and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
CENTERS FOR THE DEVELOPMENT OF MEDICATIONS TO TREAT DRUG DEPENDENCE
RELEASE DATE: May 23, 2003
RFA: DA-04-003 - (Reissued as RFA-DA-09-002)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279
Letter of Intent Receipt Date: September 15, 2003
Application Receipt Date: October 14, 2003
THIS REQUEST FOR APPLICATIONS (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 solicit applications for funding research
centers called Medication Development Units (MDUs) directed towards the
identification, evaluation and development of safe and effective medications
for the treatment of cocaine, methamphetamine, club drug, opiate, and
cannabis related disorders, including substance use (abuse and dependence)
and substance-induced disorders such as substance withdrawal and
intoxication.
The applicants must have demonstrated the capability to conduct full-scale
single site clinical trials (placebo-controlled (PC) or active controlled
(AC), double-blind (DB)) using the proposed therapeutic approach. Applicants
opting to propose multisite trials must have adequately demonstrated efficacy
in a single site PC/AC, DB trial. Such applicants must also demonstrate the
ability to affiliate rapidly with other sites (through subcontract or
collaborative mechanisms) to launch a multisite Phase II or Phase III PC/AC,
DB trial.
Under this RFA, applicants may focus on human laboratory studies on
medication interactions with other drugs; pharmacokinetic or pharmacodynamic
studies, Phase I safety/tolerability or Phase II or III clinical efficacy
studies; or, if justified, multisite efficacy studies. Research may focus on
both currently approved and/or novel, investigational medications.
Because the treatment of cocaine, methamphetamine, opiate, or cannabis
related disorders necessitates a multidisciplinary approach, optimal
pharmacological treatments require a behavioral treatment strategy.
Therefore, applications may propose the concurrent evaluation of
pharmacotherapy and behavioral treatment approaches in an integrated design,
whereby behavioral treatment components should provide a platform for the
medication trials proposed. Study designs should be of adequate size and
well controlled.
Proposals for the treatment of opiate dependence will only be considered if
they address unmet clinical needs in this treatment area (i.e., non-opiate
agonist medications, medications to treat opiate-dependent individuals who
have not responded well to currently available medications, or the treatment
of special populations such as opiate-dependent pregnant women and
adolescents).
RESEARCH OBJECTIVES
Background -
As part of NIDA's strategic plan to significantly reduce drug use-related
disorders, the discovery of safe and effective medications for the treatment
of cocaine and other stimulants, as well as opioid, cannabis and club drug
related disorders, remains a top priority. This RFA solicits research on
medications to treat a variety of aspects of the immediate and long-term
effects of drug abuse and dependence, such as craving, relapse prevention,
and the physiological and behavioral consequences resulting from drug abuse.
As part of this undertaking, NIDA has made the development of an anti-cocaine
dependence medication its number one priority. The NIDA Medications
Development Program, aimed at identifying and screening new medications as
potential pharmacotherapies, has become increasingly focused on the
involvement of catecholaminergic systems in cocaine craving and relapse and
the identification and testing of entities which directly or indirectly
modulate these systems. The types of pharmacotherapies this suggests are
dopamine or serotonin receptor agonists and antagonists, pharmacotherapies
that, directly or indirectly, through modulation of GABA, glutamate, or
endocrine systems, affect dopamine, serotonin or noradrenergic transmission.
Additionally, any target medication justified as potentially effective in
modulating aspects of cocaine dependence through other mechanisms is also
appropriate.
There is also a critical need to address the growing problem of
methamphetamine abuse and dependence. The increased HIV risk behaviors and
transmission amongst methamphetamine abusers corroborates the need for safe
and effective pharmacotherapies to treat methamphetamine abuse. The highly
addictive nature of this substance, in addition to its low cost and ease of
production, as well as the serious physiological and neurological
consequences of its abuse, has made methamphetamine dependence a problem of
major proportions. There are currently no pharmacological treatments for
dependence on methamphetamine. Medications, which affect dopaminergic or
noradrenergic systems, or that directly or indirectly modulate their
neurotransmission, may be useful to test as treatment agents for amphetamine
abuse. Additionally, strategies to reduce methamphetamine plasma
concentrations or counteract its pharmacological effects could serve as a
useful adjunct in the management of the acute medical and psychiatric
symptomatology of methamphetamine overdose and methamphetamine-induced
cognitive impairment.
Also of importance would be the development of treatments for specific drug
abusing populations, such as polydrug abusers, individuals with a co-morbid
substance abuse or psychiatric disorder, pregnant addicts, and adolescents,
either as a main focus of the research plan, or as a component or components
thereof.
Research Themes -
The following are some examples of research themes that the Medication
Development Units (MDUs) might utilize:
1. Specific substance abuse disorders: The application may focus on the
development of medications for the treatment of a specific substance use, or
induced disorders with or without other psychiatric comorbidities. For
example Phase I, II or III studies to develop a medication, or medications,
for the treatment of cocaine dependence.
2. The targeting of neurochemical mechanisms implicated in substance abuse
disorders, by the direct or indirect modulation of systems, such as:
a. Cathecolaminergic
b. Glutamatergic
c. Cannabinoid
d. GABA
e. Opioid
f. Endocrine (e.g., CRF)
g. Multiple neurochemical systems
3. Paradigms to approach substance-related disorders:
a. Initiation of abstinence
b. Relapse prevention
c. Prevention of complications
d. Intervention of surrogate variables of drug abuse
Research Components -
The purpose of the MDU is to foster transdisciplinary collaboration on
cutting edge questions in the treatment of substance-related disorders (SRDs).
Some examples of research components may include, but are not limited to:
o Developing and testing new chemical entities for treatment of substance-
related disorders.
o Phase I testing of the safety of new medications or medications previously
approved for other indications that may be effective for treatment of SRDs.
o Phase I testing of medications or combinations of medications, for which
safety concerns may exist, or for which a safety assessment may be required
by the Food and Drug Administration, before Phase II trials may begin.
o Phase II clinical trials testing the efficacy of medications using rapid
screening methods (Phase IIa) or large scale, randomized, well-controlled
clinical trials (Phase IIb).
o Multicenter clinical trials to test medications for specific clinical
conditions for which it is difficult to recruit subjects in a timely manner.
For example, studies testing medications for the treatment of substance use
disorders in pregnant women or adolescents.
o Testing of potentially additive or synergistic neurochemical mechanisms
using one medication with action in multiple mechanisms of action, or
combinations of medications each targeting a different mechanism.
o Development of new human laboratory models for evaluation of medications
for relapse prevention, initiation, and abstinence.
o Developing and testing new paradigms of treatment success.
o Optimizing the safety or efficacy of approved medications for substance-
related disorders by testing them in specific patient populations
o Testing drug-drug interactions between medications for treatment of SRDs
and other drugs/medications, including but not exclusively, illicit drugs,
anti-retroviral medications, anti-psychotic medications, etc.
o Increasing the diversity of populations in whom the medications are tested
by increasing the representation of women and minority groups in clinical
trials or by designing clinical trials that specifically address the
treatment needs of those groups.
o Pioneering methods to design and conduct clinical trials that will be more
cost-efficient while yielding reliable results.
o Innovative statistical approaches to conduct sample size estimations,
control covariates, and assess treatment outcome.
o Using pharmacogenetics and pharmacogenomic techniques to assess genetic
factors that may influence the outcome of treatment of SRD.
o Investigating innovative imaging technologies to assess subjects'
suitability for specific treatments as well as treatment progress and
outcome.
o Developing novel psychotherapeutic techniques to be utilized as a
standardized co-adjuvant therapy for subjects participating in medications
clinical trials.
o Adapting behavioral therapies that have been shown efficacious and testing
them as part of medication clinical trials.
o Novel strategies for the treatment of multiple comorbid substance-related
disorders. For example, illicit drug use plus alcohol and tobacco or comorbid
opiate and cocaine ("speedball") dependence.
o Innovative approaches of the treatment of substance-related disorders with
other medical and psychiatric comorbidities including, but not exclusively,
hepatitis C, HIV infection, anxiety-related disorders, mood disorders,
personality disorders, etc.
o Evaluation of biopsychosocial factors that may affect the treatment outcome
of SRDs.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) specialized
research center grant (P50) mechanism. As an applicant you will be solely
responsible for planning, directing, and executing the proposed project.
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. The anticipated award date is July 2004.
Applications that are not funded in the competition described in this RFA may
be resubmitted as NEW investigator-initiated applications using the standard
receipt dates for NEW applications described in the instructions to the PHS
398 application.
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
NIDA intends to commit approximately $5.5 million in total costs in FY 2004
to fund 5 to 7 new and/or competitive continuation grants in response to this
RFA. An applicant may request a project period of up to five years. Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration 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.
The size of individual awards will vary as a function of the nature and scope
of the research proposed. It is anticipated the upper limit of each award
will be $1,200,000 in total costs (direct plus indirect costs) and
applications over this amount will not be accepted for review. Budget
requests should be carefully justified and commensurate with the complexity
of the project.
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.
SPECIAL REQUIREMENTS
The MDU Director must possess recognized scientific and administrative
competence. The Center Director must show a substantial commitment of time
and effort (minimum 25%) to the program and exercise leadership in steering
the MDU direction and maintenance of its quality control. Center Directors
must not direct more than one NIDA Center. Management support and shared
functions may be accomplished through an administrative core and scientific
core components. Scientific cores may propose plans for project management
and sharing of clinical resources, laboratory equipment and support,
statistical support, etc. The Administrative Core should provide for central
operations, oversight activities, technical support and exercise of
leadership for the overall project management, as well as integration,
communication and coordination of the MDU. As part of the Core, each
application should include a plan for data entry to the NIDA Clinical Trial
Portfolio System (CTPS) and designation of dedicated staff for data entry to
the system. Applicants may obtain information regarding the CTPS from the
NIDA contact. Applicants may want to consider the addition of a plan for the
contribution of data/samples for genotyping to NIDA's Human Genome
Consortium.
The applicant must demonstrate that he/she has plans and facilities for
career development and mentoring of junior investigators in the area of drug
abuse research and treatment.
Pilot Projects
1. The applicants may propose and request funding for specific, already
conceptualized pilot projects, which may be "research and development"
pilots, feasibility studies, or other pilot work broadly defined as
foundation work for further research. These pilot studies will be reviewed by
the scientific review group as part of the assessment of scientific and
technical merit.
2. In addition, applicants may request funds for pilot projects that are yet
to be conceptualized. These projects should have the potential for developing
into, or providing the foundation for, larger projects that could compete for
funds on their own. The support of pilot project studies should be of
relatively short duration (e.g., 1-2 years), depending upon the nature of the
research. Because these projects cannot be reviewed by the scientific review
group, applicants must describe and provide a process for a within-center
scientific review of pilot projects. In general, the total amount of money
allocated to yet-to-be-conceptualized pilot projects should not exceed 10% of
the center grant's total annual direct costs, and exceptions must be strongly
justified.
3. Whether specifically proposed in the application or developed later under
center auspices, pilot projects must comply with applicable NIH policies, and
the necessary human subject and animal welfare assurances must be submitted.
4. For projects not specifically proposed in the application, center
grantees are to provide the NIDA program officer with written notification of
the initiation of new pilot projects. The notification should contain a brief
description of, and rationale for, the planned pilot project, the amount of
pilot funds to be allocated to the project, the proposed length of the
project, and a statement that the project will comply with applicable NIH
policies and that the necessary assurances have been submitted and obtained.
The program officer must also be provided with assurance that the projects
have received an appropriate within-center scientific review.
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:
Jamie Biswas, Ph.D.
Division of Treatment Research and Development
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-8096
FAX: (301) 443-9649
Email: jb168r@nih.gov
o Direct your questions about peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
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 your questions about financial or grants management matters to:
Gary Fleming, J.D., M.A.
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) 594-6847
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 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 Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
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
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.
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.
Applicants are encouraged to organize their application by initially
presenting the face page, the abstract page with key personnel, a table of
contents, summary budget pages for the entire MDU, and other documentation
pertaining to the entire MDU. This should be followed by an Introductory
Section of no more than three pages. It should be written for the proposed
MDU application describing it as a whole with respect to the overall theme,
goals, objectives, and overall research plan. The Introductory Section
should contain information on i) the overall research theme, ii) timelines
and milestones for each project in a graphic outline to clearly lay out the
sequence of research events and how each project of the MDU relates to each
other, iii) the capacity of the MDU to conduct adequately sized clinical
trials for the targeted indications within a time frame of 2-3 years per
project, and iv) the capability of the proposed Principal Investigator and
his/her institution to carry out the scientific and administrative duties
required in this RFA.
After the introductory section, each core and research project should be
presented with its accompanying individual budget, budget justification,
biographical sketches, other support information, and research plan. For each
core and research project component, there is a 25-page limit for the
sections of the research plan (i.e., specific aims, background and
significance, preliminary studies/progress report, and research design and
methods) as indicated in the form PHS 398. Appendix material limits apply to
each component separately; each component's appendix may include up to 10
publications, manuscripts, abstracts, patents, or other printed material
directly related to the project. Surveys, questionnaires, data collection
instruments, and clinical protocols may also be submitted in the appendix.
Original glossy photographs or color images may be included, provided that a
photocopy (that may be reduced in size) is included within the 25-pages of
the research plan. Applications exceeding page limits, font limits, or
appendix limits will be returned to the applicant without review. Appendices
should not be placed within the body of the application, but should be
bundled separately, component by component.
Competing renewal applications must include final progress reports from their
previous P50 grant-sponsored studies for evaluation.
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 and the
entire set of appendices 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
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
APPLICATION PROCESSING: Applications must be received on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
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.
However, when a previously unfunded application originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.
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 your application in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these
goals.
A. MDU as an Integrated Effort:
(1) Quality of integration of center components to an over-arching theme that
integrates and focuses the center, as well as the presence of an essential
relationship of each component to the theme. Interdependency and linkages of
components to each other need to be demonstrated for at least a significant
nucleus of components.
(2) Evidence of synergy as components are configured in the application. To
aid in this determination, reviewers may look at the quality of provisions
for the sharing of resources, procedures for formal and informal planning,
and plans for developmental or pilot work in order to determine if the
application reflects a depth and breadth of expertise and experience not
normally present in an individual research project grant.
(3) The involvement of different scientific disciplines or subdisciplines in
the center's activities and the demonstration of substantial interaction
among scientists from different disciplines or subdisciplines and different
perspectives.
(4) Research Environment and Facilities:
(a) Plans for development and maintenance of an environment that promotes
the conduct of the highest quality of research, innovation, and leadership.
Demonstrations of past productivity are evidence of likely future
productivity, especially in competing renewal applications.
(b) Appropriateness and adequacy of facilities for administrative, research,
and shared resources, including a clearly identifiable physical location for
the center which assures necessary functions can occur.
(c) Facilities that indicate the center is, or would soon be, a national
scientific research resource.
(d) Evidence that core components contribute toward cost-effectiveness and
quality control in resource utilization.
(e) Quality and extent of data analytic capacities, data base facilities,
coordination, and data resources.
(f) As needed, the quality of provisions for shared laboratory resources, the
quality of laboratory space, and the quality of clinical facilities.
(5) Qualifications of the Center Director:
(a) Ability to lead a scientific program (including a program with training
components, if included), as noted by scientific achievements, productivity,
stature in a relevant field, and planned activities.
(b) Ability to lead administrative and operational aspects of the center, as
noted by administrative skills, achievements, and planned activities.
(c) Evidence of ability to develop or maintain a role for the center as a
national resource.
(d) Adequacy of commitment of time and effort for the research and
administration of the center. (A minimum of 35% effort on activities directly
supported by the center funding is required.)
6. Qualifications of Investigators:
(a) Quality of cadre of investigators and their productivity, as noted by
their scientific achievements, honors, and recognition.
(b) Quality of interactions among investigators and investigative teams.
(c) Breadth of expertise represented among investigators.
(d) Quality of investigators at collaborating sites and the nature of
collaborations.
7. Administrative and Organizational Structure:
(a) Organizational and administrative structure and support conducive to
research, synergy, and joint planning.
(b) Structure for long-range planning and evaluation of center activities.
(c) Programmatic structure that effectively promotes productive scientific
interactions and takes maximum advantage of the applicant institution's drug
abuse research capacity.
(d) Arrangements for internal quality control of research, publications, and
grant applications.
(e) An organizational structure with clear lines of authority that allow for
efficient and cost-effective management and allocation of funds, as well as
leverage of resources to enable additional or future work. Evidence of how
the center has attracted additional sources of funding or leveraged resources
is especially relevant for competing continuation applications.
(f) Outside advisory structures that provide appropriate and objective advice
and evaluation, as needed.
(g) An appropriate, fully described internal process that allows for priority
setting and decision making to sustain the center.
(h) Appropriate specification of criteria and processes for determining and
sustaining individual participation in the center based on productivity,
research direction, and overall contribution.
(i) Clear and convincing evidence of the applicant institution's substantial
commitment to the center and appreciation of its goals and role in public
health.
(j) Adequacy of provisions, especially in core components, for sharing of
data base development and analytic capacities. Innovative, state-of-the-art
analytic capability.
(k) As needed, plans for recruitment, training, and supervision of staff.
8. Mentoring and Career Development:
The capacity (including plans and facilities) to provide career development
and mentoring for potential drug abuse researchers.
B. Criteria to be used for determination of scientific merit of individual
scientific project components:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in evaluating your individual projects, weighting them as appropriate for
each application. The projects do 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.
SIGNIFICANCE: Does this study address an important problem or
pharmacotherapy? 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? Would the generated data
support the advancement of a pharmacotherapy toward advanced efficacy trials
or support an NDA?
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?
Does the proposal present a medication testing and development plan? Is the
research theme clearly presented and supported by a strong rationale? Are
timelines and milestones for each project presented in a graphic outline
(Gantt and Pert charts)? Does it clearly lay out the sequence of research
events and how each project of the MDU relates to each other? Are criteria
for go/no go decisions included at critical points in the plan?
Does it provide assurance of accessibility to patient populations and
controls? Does the PI demonstrate the feasibility to recruit human subjects
for the study?
Does the proposal address data management and statistical resource? Does
each project propose a plan for data management and demonstrate appropriate
statistical resources to manage, analyze clinical data and draft summary
reports to support an IND and possible NIDA submission? Does it propose a
plan to publish and disseminate the findings to health professionals and the
general community?
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?
INVESTIGATOR: Are the investigators appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and to that of other researchers (if any)?
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?
PILOT STUDIES: What is the likelihood that the proposed research will
contribute to the development of more mature and important research projects?
C. Criteria to be used for determination of scientific merit of core
components:
Core Units provide essential facilities or services for the individual
projects, including administrative arrangements and organization to
facilitate and monitor the attainment of objectives and quality control. For
example, the cores may include plans to enhance communication and cooperation
among the investigators involved in the program and mechanisms for the
allocations of funds for day-to-day management, project management and
tracking, contractual agreements and procedures for the replacement of key
personnel, such as the principal investigators, if required on an interim or
permanent basis.
The evaluation of administrative and scientific cores will include the
following criteria:
SIGNIFICANCE: The importance and value of the proposed core? What crucial
support is provided to the research projects? Are the most efficient means
identified? How do they enhance the effectiveness of individual projects?
Are mechanisms identified to promote research collaborations, to develop new
strategies, or to conduct pilot experiments?
Are specialized substance abuse research clinics available? Has the
possibility of an advisory steering committee been considered to evaluate
progress of the program?
What standardized tests, interventions, and evaluations are administered
through the core? Are uniform operating systems proposed? Does the plan
give careful consideration to overall timelines, choice and accessibility of
medications, patient recruitment issues, data management, and statistical
resources? Is interface with FDA and other regularity agencies considered?
APPROACH: The effectiveness of administrative arrangements and
organizational structure to facilitate and monitor the attainment of
objectives and internal quality control, and plans to enhance communication
and cooperation among the investigators involved in the program.
Establishment of mechanisms for the allocation of funds for day-to-day
management. A well-designed management plan that clearly defines the lines
of authority, development timelines, points of go/no go decisions, and
clearly demonstrates that resources will be used efficiently in reaching the
goals.
INNOVATION: Are innovative ways proposed in utilizing shared resources or
benefiting from the principal investigator's leadership to support research
projects, retain integrity, achieve efficiency, or minimize utilization of
resources?
INVESTIGATORS: The leadership and administrative capability of the principal
investigator. The need for an external advisory board.
ENVIRONMENT: The quality and adequacy of available resources necessary to
perform the research and the willingness to work as part of the cooperative
program and with NIDA Scientific Coordinators. The documented commitment of
the applicant institution and capability to serve as the Central Operations
Office for the program.
ADDITIONAL REVIEW CRITERIA
In addition to the review criteria cited above and in the NIDA Center
guidelines, sites submitting renewal applications must include final progress
reports from their previous P50 grant-sponsored studies. Past progress will
be evaluated.
In addition to the above criteria, the following items will be considered in
the determination of scientific merit and the priority score.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below). Each clinical trial proposal is
required to include an initial plan for data and safety monitoring.
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations,
below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
Applicants from institutions that have a General Clinical Research Center
(GCRC) funded by the National Center for Research Resources, NIH, or a
comparably supported clinical research facility are encouraged to explore the
possibility of using the facilities or arranging for other means to conduct
some of the center's proposed research. If an applicant wishes to identify a
GCRC or comparably supported clinical research facility as a source for
conducting proposed research, a letter of agreement from the program director
or PI of the GCRC or comparably supported clinical research facility should
be included in the application material.
The applicants may request funds for use of inpatient, residential, or
outpatient facilities which are essential to the conduct of the research
(e.g., patient bed costs, research ward costs, outpatient facility and other
health services costs). In such cases of paying for beds, facilities,
services, etc., funds will be provided only when it is clear that no other
funds are available and the services are essential to the conduct of the
research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: September 15, 2003
Application Receipt Date: October 14, 2003
Peer Review Date: February/March 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 2004
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
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN OR 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 and
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html), and
http://www.drugabuse.gov/Funding/DSMBSOP.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 "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.
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 service for 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.
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.
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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on "Am I a covered
entity?" Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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 at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
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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