SERVICES RESEARCH IN THE NATIONAL DRUG ABUSE CLINICAL TRIALS NETWORK
RELEASE DATE: October 17, 2002
July 26, 2006 - This PA has been replaced by
PA-06-495 (R01), PA-06-496 (R21) and PA-06-497 (R03)
PA NUMBER: PA-03-011
EXPIRATION DATE: October 31, 2005, unless reissued.
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanisms of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The National Institute on Drug Abuse (NIDA) invites applications to conduct
health services research on the practice and delivery of drug treatment in
the National Drug Abuse Treatment Clinical Trials Network (CTN). By
encouraging the use of the existing CTN network of treatment providers and
research centers as a platform for new research, this PA enhances research
efforts to improve the delivery of drug abuse treatment, and translate
science-based treatments into practice in community treatment settings.
RESEARCH OBJECTIVES
This PA is meant to support health services research in connection with the
CTN, a research partnership of community treatment providers (CTPs) and drug
abuse researchers in multiple sites across the country. With its extensive
network of providers serving diverse populations of drug users, the CTN
provides a ready platform for investigating the accessibility, delivery,
quality, and portability of drug treatment services as well as research on
the organization and financing of treatment programs and the adaptation of
innovative strategies for the treatment of drug abuse and addiction.
The researcher-practitioner partnership that characterizes the CTN is
designed to accelerate the pace of research and determine the effectiveness
of drug abuse treatment approaches in real-life treatment settings. In
addition, services research conducted through the CTN is meant to enhance the
translation of science-based treatments into practice in community-based
treatment settings.
Background
NIDA inaugurated the CTN in 1999 as a cooperative agreement research program
consisting of drug abuse researchers, community treatment providers, and NIDA
staff. Since its beginning, the primary mission of the CTN was to conduct
studies of behavioral, pharmacological, and integrated behavioral-
pharmacological treatment interventions in rigorous, multi-site clinical
trials. Primary objectives were to: (1) determine the effectiveness of
therapies across a broad range of community-based treatment settings and
diverse patient populations, and (2) find ways to integrate proven
medications and behavioral interventions into mainstream clinical practice.
Under this PA, CTN and non-CTN investigators will be in a position to conduct
health services research in collaboration with existing regional research and
training centers (RRTCs) and CTPs. Although not all RRTCs have the capacity
to initiate health services research themselves, all Nodes are expected to
collaborate in such research and to aid in the recruitment of appropriate
subjects.
The CTN currently consists of 14 investigator-led research Nodes representing
California, the Delaware Valley, Florida, the Great Lakes region, New York
City, Long Island, the Mid-Atlantic area, New England, North Carolina, the
Ohio Valley, Oregon, the Rocky Mountain region, South Carolina, and
Washington State. Each Node consists of an RRTC and five or more
participating CTPs. Plans call for the addition of new Nodes in 2002 as well
as increased numbers of treatment providers allied with each Node. (Further
description of the CTN and currently participating RRTCs and CTPs can be
found at http://www.nida.nih.gov/CTN/Index.htm.)
New Studies
This PA encourages investigators to focus on research that will enhance the
adoption of effective treatment strategies, especially: (1) systems research
to identify organizational features, policies, and financing systems that
affect treatment delivery and the adoption of treatments found to be
effective in the CTN; and (2) practice research to identify and improve
program parameters that influence quality and accessibility of care, clinical
epidemiology, and innovation. In as much as recent research has shown that
drug abuse and addiction present different challenges to women's health and
may require different services approaches and strategies, researchers are
encouraged to take a gender-based approach to generating hypotheses that will
ultimately enhance the delivery of effective drug abuse treatments for women.
Possible research topics include but are not limited to the following
examples:
o Application of the chronic disease model to drug abuse treatment.
Research is needed to test drug abuse treatment and recovery models that
account for drug use as a chronic, relapsing disease, e.g., treatments that
target the underlying biological disorder as well as the behavioral and
social aspects of drug seeking and addiction, and that take into account the
patient's sex and ethnic background.
o Cost of various treatment services/interventions delivered in the CTN.
Cost analyses of several kinds are encouraged, including studies of the cost
effectiveness of CTN-tested drug abuse treatment and ancillary services; cost
offsets of treatment (medical or social costs); and cost/benefits of care.
Studies are also needed to improve and standardize measurements of costs,
cost effectiveness, cost offsets, and cost benefits.
o Financing of drug treatment. Studies are needed to examine the impact of
health plan parity benefits, managed care practices, and other cost control
measures on the coverage of, access to, and utilization of treatment for drug
abuse and addiction. Comparisons between more and less integrated treatment
services and between more or less tightly managed systems of care are
welcome. Research is also needed to develop outcome measures related to the
quality and management of resources.
o Linkage of drug treatment with other medical services. Research is needed
to understand how drug treatment can be effectively linked to medical service
where drug users, including those who are HIV-positive, are likely to seek
access to care, e.g., such settings as primary care, emergency care,
obstetric and gynocologic care, and mental health care. Research is needed
to develop effective methods for screening, identifying, and referring
medical patients to drug treatment services.
o Adaptation and change within CTPs. Little is known about the processes by
which innovations in treatment and service delivery are identified,
evaluated, initiated, and adopted by CTPs. Understanding the process of
adaptation and change includes research in the areas of organizational
culture, learning, and innovativeness; capacity and readiness for change;
change management and follow-through; and performance management approaches.
o Adoption of research findings in applied practices. Research is welcome on
the adoption of behavioral and pharmacological therapies found to be
effective in CTN studies, including studies of organizational motivation,
leadership, and social influence; management strategies to transfer new
methods and technologies; and mechanisms to facilitate adoption of CTN-tested
treatment approaches, such as manualized behavioral treatments, professional
society workshops, and technology transfer centers.
o Adoption of injection-related HIV risk reduction interventions by drug
treatment providers. Investigators are invited to examine factors related to
the organizational culture, policies, and treatment philosophies which
encourage or discourage providers to offer clients instruction in the
avoidance of risky injection practices, such as showing how to clean
injection equipment or providing referrals to syringe exchange programs.
o Status of the counseling workforce. Investigators are welcome to study
trends in the training, accreditation, remuneration, and stability of
employment of drug treatment counselors, especially as these trends are
affected by economic or other social factors (such as cost containment
measures, employment rates, infectious disease transmission, and so on).
o Quality of care studies. Studies are needed to identify specific
components or characteristics of care that affect treatment outcomes.
Examples include clinical practice guidelines; patient subpopulation (e.g.,
women, ethnic minorities, adolescents) outcomes linked with quality of care;
and the impact of system changes on quality of care. Additionally, studies
are needed to develop and evaluate measures of quality of care and patient
placement criteria.
o Clinical epidemiology. Studies are welcome to identify processes and
interactions of population groups with treatment providers, e.g., variations
in prevalence of substance use; clinical practices with respect to
subpopulations (such as women, ethnic minorities, adolescents, individuals
with comorbid mental health problems, and individuals who are HIV-positive),
barriers to treatment faced by specific population groups, and programmatic
features designed to reduce such barriers.
The topics bulleted above are meant only as illustrations of the types of
health services research that an applicant can propose. All applications are
welcome that are appropriate to the research objectives of this PA.
MECHANISMS OF SUPPORT
This PA will use the NIH project grant (R01), NIDA small grant (R03), and the
NIDA exploratory/developmental grant (R21) award mechanisms. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
The total project years for an application submitted in response to this PA
may not exceed five years for the R01; two years for the NIDA R03 (see
http://grants.nih.gov/grants/guide/pa-files/PA-02-170.html), and three years
for the NIDA R21
(see http://grants.nih.gov/grants/guide/pa-files/PA-02-171.html).
This PA uses just-in-time concepts. It also uses the modular budgeting
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less, use the modular format.
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
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is 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.
PARTICIPATION OF CTN INVESTIGATORS
Most research projects proposed under this PA will require participation,
collaboration, cooperation, or other support by CTN investigators or
community treatment provider staff or patients. Although the CTN is creating
a research infrastructure that will support studies such as those encouraged
here, some studies involving the CTN may not be feasible given the mission,
goals, and timetables of the CTN cooperative studies. Thus, it is incumbent
on the principal investigator of proposed research to get general preapproval
of a 1-2 page research concept from the CTN Concept Review and Development
Subcommittee, to submit evidence of support from affected CTN participant
organizations, and to obtain written approval to access any required data
that is controlled by the RRTCs or the CTN Steering Committee. Information
about the CTN, including contact information, is available at
http://www.nida.nih.gov/CTN/index.htm.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Jerry Flanzer, D.S.W.
Services Research Branch
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4222, MSC 9565
Bethesda, MD 20892-9565
Telephone: (301) 443-4060
Fax: (301) 443-6815
E-mail: jf199i@nih.gov
o Direct your questions about financial or grants management matters to:
Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
Fax: (301) 594-6847
E-mail: gf6s@nih.gov
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: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact NIDA program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that NIDA will accept your application
for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and NIDA who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be received by or mailed on or
before the receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not
accept any application in response to this PA 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 a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous
critique.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of 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 your 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 your study address an important problem? If the aims
of your application are achieved, how do they advance scientific knowledge?
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? Do you acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project challenge
existing paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out
this work? Is the work proposed appropriate to your experience level as the
principal investigator and to that of other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protection for humans, animals, or
the environment, to the extent they may be adversely affected by the project
proposed in the application.
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)
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase 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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
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.
NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on
Drug Abuse recognizes the importance of research involving the administration
of drugs to human subjects and has developed guidelines relevant to such
research. Potential applicants are encouraged to obtain and review these
recommendations of Council before submitting an application that will
administer compounds to human subjects. The guidelines are available on
NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained
by calling (301) 443-2755.
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 PA 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.
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 PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance 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.
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