STATE IMPLEMENTATION OF EVIDENCE-BASED PRACTICES II – BRIDGING SCIENCE AND 
SERVICE

RELEASE DATE:  June 7, 2004

RFA NUMBER:  RFA-MH-05-004  

EXPIRATION DATE:  October 15, 2004

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
 (http://www.nih.gov/)
Substance Abuse and Mental Health Services Administration (SAMHSA)
 (http://www.samhsa.gov/)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
Center for Mental Health Services (CMHS)
 (http://www.mentalhealth.samhsa.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.242

LETTER OF INTENT RECEIPT DATE:  September 14, 2004
APPLICATION RECEIPT DATE:  October 14, 2004  

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanism(s) of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Mental Health (NIMH) and the Substance Abuse and 
Mental Health Services Administration (SAMHSA) have entered into a partnership 
to promote and support implementation of evidence-based mental health treatment 
practices into state mental health systems.  This is directly related to Goal 
Five of the President’s New Commission on Mental Health Final Report:  
“Excellent Mental Health Care is Delivered and Research is Accelerated.” 
(http://www.mentalhealthcommission.gov/) 

NIMH seeks to enhance the research agenda of state mental health systems by 
focusing on activities that yield knowledge about the most effective and 
feasible methods for implementing evidence-based practices into state clinical 
practice settings.  SAMHSA seeks to provide direct support to states and 
localities that are ready and committed to adopting evidence-based practices.  
This Request for Applications (RFA) is designed to accomplish both objectives.

This RFA is to provide funding to states for two distinct purposes:

1) To fund 12-18 month planning grants (R24) to bridge the communication between 
science and service, focusing on the implementation of evidence-based practices 
(EBPs).

Some states are actively implementing EBPs despite limited information about what 
factors contribute to successful adoption.  There is substantial variation in 
states' readiness to implement EBPs, and this RFA is intended to allow states at 
various levels of implementation readiness to participate in bridging science to 
service activities that will further their specific agendas.  In order to ensure 
that the funding goes directly to the state, state offices (e.g., Departments of 
Mental Health, Medicare/Medicaid offices) will be required to be the applying 
organization, and a state officer will be required to be the Principal 
Investigator.  Examples of activities may include:  1) meetings to convene state 
and local stakeholders to learn about implementation, and plan EBP implementation 
strategies, 2) small pilot studies on research areas such as fidelity measurement 
assessment, and innovative cost analyses, 3) establishment of networks of 
administrators and key leaders to share information about implementation or to plan 
for alternative models of information management, and process and outcome 
measurement, and 4) planning of training, financing, and policy initiatives that 
will advance implementation of EBPs.  It is expected that the 12 to 18 month 
planning grant will lead to the submission of a research application for a full-
scale research grant application (R01), an intervention or service exploratory/ 
developmental research grant application (R34), or a small grant application (R03) 
and/or applications for SAMHSA grants.

2) To fund exploratory/developmental research studies (R34) around the 
implementation of evidence-based practices (EBPs).

A growing body of research is being developed on the individual, organizational, 
and systemic barriers and facilitators that influence the ability of an evidence-
based practice to be implemented within a “real-world” service setting.  While 
progress has been made in showing the effectiveness of evidence-based practices 
when implemented in particular treatment settings, there is very little information 
about how to take the evidence-based practices statewide.  The purpose of this RFA 
is to enable state-led implementation studies, targeted at building information on 
the effective implementation of evidence-based practices into state-run mental 
health service settings.  These studies are intended to be exploratory, using the 
NIH R34 mechanism (http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html), 
and drawing from the priorities of PA 02-131:  Dissemination and Implementation 
Research in Mental Health 
(http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-009.html).  
In order to ensure that the funding goes directly to the state, state offices 
(e.g., Departments of Mental Health, Medicare/Medicaid offices) will be required 
to be the applying organization, and a state officer will be required to be 
the Principal Investigator, and evidence of strong partnership between 
researchers and the state agency should be presented.

RESEARCH OBJECTIVES

In response to key recommendations from the NIMH "Bridging Science and Service" 
report, and SAMHSA's Science to Service goals, the Services Research and Clinical 
Epidemiology Branch (SRCEB) of NIMH and the Center for Mental Health Services 
(CMHS) of SAMHSA are issuing this RFA to offer awards through the R24 and R34 
mechanisms to stimulate science to service development activities within state 
mental health agencies.  Applications will be solicited from individual state 
offices around two distinct goals:

1) to plan activities leading toward the development of a unique science to service 
agenda around the implementation of evidence-based mental health services into 
local practice settings.  The purpose is to enable states in varying stages of 
readiness to perform research and/or build research capacity to undertake studies 
that will add to the evidence base on implementation of EBPs and improve their 
service delivery.  Bridging science to service activities may include methods of 
convening state and local stakeholders to learn about implementation and plan their 
efforts, efforts to enhance collection and aggregation of data, creation of 
mechanisms to facilitate the implementation of research findings by clinicians and 
practices, and creation of partnership networks of administrators, key leaders and 
researchers to share information and plan implementation.  It is anticipated that 
after completion of these exploratory science to service planning grants, recipient 
organizations will be in a position to compete for a variety of research and 
service enhancement mechanisms to assist states in carrying out their 
individualized plans.

2) to carry out exploratory research studies around the implementation of evidence-
based practices in state-run mental health settings.  The purpose is to enable 
states to study the process of implementing practices within local settings to 
build knowledge that will ultimately enable states to implement a practice 
throughout its system.  The mental health setting can be any state-funded setting 
(e.g., inpatient facility, school, justice system, community clinic, primary care 
setting) in which consumers can receive mental health services (treatment and 
prevention).  Studies are intended to be exploratory, using the R34 mechanism to 
develop pilot data around the implementation of evidence-based practices, which 
will be necessary for a larger-scale study.  Applicants should refer to the R34 
program announcement (http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html) 
to understand the scope of work, as well as the dissemination and implementation 
research program announcement, for more information on the content of such a study 
(http://grants.nih.gov/grants/guide/pa-files/PA-02-131.html) and the accompanying 
addendum (http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-009.html).

Evidence-based practice remains a central focus of mental health research and 
policy.  Within the last few years, research has demonstrated the effectiveness of 
a number of mental health treatments within clinical trials and other valuable 
studies.  However, difficulties remain in transporting and translating these 
treatments to fit into real-world settings (Frist, W.H., 2002, "Federal Funding for 
Biomedical Research," JAMA, 287(13):  1722-24; President’s New Freedom Commission 
on Mental Health Final Report:  67).  While the language of evidence-based practice 
is so often used in research publications and strategic plans, the knowledge base 
about how to disseminate evidence and implement EBPs is still vastly 
underdeveloped.  State mental health officials have demonstrated an interest in 
implementing EBPs within their systems, but have been constrained by limited 
resources in their ability to develop the knowledge base of how EBPs can fit within 
their system.  Given the great difficulty of determining how EBPs can fit within 
real-world settings, state research efforts toward implementation of EBPs can 
provide a wealth of information about the factors that affect implementation.  
These efforts can build a foundation for the next generation of interventions that 
more effectively accommodate the complexities of everyday practice settings.

These grants offer states the opportunity to learn more about the factors that 
contribute to successful implementation of evidence-based practices, and allow 
states to follow a course of work that reflects the level of progress that the 
states have previously made.  For states that are still in need of developing 
agendas and consensus from relevant stakeholders, these grants provide 
opportunities to begin planning concrete service improvement strategies.  For 
states that have been successful in identifying research questions and building 
partnerships across researchers, policymakers, and practitioners, these grants 
allow states to test implementation of identified evidence-based practices.

We envision that state efforts facilitated by both grant mechanisms will contribute 
to our understanding of what factors affect the implementation of evidence-based 
practices.  Responses to the RFA will be referred to the NIMH Dissemination and 
Implementation Research Program within the Services Research and Clinical 
Epidemiology Branch of Division of Services and Intervention Research.  NIMH and 
CMHS will provide joint oversight of the planning grants.

OVERVIEW OF THE FIELD OF RESEARCH

A large body of evidence across relevant disciplines forms the basis for addressing 
the need of this RFA.  Over the past several decades, mental health services and 
intervention research has seen tremendous growth in the number of empirically-
supported treatments, as defined by successful patient outcomes in scientifically-
rigorous randomized controlled trials (RCTs).  Further, research studies have 
established, to a lesser degree, the generalizability of some treatment and 
prevention programs through effectiveness studies.

However, state systems continue to implement far fewer "evidence-based" treatments 
than expected by the research community.  State mental health departments have 
demonstrated tremendous interest in the implementation of these treatments, but 
hesitate about whether the treatments are suitable for their public mental health 
services.  Questions remain about the appropriate fit between the state systems and 
the treatments, as defined within the RCT.

Evidence is lacking about the implementation of evidence-based mental health 
treatments within state care settings, and this is making decision-making difficult 
about whether to implement treatment programs within state systems.  Some have 
argued that the lack of evidence stems from the small role that state departments 
have played in research.  As a result, many important implementation questions are 
not being asked (and need to be) within research studies.  However, some important 
field approaches to implementing evidence-based practices are emerging, supported 
by efforts from large state and local networks of researchers, providers, 
consumers, family members, policy makers, and program officials (e.g., the National 
EBP project supported by SAMHSA and others).  These approaches bring unique 
opportunities to add scope and different dimensions to their promised knowledge 
through this RFA.

In addition to supporting development of EBP capacity, this RFA gives an 
opportunity for additional questions to emerge, for partnerships with researchers 
to be cultivated, and important implementation studies to be planned for future 
grant submissions.

KNOWLEDGE TO BE GAINED THROUGH THIS INITIATIVE

As indicated above, many of the research questions about implementing evidence-
based mental health treatments into public care settings have been slow to emerge.  
Several recent NIMH and SAMHSA reports and related grant initiatives have signaled 
the importance of involving more practitioners and important stakeholders in 
research, as a method of making the resulting studies more relevant to the real 
world.

This RFA enables monies to be used by state agencies for the specific activities of 
developing these questions into viable research studies and service enhancement 
projects (goal one), and where questions have been identified, launching 
exploratory studies around the implementation of an evidence-based practice within 
a state system (goal two).  The resulting knowledge will build on the existing 
efficacy and effectiveness data for a variety of interventions, and will improve 
the capacity for state agencies to inform and conduct research, and raise the 
awareness of researchers and policymakers about real-world implementation 
importance.

Activities appropriate to this RFA include, but are not limited to:

For the R24:

o  Use of sophisticated survey methodologies to solicit research questions from key 
target audiences, specifically targeting the implementation of evidence-based 
practices in state mental health care settings.

o  Development of innovative and sustainable partnerships with researchers from 
multiple disciplines, including organizational change and development, knowledge 
management, marketing, technology transfer, information technology, etc.

o  Use of existing and emerging technology transfer mechanisms to plan and sponsor 
enhanced EBP service capacity.

o  Development of rigorous and effective dissemination strategies (e.g., training, 
technical assistance) that support and sustain adoption of evidence-based 
practices.

o  Innovative, highly-focused meetings reaching out to target adopter groups (e.g., 
providers, policymakers, administrators), in preparation for the bridging science 
and service agenda development.  Use of multiple methods (e.g., virtual meetings, 
online discussion groups, conference calls, research seminars) to discuss 
implementation issues and obtain input on research questions from these 
stakeholders.

o  Development of a highly-focused science and service agenda, including short-term 
and long-term goals for researching evidence-based mental health practice 
implementation in state settings, based on a theoretical or conceptual framework of 
state-wide implementation.  It is expected that the planning activities will lead 
to one or more R01, R03, or R34 grant application submissions to NIH and to SAMHSA 
grant submissions.

o  Development of initial pilot studies to gather data on evidence-based 
implementation-related issues which will lead to the submission of R01s.

For the R34:

o  Conduct of a research study examining the implementation of an evidence-based 
practice in a state-funded mental health treatment or prevention setting.

o  Development of a research study examining whether factors influencing an 
evidence-based practice (e.g., fidelity scales, leadership, training, staffing 
issues) effectively predict the clinical success and/or sustainability of the 
practice in a state setting.

o  Development of a research study examining organizational facilitators/barriers 
to the implementation of an evidence-based practice.

o  Development of a research study examining financing issues (e.g., costs of 
start-up, infrastructure development, and training; payment methods and strategies; 
cost-effectiveness, -benefit, -offsets, and –savings; etc.) related to 
implementation of evidence-based practices.

o  Conduct of a research study examining the effectiveness of an evidence-based 
practice that has been adapted to serve a population other than the one for which 
it was original developed (e.g., use of Assertive Community Treatment for an older 
adult population with depression and anxiety disorders; use of Supported Employment 
with a Native American population; etc.)

MECHANISM OF SUPPORT

This RFA will use NIH Resource-Related Research Project (R24) and the NIMH  
Interventions Development (R34) award mechanisms.  An applicant for an R24 Planning 
Grant may request a project period of 12 to 18 months and a budget for direct costs 
of up to $100,000.  Investigators funded for an R24 under the previous RFA, “State 
Implementation of Evidence Based Practices:  Bridging Science and Service” are not 
eligible to apply for a second R24.  An applicant for an R34 Implementation Grant 
may request a project period of up to 3 years and a budget for direct costs 
(excluding Fiscal and Administrative Costs), of up to $450,000 (with no single year 
exceeding $225,000).  As an applicant you will be solely responsible for planning, 
directing, and executing the proposed project.

This RFA is a one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-initiated 
applications and will be reviewed according to the customary peer review 
procedures.  The anticipated award date is July 2005.  Applications that are not 
funded in the competition described in this RFA may be resubmitted as NEW 
investigator-initiated applications using the standard receipt dates for NEW 
applications described in the instructions to the PHS 398 application.

This RFA uses just-in-time concepts.  It also used the non-modular budgeting 
formats.  This program does not require cost sharing as defined in the current NIH 
Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

FUNDS AVAILABLE

NIMH and CMHS intend to commit approximately $1.5 million in FY 2005 to fund 10 to 
15 new grants in response to this RFA.  Because the nature and scope of the 
proposed research will vary from application to application, it is anticipated that 
the size and duration of each award will also vary but must fall within the 
requirments of the R24 and R34 noted above.  Although the financial plans of NIMH 
and CMHS 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.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the following 
characteristics:

o  Units of States, the District of Columbia, territories and tribal governments

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any state, territory, or tribe mental health department, Medicare/Medicaid office, 
or state, territory, or tribe health department full-time employee with the skills, 
knowledge, and resources necessary to carry out the proposed science to service 
development 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 inquiries concerning this RFA and welcome the opportunity to answer 
questions from potential applicants.  Inquiries may fall into three areas:  
scientific/research, peer review, and financial or grants management issues:

o  Direct your questions about scientific/research issues to:

David A. Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7133, MSC-9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-3747
FAX:  (301) 443-4045
Email:  dchamber@mail.nih.gov

Crystal R. Blyler, Ph.D.
Division of Service and Systems Improvement
Center for Mental Health Services
Substance Abuse and Mental Health Services Administration
5600 Fishers Lane, Room 11C-22
Rockville, MD  20857
Telephone:  (301) 443-3653
FAX:  (301) 443-0541
Email:  cblyler@samhsa.gov

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC-9608
Bethesda, MD  20892-9608
Telephone:  (301) 443-1340
FAX:  (301) 594-0702
Email:  mkozak@mail.nih.gov

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

Joy R. 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

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes the 
following information:

o  Descriptive title of the proposed research and/or planning grant
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel
o  Participating institutions
o  Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not enter 
into the review of a subsequent application, the information that it contains 
allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

David A. Chambers, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7133 MSC-9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-3747
FAX:  (301) 443-4045
Email:  dchamber@mail.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 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  
For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email:  
GrantsInfo@nih.gov.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the application.  
Type the RFA number on the label.  Failure to use this label could result in 
delayed processing of the application such that it may not reach the review 
committee in time for review.  In addition, the RFA title and number must be typed 
on line 2 of the face page of the application form and the YES box must be marked.  
The RFA label is also available at:  
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

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

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

At the time of submission, two additional copies of the application and all copies 
of the appendix material 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
Rockville, MD 20852 (For express/courier service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720
Email:  jnoronha@mail.nih.gov

APPLICATION PROCESSING:  Applications must be received on or before the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

The Center for Scientific Review (CSR) will not accept any application in response 
to this RFA that is essentially the same as one currently pending initial review, 
unless the applicant withdraws the pending application.  However, when a previously 
unfunded application, originally submitted as an investigator-initiated 
application, is to be submitted in response to an RFA, it is to be prepared as a 
NEW application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text must not be 
marked to indicate the changes from the previous unfunded version of the 
application.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIMH.  Incomplete and/or nonresponsive applications will not 
be reviewed.  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:

o  Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will be 
discussed and assigned a priority score
o  Receive a written critique
o  Receive a second level review by the National Advisory Mental Health 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 evaluate the 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 the 
following 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.

(1) SIGNIFICANCE:  Do your science to service planning activities or research 
topics address an important problem?  If the aims of your application are achieved, 
how do they advance scientific knowledge and application of scientific knowledge?  
What will be the effect of these planning activities and/or study on the concepts 
or methods that drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
underlying the science to service planning activities and/or study adequately 
developed, well integrated, and appropriate to the aims of the project?  Do you 
acknowledge potential problem areas and consider alternative tactics?

(3) INNOVATION:  Do your science to service planning activities and/or research 
study employ novel concepts, approaches or methods?  Are the aims original and 
innovative?  Does your project challenge existing paradigms or employ innovative 
methodologies or technologies?

(4) INVESTIGATOR/PROGRAM DIRECTOR:  Are you appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to your experience level 
as the principal investigator/program director and to that of other key personnel 
(if any)? For research study applications (R34), does the investigative team have 
the necessary scientific expertise to complete the proposed work?

(5) ENVIRONMENT:  Does the environment in which your work will be done contribute 
to the probability of success?  Do the proposed science to service planning 
activities and/or research study take advantage of unique features of the 
environment or employ useful collaborative arrangements?  Is there clear and 
unwavering evidence of State 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).

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

ADDITIONAL REVIEW CONSIDERATIONS

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    September 14, 2004
Application Receipt Date:         October 14, 2004
Peer Review Date:                 February/March 2005
Council Review:                   May 2005
Earliest Anticipated Start Date:  July 2005

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  Scientific merit (as determined by peer review)
o  Availability of funds
o  Programmatic priorities

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that applications 
and proposals involving human subjects must be evaluated with reference to the 
risks to the subjects, the adequacy of protection against these risks, the 
potential benefits of the research to the subjects and others, and the importance 
of the knowledge gained or to be gained.  
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

DATA AND SAFETY MONITORING PLAN:  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).

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.  

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).  

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution.  The OCR website (http://www.hhs.gov/ocr/) 
provides information on the Privacy Rule, including a complete Regulation Text and 
a set of decision tools on “Am I a covered entity?”  Information on the impact of 
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts can be found 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals for 
NIH funding must be self-contained within specified page limitations.  Unless 
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be 
used to provide information necessary to the review because reviewers are under no 
obligation to view the Internet sites.  Furthermore, we caution reviewers that 
their anonymity may be compromised when they directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This RFA is related to one or 
more of the priority areas.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.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.


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