Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Small Grants for Behavioral Research in Cancer Control (R03)
Activity Code	R03 Small Grant Program
Announcement Type	Reissue of PAR-09-003
Related Notices	None
Funding Opportunity Announcement (FOA) Number	PAR-12-035
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.399
FOA Purpose	This funding opportunity announcement (FOA), issued by the NCI, invites investigator-initiated Small Research Grant (R03) applications for research projects that can be carried out in a short period of time with limited resources in behavioral research in cancer prevention and control. This FOA is designed to enhance basic and applied behavioral sciences research in the context of cancer control, with a secondary goal of attracting new investigators to the field from a variety of biomedical, behavioral and public health disciplines. Proposed research projects would include pilot or feasibility studies, secondary analyses of existing data, and meta-analyses particularly in the areas of: (1) basic biobehavioral and psychological services, (2) behavioral genetics, (3) cancer survivorship and bereavement, (4) health behaviors, (5) health communication and informatics, (6) health disparities, (7) processes of cancer care including delivery and utilization, and (8) tobacco control. To be appropriate for this FOA, proposed research must be significantly applicable to cancer control research and address specific gaps in knowledge or methodologies. Although the specific study proposed may attempt only to obtain preliminary data and/or conduct pilot studies in support of a future, more detailed study, it is important that a long-term human cancer control hypothesis and supporting scientific justification be presented. Investigators new to the field of behavioral cancer control research, including early-stage and established investigators looking to refocus or apply their expertise to cancer control, are encouraged to apply for this small grants announcement.

Posted Date	December 22, 2011
Open Date (Earliest Submission Date)	January 17, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	February 17, 2012; June 19, 2012; October 18, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2012; October/November 2012; February/March 2013
Advisory Council Review	October 2012; January 2013; May 2013
Earliest Start Date(s)	December 2012; April 2013; July 2013
Expiration Date	October 19, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This funding opportunity announcement (FOA), issued by the NCI, invites investigator-initiated Small Research Grant (R03) applications for research projects that can be carried out in a short period of time with limited resources in behavioral research in cancer prevention and control. This FOA is designed to enhance basic and applied behavioral sciences research in the context of cancer control, with a secondary goal of attracting new investigators to the field from a variety of biomedical, behavioral and public health disciplines. Proposed research projects would include pilot or feasibility studies, secondary analyses of existing data, and meta-analyses particularly in the areas of: (1) basic biobehavioral and psychological services, (2) behavioral genetics, (3) cancer survivorship and bereavement, (4) health behaviors, (5) health communication and informatics, (6) health disparities, (7) processes of cancer care including delivery and utilization, and (8) tobacco control. To be appropriate for this FOA, proposed research must be significantly applicable to cancer control research and address specific gaps in knowledge or methodologies. Although the specific study proposed may attempt only to obtain preliminary data and/or conduct pilot studies in support of a future, more detailed study, it is important that a long-term human cancer control hypothesis and supporting scientific justification be presented. Investigators new to the field of behavioral cancer control research, including early-stage and established investigators looking to refocus or apply their expertise to cancer control, are encouraged to apply for this small grants announcement.

Studies suggest that the cancer burden in the United States can be reduced by as much as 50% through modification of lifestyle behaviors such as tobacco use, physical inactivity, poor eating habits, unsafe sexual practices, excessive alcohol consumption, and sun exposure. To date, discoveries in behavioral and social science have contributed to a reduction in cancer incidence via behavioral interventions (risk communication, smoking cessation, dietary modification, and physical activity) and early detection (screening and genetic testing). Behavioral research has implications for populations across the cancer continuum (prevention to end of life). Discoveries related to the physiological, psychosocial, and economic effects of treatment and survivorship have led to advances in practitioner-patient communication, amelioration of side effects, and health promotion.

Behavioral Research and Cancer Control. Behavioral research in the context of cancer control is the study of the initiation, conclusion, or maintenance of actions to prevent, detect, or ameliorate the effects of cancer. Behavioral scientists are particularly interested in elucidating the behavioral and psychosocial antecedents that predict or influence health outcomes. Research results inform new approaches to ensure adherence, increase adoption of healthier practices, and reduce risky behaviors.

Basic and Applied Research in Behavioral Sciences. In the context of behavioral sciences, basic research provides the conceptual, empirical, and methodological frameworks for identifying and developing relevant theoretical models, constructs and measures. Basic research does not address disease outcomes, but rather facilitates knowledge about underlying mechanisms and processes fundamental to improving the understanding, explanation, observation, prevention, and management of illness. Applied research refers to the resultant evaluation and dissemination of interventions based on identified basic behavioral principles, methods, and findings. It is designed to predict or influence health outcomes, risks, protective factors or behavioral or social functioning. Due to the complexity of defining firm boundaries between basic and applied research, studies may have components of both, addressing both basic and applied questions.

Scope of Small Research Grant (R03) funding opportunity for Behavioral Research and Cancer Control. Small-scale projects such as pilot and feasibility studies, secondary analyses of existing data, and meta-analyses are essential to advancing the field of behavioral research and cancer control. A large percentage of R03 projects facilitate or inform the development of larger epidemiological studies or clinical trials. Identification of new priorities in behavioral research for cancer control is rapid and includes the interplay among biological mechanisms and psychological factors, clinical translational science, and reduction of the personal, societal, and economic burdens of cancer. Conceptual work continues to be necessary to determine key variables and how best to change them; research also requires new methods to measure these variables and knowledge about the moderating effects of factors at many levels (personal, social, cultural, organizational).

The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 6 pages, an R03 grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

This FOA is intended to enhance the development of basic and applied behavioral research to control and/or reduce the burden of cancer on individuals, families, communities, and populations with a secondary goal of attracting new investigators to the field. To meet the secondary goal of attracting new investigators to the field of behavioral cancer control research, eligible applicants include individuals who have not previously competed successfully for a substantial NCI-supported cancer control-related research grant. Prior NCI-supported cancer control early stage, small research grants (e.g. R15, R03, R21) or training-related awards (e.g. F, K awards or loan repayment contracts) are not included in this criteria and PD(s)/PI(s) of these mechanisms are eligible to apply.

Use of Consultants for R03 Small Grants. In support of the goal to attract new investigators to the field of behavioral cancer control research, the inclusion of a consultant(s) with cancer control or prevention research expertise and NIH grant experience are appropriate. Consultants with prior NIH experience may be particularly valuable for facilitating the development of future research projects based upon the R03-initiated results. Consultants may be either compensated or not, and percent effort information should be included in the personnel justification section with a description of purpose and role.

Grant applications are encouraged to include justification of study design, methods, and sample size (as applicable). In addition, proposals must identify the theoretical framework used and clearly indicate the significance of the research and future goals.

Specific areas of priority research may include, but are not limited to the examples listed below:

A. Basic Biobehavioral and Psychological Services Research

• Basic research in social, cognitive, and psychological processes (e.g., social comparison, mechanisms underlying neurocognitive changes associated with cancer treatment, emotion, and motivation);
• Biological mechanisms of psychosocial or behavioral processes related to cancer control (e.g., stress/behavioral regulation of tumor biology);
• Medical decision making (e.g., role of numeracy in medical decision making, elucidating decision processes involved in maintenance of healthy lifestyle behaviors);
• Methodology and measurement in behavioral science research (e.g., psychophysiological assessment, measurement of stress and other psychological constructs);
• Psychosocial and behavioral consequences of cancer risk assessment (e.g., risk perception);
• Integration of social psychology and personality constructs and theories to advance understanding of cancer related behavior;
• Basic processes of interpersonal communication;
• Ethical issues associated with cancer control behavioral research (e.g., informed consent, privacy, use and availability of data, and confidentiality).

B. Behavioral Genetics

• Genetic determinates of cancer risk factor reduction related health behaviors (e.g. diet, satiety, physical activity or sedentary behavior, smoking, decision-making and sun safety/exposure);
• Impact of gene interaction and health-related behaviors (e.g. diet, physical activity, smoking and sun safety/exposure) on cancer risk or disease progression;
• Impact of genetic testing on screening, psychological (e.g. emotion, stress) and cancer risk factor reduction related behaviors (e.g. dietary and physical activity) on obesity and/or cancer risk;
• Genetic and environmental influences on health behaviors related to cancer control mediators and moderators of adaptation and coping;
• Psychological and social environments as moderators of genetic susceptibility to cancer including research that links levels of analysis from broad social influences to biological mechanisms;
• Integration of genes, eating behaviors and correlates (e.g. taste preferences), and physical activity and sedentary behaviors as related to obesity risk and by extension cancer control.

C. Cancer Survivorship and Bereavement

• Examine adverse and/or positive effects of cancer diagnosis and treatment;
• Studies that have the potential to improve the physical and psychosocial outcomes of cancer survivors, their families, and caregivers including pilot investigations focusing on the development, delivery, and/or evaluation of interventions, as well as behavioral, clinical and/or epidemiologic research;
• Prevalence and control of post-cancer morbidity, second cancers, and chronic diseases other than cancer. Examples include: projects examining the prevalence of late effects, behavioral risk factors for second cancers and other chronic diseases, and interventions to reduce risk for iatrogenic morbidity;
• Analyses of the economic cost of cancer survivorship, including work and employment issues, financial hardship, and issues related to maintaining adequate health insurance coverage;
• Secondary data analysis of national data bases that elucidate survivorship needs and behaviors directed toward addressing treatment side effects, and work/employment issues;
• Health promotion of cancer survivors, their families, and caregivers, such as tobacco and alcohol control, exercise promotion, and dietary interventions;
• Survivorship studies of the health and psychosocial outcomes of older adults, including those with complex medical conditions. Studies could explore the intersection of cancer-related comorbidity, aging, and chronic illness. Studies could also test the feasibility of existing interventions or develop novel interventions for those age 65 and older;
• Delivery of follow-up care, including studies of care coordination, care planning, care plans, and systems and patterns of care and their impact on survivor, provider or healthcare system level outcomes and costs;

Inquiries that will inform the development of multi-level interventions are encouraged. Studies that include understudied cancer sites (such as lung, ovarian, head and neck and colorectal cancer survivor groups) and those from underserved (e.g., rural, low SES, elderly) and ethno-culturally diverse populations are also encouraged.

D. Health Behaviors Research

• Promote improvement or maintenance of cancer preventive behaviors and/or promote new behaviors, such as those that improve healthy diet, increase physical activity, decrease sedentary behavior, and ultimately, achieve optimal energy balance as it relates to obesity prevention (in both adults and children). Studies are also encouraged to examine the role of sleep behaviors as they relate to energy balance and obesity prevention;
• Examination of decreasing and preventing virus exposure (e.g., HPV) and skin cancer prevention (e.g. UV exposure, sun safety, indoor tanning);
• Improve understanding of psychosocial risk factors relevant to healthy behaviors and reducing incidence, morbidity, or mortality from cancer;
• Examination of multiple cancer preventive behaviors (i.e., 2 or more cancer preventive behaviors) to understand patterns of overall behavioral risk, and examine underlying mechanism of how: 1) behavior may be associated with or spill over to other cancer preventive behaviors; and 2) correlates associated with these patterns of risky behaviors to prevent cancer;
• Address social determinants (e.g. housing, employment/workplace, culture, discrimination, gender, literacy) of health behaviors in cancer risk and prevention as correlates of health behavior change and its relationship with psychosocial risk factors in application and testing of behavioral theories;
• Interpersonal contexts in which cancer risk factor reduction related health behaviors occur (e.g., romantic relationships, parents and children, families), including how close others positively or negatively impact behavior change attempts, how people negotiate health behavior change within a relational context, and the potential positive or negative impact of attempted behavior change on relationship quality.
• Generational influences on mechanisms of cancer preventive behavior change including intergenerational norms, behaviors, patterns and history of prior chronic diseases within families;
• Translation of recommended cancer risk factor reduction related health promotion guidelines into behavioral counseling and clinical practice more broadly (e.g., primary care);
• Methodology to test theory-driven models, cognitive-affective, motivational and other mechanisms of behavior change, or the use of innovative technology (e.g. mobile technology, sensors) to better understand individual or multiple cancer risk factor reduction related health behaviors. Studies that examine new methodologies, development of new measures or testing of theories in investigating multi-level influences (e.g., built environmental, neighborhood, policy, workplace, schools, and social relationships) on individual level behavior change in adults and children are also of interest. New methodologies may include development of policy evaluations and metrics of key policies targeting cancer risk behaviors or mixed methods studies examining policy development and implementation processes.

E. Health Communication and Informatics Research

• Exploratory and intervention studies on communication campaigns, health communication messages and information dissemination. Topics may include but are not limited to: message design, framing and priming, effect on cancer prevention behaviors and cancer-related policy change;
• Mixed methods research to study the communication context and process in clinical encounters and public health communication, including descriptive content analyses to examine the communication and media environment for cancer control topics such as cancer prevention, screening, and survivorship, among others;
• Role of technologies and social media in communication about cancer prevention and control. Particular topics may include mechanisms of information dissemination, social networks and social support that influence cancer prevention behavior, cancer treatment processes, and survivorship;
• Risk communication studies focused on the understanding of cancer risks, decision-making, and the use of online risk tools or other technology-based communication channels;
• Studies that design and test interventions from multiple levels to facilitate and improve patient-centered communication in a variety of health care settings;
• Media effects on media coverage of cancer topics and public health campaigns at the individual level, and cancer-related public health or health care policies at the macrosocial level;
• Transdisciplinary studies led by non-traditional behavioral science and cancer control investigators, such as investigators from communication, computer science, informatics, linguistics, journalism, marketing, demography, and anthropology, among others.

F. Health Disparities

• Behavioral, societal and environmental determinants of cancer health disparities;
• Interventions focused on the reduction and elimination of cancer health disparities. Studies may use a variety of research approaches (e.g. community-based participatory research);
• Health literacy, the digital divide, knowledge gap hypothesis, and other communication-related variables that may contribute to the unequal burden of cancer across populations.

G. Processes of Cancer Care

Process of care research advances the field of behavioral research in cancer control through stimulating and facilitating innovative programs that address gaps in the activities that go on within and between healthcare organizations, health care practitioners and patients across the cancer care continuum. Process of care research seeks to understand and promote behaviors that improve health through health care delivery. Research with people from diverse socioeconomic, cultural, racial, and ethnic backgrounds and intervention research in the clinical setting or the community setting where linkage to clinical care is part of the process are encouraged. Screening is emphasized as a critical process in cancer control that requires linkage to primary care, but interventions into processes relevant to improving the quality of cancer care may be examined anywhere along the cancer care continuum.

Examples of relevant research include:

• Theory and methods development, effectiveness trials and related social, behavioral and health services research to promote the offering and appropriate uptake of effective cancer screening and detection tests, follow-up of abnormal findings and outreach to unscreened populations;
• Studies that evaluate how theory is used in screening promotion research and how to more actively test the value of theory in building interventions;
• Strategies for informed decision making regarding all cancer-screening technologies, diagnostic, and treatment options in clinical practice;
• Strategies that test approaches to actively incorporate people seeking care into the care process in non-traditional ways;
• Research to understand and influence how screening decisions are made throughout the lifespan, and especially in older adults (e.g. screening cessation in the context of clinical care, the roles of affect, values, preferences, multiple chronic medical conditions, social relationships, or contextual factors);
• Impact of personalized medicine on cancer screening, especially characteristics related to risk assessment (e.g., age, ethnicity, and genomics), uptake of screening or screening practice, adherence to guidelines, and screening outcomes;
• Studies that expand the foundational science necessary to test multilevel influences upon health care delivery,
• Multilevel intervention strategies in screening, diagnosis, treatment and long term survivorship that are efficacious in diverse settings & diverse populations;
• Interventions at multiple levels of a contextual model of individual behavior. Examples include:
• interaction between individuals (patients) and their health care providers,
• individuals (patients and providers) and the health care system,
• individuals (patients, providers, health care administrators) and the community, and
• incorporating applications associated with system science and social networks;

H. Tobacco Control Research

• Tobacco use etiology, prevention, and cessation studies; may include, but are not limited to pilot studies, studies testing strategies for improving utilization of current technologies and studies that focus on high-risk individuals and populations;
• Policies on tobacco initiation and use.

I. Resources for Addressing Behavioral Sciences

Behavioral scientists have a variety of study designs, methodologies and technologies at their disposal that are conducive to a small grants mechanism that may be applied to the identified research priority areas. Some examples include, but are not limited to:

1. Implementation Science: Applications proposing to use existing evidence-based interventions or approaches are encouraged. Publicly available resources for identifying existing programs include:

• Cancer Control P.L.A.N.E.T. (Plan, Link, Act, Network with Evidence-based Tools) (http://cancercontrolplanet.cancer.gov/) sponsored by the National Cancer Institute, Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and the Agency for Healthcare Research and Quality.
• Research-tested Intervention Programs (RTIPS http://rtips.cancer.gov/rtips/index.do) sponsored by the National Cancer Institute and the Substance Abuse and Mental Health Services Administration.

2. Multi-Level Analysis: The highly complex, personal, dyadic, organization, and societal role of behavior in the context of cancer control and the inherent transdisciplinary nature of the field, provides unique opportunities to perform multilevel analyses. Multi-level analysis promotes examination of the effects of one factor at one level (e.g. tobacco use) while controlling for confounding at another level (community characteristics). Applications proposing to collect preliminary or pilot data designed to inform larger, more complex studies are encouraged.

3. Secondary Data Analysis: For applicants interested in the conduct of secondary analyses relevant to behavioral aspects of cancer prevention and control using large, nationally representative data sets or smaller, regional, or locally based data sets. There are three types of data sets that would qualify for funding:

a) Publicly available data sets such as:

• the Health Information National Trends Survey (HINTS; http://hints.cancer.gov) conducted by the National Cancer Institute;
• the National Health and Nutrition Examination Survey (NHANES; http://www.cdc.gov/nchs/nhanes.htm) conducted by the National Center for Health Statistics (NCHS);
• the National Health Interview Survey (NHIS; http://www.cdc.gov/nchs/nhanes.htm) conducted by NCHS;
• the Current Population Survey (CPS; http://www.census.gov/cps), conducted by the Bureau of Labor Statistics and the Census Bureau;
• the Behavioral Risk Factor Surveillance System (BRFSS; http://www.cdc.gov/brfss), conducted by the Centers for Disease Control and Prevention and
• the California Health Inventory Survey (CHIS; http://www.chis.ucla.edu), conducted by UCLA Center for Health Policy Research, the California Department of Health Services, and The Public Health Institute.

b) Limited use datasets (that have requirements that the users must agree to before analyzing them) including:

• the Surveillance Epidemiology and End Results survey (SEER; http://seer.cancer.gov/); and
• the National Longitudinal Study of Adolescents Health (http://www.cpc.unc.edu/addhealth).

c) Non-public domain datasets including data collected under research grant funds, data sponsored by private entities (e.g., philanthropic foundations, motor vehicle administrations, or commercial businesses) or originally collected for purposes other than research (e.g., health care, criminal justice or insurance data).

4. Use of Standardized Measures: For projects that include primary data collection, it is recommended to use measures that can be found in measurement system tools such as GEM (http://www.gem-beta.org/), PhenX (https://www.phenx.org/) and PROMIS (http://www.nihpromis.org/). The use of standardized measures facilitates data sharing and increases the comparability of results across studies.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	A project period of up to two years and a budget for direct costs of up to $50,000 per year may be requested (i.e., a maximum of $100,000 direct costs over two years) Commensurate Facilities and Administrative (F&A) costs are allowed. F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Award Project Period	The scope of the proposed project should determine the project period.  The maximum period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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 support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

To meet the secondary goal of attracting new investigators to the field of behavioral cancer control research, eligible applicants include individuals who have not previously competed successfully for a substantial NCI-supported cancer control-related research grant. Prior NCI-supported cancer control early stage, small research grants (e.g. R15, R03, R21) or training-related awards (e.g. F, K awards or loan repayment contracts) are not included in this criteria and PD(s)/PI(s) of these mechanisms are eligible to apply.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modification:

• No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Budget Request for Single Meeting of Grantees. In the budget requests, applicants should plan for the cost for attendance at a single 2-day grantee meeting in Bethesda, Maryland, to which they, as PD(s)/PI(s), will each be invited sometime during their second year of funding.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

For this FOA, please see http://www.cancer.gov/researchandfunding/contacts for Scientific/Research Contacts at NCI.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Gina Tesauro, MSW
Public Health Advisor
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd
Rockville, Maryland 20852
Telephone:301-435-2836
Email: gina.tesauro@nih.gov

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
E-mail: ncirefof@dea.nci.nih.gov

Debbie Dunne
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3154
Fax: (301) 496-8601
E-mail: dunned@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.