MECHANISMS OF PHYSICAL ACTIVITY BEHAVIOR CHANGE
 
RELEASE DATE:  June 23, 2003
 
RFA:  CA-04-009
 
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
Office of Disease Prevention (ODP)
 (http://odp.od.nih.gov/)
Office of Research on Women's Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.399, 93.847, 93.848  
 
LETTER OF INTENT RECEIPT DATE: October 15, 2003

APPLICATION RECEIPT DATE: November 14, 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 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 purpose of this RFA is to increase the knowledge base necessary to 
develop effective physical activity interventions in children, 
adolescents, adults, and older adults. Specifically, this RFA seeks to 
elucidate the psychosocial, environmental, and physiological factors 
involved in the mechanisms of physical activity behavior change to 
better understand the factors involved in the causal pathways that lead 
to physical activity behavior change. 

RESEARCH OBJECTIVES

I. Overview

Given the importance of physical activity in the etiology, treatment, 
and prevention of many chronic diseases (such as cardiovascular 
disease, some cancers, and diabetes), it is important to understand how 
physical activity behavior can be increased. It is particularly timely 
to understand the mechanisms of physical activity behavior change since 
the majority of the U.S. population does not meet current physical 
activity guidelines (U.S. Department of Health and Human Services 
[USDHHS], 2000), and obesity continues to increase at an alarming rate 
(USDHHS, 2001). Little is known about the mechanisms of change in 
physical activity. While current physical activity interventions 
incorporate behavior change theories in their development, these 
studies do not focus on understanding the mechanisms of change, nor do 
they use a multidisciplinary perspective to understand the process. 
Understanding the psychosocial, environmental, and physiological 
factors that affect the mechanisms of behavior change is necessary for 
developing effective intervention and to avoid wasting both time and 
resources on interventions, which target correlates that are not in the 
causal pathways of physical activity (Kraemer, Stice, Kazdin, Offord, & 
Kupfer, 2001).

II. Identification of the problem

The incidences of overweight and obesity continue to rise and have 
reached epidemic proportions in the U.S (USDHHS, 2001). Currently, 
64.5% of the U.S. adult population is either overweight or obese, and 
the percentage of overweight children and adolescents has doubled and 
tripled, respectively, over the past 20 years (Flegal, Carroll, Ogden, 
& Johnson, 2002; Odgen, Flegal, Carroll, & Johnson,2002). Disparities 
in the prevalence of overweight and obesity exist by age, gender, 
race/ethnicity, and socioeconomic status (USDHHS, 2001). The overweight 
and obesity prevalence tend to increase with age, to be higher for 
women who are non-Hispanic white and for women of lower socio-economic 
status (USDHSS, 2001). In children and adolescents racial/ethnic 
disparities have been observed also. Non-Hispanic white adolescents 
from lower socioeconomic family have higher prevalence of overweight 
(USDHHS, 2001).  Physical activity can be important in preventing 
weight gain and in decreasing weight, but few adults or 
children/adolescents actually achieve the recommended 30 minutes of 
moderate physical activity on most days of the week (15% and 20%, 
respectively). More children/adolescents engage in vigorous physical 
activity (64%) than the small proportion of adults who do (23%) 
(USDHHS, 2000). Disparities in the prevalence of physical activity in 
adults have been linked to age, gender, race/ethnicity, and 
socioeconomic status. Physical activity tends to decrease with age and 
to be lower among women, non-Hispanic white, and among those with lower 
socioeconomic status (Sallis & Owen, 1999). Among youth, the prevalence 
of physical activity is lower among girls and it is affected by 
socioeconomic status as well as race/ethnicity, although it is 
difficult to disentangle the interaction between these demographic 
variables (Sallis & Owen, 1999; Sallis, Zakarian, Hovell, & Hofstetter, 
1996). To change these trends, it is essential to understand how 
physical activity behavior may be modified (i.e., to understand the 
mechanisms of behavior change). In addition, it is important to 
understand if the mechanisms of behavior change differ by age, gender, 
race/ethnicity and socioeconomic status.

Although some studies have examined whether theory-based interventions 
change physical activity behavior, the components responsible for the 
observed change have not been clearly identified, making it difficult 
to develop effective interventions (Baranowski, Anderson, Carmack, 
1998; Baranowski, Lin, Wetter, Resnicow, & Hearn, 1997; King, 2001; 
Sallis, 2001). Recent professional conferences have urged researchers 
to focus on understanding the mechanisms of change (1997 Cooper 
Institute conference entitled, "Physical Activity Intervention," and 
the 2001 Cooper Institute conference entitled, "Innovative Approaches 
to Understanding and Influencing Physical Activity"). At the 1997 
conference, Baranowski and colleagues reported how little was known 
about the mechanisms of change in physical activity, even though 
theories have been used in the development of interventions (Baranowski 
et al., 1998). The 2001 conference focused on understanding variables 
that affect physical activity in an effort to identify potential 
mechanisms of physical activity behavior change (King, Bauman, & 
Calfas, 2002). However, it became apparent that few studies have 
focused on the causal pathways and few, if any, have used a 
multidisciplinary approach that integrates the psychosocial, 
environmental, and physiological factors associated with behavior 
change. In 2001, King and Sallis published an editorial in the Annals 
of Behavioral Medicine reiterating the same concern (King, 2002; 
Sallis, 2001) and a recent Institute of Medicine report also encouraged 
researchers to use this multidisciplinary perspective to understand 
behavior change (Pellmar, Brandt, & Baird 2002).

III. Background

Few studies have investigated the mechanisms of physical activity 
behavior change, and preliminary data point to conflicting results 
(Baranowski, et al., 1998; Calfas, Sallis, Oldenburg, & French 1997; 
Sallis, Calfas, Alcarz, Gehram, & Johnson 1999; Bock, Marcus, Pinto, & 
Forsyth, 2001; Lewis, Marcus, Pate, & Dunn 2002). A review by 
Baranowski and colleagues noted that inconsistent findings are common 
in physical activity studies (Baranowski et al., 1998). Mechanisms of 
physical activity behavior change have been both empirically derived 
(Dishman & Sallis, 1994) and theoretically hypothesized (Bandura, 1986, 
Prochaska & DiClemente, 1983; Prochaska & DiClemente 1994). In physical 
activity research, constructs derived predominantly from five major 
theories/models have been used to develop interventions. These 
theories/models are the health belief model, theory of planned 
behavior, transtheoretical model, social cognitive theory, and 
ecological models (Sallis & Owen, 1999; Marshall & Biddle, 2001). 
Unfortunately, efficacious intervention studies based on these 
theories/models provide little understanding of the mechanisms of 
behavior change because researchers have used a "kitchen sink" approach 
to intervention development. To develop theory-based interventions, 
researchers typically select constructs from various theories to 
develop their interventions. Although this process provides some degree 
of confirmation for these theories, it fails to identify the true 
mechanisms of behavior change because a random process is used to 
identify these constructs, the causal pathways are not stated a-priori, 
and the theoretical assumptions about the mechanisms of change cannot 
be tested since the theories are not fully implemented and multiple 
components of various theories are tested simultaneously. Thus, this 
RFA seeks to understand the mechanisms of physical activity behavior 
change. To understand the mechanisms, the direct and indirect causal 
pathways that may be operating will need to be stated a-priori and 
studies that can test these causal inferences are targeted by this RFA. 
Designing studies that test the mechanisms of behavior change will be 
necessary as well as using adequate statistical methods (e.g., path 
analysis, structural equation modeling, and hierarchical modeling). 
According to Lewis et al. (2002) only two published papers have used 
appropriate statistical procedures, such as Baron and Kenny's (1986) 
statistical approach, to test the mechanisms of physical activity 
behavior change. Thus, to summarize little has been done to understand 
the mechanisms of physical activity behavior change and nothing has 
been done to understand if the mechanisms differ by demographic 
characteristics (i.e., gender and race/ethnicity). 

Although the five theories/models (listed above) predominantly used in 
physical activity research may serve to elucidate the mechanisms of 
behavior change, researchers have focused mostly on understanding 
individual (e.g., cognitive and psychosocial) influences on behavior. 
Researchers have not typically used a comprehensive approach to 
elucidate the mechanisms of physical activity behavior. Researchers 
have not integrated external (e.g., socio-cultural and physical 
environment) influences and socio-structural (e.g., community, 
workplace/schools, policies, media information) influences to identify 
the psychosocial and environmental factors involved in the causal 
pathways to physical activity behavior change. For example, empirical 
evidence is accumulating to suggest that enhanced access to places for 
physical activity increases levels of physical activity (Kahn et al., 
2002). It is important for future research to consider how this 
influences the mechanism of behavior change. Focusing on the 
psychosocial and environmental influences is the perspective that 
behavioral scientists have emphasized in other fields (including 
tobacco). However, as other fields have demonstrated, it is equally 
important to consider the biological factors, as individual behavior 
has biological underpinnings that are influenced by the social and 
psychological context (Pellmar et al., 2002). This multidisciplinary 
focus is the focus of this RFA. 

Genetic predisposition is expected to influence behavior and change in 
physical activity behavior; however, the science is not sufficiently 
advanced at this time to consider studying genetic predisposition as 
part of this RFA. Instead, researchers can study physiological 
phenotypes that are hypothesized to influence adoption and maintenance 
of an active lifestyle (e.g., obesity and fitness status). Note that 
this RFA focuses on understanding which physiological component affects 
physical activity participation. Specifically, to link what is 
happening at the cellular level (i.e., efficacy of mobilizing free fat 
acid and blood glucose) when someone exercises to, for example, 
positive mood and fatigue (assuming that positive mood or fatigue are 
both linked to voluntary participation in physical activity). 
Ultimately, these studies would identify the specific physiological or 
biological mechanisms that explain individual differences in voluntary 
participation in physical activity. For example, the aerobic/anaerobic 
process (i.e., the physiological process explaining oxygen delivery to 
an exercising muscle), which is linked to lactate production and 
concentration in the blood level (Åstrand & Rodahl, 1986), can impact 
physical activity adoption by affecting how people feel during and 
after exercise (feeling fatigued, light headed, or pain). As fitness 
levels increase, the aerobic/anaerobic process becomes more efficient, 
and it is less likely that this process will affect participation and 
maintenance of an active lifestyle. Finally, as there are a number of 
physiological differences between men and women, it is also important 
to study these gender differences. Understanding such physiological 
influences is targeted by this RFA. 

In addition to understanding the physiological influences associated 
with physical activity behavior change, this RFA also is interested in 
elucidating psychosocial and environmental influences. Although, all 
possible environmental influences are of interest for this RFA, studies 
will be limited in their ability to manipulate some of these components 
(such as governmental policies and the physical environment). As the 
central focus of this RFA is to understand the mechanisms of physical 
activity behavior change, it is much more appropriate to design studies 
that manipulate environmental influences in a more constrained and 
controllable environment such as schools and worksites. Designing 
controlled laboratory experiments may be better to begin to isolate the 
variables involved in the mechanisms of physical activity behavior 
change. This RFA does not expect studies to manipulate all variables 
that influence voluntary participation in physical activity, but 
researchers are expected to account for potential confounders or 
covariates in their analyses. For example, changes in nutritional 
behaviors are not targeted by this RFA but it will need to be measured, 
as it can be, both, a confounder or modifier of physical activity 
behavior.   

IV. Objectives and Scope

The purpose of this RFA is to support studies that further the 
understanding of how physical activity intervention works. 
Specifically, the focus is in supporting studies that elucidate the 
causal pathways that lead to physical activity behavior change. Studies 
that consider the psychosocial, environmental, and physiological 
factors that influence the mechanisms of physical activity behavior 
change are of interest. The physiological and psychosocial influences 
that are affected by disease status are of particular interest to this 
RFA (e.g., weight change, obesity, shift in muscle and fat mass, 
physical activity capacity, resting metabolic rate, hormonal change, 
immune functions, depression, anxiety, and quality of life).  

Appropriate topics

Sample topics that are appropriate for (but not limited to) this RFA 
are listed below. Opportunities exist for both conducting in-depth 
analyses of existing data and designing studies that determine the 
mechanisms of physical activity behavior change.

Existing data. A number of existing interventions have not fully 
analyzed their data to understand the mechanisms of change and 
opportunities exist to further explore these data under this RFA.

o Test the psychosocial, environmental, and/or physiological influences 
on the mechanisms of physical activity behavior change are appropriate 
as secondary data analysis.

o Use appropriate statistical methods (e.g., path analysis, structural 
equation modeling, growth models, and hierarchical model) to analyze 
(or re-analyze) existing data to further understand the psychosocial, 
environmental, and physiological factors involved in the mechanisms of 
physical activity behavior change. 

o Conduct group analyses to identify if the psychosocial, 
environmental, and/or physiological influences differ by age, gender, 
and race/ethnicity using appropriate methods to correct for potential 
confounders.

Mechanisms of change studies. These studies should provide the 
empirical knowledge necessary to develop effective physical activity 
programs. The following are examples of potential topics (but not 
limited to) that would be responsive to this RFA. 

o Identify the psychosocial, environmental, and physiological factors 
involved in changing physical activity behavior, including 
cardiorespiratory fitness and strength training. These studies should 
focus on understanding how the physiological (obesity, weight gain, 
cardiorespiratory fitness) and psychosocial (perceived barriers, social 
supports, and self-efficacy) factors interact to change behavior while 
considering the environmental influences. If environmental influences 
are manipulated, these studies should be conducted in a controlled 
setting (i.e., laboratory type of experiment).

o Compare how the psychosocial, environmental, and physiological 
factors involved in the mechanisms of physical activity behavior change 
are affected by health status. The NCI, for example, is interested in 
studies that focus on the physiological (obesity, change in body 
composition, sudden weight gain, decrease cardiorespiratory fitness, 
change in aerobic/anaerobic process) and psychological changes 
associated with cancer diagnosis and cancer treatment strategy. NIDDK 
is interested in studies that evaluate the impact of physical activity 
behavior change on development or amelioration of insulin resistance 
and type 2 diabetes.
 
o Understand if the mechanisms of physical activity behavior change 
differ for certain populations. For example, to elucidate if the 
mechanisms differ by gender as there are a number of psychosocial and 
physiological differences between men and women. 

o Determine how obesity and/or change in body weight (positive or 
negative) interact with the psychosocial factors to influence the 
causal pathways that lead to physical activity behavior change. Such 
studies may be conducted in a disease-free population versus a diseased 
population. Studies that compare these mechanisms by study population 
are needed. 

o Identify the physiological factors that may influence adoption of an 
active lifestyle, such as aerobic/anaerobic process, lactate 
production, and mobilization of energy (free fatty acid and blood 
glucose) in the blood and identify how these physiological factors 
interact with the psychosocial factors (i.e., identify the specific 
physiological mechanisms underlying individual differences in voluntary 
participation in physical activity). For example, researchers may study 
if body temperature, cortisol level, availability of free fatty acid 
and blood glucose levels during exercise affect post exercise 
psychological and physiological status (e.g., positive mood, feeling 
fatigued, light headed, etc…) and, in turn, assess of this influence 
physical activity participation.

o Identify the socio-demographic or cultural variables that affect the 
mechanisms of behavior change involved in minimizing health disparities 
(i.e., age, gender, race/ethnicity, educational level, and 
socioeconomic status). 

o Compare how the psychosocial, environmental, and physiological 
factors involved in the mechanisms of behavior change differ for 
adoption and maintenance.

o Determine the psychosocial, environmental, and physiological factors 
that have a direct and indirect (through change in physical activity 
behavior) effect on quality of life (fatigue, depression, anxiety, 
stress, and overall quality of life) as well as elucidate the 
underlying mechanisms.

o Combine qualitative and quantitative methods to understand the 
mechanisms of physical activity behavior change. Specifically, 
understand the context under which certain pathways may provide greater 
accuracy or become operational. Such studies should focus on 
understanding the processes underlying behavior change at the 
individual or population level. 

o Develop and test new theories/models that integrate multiple levels 
of influence (e.g., individual, family, community, environmental, 
health policy, media, etc.) on physical activity behavior and use a 
multidisciplinary perspective to understand the mechanisms of physical 
activity behavior change. Studies may allow for the possibility of 
uncovering new variables and ways in which variables may be combined 
with existing variables to predict changes in behavior (e.g., assess 
whether the variables have additive or multiplicative effects).

MECHANISM OF SUPPORT
 
This RFA will use NIH R01 and R21 award mechanisms. 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 2004. 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 as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm). 
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format. Otherwise follow 
the instructions for non-modular research grant applications. 

FUNDS AVAILABLE
 
The participating ICs intend to commit approximately $2,860,000 in FY 
2004 to fund 6 to 9 new and/or competitive continuation grants in 
response to this RFA. An applicant may request a project period of up 
to 5 years for R01 and 2 years for R21. The direct costs per year will 
be limited to $400,000 for full scale R01 and to $100,000 for full 
scale R21. 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 the IC(s) 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 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
 
Restrictions on Applications

All applications should explicitly state a-priori the underlying 
assumptions tested, even if the project uses theories to study the 
causal pathways that lead to physical activity behavior change. The RFA 
does not require that a given theory or model be tested, but it 
requires that when a theory or model is employed, all relevant 
constructs from these theories/models be included. The RFA is not 
interested in studies that assess the efficacy of a "kitchen sink 
intervention," even if the intervention used theories in its 
development. This RFA is particularly interested in understanding how 
physiological and psychological factors interact to influence the 
causal pathways of physical activity. All studies should focus on 
understanding these influences. In addition, contextual variables 
should be included to control for environmental influences by either 
manipulating these influences or accounting for their effects, as 
necessary for the proposed study. Finally, all studies should measure 
nutritional behaviors as it can be both a confounder or modifier of 
behavior.

Bi-Annual Meetings and Collaboration

In response to the RFA, investigators will be required to participate 
in an investigators' meeting that will meet semi-annually in the 
Washington, D.C. area. Applicants must include the cost to attend two 
one and half day meeting in their budget. The composition of this 
workgroup will also be supplemented (if needed) by adding key experts 
(NIH experts and extramural researchers) in the area of behavior 
change. This workgroup will enable the exchange of scientific 
knowledge, sharing of expertise, development of standards for studying 
the mechanisms of change, tracking of progress, and identification of 
new research opportunities. Applicants must plan for conference calls 
six times a year to share results among grantees and to coordinate the 
semi-annual meetings. At the completion of these awards, NIH may invite 
applicants to present their main research findings.

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:

Louise C. Mâsse, Ph.D.
Division of Cancer Control and Population Sciences
Behavioral Research Program
National Cancer Institute 
Building EPN, Room 4076
Bethesda, MD  20892-7335
FAX: (301) 480-2087
Email: massel@mail.nih.gov

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

Deborah H. Olster, Ph.D.   
Office of Behavioral and Social Sciences Research 
National Institutes of Health  
Bldg. 1, Room 256  
One Center Drive  
Bethesda, MD 20892-0183  
FAX: (301) 402-1150  
E-mail: olsterd@od.nih.gov 

Martina Vogel-Taylor, M.T.
Office of Disease Prevention
National Institutes of Health
6100 Executive Boulevard, Room 2B03
Rockville, MD 20852
Fax: (301) 480-7660
E-mail: VogelM@od.nih.gov

o Direct your questions about peer review issues to:

Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

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

Ms. Crystal Wolfrey  
Grants Administration Branch
National Cancer Institute  
6120 Executive Plaza South, Suite 243 
Bethesda, MD  20892
(For express / courier service only: Rockville, MD 20852) 
Telephone: (301) 496-8634 
FAX: (301) 496-8601 
Email: crystal.wolfrey@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:

Louise C. Mâsse, Ph.D.
Division of Cancer Control and Population Sciences
Behavioral Research Program
National Cancer Institute 
Building EPN, Room 4076
Bethesda, MD  20892-7335
FAX: (301) 480-2087
Email: massel@mail.nih.gov

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 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
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 
must be sent to:
 
Referral Officer 
Division of Extramural Activities 
National Cancer Institute 
6116 Executive Blvd., Room 8041, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8329

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER 
INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to 
courier deliveries (i.e. FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  
This change in practice is effective immediately. This policy is 
similar to and consistent with the policy for applications addressed to 
Centers for Scientific Review as published in the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

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. While the investigator may 
still benefit from the previous review, the RFA application is not to 
state explicitly how.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCI. 

Incomplete applications will be returned to the applicant without 
further consideration. And, if the application is not responsive to the 
RFA, NIH staff may contact the applicant to determine whether to return 
the application to the applicant or submit it for review in competition 
with unsolicited applications at the next appropriate NIH review cycle.

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 Division of Extramural Activities of the 
NCI 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 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 second level review by the National Advisory Council or 
Board of the relevant NIH institute.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. 
In the written comments, reviewers will be asked to discuss the 
following aspects of the application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

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

SIGNIFICANCE: Does this study address an important problem? If the aims 
of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of 
the project? Does the applicant acknowledge potential problem areas and 
consider alternative tactics?

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

INVESTIGATOR: Is the investigator appropriately trained and well suited 
to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

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

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
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).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed. 

ADDITIONAL CONSIDERATIONS 

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.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: October 15, 2004 
Application Receipt Date: November 14, 2004
Peer Review Date: February/March 2004
Council Review: May/June 2004
Earliest Anticipated Start Date: July 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 

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

Clinical trials supported or performed by NCI require special 
considerations. The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial. Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager 
or NCI program staff or a Data and Safety Monitoring Board (DSMB). 
These monitoring activities are distinct from the requirement for study 
review and approval by an Institutional review Board (IRB). For details 
about the Policy for the NCI for Data and Safety Monitoring of Clinical 
trials see: 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. 
For Phase I and II clinical trials, investigators must submit a general 
description of the data and safety monitoring plan as part of the 
research application. See NIH Guide Notice on "Further Guidance on a 
Data and Safety Monitoring for Phase I and II Trials" for additional 
information: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data safety 
monitoring plans for clinical trials funded by the NCI is available: 
http://www.cancer.gov/clinical_trials/

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

All investigators proposing clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: 
NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects. You will find this policy 
announcement in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 
A continuing education program in the protection of human participants in 
research in now available online at: http://cme.nci.nih.gov/

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: 
The Department of Health and Human Services (DHHS) issued final 
modification to the "Standards for Privacy of Individually Identifiable 
Health Information", the "Privacy Rule," on August 14, 2002. The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply). 

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

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

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This 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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