and Human Services (HHS)
EXPIRED
SPECIALIZED PROGRAM OF RESEARCH EXCELLENCE IN HUMAN CANCER FOR THE YEAR 2001 Release Date: April 6, 2000 PA NUMBER: PAR-00-087 National Cancer Institute National Institute of Dental and Craniofacial Research Letter of Intent Receipt Dates: Skin and Prostate Cancer SPOREs: December 1, 2000 Gastrointestinal and Prostate Cancer SPOREs: April 1, 2001 Brain, Head and Neck, Lymphoma, and Prostate Cancer SPOREs: August 1, 2001 Application Receipt Dates: Skin and Prostate Cancer SPOREs: February 1, 2001 Gastrointestinal, and Prostate Cancer SPOREs: June 1, 2001 Brain, Head and Neck, Lymphoma, and Prostate Cancer SPOREs: October 1, 2001 The National Institute of Dental and Craniofacial Research (NIDCR) and NCI both have interest in supporting translational research in head and neck cancer. Consequently, NIDCR and NCI will co-fund scientifically meritorious Head and Neck Cancer SPOREs. PURPOSE The Organ Systems Branch of the Office of the Deputy Director for Extramural Science at the National Cancer Institute (NCI) invites grant applications (P50) for Specialized Programs of Research Excellence (SPORE) in organ-specific cancers. Applicant institutions must be able to conduct the highest quality balanced translational research on the prevention, etiology, screening, diagnosis, and treatment of a specific organ-site cancer. SPOREs are at institutions that will make a strong commitment to the organization and conduct of these programs. SPORE applicants are judged on their current and potential ability to translate basic research findings into innovative research settings involving patients and populations. A SPORE is also encouraged to conduct research on rehabilitation and quality-of-life. A SPORE must develop and maintain human cancer tissue resources for the particular organ-site that will benefit translational research, develop extended collaborations in critical areas of research need with laboratory scientists and clinical scientists within the institution and in other institutions, and participate with other SPOREs on a regular basis to share positive and negative information, assess scientific progress in the field, identify new research opportunities, and promote inter-SPORE collaborations to resolve areas of scientific controversy. Each SPORE and the "networks" of SPOREs are expected to conduct research that will have the most immediate impact possible on reducing incidence and mortality of human cancer. A SPORE should support a mix of basic and clinical researchers whose formal interactive and collaborative research efforts will result in new approaches for early detection, diagnosis, therapy, and prevention and control. The SPORE mechanism is not intended to support basic research to the exclusion of clinical research or vice versa. This Program announcement (PA) only addresses SPORE applications for organ sites specified to be received in year 2001. See program announcement PAR- 99-167, which was released in the NIH Guide on September 23, 1999 (http://grants.nih.gov/grants/guide/pa-files/PAR-99-167.html) for the receipt dates for SPORE applications associated with specific organ sites to be received in year 2000. 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, Specialized Program of Research Excellence in Human Cancer For the Year 2001, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. GUIDELINES OF THE SPORE PROGRAM The following Eligibility Requirements, Application Procedures, and Review Considerations summarize the general components and procedures for preparing a SPORE application. However, the NCI has developed SPECIAL GUIDELINES that address programmatic, review and award concerns in detail that must be used when preparing a SPORE application. SPORE GUIDELINES CAN NOT BE SUPERSEDED BY THIS OR ANY OTHER ANNOUNCEMENT. Prospective applicants must request a copy of the SPORE GUIDELINES from the program staff listed under INQUIRIES. SPORE GUIDELINES are also available at the Internet: http://spores.nci.nih.gov/ ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Eligible institutions may include foreign components as full research projects, or shared resources, or as part of a research project or shared resources. SPOREs may also use Developmental Funding to establish collaborative research involving foreign components (see Required Components below). Participating foreign institutions must include provisions that ensure adequate representation of women, minorities, and children in all research components that involve clinical trials or any other type of human intervention, in compliance with NIH policies. To be considered eligible, applicant organizations must have: (1) a statement of institutional commitment that addresses how the institution will incorporate the SPORE high within its institutional priorities, (2) a minimum of four independent investigators who are successful in obtaining peer-reviewed research support (R01, P01, U01, U10 or equivalent) directly related to the organ-specific cancer, and who together represent experience in both laboratory and clinical research, (3) a minimum of four research projects, representing a balance and diversity of translational approaches. At least one research project must focus on early detection, screening, prevention, and/or population science. All proposed research projects must be led by co-investigators in basic and applied sciences who commit adequate percent efforts to the translational research endeavors, (4) a qualified principal investigator who is a scientific leader in the field, (5) access to a patient care and service facility that serves a substantial cancer patient population and, if the facility is not part of the parent institution, a consortium agreement with an associated institution that assures adequate access to cancer patients for clinical research, the statement must be signed by the responsible officials of the applicant institution and the consortia care facility, (6) developmental programs (7) career development programs, and (8) appropriate shared resources to support the proposed translational research of the SPORE. Although an application must be submitted by a single applicant institution, subcontracted collaborative scientific arrangements with scientists from other institutions may be included if these arrangements are clearly delineated, and formally and officially confirmed by signed statements from the responsible officials of each institution. However, a full institutional commitment must come from the applicant institution. Support will not be provided for applications with research activities focused exclusively on basic research, or clinical research or trials, or epidemiological research. NCI program staff listed under INQUIRIES should be consulted if there are questions regarding any of the above eligibility requirements or exclusions. MECHANISM OF SUPPORT Support of this program will be through the specialized center (P50) grant mechanism. This mechanism supports the full range of research and development from basic to clinical and intervention studies. The spectrum of activities comprises a multidisciplinary approach on a specific disease entity or biomedical problem. These grants differ from traditional program project grants in that they are more complex and flexible in terms of the activities that can be supported. In addition to support for multidisciplinary research projects, support is also provided for pilot research projects, specialized resources, career development programs, and shared core facilities. Applicants will be responsible for the planning, direction, and execution of the proposed SPORE program. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. NCI policy for SPORE grants establishes the following limits to the requested budgets: New or competing renewal P50 SPORE applications may request a maximum annual direct cost of $1.75 million and maximum annual total cost of $2.75 million per individual SPORE. The facilities and administrative costs related to subcontracts to other institutions or organizations will not apply toward the direct cost cap of $1.75 million. Applications can exceed these caps as a result of regular cost-of-living increases (currently 3% per year) or special supplements approved by NCI. A SPORE grant application may request up to five years of funding. Although this program is provided for in the financial plans of NCI, the award of grants pursuant to this program announcement is contingent upon the anticipated availability of funds for this purpose. RESEARCH OBJECTIVES A SPORE must address the scientific information base and provide focal points for sustaining and maintaining state-of-the-art research that will contribute to improved detection, diagnosis, treatment and prevention of an organ- specific cancer. SPORES not only are expected to conduct a wide spectrum of research activities, but also to contribute significantly to the development of specialized research resources, the development of improved research model systems and the expansion of the research base through collaborative research with scientists and clinicians in other institutions locally and nationwide. The research supported through this program must have translational potential or significance. Translational research is the movement of a laboratory discovery into a patient or population research setting or the movement of an observation in a patient or population setting into a laboratory research environment. It must also demonstrate interdependence between basic and clinical investigators in planning and implementing research and should emphasize clinical application of basic research findings with patients and populations. Translational research also applies clinical findings to advance basic research that ultimately may lead to hypothesis-driven clinical trials or interventions. It should be noted that clinical research that is not based on nor derived from laboratory findings is not considered translational for purposes of this program. 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 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit at least sixty days prior to the specified receipt date above, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. Although a letter of intent is not required, is not binding and does not enter into the review of subsequent applications, the information that it contains allows IC staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent to the program staff (Dr. George Gomez) listed under INQUIRIES by the letter of intent receipt date listed in the heading of the PA. APPLICATION PROCEDURES By NIH policy, potential new applicants intending to submit a SPORE application requesting $500,000 or more in direct costs in any year must contact the Organ Systems Branch of NCI and obtain agreement from program staff to accept the application for review and consideration of an award. When the application is eventually submitted, it must be accompanied by a cover letter identifying the program staff member who agreed to accept the application. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. 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, E-mail: [email protected]. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm Specific instructions for preparing a SPORE grant application are available from the program staff listed under INQUIRIES. These instructions are contained in the SPORE GUIDELINES and must be used in preparing the application. SPORE GUIDELINES are also available on the Internet: http://spores.nci.nih.gov/ All applications 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 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). The title and number of the program announcement must be typed in Section 2 on the face page of the application 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) 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 Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) It is important to send these copies at the same time that the original and three copies are sent to the Center for Scientific Review (CSR), otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received by the receipt date. Complete applications must be received by the specified receipt dates for the respective organ sites. If an application is received after that date, it will be returned to the applicant without review. The 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. Applications must meet all eligibility requirements summarized above and must address all programmatic requirements further described in the SPORE GUIDELINES (http://spores.nci.nih.gov/). REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and adhere to the guidelines of PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Cancer Institute in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. In addition, if a required component(s) of an otherwise meritorious SPORE application is of such low merit that it is not recommended for further consideration by the peer review committee, the entire application will also be unscored. See section D of SPORE GUIDELINES (http://spores.nci.nih.gov/) for a description of required components of a SPORE . Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. REVIEW CRITERIA The criteria to be used in the evaluation of grant applications are listed below. a. Individual Projects: Within the SPORE concept of translational research, reviewers will evaluate each research project using the five criteria listed below. Each criterion will be addressed and considered by the reviewers in assigning the overall score project merit: a.1. Significance. The importance of the translational research objective to human cancer and its likelihood of completion within the project period. a.2. Approach. The adequacy of the experimental design and methods to achieve the research objectives, clear evidence of co-leadership by a basic and more applied scientist in the conception, design and proposed implementation of the project. a.3. Innovation. Originality and novelty of the experimental design as it relates to translational research. a.4. Investigators. The qualifications of the basic and more applied co- investigators to conduct the proposed research and the appropriateness of the time commitments of each co-investigator to the conduct of the project. a.5. Environment. The scientific environment in which the translational research work will be done, and the unique features, if any, of the environment to support the proposed work. 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. b. Shared Resources (Cores) b.1. adequacy of the proposed plan and/or track record to develop and maintain a human cancer site-specific tissue resource, store the tissue and distribute the tissue with appropriate pathological and clinical data, adequacy of the proposed plan and/or track record to prioritize the distribution of tissues within and outside the SPORE, b.2. degree to which plans and/or track record indicate that shared resources effectively and efficiently support (or will support) the research of the SPORE in a manner that can not be supported through available national resources, b.3. adequacy of the justification for each specialized resource relative to its essential need for the conduct of SPORE research or pilot projects and SPORE collaborative projects, b.4. adequacy of qualifications and performance (if applicable) of managers of resources, b.5. appropriateness of the requested budgets to conduct each resource operation. c. Career Development c.1. adequacy of the process and/or track record for selecting candidates for career development who demonstrate potential for independent research careers or who are established investigators and are changing the direction of their research careers, c.2. adequacy of the procedures and/or track record to seek out and include qualified minorities, women, and persons with disabilities in the career development program, c.3. current status and research activities of individuals who have been supported by the career development program, if applicable, c.4. appropriateness of the budget relative to the proposed plans for sustaining a significant activity in career development. d. Developmental Research Program d.1. adequacy of the process and/or track record for attracting new ideas for pilot studies within and outside of the SPORE institution. d.2. adequacy of the proposed process and/or track record for continuously reviewing and funding a spectrum of pilot projects (e.g., research, technology development, resources) for their quality and importance to translational research that will have an impact on human cancer. d.3. general quality of the pilot projects provided by the SPORE to demonstrate the effectiveness of the process and/or track record of funding pilot projects, d.4. appropriateness of the budget relative to the needs and demonstrated capabilities of the SPORE. e. Overall Program Organization and Capability: e.1. scientific qualifications and involvement of the SPORE Principal Investigator, as well as his/her demonstrated scientific and administrative leadership capabilities, adequacy of the time commitment of the Principal Investigator, e.2. adequacy of the planning and evaluation process to include: determining translational research productivity of existing projects and resources, discontinuing activities of low productivity, initiating new activities in response to important translational research opportunities, establishing collaborations, and the use of external advisors, e.3. adequacy of access to patients and populations for conducting current and projected therapeutic, prevention, detection and control research, e.4. degree to which the organization and leadership of the SPORE promote and facilitate scientific interactions between projects, pilot projects, etc., and effective use of the SPORE infrastructure (e.g., tissue bank, other shared resources) in the conduct of research, e.5. effectiveness of and/or plans for promoting interdisciplinary scientific interaction, e.6. effectiveness of and/or plans for integrating SPORE research and resources with existing Cancer Center programs, e.7. adequacy of tangible institutional commitments that will enable and facilitate the research objectives of the SPORE (e.g., special facilities, recruitments, discretionary resources such as dollars and space), e.8. facilitation of technology transfer, management of the intellectual property rights of the SPORE under the requirements of the Bayh-Dole Act and NIH funding agreements, e.9. written assurance that SPORE interactions with commercial entities will uphold the principles of academic freedom, including the ability of SPORE investigators to collaborate freely, and to send and receive biomedical research materials without restriction to other scientific researchers. f. Interactions with Other SPOREs f.1. adequacy of plans (new application) or progress (competing renewal applications) to promote and maintain communication and integration of scientific projects of mutual interest with other SPOREs, f.2. willingness to interact with other SPOREs and with the NCI in sharing information, in assessing scientific progress, in identifying new research opportunities and in establishing scientific priorities. OVERALL EVALUATION AND SCORING OF APPLICATIONS A single numerical priority score will be assigned to the SPORE application as a whole after discussing all of the review elements listed above. The score will be based on the overall quality of the research projects, the career development program and the developmental research program, the overall effectiveness and adequacy of shared resources, the overall program organization and capability, and the plans for interactions with other SPOREs. Although primary emphasis will be placed on scientific merit and progress where applicable (competing renewal applications), significant consideration will also be given to interdisciplinary interactions, potential for impacting on the disease, inter-SPORE collaborations and institutional commitment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to that IC. 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: Jorge Gomez, M.D., Ph.D. Organ Systems Branch Office of Centers, Training, and Resources Office of Deputy Director for Extramural Science National Cancer Institute 6116 Executive Boulevard, Suite 7008, MSC 8347 Rockville, MD 20852 (for express/courier service) Bethesda, MD 20892-7008 (for U.S. Postal Service) Telephone: (301) 496-8528 Email: [email protected] Ann L. Sandberg, Ph.D. Chief, Neoplastic Diseases Branch Division of Extramural Research National Institute of Dental and Craniofacial Research National Institutes of Health Bethesda, MD 20892 Tel: 301-594-2419 FAX: 301-480-8318 email: [email protected] Questions of a general programmatic nature may be submitted to the e-mail address of the Organ Systems Branch that is utilized to answer these inquiries: [email protected] Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard MSC 7150 Rockville, MD 20852-7150 (for express/courier service) Bethesda, MD 20892-7150 Telephone: (301) 496-8791 Email: [email protected] Direct inquiries regarding review issues to: Ms. Toby Friedberg Division of Extramural Activities 6116 Executive Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.397 and 93.121. 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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