COMMUNITY NETWORKS TO REDUCE CANCER HEALTH DISPARITIES RELEASE DATE: April 26, 2004 RFA Number: RFA-CA-05-012 October 2, 2009 - This RFA has been reissued as (RFA-CA-09-032). (RFA-CA-07-501 is affiliated with this RFA.) (RFA-CA-06-504 is affiliated with this RFA.) (see addenda NOT-CA-04-017 and NOT-CA-04-018) EXPIRATION DATE: July 14, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.394, 93.399 LETTER OF INTENT RECEIPT DATE: June 14, 2004 APPLICATION RECEIPT DATE: July 13, 2004 This RFA is a reissue of RFA-CA-99-003, which was published in the NIH Guide on March 23, 1999. 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 Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Cancer Institute, through its Center to Reduce Cancer Health Disparities (CRCHD), invites cooperative agreement grant applications (U01) for Community Networks to Reduce Cancer Health Disparities Through Education, Research, and Training (Community Networks Program – CNP). The purpose of the CNP is to reduce cancer health disparities by conducting community-based participatory education, training, and research among racial/ethnic minorities (e.g., African Americans, Hispanics, Asians, Pacific Islanders, and Native Americans/Alaska Natives) and underserved populations (e.g., Appalachian, rural, low socioeconomic status and other underserved populations). The overall goals of this program are to significantly improve access to and utilization of beneficial cancer interventions in communities with cancer health disparities, thereby reducing these disparities. The CNP will be implemented in three phases. The goal of Phase I is to develop and increase capacity building to support community-based participatory education, research, and training to reduce cancer health disparities. The goal of Phase II is to develop community-based participatory research and training programs to reduce cancer health disparities. The goal of Phase III is to establish credibility and sustainability of the CNP. RESEARCH OBJECTIVES Background In 1989, the National Black Leadership Initiative was created to conduct cancer awareness activities in response to concerns that the incidence and mortality rates for many types of cancers were higher in black Americans than in whites. In 1992, the Hispanic Leadership and the Appalachian Leadership Initiatives were added. The general finding of the Leadership Initiatives was that there was a need to conduct more research to better understand differences in the cancer rates between these populations and other Americans. In 1999, the National Cancer Institute (NCI) decided to replace the National Leadership Initiatives on Cancer Awareness with the Special Populations Networks (SPNs) for Cancer Awareness, Research, and Training. In April 2000, the NCI funded 18 SPN Cooperative Agreements. These SPNs have developed community- based infrastructures that provide expertise in culturally competent cancer awareness activities in racial/ethnic minority and underserved populations, as well as training researchers from racial/ethnic minority and underserved populations to conduct community-based participatory research. As this SPN program draws to an end in 2005, the Center to Reduce Cancer Health Disparities (CRCHD) plans to reorient the focus of the RFA from special population awareness research to reducing cancer health disparities among racial/ethnic minority and underserved populations. Since there is a disconnect between the research discovery/development systems and the delivery systems for cancer prevention and care, there is a need to increase and sustain delivery of beneficial interventions to racial/ethnic minorities and underserved groups. The redesign and re-issuance of that RFA will focus on closing this gap in the delivery system in those communities with cancer health disparities. Purpose and Objectives The purpose of the Community Networks Program (CNP) is to reduce cancer health disparities by conducting community-based participatory education, training, and research (that is, active community participation in the activities – that are conducted by, for, and with the community) among racial/ethnic minorities (e.g., African Americans, Hispanics, Asians, Pacific Islanders, and Native Americans/Alaska Natives) and underserved populations (e.g., Appalachian, rural, low socioeconomic status and other underserved populations). The overall goals of this program are to significantly improve access to and utilization of beneficial cancer interventions in communities with cancer health disparities and provide a cadre of well-trained researchers who will continue to reduce disparities in communities. The CNP will be implemented in three phases. Activities initiated during each phase continue to the end of the grant. Phase I. The goal of Phase I is to develop and increase capacity building to support community-based participatory education, research, and training to reduce cancer health disparities. Within this phase, the objectives are as follows: (I.1) Within the first year, develop a core organizational infrastructure to support community-based participatory activities to reduce cancer health disparities by establishing a staff of multidisciplinary professionals critical to implementing the program. (I.2) Create partnerships with communities that suffer cancer health disparities and with other organizations with an interest in reducing cancer health disparities among members of these communities. These may include local, community-level organizations (e.g., health services and education outreach groups, faith-based groups, and coalitions) that serve racial/ethnic minority and underserved populations; primary prevention programs (such as smoking cessation and hepatitis B vaccination programs); secondary prevention programs (that provide screening and early detection testing); cancer treatment facilities that serve these communities (e.g, community hospitals); cancer research institutions, including NCI Cancer Centers; national cancer prevention and control organizations (e.g. the American Cancer Society); other Government agencies that can assist in reducing cancer health disparities (e.g. the Centers for Disease Control and Prevention [CDC]), Health Resources and Services Administration [HRSA], and Centers for Medicare & Medicaid Services [CMS]), and other organizations that can affect reductions in cancer health disparities. These partnerships should be documented with Memorandum of Understanding (MOU) outlining specific roles and responsibilities of partners in relation to the CNP. (I.3) Form at least four collaborations with other NCI programs (i.e, NCI Centers/Divisions/offices other than the NCI CRCHD) for the purpose of reducing cancer health disparities with other than NCI CRCHD programs. The CNP will collaborate with NCI Centers/Divisions/Offices on at least four projects involving other NCI efforts to reduce cancer health disparities during the grant period. A partnership with the Cancer Information Service’s Partnership program is mandatory. Other NCI activities on disparities include, but are not limited to, education projects with the Continuing Umbrella of Research Experience (CURE) program to promote development of minority researchers; participant recruitment to Division of Cancer Treatment and Diagnosis (DCTD) treatment clinical trials; participant recruitment to Division of Cancer Prevention (DCP) prevention and screening/early detection clinical trials; participant recruitment to Division of Cancer Epidemiology and Genetics (DCEG) epidemiological studies (such as cohort and case/control studies); Division of Cancer Control and Population Sciences (DCCPS) efforts to reduce cancer health disparities (such as the Centers for Population Health and Health Disparities grants); participant recruitment to Center for Cancer Research (CCR) intramural trials; the Energy Balance Dissemination Initiative with the Center for Strategic Dissemination and similar NCI projects. This list will be expanded as additional potential collaboration projects are identified. (I.4) Increase utilization of beneficial interventions to reduce cancer health disparities. Perform community-based participatory educational activities that reduce cancer health disparities by increasing cancer education and community use of beneficial cancer interventions. These interventions include use of, but are not limited to: primary cancer prevention, such as smoking cessation programs and hepatitis B vaccinations; screening and early detection tests, such as mammography, Pap smears, colorectal screening tests, and prostate-specific antigen (PSA) tests; and other beneficial interventions that reduce cancer health disparities, such as recruitment to clinical trials and optimizing energy balance to reduce the cancer burden. Funds for this activity will support the education of the community about beneficial intervention activities. The CNP will not pay for the primary and secondary prevention services, but rather use existing resources that provide these services. Efforts should be directed at reaching the hard-to-reach groups. (I.5) Leverage CNP activities by obtaining non-CRCHD funding for community-based participatory activities directed at reducing cancer health disparities. In collaboration with community partnerships, CNP will obtain non-CRCHD funding for community-based participatory education and training activities. Development of non-CRCHD funding sources is important in creating sustainable, community-based participatory education and training activities that can reduce cancer health disparities. Phase II. The goal of Phase II is to develop community-based participatory research and training programs to reduce cancer health disparities. Within Phase II, the objectives are as follows: (II.1) Perform community-based participatory research to reduce cancer health disparities in local communities. The CNP will develop and perform community-based participatory research that involves the full spectrum of community-based participatory research — from needs assessments to intervention research to policy assessments — with an emphasis on developing efficacious community-based participatory interventions to reduce cancer health disparities. These interventions may involve, but are not limited to: development of educational interventions that promote utilization of existing screening and early detection resources engaging community participants and their health care providers; addressing issues of cancer survivorship and quality of life; or dealing with assessing the impact of health care policies on reducing cancer health disparities. (II.2) Develop pilot research projects. As part of the CNP research efforts, the Community Networks will develop and implement collaborative developmental pilot research projects involving community-based participatory research in cancer health disparities. Pilot research projects should address the spectrum of research on cancer health disparities from needs assessments to intervention research to policy assessments. A principal objective of this research is the development of efficacious community-based participatory interventions to reduce cancer health disparities that can be used nationwide. Competitive or administrative supplements (at the discretion of the NCI) will be used to support pilot research projects. (II.3) Train researchers in community-based participatory research to reduce cancer health disparities, particularly researchers from racial/ethnic minority and underserved populations. Community Networks will provide in-depth training in cancer prevention and control and community-based participatory cancer health disparities research, with a focus on developing efficacious interventions for reducing cancer health disparities. The researchers will develop community-based participatory pilot intervention research projects designed to improve understanding of and to aid in reducing cancer health disparities. Phase III. The goal of Phase III is to establish credibility and sustainability of CNP activities that reduce cancer health disparities. Within this Phase, the objectives are as follows: (III.1) Reduce cancer health disparities at the community level. In the short term, increases in participation in primary and secondary prevention procedures and other procedures that can reduce disparities will be evaluated. In the longer term, cancer health disparities at the community level will be assessed. (III.2) Obtain funding for research proposals on reducing cancer health disparities (such as R01, R03, and K awards) developed from the Community Networks research program. In collaboration with research and community partnerships, Community Networks will develop and obtain funding for research proposals stemming from the community-based participatory research findings developed by Community Networks research projects. Development of non-CRCHD partnerships and funding sources is important in creating sustainable Community Networks research programs. This funding can come from Government and non- Government organizations. (III.3) Provide evidence-based information for reducing disparities to decision and policy makers at the local, State, and Federal levels. Analyses of policy issues in health disparities should lead to information about implementing interventions to reduce cancer health disparities, particularly in communities with the greatest burden of disease. This information may be directed to decision and policy makers at the local, State, and Federal levels. These activities must not include lobbying. Rather, policy activities should offer evidence-based information based on qualitative and quantitative research findings that demonstrate reduced cancer health disparities. CNP Organization and related activities Each CNP will have a Principal Investigator (PI), Project Manager, and two to three appropriate employees. Each CNP should also consider having a Research Coordinator to assist in the conduct of training and research activities, a Policy Analyst for health policy evaluation, a Program Evaluator for the CNP evaluation and a Clinical Coordinator to assist in clinical activities. These latter staff may have partial support up to 20 percent each. Each CNP will have a Steering Committee to advise it. This committee will be composed of community leaders; community-based participatory researchers; clinical personnel serving the community; and others needed to carry out objectives of the CNP. At least three members of the Steering Committee should be researchers in the area of community-based participatory research who can aid with development of pilot research projects. If there are regional sites, there should be a similar regional advisory committee(s). The committees should meet at least once a year; teleconferencing may be used. In addition, there should be a community-based, advisory group that meets at least twice a year. This group will be composed of community leaders and will articulate the voice of the community to program staff by advising on projects for and activities conducted in the community. The Advisory committee can also help disseminate information to their communities. Each partnership should have an MOU outlining specific roles and responsibilities in relation to the CNP. There should be partnerships with local community-based organizations, screening and early detection centers, diagnosis and treatment facilities that serve the community, Government agencies, non-Government organizations, and research organizations and university programs (as a source of cancer research expertise and research students if the applicant is not a cancer research organization or university). Requirements for Transition through the Phases – The CNP awardee may apply for transition to the next phase at the time of the non-competing continuation application or as specified by the Program Coordinator. To proceed from Phase I (year 1) to Phase II (years 2–5), a CNP awardee must present a document that addresses the following factors. The awardee must have its organizational infrastructure in place and it has established a formal partnership with at least one community experiencing disparities—and with at least one primary or secondary prevention facility. The awardee must also have established a partnership with at least one cancer research organization and/or university to facilitate recruitment and training of researchers in cancer health disparities, if the applicant is not one of these groups. In addition, the awardee needs to have performed at least one cancer education activity to increase community member participation in a primary and/or secondary prevention facility, providing a description of the activity. A detailed plan for implementation of Phase II should be included in the application. To proceed to Phase III from Phase II, a CNP awardee must prepare a document that addresses the following factors. The awardee has been awarded and completed at least one NCI-funded pilot research project addressing cancer health disparities within the targeted community. A written description of this pilot research project, as well as its findings and impact on the community, must be submitted. A detailed plan for implementation of Phase III should be included in the application. These documents will be reported as an appendix to the non-competing continuation application or as specified by the Program Coordinator. Approval and progress to the next Phase will be determined by NCI staff. Annual Cancer Health Disparities Summit Conference There will be an annual meeting of all CNP awardees, their staffs, and key persons from their community partnerships. This CRCHD “Cancer Health Disparities Summit Conference” will bring CNP staff together to share their experiences, challenges, accomplishments, lessons learned, research findings, and to identify areas in which improvement is needed and additional collaborations are possible. The agenda will be developed by NCI staff associated with management of the CNP, in collaboration with other NCI Divisions/Centers/Offices. Budget for travel to Washington, DC — once per year for up to eight individuals — to attend the “Cancer Health Disparities Summit Conference” should be included in the budget of the application. PI Meetings with CRCHD Director Awardees will meet with the Director of the CRCHD at least once per year. This may be at the “Cancer Health Disparities Summit Conference.” Other meetings will be scheduled, on an as needed basis. Funds for one additional trip to Washington, DC, by the PI should be included in the budget section of the application. Dissemination of Community Networks research findings The CNP will disseminate its research findings. There are a number of ways to achieve this objective. Examples include, but are not limited to, the following: publication of research findings in peer reviewed journals; posting of research findings on the cancer control PLANET website (http://cancercontrolplanet.cancer.gov/); and dissemination of findings by demonstrated “transport” of and “uptake” of efficacious interventions to other communities, including developing collaborations between CNP grantees and the development of resource implementation kits. MECHANISM OF SUPPORT This RFA will use the NIH cooperative agreement (U01) award mechanism. As an applicant you will be primarily responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications (such as R01 applications) using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm. The NIH (U01) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the PI 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 PI, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE NCI intends to commit approximately $24 million in FY 2005 to fund 18 to 22 grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total costs (direct plus all applicable facilities and administrative costs) of up to $ 1.75 million per year for a large scale program (headquarters and four or more geographic areas), up to $1.0 million per year for a regional program (headquarters and 2-3 geographic areas) and up to $0.5 million per year for a local program (headquarters and one geographic area). Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and cost of each award will also vary. Although the financial plans of the NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. NCI may modify awards to meet geographic, racial/ethnic minority and/or underserved population needs, overlaps, or program priorities or funds. 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, colleges, hospitals, and laboratories o Units of State and local governments o Domestic institutions/organizations o Faith-based or community-based organizations o Foreign institutions are not eligible to apply. Applications are invited from groups representing racial/ethnic minority populations, such as African American, American Indian and Alaska Native, Asian, Hispanic, and Pacific Islanders and underserved populations, such as rural and Appalachian areas. Applicants should have a documented history of involvement with the community and have qualified staff to direct the program. Collaborative applications are encouraged. Among collaborators, one must be designated as the lead applicant and assume responsibility for the project. Organizations that must rely primarily on consultants to conduct the project are ineligible. Foreign organizations are not eligible and domestic organizations may not include international (foreign) components. 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 (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial National Cancer Institute (NCI) scientific and/or programmatic involvement with the awardee(s) is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner 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 Coordinator. 1. Awardee Rights and Responsibilities a. Awardees have primary authority and responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their projects. b. Awardees must establish and maintain a Project Steering Committee. The role and responsibilities of the Steering Committee are described below under “Collaborative Responsibilities.” If appropriate, awardees with large, multi-site projects may, in addition to establishing an overall Project Steering Committee, allow their regional sites to organize regional advisory committees. Regional PIs will serve as chairpersons of their respective committee and as their representatives on the Project Steering Committee. The NCI staff does not serve as a member of any regional advisory committee. Regional advisory committees function in an advisory roles to the Steering Committee and serve as liaisons between the Steering Committee and the community. Further, regional advisory committees work to ensure that decisions and recommendations of the Steering Committee are effectively adapted to regional settings and assist in developing and implementing regionally initiated activities, identifying and encouraging minority junior researchers and students, interfacing with regional NCI Cancer Information Service (CIS) partners, and ensuring community support for project activities. c. Awardees must establish a Community Advisory Group. This group provides the community with a formal link to the Community Network activities. This group will be composed of local community-based leaders that represent the communities with disparities. This group will serve as the voice of the community, advising on activities for their communities. It will also create a way to disseminate information to the community about the Community Network activities. The Community Advisory Group should represent the spectrum of community groups served by the CNP. This committee should meet at least two times per year. d. Awardees must request supplemental funding for pilot projects; the Steering Committee and the Community Advisory Group may provide advice on key cancer awareness activities and these pilot projects. Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NCI may be brought to arbitration. (See “Arbitration,” below.) e. Awardees must establish and maintain collaborative relationships with the NCI Cancer Information Service (CIS) and relevant community organizations and groups and apprise the NCI Program Coordinator of any need for specialized printed materials and/or media messages. f. Awardees must seek technical assistance from CIS in developing local cancer prevention and control messages that are consistent with NCI guidelines. Funds awarded as a result of this RFA may not be used for print or broadcast materials that have not been approved by the NCI Program Coordinator. g. Awardees will retain custody of and have primary rights to data collected under these awards, subject to Government rights of access consistent with current Health and Human Services (HHS), such as Health Insurance Portability and Accountability Act (HIPAA) regulations, Public Health Service (PHS) policies, and National Institutes of Health (NIH) policies. h. Awardees must provide annual progress reports and additional information, as requested by the NCI Program Coordinator. In addition to descriptions of past activities and their results, the summary report due at the end of each (annual) funding period should include a complete reporting of core programs evaluation data elements, as specified by NCI; and other reports are specified by the Program Coordinator. i. Awardee must seek technical assistance from the NCI Program Coordinator if it is determined that the awardee is not meeting program goals in a timely manner. 2. NCI Staff Responsibilities - The NCI Program Coordinator (and other NCI staff) will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal program stewardship for grants, as described below. The NCI Program Coordinator shall: a. Serve as a member of the Steering Committee; b. Assist awardees with planning and establishing priorities and approve awardees’ plans prior to implementation of Phase activities; c. Determine whether an awardee-planned community activity is consistent with NCI guidelines; d. Coordinate activities with other Federal agencies (e.g., the Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), and DHHS Office of Minority Health [OMH]) and broker interactions between NCI and awardees, as necessary, to provide technical assistance and guidance in specialty areas, as well as arrange short-term training assignments for minority researchers; and e. Convene special meetings and ad hoc groups to address NCI priority issues. An NCI Program Director will be responsible for normal program stewardship of this award, including monitoring of progress and other required reports. The Program Director may identify other NCI staff to provide technical assistance in specific areas as needed. The Program Director may also serve as the Program Coordinator. The NCI Program Director will confer with awardees regarding staffing needs and must concur in hiring or replacing key program personnel. Key personnel are defined as, and should be limited to, individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salary is requested. (See NIH Grants Policy Statement.) NCI reserves the right to terminate or curtail the program (or an individual award) in the event of substantial shortfall in the performance of requirements for any single Phase or key activity of the program. 3. Collaborative Responsibilities a. Awardees will collaborate with the NCI Program Coordinator to establish and maintain for their projects a Steering Committee whose role is to function as a governing body. The Steering Committee will appropriately comprise scientists and community leaders and/or facilitators and will set policy, provide overall guidance and direction, and provide support for project-sponsored activities. Membership will include the Project PI, NCI Program Coordinator, Regional PIs, and others with expertise in relevant scientific or other cancer-related or disparity-related disciplines. Responsibilities of the Steering Committee include: reviewing and ensuring scientific soundness of project plans; guiding development and implementation of population-specific cancer control and prevention activities; approving joint and pilot research project plans and applications; prioritizing project needs; promoting collaborations; and facilitating interactions among the NCI, partners, and community populations. The PI will serve as chairperson of the Steering Committee and be responsible for selecting other members. Decisions and recommendations of the Steering Committee will be binding and take precedence over those of regional advisory committees. b. Awardees and the NCI Program Coordinator will collaborate to develop and implement an Annual “Cancer Health Disparities Summit Conference,” at which awardees may discuss progress of their projects and learn more about NCI resources/priorities, and researchers, accompanied by their mentors, can share their developmental progress and showcase their research projects via oral presentations and/or poster sessions. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between an award recipient and the NCI may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (or by the individual awardee in the event of an individual disagreement); a second member selected by the NCI; and a third member selected by the two previously selected members. This special arbitration procedure in no way affects the awardee’s right to appeal an adverse action if it is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Kenneth C. Chu, Ph.D. Center to Reduce Cancer Health Disparities National Cancer Institute 6116 Executive Blvd, Room 602 Bethesda, MD 20892-8341 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8589 FAX: (301)-435-9225 Email: KC10D@NIH.GOV o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: email@example.com o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: Crystal.Wolfrey@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; and 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: Kenneth C. Chu, Ph.D. Center to Reduce Cancer Health Disparities National Cancer Institute 6116 Executive Blvd, Room 602 Bethesda, MD 20892-8341 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-8589 FAX: 301-435-9225 Email: KC10D@NIH.GOV SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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. SUPPLEMENTARY INSTRUCTIONS: RESEARCH PLAN a. Specific Aims – Specific aims should include the goals and objectives as specified in the RFA. Applicants may augment those aims as they feel necessary. These aims will be the basis for the evaluation plan. b. Background and Significance – In this section, the applicant should provide a description of the cancer health disparities of the communities to be addressed. For each disparity, the description should include, but is not limited to, the type of the disparity, the population to be addressed, and the cancer site affected. c. Preliminary Studies/Progress Report – Description of previous work relevant to this RFA and the project proposed. d. Research Design and Methods - Describe your proposed CNP in detail. Specifically, describe the cancer education activities and health disparities research and training program, above and beyond the goals and objectives stated in the RFA. Discuss how the aims will be achieved, including a discussion of how the disparities in the community are to be reduced, the interventions to be used, the metrics that will be used to measure reductions in disparities, the partnerships and collaborations proposed, etc. In addition, the applicant will provide three plans. Each plan should be included as an appendix to the application. The plan must include details about the following aspects. 1) Cancer education activities (such as outreach, awareness activities) in the communities with disparities emphasizing the increased access to and utilization of primary and secondary prevention facilities. Justify the cancers to be addressed, the primary and secondary prevention procedures to be implemented, the proposed facilities to be utilized, and the metrics that will be used to evaluate improvements in disparities. Indicate, if possible, the current usage of these procedures/facilities by the community with disparities. (This is the baseline, against which improvements may be measured.) 2) Health disparities research program that outlines the areas of research to be undertaken, including interventions to be developed for policy assessments and other relevant factors associated in developing a health disparities research program. Provide sufficient details to allow one to evaluate your expertise in this area. 3) Training program that outlines the source of junior investigators, the training program to be undertaken, and other relevant factors associated with the training program. Furthermore, the applicant must describe at least one proposed research project that will be undertaken by the applicant as part of their health disparities research program. This proposed research project should be an appendix to the application. Format for research project - ten page maximum: abstract, background, hypotheses, study design, discussion (no additional appendices for the research project). If the applicant is applying for a regional or large scale award ($1 million or more) a minimum of two proposed research projects need to be submitted. Each partnership should have an MOU outlining roles and responsibilities in relation to the Community Networks. If the applicant is a community-based organization, partnerships with cancer research organizations and universities are particularly important to be able to meet the research and training aspects of the CNP. If the applicant is a cancer research organization or university, partnerships with community-based organizations are important to demonstrate a history of working with the community. All applicants should have partnerships with primary or/and secondary prevention facilities that offer beneficial interventions. All applicants apply for phase I. If the applicant is a previous SPN awardee or their experience qualifies them, the applicant should apply for Phase II in this application. To assess that ability, previous SPN awardees should provide evidence of readiness to move to Phase II. That is, to proceed from Phase I to Phase II, a Community Networks awardee must have its organizational infrastructure in place and have established a formal partnership with at least one community experiencing disparities—and with at least one primary or secondary prevention facility. The awardee must also have established a partnership with at least one cancer research organization and/or university to facilitate recruitment and training of researchers in cancer health disparities, if the applicant is not one of these groups. In addition, the awardee needs to have performed at least one cancer education activity to increase community member participation in a primary and/or secondary prevention facility. A detailed plan for implementation of Phase II should also be included. If the review group determines that the applicant has not met the criteria to transition to Phase II, the applicant will be considered for award beginning with Phase I. TIMETABLE Include a timetable of cancer education activities, and milestones for the development of research and training programs for the first and second years. USING THE RFA LABEL: 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/labels.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 and all five copies of the appendix material must be sent to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Appendices should be comprised of unbound materials, with separators between documents. 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.) (See http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html.) 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 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or nonresponsive applications will not be reviewed. 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 of the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 Receive a written critique o Receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will the disparities be reduced? Are there indications of the potential for applicant’s effectiveness in reaching the most difficult-to-access segments of the community? Will the results, such as the interventions, education, training and partnerships to be developed, be useful to groups in other parts of the country. What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of reducing cancer health disparities? Does the applicant acknowledge potential problem areas and consider alternative tactics? Have the cancer health disparities of the community and the proposed approaches to address them been described adequately? Are there linkages from the cancer research base to community to cancer prevention and early detection facilities? Are the plans for cancer education, research and training adequate and appropriate to address the problem of reducing cancer health disparities in the community? Has the application demonstrated that they have the abilities to reduce cancer health disparities through community-based participatory education, research and training? INNOVATION: Does the project employ novel concepts, approaches or methods to reduce cancer health disparities? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Does the investigator/staff have experience with the communities to be addressed. Does the applicant or its partners have a history of working with the communities to be addressed? Does the applicant or partners have expertise in cancer prevention and control research so that they can develop interventions to reduce disparities. ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Is there evidence of partnerships with communities with disparities? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: For large scale awards ($1 million or more), the applicant must have a demonstrated history of achievements in working with community-based organizations in the areas of community-based participatory awareness, research and training to provide evidence of the capacity to handle a large scale project. For Special Population Network (SPN) grantees, this may be demonstrated by the quality of cancer awareness activities and community partnerships, pilot projects awarded and completed and the papers published as a consequence of their SPN activities as well as obtained funding from non-CRCHD sources. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. Budget: The appropriateness of proposed budget and duration in relation to proposed project; reasonableness of proposed budget relative to proposed activities-particularly, the allocation ratio of funds retained for administrative costs and those for local programming will be reviewed. We encourage funding on local community programming while minimizing administrative costs. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 14, 2004 Application Receipt Date: July 13, 2004 Peer Review Date: October 2004 Council Review: February 16, 2005 Earliest Anticipated Start Date: April 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to participants. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998 at 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 at 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 at http://www.cancer.gov/clinical_trials/. SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible. Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 "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. 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: (if applicable) 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 is available online at: http://cme.nci.nih.gov/. HUMAN EMBRYONIC STEM CELLS (hESC): (if applicable) Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: (if applicable) The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information,” the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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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