GUIDANCE FOR BEHAVIORAL TREATMENT PROVIDERS: RESEARCH ON KNOWLEDGE AND
SKILL ENHANCEMENT
Release Date: September 16, 2002
RFA: DA-03-005
National Institute on Drug Abuse (NIDA)
(www.nida.nih.gov)
Letter of Intent Receipt Date: November 15, 2002
Application Receipt Date: December 16, 2002
THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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 National Institute on Drug Abuse (NIDA) is committed to promoting
research activities that result in improved drug abuse treatment and
reductions in HIV/AIDS risk behavior in drug-dependent individuals.
NIDA's behavioral therapies development program has supported the
development and testing of a number of efficacious therapies for drug
abuse and dependence and HIV/AIDS risk. The purpose of this initiative
is to support studies for developing and testing novel, creative
approaches to clinical training and supervision that will enhance
community treatment providers' knowledge and skills to administer
behavioral treatments with some evidence of efficacy for drug abuse
and/or interventions for HIV/AIDS risk reduction among in-treatment
drug abusers. This RFA especially encourages theory-driven approaches
to the development of novel training and supervision methods, i.e.,
approaches that apply knowledge derived from cognitive neuroscience,
psychology, medical education, and other fields of science to training
and supervision.
It is NOT intended to support the development of new behavioral
therapies, studies of strategies to reduce organizational barriers to
implementing training in a given program, program evaluation studies of
existing training approaches, or development of training and
supervision methods for treatments without any documented evidence of
efficacy. Evidence of efficacy for the purpose of this RFA is defined
as findings published or in press in a peer reviewed journal, from one
or more well-designed randomized clinical trials conducted with drug
users that demonstrated reductions in drug use, HIV/AIDS risk behavior
or other closely related outcomes. An entire treatment or a single
component of an efficacious treatment may be selected for training.
The term "behavioral therapy" is used here in a broad sense and
includes various forms of psychotherapy, behavior therapy, cognitive
therapy, family therapy, skills training, counseling, and other
rehabilitative therapies. For the purpose of this RFA, "treatment
providers" includes therapists, counselors, and others who provide
behavioral therapies (as defined above) to people in drug treatment and
who would be targets for clinical training and supervision.
RESEARCH OBJECTIVES
Background and Rationale
A heterogeneous group of public and private treatment programs,
including small local clinics and large complex programs sponsored by
medical centers and managed care organizations, comprise the community-
based drug and alcohol treatment system in the United States. A study
by the Institute of Medicine (Lamb et al, 1998) devoted to bridging the
gap between drug abuse treatment providers and researchers determined
that despite the availability of a number of behavioral treatments with
evidence of efficacy, established research-based treatments have not
been adopted widely in clinical practice. To facilitate the adoption of
such treatments by community programs methods for training and
supervising community-based providers are needed.
Weissman, Rounsaville, and Chevron (1982) describe the essential
components of training and supervision programs for behavioral
therapists in clinical trials. They suggest that investigators should
select therapists with extensive background in the theoretical
rationale for the treatment and, when possible, actual experience
delivering the treatment under study. Additionally, they describe
training and supervision efforts which are now standard for clinical
trials, intensive efforts featuring didactic workshops, completion of a
number of "practice clients," actual clients with which the new
research therapist demonstrates his/her new skills, and ongoing long-
term supervision augmented by review of audio or videotapes of
sessions. Waltz et al (1993) describe two important constructs related
to training, "competence" defined as the level of skill shown by a
therapist in delivering a treatment, and "adherence" defined as the
extent to which a therapist uses interventions and approaches
prescribed by the treatment and avoids using those proscribed by the
manual. Supervisors and independent raters, who review practice and
ongoing therapy session tapes or transcripts using standardized
checklists or rating forms, ensuring high levels of fidelity to a
treatment manual during a trial, are typically used to assess these
constructs for behavioral therapy trials.
Although a well-defined and relatively efficient methodology exists for
training research therapists, no such methodology exists for updating
or enhancing the skills of community therapists, many of whom will
practice for thirty years or more, during which time many changes take
place in the field. While the techniques to train research therapists
can be applied to training community therapists, these are not
necessarily time efficient. For example, Morgenstern et al (2001)
trained community therapists to deliver Cognitive Behavioral Treatment
using procedures similar to those used for training clinical trial
therapists. On average community therapists required 105 hours of
training and supervision over a five-month period in order to achieve
ratings of "adequate" competence and adherence. Although this may seem
like a reasonable timeframe for treating a complex disorder, it is
unlikely that most community treatment programs clinics will be able to
support treatments that require such extensive training.
Many continuing education programs advertise instruction in science-
based behavioral therapies for community-based treatment providers.
These programs typically consist of a workshop lasting from a few hours
to a few days. These workshops rarely provide the opportunity for
ongoing supervision or support when providers return to their offices
and clinics to initiate the new therapy skills. Investigators are
beginning to examine whether the typical continuing education workshop
approach is adequate for helping community providers consolidate their
new therapy skills. A study by Miller and Mount (2001) showed that for
at least one behavioral treatment with evidence of efficacy,
Motivational Interviewing (MI), a brief workshop alone is insufficient
to help community practitioners achieve sufficient competence and
adherence to this counseling approach.
In short, existing methods for training community providers in
behavioral therapies with evidence of efficacy, including use of
methods originally developed for training research therapists, appear
to be less than optimal approaches for training community treatment
providers.
New methods are needed for training and supervising community
therapists in empirically supported therapies for drug abuse and
HIV/AIDS risk reduction. Recent developments in science have resulted
in a large body of knowledge and a number of theories related to
learning and training that are available to enhance training and
supervision method development. For example, during the past several
decades researchers have learned a great deal about facets of cognition
that are directly relevant to how people learn and how to train.
Cognitive neuroscience researchers have provided both functional and
neurobiological accounts of phenomena such as: facets of memory, how
knowledge is represented and organized, forms of learning, stages in
concept acquisition, the development of expertise, automatic and
controlled forms of thinking, attention and remembering, to name just a
few of the domains that have been extensively studied. These are but a
few of the themes that are directly applicable to the design of
effective training/learning methods and environments and development of
clinical skills and expertise in the use of science-based behavioral
therapies.
Additionally, innumerable technological advances hold promise for
creating innovative and potentially efficacious therapy training
methodologies. Computer advances offer ways to standardize training and
make it available to many more providers than ever before. Technologies
that offer ways to observe and supervise therapist behavior in real
time, may allow therapists to make changes to their therapy techniques
long before proscribed behaviors become ingrained habits. Other
technological applications like the Internet and wireless technologies
offer a way to communicate with people over large distances making
expert assistance available to rural and remote providers. Finally,
virtual reality applications may standardize training experiences and
facilitate the development and practice of skills without fear of
making mistakes on human clients.
NIDA is interested in studies that use these and similar advances in
knowledge, theory and technology that might inform the development and
pilot testing of creative and innovative methods to train and supervise
community-based providers so they may reach a high level of proficiency
in administering behavioral therapies for drug abuse and dependence,
including dependence on nicotine as well as HIV/AIDS risk behavior.
Innovative and creative studies on clinical training and supervision
for community providers are encouraged. For more information on
behavioral treatments, please see Principles of Drug Addiction
Treatment: A Research-Based Guide at
http://165.112.78.61/PODAT/PODATindex.html.
Conceptual framework for the development and pilot testing of clinical
training and supervision methods in this RFA:
NIDA is committed to a comprehensive program of treatment research to
ensure that empirically supported science-based treatments and HIV/AIDS
risk reduction strategies for in-treatment populations are developed
and ultimately used by community treatment providers. This RFA should
be understood in the context of NIDA's Behavioral Therapies Development
Research Program. For more information on this program consult PA
NUMBER: PA-99-107
https://grants.nih.gov/grants/guide/pa-files/PA-99-107.html.
This RFA supports research on the development and pilot testing of
innovative training and supervision approaches for community-based
providers, ultimately a critical activity for meaningful clinical
trials of behavioral treatments in community settings.
Areas of Research Interest:
This initiative targets for funding research needed for developing,
modifying, and pilot testing innovative clinical training and
supervision methods for use with behavioral treatments having some
evidence of efficacy. Ultimately, these training and supervision
methods are intended to help community treatment providers, such as
drug abuse counselors, therapists, private practitioners and primary
care physicians, deliver efficacious behavioral treatments effectively.
Behavioral treatments selected for use in the development of training
procedures may be for drug addiction, comorbid drug abuse and mental
disorders, and/or HIV/AIDS risk for individuals in drug abuse treatment
settings. It is expected that all studies will use accepted methods
for determining therapist competence and adherence of therapists
trained with the method under development, and although large
randomized trials of training methods are not required, it is expected
that these studies will provide a pilot assessment of the method's
ability to produce competent and adherent therapists. Illustrative
examples of research described below serve as a guide and are not meant
to subsume all research topics that would be appropriate under this
RFA.
Examples of activities that are encouraged:
o Studies that develop novel, creative, and innovative methods for
training and supervising community treatment providers in behavioral
therapies based on a theory or body of knowledge from fields of science
including, but not limited to, cognitive neuroscience, psychology,
medical education, and computer science such as:
a. Mapping of knowledge organization, i.e., what are some of the types
of knowledge (including attitudes) that need to be in place prior to
training
b. Explicit and implicit knowledge
c. Concept learning and paradigm shifts in thinking
d. Development of expertise
e. The effects of spaced and massed training on learning
f. Advantages of experiential learning activities
g. Context based learning
h. Learner centered approaches such as making exercises relevant to
community therapist challenges and issues or matching training and
supervision to counselor learning styles by presenting materials in
visual, schematics, oral, and written modalities
i. Behavioral principles such as principles of reinforcement and
learning theory
o Studies that apply technologies to the clinical training and
supervision of community-based counselors and therapists to administer
behavioral treatments, including, but not limited to, methods which
utilize:
a. Computer technologies, especially methods of communication via the
Internet, including interactive networking, virtual classrooms, e-
consultation
b. Compressed or streaming video and teleconferencing, chat rooms
c. Widely accessible services such as telephone, telephone hotlines, or
email
d. Video training and supervision
e. Standardized and/or virtual reality practice clients
f. Multimedia CD-ROM or DVD self-guided learning programs
g. Methods to shape therapy skills in real time such as in room
teleprompting and "Bug-in-ear" electronic technologies
h. Personalized Systems of Instruction (PSIs)
This RFA is NOT intended to support the following types of studies:
o Studies on new therapy development
o Research on strategies to reduce organizational barriers to
implementing training in a given program or programs
o Training program evaluation studies
o Studies of training methods for therapies that do NOT have any
evidence of efficacy (see earlier definition of evidence of efficacy in
Purpose section)
MECHANISMS OF SUPPORT
This RFA will use the National Institutes of Health (NIH) research
project (R01), NIDA's small grant (R03), and NIDA's
exploratory/developmental grant (R21) award mechanisms. Foreign
applicants are not eligible for NIDA's R03 awards. Responsibility for
the planning, direction, and execution of the proposed project will be
solely that of the applicant. This RFA is a one-time solicitation.
Future unsolicited competing continuation applications will compete
with all investigator-initiated applications and will be reviewed
according to the customary peer review procedures. The anticipated
award date is July 2003.
The exploratory/developmental (R21) grants are limited to 3 years and
small grants (R03) are limited to 2 years. Both are non-renewable and
limited in direct cost amount per year (R03, $50,000; R21, $100,000).
The R03 mechanism is intended for newer, less experienced
investigators, for investigators at institutions without well-developed
research traditions and resources, or for experienced investigators
wishing to change research directions or test new methods or
techniques. The R21 mechanism is intended to encourage exploratory
research projects with sound methodology and strong rationales in
underdeveloped research areas of drug abuse, such as the areas covered
in this RFA. Investigators may also choose to include methods
development as one component within any of the other mechanisms.
This RFA uses just-in-time concepts. It also uses the modular as well
as the non-modular budgeting formats (see
https://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. Otherwise follow the
instructions for non-modular research grant applications.
FUNDS AVAILABLE
NIDA intends to commit approximately $2,000,000 in FY 2003 to fund 6-8
grants in response to this RFA. For the R01 mechanism, an applicant
may request a project period of up to five years and a budget for
direct costs of up to $250,000 per year for all years. For the R03
mechanism, an applicant may request up to $50,000 in direct costs in
each of the 2 years. For an R21 mechanism, an applicant may request up
to $100,000 in direct costs in each of the 3 years. Because the nature
and scope of the research proposed may vary, it is anticipated that the
size of each award will also vary. Although the financial plans of
NIDA provide support for this program, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit an application 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.
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:
Cecelia L. McNamara, Ph.D.
Division of Treatment Research and Development
Behavioral Treatment Development Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 402-1488
FAX: (301) 443-6814
Email: cmcnamar@mail.nih.gov
o Direct questions about peer review matters to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
o Direct questions about financial or grants management matters to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 443-6847
Email: gf6s@nih.gov
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 IC 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
6001 Executive Blvd., Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
Email: tl25u@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 https://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.
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
https://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
https://grants.nih.gov/grants/funding/modular/modular.htm.
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 two of the
face page of the application form and the YES box must be marked. The
RFA label is also available at:
https://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
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
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, Maryland 20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
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 failing to provide required information
about human subjects; data safety and monitoring; data sharing; and
inclusion of gender, minorities, and children will be considered
incomplete.
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 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?
Does the study design provide a way to begin to determine if and to
what extent therapists trained and/or supervised with the method under
development gain the knowledge and skills necessary to deliver the
therapy with integrity?
Has the applicant selected a reasonable behavioral treatment with
sufficient efficacy, as demonstrated by peer-reviewed publication in
scholarly research journals?
(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: Are you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the
experience level as the principal investigator and to that of 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?
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,
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 DATA SHARING: The adequacy of the proposed plan to share data.
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: November 15, 2002
Application Receipt Date: December 16, 2002
Peer Review Date: March/April 2003
Council Review: May 2003
Earliest Anticipated Start Date: July 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 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:
https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://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
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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 the recommendations of the Council
before submitting an application that will administer compounds to
human subjects. The guidelines are available on NIDA's Home Page at
http://www.nida.nih.gov/ under Funding or may be obtained by calling
(301) 443-2755.
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 include injecting drug users, crack
cocaine users, and sexually active drug users and their sexual
partners. For more information see
https://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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
https://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 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 https://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.
https://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.
REFERENCES:
Lamb, Sara (Ed); Greenlick, Merwyn R. (Ed); McCarty, Dennis (Ed).
Bridging the gap between practice and research: Forging partnerships
with community-based drug and alcohol treatment. [Authored Book]
Washington, DC, US: National Academy Press. (1998).
Miller, W. R., & Mount, K. A. (2001). A small study of training in
motivational interviewing: Does one workshop change clinician and
client behavior? Behavioural and Cognitive Psychotherapy, 29, 457-471.
Morgenstern, J., Morgan, T.J., McCrady, B.S., Keller, D.S., & Carroll,
K.M. (2001) Manual-guided cognitive-behavioral therapy training: a
promising method for disseminating empirically supported substance
abuse treatments to the practice community. Psychology of Addictive
Behavior, 15, 83-98.
Waltz, J., Addis, M.E., Koerner, K., & Jacobson, N.S. (1993). Testing
the integrity of a psychotherapy protocol: Assessment of adherence and
competence. Journal of Consulting and Clinical Psychology, 61, 620-
630.
Weissman, M.M, Rounsaville, B.J., & Chevron, E. (1982). Training
psychotherapists to participate in psychotherapy outcome studies.
American Journal of Psychiatry, 139, 1442-1446.