PAR-01-110: SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPORES) IN HUMAN CANCER FOR THE YEAR 2002

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

SPECIALIZED PROGRAMS OF RESEARCH EXCELLENCE (SPOREs) IN HUMAN CANCER FOR THE YEAR 2002 Release Date: June 20, 2001 PA NUMBER: PAR-01-110 National Cancer Institute Letter of Intent Receipt Dates: Breast and Gynecological Cancer SPOREs: December 1, 2001 Lung, Leukemia, and Myeloma Cancer SPOREs: April 1, 2002 Prostate and Genitourinary Cancer SPOREs: August 1, 2002 Application Receipt Dates: Breast and Gynecological Cancer SPOREs: February 1, 2002 Lung, Leukemia, and Myeloma Cancer SPOREs: June 1, 2002 Prostate and Genitourinary Cancer SPOREs: October 1, 2002 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. SPORE applicants are judged on their current and potential ability to move basic research findings into a clinical or population setting or, conversely, to take a finding from the clinic/population and expand upon it in the laboratory. A SPORE must develop and maintain human cancer tissue resources for the particular organ-site that will benefit translational research, foster extended collaborations in critical areas of research need with laboratory and clinical scientists within the institution, as well as in other institutions, and participate with other SPOREs on a regular basis in sharing positive and negative findings, assessing scientific progress in the field, identifying new research opportunities, and promoting Inter-SPORE collaborations. Each SPORE and the "network" 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, prevention and control of human cancer. The SPORE mechanism is not intended to support basic research to the exclusion of clinical research or vice versa. This Program announcement (PA) addresses only SPORE applications for organ sites specified to be received in the year 2002. See announcement PAR-00-087 which was released in the NIH Guide on April 6, 2000 (http://grants.nih.gov/grants/guide/pa-files/PAR-00-087.html) for the receipt dates for SPORE applications associated with specific organ sites to be received in the year 2001. RESEARCH OBJECTIVES A SPORE must 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 (or related group of cancers). SPOREs are expected not only to conduct a wide spectrum of research activities, but should also contribute significantly to the development of specialized research resources (or cores), improved research model systems, and collaborative research projects with other institutions. The research supported through this program must be translational in nature. Translational research is defined as the movement of a laboratory discovery into a patient or population setting or the movement of an observation in a patient or population setting into a laboratory research environment. Inherently, this process involves an interdependence between basic and applied investigators. It should be noted that clinical/ epidemiological research that does not include a laboratory component or capitalize upon a biological discovery relevant to human cancer is not considered translational for the purposes of this program. MECHANISM OF SUPPORT A SPORE is supported through the specialized center (P50) grant mechanism. This mechanism provides funding for a broad range of research and developmental activities, from basic to human intervention studies. These grants are intended to promote multidisciplinary research focused upon a specific cancer (or related cancer) site(s). SPORE grants differ from traditional Program Project (P01) grants in that they also provide support for pilot research projects and a career development program, as well as enable investigators more flexibility to modify their research activities when new opportunities arise. Applicants are responsible for the planning, direction, and execution of their proposed SPORE. 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. The facilities and administrative costs related to subcontracts to other institutions or organizations are included in the total cost cap of $2.75 million, but not the direct cost cap of $1.75 million. Applications can exceed these caps in subsequent years as a result of standard cost-of-living increases or special supplements approved by NCI. A SPORE grant application may be submitted for up to five years of funding. 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. SPOREs may also use developmental funds to establish collaborative research efforts with foreign entities. Consortia agreements with 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 and must be in compliance with NIH policies. To be considered, applications must have: (1) a statement of institutional commitment that addresses how the SPORE will be given high priority within the institution, (2) a minimum of four independent principal investigators who are successful in obtaining peer-reviewed research support (e.g., R01, P01, U01, U10, U19, ACS, DOD, or equivalent) directly related to the cancer being investigated, and who, as a group, have expertise 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) a patient care 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) a developmental research program, (7) a career development program, (8) a tissue resource, as well as (9) other shared resources designed to support the proposed translational objectives of the SPORE. Although an application can only be submitted by a single institution, subcontracted collaborative arrangements with scientists from other institutions may be included if these arrangements are clearly delineated and officially confirmed by signed statements from the responsible official at each institution. This circumstance, however, does not preclude the need for a full institutional commitment from the applicant organization. Support will not be provided for applications containing research projects focused exclusively on basic research, epidemiological research, or clinical interventions. NCI program staff listed under INQUIRIES should be consulted if there are questions regarding eligibility or the required components of a SPORE. INQUIRIES Direct inquiries regarding programmatic issues to: Jorge Gomez, M.D., Ph.D. (Leukemia, Myeloma, Prostate, and Genitourinary SPOREs) Chief Email: jg1w@nih.gov Linda Weiss, Ph.D. (Lung SPOREs) Program Director Email: lw187q@nih.gov Jane Fountain, Ph.D. (Breast and GYN SPOREs) Program Director Email: jf227t@nih.gov Organ Systems Branch Office of Centers, Training, and Resources Office of Deputy Director for Extramural Science National Cancer Institute 6116 Executive Boulevard, Suite 7013, MSC 8347 Rockville, MD 20852 (for express/courier service) Bethesda, MD 20892-7008 (for U.S. Postal Service) Telephone: (301) 496-8528 FAX: (301) 402-5319 Questions of a general programmatic nature may be submitted to the e-mail address of the Organ Systems Branch: nciosb-r@mail.nih.gov Direct inquiries regarding fiscal matters to: Ms. Kelli Oster 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) 496-8627 Email: kelli.oster@nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Division of Extramural Activities 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov LETTER OF INTENT Prospective applicants are asked to submit 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 a subsequent application, the information that it contains allows the program staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the program staff (Drs. Jorge Gomez, Linda Weiss, or Jane Fountain) listed under INQUIRIES by the appropriate receipt date provided at the beginning of the PAR. APPLICATION PROCEDURES The NIH application form PHS 398 (rev. 4/98) is to be used when applying for these grants. Application forms and guidelines are available at: http://grants.nih.gov/grants/funding/phs398/phs398.html, most institutional offices of sponsored research, or 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 301/710-0267, E-mail: grantsinfo@nih.gov. The title SPORE in (Organ) Cancer and number of the PA should be typed on line 2 of the face page of the application form and the YES box marked. Funding for the performance of a Phase I or II clinical trial can be requested in a SPORE application. 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 trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to an institutional 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 http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. 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: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available to http://www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines. GUIDELINES OF THE SPORE PROGRAM The general components and procedures for preparing a SPORE application are outlined in this PA under Eligibility Requirements, Application Procedures, and Review Considerations. SPECIAL GUIDELINES that address programmatic, review and award concerns in more detail, however, must be followed when preparing a SPORE application. SPORE GUIDELINES CAN NOT BE SUPERSEDED BY THIS OR ANY OTHER ANNOUNCEMENT. Prospective applicants should request a copy of the SPORE GUIDELINES from the program staff listed under INQUIRIES above or can view a copy at http://spores.nci.nih.gov/. Submit the original signed application, including the checklist, and three signed photocopies (without appendices) to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040, MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) At the time of submission, two additional copies of the application, along with five copies of any appendices, must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC8329 Bethesda, MD 20892-8329 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 PAR 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 the CSR and adherence to the guidelines of this PAR by NCI staff. Incomplete applications or those that do not adhere to the SPORE guidelines will be returned to the applicant without further consideration. Applications that are complete and responsive to the PAR 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 review criteria stated below. 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 will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA a. Research Projects Within the SPORE concept of translational research, reviewers will evaluate each research project using the five criteria listed below. Each of these criteria will be addressed and considered by the reviewers in assigning a merit score to the project. Note that the project does not need to be strong in all categories to be judged likely to have a major translational 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 (e.g., correlative or hypothesis generating studies) but is essential to assess the relevance of a research finding in a clinical/population setting. 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 budgets and durations, 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. Tumor Bank/Tissue Resources b.1.a. 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, b.1.b. adequacy of the proposed plan and/or track record to prioritize the distribution of tissues within and outside the SPORE, b.1.c. evidence of experienced and available personnel dedicated to the activities of tissue collection, quality control of tissue specimens, tissue storage, tissue distribution, collection of initial and follow-up clinical information, data entry, and maintenance of database and computer networks, b.1.d. adequacy of proposed plan and/or track record to obtain informed written consent for all prospectively collected tissues, b.1.e. appropriateness of the budget to conduct and integrate tissue banking activities. b.2. Other Resources b.2.a. degree to which plans and/or track record indicate that shared resources (will) effectively and efficiently support the research of the SPORE in a manner that can not be supported through available resources, b.2.b. demonstration that the resource is essential to the success of the SPORE, b.2.c. adequacy of qualifications and performance (if applicable) of resource directors, b.2.d. appropriateness of the requested budgets to conduct each resource operation. c. Developmental Research Program c.1. adequacy of the process and/or track record for attracting new ideas for pilot studies within and outside of the SPORE institution. c.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) based on their potential relevance to translational research and impact on human cancer. c.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, c.4. appropriateness of the budget relative to the needs and demonstrated capabilities of the SPORE. d. Career Development Program d.1. adequacy of the plan, in general, to sustain significant activity for career development of translational research scientists, d.2. adequacy of the process and/or track record for selecting candidates for independent careers in translational research, d.3. adequacy of the process and/or track record to seek out and include qualified minorities, women, and persons with disabilities in the career development program, d.4. current status and research activities of individuals who have been supported by the career development program, if applicable, d.5. appropriateness of the budget relative to the proposed plans for sustaining a significant effort in career development. 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 utilizing the advice 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. a balance and diversity of research activities with a minimum of four scored projects of which at least one is devoted to early detection, screening, prevention, and/or population science, 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.g., use of clinical data and safety management systems, biostatistical cores, etc.), 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. 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.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, e.10. 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. 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 and in participating in committees to assess current scientific issues, research activities, and priorities. OVERALL EVALUATION AND SCORING OF APPLICATIONS Each component of the SPORE will be given a score. A single numerical priority score will then be assigned to the SPORE application as a whole. Although this score will be based primarily 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. The overall score will be weighted as follows: o 60% scientific merit and innovation o 15% evidence of interdependent, multidisciplinary design and conduct of the research o 15% potential for impacting on the disease o 10% institutional commitment If a required component(s) of an otherwise meritorious SPORE application is of such low merit that it is not recommended for further consideration (NRFC) by the peer review committee, the entire application will also receive a NRFC. See Section I.E. of SPORE GUIDELINES (http://spores.nci.nih.gov/) for a more detailed description of each of the required components of a SPORE. AWARD CRITERIA Applications will compete for available funds with all other recommended applications assigned to that Institution/Center (IC). The following will be considered in making a final funding decision: quality of the proposed application as determined by peer review, availability of funds, and program 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 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm All projects involving human subjects must include a recruitment plan for women and minorities as well as a minority and gender inclusion table with estimated accrual numbers. Copies of these tables can be found in the PHS 398 (re. 4/98) guidelines (http://grants.nih.gov/grants/funding/phs398/instructions2/p3_definitions.htm - gender). INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the 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," published in the NIH Guide for Grants and Contracts on March 6, 1998, and available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may also obtain copies of the policies on women and minorities or children from the program staff listed under INQUIRIES. Program staff may also provide any additional relevant information concerning these policies. 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: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is now available online at http://cme.nci.nih.gov/. THE OFFICE OF MANAGEMENT (OMB) CIRCULAR A-110 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA (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 for NIH funding must be self-contained within specified page limitations. Unless otherwise noted 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, Specialized Program of Research Excellence in Human Cancer for the Year 2002, 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/. 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices