Full Text AI-97-001 WOMEN'S INTERAGENCY HIV STUDY DATA MANAGEMENT AND ANALYSIS CENTER NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA: AI-97-001 P.T. 34, II Keywords: AIDS Data Management/Analysis+ National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 7, 1997 Application Receipt Date: May 15, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to provide data management, statistical and administrative support to the Women's Interagency HIV Study (WIHS). This will permit the continuation of ongoing studies of HIV in women under the WIHS initiative and will provide a support mechanism for new, highly focused studies of HIV in women using the WIHS infrastructure. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Women's Interagency HIV Study Data Management and Analysis Center, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, units of State or local government, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Domestic applications may not include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity, by involvement in and otherwise stimulating and working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the WIHS Study to be funded under cooperative agreement(s) are discussed later in this document under the section Terms And Conditions of Award. The total project period for applications submitted in response to this RFA may not exceed five years. At present, the NIAID is administratively limiting the duration of U01 cooperative agreements to four years; this administrative limitation may change in the future. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $ 1,500,000. In fiscal year 1997, the NIAID anticipates making one award as a result of this RFA. At the current time, NIH is limiting annual inflationary increases to four percent. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES A. Background 1. HIV IN WOMEN. HIV in women is increasing worldwide. In the U.S., the epidemic began expanding among women in the late 1980s. Since many HIV-infected women in the U.S. have not yet progressed to advanced disease stages, the full extent of the epidemic in this population has yet to be clearly defined. As of December 1995, the Centers for Disease Control and Prevention (CDC) estimated that the cumulative number of AIDS cases in adult and adolescent women in the U.S. was more than 71,000, with 13,764 in 1995 alone. Women now comprise approximately 14 percent (71,818/513,486) of the total adult and adolescent AIDS cases, the highest proportion yet reported. The impact of AIDS is particularly severe in minority populations. Among women in the U.S., Blacks and Hispanics combined now represent the majority of AIDS cases (76%). In the U.S., the proportion of women acquiring HIV infection through sexual contact with HIV-infected men is increasing and expected to become the predominant mode in the next few years. In 1995, 38% of women with AIDS reported acquiring HIV infection through sexual contact, and 38% reported injecting-drug use as their main exposure category. AIDS is now the third leading cause of death for women aged 25 to 44, after cancer and cardiovascular disease. As new knowledge on HIV/AIDS is more rapidly generated, ongoing prospective cohort studies must rapidly adjust their structure to the new developments. Studies of HIV/AIDS in women can play a unique role in testing new biological or socio-behavioral hypotheses and in linking basic science findings and laboratory methods to epidemiologically well defined populations. 2. WIHS The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established in 1993 in tandem with a similar study, the HIV Epidemiology Research Study (HERS) coordinated by the U.S. Centers for Disease Control and Prevention (CDC) to carry out comprehensive investigations of the impact of HIV infection in women. The six WIHS sites, organized as consortia, are located in New York (2), Washington, Chicago, San Francisco and Los Angeles (Principal Investigators and respective study sites are identified below, under STUDY POPULATIONS). In addition to the NIAID, other NIH Institutes (the National Institute of Child Health and Human Development, the National Institute on Drug Abuse, the National Cancer Institute and the National Institute of Dental Research) fund different components of the WIHS. The WIHS has solicited the community's input from the outset to better identify problems and pursue research opportunities that are relevant in the area of women and HIV. A total of 2,641 women (2066 HIV positive and 575 negative), 80% of minority background, are under follow-up. A key objective of the continuation of the WIHS initiative is to stimulate investigators to design and conduct studies that fully utilize the network of WIHS sites, laboratories, specimen bank and data center and to encourage the integration of new studies in this established network. This goal will be more easily attained because the facilities participating in the WIHS also provide clinical care to the members of the WIHS cohort, which allows for real-time clinical observation and laboratory testing. The rapid implementation of new protocols will be especially dependent on the presence of the following project-wide characteristics: adequate infrastructure and coordination within the consortia, effective linkage between the six study sites, real-time coordination of activities by the data center, and optimal use of the clinical specimens which are being stored at an NIAID-funded repository. All activities of the WIHS are coordinated and supervised by an Executive Committee (see TERMS AND CONDITIONS OF AWARD) which collaboratively decides all scientific, policy and organizational issues concerning development and implementation of research protocols, structure and membership of working groups, publications, access to data and interim data monitoring, and access to biological specimens. The specific activities related to data collection, management analysis and quality assurance, specimen tracking, staff training as well as study-wide communication, coordination and administrative duties have been carried out, since the study's inception, by the WIHS Statistical and Clinical Coordinating Center (SACCC). Besides carrying out such activities for the WIHS, the SACCC has been simultaneously functioning as the Data Center for other NIH-funded (WITS) and CDC-funded (HERS) studies. The aim of this RFA is to replace the SACCC with a WIHS-specific Data Center (WDMAC), as described in detail below. B. Research objectives and scope The overall objective of this RFA is to ensure leadership in study design and analytical methodology for the WIHS, and to provide the study with management, coordination and quality assurance of the data. A comprehensive plan is sought in several specific areas, as described below. Applicants may identify discrete areas, among those described in this RFA, for which they plan to utilize outside contractors. This approach is encouraged if it allows the respondent to more efficiently carry out the numerous tasks that are part of the responsibilities of the WIHS Data Management and Analysis Center (WDMAC). Applicants should describe the activities to be contracted, the level of integration between the WDMAC and any contractor, and the expected advantages of such an approach. 1. Statistical and research design leadership. The WDMAC will provide leadership and intellectual input about statistical and design aspects of the study. The WDMAC's responsibilities, therefore, will include providing expert assistance to WIHS investigators in developing 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 statistical analyses. These responsibilities apply to multiple, simultaneous projects, including those funded by collaborating NIH Institutes. Expertise in theoretical statistics, modeling, repeated measures, exploratory data analysis and robust methods will be important for the investigations in the next WIHS funding cycle. A sound methodological approach to the measurement of disease progression, based on currently used or new surrogate markers, will be necessary in a number of WIHS studies where key events, such as time of HIV seroconversion, are unknown. Statistical methods that are relevant to the current WIHS scientific questions should be described. The WDMAC is expected to play a catalytic role in its interaction with the WIHS sites and to establish, in collaboration with the Executive Committee, priorities and reasonable timelines for study activities. The WDMAC also is expected to collaborate with investigators conducting new, discrete studies in the WIHS. Technical assistance provided by the WDMAC to new WIHS collaborators is particularly important to ensure that study design and implementation are compatible with the WIHS instruments. Data should be provided to these collaborators as needed and as approved by the Executive Committee. For ongoing studies as well as new collaborations, the WDMAC's responsibilities include, besides providing expertise for statistical and research design, the creation of cohesive teams of statisticians and clinical/laboratory investigators. These teams can function best when regularly monitored by the WDMAC's Principal Investigator and when formed early in the process leading to presentation and publication of WIHS results. The WDMAC will have the opportunity to engage in methodological investigations, and to develop novel methodological approaches, utilizing data from the WIHS. The standardized instruments for data collection and management used by this large prospective study will provide an opportunity for methodological investigations. For example, these data may be useful in evaluating the effectiveness of treatments for AIDS or AIDS-related conditions outside of clinical trials, the role of confounders in such evaluations, and the representativeness of specific subpopulations. These data also may be applied to the investigation of novel methodologic approaches to estimate changes in survival from different stages of HIV infection. 2. Transition of data, data software and equipment. Applicants should provide a detailed plan for an orderly and efficient transition from the current data management contractor. Transition activities will be conducted in collaboration with the outgoing data center during an overlap period of approximately six months. Specifications regarding the data currently maintained centrally, and the hardware and software currently in use, will be provided to RFA applicants to facilitate transition planning and to allow them to formulate plans regarding any new configurations of electronic data collection, management and analysis. A brief summary of the current WIHS software environment is included as an Appendix to this RFA. A similar plan also should be provided by the applicants for turning over activities to a new data center at the termination of the next grant period. Applicants should describe specific activities to effect the smooth transfer of the data and to phase in new systems and phase out old systems, including relevant software and equipment. For transition phase activities also, applicants may choose to utilize contractors for specific tasks, if more efficiency in this phase will ensue. 3. Data management and quality assurance system. a. Data Management System. The WDMAC will be responsible for ensuring the continued quality of the data management system and its adequacy to the expanding needs of the WIHS. This includes establishment of an optimal computing environment for processing, storage and retrieval of data at a central data management facility. The application should describe how multiple sets of longitudinal information are concatenated and how data files for analyses are created. The WDMAC should maintain and update an information management system for tracking transmission and receipt of data from the study sites as well as maintain and update codebooks, active files and inventory files. Combined codebooks may be needed to interface with other AIDS databases, such as the AIDS Malignancy Bank Database. The WDMAC should implement regular data back-ups centrally and at the sites, and archiving of one data copy off-site should be provided. The data base should be accessible by multiple users simultaneously and have security systems to prevent unauthorized access to data, as well as record-keeping procedures which ensure participants' confidentiality. b. Summary data. The WDMAC will be responsible for preparing and updating operations manuals and data collection forms and providing statistical summary reports, including regularly providing summary data on participants' attendance to site Project Directors and the Participant Retention Working Group. The regular dissemination of attendance reports will help to ensure that the participants' retention rates are correctly interpreted by the sites and that problems are brought to the attention of the site, the Executive Committee, NIAID and other participating NIH Institutes in a timely manner. The WDMAC should solicit and integrate comments from WIHS Working Groups; distribute this information and Working Group minutes to Principal Investigators, Executive Committee, Working Groups and NIH Institutes; distribute summary reports containing descriptive statistics of participants; and maintain and regularly distribute a list of all publications, manuscripts in progress and presentations which used data from the WIHS. Emphasis should be placed on completing the above tasks in a timely manner. For budgeting purposes, it should be assumed that such data summaries will be required twice a year. Activities such as minute taking and mailings to sites, Working Groups and Committees may be performed through a subcontractor, if this demonstrably allows for a more efficient service and a better utilization of the WDMAC's resources for other key WIHS activities. c. Protocol monitoring and modifications. The WDMAC should monitor adherence to the clinical and laboratory protocols, and coordinate implementation of any new or modified protocols that the Executive Committee approves during the course of the study. WDMAC activities related to new or modified protocols include new data collection form development, data management system modifications, operations and training manual updates and the conduct of study sites' staff training. d. Quality assurance. A study-wide quality assurance system should be implemented by the WDMAC to allow for regular evaluation of reliability, validity and completeness of data. Statistical expertise by the WDMAC will be critical in the implementation of quality assurance programs in the sites' laboratories. The WDMAC should manage and, if necessary, improve the current quality assurance system and provide documentation of any changes in the quality assurance and data entry instruction manuals. The WDMAC should bring any data suggesting quality assurance problems at study sites to the attention of NIAID, other collaborating NIH Institutes and the WIHS Executive Committee. The WDMAC will play a central role in discussing such problems and suggesting solutions at the periodic WIHS Executive Committee meetings. For studies requiring discipline-specific expertise not readily available within the WIHS, the WDMAC should plan to procure the services of experts to assure the quality of such study data. e. Relationship with study sites and site visits. A key requirement for the smooth conduct of a complex study such as the WIHS is the ability of RFA respondents to work with the other WIHS investigators and with external collaborators in a cooperative and collegial fashion. To further this goal, the WDMAC will be a full member of the WIHS Executive Committee. Data collected by the WIHS clinical sites and stored at the WDMAC are considered the property of the study as a whole and are thus governed by the formal decision processes of the WIHS. The WDMAC is expected to abide by the Executive Committee's decisions, which includes providing readily usable data sets to researchers based at WIHS sites, researchers associated with the WIHS through investigator-initiated studies, or external WIHS collaborators, as required and approved by the WIHS Executive Committee. An important element in the daily conduct of the study is adequate support to the field operations. The WDMAC should provide data collection support and field calls about data-related matters from site project directors, clinicians and laboratory staff. Carefully prepared site visits are an integral part of the support effort. A WDMAC team of individuals with different expertise is expected to visit each of the six WIHS main sites in the first 18 months of this grant's funding period. After the first visit, the frequency of subsequent visits will be determined in collaboration with NIAID and co-sponsoring NIH Institutes. To ensure that needs identified during visits are rapidly addressed, post-site visit reports should be submitted to NIAID within one month of each site visit. Likewise, separate reports by the WDMAC on studies supported by other NIH Institutes will be crucial to delineate deficiencies and rapidly implement recommendations. The WDMAC will be responsible for any staff training needs during these periodic site visits. f. Site-specific studies and WDMAC studies. A major strength of the WIHS is the combined data set from the participating study sites. However, important findings may be generated by smaller studies at individual WIHS sites. Subsequent to Executive Committee approval, a WIHS site will have the opportunity to perform research and analysis on data collected solely from that site, but site-specific studies will be limited in size and scope. The role of the WDMAC for site-specific work will mainly be to provide clean and up-to-date data sets to the sites submitting requests. The WDMAC also will have the opportunity to propose and perform independent methodological and biostatistical research with WIHS-wide data. Such WDMAC proposals will also require the Executive Committee's approval. 4. Study-wide communication, co-ordination and administrative duties. The WDMAC will have overall responsibility for the following activities: a. Establish electronic mail linkages among sites, the WDMAC, NIAID and other participating NIH Institutes. b. Develop milestones/timelines to identify major steps and anticipated accomplishments. Particular attention is necessary in setting milestones in the following areas: transition from the previous data center; revision of questionnaires and protocols and pilot testing of new procedures; methods of data input; distribution of instruments/operation manuals; ongoing training of clinical site staff; implementation of quality assurance protocols. c. Provide regularly spaced data freezes, based on a schedule established by the Executive Committee. d. Provide meeting-related administrative support for Executive Committee and Working Group meetings. This includes coordinating with the working group chairs to distribute agendas, preparing 1-2 page highlights of meetings and conferences calls and working with the Executive Committee to assemble, organize and distribute materials for study-wide Working Group and Executive Committee meetings. Type and frequency of meetings are described below under MEETINGS. e. Arrange for regular conference calls for Working Groups, Executive Committee and other ad hoc committees or study-related groups. 5. Specimen tracking system for the storage and retrieval of biological specimens. The WDMAC should provide central co-ordination of stored specimens in collaboration with staff of the NIAID National AIDS Biological Specimen Repository, under contract to Biological Resources, Inc. of Rockville, MD. This includes updating and improving as needed the current system for specimen tracking at each stage (collection, processing, transfer, storage and retrieval). The WDMAC should also plan to submit a biannual inventory of specimens from each clinical site, describing the type and quantity of all specimens. This inventory should be provided to the NIAID AIDS Specimen Repository via electronic medium in a format that can be integrated into inventory databases. To facilitate the evaluation of new studies by the Executive Committee, a repository status summary should be prepared and distributed to the Executive Committee members before their scheduled meetings. The WDMAC should also record requests for biological specimens and work with the repository and the Laboratory Working Group to account for the current amount and type of specimens available. In addition, the WDMAC should conduct training and updates about the procedures to keep track of repository specimens centrally and at the clinical sites. Project directors of clinical sites and other appropriate personnel are expected to attend these training sessions. 6. Protocol-oriented clinical research training of site staff. As part of a study-wide quality assurance system, the WDMAC should conduct periodic evaluations and site visits for clinical assessment, form completion, specimen collection monitoring and ongoing staff training. In particular, the 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. It is recommended that the visiting team include at least one physician or physician's assistant or nurse practitioner. At least one team member must be fluent in Spanish. 7. Support and coordination for data presentation at scientific conferences. The WDMAC should coordinate with WIHS investigators the process generating scientific material for presentations at conferences and meetings. Specific WDMAC responsibilities include playing a proactive role in devising original approaches to study design and data analysis, performing such analyses, and prioritizing efforts for presentations in collaboration with the Executive Committee. The WDMAC also should play a central role in the yearly WIHS-wide scientific meetings in which study results are presented and discussed. The WDMAC should provide in a timely fashion datasets for analyses by WIHS investigators and outside collaborators, as requested by the Executive Committee. 8. Communication with WIHS sites and NIH. Regular reporting of activities will help the WIHS sites, as well as the Executive Committee and the participating NIH ICs, to monitor progress and identify areas of potential interest for further investigation. For such reports, a reader-friendly format which limits the narrative and incorporates clear tables and figures is encouraged. This communication format also applies to a transition period report (if applicable) describing in detail accomplishments and challenges in all activities that are part of the WDMAC transition plan. In addition to the annual report to NIAID/other Institutes, the WDMAC should plan to produce at regular intervals (at least twice a year) a summary of study descriptive statistics, participants' attendance to clinics and inventory of biological specimens from each clinical site (with type and volume of all specimens). TERMS AND CONDITIONS OF AWARD These 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 part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used shall be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIAID scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIAID's and NIH's purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the study will be shared among the awardee and the NIAID Program Officer or designees. Under the cooperative agreement, a relationship will exist between the award recipient and the NIAID in which the awardee is responsible for the requirements and conditions described below and agrees to accept program assistance from a named NIAID Program Officer or other designated government official in achieving project objectives, as described below. Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction in budget, withholding of support, or suspension and/or termination of the award. 1. EXECUTIVE COMMITTEE. All activities of the WIHS are coordinated and supervised by an Executive Committee whose membership currently consists of: Principal Investigators, Project Directors, Working Group chairs, the Data Center representative, the Community Advisory Board (CAB) representative, the Program Officer of each funding NIH Institute, and the Program Officer of the CDC companion study (HERS). The Executive Committee collaboratively decides all scientific, policy and organizational issues concerning development and implementation of research protocols, structure and membership of working groups, publications, access to data and interim data monitoring, and access to biological specimens. The WIHS Executive Committee will be in charge of assuring that the overall conduct of the study is in keeping with high standards of scientific and programmatic achievement and that adequate mechanisms for systematic oversight of the research quality are in place. Principal Investigators will be responsible for ensuring and demonstrating to the Executive Committee that their study site and consortium subsites adequately contribute to the overall effort. The Principal Investigator of the WDMAC will be a full member of the Executive Committee. From an organizational standpoint, the Executive Committee will place particular emphasis on monitoring the coordination between study sites and WDMAC and on monitoring access to biological samples. 2. AWARDEE RESPONSIBILITIES. The WDMAC awardee is responsible for all the activities necessary to achieve the project's Research Objectives, including the following: o Research design and protocol development, including definition of objectives and approaches, planning, implementation, data collection, quality control, interim data monitoring, final data analysis and interpretation. o Establishing appropriate mechanisms for quality control and monitoring. o Establishing and maintaining a relationship with WIHS sites, NIAID and other collaborating NIH Institutes which facilitates the achievement of the study objectives. o Preparing and submitting to the NIH progress reports. A summary of the WDMAC's activities and progress should be sent annually to the NIAID (and other NIH Institutes, if applicable) Program Officer. o Cooperating in the reporting of the study findings. 3. RESPONSIBILITIES OF WIHS SITES. The quality of the WIHS research will largely depend on the degree of collaboration between the WIHS sites and the WDMAC. The generation of high-quality data in a multi-center setting will require continuous feedback by the sites to the WDMAC for data management and protocol implementation. The responsiveness of the sites in providing information to the WDMAC will be the responsibility of the WIHS Principal Investigators. In particular, sites will be responsible for: o Providing adequate and timely response to all pertinent requests by the WDMAC concerning past, ongoing, or planned research activities. o Immediate reporting of problems in data collection, record abstraction and information flow. o Immediate reporting of staff changes. o Attendance at training sessions by staff. o Submitting complete and clear analysis proposals in the standard format previously developed by the WDMAC. Requests for expedited analysis will require a written justification. o Submitting complete and clear WIHS abstract/manuscript concept sheets. o Maintaining hardware and software in optimal working condition and coordinating changes and/or upgrades. o Ensuring that all requests to the WDMAC are timely and well documented. Every effort should be made to rapidly resolve any disagreements between individual WIHS sites and the WDMAC. In case of persisting problems, the matter will be referred to the Executive Committee. 4. NIAID AND OTHER FUNDING INSTITUTES' RESPONSIBILITIES. Although scientific leadership will be the responsibility of the WIHS Executive Committee and Principal Investigators, NIAID will provide substantial assistance through the Program Officer, in the form of scientific co-ordination and advice. Coordination and advice in areas pertaining to the other funding NIH Institutes will be provided by their responsible Program Officer. o NIH Program staff will 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. o NIH Program staff will ensure and coordinate access to WIHS datasets for presentations and publication of study-wide data, to achieve even representation and multi-site contribution to the core group of WIHS subjects. Program staff will have access to and may periodically review all study protocols and data. o NIH Program Staff will oversee the collection, storage and cataloguing of samples and will ensure that appropriate access is given to the repository of biological specimens, which is a key resource for the entire scientific community. o NIH Program Staff may also exercise the option of periodic external review of progress of the WIHS, in order to ensure an optimal use of approaches and resources. 5. ACCESS TO DATA. The WDMAC, in collaboration with the Executive Committee, will be responsible for optimizing the mechanism for access to data for exploratory work or manuscript preparation. It is critical that both WDMAC and site investigators operate in a spirit of collaboration, and understand the importance of data sharing as well as the possible technical constraints of the process. Requests by investigators for raw and summary data should be managed in a timely manner by the WDMAC after clearance and prioritization by the Executive Committee. The WDMAC will provide to each center a full set of cleaned, site-specific data twice each year. The complete WIHS dataset will be kept at the WDMAC. 6. BIOLOGICAL SPECIMENS. In view of the importance of biological specimens for current and future studies, their number and volume should be regularly monitored by the WDMAC and reported to the Executive Committee and the Principal Investigators. Each site's annual report to NIAID and other Institutes should include the WDMAC's summary report on biological specimens and a detailed status report of any local repository. Problems in specimen collection by individual sites should be brought to the attention of the Executive Committee, through the WDMAC and the working groups, for appropriate remedial measures. WIHS specimens may be made available only after Executive Committee clearance. 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 Executive Committee. 7. DISSEMINATION OF STUDY RESULTS. The existing WIHS publication policy (as described in a detailed document issued in June, 1995 and approved by the Executive Committee) should be followed. The policy will be reviewed in the first six months of the funding cycle and amended, 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. Support by NIAID and other participating NIH Institutes should be acknowledged in all publications. 8. MEETINGS: The Executive Committee is expected to meet at least twice per year. Active WIHS Working Groups are expected to meet at least twice per year to present and discuss their data. An annual WIHS-wide meeting will convene Executive Committee and Working Groups at the same location. The WDMAC should ensure the availability of updated summary data for these meetings. The WDMAC is encouraged to hold an annual retreat in which research results and future plans are presented and discussed in detail. 9. ARBITRATION. Disagreements between awardees in the implementation of study matters will be resolved by the Executive Committee in collaboration with NIAID and with any other NIH Institutes involved in the specific matter. If necessary and upon request of the parties involved, an arbitration panel will be constituted. The panel will be composed of a member selected by the WIHS Executive Committee (with NIH members non voting), a member selected by NIAID (with input from other Institutes, if applicable) and a member selected by the two previously selected members. This special arbitration in no way affects the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D and HHS regulations at 45 CFR Part 16. STUDY POPULATIONS. WIHS sites and composition of consortia: o New York (PI: Dr. K. Anastos). Consortium sites: Montefiore/Bronx Lebanon, Beth Israel, Mt. Sinai; o New York (PI: Dr. H. Minkoff). Consortium sites: SUNY Brooklyn, Kings County, University Hospital. o Washington, DC (PI: Dr. M. Young). Consortium sites: Georgetown U., Howard U., G. Washington, Whitman-Walker, Montgomery County Health Dept., Inova Health System. o Chicago (PI: Dr. M. Cohen). Consortium sites: Cook County Hospital, Northwestern Memorial Hospital, Rush Presbyterian/St. Lukes, U. of Illinois. o San Francisco (PI: Dr. R. Greenblatt). Consortium sites: UCSF, San Francisco General Hospital, Alameda County Medical Center, Alta Bates Medical Center. o Los Angeles (PI: Dr. A. Levine). Consortium sites: U.S.C. Medical Center, Martin Luther King Medical Center, AIDS Healthcare Foundation, T.H.E. Clinic for Women, Prototypes/W.A.R.N., Santa Barbara Health Dept., U. of Hawaii. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The current policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11] . Investigators may obtain copies from these sources or from Dr. Paolo G. Miotti (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 7, 1997 a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 710-0267; e-mail ASKNIH@odrockm1.od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number AI-97-001 and the words "WIHS Data Management and Analysis Center" must be entered on the face page. Applications must be received by May 15, 1997. Applications that are not received on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/95) Application Kit (as modified in and superseded by, the special instructions below, for the purposes of this RFA), will be judged non-responsive and will be returned to the applicant. The RFA label in the application form PHS 398 must be affixed to the bottom of the face page. 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. If the application submitted to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore an application that is essentially identical to the one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. It is recommended that Dr. Paolo G. Miotti, NIAID Division of AIDS, be consulted before submitting the letter of intent and during the early stages of preparation of the application. See program contacts under INQUIRIES. Applications should include funds for such meetings in their budget requests. [Note: for planning purposes, assume two Executive Committee meetings and two meetings of each active Working Group per year. One such meeting of the Executive Committee and the Working Groups will occur at the same location, during the annual WIHS-wide meeting. Meeting venues are rotated among the participating WIHS sites. Approximately 20 persons attend Executive Committee meetings. Attendance at Working Group meetings varies in accordance with the size of the specific Working Group.] Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-spaced photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040-MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Dianne Tingley, Scientific Review Program at the address listed under INQUIRIES. RESEARCH PLAN PAGE LIMIT. Each application (Sections a through d) should not exceed 50 pages. For additional information, refer to page 8 of the PHS 398 application form. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, it will be returned without further consideration. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The basic review criteria for this RFA are those for unsolicited research grant applications. Successful applications should describe a coherent and detailed plan to provide scientific leadership, data management and statistical expertise, and administrative services to a large multicenter study of HIV/AIDS in women in the U.S. Specific rating criteria will include the following: 1. Strength of qualifications, research experience, and time commitments of the WDMAC Principal Investigator and other key staff, for the following activities: a. providing statistical and scientific leadership for study design and analysis in longitudinal multicenter HIV studies; and b. successful management and operation of a data center serving multiple collaborating sites and managing complex data sets. 2. Adequacy of plans for developing and maintaining systems for collection, storage, analysis, and quality control of study data, with appropriate security, confidentiality and timeliness. 3. Scientific impact and originality of approaches to protocol development and data analysis for clinical, epidemiologic and laboratory studies effectively utilizing WIHS specimens. 4. Adequacy of plans for monitoring progress of the various WIHS studies, and reporting interim and final results in a responsive and timely manner. 5. Adequacy of plans for effectively interfacing with the WIHS sites, working groups, and staff of NIAID and other Institutes (as appropriate), including establishment of an electronic mail system capable of exchanging messages through the internet. 6. Adequacy of the proposed administrative structure to carry out the proposed activities, and of the resources and facilities available to support the study. 7. Adequacy of plans for a rapid and orderly transition from the current system to a new system, and for transitioning to a new grantee at the end of the award period, should that prove necessary. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Paolo G. Miotti, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C09 Bethesda, MD 20892-7620 Telephone: (301) 402-0135 FAX: (301) 402-3211 Email: pm122m@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dianne E. Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C07 Bethesda, MD 20892 Bethesda, MD 20851 (for express/courier service) Telephone: (301) 496-2550 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Ann Devine Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C23 Bethesda, MD 20892 Telephone: (301) 402-5601 Schedule Letter of Intent Receipt Date: March 7, 1997 Application Receipt Date: May 15, 1997 Scientific Review Date: July 1997 Advisory Council Date: September 1997 Earliest Award Date: November 1997 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Allergy, Immunology and Transplantation Research. Grants are awarded under the authority of the Public Health Service Act, Title III, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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. .
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Office of Extramural Research (OER) |
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Department of Health and Human Services (HHS) |
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