and Human Services (HHS)
EXPIRED
IMPROVING DIET AND PHYSICAL ACTIVITY ASSESSMENT
RELEASE DATE: October 10, 2002
PA NUMBER: PAR-03-009 (The R01 portion of this PAR has been reissued,
see PAR-06-104)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Replacement R21 (PAR-06-103 funding
opportunity announcements have been issued for the submission date of June 1, 2006
and submission dates thereafter.
EXPIRATION DATE: November 02, 2005
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(http://www.niddk.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov/)
Letter of Intent dates: January 1, 2003, September 1, 2003, May 1, 2004,
January 1, 2005, September 1, 2005
Application receipt dates: February 1, 2003, October 1, 2003, June 1, 2004,
February 1, 2005, October 1, 2005
Revised application dates: November 1, 2003, July 1, 2004, March 1, 2005
November 1, 2005
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism of Support
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 Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
The objective of this Program Announcement is to support research to improve
diet and physical activity measurement through improved instruments,
technologies, or statistical/analytic techniques. Proposals should be aimed
at exploring the optimal combination of objective and self-report measures of
physical activity or dietary intake that can capture these behaviors in both
general and diverse populations.
RESEARCH OBJECTIVES
I. Overview
Diet and physical activity are lifestyle and behavioral factors that play a
role in the etiology and prevention of many chronic diseases such as cancer
and coronary heart disease. Both also play a role in prevention of
overweight/obesity and maintaining weight loss. Moreover, longitudinal data
on physical activity and dietary intake would be especially helpful in
understanding how the physical activity and dietary intake patterns over the
lifespan may impact on health and functional status in later years and old
age. Therefore, diet and physical activity are assessed for both
surveillance and epidemiological/clinical research purposes. The measurement
of usual dietary intake or physical activity over varying time periods or in
the past, by necessity, has relied on self-reported instruments. Such
reports are cognitively difficult for respondents, and are prone to varying
degrees of measurement error depending on the time period considered, the
ease of the instrument, and the characteristics of the respondents.
Understanding and interpretation of instruments and the concepts they address
may differ among population subgroups. The NCI, NIDDK, NIA, and NINR are
interested in promoting research to: 1) improve existing instruments that
seek to measure dietary intake and physical activity within diverse
populations over time, 2) develop or refine new technologies for the
measurement of dietary intake or physical activity, and 3) improve the
statistical and analytical techniques to correct for measurement error in
diet and physical activity assessment instruments.
II. Background and Rationale
A. Dietary Assessment
Dietary assessment instruments are used in a variety of research settings in
which intake of individual foods or nutrients are of interest, as well as
overall energy intake. Such instruments run the gamut from food records in
which respondents record all foods as they are consumed, to detailed and
standardized 24-hour recalls of all food or drink ingested in the past day,
to food frequency questionnaires in which individuals are asked to report
usual frequency of intake of a long list of foods over a specified time
period, to short screeners which ask about usual frequency of intake of a
group of foods targeting a specific food group or nutrient. Each of these
self-reported dietary assessment instruments is successfully used in various
research or public health settings, however, each has flaws and limitations
both in the amount of information obtained, the quality of the data, and the
analytic techniques used to provide nutrient or food group estimates (1).
Food records are used in a number of nutrition research settings to measure
dietary intake over a single time period, usually three to seven days.
Records require motivated, trained, and literate respondents. The strength
of the food record approach is that it provides specific details on the
amount and kind of food consumed. Methods for food recording have improved
over time and include such innovations as electronic scales or computer entry
programs. However, records have important limitations. First, there is
consistent research showing that when individuals are asked to record what
they eat, they modify their eating habits to make the task easier and/or to
represent their diet in a more positive way. In addition, the quality of
diet recording is known to decline with increasing number of days. Among
many respondents there is a tendency for energy estimates from records to be
lower than that required for energy balance. This indicates that such
respondents are either under-eating and/or underreporting their intake. Even
with accurate reporting, a diet record is not thought to represent usual
intake unless it is repeated over different time periods and seasons.
Twenty-four hour dietary recalls, in which a trained interviewer asks and
probes respondents to report the kind and amount of all food and drink
consumed the previous day, are currently used to monitor group mean intakes
in the population. It is generally accepted that a single 24-hour recall
does not represent usual individual intake and cannot be used to estimate
population intake distributions of nutrients or food groups. Multiple
recalls are required to represent usual intake of all nutrients and foods,
and for nutrients and food groups that are infrequently consumed, many days
are required. Methods to collect recalls vary from paper-and-pencil to
computerized systems. The more highly sophisticated systems have
standardized probes, multiple passes of intake over the day to prompt recall,
and "forgotten foods lists." Such innovations in the recall methods have led
to improvements in prompting recall and, therefore improved estimates of
nutrient intake among respondents. However, recalls, like records, are prone
to underreporting, although the extent of underreporting may vary by quality
of the recall. Underreporting is likely due to problems involving memory,
difficulty in reporting portion size, and biases of the respondents.
Food frequency questionnaires (FFQs) are self-administered instruments in
which respondents are presented with a long list of items and asked to report
usual frequency of consumption over a specific time period (usually one
year). The strengths of the FFQ method are that it is designed to obtain
data regarding usual intake and is much less costly to administer and code
than recalls or records. Therefore, the FFQ has been the method of choice
for large-scale epidemiological studies. However, FFQs lack the detail and
specificity of records or recalls. The food list found on FFQs is, by
design, largely composed of frequently consumed foods. The nutrient database
lacks specificity and relies on nutrient content of the most common form in
which foods are consumed rather than on specific forms. Usual portion sizes
are either assumed or queried in a general fashion. In addition, completing
FFQs is cognitively difficult, requiring good memory and estimation skills.
There are many well-developed FFQs available for use by investigators;
therefore, development from scratch is not generally necessary for most
research efforts. Many FFQs available today can be adapted to meet
particular research needs. There have been limited efforts to adapt FFQs for
culturally specific populations and there is a continuing need to adapt
instruments as research in diverse and distinct socio-cultural populations
expands.
Extensive research has led to the general acceptance that FFQs are prone to
more and/or different kinds of error than records or recalls. FFQs have
commonly been calibrated with recalls or records, which are considered to be
more precise. However, given that there is measurement error in all dietary
assessment methods, various methods employing measurement error models and
energy adjustment are used to assess validity or to adjust relative risks for
disease outcomes. More recently, intake biomarkers such as doubly labeled
water for energy expenditure or urinary nitrogen for protein intake have been
used to better understand the structure of measurement error and to devise
methods to correct for this error in epidemiological studies.
The limitations of self-administered dietary assessment instruments also pose
a significant challenge for dietary intervention and/or metabolic studies,
especially where stringent monitoring of overall dietary composition and
energy intake is required. Such studies have often opted to provide meals to
the study subjects or include doubly labeled water assessments in addition to
the self-report dietary measures. However these approaches are not
necessarily feasible (e.g., limited availability of doubly labeled water),
often entail substantial time commitment on part of the study subjects and
study personnel (e.g., preparation and distribution of meals from the
metabolic kitchen, travel time of the study participants to collect or eat
their meals at the metabolic kitchen), and may run the risk of increasing
study subject burden, thereby affecting retention and future recruitment of
study subjects. In this regard, there is a critical need for objective and
accurate dietary assessment instruments and methodology (e.g., new nutrient
biomarkers, improved doubly labeled water protocols, and alternatives to
doubly labeled water) for dietary intervention and/or metabolic studies.
B. Physical Activity Assessment
Until fairly recently, the primary focus of research and recommendations
regarding physical activity was on sustained vigorous exercise. Such
activity is usually obtained through purposeful, programmed behavior such as
jogging, swimming, or sports participation. With these characteristics,
vigorous exercise is relatively easy for respondents to report, although
validation studies generally find a bias toward over-reporting (2). Recent
physical activity guidelines (3,4) have emphasized the accumulation of
shorter episodes of moderate intensity physical activity. Moderate intensity
activity can occur in many routine daily activities. Interventions to
increase physical activity obtained through moderate intensity daily
activities have achieved comparable physiologic outcomes to those that used
more vigorous programmed activities. However, monitoring behavior to assess
moderate intensity activities is a challenge because of the need to assess
many activities of short duration that may occur as part of routine daily
functions in varying contexts transportation, occupation, household chores,
as well as recreation and sport (5). Current guidelines also note the
importance of engaging in activities to promote strength and flexibility.
Maintaining strength and flexibility are important for an aging population,
and may have beneficial effects for disease prevention. Little attention has
been given to assessment of these types of activities.
Physical activity records have been shown to be quite accurate for capturing
total activity. Records can provide desired details regarding activity
context, the type of activity (e.g., aerobic, strengthening, or for
flexibility), as well as frequency, intensity, and duration. However, like
diet records, they are burdensome to respondents, requiring responses each
time there is a change in activity throughout the day. An advantage for
physical activity, in contrast to diet, is that recent technological advances
allow physical activity frequency, duration, and intensity to be objectively
measured by wearable monitors that can record movement and/or heart rate. A
challenge with the use of monitors is capturing total activity. This is
because activity monitors selectively record movement of the part of the body
to which they are attached. Activity monitors worn on the hip primarily
capture locomotion, but not upper body movement; if worn on the wrist,
locomotion is not accurately recorded. Without supplemental data collection,
activity monitors do not capture activity context (e.g., occupation,
transportation, household, recreation).
Most evaluations of physical activity in surveillance or risk factor
epidemiology rely upon retrospective questionnaire assessment. Many
instruments have been developed and some have been validated. A major
improvement in questionnaire assessment of physical activity was the
inclusion of household sources of activity, which can be the primary context
for physical activity among women. Efforts have also been made to adapt
questionnaires to include sources of physical activity common among certain
racial/ethnic groups. However, efforts to understand constructs implicit in
physical activity questionnaires, such as leisure time activity or moderate
physical activity, across various population subgroups are limited.
C. Parallels Between Diet and Physical Activity Assessment
There are many parallels in diet and physical activity assessment research
(6). For example, assessing total physical activity is analogous to
assessing total energy intake; assessing subcomponents of physical activity,
such as occupational or leisure time activity, or cardiovascular or
strengthening activities is analogous to assessing dietary fat or fruit and
vegetable intake. Reference periods for either diet or physical activity
behaviors can vary from a week to a lifetime, and may focus on recent
behavior, a specific previous period, or may be recorded contemporaneously.
Ideally, physical activity assessment includes type of activity and context
(specified by question content or respondent), frequency of behavior,
duration of behavior, and performance intensity. Estimating performance
intensity or duration is similar in many ways to estimating portion size in
dietary questionnaires. Respondents may not have internal reference criteria
that agree with the external criteria of the investigator, and the estimates
can be influenced by cultural norms or public health messages.
As with diet and other self-reported behaviors, physical activity assessment
is prone to measurement error. This error is related to the same challenges
of memory, estimation, and bias found in dietary assessment instruments.
Perhaps even more than for diet, many aspects of physical activity,
especially moderate physical activity, are routine and therefore not salient
enough to be recalled well by a respondent. Measurement error can obscure
relationships between physical activity and disease risk, and also distorts
values used for surveillance. Recent applications of measurement error
theory to dietary assessment have shown that reporting error can obscure
potentially important relationships. Furthermore, the demonstration of
correlated errors between FFQs and 24-hour recalls have called into question
the common calibration study approach. Physical activity assessment research
has lagged behind diet in addressing methods to evaluate and address
measurement error through statistical models and analytic procedures. It may
be possible to use recent advances in addressing dietary measurement error as
a basis for exploring means to characterize and handle measurement error in
physical activity.
III. Objectives
The objective of this Program Announcement is to support research to improve
diet and physical activity measurement through improved instruments,
innovative technologies, or application of statistical/analytic techniques.
Proposals should be aimed at exploring the optimal combination of objective
and self-report measures of physical activity or dietary intake that can
capture these behaviors in both general and diverse populations.
Specifically, this PA is intended to support research and innovation in
dietary and physical activity assessment. The focus is on the assessment of
the behaviors, and not on the determinants of these behaviors. Much effort
has already been put forth in the development of dietary and physical
activity instruments. For example, there are highly developed standardized
methods for collecting 24-hour recall data (e.g., Nutrition Data System for
Research (7), USDA 5 Pass Method (8)), food frequency questionnaire data
(e.g., NCI Diet History Questionnaire (9), Block FFQ (10), Willet FFQ (11)),
and physical activity questionnaires (e.g., Seven-Day Physical Activity
Recall, International Physical Assessment Questionnaire (12)). Given this
history, it is not the primary intent of this PA to make minor adjustments to
existing instruments (such as simply adding culturally specific foods or
activities to an instrument). The purpose is to promote substantive work to
refine or improve the assessment of diet and physical activity. Applications
could include development of: novel assessment approaches, better methods to
evaluate instruments, assessment tools for culturally diverse populations,
across various age-groups including older adults, improved technology or
applications of existing technology, or statistical methods to assess or
correct for measurement error.
Research topics to be supported by this PA will be those falling within areas
of clear importance for assessing the administration, utility, and/or
validity of collecting data to measure dietary intake or physical activity.
Possible topics include:
o Refine, and test methods of dietary or physical activity assessment for use
in population surveillance, epidemiological studies, and/or behavioral
interventions within general populations, socio-culturally diverse
populations, low-literacy respondents, or specific age groups.
o Develop or refine innovative methods to improve respondent self-report of
diet or physical activity behavior. Potential areas include non-
standardized questionnaire administration, or use of life event history
calendars or other recall cues to enhance retrieval of relevant information.
o Develop or refine innovative methods to improve underreporting of energy
intake among obese and overweight individuals.
o Develop, refine and test analytic or statistical methods to address
measurement error in the collection of dietary intake or physical activity
assessment instruments.
o Improve methods for measuring the type (resistance vs. aerobic) and amount
(frequency, intensity, duration) of physical activity behavior, the energy
cost associated with physical activity, energy intake, and energy balance.
o Improve methods for assessing intake of particular types of food
constituents, such as fat subtypes and phytochemicals.
o Validate methods for measuring dietary intake or physical activity using
appropriate reference instruments, including biomarkers, objective measures,
or physiologic outcomes such as strength and fitness.
o Develop or refine new technologies for the measurement of dietary intake or
physical activity.
o Conduct cognitive testing of self-reported dietary or physical activity
instruments to assess respondents' abilities to answer questions,
particularly in population subgroups.
o Conduct validation or testing of existing instruments to assess utility in
diverse populations.
o Identify factors leading to misreporting on dietary or physical activity
assessment instruments.
o Explore psychometric properties of instruments so that questionnaire items
can be developed for various groups, compared using the same metric, or be
administered with innovative approaches such as computer adaptive testing
methodologies.
o Explore the potential of ecological momentary analysis (EMA) techniques in
the assessment of the complex, periodic behaviors of dietary intake and
physical activity.
o Develop and test new methods for accurate assessment in normal elderly and
elderly with cognitive impairment or dementing diseases, which might result
in difficulty remembering details of dietary intake and physical activity
MECHANISM OF SUPPORT
Support of this program will be through the National Institutes of Heath
(NIH) research project grant (R01) or an exploratory/developmental grant
(R21). Applicants will be responsible for planning, direction, and execution
of the proposed project. Awards will be administered under NIH grants policy
as stated in the NIH Grants Policy Statement. The total project period for
an application submitted in response to this PA may not exceed 5 years for an
R01 application and 2 years for an R21 application. For R21 submissions, you
may request up to $100,000 direct costs (four budget modules) per year unless
your application includes consortium costs, in which case the limit is
$125,000 direct costs (five budget modules) per year. The R21 grants are
non-renewable and continuation of projects developed under this PA will be
through the traditional unsolicited investigator initiated grant program.
Applicants without extensive preliminary data or who wish to explore the
utility of new dietary or physical activity assessment methods are urged to
submit applications for this PA using the exploratory/developmental grant
(R21) mechanism. Investigators are encouraged to seek continued support
after completing an exploratory/developmental grant project through a
research project grant (R01). Applicants may wish to coordinate efforts in
developing their applications. Furthermore, applicants proposing to develop
new instruments for measuring dietary intake or physical activity are
strongly encouraged to build upon existing measures and instruments and to
collaborate with other investigators undertaking work in these areas as a
means of promoting improved methods or analytic techniques that can be shared
among multiple investigators and have utility in a number of research
settings.
This PA 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.
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
NCI intends to convene one or more workshops involving grantees funded under
this program announcement to facilitate future planning and program
direction. Grantees should provide budgets that include two two-day trips to
the Washington, DC area.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this PA and welcome the opportunity answer
questions from potential applicants. We strongly encourage investigators to
go to http://riskfactor.cancer.gov/ to learn more about this PA. Inquiries
may fall into two areas: scientific/research and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Amy Subar, PhD or Richard Troiano, PhD
Division of Cancer Control and Population Sciences
National Cancer Institute
Building EPN Room 4005
Bethesda, MD 20892
Telephone: (301) 594-0831 or 301-435-6822
FAX: 301-435-3710
Email: [email protected] or [email protected]
Susan Yanovski, MD
Director Obesity and Eating Disorders Program
National Institute of Diabetes & Digestive & Kidney Diseases
2 Democracy Plaza, Rm 665
Bethesda, MD 20892-5450
Telephone: (301) 594-8882
FAX: (301) 480-8300
Email: [email protected]
Chhanda Dutta, PhD
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3E-327, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 435-3048
FAX: (301) 402-1784
Email: [email protected]
Dr. Janice Phillips
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-6152
FAX: (301) 480-8260
Email: [email protected]
o 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
Telephone: (301) 496-8634
FAX: (301) 496-8601
Email: [email protected]
Ms. Sharon Bourque
Grants Management Specialist
Division of Extramural Affairs, NIDDK
6707 Democracy Blvd.
Room 612, MSC 5456
Bethesda, MD 20892-5456
Telephone: (301) 594-8846
FAX: (301) 480-3504
Email: [email protected]
Ms. Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: [email protected]
Ms. Tara Mowery
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-5979
FAX: (301) 451-5650
Email: [email protected]
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 PA
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 NCI staff to estimate the potential review workload and plan
the review.
The Letter of Intent is to be sent to Dr. Richard Troiano, at the address
listed under WHERE TO SEND INQUIRIES.
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) 710-0267,
Email: [email protected].
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted on February 1, 2003, October 1, 2003, June 1,
2004, February 1, 2005, and October 1, 2005. Revised applications will be
accepted on November 1, 2003, July 1, 2004, March 1, 2005, and November 1,
2005.
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.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the NIH program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the relevant institute staff that the institute
will accept your application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
at the relevant institute who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
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 or mailed on or
before the receipt dates of February 1, 2003, October 1, 2003, June 1, 2004,
February 1, 2005, or October 1, 2005. Revised applications must be received
or mailed by November 1, 2003, July 1, 2004, March 1, 2005, or November 1,
2005. 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
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review group
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
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 Those that receive a priority score will undergo a second level review by
an appropriate Advisory Board.
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 your 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 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?
(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
principal investigator and to that of other researchers (if any)?
(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)
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
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
"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 PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
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 No. 93.393 and 93.866, 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.
REFERENCES
1. Thompson FE, Subar AF. Chapter 1: Dietary Assessment Methodology. In:
Nutrition in the Prevention and Treatment of Disease, Coulston AM, Rock CL,
Monsen ER (eds), Academic Press, San Diego, 2001.
2. Sallis JF, Saelens BE. Assessment of physical activity by self-report:
Status, limitations, and future directions. Res Q Exerc Sport 2000; 71:1-
14.
3. US Department of Health and Human Services. Physical Activity and Health:
A Report of the Surgeon General. 1996. US Department of Health and Human
Services, Centers for Disease Control and Prevention, National Center for
Chronic Disease Prevention and Health Promotion, Atlanta, GA.
4. Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D,
Ettinger W, Heath GW, & King AC. Physical activity and public health. A
recommendation from the Centers for Disease Control and Prevention and the
American College of Sports Medicine. 1995; J Amer Med Assoc 273:402-407.
5. Troiano RP, Macera CA, Ballard-Barbash R. Be physically active each day.
How can we know? 2001; J Nutr 131:451S-460S.
6. Friedenreich CM. Physical activity and cancer: Lessons learned from
nutritional epidemiology. 2001; Nutr Rev 59:349-357.
7. http://www.ncc.umn.edu/index.htm
8. AJ Moshfegh, N Raper, I Ingwersen, L Cleveland, J Anand, J Goldman, R
LaComb. An improved approach to 24-hour dietary recall methodology. Ann
Nutr Metab 2001; 45(suppl 1): 156.
9. http://riskfactor.cancer.gov/DHQ/
10. http://www.nutritionquest.com/
11. Rimm EB, Giovannucci EL, Stampfer MJ, et al. Reproducibility and
validity of an expanded self-administered semiquantitative food frequency
questionnaire among male health professionals. Am J Epidemiol
1992;135:1114-1126.
12. A collection of physical activity questionnaires for health-related
research. Med Sci Sport Exerc 1997;29(6, Suppl), 205 pp.
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