives. The Program Overview also should address integration of the individual research projects and scientific cores, and outline the processes and procedures to be developed or already in place to administer the IPCP-HTM.
In preparing the IPCP-HTM application, investigators should consider the fact that the application as a whole will be assigned a single priority score that reflects the integration of the individually identified research projects, the scientific cores and the Administrative Core and their perceived ability to advance the identified microbicide candidate(s) or strategy. Thus, clarity and completeness of the application’s combined components with regard to specific goals, proposed feasibility and measurable milestones and timelines are critical. Scientific milestones should be sufficiently rigorous to be valid for assessing progress and outcomes.
IPCP-HTM Scientific Advisory Panel (SAP)
Applications should describe the proposed expertise to be represented on the SAP and how this expertise will be utilized to guide the IPCP-HTM research projects, including procedures and approaches for obtaining SAP input via teleconferences, meetings, review of written materials/data, etc. If a pre-Phase I clinical trial is proposed, at least one of the SAP members should have clinical trial experience. This section should also include a discussion of the role of the SAP and its integration into the operations of the IPCP-HTM.
NOTE: Applicants MUST NOT name proposed SAP members in their applications or contact potential SAP members prior to application submission and completion of peer review.
2. MILESTONES FOR INDIVIDUAL RESEARCH PROJECTS AND SCIENTIFIC CORES
For each individual research project and each scientific core, applicants must provide well-described, quantifiable, and scientifically justified milestones that are not simply a restatement of specific aims. Milestones should be presented via a Gantt chart or equivalent, with associated timelines and identified outcomes. Milestones must specify the outcome(s) for each activity, i.e., synthesize n compounds, or, initiate pre Phase I clinical trial. It is recognized that milestones associated with more basic science-oriented projects may be difficult to quantify; however, in those cases, applicants should develop quantifiable outcomes such as minimal toxicity, marker selection, range of action, etc. Milestones should be integrated with the overall goals of the proposed IPCP-HTM program. Applicants should include plans for periodically revisiting and revising milestones and timelines, if needed, as new information becomes available, challenges to the proposed development path are encountered, and research outside the IPCP-HTM modifies the science of microbicides.
Milestones and timelines should be placed at the end of the Research Plan section for each individual research project and scientific core and fall within the 25 page limit.
3. APPLICATIONS PROPOSING PRE-PHASE I CLINICAL TRIALS
Applications proposing pre-Phase I clinical trials must address the following:
4. APPLICATIONS PROPOSING CLINICAL STUDIES INVOLVING THE USE OF HUMAN SAMPLES
For applications proposing a clinical study involving the use of human samples, such samples may be derived from clinical studies or clinical trials that are planned, ongoing or completed, and sponsored by any source of support. Applications must include:
5. ADMINISTRATIVE CORE
Applications should outline an Administrative Core for the short- and long-term management of the program. The Administrative Core should specifically address communications, group meetings and teleconferences, presentation and publication of data, resource and model sharing and transmission of information and reagents, awareness of development, progress and outcomes of other projects within the program, the identification and resolution of problems, and engagement of the SAP and NIAID as appropriate. Since IPCP-HTM programs involve potentially complex interactions among multiple investigators and institutions, the Administrative Core will be required to demonstrate its potential for leadership by providing processes and procedures that address routine activities, as well as discuss its preparedness to deal with unexpected outcomes such as delays in the finalization of inter-institutional agreements.
Applications should include travel funds for the PI, Project Leaders and Scientific Core Leaders to attend one annual scientific conference each year to be held in the Washington, D.C. area, and for the PI, Project Leaders, Scientific Core Leaders, other key IPCP-HTM personnel, and SAP members to attend one annual IPCP-HTM meeting to be hosted at a site chosen by the awardee, ideally at one of the IPCP-HTM project or scientific core sites, with the concurrence of the assigned NIH Project Scientist. Applicants proposing pre-Phase I clinical trials where travel is required to coordinate activities among clinical sites, additional travel funds may be requested for coordination with the clinical trial sites. However, all such travel requests should be well justified. Requests for additional travel to visit subcontractor or consortium sites for discussion and planning involved in supplying specific assays or services, such as GLP analytical services or animal testing must be specifically justified. Applicants should provide a justification for why the meeting needs to be face-to-face and cannot be adequately conducted via tele- or web conference.
No additional travel funds will be provided for any members of the IPCP-HTM to attend other domestic or foreign meetings.
Applications lacking any of the information described in 6. Other Submission Requirements and Information, as determined by NIAID staff, will be designated as non-responsive to the FOA and will not be reviewed.
Research Plan Page Limitations
See Section IV.2. Content and Form of Application Submission for Research Plan page limitations for the individual STI CRC components.
10.
Appendix Materials
All paper PHS 398 applications submitted must provide
appendix material on CDs only. Include five identical CDs in the same package
with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
For each project or core in the multi-project application, 3 publications (see below) plus other approved material are allowed. The Appendix may not be used to circumvent the page limitations of the Research Plan. The Appendix material should be collated as one body of material and submitted on CD only, as indicated below. Each document file must include header information clearly indicating the project or core to which it applies.
Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.
Note: Include the URL or PMC submission identification numbers along with the full reference in the Literature Cited section, the Progress Report for Competing Renewals section, and/or the Biographical Sketch section.
Color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 25-page limit of Items a-d of the research plan. No photographs or color images may be included in the Appendix that are not also represented within the Research Plan.
Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the 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 the 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 in which 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 (e.g., 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 (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.
Foreign Applications (Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
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 this FOA will be evaluated for scientific and technical merit
by an appropriate peer review group convened by the National
Institute of Allergy and Infectious Diseases and
the National Advisory Mental Health Council 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:
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. 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, and weighted 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.
1. REVIEW CRITERIA FOR THE OVERALL IPCP-HTM APPLICATION
The following items will be considered in the determination of overall scientific merit and priority score for the entire IPCP-HTM 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. If peer reviewers deem that fewer than the required two research projects have substantial and significant merit, the application will be recommended for no further consideration .
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?
Overall Program Milestones: Are the overarching program milestones applicable to the overall program, feasible within the proposed time frames, and integrated with the milestones for individual research projects and scientific cores? Do they provide quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?
2. REVIEW CRITERIA FOR IPCP-HTM 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?
Milestones for Individual Research Projects: Are the milestones appropriate, adequately described, feasible, quantifiable and achievable within the proposed time frame? Are the individual research project milestones integrated into the overarching IPCP-HTM program milestones and are they applicable to the overall program?
3. REVIEW CRITERIA FOR IPCP-HTM CORES
Administrative Core
Scientific Research Cores
Milestones for Individual Research Cores: Are the milestones appropriate, adequately described, feasible, quantifiable and achievable within the proposed time frame? Are the individual research core milestones integrated into the overarching IPCP-HTM program milestones and are they applicable to the overall program?
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:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
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 E on Human Subjects
in the PHS From 398).
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 E on Human Subjects in
the PHS From 398).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to be used
in the project, the adequacy of the plans for their care and use will be
assessed (see the Research plan, Section F on Human Subjects in the PHS From
398)..
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 and Period of Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by the
reviewers. The priority score should not be affected by the evaluation of the
budget.
Applications from Foreign Organizations: Whether the project presents 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 will be assessed.
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 NIH 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. NIH
no longer provides paper notification of the Notice of Award (NoA) letters.
See NOT-OD-08-002, October 9, 2007.
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 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 and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
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 U.S. Office of Management and Budget (OMB) administrative
guidelines, U.S. Department of Health and Human Services (DHHS) 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 PD(s)/PI(s) will have the primary responsibility for: defining the research objectives, approaches and details of the projects and scientific cores within the guidelines of the FOA. Specifically, awardees have primary responsibility as described below.
The Principal Investigator retains primary responsibility for the performance of the scientific activity, and understands the role of the Program Officer in the Cooperative Agreement award mechanism as described below.
The Principal Investigator will be solely responsible for:
Annual IPCP-HTM Meetings
All awardees are required to host an annual meeting attended by Project Leaders, Scientific Core Leaders, SAP members, other key IPCP-HTM staff and NIAID staff. The PI and other IPCP-HTM members shall present: (1) an update on the results achieved for each research project and scientific core, (2) a review of progress in achieving established milestones within the specified timelines, any modifications in milestones or timelines that are proposed or have been implemented and their rationale, and a discussion of scientific, technical and other problems and obstacles, including performance, encountered and methods/approaches proposed or implemented to overcome and/or resolve obstacles and problems, and (3) future plans for achieving remaining milestones, any identified or potential problems that may impede or slow progress, and proposed methods/approaches to dealing with such problems, including contingency plans for delays, acceleration of timelines, and/or recommended modifications to established milestones and timelines.
Annual Scientific Conference
All awardees (Project Leaders and Scientific Core Leaders) will attend a scientific conference of NIAID Topical Microbicide Program Investigators or the Annual Alliance for Microbicide Development Meeting organized yearly in the Washington D.C. area. Awardees will be informed by NIAID staff which scientific conference to attend.
IPCP-HTM Awards Involving Clinical Trials
Applicants are encouraged to familiarize themselves with Division of AIDS Clinical Research Policies, which specify requirements for conducting clinical research under NIAID/Division of AIDS sponsorship (http://www3.niaid.nih.gov/research/resources/DAIDSClinRsrch/). Protocols for clinical trials must be reviewed and approved by the Division of AIDS Prevention Sciences Review Committee (PSRC) prior to implementation. In addition, awardees engaged in the conduct of clinical trials will be required to adhere to the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).
Monitoring Clinical Studies and Pre-Phase I Clinical Trials
When clinical studies or pre-phase I trials are a component of the research conducted, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.
The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research.
Intellectual Property
The successful development of high priority products as microbicide candidates will require substantial investment and support by private sector industries, and may involve collaborations with other organizations such as academic and/or non-profit research institutions not directly involved in the IPCP-HTM. It is the intent of this initiative to encourage the formation of the appropriate public-private partnerships that are essential to meet these urgent public health needs. NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees shall understand and acknowledge the following:
Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, reports to the NIAID, and other mechanisms.
Data
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.
Publications
The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in whole or in part under this Cooperative Agreement. The Principal Investigator and Project Leaders are requested to submit manuscripts to the NIH Project Scientist within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the Principal Investigator and appropriate Project Leaders and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is required.
2. A.2. NIH
Responsibilities
An
NIH Project Scientist will have substantial programmatic involvement that is
above and beyond the normal stewardship role in awards, as described below.
During performance of the IPCP-HTM award, the NIH Project Scientist will provide appropriate assistance, advice, and guidance by: participating in scheduled meetings and teleconferences that may include, but are not limited to, Steering Committee meetings and teleconferences to discuss program coordination and/or progress; participating in annual meetings and SAP deliberations; participating in the design of the activities; facilitating collaboration with other NIAID-supported research resources; and advising in project management and technical performance. However, the role of the NIH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIH Project Scientist, and other NIAID staff identified by the Principal Investigator, the Steering Committee and/or the NIH Project Scientist as having relevant expertise, may be given the opportunity to offer advisory input. The NIH Project Scientist will facilitate liaison activities for partnerships, and provide assistance with access to NIAID-supported resources and services.
Other appropriate NIH program staff assistance will be coordinated by the NIH Project Scientist, which may include Medical Officer(s), clinical operations and regulatory staff and other expertise as required. The NIH Project Scientist, with support of the appropriate staff and expertise, will provide coordination and assistance to the awardee to meet the Division of AIDS requirements for clinical protocol content, PSRC review and pre-Phase l clinical trial initiation and conduct. For awardees conducting pre-Phase l clinical trials, the NIAID reserves the right to terminate or curtail a clinical trial in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of the protocol, (b) substantive changes in the consensus protocol to which the NIAID does not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate a premature termination.
The Government, via the NIH Project Scientist, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards.
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The
assigned program director may also serve as an NIH Project Scientist.
2.A.3. Collaborative Responsibilities
(optional)
Executive Committee
Within two months of award, an Executive Committee (EC) will be established and chaired by the Principal Investigator. The EC will consist of the designated leaders for each Project and Core, the NIH Project Scientist, other NIH scientists as identified by the Principal Investigator and/or EC, and any other key personnel identified by the Principal Investigator. The NIH Project Scientist will act in an advisory capacity and be a non-voting member of the EC. The EC may add additional members by majority vote. Each full member will have one vote. Awardee members of the EC will be required to accept and implement policies approved by the EC.
The EC will serve as the main governing board of the IPCP-HTM Program. Awardee members of the EC will be required to accept and implement policies approved by the EC. The EC will:
The NIH Project Scientist will participate in the activities of the EC as required, providing verbal or written responses to the EC or its designated subcommittees upon request.
IPCP-HTM Scientific Advisory Panel (SAP)
Each
IPCP-HTM program will establish a SAP of 3-5 investigators
not affiliated with any of the institutions participating in the IPCP-HTM
research program. The SAP will be an independent advisory body and act as a
resource for the Principal Investigator and the EC. The SAP will not be
involved in the day to day activities of the IPCP-HTM
Program. SAP membership will be determined in consultation with the NIH
Project Scientist. The SAP should be constituted within 12 months of award.
Members of the SAP are expected to attend one or more IPCP-HTM annual meetings during the award period. The complete SAP
membership is not required to attend all annual meetings, but at least one
member of the SAP must attend each annual meeting. When the complete SAP is in
attendance, it will assist in review of the IPCP-HTM
activities and evaluate progress toward achieving milestones, adherence to the
original time frames, and the continued relevance of each project and
scientific core to the overall goals of the research program. The SAP may
recommend new directions as appropriate and, if
requested by the PI, provide the PI with a comprehensive written evaluation of
the IPCP-HTM activities and recommendations after the annual meeting. For
awards involving a pre-Phase I clinical trial, the SAP may, at the discretion
of NIAID, also be called upon to evaluate the
feasibility of initiating a clinical study per the final goals and milestones.
When the complete SAP is in attendance the SAP will provide a comprehensive
written evaluation of the SAP’s activities and recommendations within 30 days of the meeting, at the PI or NIH
Project Scientist’s request.
Milestones and Timelines
NIAID shall be included in the terms and conditions of award. It is recognized that milestones and timelines may require revision and renegotiation during the project period. The Principal Investigator and NIAID must agree to all such revisions.
IPCP-HTM Scientific Advisory Panel (SAP)
Each
IPCP-HTM program will establish a SAP of 3 or more investigators not affiliated
with any of the institutions participating in the
IPCP-HTM research program. The SAP will be an independent advisory body and
act as a resource for the Principal Investigator and the EC. The SAP will not
be involved in the day to day activities of the IPCP-HTM Program. The NIH Project Scientist will provide advice on the SAP membership,
if asked. The SAP should be constituted no later than 12 months following
award. Members of the SAP are expected to attend one or more IPCP-HTM annual
meetings during the award period. The complete SAP
membership is not required to attend all annual meetings, but at least one
member of the SAP must attend each annual meeting. When the complete SAP is in
attendance, it will assist in review of the IPCP-HTM activities and evaluate
progress toward achieving milestones, adherence to
the original time frames, and the continued relevance of each project and
scientific core to the overall goals of the research program. The SAP may
recommend new directions as appropriate and, if requested by the PI, provide the PI with a comprehensive written evaluation of the
IPCP-HTM activities and recommendations after the annual meeting. For awards
involving a pre-Phase I clinical trial, the SAP may, at the discretion of
NIAID, also be called upon to evaluate the feasibility
of initiating a clinical study per the final goals and milestones. When the
complete SAP is in attendance the SAP will provide a comprehensive written
evaluation of the SAP’s activities and recommendations within 30 days of the
meeting.
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
regulation 42 CFR Part 50, Subpart D and DHHS regulation 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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Jim A. Turpin, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5114, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 451-2732
Fax: (301) 496-8530
Email: [email protected]
Roberta Black, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5135, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301)-496-8199
Fax: (301)-402-3684
Email: [email protected]
Andrew D. Forsyth, Ph.D.
Center for Mental Health
Research on AIDS
National Institute of
Mental Health
Room 6204, MSC-9619
6001 Executive
Boulevard
Bethesda,
MD 20892-9619
Telephone: (301)
443-8403
Fax: (301) 443-9719
Email: [email protected]
2. Peer Review Contact(s):
Peter R. Jackson,
Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (express mail zip 20817)
Telephone: (301)
496-8426
Fax: (301) 496-2310
Email: [email protected]
3. Financial/Grants Management Contact(s):
Mollie Shea
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2234, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614
Telephone: (301) 402-6576
FAX: (301-493-0597
Email: [email protected]
Jane Z. Lin
Grants Management Specialist/Officer
NIH/National Institute of Mental Health
6001 Executive Blvd., Room 6115, MSC 9605
Bethesda, MD 20892-9605
Phone: 301-443-2229
Fax: 301-480-1956
E-mail: [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 (45 CFR 46) 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 institutional review board (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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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 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, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS
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) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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 Part 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
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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