RELEASE DATE:  October 07, 2003
RFA Number:  RFA-HL-04-006
Department of Health and Human Services (DHHS)

National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

93.837, 93.233 

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 Supplementary Instructions
o Peer-Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The National, Heart, Lung and Blood Institute (NHLBI) invites applications for 
research project (R01) grants to test interventions that are innovative and emphasize 
environmental approaches or a combination of environmental and individual approaches 
at worksites to prevent or treat obesity in adults. The purpose is to support studies 
designed to determine whether worksite interventions that include environmental 
strategies are successful in preventing or controlling obesity.  Environmental 
strategies include programs, policies or organizational practices to influence health 
behaviors by, for example, increasing the availability of, and providing access to, 
healthful food choices and facilities for physical activity and creating a socially 
supportive climate.  


The objective of this research program is to support multiple controlled trials to 
test innovative multi-component interventions that have sufficient duration (about 2 
years) and intensity to be efficacious. The interventions must be delivered at 
worksites and must emphasize environmental approaches or a combination of 
environmental and individual approaches for the prevention or control of overweight or 
obesity in adults. 

Obesity is increasing in the United States at an alarming rate. An estimated 97 
million U.S. adults are overweight or obese, with higher prevalence in racial/ethnic 
minorities. Overweight and obesity increase the risk of hypertension, dyslipidemia, 
diabetes, sleep-disordered breathing and cardiovascular mortality. The economic costs 
of obesity and overweight in the United States approach $117 billion per year. There 
is a need to address the obesity problem from multiple fronts, including environmental 
and community approaches. This need was highlighted by the Surgeon General's Call to 
Action, by the National Nutrition Summit, and in the Healthy People 2010 Objectives 
for the Nation. 

Traditional obesity control strategies, which have focused on educating individuals to 
change diet and physical activity behaviors, often do not reach large numbers of 
people, and only a small proportion of adults are able to sustain weight loss on a 
long-term basis. Altering environmental influences on behaviors is a promising 
additional strategy that may be more generalizable, cost-effective, and sustainable.  

Environmental approaches use policies, programs, or organizational practices to 
influence behaviors by, for example, increasing the availability of, and providing 
access to, healthful food choices and facilities for physical activity and by creating 
a socially supportive environment.  More than 20 published research studies have 
altered the environment to promote healthful behaviors (e.g., facilities for physical 
activity, nonsmoking policies at worksites, lower-fat food availability in vending 
machines or cafeterias at worksites and schools).  These studies indicate that this 
approach could be used with some success, but further research is needed.

The worksite is a feasible and potentially effective setting for implementing 
environmental approaches to promote behavior change.  Worksite interventions can reach 
large numbers of adults and are viable venues for reaching the working population.  
Characteristics of worksites that may be conducive to environmental approaches include 
physical (e.g., availability of exercise rooms and cafeteria), social (e.g., social 
support from coworkers, a well-established communication system for support), and 
community environments that provide opportunities for healthful diet and physical 
activity. Low turnover rates in the organization may also be needed for successful 
interventions of this type. 

The worksite is an important setting for establishing environmental and policy changes 
leading to increased physical activity among employees (e.g., policies related to 
sleep and fitness, flextime, or fitness-center discounts) and improved dietary intakes 
of employees (e.g., through offering healthful food choices, lowering portion sizes 
and reducing prices of healthful lower calorie foods in cafeterias and vending 
machines, or providing nutrient and calorie information on foods at the point-of-
purchase).  Worksite interventions may also enhance social support from fellow workers 
to facilitate positive dietary and physical activity behaviors.  Work schedules such 
as early start times, shift work, long hours and schedules that result in shortened 
sleep patterns, as well as worksite environmental factors such as lighting and 
temperature, may contribute to unhealthful eating habits as well as physical 
inactivity. Support from worksite administration and management, as well as from 
employees is an important consideration for successful implementation of worksite 
interventions. Therefore, applicants should consider these factors and the 
organizational and environmental attributes of the workplace that can be used to 
promote behavior change and to motivate, facilitate, and sustain efforts of workers to 
prevent weight gain, lose weight, and/or promote weight control.

Many published studies on worksite interventions for weight control reveal that the 
interventions tested have largely not used the worksite environment and its social 
aspect.  Interventions have been primarily individual behavioral approaches of minimal 
intensity and short-term duration - 6 months or less- and intervention effects have been 
modest with variable weight loss (a range of about -12.1 lb to +7.9 lb over 6 months 
in controlled studies).  None addressed environmental influences on weight control 
behaviors or the psychosocial work environment and its role in employee weight 
control.  Only a few were randomized controlled trials, which limit the validity of 
the results. In addition, because most of the studies were conducted in large 
worksites (> 500 employees) and lacked information on racial and ethnic minority 
distributions, their generalizability is uncertain. 

Applicants must test interventions that emphasize environmental approaches to behavior 
change but are encouraged to emphasize and justify areas they believe are most 
important.  Environmental interventions are interventions designed for the entire 
worksite and may affect policies, programs, facilities or organizational practices to 
influence health behaviors. Such interventions may be combined with individual 
approaches.  Applicants are encouraged to use behavioral theories or prior empirical 
evidence to develop their interventions. For the individual-level component, 
behavioral theories may be used separately or in combination to plan the intervention. 
Examples of such theories are those of planned behavior, social cognition and reasoned 
action, and the trans-theoretical model (stages of change) as well as mediators such 
as self-efficacy and social networks. For planning the environmental component of the 
intervention, socio-ecological, social cognitive and organizational-change theories, 
and communication processes such as participatory involvement by workers and decision-
makers, and/or the diffusion of innovation model may be used.  Applicants are 
encouraged to apply other behavioral theories or frameworks and are not limited to the 
examples above.

Project Phases
Applications in response to this RFA will have two phases. Phase 1 is for formative 
research and recruitment, estimated to last about one year. Phase 2 is to test a two-
year intervention followed by data analysis and dissemination. The total duration of 
the study should not exceed four years. 

Phase 1 
This planning phase consists of formative research to refine the intervention and may 
include focus groups, in-depth interviews, surveys of worksite administrators and 
employees, and/or an assessment of the worksite and surrounding community environments 
to determine attributes of the environments that are conducive to environmental 
interventions. Such needs assessment approaches should be used to identify barriers to 
implementing the intervention as well as factors that could enhance participation of 
employees in the intervention. Phase 1 could be optional for some applicants who 
already have Phase 1 information, which can be presented in the application in support 
of the need for the Phase 2 study.

Phase 2 
Applicants must specify the intervention, which must be innovative, feasible, and 
attractive to worksite administrators and to employees of varying socioeconomic status 
and work schedules, have sufficient duration and intensity to be efficacious, and must 
include environmental approaches. Environmental interventions affect worksite programs 
and policies, which would result in, for example, increased physical activity and 
decreased sedentary behaviors both during and after work hours and schedules, changes 
in cafeteria or vending machine offerings to healthier lower-calorie foods, and/or 
community outreach or collaboration. The interventions could include family members or 
participants from employees' social networks outside of the worksite. 

Applicants must describe the proposed intervention in their application; some 
refinements may be anticipated based upon the formative research in Phase 1. The 
process for using formative research from Phase 1 to refine the intervention for Phase 
2 should be described. Applicants should present available background material and 
pilot data that are relevant to the proposed intervention, and describe and justify 
the innovative aspects of their intervention. Environmental interventions are intended 
to influence everyone in the target environment, and thus evaluation of their effects 
should consider the entire exposed population. Some interventions could target 
overweight and obese individuals at the worksite in addition to using environmental 
strategies for the entire worksite. Studies must be designed such that the intensity 
and frequency of the intervention are sufficient to effect change in outcome measures.  
Examples of research objectives for interventions that could be conducted in the 
worksite settings include the following: (These examples are illustrative, and do not 
comprise an exhaustive list.)  

o Intervention studies that compare environment-focused interventions with individual 
behavioral approaches to prevent and/or control obesity. 
o Intervention studies that examine the feasibility of establishing or reinforcing 
policies for environments supportive of physically active/and or healthful dietary 
o Studies of environmental interventions that are culturally appropriate and are 
conducted at the worksite in collaboration with community-based organizations to 
enhance physical activity and improve dietary practices.
o Intervention studies that use social support networks at the worksite and/or family 
members' support in collaboration with community agencies and/or businesses such as 
restaurants or food outlets to improve diet and physical activity of workers.
o Studies that test the efficacy of environmental interventions or a combination of 
environmental and individual-focused interventions to prevent obesity in worksites of 
predominantly underserved populations, including racial and ethnic minority 
populations and rural men and women. 
o Intervention studies that examine the efficacy of establishing or reinforcing 
policies for environments that reduce worksite fatigue and sleepiness as a means of 
improving the diet and physical activity of workers.

A combination of worksite environmental activities and strategies could be used. Some 
examples of these include:
o Offering smaller, healthier portion sizes of foods at lower prices, in worksite 
cafeteria and/or vending machines, or in surrounding restaurants most frequently used 
by workers.
o Providing flextime for physical activity or fitness breaks during work hours, and/or 
fitness-center discounts for physical activity before and after work hours.
o Establishing walk-to-work or bicycle-to-work days at the worksite.
o Providing pedometers for employees to enhance their motivation for physical 
o Making stairways more accessible and attractive, through lighting, signage, and open 
access, while discouraging use of elevators. 
o Mitigating the adverse effects of excessive workplace sleepiness on motivation for 
physical activity through education and changes in routine, lighting and work 

Applicants should design the interventions to be practical, cost effective and 
sustainable without undue cost after the study.

Design and outcome measures
Each successful applicant will conduct a separate study. Applicants should have a 
total of at least four worksites (two intervention and two control) allocated equally 
to intervention and control groups. Studies could be designed so that worksites would 
be the unit of randomization and analysis. Alternately, individual employees could be 
used as the unit of analysis if justified. 

The primary outcome measure should be a continuous measure of the degree of 
overweight/obesity such as body weight, body mass index, or percent body fat, or a 
measure of the proportion of overweight or obese in the population. Secondary outcome 
measures could include the following: measures at the environmental level to determine 
the impact of environmental changes such as changes in worksite programs, policies, 
and food availability as well as other environmental elements of interest; measures at 
the individual level to determine the effect of the intervention on health behaviors, 
such as employees' dietary intake, physical activity, and sleep patterns; and 
mediating variables such as self-efficacy, employee attitudes, and perceived benefits 
and barriers. Measurements of interest to the worksite, such as worker productivity, 
absenteeism rates, and intervention costs, are strongly encouraged.  Cost-
effectiveness analysis is encouraged.  Additional secondary outcome measures may 
include cardiovascular risk factors such as blood pressure, blood lipids, fasting 
blood glucose, hemoglobin A1c, and insulin.  

Critical Elements of Applications
Each applicant must:
o describe the characteristics of their proposed worksites and provide evidence of 
support from worksite administrators and employees, for example, in the form of a 
letter of intent to collaborate that should be included in the appendix of the 
o provide information on the size and type of the proposed worksites, as well as 
employee turnover rates and stability, which could affect power calculations and 
sample size. 
o provide adequate representation of minorities and women.
o use and describe methods to assure the similarity of intervention and control groups 
on important characteristics. 
o describe methods for recruiting and retaining worksites and participants and for 
maximizing intervention exposure, especially for individuals who are overweight or 
o describe and justify the intervention in detail and include an environmental 
component in the intervention plan.

Where appropriate, applicants are strongly encouraged to:
o provide information on the physical, social and surrounding neighborhood 
environments that would support an intervention to promote healthful diet and physical 
activity behaviors.
o target worksites that are small to medium size or that require sedentary activities 
and often have automated work tasks.  
o describe procedures for employees to continue to pursue healthful dietary and 
physical activity behaviors outside of the worksite setting (e.g., intervention 
activities with family members or social networks).  
o address the economic impact of the interventions on the worksite or employer (e.g., 
costs and benefits related to the impact of the intervention on absenteeism and sick 
Coordinating functions
To facilitate coordination of research activities between awardees, this RFA will also 
support the costs of performing coordination functions by one of the awardees. These 
functions include the following:
o developing a program website and email system for group communication
o arranging meetings and conference calls
o coordinating preparation of scientific publications and  dissemination of findings 
from the studies 

It is anticipated that coordinating functions will include supporting multiple 
committees that the investigators would want to form in order to collaborate. 
Applicants should propose to perform coordinating functions in addition to conducting 
the study. A separate budget should be included for this purpose. The evaluation of 
these coordinating functions would be separate from the overall review of the 
scientific merit of the research application. 


This RFA will use the National Institutes of Health (NIH) R01 award mechanism.  The 
total requested project period for an application submitted in response to this RFA 
may not exceed four years. 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 other investigator-initiated applications and will be 
reviewed according to the customary peer review procedures. The anticipated award date 
is September 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 budgeting as well as 
the non-modular budgeting formats (see 
https://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if you are 
submitting an application with direct costs in each year of $250,000 or less, use the 
modular budget format.  Otherwise follow the instructions for non-modular budget 
research grant applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 


NHLBI intends to commit a total of approximately $17 million (including direct and 
Facilities and Administrative (F&A) costs) over a four-year period to award 4 to 5 
applications in response to this RFA. About $3.0 million in total costs (direct and 
F&A costs) will be awarded in FY 04. It is anticipated that the first year will cost 
less than subsequent years because it will be for Phase 1 and start-up activities. 
Because the nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size of each award will also vary.                                      

Coordinating functions 
Applicants should also include a section in their application to conduct coordinating 
functions. NHLBI intends to commit an additional total budget of about $0.5 million 
(including direct and Facilities and Administrative (F&A) costs) over a four-year 
period to support one award for coordinating functions. 

Although the financial plans of the NHLBI 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. At this time, it is not expected that 
this RFA will be reissued. 


You may submit an application if your institution has any of the following 
o Domestic for-profit or non-profit organizations and worksites
o Public or private institutions, such as universities, colleges, hospitals, and 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Faith-based or community-based organizations
o Foreign institutions are not eligible to apply

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


Annual meetings 
Applicants funded under this RFA will be required to attend meetings in which study 
plans, findings, and issues of common interest and concern will be shared and 
discussed.  Investigators will meet:  (1) shortly after the beginning of funding to 
discuss study plans; (2) annually until the end of the study, to share experiences in 
the needs assessment, design, recruitment, and implementation of the interventions; 
(3) after completion of the analyses to share results and materials.  Applicants 
should include in their budgets funds for attending these meetings.  For budgeting 
purposes, applicants should assume that the meetings would be for 2 days in Bethesda, 
MD, at the National Institutes of Health and require the attendance of the Principal 
Investigator and up to one other person. Applicants should include the cost of meeting 
rooms and equipment in the budgets for coordinating functions for these annual 

Dissemination plan
Applicants must include in their application a plan for dissemination of research 
results and interventions, which will be implemented if the intervention is successful 
and appropriate to be used at other worksites.  Such a plan should include:
o Identification and description of target audience of the dissemination plan. 
o Description of the methods to be used to reach the audience. 
o Appropriate benchmarks for success of the dissemination plan.
o Discussion of how the intervention may be made translatable and sustainable.
o Appropriate additional personnel for developing and implementing the dissemination 
o An appropriate budget for the proposed dissemination activities for the last year of 
requested funding.  
o A statement that the investigators agree to discuss and finalize the dissemination 
plan with Institute staff prior to its implementation.

Applications that do not include a dissemination plan will be considered non-
responsive and not eligible for review. 

Final Report
At the completion of the project, the Principal Investigator (PI) of each research 
project grant must provide a report to the NHLBI Project Office with: (1) detailed 
recommendations concerning the intervention(s) evaluated, based on the study's 
findings; (2) a complete description of the intervention(s) used in the study, 
including a description of the rationale for the intervention(s), the intervention 
procedures used (e.g., manual of procedures), and any intervention materials used; (3) 
training, certification, and quality control procedures for ensuring effective 
implementation of the intervention(s); and (4) description of how the interventions 
could be tailored for other worksites.


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:

Direct questions about scientific/research issues to:

Charlotte Pratt, PhD, RD
National Heart, Lung, and Blood Institute
Division of Epidemiology and Clinical Applications
Prevention Scientific Research Group
6701 Rockledge Drive
MSC 7936, Room 8134
Bethesda, MD 20892 (20817 for Express or Courier Service) 
Tel.: (301) 435-0382
Fax: (301) 480-1669
Email: prattc@nhlbi.nih.gov

Direct your questions about peer review issues to:

Anne Clark, PhD
Chief, Review Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
MSC 7924, Room 7214
Bethesda, MD 20892 (20817 for Express or Courier Service)
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: clarka@nhlbi.nih.gov

Direct your questions about financial or grants management matters to:

Mr. Kieran Kelley
Senior Grants Management Specialist
National Heart, Lung, and Blood Institute/NIH
6701 Rockledge Drive, Rockledge 2, Room 7170
Bethesda, Maryland  20892-7926  
Fax: (301)-480-3310
email:  kelleyk@nhlbi.nih.gov


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 
Institute 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 Anne Clark at the address listed 
under Where to Send Inquiries.


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet 
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when 
applying for Federal grants or cooperative agreements. The DUNS number can be obtained 
by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. 
The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The 
PHS 398 document is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.  For 
further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 

$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 https://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 https://grants.nih.gov/grants/funding/modular/modular.htm.

The following are requirements:  

o The page limit for sections a-d is 25 pages, including tables and figures. 
o Additional three pages are allowed for coordinating functions.

Applicants must provide descriptions of how they plan to perform coordinating 
functions and must address the critical elements for coordinating functions specified 
in this RFA. Up to three additional pages will be allowed to describe these functions 
and the budget for coordinating functions should be provided separately.
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: 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the 
application, including the Checklist, and three signed, photocopies, in one package 
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 plus all five collated sets of 
appendix material must be sent to Anne Clark at the address listed under Where to Send 
APPLICATION PROCESSING: Applications must be received on or before the application 
receipt date listed in the heading of this RFA.  If an application is received after 
that date, it will be returned to the applicant without review. 

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application in response to 
this RFA that is essentially the same as one currently pending initial review, unless 
the applicant withdraws the pending application.  However, when a previously unfunded 
application, originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW application.  That is, 
the application for the RFA must not include an Introduction describing the changes and 
improvements made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NHLBI. Incomplete and/or non-responsive applications will be 
returned to the applicant without further consideration.

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 
NHLBI in accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will:

o Undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, will be 
discussed and assigned a priority score
o Receive a written critique
o Receive a second-level review by the National Heart, Lung, and Blood Institute 
National Advisory Council.

Principal investigators should not send supplementary material without first 
contacting the Scientific Review Administrator (SRA).  The SRA will be identified in 
the letter sent to you indicating that your application has been received.  If you 
have not received such a letter within three weeks after submitting the application, 
contact Dr. Anne Clark at the address listed under Where to Send Inquiries. 

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. 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.  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score.  For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

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? Does 
the intervention address obesity prevention and/or control at the worksite? Are 
environmental strategies major components of the proposed intervention? Applicants 
must include environmental strategies, which have the ability to influence an entire 
workforce, in their application. 

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, 
include subjects from 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.  


SHARING RESEARCH DATA:  Applicants requesting more than $500,000 in direct costs in 
any year of the proposed research must include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the rationale for not 
sharing research data will be assessed by the reviewers. However, reviewers will not 
factor the proposed data sharing plan into the determination of scientific merit or 
priority score. See 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html for guidance.

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

COORDINATING FUNCTIONS:  Reviewers will consider the plan for facilitating the 
coordination of research activities between awardees, but will not factor the plan 
into the determination of the scientific merit or the primary priority score. Each 
plan will receive a secondary priority score which is separate from the primary 
priority score of the parent application. The following review criteria will be used.

SIGNIFICANCE: Does the applicant address the importance of performing coordinating 
functions in order to enhance the value of the research program?

APPROACH: Are the proposed activities appropriate for facilitating coordination among 
awardees? Are state-of-the-art coordinating strategies proposed?

INVESTIGATOR: Is the applicant well suited to or experienced in carrying out 
coordinating functions?

ENVIRONMENT: Is there evidence of institutional support? Does the applicant have prior 
experience in performing coordinating functions?

DATA SHARING:  The coordinating plan will be evaluated on the adequacy of the proposed 
plan to share data. For more information on data sharing, please see the following 


Letter of Intent Receipt Date: January 15, 2004
Application Receipt Date: March 12, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 30, 2004


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.

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.

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types 
of clinical trials, including physiologic, toxicity, and dose-finding studies (phase 
I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase 
III).  The establishment of data and safety monitoring boards (DSMBs) is required for 
multi-site clinical trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, investigators 
submitting an NIH application seeking more than $500,000 or more in direct costs in 
any single year are expected to include a plan for data sharing or state why this is 
not possible. https://grants.nih.gov/grants/policy/data_sharing  Investigators should 
seek guidance from their institutions, on issues related to institutional policies, 
local IRB rules, as well as local, state and Federal laws and regulations, including 
the Privacy Rule. Reviewers will consider the data sharing plan but will not factor 
the plan into the determination of the scientific merit or the priority score.

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 responding to the RFA 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 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy 
of the updated Guidelines are available at 

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 

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 

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 

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.

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 

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 

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 

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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