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), (http://www.niaid.nih.gov/)

Title: International Epidemiologic Databases to Evaluate AIDS (IEDEA)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AI-05-014

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

Key Dates
Release Date: February 15, 2005
Letters of Intent Receipt Date(s): July 27, 2005
Application Receipt Dates(s): August 26, 2005
Peer Review Date(s): November, 2005
Council Review Date(s): January, 2006
Earliest Anticipated Start Date: March, 2006
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/rfa-05-014.htm
Expiration Date: August 27, 2005

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Applications are being sought for the:

1) establishment of the IEDEA consortium, a collaborative group of international regional data centers, for the compilation of data to address research questions in HIV/AIDS that are not possible to answer with currently existing individual cohorts, one of which will serve as the Coordinating Center; (see Section I.1., Research Objectives, for countries comprising individual regions)
2) development of regional, generalizable datasets that represent study populations based on data from different settings and populations; and
3) development of procedures and approaches to allow regions to more accurately address and monitor the HIV epidemic within their populations.

Applications will be funded, based on scientific and technical merit and available funds, using the single project Cooperative Agreement (U01) mechanism. A maximum of 5 million US dollars will be awarded in FY 2006 under this RFA. Between two and ten individual awards will be made for a maximum of five (5) years. The amount per award may vary depending upon the scope of the proposed projects and capacity of the applicant institutions/organizations. An additional $500,000 total funds for the 5-year project period will be provided to the regional data center selected to be the IEDEA Coordinating Center to support the core functions of the IEDEA consortium, including convening the IEDEA meetings. For-profit and non-profit organizations and both domestic and foreign public or private institutions, such as universities, colleges, hospitals, and laboratories, are eligible to apply for funding under this announcement. Eligible Principal Investigators will have experience with the management and/or analyses of cohort or clinical trials data, particularly in the area of HIV/AIDS, and be able to demonstrate a record of successful research collaborations with other investigators. Only one application per region will be funded and not all regions may be funded. Applications should only cover one region; however, an individual applicant may submit more than one application as long as each application covers a different region. Applicants may not submit or be co-investigators on more than one grant covering the same region.

Application materials (PHS 398 forms) are available in an interactive format at http://grants.nih.gov/grants/funding/phs398/phs398.html. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. Telecommunications for the hearing impaired is available at: TTY (301) 451-5936.

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

Purpose

To assess the overall need and enthusiasm for database collaborations within the HIV research community, a meeting, the International Databases to Evaluate AIDS (IDEA), of international experts in the field of HIV/AIDS research was held in Bethesda, Maryland on September 28-29, 2004. From that meeting, the NIAID determined that in order to address the unique and evolving research questions that cannot be answered by single cohorts, there is a need to establish databases and collaborations. This RFA seeks to provide support for the collection and harmonization of HIV/AIDS data obtained from a variety of international sources, thereby permitting analyses of regional data as well as comparisons of results between regions. The RFA also seeks to enhance partnerships involving resource-limited settings by harmonizing the collection of high-quality data in those settings. This includes data collected as part of the implementation of ART programs.

Background

In the United States, as of December 2003, there were 886,575 cases of AIDS reported to the Centers for Disease Control and Prevention and 501,669 reported deaths [CDC, HIV/AIDS Surveillance Report, 2002;14 (no. 2):1-48]. The introduction of highly active antiretroviral therapy (HAART) in 1996 in the United States has significantly impacted AIDS disease progression and mortality. In the U.S., the number of AIDS deaths has declined from 21,460 in 1996 to 14,440 in 2000, while the number of Americans living with AIDS increased. A similar phenomenon has been seen in other developed countries where HAART is routinely used for treatment of HIV infection.

The longer lifespan of HIV-positive persons receiving HAART as well as the side effects of HAART therapy have created the need for research into new or modified manifestations of HIV infection and AIDS and clinical outcomes in patients on long-term HAART treatment. Toxicities related to HAART are often part of the clinical picture of HIV/AIDS and require systematic study. These new manifestations and toxicities include conditions such as lipodystrophy and other metabolic disorders, cardiovascular disease, neuropsychatric complications (e.g. minor cognitive motor disorder and peripheral neuropathy), and malignancies. In addition, responses to HAART and its toxic effects may be affected by gender and racial differences. The examination of these outcomes, particularly if they are rare, requires follow-up of large numbers of HIV-positive and HIV-negative individuals, many more persons than would be found in even the largest cohorts in the U.S. or Europe. Combining data from many smaller cohorts has the potential to allow for study of these uncommon events. The analyses of data from different settings and populations also increases the generalizability of study results and allows regions to better define the HIV epidemic within their perimeters.

The UNAIDS estimates that in 2003 there were 37.8 million HIV-infected people world-wide, 4.73 million of whom had acquired their HIV infection in the year 2003. That same year there were an estimated 2.9 million HIV-related deaths. While use of HAART has been largely restricted to industrialized countries, new initiatives such as the President's Emergency Plan for AIDS Relief (PEPFAR) and the World Health Organization's 3 by 5 Initiative, which seeks to treat 3 million HIV-infected persons in developing countries by the end of 2005, are introducing antiretroviral therapy (ART) into populations in less-developed areas of the world. These populations have high background rates of tuberculosis and other opportunistic infections, malaria, malnutrition, worm infestations, and diarrheal diseases which could significantly add to the risk of ART-toxicity and decreased ART efficacy. As ART programs are introduced to broader and diverse segments of the population, the collection of data would allow for evaluation of ART effectiveness in the developing country setting and provide the potential for a more rapid identification of new drug toxicities, viral resistance and other factors that could undermine the population usefulness of ART. The inclusion of data from persons who are HIV negative persons will also be an important element in understanding the background rate and pattern of morbidity and mortality in populations where ART is used.

Objective

The overall objectives of this RFA are to establish regional data centers for the compilation of data to address research questions in HIV/AIDS that are not possible to answer with currently-existing individual cohorts, to increase the generalizability of study results through use of data from different settings and populations, and to allow regions to more accurately define and monitor the HIV epidemic within their perimeters. Through this RFA, the IEDEA consortium will also be established and will be composed of the Principal Investigators and regional data centers from each of the funded regions. Depending on the region, activities to augment and improve existing data systems may be required; however, this RFA will not support the creation or implementation of new data or new data systems.

The geographic regions are defined as:

1. Regional Data Center-Specific Activities

Each regional center will have responsibility for activities at the regional level and for activities related to the multi-regional IEDEA consortium. These activities include:

2. Multi-Regional IEDEA Consortium Activities

Each Regional Data Center Principal Investigator will serve as a member of the IEDEA Executive Committee (IEDEA EC). Multi-regional activities to be performed by the IEDEA EC include the following:

3. IEDEA Coordinating Center

One regional data center will be selected to serve as the IEDEA Coordinating Center and will support IEDEA-specific meetings and develop and maintain necessary communication tools such as conference calls and an IEDEA website for both internal and external collaborators. The IEDEA Coordinating Center also will maintain an IEDEA website for public access to background information on the IEDEA consortium to facilitate potential research.

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 U01 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 (U01) 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".

2. Funds Available

The NIAID intends to commit approximately $5 million (U.S.) dollars in FY 2006 to fund two to ten new grants in response to this RFA. An applicant may request a project period of up to five years. One regional data center will be funded for up to $500,000 per year in supplemental funds to support the IEDEA Coordinating Center functions. 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 provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

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:

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.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

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 programs.

2. Cost Sharing or Matching

Cost sharing is not required.

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application under this announcement; however, the individual applications must cover different regions. Only one application per region per applicant will be accepted. Not all regions may be funded.

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.

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: July 27, 2005
Application Receipt Date(s): August 26, 2005
Peer Review Date: November, 2005
Council Review Date: January, 2006
Earliest Anticipated Start Date: March, 2006

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:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive
Room 3133 , MSC-7616
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 496-8426
FAX: 301-402-2638
Email: pjackson@niaid.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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
6700B Rockledge Drive
Room 3133 , MSC-7616
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: (301) 496-8426
FAX: 301-402-2638
Email: pjackson@niaid.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. Personal deliveries of applications are no longer permitted.

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. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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 (see also Section VI.3. Reporting).

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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Applicants should complete the PHS 398 as described, except for the section entitled Research Plan. The Research Plan must not exceed 75 pages. Appendices are limited to 10 pages excluding letters of collaboration. Up to 10 scientific papers, published or accepted pre-prints, may be submitted. Each application may be for only a single region; however, an individual applicant may submit more than one application as long as each application covers a different region. Applicants may not submit or be co-investigators on more than one application covering the same region.

The Research Plan must contain the following information:

1) Proposed research questions to be addressed at the regional level during the first year of the grant as well as anticipated analyses in future years.
2) A summary of the capabilities and commitment of the applicant to collaborate in multi-center biostatistical and epidemiological research. Substantial experience with, and staff expertise in maintaining and manipulating large databases should be summarized here.
3) Sources of data

4) Detailed plan of approaches/strategies to be used in executing the responsibilities of a regional data center

5) A description of relevant capabilities and experience

Each application should describe the following:

Regional data centers applying to serve as the IEDEA Coordinating Center should include a separate section describing their proposed plan to fulfill this core function (5 page limit). Each application for this core function should include:

Plan for Sharing Research Data

The precise content of the data-sharing plan will 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.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will 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 requires that grant awardee 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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 the resources sharing plan 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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete and/or non-responsive applications will not be reviewed.

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.

1. 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?

2. 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?

3. 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?

4. 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)?

5. 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?

2.A. Additional Review Criteria:

In addition to the standard review criteria listed under Section 2 above, the following items will be considered in the determination of scientific merit and the priority score:

Research Plan: Scientific merit, feasibility and innovative nature of the research plan. Strength and merit of the plan for the compilation of data from the described data sources that allows for analysis of important questions on the HIV epidemic that are unanswerable by the individual data sources.

Research collaborations: Strength of the evidence that the approach to working with local collaborators is appropriate, feasible and optimal. Strength of the plans for obtaining sufficient, relevant data to answer a broad range of the appropriate questions in HIV/AIDS research. Strength of the letters of collaboration that are to indicate an appropriate level of commitment by collaborators. Strength and merit of the plan(s) for the review and approval of IEDEA consortium and non-consortium research proposals. Strength of the plan for collaboration with other regional data centers and with the IEDEA consortium.

Data management: Strength and feasibility of the management and analysis plan(s) to result in successful data integration and harmonization from different sources. Appropriateness and merit of the proposed approach for data management and security.

Investigator: Adequacy and appropriateness of investigator training and experience to perform the data management, data analyses, study design and coordinating roles that are central to the functioning of the regional data center. Strength, adequacy and appropriateness of the skills, training, experience and level of effort of the proposed key personnel. Strength of the evidence provided that the experience level of the principal investigator and other scientific and technical staff is appropriate for the proposed work.

Environment: Strength, adequacy and feasibility of the plans for site training and ensuring consistent data collection.

IEDEA Coordinating Center: Regional data centers applying to serve as the IEDEA Coordinating Center will be evaluated using the following criteria: Appropriateness and adequacy of plans for coordination and communication to ensure success of the IEDEA consortium. Merit of the number, training, experience and availability of the proposed staff. Merit and appropriateness of the scientific environment for the proposed work. Strength, merit and adequacy of application with respect to coordination, meeting planning and communication.

In addition to the criteria above, 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 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 Form 398).

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 the data sharing plan or the rationale for not sharing research data will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy requires that grant awardee 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/archive/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.

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 the 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 Principal Investigator will also receive a written critique called a Summary Statement.

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/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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.

NIAID will transmit the NGA via U.S. mail for a hard copy and/or via email for an electronic copy.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 (U 01 ), 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 projects within the guidelines of this RFA, and for the operational performance of the scientific activity. Specifically, the awardee has primary responsibility as described below:

A. Data Management. The regional data center will be responsible for all data management functions, including the following:

The NIAID Division of AIDS supports a contract to develop and implement the DAIDS Enterprise System (DAIDS-ES). DAIDS-ES is a comprehensive data management system to support the business functions, management and oversight responsibilities of the Division. The current and planned components of the DAIDS-ES include: DAIDS Training Calendar, DAIDS Master Contact System, DAIDS Expedited Adverse Event Reporting System (DAERS), and DAIDS Protocol Management System. Awardees will be required to interface, integrate or adapt their information system(s) to interact with these and future components of the DAIDS-ES as necessary. Additional information about these components and timelines for availability is available in “DAIDS Clinical Research Support Contracts” at: http://www.niaid.nih.gov/daids/rfa/network06.

B. Data Analysis. The Principal Investigator will provide analytical support to regional investigators in the preparation of concept sheets, analysis of data, and the preparation of manuscripts. This support will include instances when the Principal Investigator or co-Investigator is the lead author, the regional data center provides full analytic support, or the data center ensures access to data for other collaborators. In addition, the awardee will:

C. Participation in IEDEA EC. The Principal Investigator will be a member of the IEDEA EC and as such will:

One regional data center will be chosen as the IEDEA Coordinating Center by the IEDEA EC from among those applications proposing to fulfill this core function. The selection of the IEDEA Coordinating Center will occur at the first meeting of the IEDEA EC to be held shortly after award.

D. Publications. The Principal Investigator will be responsible for the timely submission of all abstracts, manuscripts and reviews authored and/or co-authored by regional investigators and supported in part or in total under this Cooperative Agreement. The Principal Investigator and co-investigators are requested to submit manuscripts to NIAID program staff within two weeks of acceptance for publication so that an up-to-date summary of program accomplishments can be maintained and joint press conferences prepared. Publications or oral presentation of work performed under this Cooperative Agreement is the responsibility of the Principal Investigator and co-investigators and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An 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, with assistance from other scientific program staff who are designated based on the research topic and their relevant expertise, may provide appropriate assistance, advice and guidance by: participating in the design of the activities; coordinating or participating in the analysis of data; advising on management and technical performance; or participating in the preparation of publications. The Project Scientist(s) will serve as a liaison/facilitator between the awardee, pharmaceutical and biotechnology industries, and other government agencies (e.g., FDA, USDA, CDC) and will serve as a resource for scientific and policy information related to the goals of the awardee's research. However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and that NIAID staff will be given the opportunity to offer input into this process. The manner of reaching that consensus and final decision-making authority for the regional data center will rest with the Principal Investigator.

The NIH Project Scientist will also:

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 Official(s) may also serve as the NIH Project Scientist(s).

2.A.3. Collaborative Responsibilities

Executive Committee:

The Principal Investigator of each regional data center and the NIH Project Scientist will serve as members of the IEDEA EC. The IEDEA EC chairperson will be elected from among the non-Federal IEDEA EC members at the first meeting to be held shortly after award. Each member will have one vote. It is anticipated that the IEDEA EC will meet on a biannual basis and that the meetings will be held on a rotating basis, as determined by the IEDEA EC, at the sites of the regional data centers. Awardee members of the IEDEA EC will be required to accept and implement policies approved by the IEDEA EC.

The IEDEA EC will be required to encourage collaboration with investigators external to the IEDEA consortium. To facilitate this, the IEDEA EC will maintain public communication forums, such as an IEDEA website. One regional data center, serving as the IEDEA Coordinating Center, will be responsible for and physically maintain this public website. It is anticipated, but not required, that this website will have password protected areas which also serve the communication needs of the IEDEA EC.

The NIH Project Scientist will also serve as a member of the IEDEA EC.

The IEDEA EC is responsible for making recommendations on all scientific, policy and organizational issues concerning development and implementation of both internal and external research concept sheets, publications and access to data. The IEDEA EC also will be responsible for developing and implementing policies and procedures to ensure access to data for exploratory work or manuscript preparation. Requests by internal or external investigators for raw and summary data will be in a standardized format and will be reviewed by the IEDEA EC and evaluated to determine if the research is scientifically appropriate and in agreement with the overall objectives of the IEDEA consortium. The individual Principal Investigator will be responsible for ensuring and demonstrating to the IEDEA EC that their regional data center adequately contributes to the overall effort.

Collaboration with Other Projects and Federal Agencies:

Where scientifically appropriate, NIAID may ask the awardee to collaborate on scientific initiatives with other NIAID-funded projects and/or U.S. government agencies, such as CDC, FDA, and USDA.

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.

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.

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:

Robin Huebner, Ph.D., M.P.H.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4104, MSC-7620
6700-B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 402-4239
FAX: 301-402-3211
Email: rhuebner@niaid.nih.gov

2. Peer Review Contacts:

Peter R. Jackson, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3133, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 496-8426
FAX: 301-402-2638
Email: pjackson@niaid.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
Telephone: (301) 402-6824
FAX: (301) 480-3780
Email: junsworth@niaid.nih.gov

Section VIII. Other Information

Required Federal Citations

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

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

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.

Public 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 public 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 PA 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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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.healthypeople.gov/.

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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