SMALL GRANTS FOR BEHAVIORAL RESEARCH IN CANCER CONTROL RELEASE DATE: November 14, 2003 PA NUMBER: PAR-04-020 (This PAR has been replaced, see PAR-06-073) EXPIRATION DATE: December 21, 2005 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.399 APPLICATION RECEIPT DATE: April 20, 2004; August 20, 2004; December 22, 2004; April 20, 2005; August 22, 2005; December 20, 2005. This Program Announcement (PAR) replaces PAR-02-037, which was published in the NIH Guide on December 13, 2001. THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR 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 Receipt and Review Schedule o Required Federal Citations PURPOSE OF THIS PAR The Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) invites behavioral research applications in cancer control from new investigators or established scientists refocusing their research interests to behavioral research in cancer. 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 behavioral cancer control research. Small grants are short-term awards to provide support for pilot projects, development and testing of new methodologies, secondary data analyses, or innovative studies that provide a basis for more extended research. RESEARCH OBJECTIVES This program is designed to encourage investigators from a variety of academic, scientific, and public health disciplines to apply their skills to behavioral research investigations in cancer prevention and control. The research may occur in a variety of settings, such as hospitals, universities, cancer centers, communities, schools, health departments and worksites. Investigators may choose any of the full range of scientific approaches to their work. Studies may contribute to the design, implementation or evaluation of intervention programs, descriptive baseline surveys, testing, modification and validation of surveys or program materials for use in the proposed population groups, testing of recruitment, intervention or compliance procedures for participants, etc. Proposals should include justification of study design, methods, and sample size. In addition, proposals should identify the theoretical framework used and clearly indicate the significance of the research and where it will lead. Program areas that are focused on behavior and cancer and that would be considered relevant to meeting the goals of this PAR include but are not limited to: Applied cancer screening theory and methods development, effectiveness trials and related social, behavioral and health services research to promote the use of effective cancer screening tests in unscreened populations, as well as strategies for informed decision making regarding all cancer screening technologies in both community and clinical practice. Basic biobehavioral research - studies that examine mechanisms, principles, and theoretical underpinnings of cancer-related behavior change across ages, racial and ethnic groups, socioeconomic strata, and cancer diagnoses. Research areas include, but are not limited to: basic research in social, cognitive, and psychological processes (e.g., risk perception); biological mechanisms of psychosocial or behavioral processes related to cancer control (e.g., pyschoneuroimmunology); decision processes involved in cancer prevention, detection, and treatment; methodology and measurement in behavioral science research; development and testing of models and theories of health behavior; psychosocial and behavioral consequences of cancer risk assessment; understanding processes and mechanisms underlying health communication; genetic and environmental influences on health behaviors related to cancer control; mediators and moderators of adaptation and coping. For additional information go to: and Applied health monitoring, methods and outcomes research - research related to evaluating patterns and trends in cancer -related behavioral risk factors, and determining the influence of those factors at the individual, societal and systems level on patterns and trends in measures of cancer burden, including incidence, morbidity, mortality and survival. Innovative approaches that address surveillance of cancer- related behaviors using newly available data, linkage between existing data systems to create enriched data systems for cancer surveillance, and contemporary statistical and economic methods are encouraged: Health communication and informatics research- examines the use of human and mediated communication, including the use of new communication technologies, in cancer prevention, control and care, including persuasive communication campaigns, risk communication, information dissemination, social support, and coordination of care. Other examples may be found at: Health disparities research - studies that seek to explain the impact of ecological, socioeconomic, ethnic or cultural factors on cancer incidence, morbidity, mortality and survivorship in underserved communities, that assess the influence of cultural factors in the medical community, or the variation in treatment based on sociocultural factors. More information may be found at: Health promotion research - studies to change current behaviors and/or institute new behaviors, such as diet, physical activity, energy balance, virus exposure, sun exposure and other behavioral risk factors relevant to reducing incidence, morbidity or mortality from cancer or to improve maintenance, or investigate the causes of lack of maintenance, to diet, physical activity, energy balance or sun exposure prevention behaviors . Other examples may be found at: Survivorship - Studies that examine the adverse and / or positive effects of cancer diagnosis and treatment or aim to prevent or control negative outcomes, and / or enhance positive outcomes such as resilience among cancer survivors and their families. Pilot investigations focusing on the development, delivery, or evaluation of interventions that carry the potential to improve the length and quality of survival from cancer are encouraged. Survivorship studies may also include behavioral, clinical, or epidemiological research on the prevalence and control of post-cancer morbidity, second cancers, and chronic diseases other than cancer, instrument development specific to cancer survivors, and analyses of the economic cost of cancer survivorship. Other examples may be found at: Surveillance research: research related to evaluating patterns and trends in cancer incidence, morbidity, mortality and survival. Innovative approaches that address surveillance using newly available data, linkage between existing data systems to create enriched databases for cancer surveillance, or contemporary statistical and economic methods are encouraged, including ecologic studies of the cancer burden among various population groups according to geographic, socioeconomic, or systems-level factors. Research that links population-based data on cancer to data on risk factors or health- related behaviors. Research in developing statistical methodologies or statistical models appropriate for analyzing trends and for evaluating the impact of cancer control interventions as well as geographic, social, behavioral, genetic, and health care delivery factors on the cancer burden. Tobacco control research - tobacco use etiology, prevention and cessation including, but not limited to, pilot studies that test strategies for improving utilization of current technologies in high risk individuals and populations; studies assessing the effect of various policies on tobacco initiation and use; secondary data analyses of existing datasets. Additional examples may be found at: Additionally, investigators may propose high priority secondary analyses in these areas. Although the specific study proposed may attempt only to obtain preliminary data and/or conduct pilot studies in support of a future, more detailed intervention study, it is important that a long-term human cancer control hypothesis and supporting scientific justification be presented. Applications not fitting one of the program areas stated above will be returned to the proposed Principal Investigator without undergoing peer review. Summary This program announcement is intended to increase the basic and applied scientific knowledge of behavioral cancer control research by facilitating and encouraging new investigators to conduct research in this area. MECHANISMS OF SUPPORT This PAR will use the NIH small grants (R03) award mechanism. Applicants are 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 applications submitted in response to this announcement may not exceed three years. Two revisions of a previously reviewed small grant application maybe submitted. The small grant is not renewable. This PAR uses just-in-time concepts. It also uses the modular budgeting format. (see Specifically, because these applications are less than $250,000 in direct costs per year, they must use the modular budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at 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 institutions/organizations o Foreign institutions are not eligible to apply o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Eligible applicants must be either new investigators who have not previously been Principal Investigator (PI) on a NCI-funded cancer control research grant (R03, R01, U01, P01, R21), or established scientists refocusing their research interests to behavioral research in cancer. Predoctoral investigators currently enrolled in an accredited doctoral degree program also are eligible to apply. Small research grants may NOT be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of research project applications under review by the Public Health Service. 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 PAR and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: For detailed information about the Small Grants Program for Behavioral Research in Cancer Control, visit: The opportunity to clarify any issues or questions from potential applicants is welcome. o Direct your questions about scientific/research issues to: Veronica Chollette, RN, MS Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd, Suite 4100 Executive Plaza North Rockville, MD 20892 Rockville, MD 20852 (express/courier service) Telephone: (301) 435-2837 Email: 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 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 Email: o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: The title and number of this PA must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted by the receipt date(s) listed on the first page of this program announcement. 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 includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package 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 and all copies of the appendix material 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) Email: Appendices should be comprised of single-sided, unbound materials, with separators between documents 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.) ( 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 APPLICATION PROCESSING: Applications must be received on or before the receipt date(s)listed on the first page. The CSR will not accept any application in response to this PAR 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS 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 PAR 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 RECEIPT AND REVIEW SCHEDULE Application Receipt Dates: April 20, 2004; August 20, 2004; December 22, 2004; April 20, 2005; August 22, 2005; December 20, 2005. Peer Review Dates: June 2004; October/November 2004; February/March 2005; June/July 2005; October/November 2005; February/March 2006. Council Review Dates: September 14, 2004; February 16,2005; June 7, 2005; September 20, 2005; February 2006; June 2006. Earliest Anticipated Start Dates: December 2004; April 2005; July 2005; December 2005; April 2006; July 2006 REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials see: For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials for additional information: Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (; a complete copy of the updated Guidelines are available at 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 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 A continuing education program in the protection of human participants in research is available online at: 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 Applicants may wish to place data collected under this PAR in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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