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)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)

Title:  Women’s Interagency HIV Study (WIHS) IV, Limited Competition (U01)

Announcement Type
Renewal

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

Request For Applications (RFA) Number: RFA-AI-07-004

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.865, 93.279, 93.396, 93.393, 93.394, 93.395

Key Dates
Release Date: December 27, 2006
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Dates(s): March 13, 2007
Peer Review Date(s):  June, 2007
Council Review Date(s): September, 2007 
Earliest Anticipated Start Date(s):  November, 2007  
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date:  March 14, 2007

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary   

WIHS Clinical Sites:

WIHS Data Management and Analysis Center (WDMAC):

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

The WIHS is a multi-site prospective epidemiology cohort study of women followed since 1994 who either are infected with HIV or are HIV-negative but at increased risk for HIV infection.  The purpose of this RFA is to continue follow-up of the WIHS cohort, thereby supporting studies of the natural and treated history of HIV infection in representative, primarily minority, adult women in the United States, as well as supporting studies of emerging questions related to long-term HIV infection and treatment.  WIHS IV awards will support ongoing WIHS research projects and the initiation of new projects on predictors of response to antiretroviral therapy and long term effects of HIV infection and HIV therapy in terms of cardiovascular disease, liver disease, hormonal function, neurocognitive impairment, cancer and other outcomes.  Additionally WIHS IV awards will provide opportunities for expanded collaborations through independent, investigator-driven research grants.   

This RFA solicits applications from the WIHS data management and analysis center (WDMAC) and from each of the six WIHS clinical sites.  Because the WIHS is an ongoing cohort study that has collected data and specimens from cohort participants since 1994, competition will be restricted to the current network of seven funded sites.  The application from WDMAC will describe the WIHS scientific research agenda; it is expected that the principal investigators of all seven WIHS awardees will contribute to the scientific research agenda.  Based on that agenda, the WDMAC and clinical site applications will describe how each will support the overall WIHS scientific research agenda.

This RFA is funded by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), and the National Cancer Institute (NCI). 

Background

HIV Infections among U.S. Women

The number of HIV-infected women has been increasing in the United States since the late 1980’s.  The impact of HIV/AIDS has been particularly severe in minority populations.  According to the CDC, women accounted for 176,286 (19%) of the 918,286 AIDS cases reported among adults and adolescents in the United States up to December 2004.  The estimated incidence rate in 2004 was 48.2 per 100,000 African-American women and 11.1 per 100,000 Latina women, compared to 2.1 per 100,000 white non-Hispanic women.  African American and Hispanic women together represented about 25% of all U.S. women but accounted for 81% of the estimated total of AIDS diagnoses among U.S. women in 2004.  Among current WIHS participants, about 27% are Latina/Hispanic, 57% black/African American, and 17% white or Asian, an ethnic breakdown that closely mirrors that of HIV-positive women in the United States.  By prospectively studying a cohort of predominantly minority women with or at high risk for HIV infection, the WIHS is providing detailed information relevant to the evolving biological and psychosocial characteristics of the HIV/AIDS epidemic in U.S. women a decade after highly active antiretroviral therapy became available. 

The WIHS

The WIHS has followed the same cohort of women for nearly 14 years.  There are currently six WIHS clinical awardees located in Bronx/Manhattan, NY; Brooklyn, NY; Los Angeles/Southern California/Hawaii; San Francisco/Bay Area, CA; Chicago, IL; and Washington, DC/Eastern Maryland/Northern Virginia.  Each clinical site represents the population of HIV-infected women in its metropolitan area.  A total of 2,625 (2,056 HIV-infected and 569 HIV-negative) women were enrolled from 1994-1995 in six metropolitan areas.  Expansion of the cohort was completed in 2001-2002 with the enrollment of 1,143 additional women.  Currently about 2,400 women are under active follow-up in the cohort.  The increased number of participants, and particularly the influx of more recently diagnosed patients, has allowed the WIHS study to evaluate clinical outcomes in the era of HAART. 

In fiscal year 2006, in addition to the seven WIHS core awards, there were 21 awards made by seven NIH Institutes in support of 28 studies that used WIHS specimens or data to address the HIV-related research aims. WIHS investigators are publishing more than 50 peer reviewed papers annually.  Key areas of current and continuing investigation include HIV virology and host immunology, long-term effectiveness of antiretroviral therapy, long-term pathogenesis of HIV infection and treatment toxicities.  Research topics include: novel statistics for analyzing cohort data; HIV progression; time to AIDS; impact of viral resistance; the effect of co-infections such as hepatitis C (HCV) and B virus (HBV), herpes simplex (HSV), human papillomavirus (HPV); therapy use and treatment effects in women with HIV; the effects of metabolic abnormalities and toxicities; the impact of hormonal factors on HIV disease; and the effects of aging and menopause on HIV disease, that includes genetics; and the assessment of neurocognitive functioning and physical impairment among WIHS participants. 

The WIHS Executive Committee (EC) is composed of Principal Investigators from each awardee, NIH program officers, and a WIHS community advisory board member selected by study subjects to represent them.  EC members develop their specific areas of research and work with investigators outside the consortium who want to conduct research using WIHS resources.  Study protocols and proposals for new research concepts for the cohort are reviewed and voted on by the EC. 

WIHS participants have been evaluated at six month intervals since enrollment.  The study visit includes the following elements:

Interview: Centrally scripted interviews are conducted at each WIHS visit.  Self-reported data collection includes general medical history; antiretroviral therapy; obstetric and gynecologic history; use of drugs, alcohol and cigarettes; sexual behaviors; health care utilization; beliefs regarding HIV and its treatments; and psychological status.  Interview content is evaluated and revised every six months.  To assure the highest quality data, centralized training was conducted for all study interviewers at the start of the WIHS and again prior to the expansion.  A designated interviewer from each consortium completed additional training to allow annual training and evaluation of new interviewers at each site.  Additionally, question-by-question guidance forms are distributed at the start of each visit to assist interviewers in administering new or changed interview material.  Centralized training is conducted as needed for specialized measures by the WIHS Data Management and Analysis Center (WDMAC) and by consultants.

Additional Surveillance: All reports of AIDS-related diagnoses are followed up with medical record abstraction.  State cancer registries, local and state tuberculosis registries, and the National Death Registry are used to augment and confirm the outcome data that are collected.

Clinical Examination: Physical examinations conducted at each regular visit include standardized assessment of vital signs (e.g., blood pressure); anthropometric measures; a skin and oral examination; an examination of the breasts, lymph nodes and abdomen; and a gynecological examination that includes cervical cytology and collection of specimens for testing and storage as described below.  The WIHS protocol includes colposcopic examination and biopsy when indicated.  Women needing further treatment are referred for care outside of the WIHS and sites have referral mechanisms that take into account the participant’s insurance coverage and ability to pay.

Laboratory Testing: All WIHS participants have had blood, urine, and cervico-vaginal swabs and lavage fluid taken for baseline laboratory tests; follow-up lab work is done at each six-month visit.  As the study evolves, new areas of testing are identified and included.  Collection of fasting samples was added in 2000 to improve the ability of the study to assess cardiovascular and metabolic complications. 

National & Local Repositories: The specimens listed above, as well as additional specimens, including hair and saliva, are collected at each visit and stored in central and local WIHS repositories.  After approval by the WIHS EC, these samples are used by WIHS investigators and by unaffiliated outside collaborators.

Since 1998 WDMAC has been at the Department of Epidemiology of the Bloomberg School of Public Health at Johns Hopkins University.  Data collected at the sites using paper forms are entered into a web-based data system maintained by WDMAC.  A data manager at each awardee oversees data entry and works with WDMAC to ensure that datasets are complete and methods of recording the data are comparable between sites.

Relationship to Other Programs and NIH Institutes

The WIHS plays an important role in the NIAID effort to foster studies of HIV infection and disease in relevant domestic populations.  Studies of the treated history of HIV in women will be critical for furthering our overall understanding of HIV infection, and for assessing differences between HIV disease and treatment outcomes in women compared to men and in different racial and ethnic groups.  Besides serving as a base for affiliated investigators, WIHS fosters the development of the next generation of observational and clinical epidemiologists.  This consortium is at the forefront in statistical analysis of observational data.  WIHS collaborates with other HIV-related research groups, including the Multicenter AIDS Cohort Study (MACS), the International Epidemiologic Databases to Evaluate AIDS (IeDEA), and the Women's HIV Interdisciplinary Network (WHIN).  The WIHS research platform currently serves as a source of data and samples for 21 investigator-initiated studies funded by the 4 co-funding institutes (NIAID, NCI, NICHD, and NIDA) and by the National Institute of Mental Health (NIMH), the National Institute of Dental and Craniofacial Research (NIDCR), and the National Heart, Lung and Blood Institute (NHLBI).   

Research Scope

The scientific agenda of the WIHS awardees may include, but is not limited to, the following areas of interest of the NIH institutes sponsoring the WIHS:

•    Research on the long-term natural and treated history of HIV infection in women, in particular research that evaluates the effect of antiretroviral therapy on the clinical course of HIV disease, taking into account long-term exposures to different combinations of therapies and various co-morbidities

•    Research on the responses to HIV therapy, including demographic, genetic, psychological, behavioral, virologic resistance, and immunologic predictors of response that informs when to initiate and how to optimize response over the long term

•    Research that better defines exposure to therapy in women, including adherence and patterns of therapy use in conjunction with pharmacokinetic studies on drug absorption and metabolism

•    Research on the short and long-term effects of HIV and prolonged HIV therapy exposure on cardiovascular disease, lipodystrophy, liver disease, neurocognitive function, psychiatric status, substance use, kidney disease, diabetes, and other outcomes

•    Pathogenesis research that takes advantage of new and reposited specimens collected when the participants were at various levels of immune competence and both before and after the initiation of antiretroviral therapy

•    Characterization of acute clinical events and concomitant infections (i.e., HBV, HCV, HPV, HSV, etc.) and their effects on HIV disease progression

•    Genetics research that examines the host environment interaction between host genetics and HIV and other exposures in terms of health outcomes such as HIV infection, HIV disease progression, response to therapy, and risk of developing other co-morbidities such as cancer

•    The effects of endocrinologic factors (endogenous and exogenous hormones), pregnancy, and menopause on: mucosal immunity and HIV expression in the female genital tract, co-infections in the female genital tract and HIV disease progression in women

•    Research on HIV-associated cancers and pre-neoplasia, including surveillance of cancer incidence, identification of risk factors (immunological, virological, genetic and environmental), molecular epidemiology of cancers occurring in the WIHS, and outcome of cancer treatment in HIV-positive women

•    Research on sociobehavioral factors that affect HIV transmission and disease progression; health literacy; health care utilization and access; patterns of use, and adherence to antiretroviral therapy; sociobehavioral factors that affect other health or quality of life issues of importance to women with HIV infection

•    The effects of continued or past substance abuse on antiretroviral treatment effectiveness and the treated history of HIV infection

•    Innovative methodologic approaches for the conduct, design and analysis of cohort studies of HIV/AIDS

•    Studies of the effects of aging on the clinical course of HIV, HIV therapy, and response to HIV therapy; consideration of how normal psychological, neurocognitive, biological, and physical processes of aging are affected by HIV treatment and disease progression.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U01 cooperative agreement award mechanism. 

Applicants 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/modular/modular.htm).  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

This initiative is a limited competition Request for Applications (RFA).  NIAID and the co-funding institutes intend to commit up to $20 million in total costs in FY 2008 to fund seven WIHS IV awards for a period of 5 years.  Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary.  Although the financial plans of NIAID and the co-funding institutes provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds.  Funding beyond the first year of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds.

Awards pursuant to this RFA may be made as early as November 1, 2007.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions
 
Applications may be submitted by the seven awardees – the current six WIHS clinical sites and the WIHS Data Management and Analysis Center (WDMAC).  The seven cooperative agreement numbers, geographic locations, principal investigators, and awardee institutions are:

WIHS Clinical Sites:

WIHS Data Management and Analysis Center (WDMAC):

U01 AI 42590, Baltimore, MD, (PI: Dr. Stephen Gange, Johns Hopkins University) 

1.B. Eligible Individuals

The principal investigator of each WIHS IV site must possess the skills, knowledge, resources, and professional experience needed to carry out the proposed research and research capacity development goals and objectives of the WIHS IV.  In addition, they should have established a demonstrably productive working relationship as scientific collaborators.  Each Principal Investigator must commit at least 20% effort per year to WIHS IV.  

2. Cost Sharing or Matching

Not applicable.

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   

Not applicable.
  

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.
 

Applicants are strongly encouraged to contact one of the program officers listed as Scientific/Research contacts in Section VII with any questions regarding the responsiveness of their proposed project to the goals of this RFA.

The Research Plan in each application should be completed as outlined in Section IV. 6. Other Submission Requirements, below.

3. Submission Dates and Times

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

3.A. Submission, Review, and Anticipated Start Dates
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Dates(s): March 13, 2007

Peer Review Date(s):  June, 2007

Council Review Date(s):September, 2007
Earliest Anticipated Start Date(s): November, 2007

3.A.1. Letter of Intent

Not applicable

3.B. Sending an Application to the NIH

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

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


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

At the time of submission, two additional exact copies of each grant application and 5 sets of all appendix material must be sent to:

Lucy A. Ward, DVM, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3117, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (express mail zip code 20817)
phone: (301) 594-6635
fax: (301) 480-7614

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

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by NIAID. Incomplete and non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review
 
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

All WIHS Clinical Site applications and Part B of the WIHS Data Management and Analysis Center (WDMAC) application must be prepared as instructed below and follow the standard PHS 398 application format.  Part A of the WDMAC application must be prepared and structured as described below.

WIHS Data Management and Analysis Center Application (includes WIHS Scientific Agenda)

Only the WDMAC application will have two parts including the Overall WIHS Scientific Agenda and Research Plan (Part A) and the WDMAC application itself (Part B).  Part A must follow the format as described below whereas Part B will follow the standard PHS 398 application format similar to that required for each WIHS Clinical Site application.

Part A. Overall WIHS Scientific Agenda/Research Plan

Part A of the WDMAC application will be limited to 100 pages and must address the following:

1. Research Progress. This section should include the key scientific contributions of the WIHS during the current award and progress to date on the current WIHS scientific agenda. This section should be limited to no more than 15 pages.

2. Scientific Agenda.  The scientific agenda should address the key areas of interest as determined by the WIHS principal investigators taking into account the areas of NIH interest identified in RESEARCH SCOPE in Section I. Funding Opportunity Description. The scientific agenda of the WIHS should be limited to no more than 75 pages and address the following:

3. Organizational Structure.  This section should describe the organizational structure and scientific oversight mechanisms of the WIHS and discuss how the WIHS administrative structure facilitates the conduct of the WIHS scientific agenda. This section should be limited to 10 pages.  

Part B. WIHS Data Management and Analysis Center (WDMAC) application.

The Research Plan items A-D in Part B of the WDMAC application is limited to 25 pages and must address the following:

A description of the role played by WDMAC as the coordinating center for epidemiology research, statistical analysis, and management of both datasets and study protocols.  This section of the application should address the following topics:

- The approaches needed to maximize data accessibility to achieve increased scientific usefulness of WIHS data

- The methods by which WDMAC, in collaboration with other WIHS Principal Investigators, allocates resources for data analysis to support the WIHS scientific agenda in terms of presentations and publications

- The means by which WDMAC provides leadership and intellectual input about epidemiologic and statistical issues in the design of studies.  This description should include development of novel design and analytic approaches, estimating sample size requirements for specific research questions, planning and performing interim and final analyses, and preparing reports that summarize the results of such analyses

- The mechanism by which the WIHS prioritizes multiple simultaneous projects to ensure that WDMAC is able to meet the needs of the study investigators and the research goals of the NIH Institutes funding the WIHS

- The means by which collaborations with the clinical sites are maintained, assuring data quality by developing appropriate study protocols, conducting training sessions and monitoring study results

- The role played by WDMAC in providing close and effective coordination of WIHS-wide research, e.g., organizing the WIHS website and conference calls,  and coordinating with federal contractors the semi-annual WIHS-wide scientific meetings in which study results are presented and discussed and collaborations are fostered

- Communication methods used between WDMAC, the other WIHS sites and NIH 

- The role played by WDMAC in assuring protection of the human subjects participating in this research

- The role played by WDMAC in assuring relevant and quality data annotation of biological samples collected by WIHS biorepositories

- The budget describing and justifying WDMAC’s costs of implementing the WIHS scientific agenda described in Part A of the application

WIHS Clinical Site Application:

The Research Plan items A-D in each clinical site application is limited to 25 pages and must address the following key points:

(1) . Progress and achievements of the WIHS site during the current funding cycle.  This section should describe both the site’s role as a clinic site for recruitment and retention of participants and its role in implementing the WIHS scientific agenda.  Each site application should include standardized tables describing the cohort’s recruitment, retention, missed visits and missing data and specimens.

(2)  Description of the site’s participation as a clinic site for the conduct of the WIHS cohort study.  Specifically, each site application should describe the following:

- The means used to maintain high participant retention rates and community outreach

- The means by which WIHS participants at each site are referred for clinical care and how relevant data related to clinical care is incorporated into the study database

- The methods used to encourage participation of WIHS subjects in sub-studies and the means by which collaborations with outside investigators are incorporated into the existing WIHS protocol

- How the site will provide leadership for and collaborate in WIHS-wide epidemiologic and/or clinical investigations with WIHS data according to the WIHS agenda

- Arrangements for specimen handling including: testing and storage at the site, and specimen shipping.  Data should be provided to show degree of completion of repository requirements; participation in special specimen banks, such as tumor specimen repositories, autopsy program, and for linkage of such databases with the WIHS database

- The site’s organization, management and methods of communication, including outreach efforts with the community and the activities of Community Advisory Boards (CAB)

- The means by which the site will follow the organizational structures and managerial mechanisms of the WIHS

- The methods used by the site to insure the protection of human subjects, including how issues of heightened sensitivity such as commercial use of specimens and genetic testing have been addressed or will be addressed in WIHS IV

- The budget describing and justifying the site’s costs of implementing the WIHS scientific agenda as described in Part A of the WDMAC application

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 

Only the Review Criteria as described below for the WDMAC application (Parts A & B) and the individual WIHS Clinical Site Applications will be considered during the review process.  The Review Criteria as outlined below in Part A of the WDMC application are intended to illuminate the synergy that is possible in a multi-center epidemiology study such as the WIHS.  Consequently, the overall Scientific Review Group (SRG) assessment of Part A of the WDMC application may be greater than the sum of its parts (with its parts being each of the WIHS Clinical Site applications and Part B of the WDMC application).  Accordingly, final funding decisions will be made only after the review of all applications and will take the following into consideration:

WDMAC – Part A: Overall WIHS Research Plan

1. Significance. How the WIHS addressed important problems relevant to HIV-1 epidemiology and pathogenesis in women during the current funding cycle should be discussed.  The applicant should also address the most important questions and potential solutions that the WIHS expects to encounter in the coming years.  The scientific vision set forth by the WIHS leadership should delineate the most important ways in which the data and specimens obtained from the cohort will continue to advance our understanding of HIV-1 infection and disease.  In particular, the agenda should address how the WIHS will study issues relevant to the HIV-1 epidemic.  How/why the WIHS is suited to use the cohort structure to address new questions in the field as they arise, and the effect of the proposed studies on the concepts or methods that will drive the field should be addressed.  Finally, if the aims of the application are achieved, how will the information provided be significant?

2. Approach.  A well-developed and well-integrated conceptual framework, design, methods, and analysis plan appropriate for this cohort of women with, or at risk for, HIV infection is required.  The applicant must acknowledge potential problem areas and consider alternative tactics. Are the scientific goals set forth in this application feasible considering the size and make-up of the cohort?  Are the core laboratory procedures well coordinated, with adequate and appropriate quality control?  Has the WIHS demonstrated flexibility and strength in its structure and data collection system so that it will remain well suited to address new questions which are not yet anticipated?  Does the scientific and organizational structure of the WIHS facilitate the conduct of the WIHS scientific agenda?  Does this structure foster collaborations with investigators outside the WIHS?  Is the structure of the WIHS flexible enough to address new questions related to HIV as they arise?

3. Innovation.  Does the scientific agenda, presented by the investigators, represent innovative study designs?  Are the aims original and innovative?  Does the project develop areas of research important for understanding the long term treated history of HIV?  Does the structure of the WIHS foster innovative responses to address new questions related to HIV as they arise?

4. Investigators.  Are the investigators and key personnel appropriately trained and experienced to manage and direct WIHS-wide research?  Are they well-suited to engage in highly collaborative interactions with other WIHS investigators and with investigators external to the WIHS who wish to utilize WIHS data and specimens, in collaboration with the WIHS?  Is the work proposed appropriate to the experience level of the Principal Investigators and other WIHS researchers? 

5. Environment.  Will the scientific environment in which the work will be done contribute to the probability of the success of WIHS-wide scientific initiatives?  Do the proposed analyses take advantage of unique features of the WIHS scientific environment or optimize useful collaborative arrangements?

WDMAC Part B: WDMAC Research Plan

1. Significance.  Has WDMAC successfully served as the WIHS data management and analysis center over the past 5 years?  Does WDMAC fulfill other roles and duties that are critical to the success of WIHS-wide scientific studies and to the work of external collaborators?  Is the role of WDMAC in the design of future WIHS analyses adequate and appropriate?  Does WDMAC propose cutting edge analytical methods to optimize the use of observational data to inform on key questions?

2. Approach.  Is the approach for managing WIHS data and ensuring its security appropriate and optimal?  Are the approaches to ensuring the close coordination of WIHS-wide research and of research performed by external collaborators appropriate and optimal?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  Is the approach for the research proposal described by WDMAC appropriate?

3. Feasibility and Logistics.  Has WDMAC appropriately addressed the responsibility of developing the logistics necessary for the EC to develop and coordinate the WIHS scientific agenda?  Has WDMAC appropriately addressed the logistics necessary to ensure that WIHS data and specimens are collected, stored and shipped in a standardized fashion?  Has WDMAC demonstrated how appropriate training is conducted to ensure consistent data collection?

4. Investigators.  Are the investigators appropriately trained and well suited to perform the data management, data analyses, study design, and WIHS-wide coordinating roles central to the functioning of WIHS?  Are there key personnel in place, and is their effort sufficient to conduct WIHS research including study design, analysis, and development of novel epidemiologic and statistical methods?  Is the work proposed appropriate to the experience level of the principal investigators and other researchers?  Have the Principal Investigators and key personnel budgeted sufficient time to ensure that adequate attention is paid to the WIHS-wide scientific issues?

5. Environment.  Does the scientific environment in which the work will be done contribute to the probability of the success of WDMAC in addressing its multifaceted responsibilities?  Does the work proposed by WIHS take advantage of unique features of the scientific environment or optimize useful collaborative arrangements?

WIHS Clinical Sites:

1. Significance.  Has this WIHS clinical site successfully served as the source for WIHS data and specimens?  Is the functioning of this WIHS clinical site critical to the success of WIHS-wide scientific studies?  Has this WIHS clinical site successfully recruited and retained sufficient numbers of participants?

2. Approach.  Are the design and methods for cohort maintenance, data and specimen collection, adequately developed, well-integrated, and appropriate to the aims of the WIHS?  Does the applicant acknowledge potential problem areas and consider alternative approaches?

3. Feasibility and Logistics. Are the plans for maintaining the cohort, obtaining data and sending data to WDMAC, and for obtaining biological specimens and sending these to the National AIDS Specimen Repository feasible and adequate?  Are the plans for maintaining relations with community groups relevant to the WIHS adequate?  Are the plans for working with WDMAC to ensure appropriate standardization and quality control of data collected at each site adequate?  Are the site-specific plans for participation in the WIHS-wide core laboratory protocol adequate?

4. Investigators.  Are the investigators appropriately trained and well suited to carry out the work specific to the WIHS clinical sites, such as data and specimen collection and the performance of site-specific data analyses?  Are there key personnel in place to conduct WIHS research including epidemiologic expertise in study design and analysis?  Have the Principal Investigators budgeted sufficient time to ensure appropriate oversight of their clinical site and the WIHS-wide scientific agenda?

5. Environment.  Does the scientific environment in which the work will be done contribute to the probability of success?  Is there evidence of institutional support?

2. Review and Selection Process

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

The review will be conducted by the NIAID Division of Extramural Activities and may include a Reverse Site Visit (RCV).  In the event of an RSV, Principal Investigators and key staff will be invited to participate.  Potential dates, time, location and agenda of an RSV will be provided after receipt of all applications.

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

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health.  In the written comments, reviewers will be asked to discuss the following aspects of the application 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. 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.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the 5 items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data
 
Data Sharing Plan: The reasonableness of 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 (see the Research Plan, Section K. Resource Sharing, in the PHS Form 398).

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.

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

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of 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 PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of  Award will be mailed to the business official.

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

 All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of 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 (U01), 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 above.

2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The PD/PI will have the primary responsibility for: defining the research objectives, approaches and details of the projects within the guidelines of the RFA, and for conducting the scientific projects.  Specifically, awardees have primary responsibility as described below. 

A. Responsibilities of WDMAC: 

The WDMAC awardee is responsible for all the activities necessary to achieve the project's Research Objectives, including the following:

- Establish and maintain relationships with the WIHS sites, NIAID and the other NIH co-funding institutes to facilitate the achievement of the objectives.

- Maintain the system developed for tracking WIHS research in collaboration with the WIHS Executive Committee (EC).  Maintain and regularly distribute a list of all publications, manuscripts in progress and presentations using WIHS data.  The WDMAC PI is a voting member of the EC.

- Maintain the mechanisms for effective communication and collaborations, including arranging regular conference calls for Working Groups, EC and other ad hoc committees or study-related groups and coordinating the semi-annual meetings of WIHS investigators and their collaborators.

- Provide semi-annual reports at the WIHS EC meetings.

- Monitor adherence to clinical and laboratory protocols, and coordinate implementation of any new or modified protocols that the EC approves during the course of the study.  WDMAC will be responsible for preparing and updating operations manuals and data collection forms as well as coordinating the revision of existing WIHS questionnaires, and the development and testing of new questionnaires for utilization in the WIHS, including the standardization of procedures for data collection.  They will also be responsible for providing adequate teaching and training to WIHS personnel at the clinical sites to assure that the questionnaires continue to be administered in a uniform, standardized fashion, performing site visits as necessary.  In particular, WDMAC will be responsible for the following evaluations: interview skills and procedures, HIV pre-test and post-test counseling, specimen collection skills and procedures, and data management at local sites. 

- Work with the NIAID specimen repository contractor to ensure that an accurate inventory of specimens is available.  WDMAC will conduct training and provide updates about the web-based tracking system to ensure that WIHS investigators can access the specimen database.  Manage requests for specimens from WIHS investigators and work with the repository contractor to prioritize requests for samples and facilitate timely delivery of samples to investigators. 

- Collect, edit, clean and store data collected from WIHS clinical sites; provide centralized storage, security, processing and retrieval of WIHS data; ensure the continued quality of the data management system and its adequacy to the expanding needs of the WIHS.

- Supply recruitment and retention data to inform sites about current cohort status.  The data must be supplied on a regular basis so that cohort retention problems can be readily corrected.

- Prepare and submit progress reports to NIH.  A summary of WDMAC activities and progress and the results of site monitoring evaluations must be sent annually to program officers at NIAID and the other NIH co-funding institutes. 

- Drafts of manuscripts should be available for review (electronically or in hard-copy) by the NIH Scientific Coordinators at the time they are circulated to co-authors and when the final manuscripts are submitted for publication.  Copies of the published articles should be forwarded to program officers at NIAID and the other NIH co-funding institutes.

 - Prepare and submit a WIHS public-use data electronic file covering the data collection period up to three years before the file's creation.

- Maintain a searchable web-based archive of WIHS publications.

B. Responsibilities of WIHS Clinical Sites:  

The quality of the WIHS research will largely depend on the degree of collaboration between and among the WIHS sites and WDMAC.  The generation of high-quality data in a multi-center setting will require continuous feedback by the sites to WDMAC for data management and protocol implementation.  The responsiveness of the sites in providing information to WDMAC will be the responsibility of the WIHS Principal Investigators.  All WIHS Clinical Site PIs will be  voting members of the Executive Committee.

In particular, sites will be responsible for:

- Quality of data and of publications involving the awardee’s site

- Research design and implementation, data collection, final data analysis and publication in collaboration with the other WIHS sites and WDMAC, within the guidelines established by the WIHS EC

- Establishing, in collaboration with WDMAC, appropriate mechanisms for quality control and monitoring and for follow-up of WIHS participants in terms of disease outcomes specified by the EC

- Collecting and submitting biological specimens specified in the WIHS protocol to the repository contractor with appropriate documentation and labels

- Establishing and maintaining relationships that facilitate the achievements of the study objectives with other WIHS sites and with the NIH institutes funding the WIHS

- Preparing and submitting progress reports and manuscripts to the NIH.  Drafts of manuscripts at the time they are circulated to co-authors, final manuscripts being submitted for publication, and copies of published articles should be sent to the program officers for NIAID and the other NIH co-funding institutes for review, in accordance with publication policies established by the WIHS EC.

The WIHS clinical sites will also be responsible for maintaining an optimal collaboration with WDMAC.

In particular the clinical sites will be responsible for:

- Providing adequate and timely response to all pertinent requests by WDMAC concerning past, ongoing, or planned research activities

- Immediate reporting of problems in data collection, record abstraction and information flow

- Immediate reporting of relevant staff changes

- Staff attendance at training sessions

- Submitting complete and clear analysis proposals in the standard format previously developed by the EC.  Requests for expedited analysis will require a written justification.

- Submitting complete and clear WIHS abstract and manuscript concept sheets

- Maintaining optimal working condition of hardware and software and coordinating changes and/or upgrades

- Ensuring that all requests to WDMAC are timely and well documented

The PD/PI will retain custody of, and have primary rights to the data information  and software developed under the cooperative agreement, subject to Government rights of access consistent with the current HHS, PHS, and NIH policies. Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH Grants Policy Statement.  

C. Responsibilities of WIHS Clinical Sites and WDMAC:

ACCESS TO DATA.  The EC, in collaboration with WDMAC, will be responsible for optimizing a mechanism for rapid access to data for exploratory work or manuscript preparation.  Requests by investigators for raw and summary data will be managed by WDMAC after clearance and prioritization by the EC.  The combined WIHS data will be kept at WDMAC, with copies of the dataset being sent to each WIHS site and to program officers at each NIH institute funding the WIHS.  Prior to approval and release of data, research plans submitted to the EC will be evaluated to determine if they are in accordance with the informed consent signed by the WIHS participants.  A WIHS public-use data set will be created yearly by WDMAC and will contain data covering the period up to three years prior to the data set’s creation.

BIOLOGICAL SPECIMENS.  In view of the importance of biological specimens for current and future studies, their number and volume should be regularly monitored by WDMAC and reported to the EC.  Each site's annual report to NIAID and the other NIH co-funding institutes should include a WDMAC summary report on biological specimens and a detailed status report of any local repository.  Problems with specimen collection at individual sites should be brought to the attention of the EC, through WDMAC and the working groups, for appropriate remedial measures.  Requests for specimens by WIHS investigators should describe in detail the study for which specimens are sought, their number and volume, in accordance with a standardized WIHS Data and Specimen request form.  WIHS specimens may also be made available to independent investigators upon approval of requests by the EC.  The EC will actively promote wider and optimal utilization of WIHS specimens by outside investigators.  Prior to approval and release of specimens, research plans submitted to the EC will be evaluated to determine if the research is in accordance with the informed consent signed by the WIHS participants and that necessary IRB approvals have been obtained.  EC approval is not necessarily applicable to specimens in local repositories.  However, notification of the EC about studies being conducted on local repository specimens is expected, and compliance with human subjects regulations is required.

INTERACTION WITH THE COMMUNITY ADVISORY BOARD (CAB).  An optimal interaction between the WIHS sites and the communities from which the participants are drawn will be critical for the long-term success of the study.  The WIHS EC will be responsible for ensuring that individual WIHS sites maintain ties to their patient communities and interact in a spirit of collaboration that is mutually responsive.  Each WIHS site will be responsible for budgeting appropriate expenses for the support of these interactions.

DISSEMINATION OF STUDY RESULTS.  The existing WIHS publication policy should be followed.  The policy will be reviewed in the first six months of the funding cycle, and amended by the EC if necessary, to achieve overall fairness and timeliness in the formal reporting of research results.  The timely dissemination of study results to the communities involved is strongly emphasized.  The support of the NIH Institutes funding the WIHS should be acknowledged and the NIH grant numbers included in all publications.

MEETINGS: Semi-annual WIHS-wide meetings will convene the EC and Working Groups at the same location.  A Spring meeting will always be held in the Washington, DC area, with rotation of the Fall meeting to each WIHS site or to other cost-effective sites.  A substantial portion of each meeting will be devoted to assessing scientific progress and establishing scientific priorities and timelines.  WDMAC should ensure the availability of updated summary data for these meetings.

2.A.2. NIH Responsibilities  

NIAID, NICHD, NIDA and NCI staff assistance will be provided by the Scientific Coordinators for each Institutes.  The Scientific Coordinators will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below.

NIH Scientific Coordinators will:

-  Be members of the Executive Committee.

- Monitor study results and quality assurance across all sites, in order to ensure the production of high-quality, unbiased results that are comparable across sites

- Ensure and coordinate access to WIHS datasets for presentations and publication of study-wide data to ensure that the seven WIHS sites have equal access to WIHS data and participants. 

- Have access to, and may periodically review, all study protocols and data.

- Oversee the collection, storage and cataloging of samples to ensure that appropriate access to the NIAID contractor-maintained repository of biological specimens, a key resource for the entire scientific community, is provided.

- In collaboration with the WIHS EC, may have data generated from the WIHS for use in preparing internal reports on WIHS activities. 

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 

The WIHS is managed by an Executive Committee (EC) comprised of the Principal Investigators from the Clinical Consortiums, the Data Management and Analysis Center and NIH co-funding institutes. The EC meets by phone conference twice monthly and in person twice a year to discuss changes in protocols, retention of the cohort, quality control of data, requests to perform research using WIHS data or samples, specimen preservation and distribution from the national repository, and other matters of interest to all institutions affiliated with the WIHS.

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

Through WDMAC, the WIHS EC must submit in electronic format an annual progress report to the program officers at the NIH institutes funding the WIHS that includes the following:

- Tables recording recruitment and retention over the past year for both the overall WIHS Study (by race/ethnicity as delineated by NIH policy: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html) and for each sub-study

- The number and type of specimens collected and sent to the national repository

- A brief report of progress in ongoing core WIHS research projects and sub-studies over the past year

- A listing of publications either published or in-press for the year being reported

- A listing of abstracts and presentations made in the past year exclusive of the list of published and in-press publications

- Tables of site-specific recruitment and retention in the past year for the overall WIHS Study and for each sub-study being conducted at the site; a table summarizing the number and type of specimens collected and sent to the national repository; and a table of participants under follow-up (by race/ethnicity as delineated in the NIH policy: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html)

- A brief summary of progress on WIHS-wide research being led by investigators at each site

- A brief summary of recruitment and retention activities conducted at each site, including interactions with the community

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:  

NIAID:

Gerald B. Sharp, Ph.D.   
                                                                                       
Division of AIDS                                                                                  
Room 4103, MSC-7626                                                                                                       
6700-B Rockledge Drive                                                                                  
Bethesda, MD 20892-7626                                                                                
Telephone: 301-451-2573                                                                                      
FAX: 301-402-3211                                                                                              
E-mail: gsharp@niaid.nih.gov 

NICHD:

Heather Watts, M.D. 
Center Research for Mothers and Children
Room 4B11, MSC-7510                                                                                                        
6100 Executive Boulevard                                                                   
Bethesda, MD 20892-7510                                                                                      
Telephone: 301-435-6874                                                                                 
Fax: 301-496-8678                                                                                               
Email: hw59i@nih.gov

NCI:

Geraldina Dominguez, Ph.D.
Office of AIDS Malignancy Program
Room 6112, MSC-7204                                                                          
6120 Executive Boulevard                                                                           
Bethesda, MD 20892-7204                                                                                 
Telephone: 301-496-3204                                                                                 
Fax: 301-480-4137                                                       
Email: domingug@mail.nih.gov

NIDA:

Richard A. Jenkins, Ph.D.                                                                                           
Prevention Research Branch                                                                                  
Room 5170, MSC - 9589                                                                                       
6001 Executive Boulevard
Bethesda, MD 20892-9589                                                                                 
Telephone: 301-443-1923
Fax: 301-480-2542                                                                                        
Email: jenkinsri@mail.nih.gov

2. Peer Review Contacts:
 
Gregory P. Jarosik, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Disease
Room 3134, MSC 7616
6700B Rockledge Drive
Bethesda, MD  20892-7616 (express mail zip: 20817)
Phone:  301-496-0695
Fax:  301-480-2310
email: gjarosik@niaid.nih.gov

3. Financial or Grants Management Contacts:

Ms. Mildred Qualls
Division of Extramural Activities                                                                                 
National Institute of Allergy and Infectious Diseases                                                      
Room 2125, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
(Regular Mail)
Bethesda, MD 20817 (Express Mail)
Phone: 301- 402-6611
FAX: 301-493-0597 or 301-480-3780
Email:
mq20b@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 sharing is not possible (http://grants.nih.gov/grants/policy/data_sharing).

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide 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 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/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

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

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

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

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

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

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

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

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

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

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

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

Authority and Regulations:  
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research, No. 93.865, Child Health and Human Development Extramural Research, No. 93.279, Drug Abuse and Addiction Research Programs, No. 93.396, Cancer Biology Research, No. 93.393, Cancer Cause and Prevention Research, No. 93.394, Cancer Detection and Diagnosis Research, and No. 93.395, Cancer Treatment 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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