PAR-99-006: SMALL GRANTS PROGRAM FOR BEHAVIORAL RESEARCH IN CANCER CONTROL

Department of Health
and Human Services (HHS)

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SMALL GRANTS PROGRAM FOR BEHAVIORAL RESEARCH IN CANCER CONTROL Release Date: April 20, 1999 PA NUMBER: PAR-99-006 P.T. National Cancer Institute Application Receipt Dates: December 20, April 20, and August 20 PURPOSE The Division of Cancer Control and Population Sciences of the National Cancer Institute (NCI) invites applications focused on cancer control behavioral research. 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 analyzes, or innovative projects that provide a basis for more extended research. New investigators in relevant fields and disciplines (e.g., medicine, public health, health promotion, health communications and informatics, epidemiology, anthropology, social work, nursing research, nutrition, health policy, health services research, and behavioral sciences, such as psychology, health education, and sociology) may apply for small grants to test ideas or do pilot studies. This Program Announcement (PA) replaces and supersedes PAR-95-091, which was published in the NIH Guide, Volume 24, Number 33, September 22, 1995. 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, Small Grants Program for Behavioral Research in Cancer Control, 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). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Foreign organizations are ineligible to apply. Eligible applicants include new investigators who have not previously been Principal Investigator (PI) on a NCI-funded cancer control research grant (R03, R01, P01), 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. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) Small Research Grant (R03) mechanism. The total project period may not exceed two years. The total budget must not exceed $100,000 in direct costs for the entire project period. The direct costs in any one year must not exceed $50,000. The small grant award is not renewable. 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 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 future phase III-V studies, e.g., 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, including any relevant theoretical concepts which underlie the research, as well as 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: o Screening and early detection - interventions to improve compliance with and utilization of current technologies. In the area of breast screening and detection, studies of breast self-examination as a single modality will not be accepted. o Cancer control sciences - studies to change current behaviors and/or institute new behaviors or health promotion interventions effective in reducing incidence, morbidity or mortality from cancer. o Tobacco prevention and cessation - pilot studies targeted at improving utilization of current technologies in target populations or organizations are encouraged. o Applications research - in modifying, feasibility testing, and adopting 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 setting. o Health communications and bioinformatics - message development, risk communication and evaluating the delivery of health information. o Basic behavioral research - studies to further understanding of fundamental mechanisms underlying behavioral and social functioning of direct relevance to cancer control, including development of behavioral theory, models, methods, measures or pre-intervention approaches to inform cancer control interventions and related social policies. o Surveillance - health services research and information data base linkage studies to monitor cancer related behaviors. Innovative approaches that address surveillance problems using newly available data and modern statistical methods (e.g., analytical methods employing GIS, microsimulation or variance estimation for age-adjusted rate trends) are encouraged. o Survivorship - psychosocial research to improve all aspects of the survivor experience and the development of behavioral, informational or educational interventions to improve quality of life. Additionally, investigators may propose high priority secondary analyzes 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 phase III-V 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. EXCLUSIONS Studies to determine the efficacy of chemotherapy, surgery, radiotherapy and other primary treatment interventions are not considered cancer control research under this PA. Laboratory animal studies will not be supported under this PA. 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 for 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, Volume 23, Number 11, March 18, 1994. NIH POLICY AND GUIDELINES ON THE 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 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications 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: grantsinfo@nih.gov. Applicants kits are also available on the internet at: http://www.nih.gov/grants/funding/phs398/forms_toc.html A letter of support from the investigator’s mentor or sponsor, outlining specific plans for providing guidance to the candidate with respect to development and execution of the research plan, should be included in the Appendix. The sponsor should be an experienced investigator in behavioral research in cancer prevention and control who is willing to devote time and effort to ensure that acceptable standards for the research are met. The page limitations in the PHS-398 Application Instructions must be observed or the application will not be accepted. Applicants responding to this PA should include one round trip, 2 day meeting to Bethesda, MD in the budget. The title and number of this 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, 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) The application receipt dates are December 20, April 20 and August 20. If an application is received after the specified date, it will be held for the next review cycle. Grants in response to this Program Announcement may receive an accelerated review. In order for applications to receive accelerated review, two additional copies must be sent to the NCI Referral Officer by the application receipt dates. Referral Officer Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636, MSC-7407 Bethesda, MD 20892-7407 Rockville, MD 20852 (for express/courier service) 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 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 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 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. The applications will 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 analyzes 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, 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. Funding decisions will be based upon quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the program announcement. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Veronica Chollette Executive Plaza North, Room 232 Phone (301) 435-2837 FAX (301) 480-6637 e-mail vc24a@nih.gov Direct inquiries regarding fiscal matters to: Bill Wells Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 ext. FAX: (301) 496-8601 Email: ww14j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Cause and Prevention Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 990158, 42 USC 241 and 285) and administered under HHS policies and grant regulations. 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.

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