CANCER RESEARCH SMALL GRANT PROGRAM

RELEASE DATE:  September 27, 2002

PA NUMBER: PAR-02-176 (see replacement PAR-04-147)

National Cancer Institute (NCI)    
 (http://www.nci.nih.gov/)

APPLICATION RECEIPT DATE:  Nov. 20, 2002;  Mar. 20, 2003; July 21, 2003; Nov. 
20, 2003; Mar. 22, 2004, July 20, 2004

This Program Announcement (PA) replaces PAR-00-025, which was published in 
the NIH Guide on December 13, 1999.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
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 Division of Cancer Prevention of the National Cancer Institute (NCI) 
invites applications that address developmental research in chemoprevention  
agent development, biomarkers, early detection, and nutrition science.  The 
Small Grants Program is designed to aid and facilitate the growth of a 
nationwide cohort of scientists with a high level of research expertise in 
cancer prevention research.  It is anticipated that these Small Grant 
Programs may lead to the submission of subsequent Individual Research Project 
Grants (R01).

New, as well as experienced, investigators in relevant fields and disciplines 
(e.g., chemoprevention, nutritional science, genetic and infectious agents, 
and early detection, including biomarker development and validation) may 
apply for small grants to test ideas or do pilot studies.

 This PA will expire in two years from the first receipt date.  NIH Grants 
policies apply to these awards.

RESEARCH OBJECTIVES

This program is designed to aid and facilitate the growth of a cadre of 
scientists with expertise in cancer prevention research.  Small grants are 
short-term awards which provide support for pilot projects, development and 
testing of new methodologies, or innovative projects that provide a basis for 
more extended research.

The Division of Cancer Prevention invites applications that address 
developmental research in chemoprevention agent development, biomarkers, early 
detection, and nutrition science, in addition to clinical studies that focus 
on specific target organs. The specific areas of research may include, but are 
not limited to:

Early Detection 

Identification, development, and evaluation of biological analytic techniques, 
methodologies, and clinical technologies relevant to pre-clinical cancer 
detection and prevention:

        Cellular, molecular, and genetic tumor markers
        Molecular epidemiology and genetic risk factors
        Imaging technology

Identification of molecular signatures of cancer-associated infectious agents 
for earlier cancer detection and risk assessment.

Transfer of basic laboratory findings into applications for early detection 
with the goal of extending this research to comparative clinical trials.

Development and evaluation of new high-throughput genomic- and proteomic-
based detection techniques and measure sensitivity, specificity, validity, 
and safety. 

Translational research to facilitate the transfer of new technologies (to the 
clinical setting) for earlier detection, prevention, and risk assessment.

Development and evaluation of computer-based data monitoring systems for 
analysis and interpretation of laboratory data on multiple markers of and for 
the development of modeling systems based on molecular, genetic and other 
risk factors to be used in the evaluation of cancer prevention approaches.

Definition and evaluation of prognostic factors of pre-cancerous lesions by 
computer models that include neural networks, artificial intelligence, and 
other techniques.             

Development of analytic techniques to identify populations that may be at 
increased risk as indicated by genetic and metabolic phenotypes 
(susceptibility markers).

Chemoprevention

Pilot testing and development of new methods of chemoprevention, dietary, or 
nutrition intervention.

Development and evaluation of molecular targets to prevent, reverse, or 
retard progression of precancerous lesions (and hence the cancer process) by 
natural, 
synthetic, and/or dietary/nutritional interventions.

Feasibility and efficacy testing of rapid screening methods to identify and 
prioritize new chemopreventive agents.

Testing of new strategies to prevent cancer or its progression in persons at 
increased genetic risk.

Development of innovative animal models to mimic the human cancer process in 
order to expedite research in cancer prevention.

Nutrition

Improvements in methodology development for assessing nutritional status, 
metabolic patterns, and dietary modulation of genetic expression.

Identification, development and validation of biochemical or biological 
markers for measuring and monitoring dietary compliance and exposure.

Development of reliable methods for analysis of nutrients, other dietary 
components and their metabolites in foods, body fluids, and tissues.

Development of mechanistic studies of dietary constituent interactions, gene-
nutrient interactions and dietary environmental factor interactions.

Determination of bioavailability and dose-response of foods, nutrients, and 
other naturally-occurring food constituents. 

Although the specific study proposed may attempt only to obtain preliminary 
data and/or conduct pilot studies in support of a future, more detailed Phase 
III through V study, it is important that a long-term human cancer prevention 
hypothesis and supporting scientific justification be presented. 

Summary

This program is designed to increase the basis and applied scientific 
knowledge of cancer prevention research, and enhance community-based clinical 
research in cancer prevention.

MECHANISM OF SUPPORT 

This PA will use the NIH Small Grants Program (R03) award mechanism.  As an 
applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The total budget may not exceed $100,000 in 
direct costs for the entire project. The direct costs in any one year must 
not exceed $50,000. The total project period for an application submitted in 
response to this program announcement may not exceed two years. NIH policy 
limits the number of amendments that may be submitted to two. The small grant 
is not renewable.

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

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

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.  

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
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 specific scientific/research issues (as noted 
in parenthesis) to:

Sudhir Srivastava, Ph.D., M.P.H. (Early Detection)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Suite 3142
Bethesda, MD 20892
Telephone: 301-496-3983
srivasts@mail.nih.gov

John Milner, Ph.D. (Nutrition)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Suite 3164
Bethesda, MD 20892
Telephone: 301-496-0118
milnerj@mail.nih.gov

Vernon Steele, Ph.D., M.P.H. (Chemoprevention)
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Suite 2117
Bethesda, MD 20892
Telephone: 301-594-0420
steelev@mail.nih.gov

Direct inquiries regarding programmatic issues to:

Ms. Anne Ryan 
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard, Suite 2022
Bethesda, MD 20892
Telephone: 301-402-0910
E-mail: ar243h@nih.gov

o Direct your questions about peer review issues to: 

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041
MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncidearefof@mail.nih.gov

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

Jane Paull
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone: 301-496-2184
Jp97x@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.

All application instructions outlined in the PHS 398 application kit are to 
be followed, with the following requirements for R03 applications:  

1.  R03 applications will use the "MODULAR GRANT" and "JUST-IN-TIME"  
concepts. The total budget may not exceed $100,000 in direct costs for the 
entire project. The direct costs in any one year must not exceed $50,000. The 
total project period for an application submitted in response to this program 
announcement may not exceed two years.

2.  Sections a-d of the Research Plan of the R03 application may not exceed 
25 pages, including tables and figures.  

3.  Follow PHS 398 for R03 appendix materials.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the dates mentioned on the first page of 
this PA.

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.

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 Boulevard, Room 8041, MSC 8329
Bethesda, MD  20892-8329
Rockville, MD  20852 (for express/courier service)

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 by or mailed on or 
before the receipt dates mentioned on the first page of this PA.  The CSR 
will not accept any application in response to this PA that is essentially 
the same as one currently pending initial review unless the applicant 
withdraws the pending application.  The CSR will not accept any application 
that is essentially the same as one already reviewed.  This does not preclude 
the submission of a substantial revision of an application already reviewed, 
but such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the National Cancer Institute.  Applications not adhering 
to the guidelines of this PA, and those applications that are incomplete as 
determined by CSR or by NCI program staff, will be returned to the applicant 
without review.

Applications that are complete and responsive to the program announcement 
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 standard NIH peer review procedures. 

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 
the National Cancer 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

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

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

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

All investigators proposing research involving human subjects should read the 
"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/

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Guidance 
for investigators and institutional review boards regarding research involving 
human embryonic stem cells, germ cells, and stem cell-derived test articles 
can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.html. Only 
research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to provide 
the official NIH identifier(s)for the hESC line(s) to be used in the proposed 
research.  Applications that do not provide this information will be returned 
without review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this 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 is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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