COMMUNITY-BASED INTERVENTIONS TO PREVENT CHILDHOOD AGRICULTURAL INJURY AND DISEASE Release Date: December 20, 2000 RFA: OH-01-007 National Institute for Occupational Safety and Health Letter of Intent Date: February 2, 2001 Application Receipt Date: March 14, 2001 THIS RFA USES THE DETAILED BUDGET FORMAT, RATHER THAN MODULAR GRANT BUDGET FORMAT. PURPOSE The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2001 funds for grant applications for research on evaluation of the effectiveness of currently used community-based interventions in reducing childhood agricultural injury and disease. Findings from these projects are intended to advance the scientific base of knowledge needed to maximize the safety and health of children exposed to agricultural production hazards. The research needs identified in this announcement are consistent with the National Occupational Research Agenda (NORA) developed by NIOSH and partners in the public and private sectors to provide a framework to guide occupational safety and health research in the new millennium towards topics which are most pressing and most likely to yield gains to the worker and the nation. The agenda identifies 21 research priorities. NORA priorities with specific relevance to this announcement are: traumatic injuries; special populations at risk; control technology and personal protective equipment; and intervention effectiveness research. Information about NORA is available through the NIOSH Home Page; http://www.cdc.gov/niosh/norhmpg.html. HEALTHY PEOPLE 2010 NIOSH is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a national activity to reduce morbidity and mortality and improve the quality of life. This program announcement is related to the focus area of Occupational Safety and Health and Injury and Violence Prevention. Potential applicants may obtain a copy of Healthy People 2010 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private nonprofit and for-profit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit and for-profit organizations, State and local governments or their bona fide agents, federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations, and small, minority, and women-owned businesses that meet the above criteria. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications are sought from organizations which work directly with implementing community-based interventions or which have the expertise to evaluate scientifically the effectiveness of their community-based childhood agricultural injury and disease prevention interventions. If such organizations do not have all of the needed expertise, they can partner with an entity such as an academic unit in a college or university to obtain the necessary expertise to conduct an intervention effectiveness evaluation. Applications lacking an existing or proposed link to an organization involving community-based activities will be considered nonresponsive to this RFA and will be returned to the applicant. Note: Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 which engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant (cooperative agreement), contract, loan, or any other form. MECHANISM OF SUPPORT The mechanism of support will be the individual research project grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested project period for an application submitted in response to this RFA may not exceed three years. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $600,000 is available in FY 2001 to fund three to four awards under this RFA. The maximum amount that may be requested is $200,000 total cost (direct plus facilities and administration) per year. Awards are expected to begin September 1, 2001. Awards will be made for a 12-month budget period within a project period up to three years. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds in future years. Use of Funds Applicants should include in their budgets funds for one trip per year for an annual meeting of grantees to be held in Morgantown, West Virginia. PREAPPLICATION CONFERENCE CALL Applicants are invited by NIOSH to participate in a preapplication technical assistance telephone conference call on January 31, 2001 at 2:00 PM (Eastern time) to discuss: programmatic issues regarding this program, how to apply, and questions regarding the content of the RFA. The conference call name is Childhood Agriculture Intervention Program. The telephone bridge number is 404/639-3277. Interested parties will need the conference code (492151) to participate. RESEARCH OBJECTIVES Background Agricultural production, which is most commonly identified with the occupation of farming, consistently ranks among the U.S. industries with the highest rates of work-related injuries and deaths, and is unique with respect to children and adolescents. Agriculture is the only major industry in which the workplace often encompasses the home. Exposures to agricultural production hazards are not confined to working adults. Children and adolescents may be exposed to agricultural production hazards not only through work activities, but by virtue of living on a farm or ranch, accompanying their parents to work, or visiting farms or ranches. Farm tractors, farm machinery, stored grain, power lines, manure pits, ponds, livestock, noise, agricultural chemicals, organic dusts, volatile organic compounds, and solvents are among the many injury and disease hazards to which youth are potentially exposed in agricultural production. Analysis of death certificates suggest that approximately 100 injury deaths occur on farms each year to youth 19 years of age and younger. These include deaths of youth who lived on the farm, visited the farm and or worked on the farm, but exclude transport-related and intentional fatalities. In 1998, as part of the Childhood Agricultural Injury Prevention Initiative, NIOSH, through the United States Department of Agriculture, conducted a childhood agricultural injury survey of 50,000 farm households. An injury was defined as any condition which occurred on the farm which resulted in at least four hours of restricted activity. An estimated 32,800 agriculture-related injuries occurred nationally to children or adolescents under the age of 20 who lived on, worked directly for, or visited a farm in 1998. For several years, community-based interventions have been utilized to prevent childhood agricultural injury and disease. These interventions have typically consisted of the distribution of educational safety materials and information throughout a community, farm safety day camps, peer safety education and child care cooperatives. The following examples illustrate how increased interest and public/private funding in the area of childhood agricultural injury and disease prevention have resulted in community-based intervention activities: 1) Farm Safety 4 Just Kids, a non-profit organization which works with community-based groups, whose mission is to promote a safe farm environment to prevent health hazards, injuries, and fatalities to children and youth, and 2) the Progressive Farmer Foundation, a non-profit foundation whose mission is to reduce the incidence of agriculture-related injuries, illness and deaths by increasing the awareness of the potential dangers associated with specific farm and ranch practices, works to implement community-based interventions. Thus, many community-based interventions are in existence and continue to be utilized by communities which have agriculture production as a major economic base. With the family- based nature of farming, community-based efforts are often viewed as being the most appropriate interventions to implement. This is impacted by the fact that agriculture production often falls outside the regulatory framework and enforcement of federal and state agencies. However, rigorous research is needed to assess the effectiveness of community- based interventions which are currently being utilized for childhood agricultural injury and disease prevention. Though well- intentioned, educational programs are not always effective. Paradoxically, sometimes education programs can have an adverse impact by increasing exposure and/or creating a false sense of security among participants. Also, effectiveness evaluation should provide the ability to identify aspects of programs which are most effective that could be used for improving programs, and identifying the most effective programs for which to channel limited resources. Research Goals Community-based research seeks to enhance the capacity of communities to participate in the processes that shape research approaches and intervention strategies. Involvement of organizations within the community(ies) that is (are) the focus of the study are essential components of the research. Thus, projects should be community-driven and community-responsive. Research efforts should reinforce collaborations between communities and scientists. Results generated by the research should be disseminated to community members in useful terms. This will mandate that all facets of the project design be culturally appropriate. Benefits of community-based research include: o The formation of bridges between scientists and communities that allow both to gain in knowledge and experience. o Better definition of a particular safety or health concern. o Assistance in development of culturally appropriate measurement instruments, thus making projects more effective and efficient. o Establishment of a level of trust that will enhance both the quantity as well as the quality of data collected. o The community gains more knowledge about safety and health problems; and has a role in addressing those problems. o Relationships are built that can have a longer term impact or influence on those problems. Research applications should include both process and outcome measures. Process measures should be detailed enough to allow for replication of the community-based intervention by other groups. Outcome measures of interest include, but are not limited to: exposure to injury hazards, knowledge of safety and health hazards, documentation of safety and health behavior change, and the incidence of childhood agricultural injuries. Research applications need to include a study plan that is designed to detect intervention effects relevant to the changes in outcomes of interest. Confounding variables, such as natural change, should be addressed, as well as the known limitations of the study plan. Applications should identify the types and geographical distribution of agricultural production which will be addressed, and the size and characteristics of child and adolescent populations which can potentially be impacted by the research findings. 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 injury 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. USEFUL REFERENCES National Committee for Childhood Agricultural Injury Prevention. Children and Agriculture: Opportunities for Safety and Health. Marshfield, WI: Marshfield Clinic, 1996. (http://research.marshfieldclinic.org/children/action/title.htm) National Institute for Occupational Safety and Health. A Model for Research on Training Effectiveness. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115 (http://www.cdc.gov/niosh/99-142.html). National Institute for Occupational Safety and Health. National Occupational Research Agenda. Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No.96-115 (http://www.cdc.gov/niosh/nora.html). Thompson NJ, McClintock HO. Demonstrating Your Program's Worth - A Primer on Evaluation for Programs to Prevent Unintentional Injury. Atlanta: GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 1998. (http://www.cdc.gov/ncipc/pub-res/demonstr.htm) HUMAN SUBJECTS REQUIREMENTS If a project involves research on human subjects, assurance (in accordance with Department of Health and Human Services Regulations, 45 CFR Part 46) of the protection of human subjects is required. In addition to other applicable committees, Indian Health Service (IHS) institutional review committees also must review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve that portion of the project applicable to it. Unless the grantee holds a Multiple Project Assurance, a Single Project Assurance is required, as well as an assurance for each subcontractor or cooperating institution that has immediate responsibility for human subjects. The Office of Human Research Protections (OHRP) negotiates assurances for all activities involving human subjects that are supported by the Department of Health and Human Services (Additional information is available at http://www.hhs.gov/ohrp/). ANIMAL SUBJECTS REQUIREMENTS If the proposed project involves research on animal subjects, compliance with the PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions is required. An applicant (as well as each subcontractor or cooperating institution that has immediate responsibility for animal subjects) proposing to use vertebrate animals in CDC-supported activities must file (or have on file) the Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health. The applicant must provide in the application the assurance of compliance number and evidence of review and approval (including the date of the most recent approval) by the Institutional Care and Use Committee (IACUC). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the CDC to ensure that individuals of both sexes and the various racial and ethnic groups will be included in supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995. All investigators proposing research involving human subjects should read the UPDATED NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research, published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES All applications must be self-contained within specified page limitations. Unless otherwise specified, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be comprised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by February 2, 2001, a letter of intent that includes the number and title of the RFA, a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, and the identities of other key personnel and participating institutions. Although a letter of intent is not required, is not binding, and is not used in the review of an application, the information that it contains is used to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be submitted to: Price Connor, Ph.D. Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1600 Clifton Road, N.E. Building 1, Room 3070B, MS D-40 Atlanta, GA 30333 Telephone 404-639-2383; Fax 404-639-2196 Email: spc3@cdc.gov APPLICATION PROCEDURES Applicants must use Form PHS 398 (rev. 4/98). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/435-0714, Email: grantsinfo@nih.gov. Application kits are also available at: www.nih.gov/grants/forms.htm. The RFA label available in the PHS 398 (rev. 4/98) 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. Need to add sentence about pdf format. Submit a signed original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review (CSR) 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 also be sent to: Price Connor, Ph.D. National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1600 Clifton Road, N.E. Building 1, Room 3062, MS D-40 Atlanta, GA 30333 Applications must be received by March 14, 2001. If an application is received after that date, it will be returned to the applicant without review. CSR and NIOSH 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. CSR and NIOSH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. SPECIAL REQUIREMENTS Since these projects are community-based and involve both research and dissemination, applicants are encouraged to create opportunities for information exchange between institutional researchers and community members. Therefore, applicants may generate a report that would describe community input, program implementation, and relevant findings that could be easily comprehended by the public. Applicants may budget for production and dissemination of such reports. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Applications determined to be incomplete or unresponsive to this RFA will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be reviewed for technical merit by a scientific review group convened by NIOSH. All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Following the scientific review, competitive applications will be reviewed for programmatic importance by a NIOSH Secondary Review Committee. Scientific Review Criteria o Significance - Does this study address an important problem related to the topical research issues outlined in this announcement? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach - Are the conceptual framework, design (including composition of study population), methods, and analyses adequately developed, well- integrated and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o 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? o Investigator - Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers, if any? o Environment - Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there documentation of cooperation from industry, unions, communities, or other participants in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? The scientific review group will also examine the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Secondary Review Criteria: o Magnitude of the problem in terms of numbers of workers affected. o Severity of the disease or injury in the worker population. o Likelihood of developing applied technical knowledge for the prevention of occupational safety and health hazards on a national or regional basis. AWARD CONSIDERATIONS Applications will be considered for award based upon (a) scientific merit, (b) program importance, (c) program balance, and (d) availability of funds. SCHEDULE Letter of Intent Receipt Date: February 2, 2001 Application Receipt Date: March 14, 2001 Anticipated Award Date: September 1, 2001 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. This RFA and other CDC Announcements can be found on the CDC HomePage (www.cdc.gov) under the Funding section (see Grants and Cooperative Agreements scroll down to Occupational Safety and Health). This RFA can also be found on the NIOSH HomePage (www.cdc.gov/niosh) under Extramural Programs, Current Funding Opportunities. Direct inquiries regarding programmatic issues to: Roy M. Fleming, Sc.D. Director, Research Grants Program National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3053, MS D-30 Atlanta, GA 30333 Telephone: 404/639-3343 FAX: 404/639-4616 Email: rmf2@cdc.gov Direct inquiries regarding grants management matters to: Joanne Wojcik Grants Management Branch Procurement and Grants Office Centers for Disease Control and Prevention 2920 Brandywine Road, Suite 3000 Atlanta, GA 30341-4146 Telephone: 770/488-2717 Email: jcw6@cdc.gov LOBBYING RESTRICTIONS Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of PHS appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. AUTHORITY AND REGULATIONS The Catalog of Federal Domestic Assistance number is: 93.262 for the National Institute for Occupational Safety and Health (NIOSH). This program is authorized under the Public Health Service Act, as amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52. This program is not subject to the intergovernmental review requirements of executive order 12372 or Health Systems Agency Review. SMOKE-FREE WORKPLACE CDC strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products, and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children. SMALL, MINORITY, AND WOMEN-OWNED BUSINESS It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should: 1. Place small, minority, women-owned business firms on bidders mailing lists. 2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services. 3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms. 4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.
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