and Human Services (HHS)
EXPIRED
DIFFUSION OF HIV INFECTION THROUGH SEXUAL RISK BEHAVIORS OF DRUG USERS
RELEASE DATE: December 18, 2002
RFA: DA-03-001
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
LETTER OF INTENT RECEIPT DATE: February 20, 2003
APPLICATION RECEIPT DATE: March 20, 2003
THIS REQUEST FOR APPLICAIONS (RFA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this RFA is to stimulate collaborative research to further
understanding of sexual transmission of HIV within and across drug-using
population subgroups and to non-drug using populations. The National
Institute on Drug Abuse (NIDA) invites cooperative agreement applications to
participate in the Sexual Acquisition and Transmission of HIV Cooperative
Agreement Program (SATH-CAP). The goal of this cooperative research program
is to support multi-disciplinary research that seeks to better understand the
dynamic behavioral, biological, and environmental processes implicated in the
sexual transmission of HIV and other sexually transmitted infections (STI)
among drug users and the diffusion of infections from drug using populations
to non-drug using populations. The SATH-CAP will include a Coordinating
Center and multiple Research Centers that will work in concert with other
centers, their respective sites, and with NIDA to conduct multi-site
collaborative research projects.
RESEARCH OBJECTIVES
Background
Earlier research initiatives have in part contributed to the observed
reduction in the annual number of new HIV infections in the United States
from its peak of 160,000 in the mid-1980s to approximately 40,000 new
infections by 1990. However, the stable annual rate of 40,000 new infections
observed throughout the 1990s, which persists to this date, does reflect the
need to develop more effective prevention interventions. Attempts to improve
the effectiveness of HIV prevention interventions require expanding the
current knowledge base, which in turn necessitates being responsive to the
dynamic nature of the epidemic. There is a need and urgency to expand the
range of prevention interventions, and it is widely recognized that such
expansion must be multi-disciplinary in nature and include behavioral,
biological, social, environmental, and biomedical elements. In order to
expand the current state of knowledge and improve the effectiveness of
HIV/AIDS behavioral interventions, several areas must be explored to further
enhance our understanding of the dynamic process of managing the myriad
aspects of the HIV epidemic and limit the imminent danger it poses to public
health.
HIV/AIDS surveillance data from the Center on Disease Control and Prevention
(CDC) have documented notable shifts in the demographics of HIV/AIDS epidemic
in the U.S. since AIDS was first identified in the early 1980s. There have
been substantial increases in the proportion of new HIV and AIDS diagnoses
among women, racial/ethnic minorities, lower-income groups, and young men who
have sex with men (MSM). Heterosexual contact is now the leading cause of
new infections among women, especially within minority communities. The most
recent annual CDC HIV/AIDS Surveillance Report (CDC, 2001) depicts a
significant increase in new AIDS cases attributable to heterosexual
transmission in the last few years. With regard to MSM, a growing concern is
exemplified by an alarming finding reported at the International AIDS
Conference in Barcelona that 77% of those MSM who participated in a recent
study and tested positive for HIV were unaware of their serostatus. This
finding is consistent with earlier released data, which indicated that the
proportion of persons with AIDS whose diagnosis represented the first time
they were tested for HIV increased from 25% in 1993 to 42% in 1998. MSM have
the highest infection rates among all risk groups with an estimated 42% of
annual new infections continuing to occur in this population.
Within drug using populations, a San Francisco study reported that within
certain IDUs populations, sexual behaviors are the main risk factors that
explained HIV seroconversion among IDUs. The strongest predictor of HIV
seroconversion for men was having sex with men, whereas among women the
strongest predictor was trading sex for money. Furthermore, results from a
Baltimore longitudinal cohort study showed that sexual risks among IDUs
accounted for a substantial proportion of new seroconversions. These reports
underscore the need for better understanding the dynamic processes of sexual
transmission but also highlight the potential for substantial
misclassification error in current coding schemes used to determine exposure
category.
In light of the growing importance of sexual transmission in describing the
current trends in new infections and the few studies that have closely
studied the underlying causal mechanisms involved within drug using
populations, it is imperative that new research efforts be devoted to
disentangling the dynamic behavioral, biological, and environmental processes
implicated in the sexual transmission of HIV among drug users. Moreover,
although the subject of many discussions, not much is known about how drug
users' sexual risk behaviors affect incidence rates of HIV and other STIs in
non-drug using populations (i.e., diffusion of HIV from drug using
populations to non-drug using populations). Consequently there is a pressing
need to better characterize how dynamic patterns of sexual behaviors impact
the spread of infections from drug using population subgroups to non-drug
using populations. Furthermore, given recent published findings that show
that current behavioral and social interventions have had modest effect in
reducing sexual risk among drug users, it is critical that innovative, novel,
and efficient sexual-risk-reduction strategies be developed based on a sound
understanding of the behavioral, biological, and environmental processes that
underlie transmission within drug using populations and bridge to the larger
non-drug using populations.
The risk of transmission in a population depends in part on the reservoir of
infection (as measured by HIV and other blood-borne pathogen seroprevalence),
the levels and distribution of risk behaviors that transmit infection,
environmental/contextual factors, and social factors. As these parameters
evolve, so does the epidemic. In order to minimize the occurrence of new
infections, ongoing monitoring systems of HIV seroprevalence, seroincidence,
levels and patterns of risk behaviors, key environmental and social factors
can help guide interventions aimed at curbing new infections. That is, new
research initiatives need to be undertaken in order to develop efficient
monitoring systems. The documented connection between drug use, sexual
contact, and AIDS points to the need to better understand the underlying
dynamics of sexual and drug use behaviors of high-risk groups, and how these
networks are linked to other social and sexual networks. Such an
understanding could benefit from the development of theoretical research and
alternative methodologies for studying such sensitive topic areas as drug use
and sexual behavior.
Objective and Scope
The overall objective of this RFA is to stimulate multi-disciplinary
collaborative research to further understanding of sexual transmission of HIV
within and across drug-using population subgroups and across to non-drug
using populations. This will be accomplished through collaborations among
scientists from various disciplines working in the following scientific
areas: (1) behavioral, (2) biological/biomedical, (3) medical sociology,
and/or (4) mathematical modeling research. The term discipline refers to
specialized areas of expertise. Some examples of disciplines associated with
the four scientific areas include but are not limited to (1) epidemiology of
HIV/STI risk behaviors, psychology, sociology, anthropology; (2) molecular
epidemiology, molecular biology, and virology, immunology, infectious
diseases (e.g., sexually transmitted diseases); (3) social epidemiology,
medical geography, and social determinants of health; and (4) statistics,
biostatistics, operational research, and applied mathematics.
Applications must include:
o All applications must integrate a HIV behavioral epidemiology (i.e., drug
use and sexual risk behaviors) component with at least two of the remaining
three scientific areas (i.e., biological/biomedical, medical sociology,
and/or math modeling) as defined above.
o Applications must target both MSM and heterosexual populations with
considerations given to minority populations.
o The primary drug using populations of interest consist of heterosexual
injection drug users and any relatively well-characterized drug using MSM
subgroups (e.g., club drug users, IDU, or any other drug using MSM group with
relatively well established drug use patterns).
o Study participants should not be part of a current ongoing intervention
study.
o Provisions for the Principal investigator of each Research Center and the
Coordinating Center to attend meetings with NIDA staff. Four such meetings
are planned for the first year of the award and up to 3 times per year
thereafter.
Areas of Research Focus:
Illustrative examples of research areas within the scope of this RFA are
outlined below. The following examples serve as a guide and are not meant to
subsume all research topics that would be appropriate to this RFA.
o Characterize and assess the influence of community, environmental, and
social/contextual factors on the sexual behaviors and risks for transmission
of HIV/STIs in drug-using populations.
o Develop new and/or improve existing estimation procedures (including
enhanced surveillance systems, modeling techniques, and ethnographic methods)
to obtain more accurate, immediate, and longer-term forecasting estimates of
rates of diffusion of HIV/STIs within and across population subgroups.
Develop data systems that allow detailed characterization of specific
behavioral, biological, and environmental factors and their interactions in
association with the spread or containment of new HIV/STI infections.
Explore how partner selection, types of partnerships, and variations in the
distribution of partnerships (e.g., drug-using and/or sexual, concurrent,
sequential, transitional, experimental) may affect the likelihood of exposure
to HIV/STIs and inform the development of more effective, partner-based
counseling and prevention intervention programs.
Characterize sexual mixing patterns and HIV/STI risk dynamics among drug
users and to non-drug users, by type of partner, personal risk group or
network, and epidemiological context (e.g., what are the relative risks
associated with patterns of partner selection and sexual mixing in different
social contexts?).
Identify and describe primary contextual (social, environmental) factors that
may shape or interact with individual HIV risk factors (e.g., behavioral and
biological) to facilitate or impede the acquisition and spread of new
infections; identify modifiable contextual factors that may be the target of
interventions to reduce or prevent HIV risk behaviors.
Elucidate the relationships among biological, behavioral, social, and
environmental factors associated with risk of and/or protection from HIV
acquisition and transmission among drug users, in order to improve the
effectiveness and efficiency of HIV prevention interventions.
Assess the relative impact of core groups and bridge populations on HIV
infection rates and the conditions (behavioral, biological, environmental)
that may limit or magnify that impact (e.g., different phases of the
epidemic; socioeconomic stresses; fluctuations in drug supplies, prices, and
patterns of use; variations in the accessibility and availability of
community-based, public health, and clinical services).
Integrate behavioral-biomedical surveillance methods (e.g., social network
methodologies and molecular epidemiological techniques) to enhance knowledge
of the persistence, distribution, and transmission dynamics of HIV/STIs among
core groups and bridge populations, and within and across population
subgroups.
Utilize multiple methods (venue-based sampling, Geographic Information System
(GIS) techniques, molecular epidemiology) to characterize HIV transmission
rates and distribution patterns in association with the dislocation, travel,
and movement of population subgroups, and with changes in HIV subtypes, in
multiple subtypes, and in recombinant viruses.
o Characterize the emergence, maintenance, and diffusion of HIV/STIs in the
context of drug use. For example, how, and under what circumstances, are
patterns of drug use associated with the introduction and spread of HIV/STIs
within a community? Are there well-characterized ("core") subgroups of drug
users within a community that contribute to the introduction and transmission
of HIV/STIs to the general population, and are the characteristics of the
"core" group identifiable with dynamic changes in the epidemic? Can changing
characteristics of the "core" group help to cue the optimal delivery of
targeted interventions to interrupt the epidemic and prevent new infections?
o Develop mathematical models and methods for the timely identification of
emerging infections and trends in different risk populations and contexts.
Develop and test mathematical models aimed at describing and predicting HIV
incidence based on current and changing patterns of sexual and drug use risk
behaviors, biological factors (host characteristics, viral strains), social
and environmental factors, and characteristics (time period, age, stage,
background prevalence) of the epidemic.
Characteristics of the System
The SATH-CAP will provide a stable infrastructure for collaborative research
to expand the scientific knowledge base on the dynamic behavioral,
biological, and environmental processes implicated in the transmission of HIV
among and across drug using population subgroups and in the diffusion of HIV
from drug using populations to non-drug using populations. The SATH-CAP will
consist of a Coordinating Center and multiple Research Centers. It is
anticipated that one Coordinating Center will be established. (See
Organization of the System, Section A.) There will be three to five Research
Centers (Section B). The Research Centers will collaborate with the
Coordinating Center and NIDA in conducting collaborative studies. A SATH-CAP
Steering Committee will constitute the primary operating and decision-making
body of the SATH-CAP (Section C).
Each Center will work in concert with other Centers and NIDA to conduct the
multi-center component (i.e., the HIV behavioral epidemiology component) of
their respective projects. Center projects are expected to be, for the most
part, Center specific with the HIV behavioral epidemiology (i.e., drug use
and sexual risk behaviors) project component spanning across all
participating centers. A "Coordinating Center" will provide SATH-CAP-wide
logistic and data support. As a cooperative agreement, there will be
substantial NIDA involvement in the management and administration of the
SATH-CAP, including the determination of how the multi-center project
component (i.e., the HIV behavioral epidemiology component) will be
standardized and implemented across centers.
Organization of the System
A. Coordinating Center. There will be one Coordinating Center. Coordinating
Center personnel would normally be expected to have expertise in epidemiology
of infectious diseases and behavioral and social sciences; knowledge of drug
abuse; experience in logistics; and experience working with grantees in
technical assistance situations. The Coordinating Center principal
investigator should be experienced in coordination of large multi-site
research studies.
It should be noted that the Coordinating Center will provide the primary data
management capacities for all aspects of Center projects; each Center will
have their own internal data entry, data management and analytical capacities
that will provide the primary support for Center specific part of their
project. The primary function of the Coordinating Center will be to provide
support to all Centers for the multi-center collaborative work of the SATH-
CAP (i.e., implementation of standardized method, data management and
analyses, and logistic support services).
Coordinating Center responsibilities typically may include:
o Collaborate with Research Centers and NIDA in refinement of research
methods and designs, and assist the Steering Committee in developing and
implementing the SATH-CAP cooperative multi-Center project component (i.e.,
the HIV behavioral epidemiology of drug use and sexual risk behaviors) and
implement multi-Center data management systems to facilitate multi-Center
collaborative work.
o To assist Centers with data quality control checks, including on-site
training for data collection, and to assist in data management and analysis.
o To facilitate cross-center data comparability, to serve as a repository for
data collected under this cooperative study, and to prepare public use data
sets.
o To develop and maintain a SATH-CAP website to facilitate dissemination of
easily accessible project management tools (e.g., progress report forms
etc.).
o To coordinate logistical functions of meetings of the SATH-CAP Steering
Committee, subcommittees, and workgroups, including production and
distribution of committee minutes. Funds for participant travel to meetings
will not be disbursed by the Coordinating Center; applicants should make
adequate provision for these funds in the budgets submitted under the present
RFA.
o To assist in development of publications, in accordance with Steering
Committee procedures to be developed.
B. Research Centers.
Research Center responsibilities generally may include:
o Under guidance of the SATH-CAP Steering Committee the Research Centers
establish policies and procedures for conducting periodic reviews to examine
recruitment accrual, data accuracy and timeliness, and compliance with study
plans.
o Within its own Center, each participating Research Center typically have
the responsibility for research coordination, data management, and quality
control.
o Ensure adequate accrual of subjects to meet the requirements of the
Center's project in numbers recruited over defined time periods.
o To establish and implement mechanisms for data management and analysis that
ensure data collection and management procedures are: a) adequate for quality
control and analysis, b) in accordance with procedures and requirements
established by the Steering Committee, and d) sufficiently uniform across all
participating sites.
o To ensure that any organizations that are engaged in research, as defined
by the Office for Human Research Protections (OHRP), must obtain an OHRP
assurance and IRB review and approval before conducting human subjects
research.
o To establish a mechanism for interim monitoring of progress and results to
be reported at least semiannually to the SATH-CAP Steering Committee and to
NIDA.
o To submit annual progress reports to NIDA's program official. Research
Center funding is contingent on progress, including collaborative
contributions and satisfactory recruitment accrual.
o To publish major findings in a timely manner, in accordance with procedures
established by the SATH-CAP Steering Committee. Publication or oral
presentation of work done under this agreement requires acknowledgement of
NIDA support.
o Monitor and manage the implementation of studies, and support operational
needs such as quality assurance, data collection, resources for analysis,
etc. Responsibilities also generally include executive secretariat functions
such as organization of necessary meetings and conference calls, developing
meeting agendas, taking minutes of sessions, photocopying and distributing
meeting materials to the other Research Centers and NIDA, and preparation of
reports to the NIDA Program Official.
C. SATH-CAP Steering Committee. The SATH-CAP Steering Committee (or, simply,
Steering Committee) will constitute the primary governing body of the SATH-
CAP. It will consist of the Principal Investigator of each Research Center,
the PI of the Coordinating Center, and the NIDA collaborating scientist, each
of who will have one vote on the Steering Committee. This group will direct
the research conducted in the SATH-CAP, develop policies and procedures for
the implementation of research plans, coordinate the implementation of
projects across the SATH-CAP, monitor progress, guide data analysis and
interpretation of results, and oversee communications within the SATH-CAP as
well as with the greater scientific community and the public.
The Steering Committee, by majority vote, will select a Chairperson from the
group of SATH-CAP Research Center Principal Investigators. Federal
participants may not serve as chair except to organize the first meeting and
conduct the election of a permanent Chairperson.
The Steering Committee will determine whether other members of the
Coordinating Center or Research Centers' teams should attend some or all
meetings as nonvoting observers or resources. The Steering committee may
also establish subcommittees and workgroups to assist it in carrying out its
functions, and these groups may include members of the Centers' teams and
others as the Steering Committee sees the need.
The Steering Committee will also establish standards and procedures for the
SATH-CAP to assure comparability and generalizability across sites. Such
standardization will include specifying how the Behavioral Epidemiological
component will be operationalized and implemented across all Research
Centers. (Note: All Research Center applications still need to specify, in
their research plan, how they propose to assess, measure, and implement the
Behavioral Epidemiological component in their respective research project.)
The Steering Committee will oversee selection or development of measurement
tools for use in the SATH-CAP. It will also develop policies on data
sharing, on access to materials and data, including making data available
beyond the SATH-CAP in a timely manner. Publication policies will be written
and authorship decided using procedures developed and approved by the
Steering Committee. All publications, whether from a single site or multiple
sites, will be submitted to the Steering Committee for review and approval.
All major scientific decisions will be determined by majority vote of the
Steering Committee. All participating Centers must agree to abide by the
policies approved by the Steering Committee, both for the common HIV
behavioral epidemiology component spanning across all Centers and study
components specific to individual Centers.
The Steering Committee may meet up to four times during the first year, and
will meet up to 3 times per year thereafter, usually in the Washington, D.C.
area. Applicants should include budgets for travel to these Steering
Committee meetings and subcommittee/workgroup meetings in their applications
and should assure that adequate provisions are made to allow Principal
Investigators to participate fully in activities of the Steering Committee
and its subcommittees/workgroups.
MECHANISM OF SUPPORT
This RFA will use NIH U01 award mechanism. As an applicant you will be
solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. The anticipated award date is
September 30, 2003.
The NIH U01 is a cooperative agreement award mechanism in which the Principal
Investigator retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the section "Cooperative Agreement Terms and Conditions of
Award
The total project period for applications submitted in response to the
present RFA may not exceed 5 years. The earliest anticipated award date is
September 30, 2003. Awards and level of support depend on receipt of a
sufficient number of applications of high scientific merit. Although this
program is provided for in the financial plans of the Institute, awards
pursuant to this RFA are contingent upon the availability of funds for this
purpose. This RFA is a one-time solicitation. Future unsolicited, competing-
continuation applications based on this project will compete with all
investigator-initiated applications and will be reviewed according to the
customary peer review procedures.
FUNDS AVAILABLE
NIDA intends to commit approximately $3.5 million to support first year total
costs of the SATH-CAP in FY 2003. This level of support is dependent on the
receipt of a sufficient number and diversity of applications of high
scientific merit. NIDA expects to make four to six awards under this RFA for
project periods of up to five years of support. It is anticipated that one
award for approximately $400,000 in total costs (i.e., direct, facilities,
and administrative costs) per year will be made for the Coordinating Center.
Approximately $3.1 million in total costs per year will be distributed among
three to five Research Centers. Because the nature and scope of the research
activities proposed in response to this RFA may vary, it is anticipated that
the size of individual awards will vary also. Budget requests should be
carefully justified and commensurate with the complexity of the project.
Although this program is provided for in the financial plans of the NIDA,
awards pursuant to this RFA are contingent upon the availability of funds for
this purpose.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
o Faith-based or community-based organizations
Note: Separate applications are being solicited for Research Centers and a
Coordinating Center to participate in this collaborative study. If an
organization chooses to apply as a research center site and as the
coordinating center, separate applications and a separate Principal
Investigator for each are required, and there should be no overlap of effort
in research or support personnel.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals with the skills, knowledge, and resources necessary to carry out
the proposed research are invited to work with their institution to develop
an application for support. Individuals from underrepresented racial and
ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH programs.
The principal investigator must commit at least 20 percent of his or her time
to the SATH-CAP.
SPECIAL REQUIREMENTS
To promote the development of a collaborative program among award recipients,
a number of issues need to be addressed in applications as discussed under
Application Procedures, below. Applicants should discuss the rationale for
their choice of research questions and design, should document their ability
to recruit a sufficient number of participants, and should demonstrate their
ability and willingness to work cooperatively with NIDA, the Coordinating
Center, other Research Center awardees, and to follow a common research plan
for the HIV behavioral epidemiology (i.e., drug use and sexual risk
behaviors) component of the research project. The following terms and
conditions will be incorporated into the award statement and provided to the
Principal Investigator(s) as well as the institutional official at the time
of award.
Cooperative Agreement 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 Parts 74 and 92, and other HHS and NIH Grant
Administration policy statements.
The administrative and funding instrument used for this program is a
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism) in which a substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during 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 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(s) for the project
as a whole, although specific tasks and activities in carrying out the
studies will be shared among the awardees and the NIDA Collaborating
Scientist.
1. Awardee Rights and Responsibilities
Awardees have primary responsibilities to define objectives and approaches,
and to plan, conduct, analyze, and publish results, interpretations, and
conclusions of their studies in collaboration with other awardees, and with
assistance from the NIDA Collaborating Scientist. Awardees shall participate
in the Steering Committee and abide by decisions of the Steering Committee.
Awardee will retain custody of primary rights to their data developed under
the award, subject to rules formulated by the Steering Committee, and
government rights of access consistent with current DHHS, PHS, and NIH
policies.
Research Center Awardees
Awardees shall develop research plans in conjunction with other awardees for
the collaborative component (i.e., HIV behavioral epidemiology component) and
submit them for approval by the Steering Committee. Implementation of the
collaborative component of the project shall be in accord with Steering
Committee policies and procedures, including policies and procedures
pertaining to instrumentation, data collection, data and safety monitoring,
and publication. Awardees shall take lead responsibility for implementation
of the Center-specific project component. That is, Research Centers will be
responsible for implementing and monitoring their own internal data entry,
data management and analytical capacities to ensure that their Center
specific research component is efficiently carried-out.
Coordinating Center Awardee
The awardee shall provide the primary data management capacities for multi-
center collaborative work. Such responsibility will entail implementing
standardized multi-Center data management systems for data collection, data
entry procedures, data monitoring and analysis of the SATH-CAP cooperative
multi-center component (i.e., the HIV behavioral epidemiology of drug use and
sexual risk behaviors) as well as providing logistic support services for
multi-Center collaborative work (e.g., logistical functions for Steering
Committee meetings; develop and maintain a website to facilitate
dissemination of project management tools such as progress report forms
etc.).
2. Federal Staff Roles and Responsibilities
NIDA Collaborating Scientist. A NIDA Collaborating Scientist with expertise
in research on HIV/AIDS among drug using populations will cooperate with
awardees in development of research plans of the collaborative component.
The NIDA Collaborating Scientist will serve as a resource for specific
information on NIDA's programmatic intentions and priorities, and will help
to foster collaborations between researchers. The NIDA Collaborating
Scientist will be a voting member of the Steering Committee, but will not
hold the position of chair. He/she will participate in the development of
instrumentation, development of study plans, in quality control, and in
coordination of projects, but will not participate in activities that
directly involve assessment, testing, or treatment of human subjects.
Other NIDA staff. A NIDA Program Official, who will not participate in the
research, publications, or Steering Committee, will be responsible for the
oversight of each cooperative agreement. The Program Official carries
primary responsibility for: (1) periodic review and approval of the progress
of the research plans in relation to their stated objectives, and (2) making
recommendations regarding continuance of the program. The NIDA Program
Official will be responsible for monitoring the conduct of the project and
overseeing the Coordinating Center and the Research Centers. The Program
Official will receive all required progress reports to determine that
satisfactory progress is being made. This person also works collaboratively
with the Grants Management Specialist to assure high quality business
management of the program, including the most effective use of Federal
financial assistance provided through this cooperative agreement.
Subject to Steering Committee invitation, other NIDA staff may attend and
participate as non-voting resources to the Steering Committee and/or its
subcommittees. Such individuals would typically be called upon to provide
specific scientific expertise (e.g., social epidemiology).
3. Collaborative Responsibilities
Steering Committee. The Steering Committee will constitute the primary
governing body of the SATH-CAP. Awardees must participate in the Steering
Committee. The voting membership will consist of the Principal Investigator
of each Research Center, the Principal Investigator of the Coordinating
Center, and the NIDA Collaborating Scientist. The Steering Committee
formulates and monitors policies and procedures guiding the research
activities, and oversees communications. The Steering Committee will develop
a Charter of Responsibilities, subject to NIDA's concurrence, defining the
roles and responsibilities for the Coordinating Center and the Research
Centers. All major scientific decisions are made by majority vote.
The Steering Committee will develop policies that will guide the standard
operating procedures of the SATH-CAP and will address protocol development
for the multi-Center HIV behavioral epidemiology component, data acquisition
and management, and analysis and publication. It will monitor progress and
establish subcommittees and workgroups as needed. Awardees agree to abide by
those procedures and policies.
Data Management, Analysis, and Access. Data generated are the property of
the awardees. However, the Coordinating Center and all Research Centers must
provide NIDA with access to all data generated under this award. Data must
be shared upon request with the Steering Committee, and subcommittees
reporting to the Steering Committee.
The Steering Committee will be convened as soon as possible after the awards
are made, and may meet up to 4 times during the first year, and up to 3 times
per year thereafter, probably in the Washington, DC area.
4. Program Review
In addition to the standard NIH requirement for submission of annual progress
reports, awardees will be required to submit semiannual reports on study
progress. NIDA will provide a suggested format for this purpose. The NIDA
Program Official will review progress through consideration of the semiannual
accrual reports, annual report, and program site visits. The inability of a
Research Center to meet the performance requirements and responsibilities may
result in an adjustment of funding, withholding of support, or suspension or
termination of the award.
5. Study Closure
NIDA may request that a study be closed for reasons including: a)
insufficient accrual rate or other problems with accrual, b) poor site
performance, c) study participant safety; and d) emergence of new information
that diminishes the scientific importance of the study question. NIDA will
not permit expenditure of Federal funds or permit expenditure of NIDA funds
after requesting closure (except to ensure safety for enrolled subjects).
6. Arbitration Process
Any disagreement that may arise between the awardee Research Center(s)and/or
the Coordinating Center and the NIDA Collaborating Scientist on scientific/
programmatic matters that is not resolved by the normal deliberations of the
Steering Committee may be brought to arbitration. An arbitration panel will
be composed of three members, one selected by the Steering Committee (with
the NIDA Collaborating Scientist not voting) or by the individual awardee in
the event of an individual disagreement, a second member selected by NIDA,
and the third member selected by the prior two members. This special
arbitration procedure 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, Grant Administration Regulations at 45 CFR part 74, and HHS
regulations at 45 CFR part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues.
o Direct your questions about scientific/research issues to:
Jacques Normand, Ph.D.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5190, MSC 9593
Bethesda, MD 20892-9593
TEL: (301) 402-1919
FAX: (301) 594-6566
Email: [email protected]
o Direct your questions about peer review matters to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Gary Fleming, J.D., M.A.
Chief, Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NIDA staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express/courier service)
Phone: (301) 443-2755
FAX: (301) 443-0538
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS
All Research Center applications must provide a research plan for their
proposed project which clearly delineates how the mandatory behavioral
epidemiological component of their project will be integrated with the two
other required scientific areas (i.e. 2 of the following 3 scientific areas:
Biological/biomedical, medical sociology, and/or mathematical modeling) as
defined on page 3 of this announcement.
Facility/Institution Section. Specific content must be present in the
application to document the technical and scientific merit of the applicant's
application for a Research Center or a Coordinating Center that will address
the fundamental goals and collaborative nature of the SATH-CAP. The
application should conform to the general instructions and requirements
(e.g., for font size and page limits) of the PHS 398 (rev. 5/2001) with the
exceptions noted below.
Internal Administration and Collaborative Plans
The administrative and managerial qualifications and experience of the PI
must be described to provide evidence of skills in managing and coordinating
research endeavors. The skills of other personnel involved in administration
and management of the research should also be clear. The Principal
Investigator must commit 20 percent or more effort to the SATH-CAP.
The application should elaborate on infrastructure capabilities for project
management, study design and development, and data systems.
(For Coordinating Center)
Plans for fulfilling the consultative role of the Coordinating Center should
be provided. The application should address how the Coordinating Center
might collaborate with Research Centers and NIDA to assist the Steering
Committee in designing collaborative components of the SATH-CAP and
implementing cooperative, multi-Center/multi-site projects. Plans for
assisting with data quality control, training for data collection, and
analysis should be given. Plans for developing and evaluating ideas for
cross-site data analyses and for serving as a repository for data collected,
including preparation of public use data sets, should be clear. Potential
needs of Research Centers and participants in the SATH-CAP should be
anticipated and addressed, as should be the challenges in fulfilling those
needs.
This section should also include plans for addressing the logistic needs of
the SATH-CAP, including coordinating meetings of the Steering Committee,
subcommittee, and workgroups, as well as distributing preparatory and post-
meeting documents.
Plans for the proposed content of a SATH-CAP website and structure of that
website should be provided. The plans should describe innovative approaches
to data sharing and for the dissemination of research findings, as well as
for development of management tools to promote efficient conduct of
government supported research.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center For Scientific Review
National Institutes Of Health/DHHS
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 copies of the application must be
sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
APPLICATION PROCESSING
Applications must be received by the application receipt date listed in the
heading of this RFA. If an application is received after that date, it will
be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NIDA. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by NIDA in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Council on Drug
Abuse
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments reviewers will be asked to discuss the following aspects
of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning your application's overall score, weighting them as appropriate
for each application. Your application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move
a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
(3) Innovation: Does the project employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
(6) Internal Administration and Collaborative Plans (Research Center):
How strong are the administrative and managerial qualifications of the PI and
key staff? Is there evidence of sufficient dedication of time and other
resources to the work? How clear and feasible are plans for project
management, coordination and communication? How well developed are the plans
for data management? Are intra-center decision-making procedures specified
and workable? How sufficient and efficient is the infrastructure for project
management and data systems activities?
(6) Internal Administration and Collaborative Plans (Coordinating Center):
What is the quality of the plans for serving as a consultative center to the
SATH-CAP? How developed are the approaches for providing consultation on
implementation, and analysis? How well are data quality control, training,
and data repository needs addressed? How well are other needs and challenges
addressed?
What is the quality of the plan for serving as a data repository? How
feasible and developed are the logistic support and operational support
plans? How well developed are the plans for including a SATH-CAP website,
for using appropriate technological resources? How strongly does the record
of experience in these areas support the application?
(7) Understanding of the Mission of the SATH-CAP
How well does the application demonstrate an understanding of the scientific
agenda of the SATH-CAP? How innovative is the vision the application
presents for utilization of the SATH-CAP?
(8) Research Capacity (Coordinating Center):
What is the quality of the scientific expertise within the Coordinating
Center, especially with respect to complex multi-site studies? How would the
Coordinating Center interact with Research Centers to accomplish SATH-CAP
goals? What is the capacity of the Coordinating Center to conduct studies
unique to the role of the Coordinating Center as specified in the RFA?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans (including
data safety monitoring plans), animals, or the environment, to the extent
they may be adversely affected by the project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research. Plans for the recruitment and
retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 20, 2003
Application Receipt Date: March 20, 2003
Peer Review Date: July 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 30, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phases I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG
ABUSE: Researchers funded by NIDA who are conducting research in community
outreach settings, clinical, hospital settings, or clinical laboratories and
have ongoing contact with clients at risk for HIV infection, are strongly
encouraged to provide HIV risk reduction education and counseling. HIV
counseling should include offering HIV testing available on-site or by
referral to other HIV testing services. Persons at risk for HIV infection
including injecting drug users, crack cocaine users, and sexually active drug
users and their sexual partners. For more information see
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants
may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.279, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
administered under NIH grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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