and Human Services (HHS)
EXPIRED
NATIVE AMERICAN RESEARCH CENTERS FOR HEALTH Release Date: August 21, 2000 RFA: GM-00-007 Indian Health Service (http://www.ihs.gov) National Institute of General Medical Sciences (http://www.nigms.nih.gov) Letter of Intent Receipt Date: October 1, 2000 Application Receipt Date: December 12, 2000 PURPOSE The Indian Health Service (IHS) and the National Institute of General Medical Sciences (NIGMS) announce a new initiative to support Native American Research Centers for Health (NARCH) which will develop opportunities for conducting research and research training responsive to the needs of Native American communities. For purposes of this announcement, "American Indian" and "Native American" refer to American Indian and Alaska Native. The NARCH initiative will support partnerships of American Indian or Alaska Native tribes or of tribal-based organizations such as the National Indian Health Board and Area Health Boards, with institutions that conduct intensive academic-level biomedical and behavioral research, these partnerships are called Native American Research Centers for Health. The purposes of the NARCH initiative are: to encourage competitive research linked to reducing health disparities, to develop a cadre of American Indian scientists and health professionals engaged in biomedical, clinical, and behavioral research that is competitive to NIH funding, and to increase the capacity of both research intensive institutions and American Indian organizations to work in partnership to reduce distrust by American Indian communities and people toward research. These purposes will be achieved by supporting research projects (including pilot projects), student development projects, and faculty development projects developed by each NARCH partnership. 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 Request for Applications (RFA), Native American Research Centers for Health, 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/. ELIGIBILITY REQUIREMENTS The proposed NARCH must be a working partnership of the American Indian organization and of the research intensive institution. Applicants eligible to receive a NARCH award are the Native American organizations of the partnerships. As the grantee, the Native American organizations will define criteria and eligibility for participation in all aspects of the partnership, consistent with this announcement. A minimum of 30% of the grant funds must remain with that Native American organization, that is, no more than 70% may be subcontracted to other institutions or organizations. The American Indian or Alaska Native applicant must be one of the following: o a federally recognized Indian tribe or tribally sanctioned non-profit tribal organization, or o a non-profit national or area Indian health board, or o a consortium of two or more of those tribes, tribal organizations, or health boards. The Research-Intensive Partner must be: o an accredited public or private nonprofit university or other institution with an established record of producing research into the health of American Indians, and that has a demonstrated commitment to the special encouragement of and assistance to Native American faculty, students, investigators, and communities for enhancing their capacity to engage in biomedical research. The proposed NARCH must have a Community and Scientific Advisory Council with more than 50% of its membership being appointed by the American Indian or Alaska Native applicant. The NARCH applicants are encouraged to have an affiliation with a component of the IHS for technical and other in-kind support, such as linking data from IHS and others to understand better the health status of the involved tribes or communities. The proposed NARCH may include additional affiliated organizations, e.g., tribal colleges, additional colleges or universities, additional tribes, other Indian communities or organizations, etc. Principal Investigator The Principal Investigator, the individual responsible for the administration (including fiscal management) of the overall project, must have his/her primary appointment with the American Indian or Alaska Native applicant. Special arrangements of employment, such as inter-organizational personnel agreements, are permissible. The Principal Investigator may be, but is not required to be, the NARCH Program Director or a Research Project Investigator. NARCH Program Director The NARCH Program Director is the individual responsible for the day-to-day leadership and management of the research and training programs within the proposed NARCH. The Program Director may be, but is not required to be, a Research Project Investigator. Research Project Investigators The NARCH initiative is an institutional developmental grant mechanism that places an emphasis on continual improvement of the research competitiveness of the research investigators. In order to be included as a research project investigator in the proposed NARCH, a prospective investigator: must have a faculty appointment at the research intensive institution or equivalent appointment at the American Indian organization or other consortium partner, and must show that the investigator has the need, based on institutional, departmental, and professional development plans, to enhance his/her research knowledge, skills, and capabilities by engaging in the proposed research program and associated activities. Student and Faculty Development and Project Participants Faculty and students may be supported in research education activities that improve their skills and abilities to be successful at the next stage of their professional development. To be included for faculty development in the proposed NARCH, the individual must have a faculty appointment at the research intensive institution or equivalent appointment at the American Indian organization or other consortium partner. Applicants are strongly encouraged to establish eligibility of their proposed applications prior to submission. Inquiries about eligibility should be sent to William L. Freeman, M.D., M.P.H. at the address listed under INQUIRIES. TRIBAL APPROVAL OF THE APPLICATION It is the policy of the IHS that all research involving American Indian tribes be approved by the tribal governments with jurisdiction. The following documentation, therefore, is required to accompany the application. Either: Tribal Resolution: If the applicant is a federally recognized Indian tribe, a resolution of support from the tribal government must accompany the application submission. Applications that affect more than one Indian tribe must include resolutions of support from all affected tribes. If the applicant is an eligible consortium of tribes, a resolution of support from each tribe of the consortium must be included. If the applicant is a tribally sanctioned non-profit tribal organization, specific tribal resolution(s) of support will not be required if the current tribal resolution(s) under which the organization operates encompasses the proposed application. (A copy of the current operational resolution(s) must be submitted with the application.) Draft resolutions that are submitted with the application are acceptable in lieu of an official resolution. If a current or draft resolution is not submitted with the application, the application will be considered incomplete and will be returned without further consideration. (If a draft resolution is sent, note the approximate date when it will come up for a vote. The official final signed resolution must be received by the Grants Management Branch, IHS, no later than April 30, 2001. A grant will not be awarded unless the final signed resolution is received by this date.) Or: Letter of Support: If the applicant is a non-profit national or area Indian health board, or is an eligible consortium of those Indian health boards, it is not required to submit a resolution. However, the applicant organization must submit a letter of support signed by the executive director of each health board involved, specifically citing the research project proposed. Each American Indian or Alaska Native organization that derives benefit from the grant must also submit such a letter. MECHANISM OF SUPPORT Awards under this initiative will be administered using the competitive institutional grant mechanism of the IHS, and will be reviewed using the NIH S06 mechanism. The responsibility for planning, directing, and executing the program, as well as data acquisition and analysis and evaluation of the proposed program, lies solely with the applicant organization. The maximum grant period may not exceed four years, with the opportunity for competing renewal at the end of that period. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire initiative is expected to be $1.5 million in Fiscal Year 2001. The actual amount may vary, depending on the response to the RFA and availability of funds. Three to five awards are anticipated. An application may request a project period of up to four years and a budget for direct costs of up to $700,000 in the first year, plus appropriate facilities and administration (F&A) costs. Because it is anticipated that all budget requests will exceed $250,000, the modular grant requirements would not apply to this RFA. A minimum of 30% of the grant funds must remain with the applicant organization. BACKGROUND The American Indian and Alaska Native tribal nations and communities have long experienced lower health status than other Americans. Although major gains of reducing health disparities were made in the last half of the twentieth century, most gains stopped by the mid 1980s (1997 Trends in Indian Health). A few diseases, e.g., diabetes, got worse. "All Indian" rates contain marked variation among the "IHS Areas" or regions (Regional Differences in Indian Health 1998-99), variation by tribe exists within Areas as well. Although the All Indian mortality rates for all cancers are about 20% lower than the US rates for all races, there is variation among IHS Areas for specific cancers, moreover, the favorable American Indian mortality rates for some cancers may be due to markedly lower incidence rates partly offset by higher case-fatality rates (NIH Publication 98-4247). The daunting tasks confronting tribes, researchers, and health care and public health programs in the beginning of the twenty-first century are to resume the reduction of health disparities that had occurred up to the 1980s, to reverse the worsening in a few diseases, to maintain and strengthen the favorable status, and to reduce the disparities among and within Areas and tribes. Factors contributing to health disparities are complex, and traditionally have included race, ethnicity, culture, socioeconomic status, gender/sex, age, geographical access to care, and levels of insurance. Yet none of these alone accounts for all of the documented differences. Even socioeconomic status as a measure of class leaves much of the variability in health status unexplained. Research on the determinants of health indicates that stress in family home and work environments, health practices, social support systems, access to health care, and attitudes toward health are all important determinants of health status. Discovering the interrelationships among these variables that affect health and disease, their relationship(s) to more traditional variables, and, ultimately, the relationship between all of these factors and the underlying biological and physiological processes involved in health and disease is critical to understand disease and hence health disparities, and to suggest ways to prevent and reduce them. Health disparities of American Indians may also reflect a lack of research relevant to improve their health status. Many Native Americans distrust research for historical reasons. One approach that combats this distrust is community-based participatory research, in which the community"s responsibility is comparable to that of a co-investigator. This approach is especially helpful both to design research relevant to health needs of the community, and to lessen distrust. Low functional health literacy influences health status among the elderly, the low-income elderly, and individuals of various racial/ethnic groups, and also may reduce the acceptability of research among Native Americans. Lower life expectancy (American Indians born today have a life expectancy 5 years less than non-Indians) and disproportionate disease burden exist also in part due to (Minority Economic Profiles): less available funding for IHS-provided health care ($1,650 for American Indians vs. $3,600 general population per capita), lower access to health professionals (in Indian Country [which refers to American Indian people on or near reservations], there are 79 per cent fewer nurses, 60 per cent fewer dentists and 45 per cent fewer physicians, with high vacancy rates for some disciplines, and with sub-specialties at only one-third or more of the total full-time-equivalent), inadequate educational resources, disproportionate poverty (the nation-wide poverty rate for Native Americans is twice as high as the rest of the country), discrimination in the delivery of health services, and cultural differences. These are broad quality of life issues rooted in economic adversity and poor social conditions. OBJECTIVES Due to the complexity of factors contributing to the health disparities of American Indians compared with other Americans, the collaborative efforts of the agencies of the Department of Health and Human Services, and the collaboration of researchers and Native American communities, are needed to achieve significant improvements in the health status of American Indian people. Reduce Health Disparities In the Indian Health Care Improvement Act, Public Law (P.L.) 94-437, as amended, IHS was legislatively mandated to improve the delivery of effective health care to Native Americans. In the NIH Revitalization Act of 1993, NIH was encouraged to increase the number of underrepresented minorities participating in biomedical, clinical, and behavioral research, including studies on drug abuse and alcoholism, and the examination of the role of resiliency in the prevention and treatment of those conditions. Also, the "Initiative to Eliminate Racial and Ethnic Disparities in Health" by HHS (http://raceandhealth.hhs.gov) encouraged NIH to help reduce health disparities. Finally, the "NIGMS Strategic Plan for Reducing Health Disparities" (http://www.nigms.nih.gov/news/reports/health_disparities.html) presents an NIGMS role in health disparity reduction through its focussed programs on research infrastructure to increase the number and capabilities of underrepresented minority health researchers. In response to these encouragements, the IHS and NIGMS have established a collaboration to support Native American Research Centers for Health. Reducing health disparities among Native American communities and individuals is fostered by greater understanding of how to enhance their strengths and resiliencies. While American Indian communities have relied on health research and medical science to reduce health disparities, they also have relied on their own psychological, organizational, and cultural, assets and strengths to survive major harms and disruptions over the centuries, and to rebound from insults to health. (For research about resiliencies, see http://www.nida.nih.gov/ResilandRiskWG/ResilandRiskWG.html) Develop a Cadre of American Indian Scientists and Health Professionals The NARCH initiative offers opportunities to develop and conduct biomedical, clinical, and behavioral research that is responsive to the needs of the Native American community and the goals of this initiative. Faculty and students at each proposed NARCH will be supported through investigator-initiated, scientifically meritorious research projects, including pilot research projects, and through science education projects designed to increase the numbers of, and to improve the research skills of investigators involved with Native Americans. Enhance Partnerships Recent community-based participatory research suggests that Native American communities can contribute much of value to partnerships with health researchers. Fully utilizing all cultural and scientific knowledge, strengths, and competencies in such partnerships can produce better understanding of the biological, behavioral, psychological, cultural, social, and economic factors either promoting or hindering improved health status of American Indians, and generate the development and evaluation of interventions to improve their health status. 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, clinical, and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of P.L. 103-43). Because the NARCH initiative targets American Indian and Alaska Native people and communities, a minority population, only the policy of inclusion of women applies to this RFA. 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, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects" research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the initiative staff listed under INQUIRIES. Initiative staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the title of the proposed NARCH, the name, address, and telephone number of the its Principal Investigator and its Program Director, the identities of the partners and of key personnel, and the 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 the IHS and NIH Center for Scientific Review (CSR) staffs to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the initiative staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES Applications are to be submitted using the grant application form PHS 398 (rev.4/98). Applicants are strongly urged to contact NARCH initiative staff at an early stage to request the specific supplemental instructions for Form PHS 398. Application kits and supplemental instructions may be obtained from the initiative contacts listed under INQUIRIES. Application kits are also available at most institutions that conduct NIH sponsored research, such as the research intensive institution, and may also be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: [email protected]. The application is also available at http://grants.nih.gov/grants/forms.htm. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and one (1) single-sided photocopy of the entire signed application (including Appendices and supporting documents) in one package to: Grants Management Branch Indian Health Service Twinbrook Metro Plaza, Suite 100 12300 Twinbrook Parkway Rockville, MD 20852-1750 Telephone: (301) 443-5204 (for express or courier service, the Zipcode is unchanged). At the time of submission, four (4) additional single-sided photocopies of the complete signed original application, including the Checklist, Appendices, and supporting documentation, must also be sent to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 2030 - MSC 7720 Bethesda, MD 20892-7720 Telephone: (301) 435-0715 or Bethesda, MD 20817 (for express or courier service). Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. APPLICATION CONTENT The purposes of the NARCH initiative are: to encourage competitive research linked to reducing health disparities, to develop a cadre of American Indian scientists and health professionals engaged in biomedical, clinical, and behavioral research that is competitive to NIH funding, and to increase the capacity of both research intensive institutions and American Indian organizations to work in partnership to reduce distrust by American Indian communities and people toward research. A proposed NARCH, therefore, may include any or all of the following: research projects (including pilot projects), student development projects, or faculty development projects. In general, a description should be provided of the current state of the research and research training enterprise at the proposed NARCH and its institutional and community partners, including faculty and student profiles. A clear statement of the overall goals, specific measurable objectives, and anticipated milestones should be presented, these elements should be presented in the context of needed improvements in the partners" organizational infrastructure and environment for research. The NARCH application should document that the research intensive partner is an institution with an established record of producing research into the health of American Indians, and that has a demonstrated commitment to the special encouragement of, and assistance to, Native American faculty, students, investigators, and communities for enhancing their capacity to engage in biomedical research. The application should also document the nature of the partnership itself, such as: the process to develop the application and proposed NARCH itself, and the past and future efforts to increase the capacity of the partners, to improve their partnership, and to contribute to the success of the NARCH. IHS and NIGMS recognize that tribes, tribal-based organizations, and research intensive institutions are diverse in their mission, their health and economic statuses, and their cultures. Therefore, the NARCH application should assess the benefits of its activities on specific, measurable outcomes identified in the application. It is expected that each proposed NARCH will implement various strategies for determining the initial and ongoing success of their efforts for organizational development. Such strategies might include a self-study by the proposed NARCH and its partners, which focuses on fact-finding, program evaluation, and recommendations for improvement in key areas. Guidance and suggestions for such program evaluation of a proposed NARCH can be obtained from http://www.faseb.org/aps/educatn/promote/evaltips.html. Research Projects NARCH applications may include a maximum of five (5) research projects and a maximum of five (5) pilot research projects. Unlike regular research projects, a pilot research project is limited in scope and is not expected to have preliminary data. It is also limited to a budget of less than $35,000 per year for three years. The pilot research project is intended for faculty without current research support. Support for faculty participating in pilot research projects is preparatory to seeking more substantial funding from NIH research grant programs (e.g., Academic Research Enhancement Award [AREA], K, and R01 awards), as well as funding from other agencies and private sources. Funds received from the proposed NARCH to support pilot research projects may not be used to supplement ongoing research projects. A NARCH application need not include both research projects and pilot research projects. Applications for only pilot research projects or for only research projects may be submitted. Individual project investigators may propose either a research project or a pilot research project, but not both. In addition, the NARCH application must show that each participating investigator has the need, based on institutional, departmental, and professional development plans to develop or enhance his/her research knowledge, skills, and capabilities by engaging in the proposed research program and associated activities. Research projects (including pilot research projects) proposed under this initiative must be in research areas normally funded by any of the National Institutes of Health. Research projects addressing health disparities are especially encouraged. A listing of grants recently funded by NIH may be found at CRISP (Computer Retrieval of Information on Scientific Projects), a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions. It may be accessed at http://crisp.cit.nih.gov/. Each research project or pilot research project should follow the instructions provided in PHS 398 (Rev. 4/98) for preparing research grant applications. The application must clearly describe how the proposed research plan will meet both the individual"s professional development goals, and the three purposes of the NARCH initiative: to reduce health disparities, to develop a cadre of American Indian scientists and health professionals, and to enhance the partnership of the proposed NARCH. The professional development goals must clearly describe specific objectives and milestones. The goals should include, but are not limited to, improving competitiveness in winning grant support, and should describe how successful completion of the proposed research project will improve research skills, thus contributing to the overall goals and specific measurable objectives of the proposed NARCH. Each research project or pilot research project must follow the IHS policy concerning tribal approval, that all research involving American Indian tribes be approved by the tribal governments with jurisdiction. That is, each project that involves people or community[ies] of an American Indian or Alaska Native tribe, or an eligible non-profit organization, must include a resolution of approval from the tribal government[s], or (if applicable) a letter of support signed by the director of the eligible Native American organization, or both (if applicable). Student Development Projects If student development projects are proposed, the NARCH application should describe new programs, modifications, or additions to existing programs of the partners, that encourage and facilitate American Indian students to enter, advance, and remain in research careers. Such projects might include, but are not limited to, providing employment as research assistants in research projects of research active mentors, providing workshops to improve technical or communication skills, providing motivating seminars or journal clubs highlighting problems of interest to students, providing contact with role models, and providing opportunities to travel to present results at national scientific meetings. If research apprenticeships are proposed, the application should clearly document the experience, proposed commitment, and quality of the mentors in providing guidance and advice to students (including responsible conduct of research and research integrity, teaching, and protection of human subjects), and in fostering the development of academic and community-based American Indian researchers. The application must have an evaluation plan for the project(s) that indicates the anticipated outcomes relative to the current baseline data. For example, one outcome might be the improved retention of students in science majors. The application should indicate the anticipated (quantitative) improvement relative to the current retention rate. The application must clearly describe how the development plans for students will meet both the individual"s professional development goals, and one purpose of the NARCH initiative: to develop a cadre of American Indian scientists and health professionals. Faculty Development Projects If faculty development projects are proposed, the NARCH application should describe the need, proposed activity, and anticipated outcomes. Faculty development projects might include, but are not limited to, short-term mentored research experiences in the lab of an active NIH-funded researcher, attendance at workshops or courses or national meetings needed for acquiring specific skills or methodologies needed for prospective research. As with student development projects, the quality of the proposed interactions must be documented and the application must have an evaluation plan for the project. Release time for preparing proposals or mini-research projects, not reviewed as pilot projects, is not allowed. The application must clearly describe how the development plans for faculty will meet both the individual"s professional development goals, and two purposes of the NARCH initiative: to develop a cadre of American Indian scientists and health professionals, and to enhance the partnership of the proposed NARCH. ALLOWABLE COSTS Administrative Costs Certain administrative costs for managing a comprehensive program are allowable and may vary, depending upon the size and complexity of the program"s activities. The costs budgeted for NARCH grants and subcontracts may not duplicate items already budgeted in other cost centers of the Native American, research intensive, and subcontracted organizations and institutions, such as accounts which make up the Facilities and Administration (F&A) cost pool. The grantee organization receiving the award must be prepared to provide documentation showing the direct relationship of proposed costs to the program and that costs of this type are charged in a uniform manner to all other grants at all institutions and organizations participating in the award. Salary (up to 25 percent, although it should generally be less) for the NARCH Program Director is allowable for that portion of time or effort specifically employed in directing the proposed NARCH. (The 25% limit does not include salary for being a research investigator.) Limited salary support for secretarial or clerical help is allowable only when in direct support of the proposed NARCH. For guidance, applicants should refer to the OMB Circular appropriate for them, A-87 (Cost Principles for State, Local, and Indian Tribal Governments, http://www.whitehouse.gov/OMB/circulars/a087/a087-all.html) or A-122 (Cost Principles for Non-Profit Organizations, http://www.whitehouse.gov/OMB/circulars/a122/a122.html), or should contact the grants management officer under INQUIRIES. Costs for evaluation activities are allowable, as are costs for the Community and Scientific Advisory Council. All applications must include costs associated with one annual meeting per year in Rockville, MD, of NARCH directors and their key scientific personnel. Research Project Costs Direct costs associated with research and pilot research projects are allowable when adequate justification is provided. These include faculty salaries, reimbursed according to percent effort. Summer salary support can be paid provided the institution"s academic schedule permits such release and when the institution approves. The maximum summer-salary support provided by the program can not exceed the equivalent of two months at 100 percent effort, or time specified by the institution as its policy. Grant funds may not be used to increase or supplement faculty academic year salaries. Salary support for technical assistance and costs for consultants, if justified, are allowable. Costs for equipment to be used to carry out the proposed research are allowable. Costs for multi-user research equipment is allowable. A plan for access to the multi-user equipment, its maintenance, management and use must be included. To aid in the review, it is suggested that a tabular summary show the estimated or actual proportional use of this equipment by each project, and other investigators and students. Justify this core component by discussing ways in which these centralized services improve quality, bring about an economy of effort, and/or save overall costs as compared to their inclusion as part of each research project. Plans to maintain the core facility beyond the grant period should be discussed. Personnel costs to maintain and service the equipment are an allowable cost. Support for very large pieces of equipment, however, may be restricted by the NARCH budget. Costs for supplies, including costs for animals, necessary to carry out the proposed research may be included. Travel costs for the investigator(s) are permitted when direct benefits to the program are expected, and when adequate justification is provided. Alterations and Renovations costs (up to $40,000) are allowable only when essential for conduct of the proposed research. Other permitted costs include animal maintenance (unit care costs and number of care days), donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, and service contracts. Also allowable, when fully justified, are consortium arrangements that may involve personnel costs, supplies, and other allowable costs, including F&A costs. Contractual costs for support services, such as the laboratory testing of biological materials, clinical services, or data processing, are allowable expenses. The intent of pilot research projects is to lead to regular research projects funded as part of the center grant or as freestanding grants. For pilot research projects, applications may request support for up to $35,000 (direct costs) per year for a period of three years, which may be spread over four years. This support is non-renewable. Student Development Costs Student (graduate, undergraduate, and high school) remuneration through salary/wages for participation in research experiences may be requested, provided all the following conditions are met. o The student is performing necessary work. o There is employer-employee relationship between the student and the proposed NARCH or its partners. o The total compensation is reasonable for the work performed. o It is the practice of the proposed NARCH or its partners to provide compensation for all students in similar circumstances, regardless of the source of support for the activity. Graduate students are allowed tuition costs as part of a compensation package. When requesting support for a graduate student, the NARCH application should provide, in the budget justification section of the application, the basis for the compensation level. The IHS staff will review the requested compensation level and, if it is reasonable and justified, will provide compensation up to a maximum of $26,000 (http://grants.nih.gov/grants/guide/notice-files/not98-168.html). Clinical post-doctoral students should be compensated at a rate commensurate with that of other post-doctoral employees at the research intensive institution. It is the expectation of the IHS and NIGMS that students who are enrolled in a Ph.D. program, as part of a proposed NARCH, will not be excluded from support from other non-federal or federal graduate training sources (such as loans and assistance under the Veterans" Adjustment Benefit Act or Pell Grants) for which they are eligible. Graduate and post-doctoral students cannot concurrently hold another federally-sponsored stipend or fellowship or any other federal award that duplicates the NARCH support. Faculty Development Costs Costs to support various activities such as workshops or courses or national meetings needed for acquiring specific skills or methodologies needed for prospective research are allowable. Such costs might include tuition, travel and per diem costs, as well as salary support appropriate to the percent effort needed for the activity. Also, allowable are costs such as travel and per diem associated with short-term research experiences in the laboratory of an active extramurally-funded researcher. Subcontracts The grant recipient may issue subcontracts to other organizations (such as the research intensive institution of the partnership), as long as at least 30% of the grant remains with the Native American organization, that is, no more than 70% may be subcontracted. Unallowable Costs Unallowable costs for research projects (including for pilots projects) include costs for student development, textbooks, journals, memberships, and Internet subscription costs, as well as other costs prohibited by OMB Circulars A-87 or A-122 as applicable. Employees of the applicant organization may not serve as paid consultants. The pilot research project is intended for faculty without current research support. Therefore, investigators with significant current support from other mechanisms such as the R01 and research funding from other extramural sources, are not eligible and the costs therefore are not allowable. Undergraduate tuition, housing, food, or recruitment expenses of any kind are not allowable under the NARCH initiative. Support for textbooks, incentives, memberships, and Internet subscriptions are not allowable. QUALIFICATIONS OF THE NARCH PROGRAM DIRECTOR AND KEY PERSONNEL As leader of the research and research training for the proposed NARCH, the NARCH Program Director is expected to possess certain essential qualifications. One is strong leadership skills, including scientific leadership experience and a strong academic and scientific background, as exemplified, ideally, by scientific publications and a record of peer-reviewed scientific support. Another is the knowledge of and personal working relationship with the Native American tribes or communities involved in the NARCH research, and with the partners of the proposed NARCH. Another is strong mentoring and supervision skills, to exercise responsibility for mentoring activities, organization of communicating skills programs, special methods workshops, tracking of student career plans, etc. In addition, the NARCH Program Director should have knowledge of IHS and NIH policies, including those concerning human participants in research, human biological material, animals, hazardous materials, and tribal review and approval of research. The names and qualifications of the NARCH Program Director, the directors of individual projects within the program (where appropriate), and any other key personnel, shall be listed in the application under Key Personnel, and their Biographical Sketches including other support should be included. REVIEW CONSIDERATIONS Upon receipt, IHS and NIH staff will administratively review applications for completeness and responsiveness. Applications that are incomplete, non-responsive to this RFA, or do not follow the guidelines of the PHS form 398 (Rev 4/98) or of supplemental instructions, will be returned to the applicant without further consideration. Applications will be evaluated in accordance with the criteria stated below for scientific and technical merit by appropriate peer review groups convened by the CSR. The National Advisory General Medical Sciences Council will provide the second level of review. Overall Review of the NARCH In reviewing the overall program, the initial scientific review group will examine evidence of the partners" commitment to the purposes of the NARCH initiative: to encourage competitive research linked to reducing health disparities, to develop a cadre of American Indian scientists and health professionals engaged in biomedical, clinical, and behavioral research that is competitive to NIH funding, and to increase the capacity of both research intensive institutions and American Indian organizations to work in partnership to reduce distrust by American Indian communities and people toward research. The evidence will include: o the quality of the partnership of the institutional and community partners, and the quality of the involvement of the Community and Scientific Advisory Council, as demonstrated by documentation of (for instance): the intellectual and tangible contributions and activities of the partners, and of the Council, in developing the application and the proposed NARCH, the interactions of the partners, and of the members of the Council, in meetings (such as those to develop the application and proposed NARCH), the past activities and future plans to increase the capacity of the partners and of the Council, the plans for future contributions and activities by the partners, and by the Council, in furthering the goals of the proposed NARCH, and the plans for future development of the partnership itself, o the experience and commitment of the institutional and community partners to recruit, retain, and advance Native American faculty and students, to support faculty and student research efforts, and to increase the role of the involved American Indian communities in the plans of the proposed NARCH, o the appropriateness of the plan for evaluating the impact of the proposed NARCH, including the quality of baseline data and milestones for accomplishments, and a system to track the future course of program participants, and o the potential of the proposed NARCH to be a regional and national resource, including: capacity to provide quality research training and mentoring for integrated promotion and development of American Indian research careers from undergraduate (or if well justified, high school) through post-doctoral levels, attainment of quality research to reduce health disparities, plans for research information dissemination and education activities, and plans for the development of research networks to support the scientific aims of the proposed NARCH. Review of Student and Faculty Development Plans The anticipated effectiveness of the proposed NARCH in making a difference relative to the current base line data (based in part on previous experience of the partners) will be assessed. Factors to be considered include: o the appropriateness of the content, phasing, quality, and duration of the student or faculty development plans in the NARCH application to achieve the scientific development of the faculty, post-doctoral, pre-doctoral, undergraduate, and (if well justified) high school students, o the experience, proposed commitment, and quality of the mentors of the partners in providing guidance and advice to candidates (including responsible conduct of research and research integrity, teaching, and protection of human subjects), and in fostering the development of academic and community-based American Indian researchers. Review of Research Projects The NIH has announced procedures to be used for the review of research grant applications (NIH GUIDE, Volume 26, Number 22, June 27, 1997 or see http://grants.nih.gov/grants/guide/notice-files/not97-010.html). For NARCH applications, the five criteria listed in this announcement will be used for the scientific review of research projects and pilot research projects. The review of research projects and pilot research projects will be the same except that applications for pilot studies may be smaller in scope and would not be expected to have preliminary data. The purposes of the NARCH initiative are: to encourage competitive research that addressed health disparities in the American Indian populations, to develop a cadre of American Indian scientists and health professionals engaged in biomedical and behavioral research, and to increase the formation of partnerships between American Indian and research intensive institutions. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these purposes. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. (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 application acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (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: o The adequacy of plans, if research on human subjects is involved, to include both genders and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. ? The adequacy of the proposed plan to share data, if appropriate. Schedule Letter of Intent Receipt Date: October 1, 2000 Application Receipt Date: December 12, 2000 Peer Review Date: February/March 2001 Council Review: May 2001 Earliest Anticipated Start Date: July 1, 2001 AWARD CRITERIA Priorities for funding will be based on the scientific and technical merit of the application, the assessed potential of investigators in the developmental stages of their careers, and the likelihood that the proposed NARCH can further the purposes of the NARCH initiative. Awards will be made only to organizations with financial management systems and management capabilities that are acceptable under PHS policy. Awards will be administered under the PHS Grants Policy Statement. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Questions on the initiative, especially regarding IHS issues and policies, may be directed to: William L. Freeman, M.D., M.P.H. Research Program, Indian Health Service Twinbrook Metro Plaza, Suite 450 12300 Twinbrook Parkway Rockville, MD 20852-1750 Telephone: (301) 443-0578 FAX: (301) 443-1522 Email: [email protected] Questions on the initiative, especially regarding NIGMS issues and policies, may be directed to: Clifton A. Poodry, Ph.D. Minority Opportunities in Research Division National Institute of General Medical Sciences 45 Center Drive, Suite 2AS.37, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3900 FAX: (301) 480-2753 Email: [email protected] Questions on the review of applications may be directed to: Michael R. Martin, Ph.D. Director, Division of Physiological Systems Center for Scientific Review MSC 7892 Room 6160 6701 Rockledge Drive Bethesda, MD 20892-7892 Telephone: (301) 594-7945 FAX: (301) 480-2065 Email: [email protected] Questions on grants management and fiscal matters may be directed to: Patricia Spotted Horse Grants Management Branch Indian Health Service Twinbrook Metro Plaza, Suite 100 12300 Twinbrook Parkway Rockville, MD 20852-1750 Telephone: (301) 443-5204 FAX: (301) 443-9602 Email: [email protected] AUTHORITY AND REGULATIONS This initiative is described in the Catalog of Federal Domestic Assistance Nos. 93.933 and 93-375. Sections 301(a) and 405 of the Public Health Service Act, as amended authorize these awards, and these are administered under PHS grants policies and Federal Regulations 42 CFR part 52c, 45 CFR part 74, and 45 CFR part 92. See also Senate Appropriations Committee Report, No. 92-316, July 29, 1971, Executive Order 12900 , Educational Excellence for Hispanic Americans February 22, 1994, Executive Order 12876, Historically Black Colleges and Universities, November 1, 1993, and Executive Order 13021, October 21, 1996, and Outline of Work Plan, August 18, 1998, White House Initiative on Tribal Colleges and Universities. Applications are 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, P.L. 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. REFERENCES FOR BACKGROUND INFORMATION Anderson, N.B. Levels of analysis in health science: A framework for integrating sociobehavioral and biomedical research. Annals of the New York Academy of Sciences, 1998, 840, 563-576. Ballantine, B., Ballantine, I. (Eds.), Thomas, D.H., Miller, J., White, R., Nabokov, P., Deloria, P.J. (Text by), Josephy, A.M. (Intro.) The Native Americans: An Illustrated History. Turner Publishing, Inc. Atlanta, GA, 1993. Gazmararian, J.A., Baker, D.W., Williams, M.V., Parker, R.M., Scott, T.L., Green, D.C., Fehrenbach, S.N., Ren, J. & Koplan, J.P. Health literacy among Medicare enrollees in a managed care organization. Journal of the American Medical Association, 1999, 281, 545-551. Freeman, W.L. The role of community in research with stored tissue samples. Weir R (Ed.) Stored tissue samples: Ethical, legal, and public policy implications. University Iowa Press. Iowa City, IA, 1998, 267-301. Haynes, M.A. & Smedley, B.D. (Eds.) The Unequal Burden of Cancer: An Assessment of NIH Programs for Ethnic Minorities and the Medically Underserved. Institute of Medicine. National Academy Press. Washington, DC, 1999. Macaulay, A.C., Commanda, L.E., Freeman, W.L., Gibson, N., McCabe, M.L., Robbins, C.M., & Twohig, P.L., (for the) North American Primary Care Research Group. Participatory research maximises community and lay involvement. British Medical Journal, 1999, 319, 774-778. Minority Economic Profiles. U.S. Bureau of the Census, Population Division. Issued July 24, 1992. (Tables 1990 CPH -L- 92, 93, 94 and 95). NIH Publication 98-4247. Women of Color Health Data Book. Office of Research On Women"s Health, Office of the Director, National Institutes of Health, 1998. 1997 Trends in Indian Health. Division of Community and Environmental Health, Office of Public Health, Indian Health Service, 1998. Regional Differences in Indian Health 1998-99. Division of Community and Environmental Health, Office of Public Health, Indian Health Service, 2000. Weiss, B.D., Reed, R.L., & Kligman, E.W. Literary skills and communication methods of low-income older persons. Patient Education and Counseling, 1995, 25, 109-119. Williams, D.R. & Collins, C. US Socioeconomic and Racial Differences in Health: Patterns and Explanations. Annual Review of Sociology, 1995, 21:349-386. Williams, M.V., Parker, R.M., Baker, D.W., Parikh, N.S., Pitkin, K., Coates, W.C., & Nurss, J.R. Inadequate functional health literacy among patients at two public hospitals. Journal of the American Medical Association, 1995, 274, 1677-1682.
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