MINORITY-BASED COMMUNITY CLINICAL ONCOLOGY PROGRAM Release Date: April 24, 2002 (see reissuance RFA-CA-04-007) RFA: CA-03-012 National Cancer Institute (NCI) (http://www.nci.nih.gov/) LETTER OF INTENT RECEIPT DATE: June 24, 2002 APPLICATION RECEIPT DATE: July 22, 2002 This RFA is a reissuance of RFA-CA-02-004, which was published in the NIH Guide on 04/2001 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), is continuing the established cancer control effort which involves practicing oncologists who serve large minority populations in the NCI clinical trials program. The Community Oncology and Prevention Trials Research Group (COPTRG), DCP, invites domestic institutions with the capability and intent to serve new cancer patients largely from minority populations to apply for cooperative agreements in response to this Minority-Based Community Clinical Oncology Program (Minority-Based CCOP) Request for Applications (RFA). Currently funded Minority-Based CCOPs are also invited to respond to this RFA. The NCI clinical trials program provides a network of support for clinical research in cancer centers, major university centers, and community programs. The purpose of this program is to support as a national resource those physicians involved in the care of minority cancer patients who are available for treatment and cancer prevention and control clinical trials research. The linkage of minority cancer patients to the current clinical trials network will also facilitate the transfer of new technology in treatment and cancer prevention and control practices to minority communities and their physicians. This reissuance of Minority-Based CCOP will: 1) provide support for expanding clinical research in minority community settings; 2) bring the advantages of state-of-the-art treatment and cancer prevention and control research to minority individuals in their own communities; 3) increase the involvement of primary health care providers and other specialists in cancer prevention and control studies; 4) establish an operational base for extending cancer prevention and control and reducing cancer incidence, morbidity, and mortality in minority populations; and 5) examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility). This Minority-Based CCOP RFA seeks to strengthen the Minority-Based CCOP by: 1) continuing the program as a vehicle for supporting community participation in cancer treatment and prevention and control clinical trials through research bases (clinical cooperative groups and cancer centers supported by NCI); 2) expanding and strengthening the cancer prevention and control research effort; 3) utilizing the Minority-Based CCOP network for conducting NCI-assisted cancer prevention and control research; and 4) evaluating on a continuing basis Minority-Based CCOP performance and its impact in the community. RESEARCH OBJECTIVES Background The NCI clinical trials network has evolved over the past 30 years. The major NCI program initiatives supporting this network are the Clinical Trials Cooperative Group Program, the Cancer Centers Program, and the Community Clinical Oncology Program (CCOP). Treatment and cancer prevention and control clinical trials research funded through these programs provides patients and their physicians with access to state-of-the-art cancer care management opportunities, and provides oncologists with a source of continuing education on innovations in cancer prevention and control interventions, diagnostic techniques, and treatment applications. One of the major efforts of NCI has been to design and implement program interventions to assure that patients treated in their own communities have access to the same quality of cancer care and the same technological advances that are available to patients treated in major centers. The CCOP, which was first initiated in 1983, has proven to be a successful model for bringing the benefits of clinical research to cancer patients in their communities by providing support for community physicians to enter patients on treatment research protocols. In addition to increasing patient accrual to treatment clinical trials, the CCOP stimulated many communities to organize their cancer activities and expedited the development of local-regional cancer programs. Increased numbers of physicians, hospitals, and other health care professionals participated in the CCOP, accruing patients and meeting the same quality control standards as other members and affiliates. In 1987, the CCOP expanded the cancer prevention and control effort to include support for research in prevention, health promotion, smoking cessation, chemoprevention, treatment applications, continuing care and rehabilitation. With the development and implementation of cancer control research through the clinical trials network, opportunities exist for the implementation of effective preventive strategies for reducing cancer incidence, morbidity, and mortality. When compared to the general population, African-Americans have an increased incidence of a number of malignancies and worse overall survival rates. Greater involvement in clinical trials research by Black, Hispanic, Asian-American, American Indian, and other racial/ethnic minority patients is needed if the advances in clinical research are to be extended to all groups, and the results of clinical trials are generalizable to the entire population. In general, there has been limited participation in clinical trials research by minority cancer patients. Broader access to clinical research protocols is needed in order to develop and implement effective treatment and cancer prevention and control strategies in minority populations. Areas of research where minority involvement is especially needed include: cancer prevention and control, interventions to improve screening and early detection practices; methodological research on ways to increase the educational awareness of individuals at risk for cancer; and studies of barriers to prevention and treatment of cancer. The Minority-Based CCOP has become an important part of these efforts. It links physicians caring for large numbers of minority patients to the NCI clinical trials network. The CCOP model has been an effective mechanism for facilitating the linkage of investigators and their institutions with the clinical trials network. The Minority-Based CCOP was initially approved by the NCI, Division of Cancer Prevention Board of Scientific Counselors in January 1989. Implementation began in the fall of 1990. By 1992 the program was beginning to succeed in its goal of providing minority populations access to clinical trials. In 2001, there were ten (10) programs in eight states, the District of Columbia and Puerto Rico involving approximately 40 hospitals and over 470 physicians. In the past, approximately 70 percent of Minority-Based CCOP patients entered on study have been minority populations. In one study, 14.1 percent of all patients entered onto NCI sponsored treatment trials were from ethnic minorities. These Minority-Based CCOPs contributed more than 10 percent of all minority accrual to NCI-sponsored cancer treatment trials. Objectives and Scope The Minority-Based CCOP initiative is designed to: (1) Bring the advantages of state-of-the-art cancer treatment and prevention and control research to minority individuals in their own communities by having practicing physicians and their patients/participants participate in NCI-approved cancer treatment and prevention and control clinical trials; (2) Provide a basis for involving a wider segment of the community in cancer prevention and control research and investigate the impact of cancer therapy and control advances in community medical practices; (3) Increase the involvement of primary health care providers and other specialists (e.g., surgeons, family practitioners, urologists, gynecologists) with the Minority-Based CCOP investigators in cancer treatment and prevention and control research, providing an opportunity for education and exchange of information; (4) Facilitate wider community participation among racial/ethnic minorities, women, and other underserved populations in cancer treatment and prevention and control research approved by NCI; (5) Provide an operational base for extending cancer control and reducing cancer incidence, morbidity, and mortality in minority populations by accelerating the transfer of newly developed cancer prevention, early detection, treatment, patient management, rehabilitation, and continuing care technology to widespread community application; and (6) Examine selected issues in Minority-Based CCOP performance (e.g., patient recruitment, accrual, eligibility, patient behavioral modification) and evaluate its impact in the community. Participating community programs (Minority-Based CCOPs) will be required to enter patients/ participants onto NCI-approved cancer treatment and prevention and control clinical trials through the research base(s) with which each Minority-Based CCOP is affiliated. Minority-Based CCOPs may contact NCI program staff directly for assistance and participation in selected cancer prevention and control protocols. Minority-based CCOP performance will be evaluated on a continuing basis by the NCI program director. Minority-Based CCOP applicants must demonstrate the potential for accessing appropriate cancer patients/participants within their communities for participation in cancer treatment and prevention and control protocols provided by their research bases. MECHANISM OF SUPPORT This RFA will use NIH U10 award mechanism. The NIH U10 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award" The total project period for applications submitted in response to this RFA may not exceed 3 years for new applicants, and no more than 5 years for applicants currently supported under this program. Currently supported applicants will be funded for 3, 4, or 5 years depending upon priority score, review committee recommendations, and programmatic considerations. The anticipated award date is June 1, 2003 NCI has determined that there is a continuing program need for community participation in cancer clinical research trials, both cancer treatment and prevention and control. This RFA will be published in the NIH Guide for Grants and Contracts periodically, provided funds are available. FUNDS AVAILABLE It is anticipated that up to $2.2 million in total costs per year for 5 years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that up to three (3) awards will be made. Because the nature and scope of the research proposed in response to this RFA may vary, award sizes are expected to vary also. Levels of support also depend on the number of meritorious applications. Although this program is provided for in the financial plans of NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Awards for research bases affiliated with Minority-Based CCOPs will be made through Cooperative Agreements under the Community Clinical Oncology Program RFA. NCI program staff will take into account demographic and geographic distributions of peer-reviewed and scored Minority-Based CCOPs in the final funding selection process. Multiple Minority-Based CCOP applicants who are proposing to use the same patient population will be considered for funding, but all may not be awarded unless warranted by the population density. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, hospitals, and health maintenance organizations o Domestic o Faith-based organizations Applications for cooperative agreements to continue or establish Minority-Based CCOPs may be submitted by domestic institutions only. Institutions, organizations and/or physician group applicants for the Minority-Based CCOP must document that at least 40 percent of their newly diagnosed cancer patients are from minority populations. Other eligibility requirements for new applicants and currently funded programs are described below. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. 1. An applicant may be a hospital, clinic, group of practicing physicians, health maintenance organization (HMO), or consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a Principal Investigator and a single administrative focus. 2. A university hospital that is the major teaching institution for that university AND which has greater than 40 percent of its new cancer patients from minority populations is eligible to apply. 3. A military treatment facility (MTF) or Veterans Administration hospital may be included in an application as a nondominant member of a consortium led by a community institution; 4. Funded cooperative group affiliate program participants are eligible to apply, but should state in the application that support through this mechanism will be relinquished if a MB-CCOP award is received. 5. An unfunded non-university clinical trials cooperative group member is eligible to apply. 6. Funded Community Clinical Oncology Program (CCOP) participants are eligible to apply for competitive renewal, but should state in the application that the current CCOP support will be relinquished if a MB-CCOP award is received. Institutions and organizations NOT eligible to apply as a Minority-Based CCOP include: 1. A comprehensive, consortial, or clinical cancer center holding both an NCI Cancer Center Support core grant and a clinical trials cooperative group U10 award funded by the Division; 2. A university hospital clinical trials cooperative group member funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI; and 3. Foreign institutions. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Cooperative Agreement Terms and Conditions of Award The administrative and funding instrument used for this program is a cooperative agreement (U10), which involves anticipated assistance to awardees from the NCI Program Staff. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partnership role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NCI Program Staff, as described below. The following terms and conditions pertaining to the scope and nature of the interaction between NCI and the investigators will be incorporated in the Notice of Award. These terms will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The terms and conditions described in this section are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines; HHS Grant Administration Regulations at 45 CFR part 74; other HHS, PHS, and NIH Grant Administration policy statements; and other NCI administrative terms of award. The NIH expects investigators supported by NIH funding to make their research data available to the scientific community for subsequent analysis. Consequently, applicants must address their plans for data sharing in the grant application (e.g., in sections related to significance, budget, and the end of the research plan). This requirement on data sharing is an extension to NIH policy regarding sharing research resources, which expects that recipients of NIH support will provide prompt and effective access to research tools. Investigators should refer to the NIH Guide: NIH Announces Draft Statement on Sharing Research Data http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-035.html and http://grants.nih.gov/grants/policy/data_sharing/ for guidance on addressing this application requirement. For additional guidance on the application of this policy to Minority-Based CCOP cooperative agreements see "Suggestions for Organizing Information for a MBCCOP Application at: http://cancer.gov/prevention/ccop. A. TERMS AND CONDITIONS OF AWARD FOR MINORITY-BASED CCOP AWARDEES The awardee's programmatic responsibilities for the conduct of the research supported by this cooperative agreement are described in the following; the INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment and Diagnosis, (DCTD), National Cancer Institute: http://ctep.cancer.gov/handbook/ GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES: http://ctep.cancer.gov/monitoring/guidelines.html and any subsequent modifications of these documents; and the Intellectual Property Option to Collaborator: http://ctep.cancer.gov/industry/ipo.html These documents are hereby incorporated by reference as terms of award and are available at the URLs cited above or from the program staff listed under "INQUIRES." 1. PROTOCOLS All protocols originating from and/or coordinated by the research bases for Minority-Based CCOPs use must be reviewed and approved by the Cancer Prevention and Control Protocol Review Committee (CPCPRC), Division of Cancer Prevention (DCP) and/or the Protocol Review Committee (PRC), Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation. Protocols will be assigned credit once they are approved by the review committee. Each research base protocol approved for Minority-Based CCOP use will be assigned a credit value. Credits will be based on the complexity of the intervention, the amount of data management required, and the duration of follow-up. For example, each patient accrued to an average Phase II or Phase III treatment protocol will count 1 credit. Cancer prevention and control protocols will be assessed for credit using a similar approach. For example, a randomized Phase III chemoprevention protocol will be assigned a value of 1 credit per participant entered. Cancer control protocols involving limited interventions will receive credit that is commensurate with the amount of data management effort required. Follow-up credit for chemoprevention protocols may also be assigned. To receive credit for accruals the Minority Based-CCOP must access NCI- approved treatment and/or prevention and control protocols through the research bases with which it has affiliation agreements. The research base is responsible for the development and implementation of high quality cancer treatment and prevention and control clinical trials, and for evaluation of the results of such studies The Minority-Based CCOP also may access treatment trials from research bases with which it is not affiliated through the NCI's Cancer Trials Support Unit (CTSU). Minority-Based CCOP accruals to protocols will receive credits and not per case reimbursement. The purpose of the CTSU is to broaden access to clinical trials and to streamline and centralize administrative, financial and data collection task associated with conducting NCI-approved treatment trials. Minority-Based CCOPs are encouraged to participate in cancer prevention and control research that is supported through other federal administrative and funding instruments. This activity is encouraged because the cooperative agreements awarded under this RFA primarily support development and conduct of studies evaluating an intervention. Research supported through these other mechanisms might include nonintervention research in cancer control (e.g., epidemiology, methods development, population-based surveys, etc.). Minority- Based CCOP participation in these studies would advance cancer prevention and control research and improve public health outcomes. This activity will be considered in the evaluation of the Minority-Based CCOP's productivity. 2. RESEARCH BASE AFFILIATION(S) Each Minority-Based CCOP must affiliate with one national multi-specialty cooperative group (research base) having a spectrum of cancer treatment and prevention and control clinical trials. Each Minority-Based CCOP can affiliate with a maximum of four additional research bases exclusive of the national multi-specialty cooperative groups (exceptions may be granted in conjunction with participation in an NCI sponsored "pilot" project). Affiliation with a sixth research base may be considered if it is with one of the cancer center CCOP research bases. NOTE: A list of currently eligible research bases is available at: http://cancer.gov/prevention/ccop/grantees.html or from the Community Oncology and Prevention Trials Research Group at (301) 496-8541. If participation in the protocols of one group competes with that of another group with which the Minority-Based CCOP is affiliated, the Minority-Based CCOP must prioritize the protocols in order to avoid bias in the allocation of patients to competing protocols. Initial affiliations should be maintained for the duration of the funding cycle. When circumstances require changes in research base affiliations, prior written approval from the DCP Program Director is required. The Guidelines for Obtaining Approval of CCOP Organizational Changes are available at: http://cancer.gov/prevention/ccop/guidelines.html 3. ACCRUAL Patient accrual to clinical trials is expected to be reflective of the new cancer patient distribution of the participating physicians; that is, greater than 40 percent of new cancer patients from minority populations. An additional measure of performance is that at least 10 percent of all new cancer patients for whom protocols are available will be placed on clinical trials by Minority-Based CCOP physicians. Each Minority-Based CCOP is required to accrue a minimum of 50 credits per year to treatment clinical trials that have been approved by the PRC, DCTD, NCI. The 50 credit minimum to treatment requirement may be waived for: 1) those applicants whose specialty is pediatrics and are able to place a majority of their eligible patients on protocols; and 2) for those applicants with an outstanding record in accrual to cancer prevention and control protocols. Each Minority-Based CCOP is eventually required to accrue the minimum of 50 credits per year to cancer prevention and control clinical trials that have been approved by the CPCPRC, DCP. Cancer prevention and control research should be intervention-oriented and may include such areas as cancer prevention, early detection, symptom management, rehabilitation, quality of life, and continuing care. New Minority-Based CCOP Awardees are required to accrue a minimum of 30 cancer control credits in the first year of funding, 40 credits in the second year, and 50 credits thereafter in cancer prevention and control. Existing Minority-Based CCOPs undergoing competitive renewal are expected to accrue a minimum of 50 credits per year in cancer treatment and 50 credits per year in prevention and control. The 50 credit minimum to cancer prevention and control requirement may be waived for those applicants whose specialty is pediatrics and are able to place a majority of their eligible patients on protocols. The Minority-Based CCOP's ability to meet projected accrual goals to both cancer treatment and prevention and control clinical trials will also be assessed by the program directors. The ability to incrementally accrue and maintain minority enrollment will be assessed and weighted toward credits gained. In addition, Minority-Based CCOPs are encouraged to participate in cancer prevention and control research that is supported through other federal administrative and funding instruments, such as investigator-initiated awards. Collaborations between Minority-Based CCOPs and independent investigators may facilitate the implementation of a wide variety of nonintervention research in cancer control such as descriptive, qualitative, survey, methods development or epidemiology that will contribute to improving public health outcomes. Participation in such research will be considered in the evaluation of Minority-Based CCOP's productivity. 4. QUALITY CONTROL In accordance with research base guidelines and NCI policies, the Minority- Based CCOP must establish and follow procedures for the assurance of data quality and for the prevention and/or identification of false or otherwise unreliable data. The Minority-Based CCOP must follow policies developed by the research bases with which they are affiliated and approved by the NCI for auditing the accuracy of scientific data submitted to them by the Minority- Based CCOP participants. A list of the research bases is available at: http://cancer.gov/prevention/ccop/grantees.html 5. DATA MANAGEMENT The Minority-Based CCOP must provide the DCP Program Director with access to all data generated under this award for periodic review of data management procedures of the Minority-Based CCOP. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data. 6. INVESTIGATIONAL DRUG MANAGEMENT Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. Specifically, all Minority-Based CCOP investigators accruing patients must have an active FDA Form 1572 on file with the Pharmaceutical Management Branch, CTEP, DCTD, NCI. 7. MONITORING Each Minority-Based CCOP must agree to periodic on-site audits by representatives of its research base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following: use of investigational drugs; compliance with regulations for institutional review board (IRB) approval and informed consent (compliance with 45 CFR 46); compliance with protocol specifications; quality control and accuracy of data recording; and completeness of reporting adverse drug reactions. Research Base evaluation reports of such on-site audits will be reviewed by the Clinical Trials Monitoring Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), DCTD, and by the DCP Program Director. In addition, NCI program and grants management staff will review protocol accrual, fiscal, and administrative procedures. All institutions participating or collaborating in the Minority-Based CCOPs on NCI-supported multi-institutional clinical trials must be in compliance with the monitoring standards established by the research base. They should include the following standards: (1) Medical records submitted in support of NCI multi-institutional trials must conform to usual standards for the maintenance of clear, accurate, and unambiguous medical records. White-outs on medical records are unacceptable; (2) If it is the usual and customary practice of a department, laboratory, clinic or office to prepare or issue official reports, then only that department, laboratory, clinic or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations. For clinical progress notes, the change must be dated and initialed by the person making the change. Only one line should be placed through the initial entry, so that both the original entry and the change are legible; (3) The improper modification of important patient records will result in additional investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding. 8. RADIOTHERAPY EQUIPMENT Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in protocols requiring radiation therapy, as required by the affiliated research base(s). 9. ORGANIZATIONAL CHANGES Certain Minority-Based CCOP organizational changes must have the prior written approval of the DCP Program Director. These include the addition/deletion of a participating physician, a health care professional other than a physician (who actively enters patients to cancer prevention and control trials), an affiliate, component, or research base. The Guidelines for Obtaining Approval of CCOP Organizational Changes are available at: http://cancer.gov/prevention/ccop/guidelines.html. 10. REPORTING REQUIREMENTS Annual progress reports must be submitted to DCP. A suggested format will be provided for this purpose. The format is available at: http://cancer.gov/prevention/ccop/. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension, or termination of the award. 11. NETWORK PARTICIPATION Minority-Based CCOPs are part of a national network for conducting cancer treatment and prevention and control clinical trials. As such, each Minority-Based CCOP may be asked to participate in strategy sessions or workshops and in the continuing evaluation of the program and its impact in the community. Minority-Based CCOPs may also be asked to share their process and outcome methods for recruiting and maintaining minority enrollment. 12. PATIENT/PARTICIPANT LOG Each Minority-Based CCOP will be asked to periodically maintain and verify a new patient /participant log or minimal registry to include age, sex, race, ethnicity, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/participant pool seen by the Minority-Based CCOP investigators. 13. FEDERALLY MANDATED REGULATORY REQUIREMENTS Each Minority-Based CCOP must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. At a minimum, these include: (1) methods for assuring that each facility at which CCOP investigators are conducting clinical trials has a current, approved assurance on file with the Office of Human Research Protections (OHRP); that each protocol is reviewed by the responsible IRB prior to patient entry; and that each protocol is reviewed annually by the IRB so long as the protocol is active; (2) methods for assuring or documenting that each patient (or patient's parent/legal guardian) gives fully informed written consent to participation in a research protocol prior to the initiation of the experimental intervention; (3) a system for assuring timely reporting of all serious and unexpected toxicities to the Investigational Drug Branch, CTEP, DCTD, according to DCTD guidelines and/or to DCP according to DCP guidelines; (4) implementation of DCP/DCTD requirements for storage and accounting for investigational agents provided under DCP/DCTD sponsorship; and (5) education on the protection of human research participants for all investigators involved in the design or conduct of research involving human subjects. In addition, the Minority-Based CCOP must have a data-sharing plan as required by the extension of NIH policy regarding sharing research resources (See NIH Grants Policy, Part II Subpart A, Availability of Research Results). Also, see the Suggestions for Organizing Information for a Minority-Based CCOP Application for guidance in the application of this policy to Minority-Based CCOP cooperative agreements at: http://cancer.gov/prevention/ccop. 14. PUBLICATIONS Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires acknowledgment of NCI support. B. NCI STAFF INVOLVEMENT 1. PROTOCOL REVIEW To be eligible for credit assignment protocols must be reviewed and approved by the CPCPRC, DCP , and/or the PRC, DCTD, NCI, prior to implementation. Credit will be assigned after the protocol is approved.. NCI will not provide investigational drugs, permit expenditure of NCI funds, or allow accrual credit for a protocol that has not been approved or that has been closed (except for patients already on study). 2. MONITORING There will be periodic on-site audits of each Minority-Based CCOP by representatives of its research base(s), NCI, or an NCI-designee, such as DCTD's current Clinical Trials Monitoring Service contractor. The DCP and CTMB/CTEP will review and provide advice regarding mechanisms established for study monitoring, including the on-site auditing program. DCP/CTEP and/or its contractor staff may attend the on-site audits conducted by the research base or its NCI designee as observers. 3. DATA MANAGEMENT The DCP Program Director will have access to all data generated under this award and will periodically review the data management procedures of the Minority-Based CCOPs. Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the Food and Drug Administration (FDA). 4. INVESTIGATIONAL DRUG MANAGEMENT The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB), CTEP, DCTD and the Chemopreventive Agent Development Research Group, DCP will advise investigators of specific requirements and changes in requirements about investigational drug management that the FDA and NCI may mandate. 5. ORGANIZATIONAL CHANGES The DCP Program Director will review requests for certain organizational changes and provide written approval. These changes include the addition/deletion of a participating physician or other health professional entering patients/participants in cancer prevention and control research in the Minority-Based CCOP, an affiliate, component, or research base. The Guidelines for Obtaining Approval of CCOP Organizational Changes may be obtained from the URL address: http://cancer.gov/prevention/ccop/guidelines.html. 6. PROGRAM REVIEW The DCP Program Director will review the annual progress report submitted by each Minority-Based CCOP. A suggested format will be developed by the DCP Program Director for this purpose. The DCP Program Director will review the progress of each Minority-Based CCOP through consideration of the Minority-Based CCOP annual report, program site visits, and reports from affiliated research bases. This review may include, but not be limited to, overall accrual credits, percent of available patients/participants placed on study, eligibility and evaluability of individuals entered on study, and timeliness and quality of data reporting. The inability of a Minority-Based CCOP to meet the performance requirements set forth in the Terms and Conditions of Award, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of the award. 7. STRATEGY SESSIONS The DCP Program Director or designee will sponsor strategy sessions when indicated, attended by principal investigators from the Minority-Based CCOPs and appropriate DCP/DCTD staff. At these meetings, information relevant to the Minority-Based CCOPs will be reviewed and discussed, including such issues as overall Minority-Based CCOP performance and the science of current or proposed clinical trials. Data will be analyzed and the outstanding research questions established and prioritized into national research goals by Minority-Based CCOP investigators and the DCP/DCTD attendees. The principal investigators will have the primary responsibility for analyzing and prioritizing the research questions to be developed into clinical trials. The DCP Program Director will also assist the Minority-Based investigators in exploring mutual interests in cancer prevention and control research. 8. FEDERALLY MANDATED REGULATORY REQUIREMENTS The DCP Program Director or designee and DCTD staff will review mechanisms established by each Minority-Based CCOP to meet the Department of Health and Human Service (DHHS) / Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. C. ARBITRATION PROCESS NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the involved NCI Program Staff related to program performance and programmatic decisions on scientific technical matters. An arbitration panel (with appropriate expertise) composed of one member of the recipient group, one NCI nominee, and a third member chosen by the other two will be formed to review the NCI decision and recommend a course of action to the Director, DCP. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Worta McCaskill-Stevens, MD, MS Community Oncology and Prevention Trials Research Group Division of Cancer Prevention, NCI Executive Plaza North - Room 2017 6130 Executive Boulevard, MSC-7340 Bethesda, Maryland 20892-7340 Telephone: (301) 496-8541 Fax: (301) 496-8667 E-mail address: wm57h@nih.gov Direct inquiries regarding review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: ncidearefof@mail.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jane Paull Grants Administration Branch Office of the Director, NCI Executive Plaza South - Room 243 6120 Executive Boulevard Bethesda, Maryland 20892 Telephone: (301) 496-7800 Fax: (301) 496-8601 E-mail: jp97x@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Worta McCaskill-Stevens, MD, MS Community Oncology and Prevention Trials Research Group Division of Cancer Prevention, NCI Executive Plaza North - Room 2017 6130 Executive Boulevard, MSC-7340 Bethesda, Maryland 20892-7340 SUBMITTING AN APPLICATION APPLICATION PROCEDURES Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at: http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: A suggested format is available at the URL address: http://cancer.gov/prevention/ccop/. All applicants are encouraged to obtain and use the suggested format instructions for organizing the specific information concerning the RFA programmatic requirements in the PHS 398. If tables from the "Suggestions for Organizing Information for a Minority-Based CCOP Application" are included, those tables should be part of the body of the application, and NOT included in the appendix. These tables may be included in the application as part of the Resources, Progress Report and/or Human Subjects Research sections, as appropriate. Also, responses to the instructions concerning "Human Subjects" verification must be included in the application at the time of submission Because the Terms and Conditions of Award (discussed in the SPECIAL REQUIREMENTS Section above) will be included in all awards issued as a result of this RFA, it is critical that each applicant include specific plans for responding to these terms. Plans must describe how the applicant will comply with NCI staff involvement as well as how all the responsibilities of awardees will be fulfilled. An application from a currently funded program will be a competitive renewal and must include a progress report that, at a minimum, consists of the following: (1) A summary of prior Minority-Based CCOP activities/accomplishments, including: a clear presentation of yearly accrual over the funding period (i.e. accrual tables from previous annual progress reports), a summary of accrual to all cancer treatment and a summary of accrual to all cancer prevention and control protocols by gender and ethnicity; and progress in meeting DCP's established accrual goals. (2) A plan for continuing to meet prevention and control accrual requirements, including plans for follow-up of participants from the large prevention trials as well as plans for implementation of additional cancer control protocols. (3) Tables of the current budget and FTEs with a justification for any request for additional resources. (4) An evaluation of Minority-Based CCOP performance by affiliated research base(s). (5) A complete description of how the applicant has met the special cooperative agreement terms and conditions of the award including staffing patterns that may have significantly contributed to minority involvement in clinical trials. Both new and currently funded applicants should address the following: 1. Each applicant must demonstrate access to a population in which at least 40 percent of new cancer patients are from minority groups and must include plans for recruiting and maintaining women and minority participants. Data from hospital registries (analytic cases), admission, discharge, clinic, and billing records may be used to document the new minority cancer patient population available to the applicant organization AND its physician participants. In describing the study population, a breakdown, by percentage of the gender and minority composition of the study population, should be provided. This information may be based on the institutional records and/or prior experience. 2. Each applicant must delineate its catchment area. A map of the service area should be provided, designating counties or zip codes from which approximately 80 percent of the patients will be drawn. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. 3. Each applicant must demonstrate the potential and stated commitment to accrue a minimum of 50 credits per year to treatment clinical trials (except if waived for applicants whose specialty is pediatrics and are able to place a majority of their eligible patients on protocols or those applicants with an outstanding record in cancer prevention and control accrual). Documentation must include any prior participation in treatment research clinical trials with a clear presentation of the number of patients and credits accrued to NCI-approved treatment clinical trials. A list of the NCI-approved treatment protocols in which the applicant expects to participate and the projected accrual to each must be provided. 4. Each new applicant must demonstrate the potential and plans for accrual of a minimum of 30 credits in the first year of funding, 40 credits in the second year, and 50 credits in the third year to cancer prevention and control protocols. Documentation must include any prior participation in cancer prevention and control research clinical trials with a clear presentation of the total number of patients and credits accrued to NCI-approved cancer prevention and control clinical trials. A list of the NCI-approved prevention and control protocols in which the applicant expects to participate and the projected accrual to each must be provided. A complete listing of NCI-approved cancer prevention and control clinical trials can be requested from the NCI program staff listed under "INQUIRIES". If applicable, Minority-Based CCOPs should describe their participation in cancer prevention and control research studies supported through other federal administrative and funding instruments such as research project grants (R01s) and contracts. Participation in such research will be considered in the evaluation of Minority-Based CCOP productivity. 5. NEW applicants must provide an implementation plan for at least two examples of NCI-approved intervention cancer prevention and control protocols appropriate for Minority-Based CCOP participation. For these two protocols, the applicant should describe their implementation, including specifics on patient/participant recruitment, compliance, and follow-up. These studies must come from research bases with which they propose to affiliate. The Minority-Based CCOP applicant must document the ability to access the appropriate physicians and patient/participant populations and adequate facilities to participate in the proposed clinical trials. 6. A designated Principal Investigator is required. An associate Principal Investigator should also be named to assure continuity in the event of resignation of the Principal Investigator. The qualifications and experience of both must be described in terms of ability to organize and manage a community oncology program which includes cancer treatment and prevention and control research and related activities as well as experience in accruing patients/participants to treatment and cancer prevention and control clinical trials must be described. 7. Each applicant is expected to have a committed multi-disciplinary professional group appropriate for its expected protocol participation. This team may include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and other disciplines (e.g., gynecology, urology, pediatrics, internal medicine, family practice) as appropriate. Where appropriate, each applicant should include plans to utilize minority professionals to assure accrual success. The training and experience of participating physicians must be provided, along with a description of working relationships. Any experience working together as a group, particularly in implementing clinical cancer treatment and prevention and control research and related activities, should be included. An organizational chart showing how the group will function must also be included. Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials may be requested. 8. Each applicant must provide the qualifications and experience of all proposed support personnel as well as a description of the proposed duties for each position. 9. Through formal affiliations with only one multi-specialty cooperative group (exceptions may be granted in conjunction with participation in an NCI sponsored "pilot" project) and up to four additional research bases, each applicant must demonstrate access to both cancer treatment and prevention and control research protocols. Evidence must be provided that an affiliation has been established with at least one NCI- funded research base that has the capacity to provide both clinical cancer treatment and prevention and control protocols. In addition, affiliations with research bases offering only cancer prevention and control protocols are appropriate. Affiliation with a sixth research base may be considered if it is with one of the cancer center CCOP research bases. The conditions of affiliation must be provided in the Minority-Based CCOP-research base affiliation agreement(s). Initial affiliations should be maintained during the funding cycle. Multiple research base affiliations are permitted provided they are not conflicting. The affiliation agreements must state specifically how the problem of competing protocols will be resolved. NOTE: A list of currently eligible research bases may be obtained at: http://cancer.gov/prevention/ccop or from the Community Oncology and Prevention Trials Research Group at (301) 496-8541 10. Quality control procedures must be described in detail. Assurance of quality is the joint responsibility of the Minority-Based CCOP and its research base(s). Quality control procedures of the research base will be applied to the Minority-Based CCOPs and should be specified in the affiliation agreement between the Minority-Based CCOP and the research base. Procedures for investigational drug monitoring and data management must also be described. 11. The Minority-Based CCOP must describe how its plan to share data. The procedures to be used and a timeline for making the data available should be included in the description of the plan. The Minority-Based CCOP also should discuss how the rights and confidentiality of participants are protected. 12. The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization and/or documentation of consortium arrangements must be provided. Evidence of involvement with community-based voluntary organizations may be submitted. In addition, each applicant must have a defined space for administrative activities and administrative personnel which will serve as a focus for data management, quality control, and communication. 13. Allocation of funds to support community costs for receipt, handling, and quality control of patient data must be specified. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Funding is not allowed for clinical care provided to patients (e.g., reimbursement of patient care expenses; transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on Minority-Based CCOP organizational/ administrative tasks. Justification must be provided for personnel time, effort, and funds requested. USING THE RFA LABLEL The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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: Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8041, MSC-8329 Rockville, MD 20852 (express courier) Bethesda MD 20892-8329 APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice- files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NCI program staff. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities (DEA) at NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Those that receive a priority score will undergo a second level review by the National Cancer Advisory Board. REVIEW CRITERIA All applicants will be evaluated on the following criteria: 1. Ability to access through participating Minority-Based CCOP physicians a population in which at least 40 percent of new cancer patients are from minority groups. In describing the study population, it is required that a description of the gender and minority population served be provided, including an outreach plan and utilization of minority personnel. This information may be based on institutional records and/or prior experience. 2. For new applicants, ability to accrue a minimum of 50 credits per year to treatment clinical trials and a minimum of 30 credits per year to cancer prevention and control clinical trials in the first year, increasing to 50 credits per year in the third year. Established Minority-Based CCOPs may be funded at a yearly accrual goal higher than 50 credits for treatment clinical trials and 50 credits for cancer prevention and control clinical trials. These established Minority-Based CCOPs will be evaluated for their past performance in meeting these accrual goals. The minimum accrual to treatment requirements may be waived for: 1) applicants whose specialty is pediatrics and are able to place a majority of their eligible patients on protocol; and 2) for applicants with an outstanding record in accrual to prevention and control protocols. Each applicant's ability to access the appropriate populations, professional disciplines, and facilities to participate with affiliated research bases in NCI-approved cancer prevention and control intervention protocols will be appraised. Any prior participation in cancer treatment and prevention and control research will be considered. Minority-Based CCOPs participation in cancer prevention and control research studies supported through other federal administrative and funding instruments such as research project grants (R01s) and contracts will be considered in the evaluation of the Minority-Based CCOP's productivity 3. Qualifications, experience and track record of the Principal Investigator/associate Principal Investigator, in terms of ability to organize and manage a community oncology program that includes both cancer treatment and prevention and control research and related activities. 4. Training, experience, and commitment of participating physicians for accruing individuals to protocols in which the applicant has agreed to participate. The experience of proposed investigators in the entry and treatment of cancer patients on research trials (gained from residency, fellowships, postdoctoral training and/or subsequent practice) will be appraised. For multi disciplinary studies, evidence of the availability of appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, gynecology, urology, pathology, internal medicine, family practice, nursing, and nutrition) will be required. Experience or special skills in cancer prevention and control research and related activities will be considered, together with availability of other community resources and personnel for such clinical trials. 5. Stability of the functional unit or group applying to become a Minority-Based CCOP. Preexisting organizational affiliations of at least a core of the group applying and evidence of stable working relationships will be appraised. Examples of established consortium arrangements and committee structure which demonstrate the participation of appropriate physicians and administrators may be submitted. Evidence of previous success as a group in implementing clinical cancer treatment and prevention and control research and related activities will be considered. 6. Qualifications and experience of all proposed support personnel relative to the individuals' position descriptions. The relevant credentials and expected contributions to the program of personnel not fiscally supported by the award will be considered. 7. Adequacy of quality assurance mechanisms for both cancer treatment and prevention and control interventions, and adequacy of procedures for investigational drug monitoring and data management identification of false or otherwise unreliable data. 8. Adequacy of available facilities, including laboratories, in-patient and outpatient resources, cancer registries, etc., and adequacy of space for administrative activities and personnel. 9. Appropriateness of research base affiliations and of the cancer treatment and prevention and control research protocols chosen. Affiliation agreements must be provided in the application. 10. The adequacy of the data-sharing plan 11. For competitive renewals, adequacy of progress during the funding period, including ability to meet the minimum accrual credits in cancer treatment and prevention and control, progress made as a Minority-Based CCOP, and evaluation of Minority-Based CCOP performance by affiliated research bases(s). Consideration will be given to previous accrual and the ability to meet the previous accrual projections for which the Minority-Based CCOP was funded. Minority-Based CCOP evaluation by affiliated research bases must be provided. Plans for continued accrual and follow-up of participants on protocols will be evaluated. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each favorably recommended application. Allowable items in the budget are requests for full or part-time administrative personnel, data managers, and study assistants; supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control); and appropriate travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel). Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials will be considered. Funding is not allowed for clinical care provided to patients. (e.g., patient care reimbursement, transportation costs). Funding is not allowed for clinical support personnel (e.g., pharmacist, physicist, clinical psychologist, dosimetrist). Physician compensation is only an allowable cost for the Principal Investigator (PI) and Co-PI, specifically for time spent on Minority-Based CCOP organizational/administrative tasks. Justification must be provided for personnel time and effort and funds requested. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 24, 2002 Application Receipt Date: July 22, 2002 Review by NCAB Advisory Board: February 2003 Anticipated Award Date: June 1, 2003 AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered by NCI program staff for award based upon: o Scientific and technical merit (as determined by peer review); o Availability of funds; o Programmatic priorities; and o Demographic and geographic distribution of applicants to assure inclusion of minority and underserved populations... Multiple Minority-Based CCOP respondents who are competing for the same patient population will be considered, but all may not be awarded unless warranted by the population density. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a 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 for the NCI for Data and 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: http://www.cancer.gov/clinical_trials/ INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 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 in now available online at: http://cme.nci.nih.gov/ PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 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 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 and proposals 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. Furthermore, we caution reviewers 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 RFA 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 No. 93.399, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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