Full Text ES-96-005 COMMUNITY BASED PREVENTION/INTERVENTION RESEARCH IN ENVIRONMENTAL HEALTH SCIENCES NIH GUIDE, Volume 25, Number 7, March 8, 1996 RFA: ES-96-005 P.T. 34 Keywords: Community/Outreach Programs Disease Control+ Disease Prevention+ National Institute of Environmental Health Sciences National Institute of Nursing Research Office of Behavioral and Social Sciences Research Letter of Intent Receipt Date: April 8, 1996 Application Receipt Date: June 11, 1996 PURPOSE The National Institute of Environmental Health Sciences (NIEHS), the National Institute of Nursing Research (NINR), and the Office of Behavioral and Social Sciences Research (OBSSR) invite research grant applications addressing development of community based strategies aimed at prevention and intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. The purpose of awards in this program of Community Based Prevention/Intervention Research in Environmental Health Sciences is to: o Stimulate further advances in the design and implementation of prevention and intervention methods that are appropriately applied to environmental health. o Develop community based public health research approaches to diseases and health conditions having an environmentally related etiology and determine the impact of these methods. o Bridge the gaps between basic and clinical research in environmental health and nursing sciences as well as gaps between institutional researchers and community members. The long range goal of this program is to improve the knowledge and behavior of disadvantaged or underserved community members regarding prevention, detection, and treatment of environmentally related diseases and health conditions, and thereby reduce incidence and mortality rates of such diseases and conditions. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Community Based Prevention/ Intervention Research in Environmental Health Sciences, is related to the priority area of Environmental Health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402 9325 (telephone 202- 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private for profit and nonprofit domestic organizations, such as universities, colleges, hospitals, laboratories, research institutions, units of state or local governments, tribal governments or organizations, and eligible agencies of the federal government. Collaborative applications are invited. Formation of a consortium involving responsible partnership of a research intensive organization institution and an Historically Black College or University, Hispanic College, or Tribal College is particularly encouraged. Among collaborators, one must be designated as the lead applicant and assume responsibility for conduct of the project. Because of the community based nature of this research effort, applicants must describe an existing or proposed involvement with one or more community based organizations in an area having an underserved population adversely impacted by an environmental contaminant (see Objectives and Scope, below). Applications lacking an existing or proposed link to such a community based organization will be considered to be nonresponsive to this RFA. The NIEHS and NINR have a significant commitment to the support of programs designed to increase the number of underrepresented minority and female scientists participating in biomedical and behavioral research. Therefore, applications from minority individuals and women are encouraged. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this program are expected to be $1,875,000 in fiscal year 1996. The actual amount may vary, depending on the response to this RFA and the availability of funds. The anticipated number of awards is five. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research demonstration and dissemination project grant (R18). These grants provide support to develop, test, and evaluate health service activities and to enhance the application or transfer of existing knowledge to efforts designed to prevent or control dysfunction or disease. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Because the nature and scope of research activities proposed in response to this RFA may vary, it is anticipated that the size of an award will also vary. The maximum allowable award is $250,000 in direct costs per year. The total project period requested in an application may not exceed four years. This RFA is a one time solicitation. RESEARCH OBJECTIVES Background The mission of the NIEHS is to define: how environmental exposures affect our health; how individuals differ in their susceptibility to these effects; and how these susceptibilities change with time. According to its broad mandate, the NINR seeks to: reduce the burden of illness and disability by understanding and easing the effects of acute and chronic illness; improve health related quality of life by preventing or delaying the onset of disease; establish better approaches to promoting health and preventing disease; and improve clinical environments by testing interventions that influence health outcomes and reduce costs and demand for health care. The OBSSR provides leadership and direction in increasing the scope and support of research on the role of human behavior and social processes in the promotion of health and prevention of disease. To help reduce the burden of environmentally associated diseases and health conditions, both Institutes must: (1) provide the scientific basis and foundation that is necessary for understanding the impact of the environment on human health; (2) translate this information into prevention and intervention strategies; and (3) communicate this information to the public. The current initiative spans all three of these elements within the missions of the NIEHS and the NINR. Environmental health policy is only as good as the scientific foundation upon which it rests. Recent advances are enabling scientists to develop more detailed and meaningful insights into the effects of environmental agents on basic cellular processes. This knowledge in turn can be used to cultivate intervention schemes based on an enhanced understanding of molecular mechanisms. In 1992 the NIEHS issued an RFA to develop interventions at the molecular level for diseases with an environmental etiology. That announcement focused on generation and use of molecular biomarkers to assess the effectiveness of intervention strategies. An understanding of the environmental components and basic biology of disorders can lead to prevention and intervention strategies to circumvent adverse health effects. Such strategies can be classified as primary, secondary, or tertiary prevention. Traditionally, most approaches have focused on primary prevention techniques aimed at intervening before disease arises, such as eliminating or reducing environmental exposures. As our understanding of the molecular and cellular basis of environmentally associated diseases increases, secondary prevention and intervention techniques can be developed to diagnose and treat people exposed to an environmental contaminant. These molecular intervention techniques, such as early detection screening, rely on manipulation of underlying biological mechanisms, e.g., activation/inactivation of particular genes, enzymes, or receptors. These methods may be especially useful in dealing with environmental exposures that are ubiquitous or difficult to eliminate. Tertiary prevention measures seek to limit injury and disability in people already affected by a specific disease process. Prevention and intervention schemes must also take into account the social and cultural lifestyle and behavioral factors that contribute to environmentally associated disorders. It is part of the responsibility of the NIEHS and the NINR to provide the scientific underpinning that can delineate the contribution of societal and cultural behaviors in development of these disorders. The cultural diversity inherent within various racial/ethnic groups has generally been overlooked by investigators conducting prevention research. Thus, there is a critical need to address diverse, culturally relevant contexts and disease etiologies in environmental health. The present RFA seeks to implement culturally relevant prevention/intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. Research efforts to identify the sources and effects of hazardous environmental exposures among underserved populations have been insufficient. Little is known about the types of environmental agents to which members of such groups are exposed, both at home and at work. Members of economically disadvantaged and/or underserved populations suffer disproportionate levels of morbidity and mortality. Additionally, they are most often the populations with the highest degree of exposure to environmental agents and are frequently the populations with the least information available as to the health consequences of such exposure. Factors such as malnutrition, health status, and socioeconomic status, in combination with behaviors such as smoking, alcohol consumption, and drug use may significantly influence the dose response, metabolism, and health effects of hazardous substances. Geographic location may also play a role in determining the degree and effect of environmental exposure among socioeconomically disadvantaged populations. For example, inner city residents often live in homes with high lead levels and are exposed to higher levels of air pollution. Toxic waste sites, nuclear facilities, and chemical plants are often located in rural areas. More effort must be devoted to identifying disadvantaged populations having high levels of exposure to environmental hazards and to generating prevention and intervention strategies to mitigate the health effects of these hazards. The current announcement is intended not only to foster additional refinement of intervention methods but also to strengthen the participation of affected communities in this effort. Given the complexity and magnitude of environmental health problems, research endeavors aimed at improving our knowledge of and ability to resolve these issues can benefit from establishing collaborative relationships with the communities experiencing these problems. Such community research partnerships have benefits for both the researcher and the community. These partnerships can, for example, facilitate the definition of important environmental issues and concerns, the development of measurement instruments that are culturally appropriate, and the establishment of trust that will enrich the value of data collected. This scheme emphasizes the involvement of community members throughout the research process, from development of research questions to interpretation, application, and dissemination of results. Only through realization of this final leg of the NIEHS mission, i.e., communication and partnership formation, can we ensure that research findings reach and are made relevant to affected individuals and communities. Objectives and Scope This RFA will support research activities that develop and implement improved prevention and intervention strategies related to environmental health that are designed to include community based, culturally appropriate approaches applicable to underserved populations. Community based prevention/intervention research seeks to expand our knowledge and understanding of the potential causes and remedies of environmentally related disorders, while at the same time enhancing the capacity of communities to participate in the processes that shape research approaches and intervention strategies. Community based research is thus more than just a community placed outreach activity. These research projects are community driven and responsive so as to maximize the potential for change in knowledge, attitudes, and behavior. They are conducted in a manner that reinforces collaboration between community members and research institutions. Relevant results from these projects are disseminated to the community in clear, useful terms. Moreover, these studies are designed to be culturally appropriate, i.e., due consideration is given to the social, economic, and cultural conditions that influence health status. Identifying and incorporating unique cultural factors into intervention strategies may result in increased acceptability, use, and adherence. Each application should develop a comprehensive, strategic plan with time schedules and milestones to address all key aspects. This plan should include: o Identification of target community. Population(s) should be clearly identified, community boundaries described, and known environmental health hazards delineated. o Community collaboration. How will communication and regular exchange of information and ideas between community members and institutional researchers be initiated and enhanced? How are productive relationships with local representatives established and maintained? How are local organizations and leaders recruited? What are the mechanisms for communities to identify their environmental health needs? How will activities be designed to meet these needs? How will findings be disseminated within the community? o Research program definition and implementation. A variety of research designs may be proposed. Primary, secondary, or tertiary prevention strategies may be included. Interventions should be based on appropriate behavioral and scientific theories. They should also be built on the results of previous methods shown to be efficacious in changing risk factors related to knowledge, attitudes, and behaviors. Interventions should use multiple, culturally sensitive, community based approaches and be adapted to the special needs of underserved populations. o Evaluation. Both outcome and process evaluations should take place. Only projects having well developed, comprehensive evaluation plans will be supported. The application must include detailed descriptions of process and outcome evaluation, specify the measures and instruments for data collection, and indicate a time frame for conducting all evaluation activities. Experimental design is not restricted by this RFA. Applicants should develop their own independent design and provide appropriate justification. Designs should focus on an integrated approach employing various culturally appropriate factors that have been previously shown to be effective. It is important that the study population be clearly identified and that community involvement in developing the design be demonstrated. An experimental design with a defined hypothesis is the preferred approach. A randomized design, comparing specially constructed interventions against usual and customary conditions, would be one appropriate study design to test intervention models. Other designs may also be considered responsive. Elements that may be considered in assembling a research design include sampling procedures, instrumentation and measurement, data collection, quality control, recruitment, retention, tracking and follow up, and data analysis. State of the art econometric techniques for measuring cost effectiveness of prevention efforts may also be included. Applicants are encouraged to test and compare multiple innovative strategies and to assess their relative effectiveness. In community based research, active cooperation and participation of organizations within the community(ies) that is (are) the focus of the study are essential components of the research. Hence, applicants must describe an existing or proposed involvement with one or more community based organizations in an area having an underserved population adversely impacted by an environmental contaminant. This connection is essential to the development of community based approaches and should also enhance the potential for long term impact of the project. Community input is most meaningful and best utilized if it is built into the research process from the outset. Community representatives should be given a voice in choosing research topics, developing the application, collecting data, and interpreting results. Involvement of an Historically Black College or University, Hispanic College, or Tribal College and/or recruitment of staff from the community may be appropriate. However, such efforts will not substitute for direct involvement of a community based organization. Applications lacking an existing or proposed link to a community based organization will be considered to be nonresponsive to this RFA. SPECIAL REQUIREMENTS Annual meetings, to be held in Research Triangle Park, NC, are planned for the exchange of information among investigators. Applicants must budget travel costs associated with these meetings in their applications. Since projects may include behavioral based prevention/intervention strategies as part of their methodology, the Office of Behavioral and Social Sciences Research will contribute to this initiative by co-sponsoring these conferences. In addition, since these projects are community based and embrace both research demonstration and dissemination, applicants are expected to maximize opportunities for information exchange between institutional researchers and community members. As part of this program, applicants must generate a report that describes community input, program implementation, and relevant findings. This report must be produced at least annually and distributed among community members in such a way that it can be easily comprehended by the public. Applicants must budget for production and dissemination of such reports. This requirement is intended to establish a minimal level of communication among project participants; additional, more frequent dissemination efforts may be appropriate. Relationship to Environmental Justice Activities conducted under this RFA should be consistent with Federal Executive Order No. 12898 entitled, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations. To the extent practicable and permitted by law, grantees shall make achieving environmental justice part of their project s mission by identifying and addressing, as appropriate, disproportionately high and adverse human health effects of environmental contaminants on minority and low income populations. The current RFA builds upon the framework established by the separate NIEHS grant program entitled Environmental Justice: Partnerships for Communication. That program, initiated in 1993, supports outreach, training, and education efforts that will become the catalyst for reducing exposure to environmental pollutants in underserved populations. Its main objective is to establish methods for linking members of a community, who are directly affected by adverse environmental conditions, with environmental health researchers and health care providers. This endeavor will help to ensure that the community is aware of basic environmental health concepts and that they have a role in defining problems and shaping approaches to their solution. The present RFA differs from the Environmental Justice grant program in that the former is a scientific research demonstration and dissemination project, whereas the latter is an education project. Thus, this RFA is intended to support specific, rigorous, scientific research projects that develop and implement community based, culturally appropriate prevention/intervention strategies in underserved communities. The Environmental Justice program supports education projects that enhance the flow of information and communication among scientists, health care providers, and community members. Although these programs are complementary, it is important to differentiate the substantial research orientation of this RFA from the educational goal of the Environmental Justice program. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103 43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. 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 58 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections A D of the Research Plan and summarized in Section E, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned to the applicant. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are requested to submit, by April 8, 1996, a letter of intent that includes a descriptive title of the proposed project, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. The letter of intent influences neither review nor funding decisions, but it is helpful to NIEHS staff in planning the review process, e.g., in estimating workload and avoiding conflict of interest. Letters of intent are to be directed to: Allen Dearry, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences P.O. Box 12233, MD 3-04 111 T.W. Alexander Drive Research Triangle Park, NC 27709 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office 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 RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express.courier service) At the time of submission, two additional copies of the application must be sent to: Ethel Jackson, D.D.S. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 17 09 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Applications must be received by June 11, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. All human and animal welfare as well as misconduct assurances must be complete for a proposal to be reviewed. All follow up assurances and approvals submitted as pending must be received within 60 days of the application receipt deadline or the application will not be reviewed. The following is the schedule planned for this initiative. It should be noted that this schedule may be changed without notification due to factors that were unanticipated at the time of the RFA. Contact the program official listed under INQUIRIES regarding any changes in the schedule. Letter of Intent Receipt Date: April 8, 1996 Application Receipt Deadline: June 11, 1996 Initial Scientific Review: July 1996 Advisory Council Review: September 1996 Anticipated Date of Funding: September 30, 1996 REVIEW CONSIDERATIONS Review will be carried out by the Scientific Review Branch, Division of Extramural Research and Training, NIEHS. Upon receipt, applications will be screened for completeness by staff of the DRG and for responsiveness to the RFA by staff of the NIEHS. Those applications that are incomplete or nonresponsive will be returned to the applicant without review. Complete and responsive applications will be reviewed by either the Environmental Health Sciences Review Committee or a special review committee impaneled by the Scientific Review Branch. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Environmental Health Sciences Council and/or the National Advisory Council for Nursing Research. The major review factors listed below will be used in evaluation of applications for this RFA: o Scientific, technical, or clinical significance, merit, and originality of the proposed research. o Appropriateness, adequacy, and feasibility of the proposed approach and methodology. If applicable, sample size, recruitment, and retention plans should be discussed. Extent to which the design demonstrates sensitivity to cultural and socioeconomic factors in the community. o Extent of community sanction/liaison. Rationale for selection of the targeted population and documentation of environmental health needs and risk factors. Evidence of access to, interaction with, and participation of community members and community leaders in development and conduct of the project. Establishment of collaborative interactions among all project participants. Demonstration of effective communication channels between researchers and community members. Plans for useful and practical dissemination of project activities and findings within the affected community(ies). Active involvement of at least one community based organization is a minimal requirement for responsiveness to this RFA. o Qualifications and experience of the principal investigator and staff. Personnel should demonstrate knowledge of the needs of their target audience. o Strength of institutional commitment as evidenced by provision of resources, services, technical support, and allocation of space necessary to perform the research. o Appropriateness of proposed budget and duration in relation to the project's objectives. o Adequacy, appropriateness, feasibility, and comprehensiveness of the evaluation plan, including sufficient allocation of resources. o Feasibility of plans for independently continuing the program. Evidence of continuing commitment on the part of the proposing institution(s). The potential long term impact of the proposed project is especially important. o The initial review group will also examine provisions for protection of human subjects. AWARD CRITERIA The following will be considered in making funding decisions: o Merit of the application as determined by peer review. o Availability of funds. o Program balance among research areas of the NIEHS and the NINR. INQUIRIES NIEHS and NINR staff welcome the opportunity to clarify any issues or questions from potential applicants. Written and/or telephone inquiries concerning the objectives, scope, and application procedures for this RFA or inquiries about whether or not specific proposals would be responsive are encouraged and may be directed to: Allen Dearry, Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 3 04 Research Triangle Park, NC 27709 Telephone: (919) 541 4500 FAX: (919) 541 2843 Email: [email protected] J. Taylor Harden, Ph.D. Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN 12 45 Center Drive, MSC 6300 Bethesda, MD 20892 6300 Telephone: (301) 594 5976 FAX: (301) 480 8260 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Carolyn Winters Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD 2 01 Research Triangle Park, NC 27709 Telephone: (919) 541 7823 FAX: (919) 541 2860 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.113, 93.114 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 100 607) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. The program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke free workplace and promote the non use of all tobacco products. In addition, Public Law 103 227, the Pro Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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