MAINTENANCE OF LONG TERM BEHAVIORAL CHANGE

RELEASE DATE:  January 15, 2003 (see NOT-OB-03-002)

RFA NUMBER: OB-03-003

Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
Office of Disease Prevention (ODP)
 (http://odp.od.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Eye Institute (NEI)
 (http://www.nei.nih.gov/)
National Institute on Aging (NIA) 
 (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
 (http://www.niaaa.nih.gov/)
National Institute of Child Health and Human Development (NICHD) 
 (http://www.nichd.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
 (http://www.niddk.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR)
 (http://www.ninr.nih.gov/)

LETTER OF INTENT RECEIPT DATE: March 11, 2003
APPLICATION RECEIPT DATE: April 11, 2003

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 Special Requirements
o Where to Send Inquiries
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 above named organizations invites applications for research projects that 
(a) examine biopsychosocial processes and test interventions designed to 
achieve long-term health behavior change and (b) a Resource Center to provide 
coordination for this set of research projects. Past research has typically 
focused on short term behavioral change, yielding little information on how 
change, once achieved, is maintained over the long term.  This Request for 
Applications (RFA) encourages investigators to expand on the current 
theoretical base of change processes and intervention models, as well as to 
consider new conceptualizations from basic research in the social and 
behavioral sciences. Applications must focus on important health-related 
behaviors already demonstrated amenable to short-term change, such as tobacco 
use, exercise, eating habits, alcohol and drug use, inoculation obtainment, 
disease screening, stress reduction, adherence to health care regimens,human 
immunodeficiency virus (HIV)or sexually transmitted infection (STI) risk 
practices, bullying and abuse of others, sun exposure, and failure to use 
safety equipment.

RESEARCH OBJECTIVES

Background

This Request for Applications follows on a 1997 RFA focusing on "Innovative 
Approaches to Disease Prevention Through Behavior Change."  The goal of the 
1997 RFA was to stimulate investigation of innovative strategies designed to 
achieve healthy behavior change by focusing on tobacco use, sedentary 
lifestyle, poor diet, and alcohol abuse. The RFA solicited intervention 
studies aimed at either a comparison of theoretical approaches to behavior 
change or assessment of the utility of specific behavior change theory in a 
multibehavioral framework.

Although programs funded through that and other NIH efforts have been 
successful in achieving change during and immediately following the 
intervention phase, little empirical attention has been given to 
understanding factors that sustain and support behavior change after risk 
practices are identified, appropriate interventions implemented, and initial 
outcomes assessed. Indeed, other research indicates that relapse rates for 
addictive behaviors such as substance abuse and tobacco use are very high.  
For example, most individuals who stop smoking cigarettes relapse within six 
months.  Adherence to exercise, diet and other health regimens is no better, 
despite the fact that initial success rates for various behavior change 
programs are very high. Thus long term maintenance of behavior change is as 
challenging, if not more so, than the initiation of behavior change.  NIH 
believes that progress in this area may be accelerated by a more thorough 
examination of behavioral change processes that address factors influencing 
the initiation, maintenance, and resumption of behavior change at multiple 
levels. 

In 1998 the National Heart, Lung, and Blood Institute held a conference on 
"Maintenance of Behavior Change in Cardiorespiratory Risk Reduction."  Cross-
cutting themes and research recommendations that emerged from this conference 
included the need for (a) new models of population health behavior change and 
maintenance that integrate individual-level with broader environmental and 
macro-level policy influences; (b) a fuller model, which views maintenance 
more as a process than as a destination; and (c) more theory-based and 
interdisciplinary research on the maintenance process and on strategies for 
assisting special populations and addressing more than one behavioral risk at 
a time.  Participants suggested that researchers should focus on 
understanding those who are successful at long-term maintenance, and on 
developing new approaches that can be used to help those who are not.

The National Research Council 2001 report, "New Horizons in Health: An 
Integrative Approach", suggested that behavioral and social interventions 
have traditionally emphasized acute change. These interventions assume that 
the individual, group, community, or population has an adverse influence on 
health that could be corrected by a brief program of change.  In its report, 
the committee recognized the need for new models of behavior change that 
address sustaining change in the face of constantly shifting personal, social 
and environmental circumstances ( p.157).

Similarly, the Institute of Medicine (IOM) 2001 report, "Health and Behavior: 
The Interplay of Biological, Behavioral, and Societal Influences", noted that 
most studies, while demonstrating the ability to alter behavior, either do 
not test, or when tested do not demonstrate, sustained behavior change 
(p.334).  The IOM committee indicated that interventions are most likely to 
be effective when they address the context in which behavior occurs.  In 
their recommendations, they suggested the need to study both longer duration 
efforts, and concurrent interventions at the multiple levels that influence 
behavior: individual (physiological, psychological), family, social networks, 
organization, community, and society.  

Research Goals and Topics

This RFA seeks to stimulate studies of biopsychosocial processes and 
interventions that target long-term maintenance of behavioral change.  
Investigators are encouraged to expand on the current theoretical base of 
change theories and intervention models to include relevant areas, such as  
motivational interviewing, contingency management, goal setting, social 
marketing, and innovation diffusion, as well as to consider new 
conceptualizations from basic research in the social and behavioral sciences, 
including behavioral extinction, behavioral momentum/choice theory, 
behavioral economics, models of decision-making, and goal-directed behaviors. 

Applications must focus on important health behaviors previously shown to be 
amenable to short-term change, such as such as tobacco use, exercise, eating 
habits, alcohol and drug use, immunization, disease screening, stress 
reduction, adherence to health care regimens, HIV/STI risk practices, 
bullying and abuse of others, sun exposure, or use of safety equipment.  
Multi-level (individual, interpersonal, community and/or societal) approaches 
to the understanding of behavior and intervention are encouraged, as is an 
interdisciplinary perspective. Studies are welcome that expand upon currently 
funded projects to ascertain influences on participants' failure to maintain 
behavior change following intervention. Also, encouraged are studies that 
explore interpersonal or social contexts that may interfere with maintenance 
of behavior change. Studies may be observations, experiments, epidemiological 
surveys, intervention trials, or examinations of archival data. Cost/benefit 
analyses are also encouraged. 

The examples listed below are not exhaustive; it is expected that additional 
important strategies and topics will be identified by investigators who 
respond to this RFA.  Studies in these areas can include:

1) Research on factors affecting maintenance of behavior change, including:

Studies of risk and protective factors operating and interacting at 
different levels: individual level (isolation, genetics, poverty, lack 
of confidence, personality, stage of readiness to change, personal 
history of behavior change, coping skills, changing neurobiological 
substrates); interpersonal level (caregiving, peer pressure, friends 
and partners who smoke or drink, social support); community level 
(norms, stigma, community support, enforcement of laws, exposure to 
negative cues, neighborhood resources, safety); and/or societal level 
(food labels, changing policies, taxes, media, environmental 
determinants)

Studies examining whether different neurobiological, 
social/psychological, cultural, and other processes are involved in 
adopting a new behavior (short term change)  versus sustaining a 
behavior over time (long term change), including tests of the 
underlying assumptions of various maintenance theories

Research examining maintenance of behavior change in persons with 
multiple risk behaviors (e.g., comparing long term intervention 
response of people who engage in multiple risk or problem behaviors to 
those who engage in a single risk behavior; and analyzing possible 
transfer of behavior skills from one behavior to another).

Research examining the factors associated with maintenance of behavior 
change in those who achieved change themselves versus those who 
participated in formal interventions programs; or in those whose 
participation is voluntary versus court-mandated. 

Investigations of the extent to which social contexts sustain and 
support behavior change after behaviors are targeted, an intervention 
is implemented, and initial outcomes of intervention are determined. 
These factors may include continuation of cues and supports, and 
maintenance of reinforcement schedules supporting change. Studies that 
ascertain how social environments may be modified to provide greater 
reinforcing value or that increase the cost or delay of rewards 
associated with targeted health risk behaviors.

Research that explores ways to sustain skills that are newly acquired 
or enhanced through intervention but that decay over time due to lack 
of opportunity to practice or mastery experiences.

2)  Research on intervention, including studies of:

Intervention target: Investigations of various underserved or high-
risk/special need populations across the life-course, with respect to 
the effectiveness of different maintenance interventions for different 
and potentially vulnerable population groups (e.g.,  psychiatrically 
high-risk populations, ethnic or minority populations; economically 
disadvantaged populations; children, adolescents, elderly; injecting 
drug users and their sexual partners).  Also studies that describe how 
people lapse or relapse after behavioral proficiency is demonstrated in 
the context of intervention; studies examining the "match" between the 
intervention type and delivery style to individual or target population 

Intervention type and delivery channel: Studies of factors associated 
with intervention success or failure (e.g., therapeutic relationship, 
continuous care/ contact; tailored messages; self-help; dual behavior 
programs; partner support programs; relapse prevention training; 
varying learning contexts; providing retrieval cues; financial 
incentives; use of multiple media; pharmacotherapy; program intensity; 
integration into lifestyle, consistency of community enforcement 
programs)

Intervention setting: Studies of factors associated with the 
environment in which the intervention is delivered (e.g.,home, 
community centers, community task forces, social institutions such as 
schools and law enforcement, mass media) that either enhance or 
undermine successful maintenance

Intervention timing, duration, intensity: Studies that compare 
initiation and maintenance phases of behavioral change efforts, to 
determine how best to structure interventions designed to maintain 
behaviors (e.g., is it best to structure interventions so that they are 
initially intensive, then decreasing in intensity during maintenance, 
or should less intensive interventions be used for longer periods of 
time, or intensity maintained at high levels throughout?) Also included 
are studies that test the sustainability of various interventions over 
time, with and without "reintervening" or the use of "boosters" 
following some initial shorter follow-up period.  In this regard, 
studies that have demonstrated short-term, positive impact are 
encouraged to apply for funding to demonstrate longer-term 
sustainability.  The initial grant in which short-term outcomes were 
found does not necessarily have to be NIH funded.

Intervention level: Studies that compare single level interventions 
with programs that either intervene or coordinate at more that one 
level (individual, family, organizational, community, and/or societal); 
studies that capitalize on naturally occurring community or societal 
changes as these affect the success of structured interventions in 
maintaining changes in behavior; studies that identify how to make  
maintenance interventions self-sustaining after research funding ends

Active elements: Research that identifies the mechanisms of action or 
active components of behavioral, institutional, and community 
interventions that promote the maintenance of behavioral change, and 
how these may differ from active elements in interventions successful 
in producing acute change effects. These studies may focus on testing 
the underlying assumptions of various maintenance theories.

3) Other topics/special issues, including:

Studies that develop, adapt, or assess new technologies for either 
studying the natural history of behavior or delivering interventions 
designed to maintain  behaviors over the long term (e.g., examining 
whether internet-based programs can facilitate behavior maintenance or 
function in place of direct therapist support)

Interdisciplinary research that links biomedical, behavioral, 
sociological, anthropological, and policy perspectives to gain a more 
comprehensive understanding of maintenance as a process involving the 
interaction of multiple influences (e.g., metabolic, developmental, 
socioeconomic, physiological, psychosocial, and cultural influences on 
dietary patterns) 

Studies that examine the role of different financing factors and 
mechanisms (e.g., health plan parity benefits, managed care practices, 
other cost control measures, public vs. private insurance) in enhancing 
or undermining the effectiveness of behavioral, institutional, and 
community interventions designed to promote the maintenance of 
behavioral change.

MECHANISM(S) OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
(R01) award mechanism.  The total project period for an R01 application 
submitted in response to this RFA may not exceed 5 years.  As an applicant 
you will be solely responsible for planning, directing, and executing the 
proposed project.  The anticipated award date is October 2003.

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).

FUNDS AVAILABLE 

The co-sponsors intend to commit approximately $6,150,000 in 2003 to fund 
between 16-19 awards. The total cost of the Resource Center (see below)is not 
to exceed $200,000 annually.  Studies of complex intervention trials are not 
to exceed $750,000 in annual total cost per individual grant.  Studies of 
pyschosocial processes are expected to cost significantly less. 
Administrative adjustments in project period or amount of support may be 
required at the time of the award.   Since a variety of approaches would 
represent valid responses to this RFA, it is anticipated that there will be a 
range of costs among the grants awarded. 

The usual NIH policies governing grants administration and management will 
apply. Although this program is provided for in the financial plans of the 
sponsoring Institutes and Offices, awards pursuant to this RFA are contingent 
upon the availability of funds for this purpose and the receipt of a 
sufficient number of applications of high scientific merit.

ELIGIBLE INSTITUTIONS 

You may submit an application 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 or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

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

SPECIAL REQUIREMENTS

It is anticipated that a successful grant application will contain the 
following key elements:

Research Sites

Process studies
Studies of behavior and social processes may involve either the examination 
of archival data or the collection of new data.   Preference will be given to 
studies that are guided by conceptualizations that expand on the current base 
of change theories to include relevant areas, such as  motivational 
interviewing, contingency management, goal setting, social marketing, and 
methodology of innovation diffusion. Also receiving preferencial 
consideration will be studies that examine new conceptualizations from basic 
research in the social and behavioral sciences, including behavioral 
extinction, behavioral momentum theory, behavioral economics, models of 
decision-making, and goal- directed behaviors. Applicants are expected to 
show the relevance of their previous work to the current effort.

Interventions 
Interventions should be maintenance effectiveness trials in real world 
settings (e.g., home, clinic, workplace, club, church). Community-level 
interventions (e.g., studies of community-based regulatory or policy changes) 
will also be supported under this initiative.  When appropriate, the nature 
of the proposed intervention should be specified in terms of, for example, 
its intensity, duration, and frequency of contact.  Plans for assuring 
treatment fidelity and implementation must also be specified.  Applications 
must explain how the design will handle external factors that can affect 
intervention implementation and success.  Involvement of a community advisory 
panel and/or partnership with a non-academic community or health organization 
may be helpful in devising strategies to enhance intervention design, 
implementation, outreach, and interpretation of findings. Preference will be 
given to those with data demonstrating the efficacy of affecting shorter-term 
change on the same study cohort and behavior(s) of interest as the proposed 
study.  

Resource Center 

Applications are also requested for one Resource Center (CC)to interact with 
the selected grant Sites and the NIH program administrators on a variety of 
topics ranging from seeking and compiling information, to providing technical 
assistance, to assisting in cross-site analyses, to disseminating outcomes 
via mechanisms such as a website.  Because the behaviors, samples, and 
objectives may vary considerably across projects, the CC's first task will be 
to help the sites assess the potential for cross-study analyses and common 
measures. It is likely that commonalities will be found in subgroups of 
grantees rather than in the cohort as a whole.   

In consultation with the Sites and NIH, the CC will facilitate and coordinate 
selection of any common instruments (e.g., compiling the listing of proposed 
common measures; reviewing the literature and assessing the advantages and 
disadvantages of different measures for common study variables). 
Additionally, the CC will be responsible for tracking recruitment and 
retention across the different Sites, and advising the Sites on strategies 
for enhancing recruitment/retention, especially in minority or ethnic 
populations. The CC will work with projects to maximize the potential for 
cross-site comparability of data.   

While different sites may take the lead on different cross-study projects, 
including application for supplemental funding, the CC staff will collect and 
store shared data generated by the Sites, and have the option of 
participating with other awardees as co-authors in preparing manuscripts that 
report results from the common data sets. In addition, the CC will perform a 
variety of functions, such as, maintaining a directory of investigators and 
co-investigators; arranging all conference calls and meetings, and ad-hoc 
meetings of project directors; and facilitating information exchange among 
the Sites and NIH, and between the NIH and the general research community.  
Along these lines, the Resource Center will be responsible for planning the 
agendas and handling the logistics for the semi-annual meetings of the 
Research Sites, to be held in the Washington DC area. The CC will post 
minutes of the conference calls and meetings on a website that it will 
establish and maintain. The CC will post discussions of progress, problems, 
and accomplishments of the individual Sites and working groups that are 
formed to address topics of common concern (e.g., recruitment and retention, 
common measures, social support, common behaviors).  The latter role will 
also include compiling specific reports and developing and implementing 
common formats across Sites for all reports, protocols and descriptions. The 
CC will also devise plans for the dissemination of information resulting from 
these studies, including the preparation of slides for presentation of study 
objectives, methods, and findings. Up to $20,000 per year for cross-site 
consultants and small working group sessions should also be budgeted. Two 
completely separate applications from different applicant-investigators must 
be filed if an institution seeks selection as both a Research Site and the 
Resource Center. New Research Sites may be added in subsequent years.

Bi-Annual Meetings and Collaboration

All prospective awardees should describe strategies for the establishment of 
collaborative arrangements with other awardees.  Applicants must plan for 
conference calls four times a year among grantees supported as a result of 
the RFA, to discuss new developments, review research progress and 
difficulties, coordinate ongoing research and plan future research.  In 
addition, application budgets must include funds to attend two collaborative 
meetings to be held in the Washington DC area, for three investigators from 
each site per year.  The first collaborative meeting will occur shortly after 
grant award, and will focus on research designs, objectives, and possible 
collaborative arrangements that might foster increased productivity or 
efficiency in addressing the objectives proposed by the applicants.  Where 
feasible, it will be desirable to achieve some uniformity in measurement of 
key behaviors across the different funded sites. Applicants should include a 
statement about their willingness to participate in such activities.  The 
Resource Center will assist grantees with collaborative activities, such as 
conference calls, meeting logistics, and the development of common measures 
and methods. 

Data from any shared data sets will be submitted to the Resource Center on a 
regular basis, where it will made available for cross-site analyses and 
archived for public use within two years after the end of the initial award 
period. The CC, Sites and NIH program representatives will jointly define 
rules regarding publication of findings from analysis of the shared data sets.

It is hoped that the spirit of collaboration which spawned this initiative 
will carry forward throughout the project and beyond.  Toward this end, 
researchers are encouraged, after a reasonable period of time for primary 
analyses and publication, to make the data collected as a result of this RFA 
readily available to future researchers wishing to use this data at their own 
research site.  This availability may be achieved by either archiving the 
data and related documentation at any recognized data archive, placing the 
data and documentation on a publicly available file server maintained by the 
grantee organization, or supplying the data and documentation at cost upon 
request. 

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 three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

Direct your questions about scientific/research issues to:

Linda Nebeling, PH.D., MPH, RD, FADA ,Chief  
Health Promotion Research Branch  
Behavioral Research Program  
Division of Cancer Control and Population Sciences
National Cancer Institute  
6130 Executive Blvd, EPN 4080  
MSC 7335 Bethesda, MD 20892-7335 
(Rockville, MD 20852 for express mail) 
Telephone:  (301) 451-9530 
Fax:  (301) 480-2087 
Email:  nebelinl@mail.nih.gov

Maryann Redford, D.D.S, M.P.H.
Division of Extramural Research
National Eye Institute
Building EPS, Room 350
6120 Executive Blvd, MSC 7164
Bethesda, MD  20892-7164
Telephone:  (301) 451-2020
FAX:  (301) 402-0528
Email:  maryann.redford@nei.nih.gov 

Sidney M. Stahl, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533/Gateway
Bethesda, MD  20892-9205
Telephone:  (301) 402-4156
Fax:  (301) 402-0051
Email:  StahlS@nia.nih.gov

Jan Howard, Ph.D., Chief 
Prevention Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
6000 Executive Blvd. Suite 505
Bethesda, MD 20892
Telephone:  (301) 443-1678
Fax:  (301) 443-8774
E-mail:  jhoward@niaaa.nih.gov

Lynne M. Haverkos, MD, MPH
Behavioral Pediatrics and Health Promotion Research Program
National Institute of Child Health and Human Development
6100 Executive Blvd., Rm 4B05, MSC 7510
Bethesda, MD  20892-7510 
(Rockville, Md  20852 for Fed Ex or UPS)
Phone:  (301) 435-6881
Fax:  (301) 480-0230
E-mail:  haverkol@mail.nih.gov

Minda R. Lynch, Ph.D.
Behavioral and Cognitive Sciences Research Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., Rm. 4282
Bethesda, Maryland  20892
Phone:  (301) 435-1322
Fax:  (301) 594-6043
E-mail:  mlynch1@nida.nih.gov

Robert J. Kuczmarski, Dr. P.H.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 673 (MSC 5450)
Bethesda, MD  20892-5450  (for express mail, use 20817)
Telephone:  (301) 451-8354
FAX:  (301) 480-8300
E-mail:  RK191R@NIH.GOV

Andrew D. Forsyth, Ph.D.
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Blvd, MSC 9619
Bethesda, MD 20892
Telephone:  (301) 443-8403
FAX:  (301) 443-9719
Email:  aforsyth@mail.nih.gov

Janice Phillips, PhD, RN, FAAN
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
(Express Mail Zip Code - 20817)
Telephone:  (301) 594-6152
FAX:  (301) 480-826o
Email:  phillipsj@nih.gov

Direct your questions about peer review issues to:

Michael Micklin, Ph.D.  
Risk, Prevention, & Health Behavior Integrated Review Group  
Center for Scientific Review  
National Institutes of Health  
6701 Rockledge Drive, Rm. 3178 MSC 7848  
Bethesda, MD 20814-9692  
Telephone:  (301) 435-1258  
Fax:  (301) 480-3962 
Email:  micklinm@csr.nih.gov

Direct your questions about financial or grants management matters to:
Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD  20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8634
E-mail:  crystal.wolfrey@nih.gov

William W. Darby
Grants Management Officer
National Eye Institute
Building EPS, Room 350
6120 Executive Blvd, MSC 7164
Bethesda, MD  20892-7164
Telephone:  (301) 451-2020
FAX:  (301) 496-9997
Email:  wwd@nei.nih.gov

Linda Whipp
Grants and Contracts Management Officer
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email:  whippl@nia.nih.gov

Judy Fox
Chief, Grants Management Branch
Office of Planning and Resource Management 
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd. Suite 504
Bethesda, MD.  20892-7003
Phone:  (301) 443-4704
Fax:  (301) 443-3891
Email:  jsimons @niaaa.nih.gov

Dianna N. Bailey
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Blvd., Rm 8A01, MSC 7510
Bethesda, Md  20892-7510 
(Rockville, Md  20852 for Fed Ex or UPS)
Phone:  (301) 435-6978  
Fax:  (301) 480-4783
Email:  db405m@nih.gov  

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131
Bethesda, MD 20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
E-mail:  gf6s@nih.gov

Teresa Farris Marquette
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 728
Bethesda, MD  20892-5450 
Telephone:  (301-594-7682)
FAX:  (301) 480-3504
E-mail:  Marquettet@extra.niddk.nih.gov

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Blvd, MSC 9605
Bethesda, MD 20892
Telephone:  (301) 443-2805
Fax:  (301) 443-6885
Email:  diana_trunnell@nih.gov

Tara Mowery
Grants Management Specialist
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
(Express Mail Zip Code - 20817)
Telephone:  (301) 594-5979
Fax:  (301) 451-5650
Email:  tara_mowery@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 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:

Susan D. Solomon, PhD
Senior Advisor
Office for Behavioral and Social Sciences Research
National Institutes of Health
One Center Drive, Room 256 
Bethesda, MD 20892
E-mail (preferred):  ssolomon@nih.gov 
Phone:  (301) 496-0979
Fax:  (301) 402-1150 

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) 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, 
number, and type of application: "Site," or "Resource Center," must be typed 
on line 2a of the face page of the application form and the YES box must be 
checked. 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 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  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

Upon receipt, applications will be reviewed for completeness by the CSR.  
Incomplete applications will be returned to the applicant without further 
consideration.  Applications that are complete will be evaluated for 
scientific and technical merit by an appropriate scientific review group 
convened by CSR in accordance with the review criteria stated below.

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 FOR THE RESEARCH SITES

The goals of NIH-supported research are to advance our understanding of 
biopsychosocial systems, improve the control of disease, and enhance health.  
In the written comments, reviewers will be asked to discuss the following 
aspects of Research Site applications 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?  If an intervention is proposed, are the conceptual models well 
integrated into the design and testing of the proposed intervention? Will the 
intervention take place in a real world setting? Has sufficient detail about 
the intervention been provided to understand the intervention processes and 
mechanisms of change? Have provisions been made for extended follow-up, 
including methods capable of assessing maintenance of change and confounding 
variables?

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

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
PI and to that of other researchers (if any)? If an intervention has been 
proposed, has there been provision for partnerships between behavior change 
experts, intervention specialists, and appropriate health professionals or 
community leaders?

(5) ENVIRONMENT:  Does the scientific environment in which your 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.

REVIEW CRITERIA FOR THE RESOURCE CENTER

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 deserving of a high priority score. 

(1) CROSS SITE STUDY COORDINATION: Prior experience of the Principal 
Investigator and other key personnel in functioning as a Resource Center in a 
multi-site study, including coordination of both substantive and 
administrative aspects of multi-site studies 

(2) METHODS AND MEASURES:  Previous experience in instrument selection and 
development

(3) CONTENT:  Substantive familiarity with issues related to maintenance of 
behavioral change 

(4) DISSEMINATION:   Experience with communication and dissemination of 
information, including the preparation of slides and reports; establishing 
and maintaining a multi-site website; facilitating information exchange among 
the Sites, the NIH, and the general research community. 

(5) BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed set of activities.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    March 11, 2003
Application Receipt Date:         April 11, 2003
Peer Review Date:                 June/July 2003
Council Review:                   September 2003
Earliest Anticipated Start Date:  November 2003

AWARD CRITERIA

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

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities
o Content area balance
o Practice relevance

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 
IH 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://grants.nih.gov/grants/stem_cells.htm 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 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 RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

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 Numbers 93.395 (NCI), 93.867(NEI), 93.886 (NIA), 
93.273 (NIAAA), 93.865 (NICHD),93.279(NIDA), 93.242 (NIMH), and 93.361(NINR), 
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) and administered under NIH grants policies 
described at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

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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