This Program Announcement will expire on December 23, 2003, unless reissued. SMALL GRANTS PROGRAM FOR BEHAVIORAL RESEARCH IN CANCER CONTROL Release Date: December 13, 2001 PAR NUMBER: PAR-02-037 (see replacement PAR-04-020) National Cancer Institute ( Application Receipt Dates: April 22, 2002, August 20, 2002, December 20, 2002, April 21, 2003, August 20, 2003, and December 22, 2003 THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT This Program Announcement (PA) replaces PAR-99-006, which was published in the NIH Guide on April 20, 1999. PURPOSE 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. The following program areas focused on behavior and cancer are appropriate for small research grant applications: Screening and early detection preliminary studies to improve compliance with and utilization of proven screening technologies, research regarding patient and provider decision making when screening guidelines are controversial or uncertain (e.g., PSA testing). The development and design of new approaches to increase screening in diverse populations as well as the refinement of behavioral measures are encouraged. In the area of breast screening and detection, studies of breast self-examination as a single modality will not be accepted. Other examples can 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. Other examples may be found at: 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: Applications research studies that examine the feasibility and adoption of proven state-of-the-art intervention programs and strategies from other research projects (e.g., screening, smoking prevention etc.) for use in special populations, state and local health agencies, or other organizational and community settings. Health communications and informatics research- message development, risk communication and evaluation of the delivery of health information to understand and apply the most effective communications approaches to maximize access to, comprehension of, and use of cancer information. Other examples may be found at: 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: development of testing of models and theories of health behavior, behavioral genetics, psychoneuroimmunology, decision making, methods and measurement in behavioral science research, and basic research in social and psychological processes potentially related to cancer control. Other examples may be found at: Applied surveillance 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 (e.g., analytical methods employing GIS, microsimulation or variance estimation for age-adjusted rate trends) are encouraged: Survivorship studies that explore the development, delivery, or evaluation of interventions to increase the length of survival for cancer patients, or to improve the quality of survival of individuals diagnosed with cancer and/or their family members. This may also include research on prevention of subsequent disease and disability, instrument development, and analyses of the economic cost of cancer survivorship. Other examples may be found at: Health Disparities studies that seek to explain the impact of ecological, socioeconomic, ethnic or cultural factors on cancer incidence, morbidity, mortality and survivorship in underserved communities. More information 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. MECHANISM OF SUPPORT Support of this program announcement will be through individual research project grants (RO3). 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 two years. The NIH has adopted a policy that limits the number of amendments to two. The small grant is not renewable. The earliest anticipated award date is December, 2002. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and not-for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, eligible agencies of Federal government, and small businesses. Foreign organizations are ineligible to apply. 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. All applicants should identify a mentor or sponsor from whom they will receive guidance regarding the proposed research. 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. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. INQUIRIES Inquiries are encouraged. 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. Direct inquiries regarding programmatic issues to: Veronica Chollette, RN Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd, Suite 4100 MSC 7331 Executive Plaza North Rockville, MD 20892 Telephone: (301) 435-2837 Email: Direct scientific inquiries to the appropriate small grants program director, who are identified by area of content expertise at: Direct inquiries regarding review issues to: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8109, MSC-8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at must be used in applying for these grants and will be accepted at the standard application deadlines ( as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are strongly encouraged to call the program contacts listed in INQUIRIES with any questions regarding the adherence to the guidelines of their proposed project to the goals of this PA. Applicants responding to this PA should include one round trip, 2 day meeting to Bethedsa, MD in the budget. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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 8109, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) The application receipt dates are April 22, 2002, August 20, 2002, December 20, 2002, April 21, 2003, August 20, 2003, and December 22, 2003. If an application is received after these specified dates, it will be returned to the applicant without review. The Center for Scientific Review (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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review and for adherence to the guidelines to this PA by the National Cancer Institute. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the Division of Extramural Activities of the National Cancer Institute in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique, and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and 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. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a 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. 1. 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? 2. 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? 3. Innovation: Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. 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)? 5. 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? The initial review group will also examine: o the appropriateness of proposed project budget and duration, o the adequacy of plans to include genders, minorities (and their subgroups), and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, o the provisions for the protection of human and animal subjects, o the safety of the research environment, AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer reviews, availability of funds, and program priority. Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 (, 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. It is the policy of NIH 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 clear and compelling 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," published in the NIH Guide for Grants and Contracts, March 6 on 1998, and available at the following URL address: Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: A continuing education program in the protection of human participants in research is now available online at DATA AND SAFETY MONITORING OF CLINICAL TRIALS All clinical trials supported or performed by NCI require some form of monitoring. 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 to 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 of the NCI for Data 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 to 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 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. Reviewers are cautioned 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, Small Grants Program for Behavioral Research in Cancer Control, is related the priority area of Cancer. 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 No. 93.399, Cancer Control. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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