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) 435-0714; 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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