NATIONAL DIGITAL MAMMOGRAPHY DEVELOPMENT GROUP NIH GUIDE, Volume 21, Number 12, March 27, 1992 PA NUMBER: PA-92-57 P.T. 34 Keywords: Diagnosis, Medical Medical/Diagnostic Imaging Computer Science National Cancer Institute PURPOSE The National Cancer Institute (NCI) through the Diagnostic Imaging Research Branch (DIRB) of the Radiation Research Program seeks grant applications through Interactive Research Project Grants (IRPGs) in order to form a National Digital Mammography Development Group (NDMDG) that will consist of six major components: (1) software and hardware for digital mammography; (2) image processing; (3) computer-aided diagnosis; (4) telemammography; (5) pre-clinical and clinical technology evaluation; and (6) Headquarters for the scientific leadership (development of experimental design and data processing). The objective of this program announcement (PA) is to establish a multi- institutional, multi-disciplinary scientific group to facilitate integrated development and evaluation of digital mammography and related technologies, such as image processing, computer-aided diagnosis (CAD), and tele-mammography, for improved breast cancer imaging and characterization. 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, National Digital Mammography Development Group, 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT This program will be supported through the research project grant (R01) mechanism. The NCI encourages the coordinated submission of related research project grant applications from investigators who want to collaborate on a common cancer research theme but do not require extensive shared physical resources or core functions. A minimum of three independent investigators with related research objectives are encouraged to submit concurrent, collaborative, cross-referenced individual research project grant applications (R01) that share a common research focus. Applications may be from either a single institution or a consortium of institutions. Applications will be reviewed independently for scientific merit. Meritorious applications will be considered for funding both as independent awards and in the context of the overall proposed collaboration. Applicants will be responsible for the planning, direction, and execution of the proposed projects. One Principal Investigator out of the group MUST be identified as the "Program Coordinator," and must be cited in all applications on page 2 of form PHS 398. Individual investigators may request funds for the time and effort contributed toward the coordination of the overall research and for collaborative resource activities. Additional information about the interactive R01 mechanism may be found in the NIH Guide for Grants and Contracts, January 10, 1992, in Interactive Research Project Grants for Cancer, PA-92-29." Awards will be administered in accordance with Public Health Service Policy as described in the PHS Grant Policy Statement, DHHS. Publication No. (OASH) 90-50,000 revised October 1, 1990. RESEARCH OBJECTIVES Background Information The goal of this announcement is to stimulate research in the area of digital mammography and related technologies to improve breast cancer detection and staging. The scope of the proposed research will encompass technologic developments in digital mammography integrated with basic research in critical avenues that can be opened by digital mammography, such as image processing for improved lesion visualization, computer-aided diagnosis (CAD) for enhanced image interpretation and teleradiology, or electronic image transmission, as a potential mechanism to bring world expertise to community hospitals. To achieve the above-stated goals, the NDMDG will be established to ensure comprehensive collaboration among industry (e.g., design of receptor or display systems), the academic community, and the NCI for an integrated, multi-component approach to digital mammography development. The NDMDG will be supported by the interactive program by using the R01 funding mechanism (as described in the NIH Guide for Grants and Contracts, January 10, 1992) and will consist of six major components: (1) digital mammography; (2) image processing; (3) CAD; (4) teleradiology; (5) pre-clinical and clinical technology evaluation; and (6) Headquarters for the scientific leadership (centralized development of experimental design and data processing). Research Goals and Scope The major thrust of this initiative is to facilitate integrated technologic development of digital mammographic systems. This PA encompasses a full range of studies from basic technology and instrumentation development through pre-clinical and clinical evaluation. The research agenda for the NDMDG encompasses the following goals: o To develop and evaluate new technologic advances to increase image quality in digital mammography (e.g., spatial/contrast/time resolution); o To develop and validate new digital imaging methodology (dynamic or "real time" imaging); o To develop and validate new image processing techniques to increase the sensitivity of the detection of lesions; o To develop and validate new algorithms, neural networks, and other forms of machine intelligence for CAD; and o To develop and validate practical methods of data compression, storage, and image transmission for telemammography. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The following is a statement of NIH and ADAMHA policy regarding he inclusion of women and minorities in study populations. Applications that are responsive to this PA will, by definition, meet the requirement for inclusion of women, However, the inclusion of racial and ethnic minorities must be addressed in applications submitted responding to this PA. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Section 2, 1-4 of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including not but limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this program announcement. These forms are available at most institutional business offices, from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441, and from the NCI program director named below. The PA number and title must be typed on line 2a of the face page of the application form. The use of the IRPG mechanism must be mentioned briefly in form PHS 398, Sections 1-4 of the Research plan. The goal of the collaborative efforts MUST be identified in the specific aims of each application, with the major rationale and explanation for the use of the IRPG mechanism to be given in Section G, Consultants/ Collaborators. A complete list of applications in the IRPG must be provided in Section G, and an indication of the specific collaborations to be established for the individual application under consideration. Requests for limited shared resources, if any, must be proportionally budgeted in each application based on anticipated use, with a full explanation given in the budget. Personnel Time and Effort requests for management of shared resources are allowable. If consortium arrangements between independent institutions are proposed that would make transfer of funds for required new equipment impractical, the entire equipment request may be budgeted by the responsible laboratory. This must be clearly justified. All PHS and NIH grants policies will apply to applications received in response to this announcement. If the applicant has an approved assurance covering the research (multiple project assurance for human subjects/full assurance of compliance for animal subjects), the applicant should provide with the application certification of institutional review board (IRB) approval if humans are involved and verification of the institutional animal care and use committee (IACUC) approval if animals are involved. These reviews and approvals should occur PRIOR TO SUBMISSION of the applications and the certifications and verifications should be SUBMITTED WITH the applications. If animals or humans will be subjects of research at PERFORMANCE SITES OTHER THAN THE APPLICANT ORGANIZATION, the applicants must identify, with the application, the assurance status of each participant. Submit a signed, typewritten original of the application, including the Checklist, and five signed, exact photocopies, in one package to the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Written and telephone inquires concerning the objectives and scope of this PA and inquiries about whether or not specific proposed research would be responsive are encouraged and are to be directed to: Faina Shtern, M.D. Chief, Diagnostic Imaging Research Branch Radiation Research Program National Cancer Institute Executive Plaza North, Suite 800 Bethesda, MD 20892 Telephone: (301) 496-9531 Dr. Shtern welcomes the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Joan Metcalfe Grants Management Specialist National Cancer Institute Executive Plaza South, Room 242 Bethesda, MD 20892 Telephone: (301) 496-7800, extension 28 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.395, Cancer Treatment Research. Awards are made under the authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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