RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY AND PSYCHOSOCIAL
INTERVENTIONS (RUPP-PI)
Release Date: August 31, 2001
RFA: RFA-MH-02-002
National Institute of Mental Health
(http://www.nimh.nih.gov/)
Letter of Intent Receipt Date: December 11, 2001
Application Receipt Date: January 11, 2002
PURPOSE
The National Institute of Mental Health (NIMH) requests applications from
qualified research institutions for funding Research Units on Pediatric
Psychopharmacology and Psychosocial Interventions (RUPP-PI). The RUPP-PI
network will be supported under a cooperative agreement, for multi-site
clinical trials to study the efficacy and effectiveness of mental health
interventions for children and adolescents.
The purpose of the initiative is to expand the research network of the
existing Research Units on Pediatric Psychopharmacology (RUPP), which has
been supported by NIMH under a contract mechanism.
The initiative will expand the scope of the RUPP research by including multi-
site clinical trials on psychosocial treatments in addition to
psychopharmacologic interventions, and will encourage the development of
multimodal treatment models as clinically appropriate. Emphasis will be on
testing the efficacy, safety, and effectiveness of interventions already in
use without adequate testing, conducting pilot studies for innovative,
theoretically-driven and conceptually-based interventions, and promoting
innovative clinical trial designs, especially those involving research in
community practice settings. The research units will also provide sites for
training promising clinicians and junior investigators.
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, Research Units
on Pediatric Psychopharmacology and Psychosocial Interventions, 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted from children’s hospitals or their equivalent
or educational institutions with accredited medical schools, within the
United States. Each RUPP-PI must be an identifiable unit within its
institution, with a history of exemplary treatment research. Existing RUPP
sites, which have been funded under contract mechanisms, are eligible to
compete under this initiative, but an existing RUPP is not a requirement for
application. Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal Investigators.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) clinical research
cooperative agreement (U10) award mechanism. See below for TERMS AND
CONDITIONS OF AWARDS. The total project period for an application submitted
in response to this RFA may not exceed five years. This RFA is a one-time
solicitation. Future unsolicited competing continuation applications
originating from this RFA will compete with all investigator-initiated
applications and will be reviewed according to the customary peer review
procedures.
FUNDS AVAILABLE
The NIMH intends to commit approximately $4,600,000 in FY 2002 to fund up to
8 RUPP-PIs in response to this RFA. An applicant may request a project
period of up to five years and a budget for direct costs of up to $350,000
per year. 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 NIMH 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.
RESEARCH OBJECTIVES
Background
The recent Report of the Surgeon General’s Conference on Children’s Mental
Health: A National Action Agenda (2000)
(http://www.surgeongeneral.gov/cmh/childreport.htm) documented the need for
continued efforts in preventing and treating child mental illness. The
document reports that 1 in 10 children in the U.S. suffers from mental
illness severe enough to interfere with normal development and functioning.
Children with mental illness are at greater risk for school failure and
impairment as adults. Yet, only about 1/5 of those children receive
specialty mental health services. Advances in the neurosciences, behavioral
sciences, and social sciences, have prompted an increased national interest
in child mental health. While there have been significant advances, the
National Action Agenda specifies significant gaps in knowledge and several
areas in need of further investigation. At this time, the opportunity is
great for productive interdisciplinary exchange to stimulate collaborative
research.
The network of Research Units on Pediatric Psychopharmacology was started in
1996 through competitive contracts, with subsequent additions in 1997, for a
total of 7 units currently active at academic research settings. Research
has focused on short-term efficacy and safety studies of psychotropic
medications commonly used in children and adolescents with mental disorders.
The current RUPP includes studies of: selective serotonin reuptake inhibitor
(SSRI) for children with Anxiety Disorders (Walkup, JT et al (2001).
Fluvoxamine for the Treatment of Anxiety Disorders in Children and
Adolescents. The New England Journal of Medicine, 334(17), 1279-1285),
risperidone for children with Autism and behavioral disturbance (data
analysis in progress), SSRI for depressed children with Bipolar Disorder, and
sequential treatments for children with co-morbid ADHD and Anxiety Disorders.
The purpose of RUPP-PI is to continue and expand the research scope of the
RUPP in psychopharmacology research and add psychosocial treatment research.
Gaps in pediatric mental health interventions research remain. For example,
there are insufficient data on the treatment of youths with bipolar
disorders, depression (especially in pre-pubertal children), psychosis,
obsessive-compulsive disorder, and with two or more co-existing conditions
(e.g., ADHD and comorbid mood disorders). Mental illness in the context of
autism, pervasive developmental disorders, and mental retardation, are under-
studied conditions. Data are needed to guide the management of aggression
and extreme mood instability in various clinical contexts. Research is
needed on the long-term effects of medications, especially when
pharmacological treatment is started in early childhood. Some widely used
psychosocial interventions have not been tested for efficacy and
effectiveness. Scientifically proven interventions have not been adequately
disseminated to the clinics, schools, and other community programs where they
can be easily accessed. Research is needed to identify the barriers to
dissemination, and a new model of intervention development is needed that
addresses dissemination from the beginning. Research is also needed to
compare psychosocial and pharmacological interventions, and to study the
potential advantage of combining pharmacological with psychosocial
interventions. One intention of this RFA is to encourage the formation of
partnerships between investigators familiar with psychosocial treatments and
those with pharmacology expertise.
Objectives and Scope
The purpose of this RFA is to expand the scope of the currently ongoing
research network, RUPP, which has been funded under the contract mechanism
and is approaching completion. Studies conducted under the expanded RUPP
(RUPP-PI) will be clinical and for the pediatric (child/adolescent) age
group. It is expected that the RUPP-PIs will be involved in collaborative
psychopharmacological and/or psychosocial clinical trials with other units in
the network and staff at NIMH, using peer-reviewed protocols determined by
consensus. The overarching aim of the expanded RUPP-PIs will be to address
through research, important clinical questions about the efficacy, safety,
and effectiveness of interventions for youths with emotional and behavioral
disturbances. Of particular interest are studies that address the current
gaps in pediatric treatment research, including innovative treatment for
developmental disorders such as Autism/PDD, and severe mental illnesses.
Another important objective is to provide training experiences for promising
clinicians and junior investigators. The following are examples of possible
areas of investigation:
o Study the therapeutic effects of psychosocial and/or pharmacological
interventions that are commonly used in the community but have not been
adequately tested for efficacy, safety, or effectiveness
o Compare alternative psychosocial or pharmacological interventions for the
treatment of a specific disorder with respect to efficacy, safety,
effectiveness, and cost-effectiveness
o Develop approaches to examine the effects of combined behavioral and
psychopharmacological treatments, as compared to unimodal treatments
o Test the effectiveness of interventions in community practice settings,
including identification of social contextual variables that influence
whether an intervention is adopted in a community setting
o Identify clinically meaningful moderators and mediators of treatment
response that can inform choices of treatment in the community
o Study the relationship between dose, intensity, and duration of treatment,
on one hand, and treatment effects, on the other
o Study the pharmacokinetics and pharmacodynamics of psychotropic
medications, as clinically indicated
o Conduct pilot testing for innovative, conceptually-driven and
theoretically-oriented psychosocial interventions
o Develop and test effective treatments of symptoms that are often the
targets of psychopharmacology management for children in practice settings
(e.g., aggression, sleep disorders, self-injurious behaviors)
o Study the long-term effects of treatments, with respect to both safety and
effectiveness, especially on distal outcomes such as illness recurrence,
emergence of comorbid disorders, academic achievement, and social adaptation
o Test the comparative effectiveness and safety of different treatment
strategies and approaches (i.e., study of alternative algorithms rather than
single interventions)
o Develop effective approaches to pharmacological management of children
with two or more co-existing disorders (e.g., ADHD and moods disorder),
medication side effects, and treatment resistance
o Develop developmentally sensitive measures of treatment outcomes,
including behavioral and neurobiological outcome measures that are
hypothesized to be associated with behavior change
o Study the effects of polypharmacy, including interactions of drugs with
each other and with nutrients, in situations when polypharmacy is clinically
justified
o Test the efficacy and safety of promising alternative treatment
approaches, such as dietary interventions or supplements, for youths with
emotional and behavioral disturbances
Management Structure
Multi-site collaboration will be an essential feature of the RUPP-PI network.
Units will be involved in collaborative clinical trials with other units in
the network through one or more protocols determined by the consensus of the
Steering Committee (see Terms and Conditions below). Units will likely have
different and complementary research expertise in child/adolescent
interventions research, but should be capable, through training and addition
of staff, of obtaining any additional necessary expertise that the protocols
will require for each unit.
The management of the RUPP-PI network includes two main committees: (1) The
project Steering Committee, and (2) a Data Safety and Monitoring Board
(DSMB)(see below).
TERMS AND CONDITIONS OF AWARDS
1. Applicability
These special Terms of Award are in addition to and not in lieu of otherwise
applicable Office of Management and Budget (OMB) administrative guidelines,
Department of Health and Human Services (DHHS) grants administration
regulations in 45 CFR part 74 and 92, and other HHS, PHS, and NIH grant
administration policy statements.
Under the cooperative agreement, the NIMH purpose is to support and/or
stimulate the recipients activities by involvement in and otherwise working
jointly with the awards recipients in a partner role, but it is not to assume
direction, prime responsibility, or a dominant role in the activity.
Consistent with the above concept, the dominant role and prime responsibility
for the activity reside with the awardees for the project as a whole,
although specific tasks and activities in carrying out the study will be
shared between the awardees and the NIMH scientific collaborators or
designee.
Under the cooperative agreement, a relationship will exist between the
awardees and the NIMH, in which the performers of the activities are
responsible for the requirements and conditions described below and agree to
accept program assistance from NIMH staff collaborators in achieving project
objectives.
Failure of the awardees to meet the performance requirements, including these
special terms and conditions of award, or significant changes in level of
performance, may result in a reduction of budget, withholding of support,
suspension and/or termination of the awards.
2. Awardee Rights and Responsibilities
The awardees have the primary authority and responsibility for defining
objectives and approaches and for planning, conducting, analyzing, and
publishing results, interpretations, and conclusions of the study. The
awardees shall retain custody of and primary rights to the data developed
under this award, subject to Government rights of access and consistent with
current HHS, PHS, and NIH policies, however, the data base will be put into
the public domain no more than 36 months after the last wave of data has been
cleaned.
The awardees will be responsible for planning and participating
collaboratively with NIMH under this cooperative agreement. Through
participation in meetings of the Steering Committee for this project and
conference calls, the awardees will work with the NIMH staff collaborators in
the development and implementation of one or more multi-site protocols, and
in the establishment of quality control and monitoring procedures which are
to be reported in non-competing continuation applications.
Management of the multisite database and final statistical analyses will be
provided under a separate NIMH contract mechanism. However, some capability
of data management functions will need to be present at each RUPP-PI. These
functions will include: (1) ongoing monitoring of the data collected at the
unit for clarity, completion, and accuracy as compared with the source
documents, (2) transferring of data to the central database by batching,
copying, and mailing the data, or faxing them to the data management center,
and (3) addressing possible queries from the data management center about the
data.
3. NIMH Responsibilities
At least one NIMH staff collaborator or a designee will have scientific
involvement in the conduct of this activity, through membership on the
project Steering Committee. The participation of NIMH staff collaborator(s)
is intended to assist the project Steering Committee in its efforts to ensure
that the broad scientific goals of NIMH are reflected in the final design,
implementation, and reporting of results of the studies. Specifically, the
staff collaborators will participate in decisions about study design,
instrumentation, and clinical assessment. The NIMH staff collaborators will
participate in all major project meetings and may cooperate with the awardees
as author or co-author of resulting publications in accordance with
publication policies developed by the Steering Committee of this project.
Publications involving NIMH staff must follow NIH and NIMH publication
policies.
In addition to the NIMH staff collaborators, an NIMH Project Officer will be
responsible for normal stewardship, and will provide technical assistance,
programmatic monitoring, and assistance in the coordination of the overall
project, but will not be a voting member of the project Steering Committee.
An independent panel of experts in clinical trials, forming a Data Safety and
Monitoring Board (DSMB) will be appointed by NIMH to monitor safety, quality
of data collection, and integrity of the study. The costs of the DSMB will
come from an NIMH source independent of the cooperative agreement. NIMH will
obtain the advice of independent experts in the field(s) of interest for
suggestions regarding methodology, scientific content, and other aspects of
the proposed research.
NIMH will support, through a separate contract mechanism, the management of
the multisite database and final statistical analyses.
4. Collaborative Responsibilities
The project Steering Committee will be the principal decision-making body for
the study. It will have overall responsibility for the study and will make
modifications in the protocols as necessary. The NIMH staff collaborator(s)
will jointly have one vote on the project Steering Committee. Each awardee
will jointly have one vote, although up to three persons from each site may
be members of the project Steering Committee. A representative of the
contracted database management component will participate on the Steering
Committee, but will not be a voting member. A quorum will require one NIMH
staff collaborator or designee and at least four representatives, each from
one of the participating sites. The project Steering Committee will elect a
chairperson, and may establish additional by-laws, subcommittees, or
workgroups for specific tasks, including a Publications Committee to develop
policies on publication and authorship. An NIMH staff collaborator may not
chair any committee or subcommittee. Membership on the project Steering
Committee becomes effective for the site upon receipt of the notice of award.
Decisions will be made by majority vote of a quorum, with an attempt for
consensus when possible. Any project Steering Committee member who considers
a committee decision unacceptable may appeal by following the arbitration
procedure described below. The project Steering Committee will meet
annually, and convene through telephone conferences or in person, as needed,
for the duration of the study.
Responsibilities of the project Steering Committee members (collaborators)
include: (1) collaboratively selecting, from among the peer-reviewed
protocols, the one(s) to be implemented, (2)collaboratively finalizing the
study plan, including design, assessment instruments, component protocols,
and detailed implementation procedures, (3)abiding by and directing the study
plan determined by the project Steering Committee, (4) monitoring the study
and developing and implementing quality control procedures, (5) conserving
grant funds in the service of the common objectives and of the research plan
agreed on by the project Steering Committee, (6) facilitating the analysis of
data and the eventual release to the larger scientific community (see Public
Domain below), submitting data on time in the form and on the schedule
determined by the project Steering Committee, (7) evaluating and reporting
study results: defining rules regarding access to data and publication of
findings from analyses of the data set, and (8) abiding by all scientific,
practical, and policy decisions of the project Steering Committee.
5. Progress Reviews
After the initial year, for which the NIMH requires a mid-year report,
progress of the project will be reviewed by the NIMH Project Officer annually
at the time of each continuation application. These reports will be assessed
to assure that satisfactory progress is being made in achieving the project
objectives, especially with respect to enrollment and quality of data
collection, and that the site is following the procedures recommended and
approved by the project Steering Committee.
By acceptance of these awards, the awardees agree to abide by decisions and
policies of the project Steering Committee and the other terms and conditions
listed above or referenced in the Notice of Grant Award.
6. Arbitration Procedures
If a decision related to a scientific or programmatic issue between/among
NIMH and the awardee(s) is not acceptable to the awardee(s) or NIMH, either
may, within 30 days of notification of the decision, request a review by an
arbitration panel composed of one arbitrator nominated by the awardee(s), one
nominated by NIH, and one chosen by the first two nominees. This panel will
make a decision within 60 days of the request. Failure to comply with the
decision of the panel may result in termination of support for the awardee(s)
by NIMH. This arbitration procedure in no way affects the right by the
awardee(s) to appeal any adverse action in accordance with PHS regulations at
42 CFR Part 50, subpart D, and HHS Grant Administration Regulations at 45 CFR
Part 74, section 304, and HHS regulations at 45 Parts 16 and 75. This
procedure may also be used for disagreements between the awardees and the
NIMH staff collaborator(s) if the disagreement relates specifically to a
scientific or programmatic issue.
7. Data and Safety Monitoring
The study data will be reviewed by the NIMH DSMB every 3-6 months. The DSMB
will receive a report from the study data management and statistical center
usually about 4 weeks before each review date. Such a report will include
the major variables necessary for monitoring safety and quality of data
collection and integrity of the study. As study protocol and consent forms
are relevant to safety and quality of data, the DSMB will also review these
documents before the onset of the study. Based on this review, the DSMB has
the authority to prevent the study from starting or to stop the study after
it has started.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
NIH GRANTS POLICY STATEMENT
The NIH Grants Policy Statement (NIHGPS) has been revised and reissued. The
provisions of the revised NIHGPS are effective for all funded NIH grants and
cooperative agreements with budget periods beginning on or after March 1,
2001. The revised NIHGPS is available at:
http://grants.nih.gov/grants/policy/nihgps_2001.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the principal investigator, the identities of other key personnel
and participating institutions, and the number and title of the RFA in
response to which the application may be submitted. 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 to Ann Wagner, Ph.D. by the letter of
intent receipt date listed.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001)
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in
applying for these grants. This version of the PHS 398 is available in an
interactive, searchable PDF format. For further assistance contact
GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov.
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.
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:
Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
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.
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.
SPECIFIC REQUIREMENTS FOR APPLICANTS
Research Unit Specifications
Cooperative agreements awarded under this RFA will provide support for
research units that demonstrate the knowledge, expertise, and resources to
conduct empirically sound interventions research with a pediatric population
(children and adolescents). Applications can be related to (1)
psychopharmacological intervention, (2) psychosocial intervention, or (3)
multimodal interventions. There is no preference for one of the three types
of research, but the applicant will be reviewed and awards will be given
based on the clinical significance of the proposed research, scientific
strength of the proposed design and methods, innovation, and
conceptual/theoretical framework of the study. Evidence that the research
plan is feasible must be presented, including evidence of the investigators
expertise, access to an appropriate subject pool, and the necessary
institutional support.
The application should address the following areas: (A) Research resources,
(B) Exemplary research protocol, (C) Training capabilities, and (D) Budget
justification.
A. Research Resources
Awardees will have a successful track record of pediatric mental health
research. Applications should document the expertise of the principal
investigator and other important personnel and discuss the possibility of
adding certain expertise to existing resources in order to conduct future
studies in the RUPP-PI network (e.g., site with existing strong expertise in
psychosocial intervention research, but in need of additional expertise in
psychopharmacology research, or vice versa). Qualifications and academic
productivity of the principal investigator must be documented. The principal
investigator must be well-established, preferably holding independent peer-
reviewed grant or contract support, actively publishing in the field. The
principal investigator will be required to devote at least 25% of her/his
time to the RUPP-PI activities. Applicants who are current RUPP principal
investigators should describe their participation in the project research
during the current award period. New applicants should describe their
research achievements and their participation in randomized trials,
especially of a collaborative and/or multisite nature.
Applications must document that there is access to a sufficient number of
eligible research subjects in the pediatric age group: infants, children,
and adolescents. This is an essential component of the application and must
be detailed in the proposal. The application should address whether the
subject pool is sufficiently representative with regard to sex, ethnicity,
and SES. The application must present convincing evidence (such as prior
recruitment success) that the investigator will be able to recruit and retain
a sufficient and appropriate sample.
Applications must include a description of the available infrastructure and
facility, including necessary clinic and/or laboratory equipment. Evidence
of departmental and institutional support, documented by letters to the
investigator, must be provided. The institution should have a history of
past support and clinical research productivity. Long-term institutional
commitment to the RUPP-PI may take various forms, including (but not limited
to) waiver of facility fees for use of an outpatient clinic or research ward
for patients on protocol, equipment and space for a core laboratory, release
time for faculty to perform clinical trials research, and/or funding for
support personnel.
Research units will need statistical support and/or consultation within their
institution for assistance with research design and plan of analysis. Costs
for centralized data management and statistical analysis will not be incurred
by the institution, as this will be provided separately by the NIMH, but each
RUPP-PI must include resources to manage research data locally, as previously
described.
B. Exemplary Research Protocol
Applicants should submit an application for a collaborative study, in which
three to five RUPP-PIs would coordinate clinical trials utilizing a protocol
determined by consensus. The application should include a research proposal
in the form of a draft protocol to address a clinically important issue
relevant to the mental health treatment of children and adolescents. The
protocol can be a research project in psychopharmacology, psychosocial
treatments, or combined treatment interventions, to be conducted at multiple
sites. Because this is a collaborative effort, NIMH recognizes that a fully
described protocol is not possible at this phase in the process.
Nevertheless, in order to evaluate the merit of the proposed research goals
and objectives, and the applicant’s ability to successfully complete the
study, a well-described draft protocol should be submitted. The protocol
should contain enough detail to explain the rationale, methods, experimental
design, time line, general statistical plan, and budget outline.
Individual RUPP-PIs may have different and complementary research strengths
in pediatric research. Applications should address the expertise available
at their site, as well as additional expertise that would need to be supplied
by coordinating sites. The full range of expertise needed to successfully
carry out the study should be described. Collaborating sites may be
determined ahead of time by the applicant, in which case documentation of the
collaborator(s)" commitment to participate, and available resources, should
be included in the application. Alternatively, the collaborating sites may
be left unspecified, and the protocol should be described in a way that would
be transportable to collaborating institutions.
After a cooperative agreement is funded and the Steering Committee is in
place, there may be adjustments or changes to the proposed protocol(s). The
RUPP-PI steering committee will finalize the protocol(s) for implementation
based on various factors, such as comments and recommendations of the peer
review process at the initial review group, programmatic priorities, and
funds availability.
C. Training Capabilities
Applicants should describe how the RUPP-PI will provide research education
and training opportunities for junior investigators or established
investigators willing to redirect their effort to interventions research.
Training must be relevant to treatment research in the area of child and
adolescent mental health.
D. Budget Justification
Allowable costs in NIH cooperative agreements are governed by rules set forth
in the NIH Grants Policy Statement and as stated on the Notice of Grant
Award. Under these rules the PI may exercise flexibility to meet unexpected
requirements by rebudgeting or requesting approval to rebudget among
categories within the total direct cost budget of the RUPP-PI (as shown on
the Notice of Grant Award), within the ceilings set in these guidelines.
RUPP-PI grants are for up to five years, at a maximum level of $350,000 in
direct costs for each year, plus negotiated Facilities and Administrative
Costs, formerly known as indirect costs. Items fundable through a RUPP-PI
cooperative agreement may include:
1. Personnel: Principal investigator (minimum 25 percent time and effort,
which can include mentoring junior investigators), other senior
investigators, junior investigator, nurse coordinator, research nurse,
clinical pharmacologist, and data coordinator (time and effort as needed,
with appropriate justification).
2. Support services directly related to the project: project-specific
supplies, duplication costs, dedicated telephone line.
3. Clinical costs: Cost of clinical care that is directly related to the
research project, and is not covered by other sources. Cost of
pharmaceuticals to be used in the study, other pharmacy and laboratory costs,
as justified by the research protocol.
4. Travel: Travel for the principal investigator and one co-investigator for
a yearly network meeting, additional travel for training in multi-site
protocols as needed.
The following items are not fundable through a RUPP-PI grant:
Costs of routine clinical care that are not directly related to the research
project, or are covered by other sources, rent, administrative or secretarial
services.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIMH. 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 the NIMH in accordance with the review criteria stated below. As
part of the initial merit review, all applications will receive a written
critique and 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, assigned a priority score, and receive a
second level review by the NIMH National Advisory Council.
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. Each
of these criteria will be addressed and considered in assigning the overall
score, weighting them as appropriate for each application. Note that the
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, an investigator 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? How does
the proposed study contribute to knowledge in understudied populations,
understudied conditions, untested interventions, or otherwise address gaps in
the current empirical base. If the aims of the application are achieved, how
will scientific knowledge be advanced? What will be the effect of these
studies on the concepts or methods that drive this field?
(2) Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Is there sufficient attention to testing for efficacy, safety,
and/or effectiveness? Does the protocol reflect an understanding of the
implications of developmental level on treatment delivery and outcome
measures? Does the protocol demonstrate sensitivity to social contextual
variables that would influence implementation in the community? Are plans
for recruitment and retention of subjects feasible and well-described? Does
the applicant acknowledge potential problem areas and consider alternative
tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies? Does the
project involve novel targets of treatment or outcome variables?
(4) Investigators: Is the proposed team of investigators at the RUPP-PI
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator
and other researchers? Is the combined expertise of the investigators
sufficient to cover all aspects of the project (e.g., expertise in both
pharmacology and psychosocial interventions for multimodal studies)? Do the
primary investigators have a history of successful completion of
collaborative research?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Does the institution (and its
collaborators, if specified) have a history of rigorous scientific
productivity? Do the proposed studies take advantage of unique features of
the participating institution(s)? Are the institutions suited to recruiting
and treating children and adolescents? Is there evidence of institutional
support for conducting clinical research?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to: (1) adequacy of plans to
include both genders, minorities and their subgroups, and children as
appropriate for the scientific goals of the research, (2) provisions for the
protection of human and animal subjects, the safety of the research
environment, (3) plans for the recruitment and retention of subjects, and (4)
the reasonableness of the proposed budget and duration in relation to the
proposed research.
SCHEDULE
Letter of Intent Receipt Date: December 11, 2001
Application Receipt Date: January 11, 2002
Peer Review Date: March/April 2002
Council Review: May 2002
Earliest Anticipated Start Date: July 1, 2002
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of appropriate study populations
o extent of investigators experience and expertise
o adequacy of research facilities
o availability of funds
o programmatic priorities
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or answer questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Ann Wagner, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7149, MSC 9633
Bethesda, MD 20892-9633
Telephone: (301) 443-4283
FAX: (301) 443-4045
Email: awagner@mail.nih.gov
Direct inquiries regarding fiscal matters to:
Joy Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
Fax: (301) 443-6885
Email: jk173r@nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.242. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-277, 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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