Part I Overview Information


Department of Health and Human Services
 
Participating Organizations
National Institutes of Health (NIH) ( http://www.nih.gov)

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID) ( www.niaid.nih.gov)

Title: HIV Interdisciplinary Network for Pathogenesis Research in Women (U19)

Announcement Type
New

Request For Applications (RFA) Number: RFA-AI-07-009

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856

Key Dates
Release Date: January 31, 2007
Letters of Intent Receipt Date(s): May 14, 2007
Application Receipt Date(s): June 25, 2007
Peer Review Date(s):  October, 2007
Council Review Date(s): January, 2008
Earliest Anticipated Start Date(s):  March, 2008
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date(s):  June 26, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Nature of the research opportunity

The National Institute of Allergy and Infectious Diseases (NIAID) invites applications from single institutions and consortia of institutions to participate in a cooperative high quality, focused, multidisciplinary pathogenesis research program in HIV-infected women.  The HIV Interdisciplinary Network for Pathogenesis Research in Women program will establish consortia of investigators to address research questions of mutual interest in the pathogenesis of HIV transmission, acquisition, and disease progression in women.

Background

Approximately 39.5 million individuals are infected with HIV/AIDS, according to the Joint United Nations Programme on HIV/AIDS (UNAIDS) http://www.unaids.org/en/HIV_data/default.asp; approximately 50 percent of these infections are in women and girls.  Rates of HIV/AIDS in women vary according to geographic area; however, world-wide, the majority of HIV-positive women are of childbearing age and become infected through heterosexual intercourse.  Although basic mechanisms of viral replication and the HIV-specific immune response may not differ significantly in women and men, research has shown that there are sex differences in the way HIV disease interacts with its host through the course of HIV infection.  The factors driving these differences are complex and probably reflect basic biologic differences, both physiologic and anatomic, between men and women. The mechanisms underlying these differences are unclear and may include mode of viral transmission through the mucosa of the female genital tract, lower viral loads and CD4 counts in women compared to men especially during the acute phase of the infection, and varying susceptibility to infection due to hormonal fluctuations during the menstrual cycle.  Other female-specific pathologic consequences of HIV infection include early onset of menopause and altered hormonal patterns with aging.  Focused research on HIV pathogenesis in women is urgently needed to better understand the mechanisms of infection and disease progression in order to improve prevention strategies and the care of HIV-infected women around the world.

Research Objectives and Scope

The purpose of this RFA is to support research that will enhance knowledge of the pathogenesis of HIV infection in women through investigations of biologic mechanisms that impact HIV transmission, disease acquisition, progression, and manifestations of HIV in women.  Applications are sought that pursue research addressing female-specific differences in one or more of the following areas of HIV-infection in women at every age and all stages of the reproductive cycle: 1) immunology, 2) virology, 3) response to and complications of therapy, and 4) genetics.

The HIV Interdisciplinary Network for Pathogenesis Research in Women program s not intended to establish a new cohort study but rather to encourage investigators to obtain, whenever possible, research subjects, stored biologic samples, and/or clinical datasets through collaborative associations with existing NIH-sponsored clinical networks, programs and cohorts that include women.  However, it is recognized that under special circumstances certain research projects may require recruitment of specific populations of HIV-infected women that are not available through existing networks or cohorts.  Current cohort studies have substantial specimen repositories and longitudinal measures of host factors, co-morbidities and disease outcomes that are available to collaborators.  In addition, NIAID-supported observational cohort studies have mechanisms available for specific specimen or data collection, when needed to fulfill specific research goals.  NIH-funded cohorts, networks and biologic sample repositories include: the Women’s Interagency HIV Study (WIHS)  (https://statepiaps.jhsph.edu/wihs/), HIV/AIDS Clinical Trials Network  http://www3.niaid.nih.gov/news/newsreleases/2006/leadership.htm, the Center for HIV/AIDS Vaccine Immunology (CHAVI)  (http://grants2.nih.gov/grants/guide/rfa-files/RFA-AI-04-051.html), the Multicenter AIDS Cohort Study (MACS)  (http://statepi.jhsph.edu/macs/macs.html), the National NeuroAIDS Tissue Consortium (NNTC)  (http://www.hivbrainbanks.org), the Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions  (http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-025.html), and the AIDS and Cancer Specimen Resource  (http://acsr.ucsf.edu).  Investigators also are encouraged to utilize the clinical infrastructure support of the Centers for AIDS Research (CFAR) (http://www.niaid.nih.gov/research/CFAR/).  Tissue and organ samples from HIV-positive and healthy donors are available through the NIH-supported National Disease Research Interchange (NDRI) (http://www.ndriresource.org/).

To further facilitate collaborations with existing networks and cohorts, the HIV Interdisciplinary Network for Pathogenesis Research in Women program will hold annual scientific meetings in coordination with a meeting of another NIH-sponsored research or clinical trials program that includes women as study subjects.

Research Topics

This RFA complements ongoing epidemiological and other research studies in the area of HIV and women.  Applicants are encouraged to explore and develop innovative projects and research ideas that are consistent with the overall objectives of this RFA.  Applicants are strongly encouraged to establish collaborations to access reposited human samples and female study subjects enrolled in existing NIH-sponsored programs or cohorts.  Research topics responsive to this RFA include, but are not limited to:

This RFA will NOT support:

Applications proposing such studies will be considered non-responsive and will be returned to the applicant without review.

Pilot Projects

Applicants should propose, through the Administrative Core, a pilot projects program to support small scientific studies for short periods of time (up to one year) to develop preliminary data for peer-reviewed research applications.  The pilot projects program is intended to attract and further the success of new investigators, investigators new to the HIV/AIDS field, and to provide a mechanism for the conduct of studies in new areas of scientific interest and/or emerging research opportunities in women’s HIV pathogenesis.  Examples of situations that may be considered eligible for such pilot project support include: (1) investigators new to AIDS research who have not previously received investigator-initiated awards in AIDS research and wish to embark on studies of HIV pathogenesis in women; (2) feasibility studies in female-specific HIV pathogenesis; (3) emerging research opportunities based on new discoveries related to mechanisms of HIV pathogenesis in women; and (4) AIDS research activities of newly recruited faculty who want to pursue studies in women’s pathogenesis.  The pilot projects program will be run by the Administrative Core which will, on an annual basis, solicit, establish review proceedings for, fund, administer and manage the awarded projects.  The Steering Committee will conduct an annual review of the pilot project applications for scientific and programmatic relevance and perform a second level of review of funding decisions on applications deemed scientifically meritorious by the Administrative Core.  Funds for pilot studies will be limited to $50,000 per year and should be included in the Administrative Core budget.  Investigators eligible for pilot project support must be affiliated with the awardee.  Applicants may wish to consult program staff listed under Section VII. "Agency Contacts" to discuss how pilot funds are used in other currently funded NIAID programs.   

Scientific Cores

Scientific cores to support the individual research projects may be proposed if they will be utilized by at least two of the proposed research projects.  Such cores should provide services and/or facilities that are already available and/or are not funded through other means for the purposes proposed.  Examples of scientific cores include performance of specific assays; clinical specimen collection, processing and coordination; enrollment of study subjects when required; and providing equipment, services, quality control, and expertise. 

The following activities will NOT be supported through a scientific core:

Steering Committee

A Steering Committee will serve as the governing board of this collaborative research program; its actions and decisions will be determined by majority vote.  Voting membership will include each PI, the NIH Project Scientist, other NIH staff as identified by the NIH Project Scientist, and up to two additional key personnel identified by each PI.  Steering Committee responsibilities are further described under Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award – “Collaborative Responsibilities.”

External Scientific Advisory Panel

The Steering Committee will establish an External Scientific Advisory Panel (ESAP) of 3-4 selected scientists other than the awardees with appropriate scientific expertise to provide the Steering Committee with scientific breadth and balance, and advise NIH staff on scientific opportunities, emerging needs, and research obstacles.  The ESAP will be established no later than 8 months post award.   ESAP responsibilities are further described under Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award – “Collaborative Responsibilities.”

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the multi-project U19 Cooperative Agreement award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 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.

The NIH U19 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

At this time, NIAID has not determined whether and how this solicitation will be continued beyond the present RFA.

2. Funds Available

The NIAID intends to commit approximately $6 million dollars in FY 2008 to fund 3-4 new grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs up to $1.5 million per year. 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 NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The anticipated start date is March 2008.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

NOTE: Foreign institutions are not eligible to apply as the primary applicant but may enter into a consortium with a domestic institution as the primary applicant.  Applicant Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. 

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

An institution may submit only one application; however, applications may include investigators from more than one institution if such arrangements enhance the scientific strength of the proposed research program.  In addition, a Principal Investigator on one application may also serve as a Project Leader and/or Scientific Core Leader on another multi-project application if there is no scientific overlap between the applications.

The PI is requested to commit substantial time and effort to ensure success of the Program.  It is recommended that the PI devote a minimum of 15% effort, and that the Project Leaders and Core Leaders devote a minimum of 15% effort.  The level of effort is expected to be commensurate with the direct involvement necessary to ensure successful implementation and management of the Program.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Multi-Project Applications

Essential elements of the multi-project cooperative agreement mechanism (U19) include: 1) a minimum of two interrelated individual research projects organized around a central theme; 2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; 3) a single PI who will be scientifically and administratively responsible for the group effort;  4) a single applicant institution that will be legally and financially responsible; 5) an Administrative Core that will coordinate projects and comprise a mechanism to award funds and manage pilot studies to new investigators, investigators new to AIDS research, or investigators proposing research in new areas of scientific interest and/or emerging opportunities in HIV pathogenesis research in women; and 6) where appropriate, scientific core resources or facilities to support the research projects, provided each scientific core will support at least two research projects.  Such core facilities should provide services that are already available, do not need to be developed, and are not funded through other means for the purposes proposed.  The services provided should be well justified within the description of the proposed scientific core facility and also within each relevant research project.

Supplemental Instructions for the Preparation of Multi-project Applications

The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research grant (R01) applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme. 

The supplemental instructions below are divided as follows:

A. General Instructions – addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for Individual Projects – describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

C. Specific Instructions for Core Units – Cores must provide services or resources to support at least two research projects. Instructions describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

A. General Instructions

All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.

1.  Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2.  Form Page 2

Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

3.  Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g. Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4.  Composite Budget

Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850



5.  Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.

6.  Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the Principal Investigator first, followed by those of other key personnel in alphabetical order.

7.  Other Support Format Page

Do not complete. (Any required information will be requested from successful applicants prior to grant award.)

8.  Resources Format Page

Do not complete. Essential information is to be presented in the individual research project and core sections of the application.

9.  Program Overview (Research Objectives and Strategic Plan)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.

10. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application. Individual research projects and cores do not require a checklist.

11. Appendix

A change in policy limiting Appendix materials began with receipt dates on or after January 3, 2007 (NOT-OD-07-018). http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

For each project or core in the multi-project application, 3 publications 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 at the end of the application with each document clearly labeled referring to the project or core to which it applies.

(Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.)

Note: publications and/or abstracts in press should no longer be included in the appendix material. 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.

Appendix materials may be submitted in paper format; five collated sets are needed.  Applicants are encouraged to send Appendix materials on a CD in PDF format in lieu of the five collated sets. See the PHS 398 application instructions for details on preparing CDs. Only a single CD need be sent. 

For materials that cannot be submitted electronically or materials that cannot be converted to PDF format; (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Administrator (SRA) for instructions following notification of assignment of the application to a study section. Applicants should contact the SRA listed in Section VII. Agency Contacts – Peer Review Contacts in advance to address acceptability of materials.

B. Specific Instructions for Individual Research Projects

1.  Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

Project Number and Title: (e.g., 1. Preclinical Evaluation of HIV Microbicides)

Name of Project Leader: (e.g., Jones, Roberta A.)

Human Subjects: (Yes or No)
If Yes, exemption number:
(or)
IRB Approval Date: (e.g., 12/13/2006,or "Pending")
(and)
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 the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.

3.  Form Page 3

Prepare a Table of contents for the research project using Form Page 3 of the PHS 398.

4. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

5.  Research Plan (Items A-D cannot exceed 25 pages)

6.  Appendix. Do not create an appendix for an individual project.

For all other items in the individual research project application, follow the usual PHS 398 instructions.

C.  Specific Instructions for Cores

1.  Cover Page.

The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:

Core Letter and Core Title: (e.g., A. Monoclonal Antibody Production Core)

Name of Core Leader: (e.g., Smith, Robert A.)

Human Subjects (Yes or No)
If Yes, Exemption Number
(or)
IRB Approval Date (e.g., 5/14/06, 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
(full address)

2.  Form Page 2.

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

3.  Form Page 3.

Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.

4.  Biographical Sketches.

Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

5.  Core Research Plan (Items A-D cannot exceed 25 pages)

For all other items in the individual core application, follow the usual PHS 398 instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): May 14, 2007
Application Receipt Date(s): June 25, 2007
Peer Review Date(s):  October, 2007
Council Review Date(s): January, 2008
Earliest Anticipated Start Date(s):  March, 2008

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 at the beginning of this document.

The letter of intent should be sent to:

Barney Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139 MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)

Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-451-2592
FAX: 301-480-2408
Email: dp298s@nih.gov

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:

Barney Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139 MSC-7616
6700B Rockledge Drive 
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824 (for Express Couriers)
Telephone: (301) 451-2592
FAX: 301-480-2408
Email: dp298s@nih.gov
    

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) 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 the NIAID. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Special requirements of this RFA include:

1. Program Overview (Research Objectives and Strategic Plan)

An introduction to the proposed research is required and should be placed ahead of the discussion of individual research projects, the Administrative Core and Scientific cores.  The introduction 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 program.  The program introduction must not exceed 25 pages.  Pages in excess of this number will be removed and will not be reviewed.  The introduction should address the entire application and include:

(1) Specific aims or objectives of the overall program.  This section should identify the specific questions that are to be explored and the new approaches and collaborations that will result from the establishment and future development of the program.  The synergies to be achieved through the establishment of multi-disciplinary teams and novel collaborations should be fully described.

(2) Background and significance of the program

(3) Preliminary Studies

(4) Research Design and Methods.  This section should address the overall design of the program, and how its stated objectives will be accomplished.

(5) Timelines, where appropriate

(6) External Scientific Advisory Panel.  The ESAP will be constituted post award; however, applicants should describe the desired areas of expertise to be represented on the ESAP and how this expertise will be utilized to provide advice and guidance on scientific opportunities, emerging needs, and research obstacles.  Applicants must not name proposed ESAP members in their applications or contact potential ESAP members prior to completion of application peer review.

In preparing the 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 Administrative Core and scientific cores, if included, and their perceived ability to answer the proposed research aims and advance knowledge of the pathogenesis of HIV infection in women  Thus, clarity and completeness of the application’s combined components with regard to specific goals, proposed feasibility and progress towards stated goals are critical.  Scientific progress will be assessed based on the program’s advance toward achieving the stated aims in the application.

2.  Collaborations

Applications must demonstrate the feasibility of establishing collaborations with existing cohorts and clinical networks and include detailed plans for specific collaborations and letters documenting access to research subjects, biologic specimens and/or datasets. These collaborations include, but are not restricted to, established NIH-supported research cohorts and clinical networks, such as the newly restructured HIV/AIDS Clinical Trials Networks (http://www3.niaid.nih.gov/news/newsreleases/2006/leadership.htm). 

Applicants proposing to collect new samples must document why existing cohorts and clinical networks are not suitable for obtaining samples based on the proposed research purposes.

3. Statistical Considerations

Each individual research project must include a description of the proposed method of data analysis and power calculations, as well as a justification for the required sample size.  Applications must describe the statistical procedures that will be used to analyze the data.  If appropriate, a statistician should be a part of the research team, and actively involved in preparation of the application.  Documentation of the appropriate statistical expertise should also be included in the application.

4. Documentation on the Use of Human Specimens

All applications will involve the use of human samples.  Such samples may be derived from tissue banks, repositories, clinical studies or clinical trials that are planned, ongoing or completed.  Depending on the origin of the human specimens used in the proposed studies, applications should include as appropriate:

(1)     Documentation of the ability to acquire human samples, including written agreements between the PI and the applicant institution, the clinical trial sponsor(s), including drug companies, if applicable, and the IND sponsor, if not one of the above, for the conduct of the study proposed in the application.

(2)     A draft consent form, when necessary, to obtain human samples not provided for in the associated clinical trial/study.

(3)     A detailed description of the proposed clinical study, including: hypothesis, study objectives, study population, relevance of the proposed study to clinical disease/patient outcome, statistical design and analysis plan, plan for management and quality control of data, and plan for receipt and storage of human samples. 

5.  Administrative Core

Applications must provide a plan for the overall administration, coordination and management of the program.  This plan should specifically address communications, group meetings and teleconferences, presentation and publication of data, allocation and re-allocation of resources to meet program goals, prioritization of fiscal and other resources, resource sharing and transmission of information and reagents, budgeting for research-related travel, and the identification and resolution of problems and unexpected outcomes.  Because of the potential for complex interactions among multiple investigators and multiple institutions, the plan must also provide an organizational structure with descriptions of the roles, training and experience of proposed Administrative Core staff, and delineate administrative and leadership mechanisms that will foster interactions among investigators and institutions, and will ensure a productive research effort.

A pilot studies program must be included under the Administrative Core detailing a plan to support the responsibilities associated with disbursement, administration, evaluation, and reporting on the use of pilot funds.  Such applications must include: (1) proposed methods/procedures for soliciting, evaluating, prioritizing, selecting and monitoring progress of pilot projects; (2) the experience/qualifications of the Administrative Core Leader and all proposed staff who will be involved in the pilot studies program; (3) proposed procedures, format and timing for reporting on the status of pilot fund use; (4) proposed outcome evaluation of funded pilot projects; and (5) institutional commitment to the administration of the pilot fund.

Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, travel, etc., should be included in the Administrative Core budget.  Each application should include travel funds for the PI, Project Leaders, and Core Leaders to attend two meetings each year, one to be held in the Washington, D.C. area, and one to be hosted at a different location chosen by the Steering Committee.  Each application should also budget travel funds for one member of the ESAP, to be named when the ESAP is constituted post award, to attend one meeting annually.  Funds should also be budgeted for sharing in the organization and hosting of these meetings. Applicants should also include in the Administrative Core budget, the amount of funds allocated to support the pilot studies program.

6. Scientific Core

Application proposing scientific core(s) must indicate the specific projects to be served by the scientific core(s) and explain why these core resources are not otherwise available at the applicant institutions or through other grant mechanisms, for example NIH-funded centers programs or clinical networks. 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 which will utilize each scientific core must also be presented.

Applications should describe the specific function of the core(s) to be supported at the time of award and any changes in the use of the core(s) anticipated during the course of the award.  Mechanisms should be described to evaluate core use annually, and justify level of continued support in the context of evolving progress in the program. 

Applications lacking the information described here, as determined by NIAID staff, will be designated as non-responsive to the RFA and will be returned to the applicant without review.

Plan for Sharing Research Data

Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The precise content of any data-sharing plan submitted can vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of any data sharing plan submitted or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of any resources sharing plan submitted and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Review Criteria - Overall Application

The following items will be considered in the determination of overall scientific merit and priority score for the entire application:

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 preventive 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 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.

Review Criteria - 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?

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”

Review Criteria - Cores

Administrative Core

Scientific Cores

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 priority score:

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 Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both gender, 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 Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of any data sharing plan submitted or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of any data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2. A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A. 1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for defining the research objectives, approaches and details of the projects and scientific cores within the guidelines of the RFA.  Specifically, awardees have primary responsibility as described below.

The Principal Investigator retains primary responsibility for the performance of the scientific activity, and agrees to accept close assistance, coordination, cooperation and participation of NIAID staff in scientific and technical management of the project.  The responsibility for planning, direction, and execution of the proposed project will be solely that of the Principal Investigator.

The Principal Investigator will attend Steering Committee meetings, serve as a voting member of the Steering Committee, and accept and implement policies and procedures developed by the Steering Committee.

Semi-Annual Meetings

All awardees are required to meet semi-annually, once in the Washington D.C. area and once at an awardee site.  One of the meetings should occur ideally in conjunction with a meeting of another NIH-supported program, cohort or clinical network that includes women as research subjects.   Such meetings should include the PIs, Project Leaders, all Core Leaders, Steering Committee members, and NIAID staff.  The PIs, Project Leaders, and Core Leaders shall present:  (1) an update on the results achieved for each research project and scientific core; (2) a review of progress in achieving proposed aims within a reasonable time, any modifications in the research that have been implemented, and a discussion of scientific, technical and other problems and obstacles, including performance, encountered and methods/approaches implemented to overcome and/or resolve obstacles and problems; (3) future plans for achieving remaining goals, any identified or potential problems that may impede or slow progress, and proposed methods/approaches in dealing with such problems, including contingency plans for delays, acceleration, and/or recommended modifications to projected research progress towards stated aims; and (4) an update on the pilot studies program including status of pilot fund expenditures, description of pilot fund applicants and awardees, description of pilot studies proposed, progress of ongoing pilot studies, and an evaluation of the results and preliminary data obtained from pilot studies completed.

Monitoring Clinical Studies

When clinical studies are a component of the research proposed, 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 human subjects.

Pilot Studies

The PI will be responsible for ensuring that all pilot studies involving human or animal subjects have the appropriate clearances (i.e., IRB, FWA, IACUC, human subjects’ research training, etc. in domestic and foreign institutions).   The PI must inform the NIH of any awards made for pilot studies involving foreign sites prior to their initiation.  Pilot studies involving foreign sites cannot be initiated without first obtaining NIH clearance and approvals for protection of human subjects and animals, including specimens. 

Intellectual Property

The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.

Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.

The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).

Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID, or 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 part or in total under this Cooperative Agreement. The Principal Investigator and Project Leaders are requested to submit manuscripts to the NIH Program officer 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 encouraged.

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 award, the NIH Project Scientist will provide appropriate assistance, advice, and guidance by: participating in scheduled teleconferences that may include, but are not limited to Steering Committee teleconferences to discuss program coordination and/or progress; participating in semi-annual meetings; 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 PI, Steering Committee and/or the NIH Project Scientist as having relevant expertise, may be given the opportunity to offer advisory input into this process.  The NIH Project Scientist will be a liaison for collaborations, and provide assistance with access to NIAID-supported resources and services.

The NIH Project Scientist will serve as a voting member of the Steering Committee, schedule the first meeting of the Steering Committee, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.

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 expertise.  The NIH Project Scientist, with support of the appropriate staff and expertise, will provide coordination and assistance to the awardees to meet the NIAID Division of AIDS (DAIDS) requirements, including, when needed, compliance with clinical study regulations, review of clinical protocols by the DAIDS, laboratory assay QA/QC, etc. 

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 NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3.Collaborative Responsibilities

Steering Committee

A Steering Committee will serve as the governing scientific and administrative board of the overall Program, its actions and decisions determined by majority vote.  Membership will include the PIs, the NIH Project Scientist, other NIH scientists as identified by the NIH Project Scientist, and up to two other key personnel identified by each PI.  The Steering Committee may add additional members by majority vote.  A Steering Committee Chair from among non-federal Steering Committee members will be elected by majority vote at the first Steering Committee meeting.  Each member will have one vote. 

Specific responsibilities of the Steering Committee include the following:

Each full member will have one vote.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

External Scientific Advisory Panel (ESAP)

The Steering Committee will establish an ESAP of 3-4 scientists with specific expertise, not affiliated with any of the institutions participating in the research program.  The ESAP should be constituted no later than 8 months following award.  The ESAP is expected to attend one annual meeting of the HIV Interdisciplinary Network for Pathogenesis Research in Women program.

Specific responsibilities of the ESAP include the following:

2. A. 4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Success of the program will focus on the productivity of the investigators as measured by the completion of the Specific Aims of the funded research projects, number and quality of publications arising from the funded research, successful competition by consortia members for additional grants and/or research contracts based on work produced by the consortium, the degree of collaboration across the consortium, and the degree of collaboration with existing cohorts.  Failure to achieve progress of the stated goals in a timely manner might results in a suspension of funds. 

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Nabila Wassef, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4150 MSC-7626
6700B Rockledge Drive 
Bethesda, MD 20892-7626
Telephone: (301) 435-3751
FAX: 301-402-3211
Email:
nwassef@niaid.nih.gov

2. Peer Review Contacts:

Barney Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139 MSC-7616
6700B Rockledge Drive 
Bethesda, MD 20892-7616
Bethesda, MD 20817-1824 (for Express Couriers)
Telephone: (301) 451-2592
FAX: 301-480-2408
Email:
dp298s@nih.gov

3. Financial or Grants Management Contacts:

Jane Unsworth
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2128, MSC-7614
6700B Rockledge Drive 
Bethesda, MD 20892-7614
Telephone: (301) 451-2592
FAX: (301) 480-2408
Email:
ju3a@nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA 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/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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