PAR-00-025: CANCER PREVENTION RESEARCH SMALL GRANT PROGRAM

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

CANCER PREVENTION RESEARCH SMALL GRANT PROGRAM Release Date: December 13, 1999 PA NUMBER: PAR-00-025 National Cancer Institute Application Receipt Date: March 20, July 20, November 20 THIS PROGRAM ANNOUNCEMENT (PA) USES THE MODULAR GRANT AND JUST-IN-TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. This PA replaces PAR-95-091, which was published in the NIH Guide, Volume 24, Number 33, September 22, 1995. PURPOSE The Division of Cancer Prevention of the National Cancer Institute (NCI) invites applications that address developmental research in chemoprevention agent development, biomarkers, early detection, and nutrition science. The Small Grants Program is designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of research expertise in cancer prevention research. It is anticipated that these Small Grant Programs may lead to the submission of subsequent Individual Research Project Grants (R01). New, as well as experienced, investigators in relevant fields and disciplines (e.g., chemoprevention, nutritional science, genetic and infectious agents, and early detection, including biomarker development and validation) may apply for small grants to test ideas or do pilot studies. This PA will expire in two years from the first receipt date. NIH Grants policies apply to these awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Cancer Prevention Research Small Grant Program, is related to the priority area of Cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202-512-1800, or at http://odphp.osophs.dhhs.gov/pubs/hp2000. 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. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support of this program announcement will be through NIH Small Grants Program (R03). The total budget may not exceed $100,000 in direct costs for the entire project. The direct costs in any one year must not exceed $50,000. The total project period for an application submitted in response to this program announcement may not exceed three years. NIH policy limits the number of amendments that may be submitted to two. The small grant is not renewable. Specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts now in effect at the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm For this PA, funds must be requested in multiples of $25,000 direct cost modules. A feature of the modular grant is that no budget escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information is required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. RESEARCH OBJECTIVES This program is designed to aid and facilitate the growth of a cadre of scientists with expertise in cancer prevention research. Small grants are short-term awards which provide support for pilot projects, development and testing of new methodologies, or innovative projects that provide a basis for more extended research. The Division of Cancer Prevention invites applications that address developmental research in chemoprevention agent development, biomarkers, early detection, and nutrition science, in addition to clinical studies that focus on specific target organs. The specific areas of research may include, but are not limited to: Early Detection Identification, development, and evaluation of biological analytic techniques, methodologies, and clinical technologies relevant to pre-clinical cancer detection and prevention: Cellular, molecular, and genetic tumor markers Molecular epidemiology and genetic risk factors Imaging technology Identification of molecular signatures of cancer-associated infectious agents for earlier cancer detection and risk assessment. Transfer of basic laboratory findings into applications for early detection with the goal of extending this research to comparative clinical trials. Development and evaluation of new high throughput molecular- and proteomic- based detection techniques and measure sensitivity, specificity, validity, and safety. Translational research to facilitate the transfer of new technologies (to the clinical setting) for earlier detection, prevention, and risk assessment. Development and evaluation of computer-based data monitoring systems for analysis and interpretation of laboratory data on multiple markers of and for the development of modeling systems based on molecular, genetic and other risk factors to be used in the evaluation of cancer prevention approaches. Definition and evaluation of prognostic factors of pre-cancerous lesions by computer models that include neural networks, artificial intelligence, and other techniques. Development of analytic techniques to identify populations that may be at increased risk as indicated by genetic and metabolic phenotypes (susceptibility markers). Chemoprevention Pilot testing and development of new methods of chemoprevention, dietary, or nutrition intervention. Development and evaluation of molecular targets to prevent, reverse, or retard progression of precancerous lesions (and hence the cancer process) by natural, synthetic, and/or dietary/nutritional interventions. Feasibility and efficacy testing of rapid screening methods to identify and prioritize new chemopreventive agents. Testing of new strategies to prevent cancer or its progression in persons at increased genetic risk. Development of innovative animal models to mimic the human cancer process in order to expedite research in cancer prevention. Nutrition Improvements in methodology development for assessing nutritional status, metabolic patterns, and dietary modulation of genetic expression. Identification, development and validation of biochemical or biological markers for measuring and monitoring dietary compliance and exposure. Development of reliable methods for analysis of nutrients, other dietary components and their metabolites in foods, body fluids, and tissues. Development of mechanistic studies of dietary constituent interactions, gene- nutrient interactions and dietary environmental factor interactions. Determination of bioavailability and dose-response of foods, nutrients, and other naturally-occurring food constituents. Although the specific study proposed may attempt only to obtain preliminary data and/or conduct pilot studies in support of a future, more detailed Phase III through V study, it is important that a long-term human cancer prevention hypothesis and supporting scientific justification be presented. Summary This program is designed to increase the basic and applied scientific knowledge of cancer prevention research, and enhance community-based clinical research in cancer prevention. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435/0714, email: [email protected]. For those applicants with internet access, the 398 kit may be found at: http://grants.nih.gov/grants/forms.htm Applicants are strongly encouraged to call the program contacts listed in INQUIRIES below with any questions regarding the responsiveness of their proposed project to the goals of this PA. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap if applicable and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further review. In addition, the PA title and number 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: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC 8329 Bethesda MD 20892-8329 Rockville, MD 20852 (for express/courier service) Applications must be received by March 20, July 20, or November 20. If an application is received after that date, 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 Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the National Cancer Institute. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI,. in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will 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 and 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: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NCI. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Barry Portnoy, Ph.D. Division of Cancer Prevention National Cancer Institute Building 31, Room 10A49 Bethesda, MD 20892 Telephone: (301) 496-9568 FAX: 301-496-9931 Email: [email protected] Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC 8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: [email protected] Direct inquiries regarding fiscal matters to: Bill Wells Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8796 FAX: (301) 496-8601 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.393. Cancer Cause and Prevention Research. Awards are made under authorization of the 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 Public Health Service (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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices