Full Text CA-97-017 CANCER RESEARCH NETWORK ACROSS HEALTH CARE SYSTEMS NIH GUIDE, Volume 26, Number 30, September 5, 1997 RFA: CA-97-017 P.T. Keywords: National Cancer Institute Letter of Intent Receipt Date: October 17, 1997 Application Receipt Date: November 25, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to encourage the expansion of collaborative cancer research among health care provider organizations that are oriented to community care, have access to large, stable and diverse patient populations and are able to take advantage of existing integrated data-bases that can provide patient-level information relevant to research studies on cancer control and cancer-related population studies. Health care provider organizations range from traditional staff model health maintenance organizations (HMO) to extended health care networks associated with academic medical centers. A CRN would consist of a research network of such health care provider organizations that possess in-house clinical research capacity, that collaborate with other provider organizations with such capacity, or with clinical researchers affiliated with academic health centers. A CRN should consist of diverse members drawn from a number of financially autonomous and managerially distinct organizations. In this RFA, organizations which affiliate for research purposes as components of the Cancer Research Network will be referred to as CRN members. The Division of Cancer Control and Population Studies (DCCPS), National Cancer Institute, invites applications for cooperative agreements to develop and support a cancer research infrastructure, consisting of 1 or more networks, composed of health care provider organization researchers who will be capable of conducting studies of cancer epidemiology, treatment, and prevention and control. The central objective of this RFA is to encourage cancer research uniquely well-suited to the research interests and strengths of researchers affiliated with health care provider organizations as well as of high priority to NCI. The RFA is also intended to encourage collaboration between researchers based as health care provider organizations and researchers affiliated with academic medical centers. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Cancer Research Networks Across Health Care Systems, is related to multiple priority areas, but centrally related to cancer surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS The CRN will be led by a Principal Investigator, a researcher affiliated with one of the CRN members, who will coordinate of overall activities of the CRN. Each CRN member will also be represented by a co-Principal Investigator, who may also be designated as lead researcher on one or more of the specific research projects of the CRN. The organizational entity with which the CRN Principal Investigator is affiliated will be the awardee institution for this RFA and the lead institution for the CRN. The application must name the CRN Principal Investigator, co-Principal Investigators and the respective CRN organizational members. Applications may be submitted by domestic for-profit and non-profit health care provider organizations (network members) acting jointly as a U.S. research network. A domestic application may not include an international component. Networks must include a sufficient number of health care provider organization members, such that total patient enrollment is at least 2 million adults (ages 18 and over). Also, network covered populations must include diverse populations with respect to gender, race/ethnicity and, to the extent that is it practical, rural/urban and geographic location. Applicants must demonstrate a shared commitment among all participating network members to working together on proposed research studies. Applicants must show evidence of ability to access and organize data collection from all participating network members. Applicants are encouraged to demonstrate the capability of data linkages with local centralized tumor registries, pathology and radiologic facilities, and state vital records. If these capabilities do not currently reside within one or more of the network members, the applicant may assemble a group with plans to develop the necessary expertise across all network members. Each network member must have access to a resource unit that supports research data management locally or centrally. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. (The U19 is a program project cooperative agreement. Therefore, the NCI Program Project Guidelines must be used in the preparation of applications in response to this RFA [vide infra]). 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 partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed 4 years. The anticipated award dates will be Summer 1998. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is included in the financial plans of the National Cancer Institute, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, the National Cancer Institute has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this program is $4 million. It is anticipated that 1 or 2 applicants will receive awards. RESEARCH OBJECTIVES The purpose of this RFA is to enhance research on cancer epidemiology, prevention, early detection and control in the context of health care delivery systems. To accomplish this, the initiative will support the development of research capabilities across multiple healthcare provider organizations for the conduct of cancer research projects. The CRN will accomplish two major objectives: - Formulate and implement a joint CRN research agenda resulting in the conduct of three or more specified research projects in selected areas of cancer control and population studies. - Develop standardized data collection instruments, surveys and analytical methods to promote the development of consistent and uniform data bases, and other research materials that can be shared across member institutions and utilized in joint research projects using uniform protocols when appropriate. Meeting these research objectives will be facilitated by ongoing meetings and communication. These meetings would be structured to foster collaboration between clinical practice and research personnel within individual CRN organizations, between researchers at different CRN organizations and between CRN researchers, researchers affiliated with academic medical centers and NCI. In accomplishing these objectives NCI anticipates the development of increased cancer research capacity through increased sharing of specific expertise, thereby raising research competence of all CRN members. This would enable more CRN based researchers to participate more fully in existing NCI-sponsored research mechanisms, such as CCOPs and Cooperative Groups and to collaborate with NCI-sponsored cancer centers. Background The National Cancer Institute has long supported a program of research in cancer control that is designed to identify promising innovations in cancer prevention, detection, treatment and rehabilitation and to demonstrate, through controlled studies, which interventions are efficacious. As cancer control research matures there is a growing need to identify existing patient care settings and existing data resources that will facilitate the conduct of cancer control translational research. Once efficacy for specific interventions has been demonstrated in selected populations, research on effectiveness in larger, more diverse populations found in representative community settings is essential to ensure the full benefit of the intervention is realized. Efficacy, which denotes how well the intended objectives of a procedure or treatment are realized in ideal settings, such as a research trial, is a necessary but not sufficient prerequisite of effectiveness. Effectiveness implies that an efficacious intervention is also feasible and can be replicated in diverse settings at reasonable economic cost. Settings that capture large, diverse care populations also constitute a valuable resource for conducting studies of primary prevention interventions, novel methods of early detection and interventions designed to increase the quality-of-life and reduce the risk of recurrent disease in cancer survivors. In order to conduct studies of effectiveness at the national level, it is necessary to capture a large and diverse patient population with adequate representations of individuals by age, gender, income, education, minority status and urban/rural and geographical locations. Sample size requirements will vary from study to study, but many studies may require a CRN population of a few million persons. This would be true of many studies that require cancer incidence, stage-at-diagnosis, survival, or cancer patterns of care as study endpoints. For example, a health care provider organization with a membership of one million individuals over the age of 18 would expect about 750 newly diagnosed breast cancer cases each year and about 133 deaths from breast cancer. Much smaller numbers of cases would be expected for specific sub-populations that may be of interest or for the less common cancer sites. Effectiveness research often requires large and diverse populations because the effectiveness of an intervention may vary as a function of such individual characteristics as education, income, age, gender and minority status as well as by health care system characteristics. Effectiveness research is greatly facilitated when pre-existing database systems can be used to track, retrospectively or prospectively, longitudinal patterns of health services resource use and clinical outcomes at the individual patient level. While historically less research oriented than academic medical centers, some large health care provider organizations have substantial records of conducting clinical research supported by R01 grants as well as internal funds. There is currently growing interest on the part of provider organizations in participating in clinical research, and there has been rapid development and standardization, among these organizations, of integrated epidemiological-clinical-financial databases that would greatly facilitate the conduct of cancer control research on a large population-based scale. In addition, many academic health centers have developed extensive primary care networks that provide formal links between primary care delivery systems and the research capabilities of traditional academic centers. There is a great diversity in the operation and structure of health care provider organizations. However, certain provider organizations possess characteristics that make them particularly well suited for population-based medical research. This is especially true of provider organizations that have: - Patient populations enrolled in the provider organization over an extended period that are roughly representative of the general population, and that receive most or all of their medical care services through those organizations. - Research resources including qualified and experienced clinical research personnel with institutional access to research-oriented primary care and specialty physicians. - A history and/or willingness to establish collaborative research relationships with clinical research personnel affiliated with academic medical centers. - Practice settings with an emphasis on prevention, detection and treatment of early stage disease. - The capability to track individual patients longitudinally and, by record linkage from diverse sources, to integrate information on patient clinical characteristics with information on behavior, knowledge and attitudes, health status, and medical care use, cost and cancer outcomes. - An organizational structure that facilitates the collection of study specific data on organization members, recruitment of members into intervention trials and demonstration projects, and the linkage of these data with existing patient-specific clinical data. - An emphasis on the practice of evidence-based medicine, with a priority on the public health and welfare of organization members. Objectives and Scope The ultimate purpose of the type of research funded by this RFA is to reduce the burden of cancer morbidity and mortality. Therefore, it is appropriate that studies funded by this RFA focus on cancer sites that are responsible for substantial components of cancer morbidity and mortality. Research funded by this RFA might address any of the diverse areas noted below. The following broad areas are of particular interest: - Studies which address the distribution of preventable cancer risk factors and the burden of disease in the covered population of the CRN; - Studies which evaluate how innovative cancer prevention and control programs, based on rigorous intervention research, can be effectively disseminated throughout and implemented in the context of health care provider systems; - Studies of the relationship between health care delivery system organizational structure and patterns of cancer prevention and control service delivery associated with access to care and favorable outcomes. In addition, research funded by this RFA should be designed to take advantage of the large patient populations and diverse patient care settings, the integrated data systems and the other complimentary research resources made available by the CRN to achieve research objectives that would otherwise be infeasible or prohibitively expensive. Areas of research that would be particularly enhanced by this mechanism include, but are not limited to: Epidemiological Studies - Epidemiological studies in which longitudinal medical records are particularly useful in identifying cancer risk factors, including the potential risks associated with pharmaceuticals, medical devices, and other forms of non- cancer treatment. - Studies of the long-term risk of second cancers or other late effects of cancer treatment. Behavioral Cancer Prevention and Control - Studies of the feasibility, cost-effectiveness and dissemination of efficacious bio-behavioral cancer prevention and control interventions. - Studies of innovative behavioral cancer prevention and control interventions targeted to specific populations in different organization settings, e.g., physician practice, ancillary health personnel, or public education. - Studies of delivery systems for counseling and other approaches used for genetic testing, monitoring for cancer occurrence and preventive interventions.. Evaluation and Methodological Studies Related to Clinical Trials - Research on the costs and benefits to patient enrollees and health care provider institutions that result from participation in NCI or other trials. One purpose of this research is to identify strategies for increasing accrual to NCI trials. - Methodological research on the incorporation of quality- of-life, patient satisfaction and economic endpoints in NCI trials through direct clinical trial data collection or by other methods such as using modeling or other extrapolation methods to make it possible to use retrospective data to supplement the analysis of within-trial data. Survivorship Issues - Studies of indirect costs, quality-of-life, complications and recurrence as a function of treatment approach, care setting and referral patterns. - Studies of interventions to prevent morbidity associated with cancer and its treatment Cancer Control Surveillance and Outcomes Research - Studies of existing patterns of care for cancer prevention, screening, treatment, and rehabilitation in relationship to existing evidence of efficacy, cost-effectiveness, clinical recommendations and practice guidelines. - Studies of the effectiveness of preventive medicine and evidence-based medical practice. - Studies of the diffusion of state-of-the-art cancer prevention, screening, treatment, care and rehabilitation. - Studies of the formulation and implementation of organizational policy regarding the dissemination of innovative technology, e.g., counseling, screening for genetic predisposition to cancer and newly approved advanced diagnostic imaging tools. Clinical Informatic Studies - Studies of the feasibility, effectiveness and cost of using clinical informatic systems to identify, recruit and track organization members for targeted cancer prevention and screening interventions. - Studies of the feasibility, effectiveness and cost of using clinical informatic systems to aid patient/physician decision making for cancer prevention, screening and treatment. - Studies of the feasibility, effectiveness and cost of using clinical informatic systems as an aid to multi-disciplinary management of cancer care. SPECIAL REQUIREMENTS Applications in response to this RFA are required to describe four components: the CRN research agenda component, a research study component consisting of three or more specific research studies, an infrastructure component and an evaluation component. The research agenda component should discuss the theme of the CRN research agenda and the rational for this them. The research study component should describe the specific collaborative studies that the CRN proposes to conduct. The infrastructure component would describe the proposed means by which the CRN would build the collaborative cancer research capacity of the network to support the proposed studies. The evaluation component should describe an evaluation study designed to determine how successful the development of the CRN has been in meeting the goals of this RFA. The following issues should also be addressed in the infrastructure component of the application: CRN Member Characteristics - The nature of health care provider organization patient enrollment for each of the CRN members must be documented. The following characteristics of the enrollment are relevant to the application: - size of enrollment; - geographical location of enrollment; - sociodemographic characteristics of membership (age, gender, race/ethnicity, socioeconomic status, health status); - length and continuity of enrollment (for enrollees with and without a history of cancer); - benefit coverage; - longevity and stability of health care provider organization; - size and composition (practice specialty) of medical staff; - structure (staff model, IPA, point-of-service, etc.); - type and/or proportion of services offered "within plan" and "contracted-out." - The nature of CRN member data systems must be documented. What type of systems are available for the acquisition, storage and analysis of epidemiological, clinical and resource use and cost data? Are data systems automated? How much retrospective data is available? Do capacities exist to link data across CRN members? What planned centralized data coordination or management is in place? What type of data elements can be shared for research purposes? What mechanisms and procedures exist to protect the confidentiality of research subjects. Data Linkage - Linkage to cancer registry. The feasibility and willingness of CRN members to link data to a SEER cancer registry or other population-based (e.g., state cancer registries) or hospital-based tumor registries should be described. Existing linkage to cancer registries should be documented in the application. - Linkage to other data resources. The feasibility and willingness of CRN members to link to other types of data resources, such as registries related to cancer surveillance or genetics, health related survey data, radiology and pathology facilities data, demographic and socioeconomic data, data on use of out-of-plan services, and state vital records should be described. Through letters of intent, or other documentation, the application should demonstrate that the CRN has identified appropriate data resources of value to the overall research goals of the CRN and initiated efforts to implement data linkage with these resources. Research Capacity Development - Research capacity and experience. The institutional research capacity and experience of each member of the CRN must be documented, including the number and qualifications of in-house research staff. All research capacity and experience related to cancer research must be documented, including collaboration with or membership in existing NCI cancer centers, cooperative groups, CCOP research bases, or consortia. Emphasis should be placed on the research capacity and experience which is expected to be most relevant to the activities of the proposed CRN. Individual members of the CRN must demonstrate a capacity and willingness to facilitate professional interaction between research and clinical care staff of the health care provider organization. - The applicant must describe how the activities of the CRN will result in the increased capacity of individual members of the CRN or the CRN as a whole to conduct research under existing NCI mechanisms. Administrative Procedures - The applicant CRN must specify a set of criteria and a process to be used to consider adding new (organizational) members to the CRN, in the event that this warranted by the research needs of the project. Addition of new members would require the consultation and approval of the NCI Program Director. - The applicant must specify a set of criteria and a process to be used to consider extending or modifying research studies initially proposed in the application and approved for funding, and initiating new or related research studies within the scope of the approved award, in the event that such extensions, modifications or initiations are warranted by scientific considerations and can be accommodated by the time schedule and funding of the project (or through various mechanisms that might become available to extend time and/or funding). The proposed process should take the interactive nature of the funding mechanism into account and provide a consultative role for the NCI Program Director and the NCI Review Committee.. It is recommended that the infrastructure component of the study comprise approximately one-third of the (total 4 year) budget of the CRN. The infrastructure component should be designed to meet two goals: support of the specific research studies proposed and development of the general research capacity of the CRN and its affiliated network members. The infrastructure component may include, but is not necessarily limited to, meetings of researchers to share research expertise and engage in joint planning, development of research support personnel, development of standardized data acquisition and processing systems, development of central data coordination centers, and development of communications systems for facilitating interaction between researchers. In the research component of the application the applicant CRN must describe at least three specific research studies planned for the funding period. It is recommended that the research component of the study comprise approximately two-thirds of the (total 4 year) budget of the CRN. The application must include proposals for specific research studies along the lines suggested in the section on Objectives and Scope. All or some sub-group of all CRN network members should be involved in each of the proposed studies. Descriptions for each proposed study should include all the elements that would be included in a standard R01 grant application for a research study, including budget. It is recommended that the evaluation component comprise between 2-5% of the budget of the CRN. The purpose of the evaluation component is to evaluate how well the CRN, and especially the infrastructure component, performs to meet the goals of this RFA. The evaluation component should describe objective criteria and methods for evaluation, including a baseline assessment of the research strengths and weakness of the CRN and individual network members at the beginning of the project and identify existing barriers to network members participation in cancer research activities as well as opportunities for overcoming these barriers through the CRN mechanism. Specific criteria that should be considered in the evaluation are: the extent to which the overall cancer research capacity of the CRN has increased as a result of the funded project, the extent to which cancer research capacity of the network members has been enhanced through the complementary sharing of resources across network members and through collaboration with academic medical center affiliated researchers, the extent to which network members ability to compete for R01 grants and participate in other research mechanisms has been enhanced, the extent to which "research culture" has been engendered and enhanced in the clinical care setting of network members, and the extent to which enduring research-oriented data systems, research methods and collaborative relationships have been established and institutionalized. The evaluation budget should be carefully described and justified for each budget period. To promote the orderly development of a CRN, a number of issues must be addressed in the application. The applicant must describe or propose an organizational structure consisting of a network of health care provider organizations with documented institutional commitment from each member of the proposed CRN to participate in the proposed activities of the CRN. The CRN need not have a centralized physical location, but it must have an identifiable Steering Committee which will work with an NCI Program Director in the context of a Cooperative Agreement. Membership of the Steering Committee shall consist of the CRN Principal Investigator, the co-Principal Investigators of the CRN, and the NCI Program Director. The Steering Committee will convene Working Groups for planning and supervising the specific research activities of the CRN. Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. 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 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 Director, with consultation from other NCI scientists as appropriate.. The inability of an awardee 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 adjustment of funding, withholding of support, suspension or termination of award. 1. Awardee Rights and Responsibilities Awardees will have primary and lead responsibilities for the development and formation of a Cancer Research Network with a central objective to conduct approved research projects and develop standardized data collection instruments, surveys and methods. The Principal Investigator and Co-Principal Investigators associated with each CRN member institution and/or major research project will meet at the initiation of the award with the NCI Program Director to discuss scientific and technical direction and strategies relating to the conduct of specific studies proposed by each Network. CRN members will agree to follow common protocols approved by the Steering Committee. In the event that more than 1 CRN award is made, representatives from all CRNs will meet annually to jointly discuss ongoing research plans and progress. The award recipients are encouraged to provide information to NCI of progress on other funded projects external to the collaborative activities but relating to the activities funded under this RFA. While joint research projects are strongly encouraged under this RFA, research projects conducted at individual CRN member institutions under the supervision of a single Co-Principal Investigator, that otherwise contribute to meeting the goals and objectives of this RFA , are allowed. Co- Principal Investigators of such single institution studies will have equivalent status with all other Co-Principal Investigators in regard to participation on the CRN Steering Committees and other CRN committees. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. All awardees and NCI will jointly develop appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions involved in CRN research projects. No identifying information of individual patients or providers should be available through pooled CRN research databases. Encrypted study identification numbers will be used for all pooled CRN studies. 2. NCI Staff Responsibilities The NCI Program Director will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. a. Establishment of NCI /CRN Review Committee NCI oversight of the CRN will be the responsibility of the NCI Program Director, with the advice of a CRN Review Committee composed of NCI professional staff drawn from relevant NCI Divisions and Programs. The NCI Program Director, or a designated NCI staff person from the NCI CRN Review Committee, will have voting membership on the CRN Steering Committee(s), and, as determined by those committee(s), their subcommittees. The NCI Program Director, with assistance of NCI staff from the Review Committee, will have scientific-programmatic involvement in the conduct of the proposed research studies. The dominant role and prime responsibility for the studies resides with the awardee for the studies as a whole, although specific tasks and activities in carrying out particular studies may be shared among awardees and NCI staff. The NCI Program Director will provide assistance and guidance as needed on an ad hoc basis, in developing shared study protocols among CRN members, selecting data elements, obtaining cooperation from the CRN members, linking databases, and analyzing pooled data. b. Strategy Sessions The NCI Program Director or designee, in cooperation with the CRN, will sponsor strategy sessions (to be held in conjunction with selected biannual meetings of the CRN Steering Committee), attended by CRN co-Principal Investigators and other appropriate staff from the CRN and appropriate NCI staff. c. Data Management Each awardee will retain custody of and primary rights to their own data and is responsible for statistical analysis, computer processing and statistical interpretations. The NCI Program Director will have access to all data generated under this award and will periodically review the data management and analysis procedures. d. Monitoring and Program Review In addition to normally prescribed duties of program and grants staff, an on-site program review will occur as early as 10 months but no later than 18 months after award. The program review will be conducted to evaluate progress of the CRN in meeting the goals and objectives of this RFA. The inability of a participating CRN member 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. e. Rights Reserved to NCI The NCI reserves the right to terminate or curtail the study (or an individual award) in the event of shortfalls in participant recruitment, follow-up, data reporting, quality control, or other major breach of study protocols, reaching a major study endpoint substantially before schedule with persuasive statistical significance, or human subject ethical issues that may dictate a premature termination. 3. Collaborative Responsibilities The CRN Steering Committee will be the main governing board of the CRN and will have primary responsibility for overall policies and procedures of the CRN and for decisions about and approval of specific research protocols and pooled data analysis. The CRN Principal Investigator, named in the CRN application, will serve as the Chairperson of the Steering Committee. The CRN Steering Committee will convene as needed to discuss collaborative study progress and address scientific-technical aspects of implementation. The voting membership of the Steering Committee shall consist of the CRN Principal Investigator, all CRN Co-Principal Investigators and the NCI Program Director. The Steering Committee should plan on at least 2 meetings per year, with at least the co-P.I. representing each participating CRN member in attendance. When deemed necessary at least one data manager as well as one co-P.I. from each CRN member will attend such meetings. Subcommittees will be established by the Steering Committee, as it deems appropriate. In the event that more than one CRN is funded, the respective CRN steering committees, in consultation with the NCI Program Director, will determine the need for joint activities across the CRNs. 4. Arbitration Process The Terms and Conditions of Award require that the NCI Program Director make post-award decisions related to program performance and programmatic decisions on scientific-technical matters. NCI will establish an arbitration process when a mutually acceptable agreement cannot be obtained between the awardee and the NCI Program Director. An arbitration panel (with appropriate expertise) composed of one member selected by 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, NCI. 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 DHHS regulations 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by October 17, 1997, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The Letter of Intent is to be sent to: Martin Brown, Ph.D. Applied Research Branch National Cancer Institute Executive Plaza North, Room 313 6130 Executive Blvd. Bethesda, MD 20892-7344 Telephone: (301) 496-5716 FAX: (301) 435-3710 Rockville, MD 20852 (if express/courier service) APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/710-0267, E-mail: ASKNIH@odrockm1.od.nih.gov. In addition since the U19 mechanism is being used, applicants must use the instructions for NCI Program Project Grant Applications. These are available from the NCI Referral Officer (301) 496-3428. The RFA label available in the PHS 398 (rev.5/95) application form must be affixed to the bottom of the face page of the application. 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. Submit a signed, typewritten original of the application, including the Checklist, and three signed exact photocopies, in one package to: Division of Research Grants 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 also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Room 636 Bethesda, MD 20892 Rockville, MD 20852 (if using express/courier service) It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with the other applications received on or before the designated receipt date. Applications must be received by November 25, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. Application Preparation All applications must be submitted on the form PHS 398 (rev. 5/95). The rationale an theme of the proposed CRN research agenda should be discussed in an introductory section. Separate research plans should be prepared for the infrastructure component, each proposed research study, and the evaluation component. Maximum page limitations for each section are: introductory section - 5 pages, research agenda component - 10 pages, infrastructure component - 25 pages, each proposed research study - 25 pages, evaluation component - 10 pages. Regardless of the number of proposed research studies, the maximum page limitation for the entire research plan is 200 pages. Each application must contain a detailed budget for the first 12-month period and a budget for the entire proposed project period for direct costs. Separate budgets should be submitted for each component of the CRN: the infrastructure component, each proposed research study, and the evaluation component. Budgets for each CRN member organization other than the lead CRN institution must be submitted as sub-contracts the lead institution (or consultant contracts to the lead institution may be used when only the professional services of specified individuals are involved). Additional instructions are in the NCI Program Project Grant Guidelines. REVIEW CONSIDERATIONS General Considerations All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the scientific merit of the proposed research is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as the importance and timeliness of the proposed studies, access to patients, and multi disciplinary nature of the studies, will be part of the evaluation criteria. Review Method Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness to the RFA by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned and receive no further consideration. 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 NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process by which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria Applicants are encouraged to submit and describe their own ideas about how best to meet the general research and infrastructure goals outlined in this RFA, and are expected to address issues identified under SPECIAL REQUIREMENTS of the RFA. Four general areas will be considered in review of applications: research agenda; the feasibility of the infrastructure component of the proposal and the likelihood that this component will effectively contribute to meeting the goals of the RFA; the importance and scientific merits of the proposed research studies to be conducted by the CRN; the objectivity and methodological soundness of the evaluation component. The following review criteria will be used: - Research Agenda How well does the research agenda meet the goals and priorities of the RFA? How successful is the research agenda in providing a coherent basis for the integration of the separate CRN research projects? Does the proposed research agenda address an important set of problems? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? - Infrastructure Component Is the infrastructure proposal realistic and feasible given the resources allocated to it and the characteristics of CRN members? How well does the infrastructure component serve to support the overall goals and priorities of the proposed research agenda and the conduct of specific proposed research studies? How well does the infrastructure component serve to increase the cancer research capabilities of the CRN as a whole and individual CRN members by facilitating the development of shared resources, knowledge and information? - Evaluation Component Are objective criteria and methods of evaluation proposed? Are appropriate resources and expertise proposed to ensure an adequate evaluation study? Is the statistical design of the evaluations study sound? - Research Studies Specific CRN research studies will be reviewed using the current criteria that is applied to R01 grants (NIH GUIDE, Volume 26, Number 22, June 27, 1997), as follows: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigators: 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: * The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. * The reasonableness of the proposed budget and duration in relation to the proposed research * The adequacy of the proposed protection for humans and animals, and the safety of the research environment. In addition to the above criteria, CRN proposals will be reviewed with regard to commitment to conduct pooled analyses of combined data across CRN members for research objectives that require pooled analyses of data and adequate plans for central data coordination centers when necessary to support pooled analyses. Such commitment may be demonstrated by the identification of specific central data coordination centers in the application, identification of data managers for each CRN member and description of mechanisms for ensuring data quality and comparability. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and (c) availability of funds. Letter of Intent Receipt Date: October 17, 1997 Application Receipt Date: November 25, 1997 Review by NCI Advisory Board: May 11-13, 1998 Anticipated Award Date: August 1, 1998 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: Martin Brown, Ph.D. Applied Research Branch National Cancer Institute Executive Plaza North, Room 313 6130 Executive Boulevard Bethesda, MD 20892-7344 Telephone: (301) 496-5716 Email: mb53o@nih.gov Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20892-7150 Telephone: (301) 496-7800 x213 Email: wolfreyc@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3 . . . [use appropriate program number]. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities ( or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |