DISSEMINATION AND IMPLEMENTATION RESEARCH IN MENTAL HEALTH

RELEASE DATE:  July 19, 2002 (This PA has been reissued, see PAR-06-171, PAR-06-072, and PAR-06-039)
                             (see addendum NOT-MH-02-009)

PA NUMBER:  PA-02-131 

EXPIRATION DATE:  July 2005, unless reissued.

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

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  Special Requirements
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 Program Announcement (PA) replaces PA-99-068.

The National Institute of Mental Health (NIMH) invites grant applications for 
research that will build knowledge on methods, structures, and processes to 
disseminate and implement mental health information and treatments into practice 
settings.  For many years, mental health researchers have assumed that an 
intervention deemed efficacious within clinical trials will be easily transmitted 
to the field, unfortunately, this has not been the case.  Recent literature has 
instead underscored the importance of understanding the many factors that affect 
whether the practice community will use a given intervention.  Invited research on 
dissemination will address how information about mental health care interventions 
is created, packaged, transmitted, and interpreted among a variety of important 
stakeholder groups.  Research on dissemination and implementation will address the 
level to which mental health interventions can fit within real-world mental health 
service systems.  The goals of this PA are to encourage mental health researchers 
to work with interdisciplinary scientists and practice stakeholders to develop 
conceptualizations of dissemination and implementation that are applicable across 
diverse practice settings, and design studies that will accurately assess the 
outcomes of dissemination and implementation efforts.

This PA addresses priorities laid out in Bridging Science and Service: A Report by 
the National Advisory Mental Health Council"s Clinical Treatment and Services 
Research Workgroup (http://www.nimh.nih.gov/research/bridge.htm), and in 
Translating Behavioral Science into Action: A Report of the National Advisory 
Mental Health Council"s Behavioral Science Workgroup 
(http://www.nimh.nih.gov/tbsia/tbsiatoc.cfm)

RESEARCH OBJECTIVES

Dissemination and implementation research intends to bridge the gap between 
clinical research and everyday practice by building a knowledge base about how 
mental health care information and new practices are transmitted and translated for 
health care service use in specific settings.  Unfortunately, there continues to be 
great variation in how these terms are used.  Dissemination and implementation have 
both been used to represent the complete process of bringing "evidence" into 
practice, originally defined as "diffusion."  While using the terms of 
dissemination and implementation to cover such a wide area can be very helpful in 
enabling discussion, it does not allow for the division of this very complex 
diffusion process into smaller, more easily addressed research questions that can 
develop a robust knowledge base.  We are inviting applications that will begin to 
break down the complexity of bridging research and practice.

For the purpose of this PA, we make a distinction between "dissemination" and 
"dissemination-implementation."

o  Dissemination is the targeted distribution of information to a specific 
audience.  The intent is to spread knowledge, in this case about mental illness and 
the associated evidence-based interventions.

o  Dissemination-Implementation (DI) is the use of strategies to introduce or 
change evidence-based mental health interventions within specific settings.

This distinction needs to be made because interventions developed in the context of 
efficacy and effectiveness trials are rarely transferable without adaptations to 
specific settings.  Therefore we need research that examines the process of 
transferring interventions into local settings, settings that may be very different 
from the ones in which the intervention was developed and tested.

Dissemination Research

We are currently missing critical information about how, when, by whom, and under 
what circumstances research evidence spreads throughout the agencies, 
organizations, and front line workers providing mental health services.  As a 
necessary prerequisite for unpacking how information can lead to treatment or 
service changes, we need to understand how and why information on mental health 
treatments may or may not reach many different stakeholders.  We need to understand 
what underlies the creation, transmission, and reception of information on 
evidence-based psychopharmacological and psychosocial interventions.  Successful 
dissemination of mental health information (including information about 
underutilized interventions) may occur quite differently depending on whether the 
audience consists of consumers, caregivers, practitioners, policymakers, employers, 
administrators, or another stakeholder group.  We need studies that will identify 
mechanisms and approaches to package and convey the evidence-based information 
necessary to improve care.

Dissemination-Implementation (DI) Research

Previous efforts in dissemination research have often assumed that interventions 
can be transferred into any service setting without modification and that a uni-
directional flow of information (e.g., publishing a guideline) is enough to achieve 
practice change.  "Success" of the transfer has been largely assessed based on 
structural measures (such as counts of personnel or contacts) or patient outcome 
measures that do not specifically assess how the intervention was implemented or 
whether the implementation remained faithful to the original conceptualization and 
intent of the intervention.  We need the field to develop a knowledge base about 
"how" interventions are transported to real-world practice settings, which is 
likely to require more than the dissemination of information about the 
interventions.  This research announcement encourages theory-driven, mixed methods 
studies to develop conceptual frameworks around the combined dissemination and 
implementation (DI) process that move away from the "top-down" approach to a 
greater emphasis on the resources of local care settings and needs of multiple 
stakeholders.

Dissemination and DI research needs to be interdisciplinary, and can utilize 
theories, empirical findings, and methods from a variety of fields not 
traditionally associated with mental health research.  Relevant fields include: 
information science, clinical decision-making, organizational theory, finance, 
strategic and behavioral change, anthropology, learning theory, and marketing.  
Meaningful research will include collaboration with stakeholders from multiple 
mental health settings as well as consumers of services and their families/social 
networks

Research Issues:  Listed below are examples of topics supported by this program 
announcement for dissemination and implementation research in mental health.  The 
list is illustrative, not exhaustive.  It is expected that investigators responding 
to this program announcement will identify other important research areas.

o  Analysis of factors influencing the creation, packaging, transmission and 
reception of valid mental health research knowledge, ranging from psychological and 
socio-cultural factors affecting individual practitioners, consumers, primary 
caregivers and other stakeholder groups to investigations addressing large service 
delivery systems and funding sources.

o  Experimental studies to test the effectiveness of individual and systemic 
dissemination strategies, focusing on outcomes related to the direct outcomes of the 
strategies (e.g., acquisition of new knowledge, maintenance of knowledge, attitudes 
about the dissemination strategies, use of knowledge in practice decision-making).

o  Studies of efforts to implement treatments or clinical procedures of 
demonstrated efficacy into existing care systems to measure the extent to which 
such procedures are utilized, and adhered to, by providers and consumers.

o  Studies of the capacity of specific care delivery settings (primary care, 
schools, community mental health settings, etc.) to incorporate dissemination or DI 
efforts within current organizational forms.

o  Studies on the fidelity of implementation efforts, including the identification 
of components of implementation that will enable fidelity to be assessed 
meaningfully.

o  Development of outcome measures and suitable methodologies for dissemination and 
DI approaches that accurately assess the success of an approach to move evidence 
into practice (i.e., not just clinical outcomes).

o  Longitudinal and follow-up studies on the factors that contribute to the 
sustainability of research-based improvements in clinical practice.

o  Studies testing the utility of alternative dissemination strategies for service 
delivery systems targeting rural, minority, and/or other underserved populations.

o  Studies on how target audiences are defined, and how evidence is packaged for 
specific target audiences

MECHANISM(S) OF SUPPORT 

This PA will use the NIH research project grant (R01), small grant (R03), and 
exploratory/developmental grant (R21) award mechanisms.  As an applicant, you will 
be solely responsible for planning, directing, and executing the proposed project.

The Small Grant (R03) provides two years of funding with a maximum of $50,000 
direct costs for each year.  Information and application instructions for the NIMH 
Small Grant are available at: 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html.

The Exploratory/Development Grant (R21) provides up to two years of funding with up 
to $100,000 in total direct costs annually.  Information and applications 
instructions for the NIMH Exploratory/Developmental Grant are available at: 
http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html.

This PA uses just-in-time concepts.  It also uses the modular 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 format.  Otherwise follow the instructions for non-modular 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
o  Faith-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 scientific/research issues to:

David A. Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
Neuroscience Center, Room 7133 MSC-9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-3747
FAX:  (301) 443-4045
Email:  [email protected]

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

Brian Albertini
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD  20892-9625
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 443-0004
FAX:  (301) 443-6885
Email: [email protected]

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  
For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 
[email protected].

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 GRANT APPLICATIONS:  Applications requesting up 
to $250,000 per year in direct costs must be submitted in a modular grant format.  
The modular grant format simplifies the preparation of the budget in these 
applications by limiting the level of budgetary detail.  Applicants request direct 
costs in $25,000 modules.  Section C of the research grant application instructions 
for the PHS 398 (rev. 5/2001) at 
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 received by or 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 application already reviewed, but such application must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established PHS 
referral guidelines.  An appropriate scientific review group 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  Receive a written critique
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 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 discuss the following aspects of your 
application in order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals:

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria in 
assigning your application"s overall score, weighting them as appropriate for each 
application.  Your application does not need to be strong in all categories to be 
judged likely to have major scientific impact and thus deserve a high priority 
score.  For example, you may propose to carry out important work that by its nature 
is not innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims of 
the application are achieved, how 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?  
Does the applicant acknowledge potential problem areas and consider alternative 
tactics?  Does the applicant acknowledge the complexity of the specific settings, 
populations, and professions engaged in each study?

(3) Innovation:  Does the project employ novel concepts, approaches or method? Are 
the aims original and innovative?  Does the project challenge existing paradigms or 
develop new methodologies or technologies?

(4) 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)?  Has the principal 
investigator involved researchers from other fields that, if necessary, complement 
the PI"s experience?

(5) Environment:  Does the scientific environment in which the work will be done 
contribute to the probability of success?  Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?  Is there evidence of institutional support?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your application 
will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or the 
environment, to the extent they may be adversely affected by the project proposed 
in the application.

INCLUSION:  The adequacy of plans to include subjects from both genders, all racial 
and ethnic groups (and subgroups), and children as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of subjects will 
also be evaluated.  (See Inclusion Criteria included in the section on Federal 
Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data. 

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

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for assessment of 
patient eligibility and status, rigorous data management, quality assurance, and 
auditing procedures.  In addition, it is NIH policy that all clinical trials 
require data and safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide 
for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of the 
NIH that women and members of minority groups and their sub-populations must be 
included in all NIH-supported clinical research projects unless a clear and 
compelling justification is provided indicating that inclusion is inappropriate 
with respect to the health of the subjects or the purpose of the research.  This 
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 
103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on 
October 9, 2001 
(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.

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.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of Federal 
Domestic Assistance No. 93.242, and is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.  Awards are 
made under authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284)(or other authorizations) and administered under NIH 
grants policies described at http://grants.nih.gov/grants/policy/policy.htm (cite 
other relevant policies) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92 (cite other relevant regulations).

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.

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