ENHANCING STATE CAPACITY TO FOSTER ADOPTION OF SCIENCE-BASED PRACTICES 

RELEASE DATE:  April 27, 2004

RFA NUMBER:  RFA-DA-05-002 

EXPIRATION DATE:  August 18, 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 
 (http://www.samhsa.gov)

COMPONENT OF PARTICIPATING ORGANIZATONS:
National Institutes on Drug Abuse (NIDA)  
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.279
 
LETTER OF INTENT RECEIPT DATE:  July 17, 2004
APPLICATION RECEIPT DATE:       August 17, 2004  

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

As managers of publicly supported substance abuse service delivery, State 
Alcohol and Drug Abuse Agencies (referred to herein as “State Agencies”) are 
in a unique position to bridge the persistent and nationwide gap between 
science and services.  This initiative is designed to strengthen State 
Agencies’ capacity to support and engage in research that will foster 
statewide adoption of meritorious science-based policies and practices.  
Specifically, the National Institute on Drug Abuse (NIDA), with support from 
the Substance Abuse and Mental Health Services Administration (SAMHSA), will 
provide grants to State Agencies to conduct preliminary or pilot research 
that helps to create, implement, expand, and/or sustain a process of 
continuous science-based practice improvement in publicly supported drug 
abuse prevention and treatment programs.  This initial research should serve 
as a foundation for more in-depth services research to be conducted 
subsequently by the State Agency and its collaborators to enhance continuous 
practice improvement in the prevention and treatment of drug abuse and to 
foster implementation of proven, innovative therapeutic and management 
policies and practices.  

State Agencies (defined as agencies responsible for administering the 
Substance Abuse Prevention and Treatment Block Grant) are required to be the 
applicant organization under this Request for Applications (RFA), and a state 
officer is required to be the Principal Investigator.  State Agencies without 
adequate research capacity are encouraged to partner with researchers from 
organizations that do, such as universities and research institutes.  In 
either case, applications must propose research questions of relevance and 
value to the State Agency regarding its efforts to improve the delivery of 
publicly supported drug abuse prevention and/or treatment services.  
Furthermore, NIDA encourages applicants to consider conducting research on 
SAMHSA supported activities designed to foster adoption of science-based 
practices, including State Incentive Grants (SIGs), other service and 
infrastructure development grants, and Block Grants and/or to consider how 
the proposed research will contribute knowledge that can be directly applied 
through such SAMHSA funding opportunities.  

RESEARCH OBJECTIVES

Background

Since publication in 1998 of the Institute of Medicine report, entitled 
Bridging the Gap between Practice and Research, NIDA has focused attention 
and resources on improving the process of transporting science-based practice 
into community-based services.  Initial research-to-practice efforts focused 
on identification, manualization, and dissemination of science-based 
interventions; adoption by community-based programs; and service provider 
fidelity to manual guidelines.  Yet in spite of these efforts to expand the 
delivery of efficacious practices, many communities find it difficult to 
select, implement, and sustain services innovations that can increase access 
to services and the quality and economy of services for those suffering from 
or at risk for developing problem drug use.  

Increasingly, researchers have turned their attention to the change processes 
that occur in organizations seeking to improve their drug abuse prevention 
and treatment practices.  Focus has shifted from viewing the “science-to-
services” process as a one-time linear transfer of innovation from 
researchers to providers, to viewing it as a complex multidirectional process 
of continuous practice improvement that involves the interaction of multiple 
individual- and systems-level factors.  The process often involves providers 
becoming aware of a problem and being exposed to information about science-
based innovations that may address the problem.  Providers may then search 
for a solution by assessing available innovations, often in comparison with 
usual practice; adopt one or more innovations that appear promising for some 
clients; and then implement, reconsider, adapt, and, sometimes, sustain use 
of the innovation over time.  This newly emerging science-to-services model, 
although complex, acknowledges the often chaotic, multidirectional, and 
iterative nature of innovation and practice improvement.  Too often, however, 
practice improvement occurs in the absence of systematic examination, so that 
identifying the optimal process for ongoing innovation remains an elusive 
goal.

Recently, NIDA’s Blue Ribbon Task Force on Health Services Research issued 
its final report of recommendations for increasing the relevance and use of 
drug abuse research in practice and policy 
(http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf).  
In its report, the Task Force exhorts NIDA to stimulate and support 
innovative research to determine the components (e.g., administrative and 
service delivery structures, organizational and management functions, 
personnel qualifications) necessary for adopting, adapting, delivering, and 
maintaining effective research-supported policies, programs, and practices.  
Such research would include the development and analysis of the research 
infrastructures states require in order to adequately and continuously 
examine and improve performance in their systems for delivering drug abuse 
prevention and treatment services.  

Given adequate infrastructure and capacity, State Agencies are uniquely 
positioned to bring synergy, coherence, accountability, and long-term success 
to practice improvement in drug abuse prevention and treatment services.  
Situated between federal research efforts to develop scientifically sound, 
effective services and the local communities where such services are 
delivered, State Agencies can examine the systems-level structures, policies, 
strategies, methods, and tools that facilitate practice improvement.  
Moreover, because they set policy and allocate public health resources, State 
Agencies can influence the nature and pace of innovation adoption so that 
science-based services delivered by a range of providers can and do reach 
large numbers of individuals in diverse community settings and produce 
replicable and sustainable effects at reasonable cost.  

However, State Agencies often lack the resources to conduct research needed 
to support their efforts to initiate, develop, implement, and sustain a 
continuous science-based practice improvement process.  For example, state 
databases often lack the capacity to capture and/or integrate information 
about the nature and extent of community needs and resources and those 
factors that contribute to local adoption, adaptation, implementation, and 
sustained use of evidence-based innovations and practices.  States may lack 
resources to obtain accurate information for estimating the cost to implement 
service innovations.  Furthermore, states vary in their levels of readiness 
to institutionalize a practice improvement process that can refine data, 
clarify areas for improvement, and monitor the success of innovation efforts.  
Accordingly, this grant program is appropriate for states at any level of 
capacity development, and NIDA encourages State Agencies to conduct research 
geared to their specific level and needs on the path of developing, 
implementing, modifying, expanding, or sustaining a process of continuous 
practice improvement in their publicly supported programs.  States will not 
be at a disadvantage either for being at an early stage of development or at 
a more advanced stage.

Research Areas of Interest

This RFA encourages State Agencies to conduct research which increases their 
capacity to ensure that science-based drug abuse prevention and treatment 
services can and do reach the large numbers of individuals who need them, are 
widely adopted in diverse community settings, are effectively implemented by 
a range of educators and health care and social services providers with 
varying levels of training and expertise, and produce replicable and 
sustainable effects at reasonable cost.  In designing research, State 
Agencies should fully consider the chronic relapsing nature of drug abuse and 
the additional service delivery issues of developmental appropriateness for 
clients of different ages; gender sensitivity; cultural relevance; health 
disparities; comorbid mental, social, and medical conditions; and links 
between drug abuse and sexually transmitted and other infectious diseases.  
Appropriate and fundable research under this initiative includes preliminary 
or pilot studies on (1) state readiness and capacity for practice 
improvement; (2) systems-level factors that facilitate or impede the 
development, implementation, modification, expansion, or maintenance of 
continuous statewide process of practice improvement; and (3) cost or cost-
effectiveness analysis of continuous statewide process of practice 
improvement.
 
State Readiness and Capacity for Practice Improvement.  There is substantial 
variation in states’ current readiness and capacity for practice improvement.  
Some states currently promote and disseminate science-based services with 
little information about the factors that contribute to local adoption, 
implementation, and sustained use.  Scant knowledge about the most effective 
role of state leadership in fostering adoption of science-based practices 
precludes states from taking a systematic science-based approach to 
continuous practice improvement.  NIDA encourages State Agencies to assess 
state readiness and capacity to develop, implement, modify, expand, or 
sustain a process of continuous practice improvement in publicly supported 
drug abuse prevention and/or treatment programs.  The following research 
areas are illustrative of those that might be proposed:

o   Evaluate the capacity of service providers statewide to deliver 
coordinated/integrated services, to target services to specified 
subpopulations commensurate with treatment needs given their particular 
drug use and treatment careers, and/or to deliver services that support 
continuous recovery management.

o   Clarify differing provider organization needs for improvement in the 
quality and/or quantity of services as a function of community, setting, 
subpopulation, treatment approach, and other characteristics.

o   Quantify the training, expertise, and performance of substance abuse 
service providers statewide to identify ways to enhance career development 
policies and practices that ensure continuity of care, professionalism, 
and retention in the various substance abuse treatment provider 
professions.

o   Develop and assess the effectiveness of methods to enhance state capacity 
to synthesize (or support the synthesis of) available information on drug 
abuse prevention and treatment service needs to support priority setting 
and decision-making.

o   Identify monitoring tools and systems for assessing local provider 
performance and adherence to treatment guidelines; determine the degree of 
public support for administering incentives and sanctions based on 
performance.

o   Examine the effectiveness of research dissemination strategies currently 
in use to help service providers, community service programs, and state 
administrators keep abreast of current research, particularly regarding 
how well they support making timely, informed decisions about adopting, 
adapting, implementing, and sustaining use of science-based practices. 

Systems-level Factors that Facilitate/Impede Continuous Practice Improvement.  
Structural, organizational, management, staffing, and financial arrangements 
affect the accessibility, quality, cost, outcomes, and delivery of drug abuse 
services.  For example, inconsistent management and high rates of staff 
turnover can have a negative impact on the continuity of practice improvement 
efforts.  Similarly, innovations in financing policy and practice are a key 
component of the drive to improve services, given that practice is largely 
determined by complex reimbursement schemes involving state, local, and third 
party payers.  Moreover, all of these systems include interrelated multi-
level factors, suggesting that innovative changes may have direct as well as 
indirect effects on services.  The following research and development areas 
are illustrative of those that might be proposed:

o   Develop and evaluate integrated systems for managing state and local data 
on substance abuse service delivery that can help validly determine how 
policies and practices affect the quality, outcomes, and costs of 
services.

o   Institute and assess the effectiveness of training, financing, and/or 
policy initiatives designed to establish and support data-based continuous 
practice improvement as a state-wide business practice.  

o   Develop and assess systems to monitor organizational and management 
factors within provider agencies that can (a) identify programs, policies, 
and/or practices that optimize service efficiency and economy, quality, 
and long-term effectiveness; (b) guide the identification of innovative 
approaches to overcoming barriers to optimal service delivery; and (c) 
enable ongoing assessment of innovations, adoption of innovation, and 
implementation, evaluation, and sustained use of innovation. 

o   Establish and assess systems and methods designed to link indicators of 
quality care to changes in the structure, organization, management, 
staffing, and financing of service systems.

o   Monitor and assess the effects of inter-organizational collaboration 
(e.g., high-involvement teams, high-performance teams, corrective action 
teams, service and quality improvement teams, project teams, task forces, 
steering councils, process management and improvement teams, problem-
solving teams, cross-functional teams, departmental teams, regional/branch 
teams, self-directed or semi-autonomous teams, matrix teams) on the 
quality and outcomes of services in publicly supported drug treatment 
programs.

o   Establish systems and methods for monitoring effects of the state’s 
financing system(s) to (a) quantify financing effects on access to 
treatment for various subpopulations; and (b) assess how financing may 
facilitate or impede the delivery of integrated care services for managing 
the chronic relapsing condition of drug abuse.

Costs and Cost-Effectiveness of Practice Improvement.  A priority in 
understanding the public health relevance of drug abuse is cost-both service 
costs and societal costs.  Economic and accounting costs must be applied 
throughout management cost systems.  Accordingly, State Agencies will need to 
consider the costs and cost-effectiveness of developing, implementing, 
modifying, expanding, or sustaining a process of continuous practice 
improvement in publicly supported substance abuse programs. The following 
research areas are illustrative of those that might be proposed:

o   Identify the relative costs and distribution of drug abuse prevention and 
treatment services across the state; establish a system for tracking 
changes over time.

o   Identify cost efficient strategies to continuously upgrade the quality and 
professional standards of practicing providers and to train and attract 
new providers to the field.

o   Examine strategies for establishing and implementing a results-based 
reimbursement system statewide (e.g., pay-for-performance contracts with 
incentives to meet desired outcomes) for promoting optimal access to care, 
retention in care, and outcomes of care.

o   Examine the effects of pay-for-performance contracts on other treatment 
elements such as training, credentialing, and use of science-based 
practices, and efficient information systems.

MECHANISM OF SUPPORT

This RFA will use the R21 exploratory/developmental research award mechanism 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html)  As an applicant State 
Agencies will be solely responsible for planning, directing, and executing the 
proposed project.  This RFA is a one-time solicitation.  The anticipated award date 
is April 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 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.  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

NIDA, with support from SAMHSA, intends to commit approximately $1.35 million 
in FY 2005 to fund 10 to 12 grants in response to this RFA.  NIDA may give 
funding priority within this RFA to applications to examine SAMHSA supported 
activities aimed at fostering adoption of science-based practices or to 
applications designed to contribute knowledge that can be directly applied 
through such SAMHSA funding opportunities.  An applicant may request for the 
R21 project period up to 2 years and up to $100,000 in direct costs per year 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html).  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.  Although the financial plans of NIDA provides 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

State Agencies (defined as agencies responsible for administering the 
Substance Abuse Prevention and Treatment Block Grant) are required to be the 
applicant organization under this Request for Applications (RFA).  Each state 
may submit no more than one application. 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any state officer with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with his/her state agency 
to develop an application for support.    

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:

Beverly Pringle, Ph.D.
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4222, MSC 9565
Bethesda, Maryland 20892-9565
Telephone: (301) 443-4060
FAX: (301) 443-6815
Email: bpringle@mail.nih.gov

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland 20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 270, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@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
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 NIDA 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:

DA 05-002
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@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.

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.

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/label-bk.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/DHHS
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 
five (5) copies of the appendix material must be sent to:

DA 05-002
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)

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 
assignments 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 NIDA.  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 NIDA 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 Council on Drug 
Abuse.

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:  Does this study address an important problem of relevance 
and value to the State Agency regarding its efforts to improve the delivery 
of publicly supported drug abuse prevention and/or treatment services?  If 
the aims of the application are achieved, will the State’s capacity to 
continuously improve its publicly supported drug abuse service system be 
advanced?  Will these studies advance the field?  Does the study address an 
important problem consistent with the goals of this RFA?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Is the approach appropriate to the issues facing the particular 
state?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?  Is there adequate attention to systems-level and 
individual-level variables?  

(3) INNOVATION: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies to understand 
opportunities for, and barriers to, adoption of science-based policies and 
practices?  Does the project involve research on SAMHSA supported activities 
designed to foster adoption of science-based practices, including State 
Incentive Grants (SIGs), other service and infrastructure development grants, 
and Block Grants?

(4) INVESTIGATOR: Is the investigator appropriately trained and well suited 
to carry out this work, or does the investigator propose a reasonable 
partnership with others who are 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)?

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

(6) APPLICABILITY: Will the proposed work improve or advance current clinical 
practices and/or inform State health policy?  How well will the work address 
the identification and removal of barriers to improvements in clinical 
practice and/or health policy?  How well are the issues of relapse, 
comorbidity, developmental stage, gender, culture/ethnicity, and other 
factors taken into account?  How well are organizational, management, and 
cost factors taken into account?  Does the proposed research contribute 
knowledge that can be directly applied through SAMHSA funding opportunities, 
including State Incentive Grants (SIGs), other service and infrastructure 
development grants, and Block Grants?     

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:    July 17, 2004 
Application Receipt Date:         August 17, 2004
Peer Review Date:                 November/December 2004
Council Review:                   February 2005
Earliest Anticipated Start Date:  April 30, 2004

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 SAFETY AND 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 Safety and Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA: Investigators submitting an NIH application seeking  
$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 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. 

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing service for persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
Drug Abuse recognizes the importance of research involving the administration 
of drugs to human subjects and has developed guidelines relevant to such 
research.   Potential applicants are encouraged to obtain and review these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at http://www.nida.nih.gov under the Funding, 
or may be obtained by calling (301) 443-2755.

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.health.gov/healthypeople.

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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