ENVIRONMENTAL JUSTICE: PARTNERSHIPS FOR COMMUNICATION RELEASE DATE: April 22, 2003 RFA NUMBER: ES-03-007 National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute for Occupational Safety and Health (NIOSH) (http://www.cdc.gov/niosh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.113, 93.114, 93.115 (NIEHS), and 93.956 (NIOSH) Letter of Intent Receipt Date: September 17, 2003 Application Receipt Date: October 17, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this program is to strengthen the National Institute of Environmental Health Sciences' (NIEHS) and the National Institute for Occupational Safety and Health's (NIOSH) support of research aimed at achieving environmental justice for socioeconomically disadvantaged and medically underserved populations in the United States. One goal of the NIEHS and NIOSH is to understand the influence of economic and social factors on the health status of individuals exposed to environmental toxicants and occupational hazards and impact public health. The intent is to promote health research, education and intervention programs that address improved ways to serve low income, immigrant, and minorities who may be disproportionately exposed to environmental and occupational stressors. This component of the research program in environmental justice is designed to encourage community outreach, training, research, education and evaluation efforts that will become the catalyst for reducing exposure to or reducing the health impact from environmental and occupational stressors in underserved populations. The main objective of this RFA is to establish methods for linking members of a community, who are directly affected by adverse environmental or occupational conditions, with researchers and health care providers and to create partnerships that can address environmental and occupational health problems and develop appropriate research and policy strategies to impact public health. With the intention of impacting public health and policy the National Institute of Environmental Health Sciences established the Translational Research Program. This effort supports research and education examining the effects and risks to human health from exposure to physical and social environmental agents. The Environmental Justice agenda, which falls within the Translational Research Program, is one such endeavor that seeks to minimize and prevent adverse health effects from environmental exposures through public outreach and education coupled with innovative research to develop solutions and have significant impact on public health and policy. For further information on the Translational Research Program, see http://www.niehs.nih.gov/translat/envjust/envjust.htm. This current effort on environmental justice will ensure that: o The community is aware of basic environmental/occupational health concepts, issues, and resources. o The community has a role in identifying and defining problems and risks related to environmental and occupational exposures and stressors. o The community is included in the dialogue and is integral in shaping research and policy approaches to the problem. o The community actively participates with researchers and health care providers in developing responses and setting priorities for education and intervention strategies. One aim of this program is to facilitate the process of developing the trust needed for establishing effective partnerships among individuals who are adversely impacted by environmental and occupational hazard(s) in a socioeconomically disadvantaged community, researchers in environmental/occupational health, and health care providers. The collaborative team should then be able to initiate a research program that incorporates all parties and seek to reduce exposure to or health impact from environmental and occupational stressors that may manifest in the workplace or home environment. It is important to note that, because of the wide range of environmental and/or occupational health problems to be addressed and the diversity of affected communities, applications must be multidisciplinary in nature. At least one member of each of the following three personnel groups must have an active and meaningful role in both the development of the application and conduct of the proposed project: o A research scientist in environmental health sciences (including but not limited to those at NIEHS Environmental Health Sciences Centers or NIEHS Centers for Children's Environmental Health and Disease Prevention Research or NIOSH Educational and Research Centers or Agricultural Research Centers). o A primary health care provider directly involved in a community affected by environmental or occupational hazard(s). This may include a public health nurse and other such professionals. This individual must have a record of providing health care to the participating community. It is not necessary that the person be affiliated with a county or state public health department. o A community-based organization (CBO) in an area having an underserved population that is adversely affected by an environmental or occupational hazard. This CBO must work directly and regularly with the affected community. These personnel must be listed on Page 2 of the PHS 398 application, and a biographical sketch must be provided for each. The role of each member of these three personnel groups in developing the application and carrying out the project must be clearly identified and fully described. There should be an equitable distribution of responsibilities as well as of requested financial resources among the three personnel groups. This goal is often accomplished through the inclusion of one or more subcontract arrangements, which may be helpful in defining all parties' programmatic and budgetary roles. Applications lacking the required personnel will not be considered. The NIEHS and NIOSH have a significant commitment to the support of programs designed to increase the number of underrepresented minority and female scientists participating in biomedical, environmental, and behavioral research. Therefore, applications from minority individuals and women are encouraged. Since the projects are situated in the community, well-established community-based or faith-based organizations are encouraged to consider their capacity to serve as the primary applicant organization. Due to the complex administrative, programmatic, and financial responsibilities associated with this role, such groups should contact Program Staff listed under WHERE TO SEND INQUIRIES for guidance. RESEARCH OBJECTIVES Background Generally, people want to live long and healthy lives, and a majority of them achieve that goal. However, people who are economically disadvantaged and/or who live or work in areas and occupations where conditions result in greater exposure to hazardous substances are less likely to do so. At every stage of life, these persons suffer disproportionate levels of morbidity and mortality. Research evidence suggests that certain groups, especially minorities and low-income communities, bear an uneven burden of hazardous environmental or occupational stressors. These socioeconomically disadvantaged people suffer the lowest life expectancy and the highest adverse health consequences of inadequate access to high quality health care. Additionally, they most often experience the highest degree of exposure to environmental agents and frequently have the least information available about the health consequences of exposure to these agents. Environmental justice refers to the need to remedy the unequal burden of exposure and disease borne by socioeconomically disadvantaged persons in terms of residential exposure to greater than acceptable levels of environmental pollution, exposure to occupational hazards, and fewer civic benefits such as sewage and water treatment. Geographic location plays an important role in environmental exposure of socioeconomically disadvantaged persons. Health problems may be exacerbated by issues relating to geographic location and consequences of the built environment such as the lack of consistent planning and negligent or unregulated policies in land use and zoning, the development and expansion of highways near low income and indigent neighborhoods or inadequate transportation facilities. A specific under-addressed area of interest to NIEHS is the public health challenge arising from the health impact of the built environment. For information on the built environment, see http://www.niehs.nih.gov/translat/news.htm. The lack of resources for early identification of the effects of toxic agents may lead to an increased disease burden among people who are economically least able to cope with it. Most complex chronic health conditions or diseases have an environmental component in their etiology. An amalgamation of factors result in exacerbating the health conditions for low income and minority populations. Many low-income workers are temporary employees or may be employed in substandard workplaces and therefore may receive inadequate workplace protections and occupational health and safety training programs. These workers may also face language or cultural barriers at the workplace. When this is the case, the community rather than the workplace may be the preferable place to reach these workers to conduct occupational health outreach and intervention programs. For more information about occupational health priorities see http://www.cdc.gov/niosh/nora.html. Some of the issues identified by research in the field of environmental and occupational health are: o Inner-city poor often live in homes with high lead levels and may also be exposed to higher levels of air pollution. o Toxic waste sites are more frequent in rural, low socioeconomic counties in the United States. o Nuclear facilities and chemical plants are often located in rural areas. o Exposure to pesticides is another example where rural, socioeconomically disadvantaged populations are at a greater than average risk. o Disadvantaged neighborhoods may rely on well water that may be polluted with toxic chemicals. o Medical care is often inadequate or unavailable to a significant proportion of the socioeconomically disadvantaged and minority people. o Lead poisoning and the cognitive and developmental damage associated with exposure to lead occur disproportionately among minorities. o High blood pressure and prostate cancer are very common among African Americans. o Low birth weight babies and other problems during pregnancy are common among groups of women who do not have access to good prenatal care. o Minority and immigrant workers are employed disproportionately in industries with higher injury and illness rates, such as food processing, textile and garment manufacturing, services including health care services, construction and agriculture. o Both African-American and Hispanic workers have been shown to be disproportionately impacted by workplace injuries and fatalities. o Workers exposed to hazardous substances at workplaces with inadequate cleanup facilities can contaminate their homes with toxic substances. Recent Progress and Opportunities Over the past nine years, the NIEHS has supported a variety of environmental justice and community-based participatory research programs. For information on previously funded Environmental Justice projects, see http://www.niehs.nih.gov/translat/envjust/envjust.htm, and for community based participatory research programs, see http://www.niehs.nih.gov/translat/cbpr/cbpr.htm. These programs have been very successful in achieving open and honest communication between researchers and community members and have had an impact on the health of the public. Working together, researchers and community leaders have been successful in identifying the disproportionate environmental health risks in certain communities and have formulated viable research agendas. A needed step in this process is gaining participation of community members in efforts to understand the problem as well as gather preliminary health and exposure data. Ongoing projects within the Environmental Justice: Partnerships for Communication Program are committed to enhancing community participation in research studies and facilitating communication among environmental/occupational health researchers, community health care providers, and community members. Methods utilized in these projects include: o Assessment and/or surveys of environmental/occupational hazard(s). o Community based exposure assessment of environmental pollutants and hazards. o Characterization and evaluation of the distribution and health impact of environmental contaminants and occupational hazards. o Provision of environmental health and toxic exposure training for health care providers. o Development of culturally and linguistically appropriate education and communication materials. o Development and implementation of exposure reduction/pollution prevention strategies. o Evaluation of training and education materials and assessment of policy impact. Objectives and Scope One component of the mission of the NIEHS and the NIOSH is to promote research aimed at achieving environmental justice by identifying and addressing disproportionately high and adverse effects of environmental pollutants and occupational hazards on human health in low income and minority populations. The two main objectives of this program are to: establish methods for linking members of a community, who are directly affected by adverse environmental/occupational conditions, with researchers and health care providers; and enable this partnership to develop appropriate research strategies to address environmental/occupational health problems of concern to impact public health and health policy. Development of such community-based strategies to address these health problems requires approaches that are not typically familiar to environmental, occupational and medical research communities. Customary approaches to risk assessment and management often neglect the knowledge and experience of at risk populations and the socio-cultural context of environmental/occupational hazards. The distinctive needs of individual communities are only rarely considered in identifying environmental or occupational health problems and devising appropriate disease and pollution prevention tactics. In addition, for occupational health a community setting may be the workplace where the social and political dynamics are very different from a residential community setting. Occupational health researchers generally construct their exposure assessments based on observations and measurements in the workplace and/or documents provided by the employers. In the residential community setting many of these exposure sources may be unavailable. Underserved populations are often diverse, fragmented, and isolated, making it difficult to obtain their input and to integrate their concerns in decision-making processes. Assays of the health effects of environmental pollution, as well as regulations based on such assays, are often performed with little or no input from the affected community. The purpose of this program is to institute mechanisms to bridge this communication gap. Once communication and collaboration have been achieved, researchers and community members should then develop a research agenda to identify and assess environmental or occupational risks. Establishing and maintaining trust among all partners is important throughout the process, as it will enhance the capacity to collect preliminary health and exposure data. Since the ultimate goal of this program is to improve health in these populations and reduce the burden of disease, participation of the affected community is essential for both the identification of health risks as well as the effective implementation of policies to reduce exposure. Applicants are therefore expected to create equitable partnerships among researchers in environmental/occupational health, health care providers, and representatives of low income or medically underserved communities affected by environmental health problems. Types of activities that may be proposed include, but are not limited to: o Develop efficacious methods for risk communication in low-income and underserved communities unfavorably impacted by environmental/occupational hazards. o Develop community-based, culturally sensitive educational programs to mitigate adverse health effects from environmental toxicants or occupational hazards in low-income and underserved communities. o Carry out community-based training to increase environmental and/or occupational health literacy, i.e., increase awareness of the public, in such neighborhoods. o Train and educate neighborhood health care professionals in the prevention, diagnosis, and treatment of disorders having an etiology related to exposure to hazardous substances, i.e., increase awareness of health care providers. These providers should have a direct role in assisting a community affected by exposure to an environmental or occupational hazard. o Develop a research agenda to measure population exposure and/or quantify human health impacts. We wish to encourage a broad, comprehensive approach to this problem that emphasizes both education and research. o Include a comprehensive plan to have an ongoing evaluation from the inception of the project to its completion – including but not limited to an assessment of the partnership among various team members and policy and public health impact. o Suggest recommendations for future activities, beyond the period of current funding, to assure continued participation of community members in research and service programs addressing environmental injustices. The following four elements must be included in applications submitted in response to this RFA. Applications lacking any one of the following elements will be considered non-responsive. Potential applicants are strongly encouraged to consult Program Staff listed under WHERE TO SEND INQUIRIES about their capacity to address each of these factors. The required four elements for each application are: o Assessment Plan. Identify means of establishing effective input from an underserved community affected by an environmental/occupational hazard. Applicants are encouraged to create a community-based advisory board or steering committee to facilitate planning, education, outreach, dissemination, and evaluation efforts. Input could be obtained directly from members of a community affected by an environmental toxicant and/or occupational hazard as well as from representatives of such groups as community and neighborhood associations, churches, public housing resident councils, community health centers, local public health service departments, and minority educational institutions. An objective assessment process should be designed to: - Identify priority areas in environmental/occupational health as perceived by community members. - Identify and characterize environmental/occupational stressors of concern. - Develop a consensus among community members about plausible approaches. - Build upon existing experience and knowledge within the community. - Detect any potential constraints in implementing the project. o Implementation Plan. - Develop appropriate education and communication modules. - Develop research, intervention and policy approaches. For example, projects to collect and analyze exposure/health data would be appropriate and are encouraged. - Training/Educational programs in the community and at universities. o Communication and Dissemination Plan. - Methods and process for dissemination within the community. - Method for community members to have a voice that reaches researchers and health care providers. - Policy/regulatory impact of the activities carried by this project. o Evaluation Plan. Evaluation of the project's public health impact should be integral to the project. Both process and outcome measures should be addressed. A procedure must be developed to have an ongoing evaluation of the project, including the usefulness of the project's education, communication and research activities. - Process evaluation, includes, but is not limited to: 1. Assessment of interaction and association among various partners in the project. 2. Assessment of the process of developing and disseminating the education and training information. 3. The degree of capacity building and leadership training in the community, of researchers, and health care providers. - Outcome evaluation, includes, but is not limited to: 1. Assessment of the usefulness of the information disseminated at meetings, through brochures, etc, to influence the public and health care providers knowledge and behavior. 2. Assessment of hazardous environmental or occupational exposures and the capacity of the project to reduce such exposures. 3. Policy, regulatory or legislative impact that results in improved public health. 4. Assessment of public health outcomes as measured, for example, by lower rates of exposure to pesticides or/and allergens, etc. 5. Assessment of whether and to what extent the project has been capable of translating research in environmental/occupational health to the public to develop prevention, education, and training programs. It is further encouraged that a social scientist be involved in the development of quantitative and qualitative tools to assess progress and programmatic achievements. Applications that do not contain both process and outcome evaluation components will be considered non-responsive and returned to the applicant without review. All of the above elements are essential to fulfill the education, communication, research, and outreach aims of this RFA. Applicants lacking any of the above components will be considered non-responsive. It is important to note that award of a grant under this RFA does not imply a commitment to future funding of any extensions or new projects planned with the support of such a grant. Separate applications must be submitted for such programs, and such applications will be evaluated on the basis of their own merits. Activities conducted under this RFA should be consistent with Federal Executive Order No. 12988 entitled, "Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations." For further information, see http://www.fhwa.dot.gov/legsregs/directives/orders/6640_23.htm. To the extent to which it is practical 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, low-income, and medically underserved populations, including African, Hispanic, Asian, Pacific Islander, and Native American. MECHANISM OF SUPPORT This RFA will use the NIH Education Research Program grant (R25) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. This RFA uses the non-modular budgeting format. Applicants must follow the instructions for non-modular research grants applications. The anticipated award date is July 30, 2004. FUNDS AVAILABLE The NIEHS intends to commit approximately $1.67 million in FY04 to fund five to six new and/or competitive continuation grants in response to this RFA. The NIOSH intends to commit approximately $500,000 in FY04 to fund two to three new grants in response to this RFA. An applicant may request a project period of up to four years and a budget for direct costs of up to $225,000 per year. Indirect costs will be paid at eight percent of direct costs less appropriate exclusions. This is not a modular grant and a detailed budget is expected. The application should include within its scope the plans for the entire length of the grant. Although the financial plans of the NIEHS and NIOSH provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBILE INSTITUTIONS Community-based organizations are especially encouraged to apply. You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Faith-based or community-based organizations Foreign institutions are not eligible to apply. Usually, only one award under this RFA will be funded at an institution or organization. Although a single institution or organization must be the applicant, a multi-institutional arrangement (consortium) is possible. Such consortia, entailing active participation by more than one organization, are encouraged if there is clear evidence of close interaction and responsible partnership among the participants. Competitive continuation application from existing grantees in the NIEHS Environmental Justice: Partnerships for Communication Program in their fourth year of support will be accepted for consideration under this RFA. Such applications must follow PHS398 guidelines for competitive renewal, including a progress report. Such applicants are strongly encouraged to contact Program Staff listed under WHERE TO SEND INQUIRIES for additional guidance. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, women and individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS To encourage applicants to share information gained via these grants, a member of each of the three types of required personnel on each project (scientist, health care provider, and a member of the community-based organization) will be asked to attend an annual meeting in the Research Triangle Park, NC area. Applicants should include such travel in their budget requests. During the four-year project period, the NIEHS may provide supplemental funds for logistical arrangement for the annual Environmental Justice grantee meeting. This meeting will convene all the Environmental Justice grantees and will serve to inform other Environmental Justice grantees and the research community of the progress to-date in developing the program, creating educational materials, the process of dissemination, and the evaluation program. NIEHS may provide these supplemental funds to the selected host institution, after the receipt of an appropriate application and review by Program Staff. Applicants are still expected to provide travel for the three types of required personnel on each project (scientist, health care provider, and a member of the community-based organization) in their grant budget. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Shobha Srinivasan, Ph.D. Scientific Program Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-21 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Phone: (919) 541-2506 Fax: (919) 316-4606 Email: sriniva2@niehs.nih.gov Adele M. Childress, Ph.D., M.S.P.H. Program Administrator Office of Extramural Programs National Institute of Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Executive Park Building 24, Room 1427, MS E-74 Atlanta, GA 30333 Phone: (404) 498-2509 Fax: (404) 498-2571 Email: ahc0@cdc.gov o Direct your questions about peer review issues to: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: worth@niehs.nih.gov o Direct your questions about financial or grants management matters to: Ms. Carolyn Winters Grants Management Specialist Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-22 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-7823 Fax: (919) 541-2860 Email: winters@niehs.nih.gov Robin Solow Contracts Management Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Telephone: (412) 386-6428 Email: rsolow@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIEHS staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: worth@niehs.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form, and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Leroy Worth, Jr., Ph.D. Scientific Review Administrator Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-30 111 T.W. Alexander Drive Research Triangle Park, NC 27709 79 T.W. Alexander Drive, 4401 Building, 3rd Floor (courier/express service) Telephone: (919) 541-0670 Fax: (919) 541-2503 Email: worth@niehs.nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIEHS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique. o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score. o Receive a second level review by the National Advisory Environmental Health Sciences Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does the project identify key environmental/occupational stressors that affect the health and quality of life of people who live in or around communities thought to be at risk? If the aims of the application are achieved, to what extent will the project further the goals of improving understanding of environmental/occupational hazards and disease susceptibility? If the aims of the application are achieved, how do they advance scientific knowledge? 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, analyses, and evaluation components well developed and integrated, and appropriate to the aims of the project? Are potential problem areas identified and alternative tactics suggested? (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? Does the project establish a focus and adopt appropriate strategies and procedures for information exchange related to environmental/occupational health problems in socioeconomically disadvantaged communities? Does the project have a direct impact on the health or quality of life of individuals in affected communities (including but not limited to policy and prevention programs), e.g., by diminishing exposure to environmental toxicants or occupational hazards? (4) INVESTIGATOR: Are the investigator and partners appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level as the Principal Investigator and to that of other researchers? Is there evidence of access to, interaction with, and input from a minority, low-income, or underserved community, whose members' health is adversely impacted by an environmental or occupational hazards? There should be evidence of effective involvement of such a community in development of the application as well as in conduct of the project. There should be evidence of effective cooperation and interaction in development of the application as well as in execution of the project among the three types of required personnel: a researcher in environmental/occupational health sciences, a health care provider, and a community-based organization in an area having an underserved population that is adversely affected by an environmental/occupational hazard. There should be an equitable distribution of responsibilities among the three types of required personnel. (5) ENVIRONMENT: Does the scientific and community environment in which your work will be done contribute to the probability of success? Is there evidence of institutional support commitment as evidenced by provision of appropriate resources, services, technical support, and allocation of space? Is the approach and methodology proposed to accomplish the project's objectives appropriate and adequate? Has consideration been given to the effectiveness of the proposed plan in reaching the target audience? For example, many socioeconomically disadvantaged persons tend not to obtain information from the written word. Low literacy and/or inability to read and understand English may be challenges. Materials may need to be generated that are linguistically and culturally appropriate. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section of Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data and any publication (such as brochures and other materials). BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. In conjunction with the consistent and an equitable distribution of responsibilities, there should likewise be an equitable distribution of requested financial support among the three types of required personnel. o OTHER REVIEW CRITERIA: The major review factors listed below will be used in evaluation of applications for this RFA: - EVALUATION: Plans for evaluation of factors contributing to the project's effectiveness. Evaluations should include a measure of the impact of the project on community members' knowledge and awareness of issues and resources related to environmental health sciences. Similarly, evaluation of the effectiveness of health care provider training should be conducted. Both process and outcome evaluation tools should be incorporated. Applications without evaluation components will be returned without review. It is imperative to assess whether the project enhances awareness of environmental health problems among members of the public and/or health care providers living or working in low-income or underserved communities. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 17, 2003 Application Receipt Date: October 17, 2003 Peer Review Date: February 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review). o Availability of funds. o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects involving human subjects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research read the AMENDMENT "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research B Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001, http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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