Full Text ES-96-008 COMMUNITY-BASED PREVENTION/INTERVENTION RESEARCH IN EHS NIH GUIDE, Volume 25, Number 39, November 15, 1996 RFA: ES-96-008 P.T. 34 Keywords: Community/Outreach Programs Disease Prevention+ Environmental Health National Institute of Environmental Health Sciences Office of Behavioral and Social Sciences Research Letter of Intent Receipt Date: December 10, 1996 Application Receipt Date: February 11, 1997 PURPOSE The National Institute of Environmental Health Sciences (NIEHS)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 science 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325 (telephone 202-783-3238). 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 health science center and an institution serving an economically disadvantaged community 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 has a significant commitment to the support of programs designed to increase participation of individuals from economically disadvantaged communities in biomedical and behavioral research. Therefore, applications from such individuals are encouraged. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this program are expected to be $1,500,000 in fiscal year 1997. The actual amount may vary, depending on the response to this announcement and the availability of funds. The anticipated number of awards is four. Although this program is provided for in the financial plans of the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the award will be contingent upon satisfactory progress and fulfillment of the Special Requirements (see below) during the preceding year and availability of funds. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory research project grant (R21) mechanism. These grants provide support to develop new research activities in categorical program areas, e.g., prevention/intervention research. 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. Indirect costs will be paid at the approved indirect cost rate for the applicant organization less appropriate exclusions. The total project period for an application may not exceed four years. This RFA is a one-time solicitation. REANNOUNCEMENT AND REVISED APPLICATIONS This RFA, ES-96-008, is a reannouncement of RFA ES-96-005. An applicant who responded to the original RFA but did not receive an award may submit a revised application based on criticisms contained in the summary statement. Applicants interested in submitting such a revised application are urged to read the appropriate instructions on page IV-5 of the PHS 398 and to contact program staff listed under INQUIRIES. 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. 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 agencies 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 OBSSR. 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 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 (see below). 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. Research 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 in an experimental cohort against usual and customary conditions in a control cohort, would be an appropriate study design to test intervention models. Other designs may also be considered responsive. Elements that should be considered in assembling such a research design include: o Conceptual framework. o Sampling procedures. o Instrumentation and measurement. o Data collection. o Quality control and process evaluation. o Recruitment, retention, tracking, and follow-up. o Data analysis, statistical methods, and power considerations. 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. Strengths of this approach are its incorporation of local knowledge and beliefs and the possibility of positioning local people as owners and implementors of the intervention. The result should be an intervention tailored to the specific concerns, needs, and interests of the local community. 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. For this reason, 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, 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 announcement 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 socioeconomically disadvantaged or 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 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. STUDY POPULATIONS 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 9, 1994 (FR 58 11146-11151) 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, it 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 December 10, 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 should be directed to: Allen Dearry, Ph.D. Chemical Exposures and Molecular Biology Branch Division of Extramural Research and Training 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: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the 5/95 revision of the PHS 398 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 two 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. Chief, Scientific Review Branch Division of Extramural Research & 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 February 11, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this 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 (see REANNOUNCEMENT AND REVISED APPLICATIONS above). 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 30 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 announcement. Please contact the program official listed below regarding any changes in the schedule. RFA Announcement: November 8, 1996 Receipt of Letters of Intent: December 10, 1996 Application Receipt Deadline: February 11, 1997 Initial Scientific Review: March, 1997 Advisory Council Review: May, 1997 Funding: July, 1997 REVIEW CONSIDERATIONS Review will be carried out by the Scientific Review Branch, Division of Extramural Research and Training. 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 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. INQUIRIES NIEHS staff welcome the opportunity to clarify any issues or questions from potential applicants. Written or telephone inquiries concerning the objectives, scope, application procedures, and submission of revised applications for this RFA or inquiries about whether or not specific proposals would be responsive are encouraged and should be directed to the following: Allen Dearry, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences Division of Extramural Research and Training P.O. Box 12233, MD 3-04 Research Triangle Park, NC 27709 Telephone: (919) 541-4500 FAX: (919) 541-4937 or (919) 541-2843 E-mail: DEARRY@NIEHS.NIH.GOV Questions of an administrative or fiscal nature not directly related to the programmatic aspects of this RFA should be directed to the Grants Management Branch official listed below: Ms. Carolyn Winters Grants Management Specialist Grants Management Branch National Institute of Environmental Health Sciences Division of Extramural Research and Training P.O. Box 12233, MD 2-01 Research Triangle Park, NC 27709 Telephone: (919) 541-7823 FAX: (919) 541-2860 E-mail: WINTERS@NIEHS.NIH.GOV 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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