and Human Services (HHS)
EXPIRED
PATIENT NAVIGATION RESEARCH PROGRAM RELEASE DATE: August 6, 2004 RFA Number: RFA-CA-05-019 (also see NOT-CA-04-029) EXPIRATION DATE: November 19, 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: October 18, 2004 APPLICATION RECEIPT DATE: November 18, 2004 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 the Patient Navigation Research Program: Eliminating Barriers to Timely Delivery of Cancer Diagnosis and Treatment Services (PNRP). This RFA is challenging principal investigators to develop operationally effective and cost-effective patient navigation interventions. These interventions must address patient-access barriers to quality, standard cancer care in a cost- effective manner. The purpose of the Patient Navigation Research Program (PNRP) is to develop interventions to reduce the time to delivery of standard cancer care services-non-cancer resolution or cancer diagnosis and treatment after identifying an abnormal finding from a cancer detection procedure. RESEARCH OBJECTIVES Background A major disconnect or gap exists between cancer discovery and development research and delivery for many Americans. Discovery and development research results in beneficial procedures for cancer prevention, early detection, diagnosis, and treatment that are intended for all Americans. Health disparities arise when the delivery system does not provide access to timely, standard cancer care to everyone in the nation. NCI has established the goal of eliminating suffering and death due to cancer by 2015. To address this goal requires immediate action to address the gap between development and delivery, particularly among underserved populations. This research concept is consistent with DHHS Healthy People 2010 goal to eliminate health disparities. Major reports on health care access mandated by Congress and the Administration over the past 3 years provide evidence that this nation’s fragmented health care system fails to provide adequate information and access to effective cancer prevention, diagnosis, and treatment services in an equitable and timely manner. This is particularly evident among racial/ethnic minorities, people of lower socioeconomic status, residents of rural areas, and members of other underserved populations for whom the unequal burden of cancer continues to be documented through the nation’s cancer surveillance networks. Substantial evidence shows that these population groups do not have equal access to health care systems and do not always receive timely, standard care when confronted with a cancer diagnosis. Unacceptable delays often occur in follow-up of abnormal findings, definitive diagnoses, and subsequent treatment due to a range of cancer care access barriers. While reasons for disparities are complex, a central issue is that underserved patients face a variety of barriers (e.g., standard cancer prevention, information, screening, diagnosis, treatment, and follow- up) inhibiting timely access to health services. Recent government reports state that access to care is essential to receive quality care, increase the quality and years of healthy life, and to eliminate health disparities, and that access-related factors may be the most significant barriers to equitable care, and must be addressed as an important first step toward eliminating health care disparities. The President’s Cancer Panel (2001) reported on barriers contributing to the disconnect between development and delivery. These included system barriers (e.g., fragmentation of care), financial barriers (e.g., lack of insurance or underinsurance), physical barriers (e.g., excessive distance from treatment facilities), information and education barriers (both provider- and patient-related), and issues of culture and bias. Other barriers that must be overcome include insufficient culturally sensitive information and educational materials for cancer patients and their families; inadequate transportation assistance to get to medical appointments; missed appointments due to travel or childcare barriers; patients fiscal inability to take time off from work for screening and wellness care; and failure of providers to obtain patients medical test or laboratory results in a timely fashion. Cultural and language barriers also impede patient understanding and acceptance of standard cancer care. These factors are not mutually exclusive; multiple barriers usually affect members of underserved populations. The cumulative effect of these barriers is unequal delivery of cancer prevention services and delays in detection, diagnosis, and quality treatment of cancers. Many racial/ethnic minorities, people of lower socioeconomic status, residents of rural areas, and other underserved populations facing such barriers simply give up out of frustration or misunderstanding and drop out of cancer care services. NCI can begin addressing these unequal patterns of standard cancer care access by conducting this NCI-sponsored Patient Navigation Research Program at multiple sites. This new program, Patient Navigation Research Program: Eliminating Barriers to Timely Delivery of Cancer Diagnosis and Treatment Services, will begin to address many of the cancer access and care barriers described above. Objective and Scope The objective of this RFA is to invite research applications for cooperative agreements to develop and implement structured patient navigation interventions in community areas with an adequate number of cancer patients to answer primary and secondary research questions and hypotheses proposed in the application. For this program,(Program is defined as the overall cooperative agreement research effort at the CRCHD-level and consisting of multiple individual grant projects), patient navigation for cancer care refers to support and guidance offered to persons with abnormal findings in accessing the cancer care system and overcoming barriers to quality, standard care. Navigation spans the period from abnormal finding from cancer detection procedure through necessary cancer diagnostic tests to completion of cancer treatment. Individuals working in primary care venues, community health centers, or hospitals will offer this support and guidance, connecting to a variety of existing programs and service delivery systems. Such individuals may be community lay people or professional people. Cost-effectiveness of patient navigation is an important consideration. The basic goal of patient navigation is to facilitate timely access to quality, standard cancer care in a culturally sensitive manner for all patients. The patient navigator will assist patients and their families through the cancer care continuum. Examples of navigation services may include: arranging various forms of financial support, arranging for transportation to and childcare during scheduled diagnosis and treatment appointments, identifying and scheduling appointments with culturally sensitive caregivers, coordinating care among providers, arranging for translation/interpretation services, ensuring coordination of services among medical personnel, ensuring that medical records are available at each scheduled appointment, and other services to overcome access barriers encountered during the cancer care process. The patient navigator will link patients and families with appropriate follow-up services. Presently, many outpatient organizations have to shop for providers willing to treat underserved populations. Formal arrangements among primary care and community health centers with hospitals will assist patient navigators in overcoming health care system access barriers that should result in decreased time between abnormal finding, diagnosis, and resolution for patients in the program. This research grant program will develop patient navigator interventions to reduce or eliminate disparities in clinical outcomes related to lack of timely access to quality, standard cancer care among racial/ethnic minorities, people of lower socioeconomic status, and members of other underserved populations. Improving timely access to standard cancer care will contribute to substantial progress towards the Healthy People 2010 goal of eliminating cancer health disparities as well as NCI’s 2015 Director’s Challenge goal of eliminating suffering and death due to cancer. The proposed research concept focuses on developing a variety of effective patient navigator interventions. Each project will encompass one or more of the four cancers (breast, cervical, prostate, and colorectal) with the greatest disparity in screening and follow-up. These Patient Navigation Research Projects (Project is defined as an individual patient navigation research grant award) will conduct formal qualitative and quantitative evaluations to demonstrate effectiveness, in terns of cost and meeting research program objectives. Examples of the major research questions for this program are: 1. What is the impact of the patient navigator assisting patients in coordinating services, from point of suspicious cancer finding through non-cancer resolution or cancer treatment, e.g., overcoming access barriers such as financial, lack of information, and health system barriers? 2. To what extent does type/degree of service result in reduction and/or elimination of patient-access barriers, thereby providing more timely access to quality standard cancer care for all patients? 3. To what extent does demographic matching of patient and navigator (e.g., race, ethnicity, gender, etc.), or fluency in primary language of the patient affect standard-of-care adherence and perceived satisfaction with the health care system? 4. How effective, in terms of cost and meeting research program objectives, is a patient navigator in providing patient support and assistance to eliminate patient access barriers and improve timely delivery of quality, standard cancer care? Examples of the research hypotheses are that navigated patients will: (1) receive timelier, definitive diagnoses following screenings and abnormal findings; (2) receive timelier treatments following positive diagnoses; and (3) improve their satisfaction with the health care system experience. Examples of secondary research questions may include: Which patient navigation strategies are most effective, i.e., those of an indigenous nonprofessional (cancer survivor, community layperson) or those of a professional health care provider (nurse, social worker, other allied health professional), paid navigator, or volunteer navigator? Does the primary location (e.g., community-based organization, primary care screening/diagnosis clinic/center, or hospital/center) of the patient navigator have an impact on navigation success? Does a patient navigator assisting patients in coordinating care among multiple physicians affect standard-of-care adherence and perceived satisfaction with the health care system? Does a patient navigator assisting patients through the cancer care continuum increase patients and their families identification and use of a usual source of care, for both cancer follow-up and other medical conditions? Successful implementation of patient navigator interventions to address these primary and secondary research questions in diverse underserved communities will provide successful implementation of patient navigator interventions to address these primary and secondary research questions in diverse underserved communities will provide community-based patient navigator interventions that can be implemented in other communities across the nation. Patient navigator interventions, by identifying innovative methods for overcoming access barriers for people in underserved communities (thereby improving cancer diagnosis, treatment timeliness, and delivery of quality standard care) should have substantial impacts on reducing cancer health disparities and the burden of cancer within the next decade. The central data coordination and program evaluation contractor will conduct formal qualitative and quantitative evaluations to address a variety of process and outcome research questions, along with a comprehensive cost-effectiveness evaluation of the patient navigator process. Research results from this Patient Navigation Research Program will: (1) improve NCI’s knowledge and understanding of how to best support racial/ethnic minorities and other underserved populations with cancer-related abnormal screening findings in accessing and navigating the cancer care system; (2) assess the impact of patient navigators on timely provision of quality standard care and patients adherence to standards-of-care; and (3) encourage research collaborations and partnerships across cancer care delivery systems and organizations (e.g., primary care facilities, community health centers, hospitals, and academic centers). Applicants must address navigating patients with one or more of the following cancer types; breast, cervical, prostate, and colorectal. These patients must include a significant number of racial/ethnic minorities, people of low socioeconomic status (SES), and members of other underserved populations. Applicants must propose approaches to develop and implement formal referral and care arrangements between community outpatient settings and a hospital that offers quality, standard cancer treatment. Applicants will be required to identify, where available, other local Federally funded programs that could augment successful interventions, such as the Centers for Disease Control and Prevention’s (CDC) National Breast and Cervical Cancer Early Detection Program - Reducing Mortality Through Screening and similar programs funded by CDC, Health Resources and Services Administration (HRSA), Centers for Medicare and Medicaid Services (CMS), or other agencies, and are encouraged to elicit coordination and collaboration with Federal, or similar State, regional, or local programs. The PNRP does not pay for screening, diagnosis or treatment costs, existing health care systems are to be used for this purpose. Applicants must present methodologies and techniques for overcoming barriers (e.g., utilizing primary language other than English) to timely access to cancer diagnosis and treatment services. Applicants must demonstrate that the treatment hospital has a service area with adequate cancer screening rates. These rates will need to ensure that a sufficient sample (i.e., based on power analysis) of patients with abnormal findings are referred to the patient navigator to scientifically answer the research questions proposed. Applications must address plans for: conducting a needs assessment, selecting and training navigators, tracking patients, conducting a rigorous program evaluation, and disseminating findings. The applicant’s research design must include baseline historical data and plans for a continuous comparison group throughout the study period. This design must address history effects, system biases, community activities that may impact changes in cancer disparities (e.g., other organizations efforts to increase cancer screening rates), and other confounding factors. Community cross-sectional surveys should be considered to interpret changes over time. All research designs will be reviewed for ethical concerns and Human Subjects issues within vulnerable populations. Rigorous evaluations of navigation intervention effectiveness and cost effectiveness are critical components of the patient navigator program. In collaboration with the Program Scientist of the NCI CRCHD, grantees will establish intervention and cost-effectiveness evaluation criteria for their research, using qualitative and quantitative indicators collected at the start of the project and regularly updated throughout the grant period of performance. This Program’s evaluation process, cost-effectiveness analysis, and associated outcome metrics will be developed to address research hypotheses and other outcome measures. Metrics will also provide insights into community changes possibly related to the project, such as increases in observed short-term reductions in stage at diagnosis; and increases in cancer prevention, screening, and treatment knowledge and cancer-preventive behaviors. Documentation should be maintained on aspects of the Program that may be implemented for other cancers and diseases. Several anticipated features of this study are described so that applicants have a common understanding of the factors necessary for the collaborative effort, timetable, general evaluation criteria and data collection requirements, and handling of certain central functions. Although some of the characteristics of the study populations and experimental interventions are specified, the specific design of the study testing the effectiveness of patient navigators on timely access to standard cancer care services remains in the hands of the investigators. In order to accumulate a sufficient sampling of differing patient navigator characteristics, settings, and population groups to test the effect of patient navigators on patient access barriers, a collaborative effort will be required among participating research projects. In this collaborative effort, participant institutions must agree to follow a uniform study protocol with respect to CRCHD-required standardized data collection and documentation procedures. The collaborative protocol will be developed by the Steering Committee (SC), composed of the Principal Investigators (PIs) and the NCI CRCHD Program Scientist. Awardees are permitted to collect project data to address independent research questions. Study Design and Timetable The PNRP can be implemented in multiple phases as designed by the applicant. A first phase might consist of formative research to assist the PI in planning, designing, and implementing the unique patient navigator research protocol components. A component of the formative research might be a needs assessment to determine the most frequent patient-access barriers and identify methods and techniques to overcome these access barriers in a timely, efficient manner. Based on this formative research, different models may be planned and implemented within different project settings. Additional formalized pre-implementation phases might include patient navigator training and project start-up. A patient navigator-training phase should focus on training the patient navigator individual(s) based upon formative research findings. These efforts might include selecting, training, and orienting the patient navigator(s) to cancer screening, diagnosis, and treatment. In training patient navigators, characteristics and qualities identified from the formative research process might include: a. Ability to provide timely, accurate information to the patient at time of abnormal finding in a supportive, culturally sensitive manner. b. Knowledge of the health care delivery system that cancer patient must depend on for care. c. Knowledge of various financial resources and financial alternatives available to the patient to pay for cancer care services. d. Interest in ensuring that culturally and linguistically appropriate services are offered to the patient, which are respectful of and responsive to cultural and linguistic needs. e. Acceptance within the health care system by administrators, physicians, and associated health care professionals. f. Commitment to high-quality, timely care for all cancer patients. g. Consideration and acceptance of patient fears, cultural beliefs, and hopes. h. Ability to connect and communicate with medical decision-makers in the health care system. The investigators should also gather information on community screening rates and numbers of abnormal findings currently in the cancer care continuum; establish rapport with primary care and cancer care providers and nursing staff; and engage the targeted community(s) in the patient navigation process. The patient navigator should establish familiarity with screening protocols and procedures within their respective health care system. A tracking system should be established to cover from the time of referral to treatment resolution. The patient navigator and the clinical supervisor may need to jointly develop a scope of practice, i.e., job responsibility/description in order to establish clinical/administrative supervision and mentoring with provider senior staff. Also during this early phase of the application project, the project should include discussions of the development of manual and automated systems for outcome and process measurement criteria and data collection procedures. During project start-up, the investigator team should develop, document, and implement strategies to address and overcome identified barriers. From project start-up, the study effort should formally implement collection of all core and supplemental process and outcome measures. It is expected that intake interviews will be completed at the time referrals are sent to the patient navigator. By the end of the first year after award, the patient navigator project should be in full operation, receiving referrals from primary care centers for persons with abnormal findings, and navigating patients through the cancer care continuum. Through community and hospital partnerships and collaborations, the patient navigator project should then be capable of sustaining the infrastructure required to overcome the unique barriers to cancer care experienced by the targeted populations in their community. In addition to working with all referred patients, each project should have systems in operation to track each patient’s progress through the cancer-care system, to record all established outcome and process measures, to provide cancer care coordination, to overcome patient barriers to timely care, and to establish sustainable cooperation between health care settings and cancer care treatment. The proposed project schedule should include sufficient time to perform thorough analyses and evaluations of all project activities. Local data should be analyzed with respect to primary and secondary research questions. Process data should be analyzed to augment the quantitative analyses and to provide information for interpreting outcome results. Presentations and publications should be prepared to publicize research findings to NCI, the scientific community, and the local targeted communities. Documentation of all Patient Navigator Project implementation and operation processes should be completed, so those successful programs can be transferred to other similar communities. PNRP Organization and Related Activities In developing the PNRP organizational structure, issues that might be considered include: (1) having a PI and a Co-PI located at the diagnosis and treatment facility and the community outpatient setting, respectively; (2) having patient navigators to address different population segments; (3) having an administrative core group consisting of a project coordinator for day-to-day management, a research assistant for daily project administration, and a research coordinator/data manager to assist in conduct of data collection and process documentation activities; and (4) having a research core group consisting of qualitative and quantitative researchers to direct and conduct the formative research and the required project outcomes evaluations. Each project must establish a Community Advisory Panel (CAP) to advise the project PI. This committee would probably be composed of community leaders; community-based participatory researchers; clinical personnel serving the community; and others needed to carry out objectives of the PNRP. At least one-quarter of the panel’s membership should represent community-based organizations. At least one-third of the membership should be composed of racial/ethnic minorities, people of low SES and members of other underserved populations. Such a panel must meet at least once a year to review project activities and accomplishments as well as activities planned for the following year. This committee should also advise on methods to sustain the patient navigator activities after conclusion of grant funding. There must be actively participating partnerships with local community- based organizations, screening and early detection centers, and diagnosis and treatment facilities that serve the targeted communities experiencing cancer care services disparities. Evaluation of the Program Evaluation of the Program The Steering Committee will collaboratively establish a core set of standardized processes and outcome evaluation criteria for the program’s research using qualitative and quantitative indicators collected at the start of the project and regularly updated throughout the grant periods-of-performance. This Program’s core evaluation process and associated outcome metrics will be developed to address the primary research hypotheses stated above. Core metrics will also provide insights into community changes possibly related to the Program, such as increases in cancer screening rates; observed short- term reductions in stage at diagnosis; and increases in cancer prevention, screening, and treatment knowledge and cancer-preventive behaviors. Grantees also will be required to document each step in the implementation, training, conduct, and evaluation of navigation services to provide a basis for exemplary programs to disseminate collaboration and operating information, best practices, and lessons learned to other communities throughout the nation. Additional unique project qualitative and quantitative indicators to address individual project research questions may also be included. Individual Grant Project Evaluation A first step in the evaluation of each grantee’s project will be baseline research to formally document baseline time from abnormal finding to resolution of abnormal findings and time from positive cancer diagnosis to commencement of standard cancer treatment. A variety of additional pathway measures may be collected as determined appropriate by the Steering Committee during start-up meetings. During conduct of the individual research projects, a core set of evaluation metrics will be established collaboratively by the Steering Committee and must be collected by all grantees. These qualitative and quantitative measures may include, but are not limited to: o Number of patients referred; o Type of cancer and stage at diagnosis; o Appointments kept/missed and reasons; o Number of patients accepting navigation; o Number of current dependents in patient’s family; o Reasons for accepting or not accepting navigation; o Baseline knowledge of cancer treatment alternatives; o Education/information materials provided to patient/family members; o Patient demographics (i.e., gender, race/ethnicity, age, socioeconomic status, primary language); o Patient-access barriers and time to resolve each barrier, including issues addressed in resolving access; o Distance of patient’s home from diagnosis and treatment centers; o Recommended diagnostic procedures and adherence to schedule; o Patient’s primary mode of transportation to diagnosis and treatment centers; o Recommended treatment procedures and adherence-to-treatment protocol; and o Other non-access-specific navigation services requested/provided. Primary outcome measures for each grantee should include, at a minimum, changes in time from abnormal finding to diagnosis or other resolution and positive diagnosis to treatment initiation. Other outcome measures may include, but are not limited to, improvements in satisfaction with the cancer care system experience and measures of how well the patient navigator achieves program goals. Documentation should be maintained on aspects of the Program that are reproducible or translatable to other cancers and other diseases. Projects should also document to what extent the community and health care delivery system can sustain patient navigator services beyond the grant funding period. Cost-effectiveness measures will include labor cost of the navigator, cost of training the navigator, and time of patient navigator spent on various activities (e.g., contacting patient, coordinating patient records with providers, overcoming various types of access barriers such as arranging transportation, community education about navigation processes, and similar patient navigator activities). Patient follow-up surveys may be administered to measure patient and family changes in knowledge of cancer prevention and control-specific to both the patient’s cancer and to cancer in general-changes in usual source of care and satisfaction with the health system experience. Community outcome measures may include community member changes in perceptions regarding accessibility of timely, high-quality, standard cancer care; ability of patients with abnormal findings to overcome barriers to timely diagnosis and treatment; and satisfaction with services and quality of care provided by the local cancer care system. Overall Patient Navigator Program Evaluation The SC will establish standardized evaluation criteria and associated qualitative and quantitative measurement metrics within the first year of the Program. Primary metrics to demonstrate success of this Program will be: (1) improved timeliness of resolution following an abnormal finding for a majority of participating patients; (2) improved timeliness of commencement of standard cancer treatment following a positive cancer diagnosis for a majority of participating patients; and (3) improved patient satisfaction with the health care system experience for a majority of participating patients. Process evaluation measures will investigate what characteristics are important to the patient navigation process, for example: (1) How important is matching of patient and navigator demographic characteristics? (2) How important is the type of navigator- professional navigator (nurse, social worker) versus indigenous community navigator (cancer survivor, community health worker)? (3) What services are critical to provide to the cancer patient-only overcoming cancer care access barriers or also emotional, psychological, and referral support and access for medical treatment of comorbidities? (4) What training and support is critical to the patient navigator-cancer prevention and control, hospital procedures and administration, medical information, and/or emotional and psychological support to minimize burnout? (5) How many patients can a patient navigator effectively assist simultaneously? and, (6) Do other program linkages and partnerships (e.g., local Federally funded CDC, HRSA, CMS, or other agency programs) have an impact on the success of the patient navigator intervention strategies? Centralized data collection, data management, and data quality assurance will be coordinated by the NCI CRCHD Program Scientist through a central data coordination and evaluation contractor. All awardees will collaborate in the sharing of standardized core process and outcome data with the central data coordination and evaluation contractor and will collaborate in primary research data analyses and publications using the aggregated data sets, as component parts of the awarded grant funding. Collaboratively developed standardized evaluation criteria and metrics will be used by all grantees. Development of additional, individualized project metrics will also be encouraged in order to evaluate unique research hypotheses. The central data coordination and evaluation contractor will assist the Steering Committee to monitor Program implementation progress by examining patient accruals, conducting periodic analyses of critical metrics, and preparing interim reports on trends in outcome measures. Continuous monitoring in collaboration with awardees will enable the NCI CRCHD Program Scientist to obtain a snapshot of the progress and to make midcourse Program adjustments, if necessary, among individual grantees or in the entire Program’s implementation procedures. The NCI CRCHD Program Scientist, in collaboration with grantee investigators, will conduct appropriate descriptive and inferential statistical analyses of the aggregated data sets to validate that patient navigators are an effective method for reducing cancer health disparities. Process documentation will be evaluated to describe characteristics and qualities of navigators, communication and relationships between patients and their patient navigators, and communication and relationships between patient navigators and health care professionals providing standard cancer care. Dissemination of PNRP Research Findings The PNRP will disseminate its research findings. There are a number of ways to achieve this objective, including, but not limited to, having findings published in peer reviewed journals or published on the cancer control PLANET website (http://cancercontrolplanet.cancer.gov/), and disseminating findings and effective interventions to other communities through collaborations between PNRP grantees to develop resource documentation. 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. Future unsolicited applications based on this program will compete with all investigator- initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated 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 uses the non-modular budgeting format so follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.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 $4.8 million in FY 2005 to fund six grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for total costs of up to $0.8 million per year. Please note that facilities and administrative (F&A) cost requested by consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040. 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 cancer services delivery organizations; o Public or private institutions, such as universities, colleges, hospitals, and laboratories; o Domestic institutions/organizations; o Faith-based or community-based organizations; and 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. 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 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, the NCI CRCHD Program Scientist, and other NCI staff with required expertise. 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.Awardee will participate in PNRP Steering Committee (SC), composed of PIs and one NCI CRCHD Program Scientist, agree to follow the SC approved standardized data, procedures, protocols, and analyses, and agree to share data with the NCI established central data coordination and evaluation contractor. Awardees may collect project data to address independent research questions in addition to the collaborative projects. Awardees will retain custody of and have primary rights to data collected under these awards, subject to Government rights of access consistent with current U.S. Department of Health and Human Services (DHHS), Public Health Service (PHS), and National Institutes of Health (NIH) policies, such as Health Insurance Portability and Accountability Act (HIPAA) regulations. c. Awardees must establish and maintain a Community Advisory Panel (CAP). The role and responsibilities of the Panel are described below. The NCI CRCHD Program Scientist will serve as a voting member of any advisory panel (wirh only one NCI vote on any such panel). a. Awardees will establish and maintain for their projects a CAP whose role is to function as an advisory body. The CAP may include the Project PI, all Co-PIs, and all Co-Investigators, community leaders and/or facilitators, representatives of community-based organizations, community-based participatory researchers, clinical personnel serving the community, and others with expertise in relevant scientific or other cancer-related or disparity-related disciplines necessary to carry out objectives of the PNRP. At least one-quarter of the panel’s membership should represent community-based organizations. At least one-third of the membership should be composed of racial/ethnic minorities, people of low SES and members of other underserved populations. The CAP should provide overall guidance and support for project-sponsored activities. This Panel should also advise on methods to sustain the patient navigator activities after conclusion of grant funding. d. Awardees must provide annual progress reports and additional information, as requested by the NCI CRCHD Program Director. In addition to descriptions of past activities and their results, the report due at the end of each funding period should provide core program evaluation data elements annually, as determined by NCI; e. Awardee must seek technical assistance from NCI staff if it is determined that the awardee is not meeting program goals in a timely manner. f. Awardee will participate in two meetings per year. 2. NCI Staff Responsibilities - The NCI CRCHD Program Scientist 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. The NCI CRCHD Program Scientist will: a. participate as a voting member in the PNRP Steering Committee, attending semi-annual meetings. b. Coordinate awardee interaction with the NCI data coordination and evaluation contractor. The NCI Program Director will be responsible for normal stewardship of the award. The Program Director may also serve as the Project Scientist. The Program Director will also designate other NCI staff who are subject matter experts to assist the Project Scientist. For projects with phased implementation, the Program Director must approve moving into the next phase based on progress made and proposed plans. 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 Awardees and the NCI CRCHD Program Scientist will form a Steering Committee, which will be the governing body for the collaborative effort of the awardees. The awardees and the NCI Program Scientist will each have one vote. The chair will be a non-federal person. The SC will establish standardized evaluation criteria and associated qualitative and quantitative measurement metrics that will be collected throughout the period of performance. The SC members will collaborate on the design and implementation of program analysis plans; will participate in the program process and outcome analyses, and will prepare primary outcome publications and presentations. a. The SC will plan and implement semi-annual program meetings of all PNRP PIs and Co-PIs to share research and operational implementation experiences, challenges, and accomplishments; lessons learned; and research findings, and identify areas in which improvement is needed and additional collaborations are possible. 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 SC (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: A. Roland Garcia, 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: [email protected] o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: [email protected] o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-8796 FAX: (301) 496-8634 Email: [email protected] PRE-APPLICATION MEETING A pre-application workshop will be held on September 15, 2004 from 1-5 p.m. in the Natcher Auditorium (Building 45) the on NIH campus. This meeting is open to the public. Investigators planning to submit applications in response to RFA CA-05-019, "Patient Navigation Research Program" are encouraged to attend. This public meeting will provide prospective applicants with opportunities to receive answers to their questions about the RFA. The meeting will include presentations from CRCHD staff on the intent and requirements of the RFA, and presentations from other NIH and DHHS staff on human subjects protections, grants management, and grant writing. Potential applicants to the RFA are not required to attend the pre-application meeting. A written transcript of the meeting will be posted at http://crchd.nci.nih.gov/ as a public document as soon as possible after the meeting, to provide applicants unable to attend the meeting with access to the proceedings. The workshop will be webcast at http://www.videocast.nih.gov/. Please click on the Patient Navigator Research Pre-Application Workshop on September 15 to access the broadcast. Registration is required for participation in the pre-application meeting to facilitate technical planning. Participants may register with and direct any questions regarding logistics to Christine McCann, NOVA Research Company, at 301- 986-1891, ext. 130, or via e-mail at [email protected]. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: A. Roland Garcia, 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) 496-7072 FAX: (301) 435-9225 Email: [email protected] 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B 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) 710-0267; Email: [email protected]. SUPPLEMENTARY INSTRUCTIONS: See additional guidance in the RESEARCH OBJECTIONS section (above) and the following instructions: RESEARCH PLAN a. Specific Aims Specific aims should address the goals and objectives as specified in the RFA. b. Background and Significance -In this section, the applicant should provide a description of cancer care delivery (i.e., diagnosis, treatment, and mortality) disparities in the communities to be addressed and cancer screening rates and diagnosis rates for the four primary screenable cancers, breast, cervical, prostate, and colorectal. For each disparity, the description should include, but is not limited to, the type of disparity, population to be addressed, cancer site affected, and potential reasons for the observed disparity. c. Preliminary Studies/Progress Report - description of previous work relevant to this RFA. d. Research Design and Methods - Describe your Patient Navigation Research Project in detail. Provide current hospital screening rates of selected cancer sites. Describe the minority and/or low SES/underserved population in your community. Provide data to demonstrate the cancer disparities of these populations within your community. Specifically, describe cancer care delivery activities in targeted communities, how patient navigator intervention(s) will be implemented within the cancer care delivery infrastructures, how a comparison group will be selected and maintained, how cancer care delivery organizations will coordinate from abnormal finding through completion of treatment, how the targeted communities will participate, how intervention activities will be measured and evaluated, how research findings will be disseminated back to the targeted communities, and how effective programs will be sustained in the cancer care delivery system after completion of this research project. Applicants must also address methods for conduct of the cost- effectiveness evaluation and appropriate measurement criteria. Describe specifically, how each research aim will be achieved, including a discussion of how changes in cancer care disparities in the community will be evaluated. Research Plan Sections e-i, as appropriate. BUDGET FOR TRAVEL TO PNRP PROGRAM MEETINGS Budget for travel to Washington, DC (twice per year for up to four individuals) to attend these semi-annual 3-day meetings should be included in the budget. 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 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) Telephone: (301) 496-3428 (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.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html): This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice 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 non-responsive 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 important cancer disparities? If the aims of the application are achieved, will patient access barriers be reduced and/or eliminated and will cancer care disparities be reduced? What will be the effect of this project’s concepts or methods that drive this field? Is the proposed project likely to improve access to cancer care service from abnormal findings through cancer treatment or non-cancer resolution through cancer care provider collaborations and community-based participation? Will the results, such as the interventions to be developed, be useful to groups in other parts of the country? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of patient navigation to reduce patient access barriers? Does the applicant acknowledge potential problem areas and consider alternative tactics? Has applicant addressed plans for needs assessments, selecting and training navigators, tracking patients throughout the cancer care continuum, collecting and sharing information and core data with the NCI CRCHD Program Scientist and other grantees, conducting qualitative and quantitative program evaluations, and disseminating findings through publications and other methods designed to inform communities? Has the applicant adequately addressed methods for conduct of the cost- effectiveness evaluation and appropriate measurement criteria? Has the applicant described formation, representativeness, and responsibilities of a CAP? Have cancer care disparities of the community been described adequately? Has applicant adequately described institutional, system and patient access barriers to timely, quality cancer care and proposed methods and techniques for overcoming these barriers? Are there linkages from the cancer care delivery facilities to the cancer research base and to the community? Are there indications of the potential for applicant’s effectiveness in reaching the most difficult- to-access segments of the community? Do they have a clear plan for establishing and maintaining a suitable comparison group throughout the study period? Are there adequate plans for involving all segments of the cancer care services delivery infrastructure to address the problem of reducing cancer care access barriers in the targeted community? Are there adequate plans for evaluation of the proposed patient navigation interventions? Does the applicant demonstrate effective approaches to developing and implementing formal referral and care arrangements between community outpatient settings and a hospital that offers quality, standard cancer treatment? INNOVATION: Does the project employ novel concepts, approaches or methods to provide patient navigation access and reduce cancer care disparities? Does the project challenge existing paradigms, develop new methodologies or technologies, or address critical barriers? 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? Does the investigator/staff have experience working with the cancer care delivery components and 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 care services delivery and research so that they can develop interventions to address the Program objective and four major research questions specified. ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed interventions take advantage of unique features of the scientific and community environments or employ useful collaborative arrangements? Does the environment include a significant number of racial/ethnic minorities, people of low SES, and members of other underserved populations? Is there evidence of institutional support? Is there evidence of community support? Is there evidence that applicants have identified, where available, other local Federally funded programs and other agencies programs that could augment proposed interventions, and elicited coordination and collaboration. 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. 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 $500,000 or more 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: 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 18, 2004 Application Receipt Date: November 18, 2004 Peer Review Date: February/March 2005 Council Review: June 2005 Earliest Anticipated Start Date: July 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; and o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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 the 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; for additional information, see NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials 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: 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): 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: 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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