EFFECTIVENESS, PRACTICE, AND IMPLEMENTATION IN CMHS’ CHILDREN’S SERVICE SITES

RELEASE DATE:  November 10, 2003

PA NUMBER:  PA-04-019 (Reissued as PA-06-526)

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. Parent 
R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been 
issued for the submission date of June 1, 2006 and submission dates for AIDS and 
non-AIDS applications thereafter. Applications relating to R33 and R34 activities 
must be in response to NIH Institute/Center (IC)-specific announcements.

EXPIRATION DATE for R03 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 AIDS and AIDS-Related Applications: May 2, 2006 
EXPIRATION DATE for All R01 Applications: August 14, 2006, unless reissued.

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Research Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This PA replaces PA-00-135.

The purpose of this program announcement (PA) is to encourage research grant 
applications on services delivered to children, adolescents, and their families 
through the Center for Mental Health Services’ (CMHS) Comprehensive Community 
Mental Health Services for Children and Their Families Program initiative 
(hereafter referred to as the Children’s Services Program) or through the Safe 
Schools/Healthy Students Interdepartmental Initiative (SS/HS), also supported 
by the CMHS, and by the Departments of Education and Justice.  This PA 
encourages studies of the effectiveness of interventions delivered at these 
sites, the nature and impact of routine prevention or clinical practice, and 
factors related to successful implementation of preventive or treatment 
interventions.

Conducting the proposed research at one of the Children’s Services Program or 
SS/HS sites (either existing sites or “graduated” sites) is a prerequisite for 
funding under this PA.  Within multi-site studies, only one site is required to 
be a past or currently funded Children’s Services Program or SS/HS site.  Grant
principal investigators are strongly encouraged to work collaboratively with 
Children’s Services Program or SS/HS site program staff and associated family 
members.  Such collaboration might include the joint negotiation of primary 
research aims, direct participation in research activities, or the establishment 
of a community advisory board to oversee research activities.

This PA addresses recommendations set forth in the NIMH report, "Bridging 
Science and Service:  A Report by the National Advisory Mental Health Council’s 
Clinical Treatment and Services Research Workgroup," and in the NIMH report 
"Blueprint for Change:  Research on Child and Adolescent Mental Health."  
Applicants may obtain a copy of these reports at 
http://www.nimh.nih.gov/research/bridge.htm and 
http://www.nimh.nih.gov/child/blueprint.cfm.  
This PA also addresses research-related issues raised in the report from the 
President’s New Freedom Commission on Mental Health, "Achieving the Promise:  
Transforming Mental Health Care in America" and in the "Report of the Surgeon 
General’s Conference on Children’s Mental Health:  A National Action Agenda."  
Applicants may obtain copies of these reports at 
http://www.mentalhealthcommission.gov/ and 
http://www.surgeongeneral.gov/topics/cmh/childreport.htm.

RESEARCH OBJECTIVES

Background

The field of child mental health research has made enormous strides in the 
development, testing and application of intervention strategies.  While there is 
still much to learn, scientific evidence indicates that the prevention or 
treatment of mental disorders in childhood can reduce the risk of onset of child 
psychopathology, reduce symptoms or delay their onset, improve adaptive 
functioning, and serve as a buffer to further long-term impairment.  In contrast 
to the growing scientific base on the efficacy of interventions, empirical data 
on the effectiveness of research-based strategies in community settings, 
information about typical community practices, and evidence identifying key 
intervention implementation strategies remain very limited.  As efficacious 
preventive and treatment interventions are moved into real-world community 
settings, scientific knowledge in these areas becomes especially important.  The 
purpose of this PA is to encourage research to be conducted within the 
Children’s Services Program or SS/HS sites to assess the effectiveness of child 
mental health interventions (either preventive or treatment), the nature and 
impact of routine prevention or clinical practice, or factors related to the 
successful implementation of child mental health interventions.

The majority of children who receive mental health care in the United States do 
not receive such care within the specialty mental health system.  Typical child 
mental health-oriented preventive and/or treatment services occur across a broad 
array of service arenas including, but not limited to, education, primary health 
care, child welfare, juvenile justice, and community-based mental health 
settings.  Preventive and treatment services within the Children’s Services 
Program and SS/HS sites are provided within such diverse service settings and 
consequently represent excellent environments in which to conduct effectiveness, 
practice, or implementation research.

For the purposes of this program announcement, effectiveness research is defined 
broadly to include studies which examine the impact of specific treatment 
(including psychosocial, pharmacological, and/or innovative service delivery 
strategies) or prevention models (including universal, selective, and/or 
indicated preventive interventions) on clinical, functional, environmental, 
service, or systemic outcomes for children, adolescents, and their families.  
Effectiveness research may also include the study of intervention or service 
delivery processes (e.g., mechanisms of action) within community settings that 
reduce risk or delay onset of psychopathology or improve child mental health 
outcomes, as well as studies of the quality of preventive or treatment services.  
Effectiveness research is intended to facilitate the successful uptake of 
efficacious preventive and treatment intervention services into child service 
systems in the most efficient and cost-effective manner.

Practice research is defined here to include research that examines those 
features of routine prevention program delivery or clinical care that 
interventionists or clinicians employ (e.g., intake, assessment, engagement 
strategies, case management, supervision) when providing a particular service.  
Such research might include the study of clinician decision-making strategies, 
the relationship between typical organizational structures upon care quality, 
the impact of routine mental health program delivery on child functioning, or 
care system efficiency.  Practice research is intended to broaden the scientific 
understanding of current clinical practice and to identify promising (but as of 
yet untested) innovative practices.

Implementation research includes the study of strategies to introduce 
efficacious mental health interventions into community settings.  Such research 
includes the study of specific implementation strategies (e.g., training, 
program fidelity, care setting capacity building) as well as the study of 
barriers and facilitators to program implementation (e.g., program 
accessibility, provider attitudes, or organizational culture).  Of particular 
interest are studies that will examine aspects of prevention or treatment 
program delivery that improve child and family outcomes, and enhance the 
likelihood of program adoption, whether these aspects are specific to the 
intervention strategy, routine clinical practices, or implementation models.  
Implementation research is intended to develop a knowledge base about how 
interventions are integrated within real-world practice settings.

Children’s Services Program

The Comprehensive Community Mental Health Services Program for Children and 
their Families (or Children’s Services Program) was created as part of the 
Alcohol, Drug, and Mental Health Administration Reorganization Act -- Public Law 
102-321, Section 119).  This program is administered by the CMHS of the 
Substance Abuse and Mental Health Services Administration (SAMHSA).  Under this 
authority, grants and cooperative agreements are provided to State governments, 
governmental units within political subdivisions of States (e.g., counties, 
cities, towns), Indian tribes, tribal organizations, territories, and the 
District of Columbia, to provide a broad array of comprehensive community-based 
services for children with serious emotional, behavioral, or mental disorders in 
order to enable communities to develop local systems of care consisting of 
mental health, child welfare, education, juvenile justice, and other child-
serving agencies.  Funds for the CMHS program are authorized to be spent on 
services that are underdeveloped or nonexistent in most communities such as 
intensive home-based services; school or clinic-based services; crisis 
intervention; emergency services; therapeutic foster care; day treatment; 
diagnostic and evaluation services; and, respite care.  Children can be served 
in small therapeutic group homes that have a capacity of less than 10 beds.  
Additionally, each child must have an individualized service plan, developed 
with the participation of family and, where appropriate, the child.  The plan 
must designate a case manager to assist the child and family by coordinating 
services among several child-serving agencies.

To date, 85 grants or cooperative agreements have been awarded in 46 states, 10 
American Indian or Alaskan Native Tribes, and two territories by the CMHS since 
the first Request for Applications was announced in the Spring 1993.  Over 
56,000 children and adolescents with serious emotional, behavioral or mental 
disorders have received or are receiving services in systems of care.  Many 
Children’s Services Program sites serve a substantial number of children and 
families from American Indian, Hispanic, and African-American backgrounds.  Some 
of these communities have developed and used services and treatments that are 
specific to the culture.  Such services may offer the opportunity to gather 
empirical evidence around the effectiveness of these practices.

Further information on the Children's Services Program, including a list
of currently funded sites, may be found at http://www.samhsa.gov 
and at http://systemsofcare.net.

Safe Schools/Healthy Students Interdepartmental Initiative

The Safe Schools/Healthy Students Interdepartmental Initiative (SS/HS) is 
supported by an unprecedented collaboration among the Departments of Education, 
Health and Human Services, and Justice.  The CMHS is the primary DHHS partner.  
The goals of SS/HS are to 1) help students develop the skills and emotional 
resilience necessary to promote positive mental health, engage in prosocial 
behavior, and prevent violent behavior and drug use; 2) ensure that all students 
learn in a safe, disciplined, and drug-free environment; and 3) develop an 
infrastructure that will institutionalize and sustain integrated services.

The Federal partners have challenged communities to develop a new way of doing 
business by forging formal partnerships across 3 traditionally disparate 
sectors--education, mental health, and justice.  Sites are required to establish 
a comprehensive, integrated strategy to promote healthy students and families in 
a safe school and community environment.  Each local strategic plan addresses 
six required elements across the three sectors:  1) school safety; 2) alcohol, 
other drugs, and violence prevention and early intervention programs; 3) school 
and community mental health preventive and treatment services; 4) early 
childhood psychosocial and emotional development programs; 5) educational 
reform; and 6) safe school policies.  In addition to the key partnership across 
education, mental health, and justice, the local SS/HS coalitions have multiple 
partners, including representatives of the faith community.

A total of 143 SS/HS grant awards have been made between 1999 to 2002 to urban, 
suburban, rural, and tribal sites in nearly every U.S. state.  In addition to 
grant funds, support is provided for technical assistance to all SS/HS grantees; 
there is additional support for a SS/HS communications component to help local 
sites achieve sustainability after Federal support ends.  Sites are required to 
conduct local evaluations; the majority of the SS/HS sites also participate in a 
cross-site National Evaluation.  Additional information about the SS/HS 
initiative along with a list of currently funded sites may be found at:  
http://www.sshsevaluation.org/initiative/.

Research Issues

Examples of research topic areas that are of interest under this PA include, but 
are not limited to:

o  Studies of the portability, adaptation, and/or implementation fidelity of 
efficacious preventive, pharmacological, psychosocial or combined interventions 
in novel communities, settings, and populations.

o  Research on factors associated with the development of effective prevention 
and treatment practices in specific geographic contexts such as urban, suburban, 
rural and frontier.

o  Examination of the economic issues (e.g., financing streams and mechanisms, 
costs, benefits, cost offsets) associated with effective preventive or treatment 
interventions.

o  Research on the potent elements of effective preventive and/or treatment 
services, including elements directly associated with a specific intervention or 
its implementation.

o  Studies of the effectiveness of preventive and/or treatment services for co-
occurring conditions, such as other emotional, behavioral, or mental disorders; 
drug or alcohol abuse; AIDS; or homelessness.

o  Studies that propose secondary analyses of site-specific SS/HS or Children’s 
Services Program National Evaluation data, or studies that combine National 
Evaluation data with local evaluation data, especially studies focused on 
outcomes.

o  Research on the effectiveness of family-driven or culturally-based treatment 
or services, contrasted with provider-driven or usual care delivery.

o  Research on the impact of efficacious prevention or treatment approaches on 
the routine community delivery of mental health interventions, associated 
outcomes, or quality of care.

o  Studies of the impact of different levels of service intensity, service 
quality, service integration, or service matching on short-term and long-term 
outcomes for children and adolescents with different levels of impairment.

o  Studies of routine practices (e.g., supervision, assessment, referral, 
triaging) by clinical practitioners (e.g., case managers, pediatricians, social 
workers, clinicians) which impact clinical outcomes or the quality of care.

o  Studies examining the impact of processes within preventive and/or treatment 
interventions or services (e.g., therapeutic engagement, family choice or 
involvement in program care delivery) on outcomes.

o  Development of improved methods for measuring and analyzing preventive and/or 
treatment service integration, intensity and/or outcomes within comprehensive 
systems.

o  Studies of the meaning of “quality” to children and families from diverse 
ethnic or geographic backgrounds.

o  Pilot intervention outcome research studies to test the impact of innovative 
service delivery models identified as promising practices within Children’s 
Service Program or SS/HS sites.

o  Research on implementation strategies (e.g., fidelity monitoring, provider 
training, sustainable infrastructure support) for successfully deploying 
efficacious preventive or treatment interventions into service communities.

o  Research on the barriers (cultural, administrative, structural) to deploying 
preventive and treatment interventions into service communities.

o  Research on organizational (e.g., culture, structure) or individual-level 
(e.g., provider or consumer beliefs/attitudes) variables that enhance or detract 
from the implementation of (or outcomes associated with) efficacious preventive 
and/or treatment services.

MECHANISM(S) OF SUPPORT

This PA will use the NIH research project grant (R01), small grant (R03), 
exploratory/development grant for intervention and services research (R34) and 
the Collaborative R01s for Clinical Studies of Mental Disorders mechanisms.  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The total project period for an R01 application 
submitted in response to this PA may not exceed five years.  An application for 
an R03 award is limited to $50,000 direct costs per year, is limited to two 
years, and is not renewable.  An application for an R34 award is limited to 
$450,000 in direct costs for up to three years, with no single year exceeding 
$225,000, and is not renewable.

Instructions and information on the Small Grant (R03) is available at: 
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html

Instructions and information on the R34 mechanism is available at: 
http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html

Instructions and information on the collaborative R01 mechanism is available at:  
http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html

This PA uses just-in-time concepts.  It also uses the modular budgeting as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in each 
year of $250,000 or less, use the modular budget format.  Otherwise follow the 
instructions for non-modular budget research grant applications.

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 institutions/organizations
o  Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry out 
the proposed research is invited to work with their institution to develop an 
application for support.  Individuals from underrepresented racial and ethnic 
groups as well as individuals with disabilities are always encouraged to apply 
for NIH programs.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two areas:  
scientific/research and financial or grants management issues:

o  Direct your questions about NIMH scientific/research issues related to the 
Children’s Services Program to:

Heather Ringeisen, Ph.D.
Chief, Child and Adolescent Services Research Program
National Institute of Mental Health
6001 Executive Boulevard, Room 7146, MSC 9631
Bethesda, MD  20892-9621
Telephone:  (301) 496-7227
FAX:  (301) 443-4045
Email:  hringeis@mail.nih.gov

o  Direct your questions about NIMH scientific/research issues related to the 
Safe Schools/Healthy Students Initiative to:

Eve K. Moscicki, Sc.D., M.P.H.
Office of Child and Adolescent Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7167, MSC 9630
Bethesda, MD  20892-9630
Telephone:  (301) 443-3775
FAX:  (301) 480-3257
Email:  em15y@nih.gov

o  Direct your questions regarding the CMHS Children’s Services Program to:

Rolando L. Santiago, Ph.D.
Center for Mental Health Services
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, Room 11C-16
Rockville, MD  20857
Telephone:  (301) 443-3808
FAX:  (301) 443-3693
Email:  rsantiag@samhsa.gov 

o  Direct your questions regarding the CMHS Safe Schools/Healthy Students 
Initiative to:

Denise L. Middlebrook, Ph.D.
Division of Program Development
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, Room 17C20
Rockville, MD  20857
Telephone:  (301) 443-4199
FAX:  (301) 443-7912
Email:  dmiddle@samhsa.gov

o  Direct your questions about financial or grants management matters to:

Joy R. Knipple
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6131 MSC 9605
Bethesda, MD  20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-8811
FAX:  (301) 443-6885
Email:  jk173r@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal 
Identifier when applying for Federal grants or cooperative agreements.  The DUNS 
number can be obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/.  The DUNS number should be 
entered on line 11 of the face page of the PHS 398 form.  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.

The title and number of this PA must be typed in line 2 of the face page of the 
application form and the YES box must be checked.

APPLICATION RECEIPT DATES:  Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which are 
available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail.  Applicants request direct costs in $25,000 modules.  Section 
C of the research grant application instructions for the PHS 398 (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html includes 
step-by-step guidance for preparing modular grants.  Additional information on 
modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:

Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.

Applicants requesting more than $500,000 must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application 
for consideration for award; and,

3) Identify, in a cover letter sent with the application, the staff member and 
IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised version 
of these grant application types.  Additional information on this policy is 
available in the NIH Guide for Grants and Contracts, October 19, 2001 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of the 
application, including the checklist, and five signed photocopies in one package 
to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be mailed on or before the receipt 
dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm.  
The CSR will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept any
application that is essentially the same as one already reviewed.  This does not 
preclude the submission of a substantial revision of an unfunded version of an 
application already reviewed, but such application must include an Introduction 
addressing the previous critique.

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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  Appropriate scientific review groups convened in 
accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) 
will evaluate applications for scientific and technical merit.

As part of the initial merit review, all applications will:

o  Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o  Receive a written critique
o  Receive a second level review by the appropriate national advisory council or 
board

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 evaluate your application in order 
to judge the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.  The scientific review group will address 
and consider each of these criteria in assigning the application’s overall 
score, weighting them as appropriate for each application.

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

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.

SIGNIFICANCE:  Does this study address an important problem?  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?

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?

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:  Is the investigator 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 (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?

ADDITIONAL REVIEW CRITERIA:  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). 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
 
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 
will be assessed.  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 REVIEW CONSIDERATIONS

SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct costs 
in any year of the proposed research are expected to include a data sharing plan 
in their application.  The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the reviewers.  
However, reviewers will not factor the proposed data sharing plan into the 
determination of scientific merit or priority score.

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds with 
all other recommended applications.  The following will be considered in making 
funding decisions:

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds
o  Relevance to program priorities

REQUIRED FEDERAL CITATIONS

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:  Data and safety monitoring is required for all 
types of clinical trials, including physiologic, toxicity, and dose-finding 
studies (phase I); efficacy studies (phase II), efficacy, effectiveness and 
comparative trials (phase III).  The establishment of data and safety monitoring 
boards (DSMBs) is required for multi-site clinical trials involving 
interventions that entail potential risk to the participants.  (NIH Policy for 
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or more 
in direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing.  
Investigators should seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and Federal 
laws and regulations, including the Privacy Rule.  Reviewers will consider the 
data sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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.

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.

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 PA is related to 
one or more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.healthypeople.gov/.

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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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