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 301/435-0714, 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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