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/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (www.nichd.nih.gov)
National Cancer Institute (NCI), (www.nci.nih.gov)

Title:  International Epidemiologic Databases to Evaluate AIDS (IeDEA) (U01)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-AI-05-014.

Request for Applications (RFA) Number: RFA-AI-10-030

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856, 93.394, 93.865

Key Dates
Release Date:  August 5, 2010
Letters of Intent Receipt Date: October 8, 2010
Application Receipt Date: November 10, 2010
Peer Review Date:  March, 2011
Council Review Date:  May, 2011
Earliest Anticipated Start Date:  July, 2011
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: November 11, 2010

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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

NIAID initially sought advice on the overall need and enthusiasm for database collaborations within the HIV research community through a meeting of international experts held in Bethesda, MD on September 28-29, 2004.  Subsequent to this consultation, NIAID developed the International Epidemiologic Databases to Evaluate AIDS (IeDEA) program and awarded grants to establish 7 regional data centers in FY 2005.  Based on the success of the initial awards, the NIAID continues to see the value of large data sets in addressing the unique and evolving research questions in HIV care and treatment that cannot be answered by single cohorts.  Advances in statistical methods and the management of patient data, combined with dramatic increases in the numbers of patients on antiretroviral therapy, have allowed for robust analysis of care and treatment outcomes in almost real time.  Furthermore, data from representative patients and care settings can inform on population effectiveness, implementation success and cost-effectiveness of different approaches to all aspects of care and treatment.  NIAID remains committed to the support of observational data approaches as one way to improve our understanding of the epidemic and to have an impact on improving outcomes.  This FOA seeks to continue support for the collection and harmonization of data on HIV/AIDS and on the impact of HIV on incidence, prevalence, and the spectrum of cancers from a variety of clinical and research sources in diverse geographical regions, and to expand the activities of the IeDEA consortium to include TB, malaria, and other infectious disease (HTMC&O) in the context of HIV/AIDS.  These data permit analyses of regional data as well as comparisons of results between regions.  This FOA will also support improvements to databases contributing to the IeDEA consortium to ensure the collection of high-quality, harmonized data.

Background

At the end of 2006, an estimated 1.1 million persons in the United States were living with diagnosed or undiagnosed HIV/AIDS (http://www.cdc.gov/hiv/topics/surveillance/basic.htm#hivest), representing a fraction of the 33 million people estimated to be infected worldwide (UNAIDS Report on the global AIDS epidemic 2008:  http://www.unaids.org/en/KnowledgeCentre/HIVData/Epidemiology/epidemiologySlidesAuto.asp).  The CDC estimates that approximately 56,300 new infections occurred in the U.S. in 2006 (http://www.cdc.gov/hiv/topics/surveillance/basic.htm#hivest), and there were 2.7 million people worldwide newly infected with HIV (http://www.unaids.org/en/KnowledgeCentre/HIVData/Epidemiology/epidemiologySlidesAuto.asp).  The introduction of highly active antiretroviral therapy (HAART) in 1996 in the U.S. 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 14,561 in 2007 (http://www.cdc.gov/hiv/topics/surveillance/basic.htm#hivest), while the number of Americans living with AIDS increased.  The longer lifespan of HIV-positive persons receiving HAART as well as the side effects of HAART therapy have dramatically altered patient outcomes.  Long-term treated patients are at risk for treatment related toxicities, metabolic disorders, cancer, cardiovascular disease, and neuropsychiatric complications (e.g., minor cognitive motor disorder and peripheral neuropathy).  While the use of HAART had been largely restricted to industrialized countries, the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund increased the number of people on treatment to nearly 3 million men, women and children in low and middle income countries at the end of 2007 (http://www.unaids.org/en/KnowledgeCentre/HIVData/Epidemiology/epidemiologySlidesAuto.asp) and provided care to nearly 11 million people affected by HIV/AIDS worldwide (http://www.pepfar.gov/press/137673.htm). 

Globally, persons with HIV/AIDS have high background rates of tuberculosis and other opportunistic infections, malaria, malnutrition, worm infestations, and diarrheal diseases that significantly add to the risk of ART toxicity and decreased ART efficacy.  A significant proportion of this population, particularly in sub-Saharan Africa, also have a high background of oncogenic viral infections and cancers, such as Kaposi’s sarcoma and certain types of lymphomas.  As ART programs have been introduced to broader and more diverse segments of the population, the systematic collection of data has the potential to allow for the evaluation of ART effectiveness, rapid identification of new drug toxicities and monitoring for viral resistance.  The inclusion of data from persons who are HIV negative will also be an important element in understanding the background rate and pattern of morbidity and mortality in populations where ART is used.  On a global basis, it is estimated that approximately 430,000 children are newly infected with HIV each year, nearly 1,000 children each day, the majority in sub-Saharan Africa (http://www.unaids.org/en/KnowledgeCentre/HIVData/Epidemiology/epidemiologySlidesAuto.asp).  The primary mode of acquisition of HIV in children worldwide is through mother-to-child transmission (MTCT).  Interventions to prevent MTCT in resource-limited countries are rapidly evolving and new WHO recommendations raising the CD4 threshold for treatment to less than 350 cells/microliter will result in an increasing number of pregnant women receiving triple drug therapy for their own health.  While this will hopefully result in many fewer infected children, an increasing number of uninfected children will have in utero exposure to multiple antiretroviral agents.  While there are current studies to assess short- and long-term effects of such exposure in HIV-exposed children in the U.S. and South America, there are no such studies in resource-limited settings.  Study of an open cohort of HIV-uninfected children with fetal and neonatal antiretroviral exposure to identify ART’s potential consequences is a critical need in resource-limited countries.  The period of transition from short course therapy to more complex therapies in pregnant women in resource-limited countries offers the additional important opportunity to compare outcomes in children with lesser vs. greater antiretroviral exposure (e.g., those exposed to zidovudine/single-dose nevirapine prophylaxis alone compared to those exposed to triple combination drugs).  Pediatric HIV infection is a world-wide public health challenge disproportionately affecting children in the poorest parts of the world.  It is estimated that 2.1 million children are currently living with HIV and that about 38% of infected children who require therapy are receiving treatment, although in the last 2 years there has been a dramatic increase in these numbers.  HIV disease in children progresses more rapidly than in adults, with high mortality in the first few years of life.  It is critical to document the effect of the expansion of antiretroviral drug exposure on pediatric morbidity and mortality and to enhance understanding of the obstacles to pediatric HIV care and delivery in resource-limited countries.  Additionally, underlying co-infections (e.g., malaria, TB) and malnutrition in children in these areas may affect response to therapy, result in drug interactions, and increase drug toxicities.  As children with treatment in resource-limited countries live longer, it will also be important to document the long-term consequences of perinatal HIV infection and its treatment as the children grow into adolescence.  Young people living with HIV have particular challenges related to treatment and adherence, and it is important to address safe sex behaviors as these young people grapple with their emerging sexuality.  Health care delivery for adolescents is often based on pediatric and adult care models – neither of which is an appropriate fit. Countries will be challenged to develop appropriate ways of caring for HIV-infected youth, and documentation of best practices in resource-limited settings will be important.  Previous work carried out by IeDEA researchers has resulted in a better understanding of clinical outcomes in the era of HAART and challenges faced in the massive scale up of treatment globally. 

The research agenda of the IeDEA consortium addresses key scientific questions surrounding the care and treatment of HTMC&O in specific regions.  In particular, the consortium is focused on answering questions in HTMC&O that are not possible to answer with smaller individual cohorts. 

Geographic Regions for Regional Data Centers:  Applicants may submit more than one application, provided each application is scientifically distinct and covers a different geographic region.  Only one application per region will be funded and not all regions may be funded.  Applications will be accepted only from the regions defined below.

Region 1 – North America including Canada and the United States of America

Region 2 – Central and South America and the Caribbean

Region 5 – Australia, India, Pakistan and China and the rest of Asia

Region 8 – West Africa – Benin, Burkina Faso, Cape Verde, Chad, Cote d’Ivoire, Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Mauritania, Niger, Nigeria, Senegal, Sierra Leone, Togo

Region 9 – Central Africa – Burundi, Cameroon, Central African Republic, Congo, Democratic Republic of the Congo, Equatorial Guinea, Gabon, Rwanda, Sao Tome & Principe

Region 10 – East Africa – Djibouti, Eritrea, Ethiopia, Kenya, Uganda, Somalia, Sudan, Seychelles, Tanzania

Region 11 – Southern Africa – Angola, Botswana, Comoros, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, South Africa, Swaziland, Zambia, Zimbabwe

Scope of Diseases and Populations

IeDEA is currently focused on HIV disease.  However, NIAID is increasingly interested in expanding the efficiency of research by capitalizing on instances where investigators can leverage their existing resources to answer key questions in infectious diseases.  IeDEA applicants are expected to retain a focus on HIV/AIDS and its co-infections and co-morbidities but may also demonstrate capacity to leverage their infrastructure to include other infectious diseases important in their community.  

IeDEA research populations are anticipated to be primarily persons with HIV infection.  Research on HIV related disease and treatment outcomes (survival and toxicity) may require addition of other populations of patients.  Furthermore, leveraging of infrastructure to study other infectious diseases will necessitate the inclusion of populations at risk for these diseases.  IeDEA is eager to support research across the lifespan and this solicitation encourages the enrollment of patients of all ages.

Scope of Research may include, but is not limited to:

NIAID recognizes the gaps in data and data quality that will require new approaches and additional resources.  With this in mind, regional data centers may propose methods to enhance the quality of data within their region.  Applicants may choose to support selected sites that, with increased support, could provide enhanced data to address key questions.  These activities should be highly focused and limited in scope to collecting data in support of key questions.  Applicants may propose a variety of approaches to enhance data including sentinel cohort sites, one-time data collections, or database registry matches.

Some examples include but are not limited to:

NCI Specific Objectives:

NCI seeks to continue support for projects that incorporate understanding of the impact of HIV on incidence, prevalence, and spectrum of cancers in the regions covered by IeDEA.  Building on initial awards that included core mechanisms for the collection of information on cancer as a co-morbidity in HIV patients, NCI supports research in the following areas:

In addition, to maximize the benefits of the investment, NCI also encourages infrastructure development at the local level including:

NICHD Specific Objectives

NICHD has co-funded IeDEA since 2006 to include pediatric patients in the database.  For this FOA, NICHD is specifically targeting pediatric data collection in the 4 African and the Asian regional networks, since there are existing programs previously funded by NICHD in North and South America.  The purpose of NICHD’s involvement in IeDEA is to continue support for the collection of data on pediatric HIV infection.  Research applications may include, but are not limited to, the following areas:

Additionally, linkage of maternal and child data is critical to assess the efficacy of interventions to prevent MTCT and to evaluate the short- and long-term effects of prevention interventions on both maternal and child health.  The IeDEA consortium has had limited data collection on antiretroviral drug use in pregnancy and the efficacy of interventions to prevent MTCT to date.  With new WHO recommendations on antiretroviral prophylaxis for women who don’t require treatment, and expanded treatment recommendations, it will be important to evaluate the efficacy of these interventions, the effect on pregnancy outcome, and the effect on long-term maternal and child health, including those children who are uninfected but exposed to antiretroviral drugs in utero.  NICHD is interested in supporting research in the following areas:

1.    Regional Data Center-Specific Activities

Each regional data 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 Award

Applications for the IeDEA Coordinating Award may be submitted by the regional data center applicant institutions or by non-IeDEA consortium institutions/organizations.  The Coordinating Award will be responsible for providing the following services to the consortium:

The IeDEA Coordinating Award will have the capacity to manage data for internal and external investigators, including site level data.  At this time the Coordinating Award is not anticipated to have extensive data management functions; however, applicants are encouraged to describe their potential to provide innovative centralized data management and analysis capacity including the ability to coordinate harmonization and standardization of data analysis requirements across the various IeDEA Data Centers with the ability to expand to include more data functions when needed.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the U01 award mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use an NIH cooperative agreement award mechanism.  In the cooperative agreement mechanism, the PD(s)/PI(s) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PD(s)/PI(s), as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct and each application covers a different region. Only one application per region will be funded and not all regions may be funded.  Applications will be accepted only from the defined regions listed in Part II, Section I, Part 1 of this FOA.     

Resubmissions. Resubmission applications are not permitted in response to this FOA.  

Renewals.  Renewal applications will be permitted for this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current 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

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-Domestic [non-U.S.] Entities)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the section of the Research Plan entitled, “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: October 8, 2010
Application Receipt Date: November 10, 2010
Peer Review Date:  March, 2011
Council Review Date:  May, 2011
Earliest Anticipated Start Date:  July, 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Tracy Allan Shahan, Ph.D., MBA
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3140, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  (301) 451-2606
FAX: (301) 480-2408 
Email:  Ts347i@nih.gov

3.B. Submitting an Application Electronically to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Tracy Allan Shahan, Ph.D., MBA
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3140, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  (301) 451-2606
FAX: (301) 480-2408 
Email:  Ts347i@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

6. Other Submission Requirements 

Each application must be for a single region; however, an applicant may submit more than one application as long as each application covers a different region.  PIs may not submit or be co-investigators on more than one application covering the same region.

Regions should include specific research agendas to address the interests of the National Cancer Institute and the Eunice Kennedy Shriver National Institute for Children and Human Development.  These proposed agendas should be supported by separate budgets.

Regional Data Center Research Strategy:  The Research Strategy for the Regional Data Center must contain the following information:

Applicants should discuss how the proposed research is innovative and will lead to new findings in HIV/AIDS; other infectious diseases, and/or cancer.  In this section, applicants should describe capabilities and commitment 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.  Applications in regions 5,8,9,10 and 11 applying for NICHD funds should discuss how the proposed research is innovative and will lead to new findings in pediatric and maternal HIV/AIDS, and when relevant, effects of in utero antiretroviral exposure on HIV-exposed but uninfected infants.  Applicants must describe specific plans to address pediatric and maternal-child research objectives, and include a separate budget for these aims.

Applicants should describe the epidemiological, statistical and administrative methods used to produce the most innovative and significant research.  Applicants should describe the populations and sources of data included in their region and its appropriateness for the proposed research agenda.  Information on the establishment and maintenance of the research collaborations should be included.  The epidemiologic methods and administrative oversight necessary for this collaborative study should include descriptions of the types of data available, methods used to merge, harmonize, explore and validate the database, and how the regional datacenter proposes to enhance data to answer significant questions.  How data are shared across the consortium and how approvals are secured for regional and multi-regional projects should be presented.  Previous experience with large collaborations by proposed research personnel should be highlighted.  Recognizing the importance of the site level cadre of researchers, applications should describe how the proposed projects will strengthen existing structures and capacity.

Letters of Collaboration:  Applicants should include the letters of collaboration as line Item 14 (Letters of Support) included in the Content of Research Plan section of the PHS 398.

 If letters of collaboration are in a language other than English, they must be accompanied by an English translated version.  Sites may take this opportunity to highlight their capacity to be a strong contributor to the region’s research agenda.  Sites applications may, but are not limited to include:

Applicants should describe the unique capabilities of the proposed investigators and staff, including:

IeDEA Coordinating Award

Each application for the IeDEA Coordinating  Award must include the following information:

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this should be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does the proposed research have a high probability of success in answering questions of importance in the HTMC&O in adults and children?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Are the PI’s 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 appropriate and strong?.  Are the skills, training, experience and level of effort of key personnel sufficient?  How strong is the evidence provided that the experience level of the PI and other scientific and technical staff is appropriate for the proposed work? As applicable, is the proposed staff experienced in conducting the work intended for the coordinating award?

Innovation.   Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?  Does the research demonstrate a solid approach to data management, integration and harmonization from different sources?  Does the analysis approach have a strong likelihood of producing valid answers to questions proposed? Does the application demonstrate innovative approaches to maximize communication across multiple regions, including website development and maintenance?

Approach.   Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and   benchmarks for success presented?  If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Is the data to be made available representative of the regional population and of sufficient quality and quantity to fulfill the research aims?  Does the application describe how enhanced data collection, i.e. sentinel cohorts, would be performed?  Does the enhanced data collection add significantly to the aims of the proposal?  Does the analysis plan present the strengths and weaknesses of the proposed research approach and suggest alternative analysis techniques to address the weaknesses? Is the plan for the review and approval of IeDEA Consortium and non-Consortium research proposals appropriate?  Have data sharing and ownership issues been adequately addressed? Is the proposed plan for coordination and communication across the seven IeDEA Regional Centers that constitute the consortium adequate and appropriate? Does the proposed coordinating center demonstrate experience with meeting planning?  Does the application demonstrate strength in the capacity to manage the IeDEA site assessment process and potential expansion to perform data management for specific projects?

Environment.   Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Are the regional collaborations appropriate, feasible and optimal? Is the plan for obtaining sufficient, relevant data to answer a broad range of the questions in HTMC&O research strong?  Do the letters of collaboration indicate an appropriate level of commitment by collaborators?  Are the plans for site development and ensuring consistent data collection strong?

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  Resubmission applications are not applicable to this FOA.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications.  Revision applications are not applicable to this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations.  As applicable for the FOA or submitted application, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Budget and Period of Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

2. A.1. Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for defining the research objectives, approaches and details of projects within the guidelines of this FOA, 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:

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 regional 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:

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 draft manuscripts to the NIH Project Scientist prior to submission 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 NIH 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 DHHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

The 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 (including staff from NICHD and NCI), 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, the 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 and co-sponsoring NIH institutes 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, NICHD and NCI staff will be given the opportunity to offer input into this process.  The manner of reaching consensus and final decision-making authority for the regional data center will rest with the Principal Investigator.

The NIH Project Scientists 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.

2.A.3. Collaborative Responsibilities

Global 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 and rotate at the discretion of the EC.  Each member will have one vote.  In addition to regional meetings it is anticipated that the IeDEA EC, along with other appropriate key personnel, will meet on a semi-annual 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 or around major international meetings.  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.  The IeDEA Coordinating Award will be responsible for physically maintaining this public website.  It is anticipated, but not required, that this website will have password protected areas which also serves the communication needs 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 Investigators 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 or another co-funding IC may propose that the awardee collaborate on scientific initiatives with other NIAID, NICHD or NCI-funded projects and/or U.S. government agencies, such as CDC, FDA and USDA.

2.A.4. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3.   Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Lori Zimand, MBA, MPH
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4126, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20892-7620
Telephone: (301) 435-3742
FAX:  (301) 402-1505
Email: lz36k@nih.gov

Malla Rao, Ph.D.
Division of Microbiology and Infectious Diseases
National Institutes of Allergy and Infectious Diseases
Room 3207, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-3749
FAX:  (301) 402-0659
Email: mrao@niaid.nih.gov

Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute
Building 31, Room 3A/33
31 Center Drive
Bethesda, MD 20892-2440
Telephone: (301) 496-3204
Email: domingug@mail.nih.gov  

Lynne Mofenson, M.D.
Pediatric, Adolescent and Maternal AIDS Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Room 4B11E, MSC-7510
6100 Executive Boulevard
Rockville, MD 20852-7510
Telephone: (301) 435-6870
FAX:  (301) 496-8678
Email: LM65D@nih.gov

2. Peer Review Contact(s):

Tracy Allan Shahan, Ph.D., MBA
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3140, MSC 7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Telephone:  (301) 451-2606
FAX: (301) 480-2408 
Email:  Ts347i@nih.gov

3. Financial/Grants Management Contact(s):

Dawn Mitchum, MPH, CRA
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2113, MSC 7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 451-2667
FAX: (301) 493-0597
Email: dmitchum@niaid.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).

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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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