EXPIRED
INTERVENTION EFFECTIVENESS RESEARCH IN OCCUPATIONAL SAFETY AND HEALTH Release Date: February 23, 2000 RFA: OH-00-002 National Institute for Occupational Safety and Health Letter of Intent Date: March 23, 2000 Application Receipt Date: April 26, 2000 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 funds for grant applications to accomplish research in the National Occupational Research Agenda (NORA) Priority area of intervention effectiveness. Information about NORA is available through the NIOSH Home Page; http://www.cdc.gov/niosh/norhmpg.html. The purpose of this initiative is to stimulate research on the effectiveness of intervention techniques that have been implemented or proposed for reducing or preventing workplace injuries and illnesses. While many workplace interventions have been implemented, there has been little research on the effectiveness of these activities. Before work place intervention strategies can be universally applied, there is a critical need for information on the effectiveness of the many strategies and approaches currently used or planned. The results of these investigations will contribute significantly to improving worker health and safety by identifying intervention strategies that are effective. Because the issue of intervention effectiveness is of importance to many membership groups (unions, professional associations, etc), industries, and state health departments, collaborative research projects between these organizations and academic researchers are particularly encouraged. HEALTHY PEOPLE 2010 CDC is committed to achieving the health promotion and disease prevention objectives of AHealthy People 2010, a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the focus area(s) of occupational safety and health. For information on the conference on AHealthy People 2010, visit the internet site: http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, 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, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations. FUNDS AVAILABLE Approximately $1,200,000 is available in fiscal year (FY) 2000 to fund 5-7 research project grants under this RFA. Approximately $500,000 of this amount is planned for mine safety and health research, and $200,000 is planned for research on violence against women in health care. Approximately $500,000 is for the other areas identified in this RFA. Awards are anticipated to range from $150,000 to $250,000 in total costs (direct and facilities and administrative) per year. A higher budget may be requested, but only if the applicant first corresponds with program staff (see contact in the INQUIRIES section) and receives written approval prior to the submission deadline. Applicants should include in their budgets funds for one trip per year for an annual meeting of grantees to be held in Atlanta, Georgia. Awards will be made for a 12-month budget period within a project period not to exceed 3 years. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds in future years. Awards are expected to begin in August 2000. Only applications that are found to be of high scientific merit will be considered for funding, and not all of the funds will be spent if there are not enough highly meritorious applications. MECHANISM OF SUPPORT The mechanism of support will be the individual research project grant (R01). The total requested project period for an application submitted in response to this RFA may not exceed three years. However, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. Complete and detailed instructions and information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Applications will request direct costs in $25,000 modules, up to a direct cost request of $250,000 per year (however, see "FUNDS AVAILABLE" for guidance on budget). A typical modular grant application will request the same number of modules in each year. Application budgets will be simplified. Detailed categorical budget information will not be submitted with the application; budget form pages of the application kits will not be used. Instead, total direct costs requested for each year will be presented. Information, in narrative form, will be provided only for Personnel and, when applicable, for Consortium/Contractual Costs. See section on APPLICATION PROCEDURES below. Additional narrative budget justification will be required in the application only if there is a variation in the number of modules requested. There will be no routine escalation for future years. In determining the total for each budget year, applicants should first consider the direct cost of the entire project period. Well-justified modular increments or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested. For example, purchase of major equipment in the first year may justify a higher overall budget in the first, but not in succeeding years. "Other Support" pages of the PHS 398 will not be submitted with the application. Information on research projects ongoing or completed during the last three years of the principal investigator and key personnel will be provided as part of the "Biographical Sketch." This information will include the specific aims, overall goals and responsibilities and should include Federal and non-Federal support. This information will be used by reviewers in the assessment of each individuals qualifications for a specific role in the proposed project. Following peer review, information about Other Research Support will be requested from the applicant for applications being considered for award. Additional budget information will be requested only under special circumstances. 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. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. RESEARCH OBJECTIVES Background Many workplace prevention and intervention programs have been developed and implemented, yet few have undergone systematic evaluation to determine their impact on health and safety outcomes. Evaluations of the effectiveness of intervention efforts can provide crucial guidance and corrective feedback for current and future occupational safety and health intervention efforts. Evaluation research, whether descriptive or experimental, can provide a firm base of evidence for what works, what does not, and why, and assure better use of limited resources in the implementation of preventive and control strategies. Research Goals Research applications are sought that focus on the systematic evaluation of the effectiveness of interventions that address any of the following disease or injury areas: o Allergic and Irritant Dermatitis o Asthma and Chronic Obstructive Pulmonary Disease o Fertility and Pregnancy Abnormalities o Hearing Loss o Infectious Diseases o Low Back Disorders o Musculoskeletal Disorders of the Upper Extremities o Traumatic Injuries Within the overall research goals for intervention effectiveness in this RFA, two areas with targeted funds (see FUNDS AVAILABLE) are: 1. Mine safety and health Examples of intervention research needs in mine safety and health include the following (which may involve evaluation of new training methods, such as virtual reality): o Recurring areas of high fatalities: powered haulage (in underground and surface mines, for all sectors of the mining industry), working in and around machinery (likewise, in underground and surface mines, for all sectors of the industry), and underground mine ground control (all sectors) o Recurring areas of high injury incidence: handling materials, slips/falls, and musculoskeletal disorders (especially among aging miners) o Recurring areas of unacceptable disease prevalence: silicosis among coal mine drill operators, and coal workers' pneumoconiosis (needing especially some breakthrough technology for controlling dust on longwall panels) 2. Violence against women in health care Examples of intervention research needs related to violence against women in health care include evaluation of programs designed to reduce violence against: o Nurses and nursing aides in hospitals (including private and public general care, psychiatric, and forensic hospitals) and nursing homes o Home health care workers o Workers in community mental health clinics Violence prevention programs to be evaluated could include some or all of the following elements: o Worksite analysis to identify existing hazards and potential hazards o Engineering controls such as alarm systems, metal detectors, or video monitoring systems o Administrative and work practice controls o Medical management and counseling o Recordkeeping and evaluation o Training and education Regardless of the occupational situation addressed in an application, of interest are fully-developed interventions which are ready for implementation as well as evaluations of the effectiveness of interventions which have already been implemented. Applications for comparative analyses of the effectiveness of alternate options (e.g., cost effectiveness) are also solicited. The interventions to be evaluated could be defined at any level of complexity, and range from a regulatory or voluntary occupational safety or health standard to the change of a single, specific work process, control technology, training program, or informational campaign. Evaluations may address (1) the practicality and usability of specific control strategies, technologies and/or personal protective equipment in the elimination or reduction of hazards; (2) the identification of critical factors for implementing and conducting effective occupational safety and health programs; (3) the components of effective occupational safety and health programs, including worker participation programs, training or other organizational and administrative aspects, as well as engineering solutions; and (4) identification and elimination of barriers to the implementation of interventions, such as a lack of acceptance due to practicality, perception that cost is prohibitive, etc. Interdisciplinary applications are encouraged which include, as appropriate, the fullest complement possible of outcome measures. These measures could include health and safety outcomes (e.g., reductions in injury, disability, stress, or hazard exposure); economic outcomes (e.g, the effect of the intervention on productivity, employee turnover, income, medical, and or societal costs); and/or social outcomes (e.g., social roles and relationships at work and in the family and other aspects of the work-family interface). These examples of potential health, economic, and social outcome measures, are provided only to illustrate a range of outcomes of interest, rather than an exclusive listing. Useful References 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). 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.96-142 (http://www.cdc.gov/niosh/99-142.html). SPECIAL REQUIREMENTS Access to work sites and/or worker groups Since the proposed studies are expected to be conducted in actual work places, the applicant organizations should provide written documentation of collaborative relationships with participating companies/membership groups concerning access to work locations and/or worker records. Applications that do not have documented evidence of these arrangements may be returned without review. Human Subjects 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 for Protection from Research Risks (OPRR) at the National Institutes of Health (NIH) negotiates assurances for all activities involving human subjects that are supported by the Department of Health and Human Services. 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 for the Protection from Research Risks (OPRR) 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 Centers for Disease Control and Prevention (CDC) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC-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. This policy was published in the NIH Guide for Grants and Contracts, March 18, 1994, and is available at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. LETTER OF INTENT Prospective applicants are asked to submit, by March 23, 2000, 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 it 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: Ms. Ann Cronin 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 404-639-2376; Fax 404-639-0035 Email: [email protected] 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 301/710-0267, Email: [email protected]. Application kits are also available at: http://grants.nih.gov/grants/forms.htm. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. (However, see "FUNDS AVAILABLE" for guidance on budget.) Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and honora; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applicants not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. The RFA label found in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application and must display the number of this RFA (OH-00-02). A sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 (Intervention Effectiveness Research in Occupational Safety and Health) and number (OH-00-02)must be typed on line 2 of the face page of the application form and the YES box must be marked. If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included. Submit a signed, typewritten original, including the checklist, and three signed, clear, and single sided 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 also be sent to Ms. Ann Cronin at the address under LETTER OF INTENT. Applications must be received by April 26, 2000. If an application is received after that date, it will be returned to the applicant without review. 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. The CSR 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH (applicants should clearly indicate in the project Description, on page 2 of application, which priority area of this RFA is being addressed by their proposal). Applications determined to be incomplete or unresponsive to this RFA will be returned to the applicant without further consideration, including applications that do not provide written documentation of collaboration with the work sites where the research will be conducted. Applications that are complete and responsive to the RFA will be reviewed for technical merit by a scientific review group. Reviewers will identify those applications with the highest scientific merit, which generally comprise the top half of applications reviewed. Those applications will be discussed fully and assigned a priority score between 100 and 300 (100 is the best possible score). For all other applications, there will be a limited discussion and they will not be scored. Notification of the scientific review results will be sent to the applicants after the review. Following the scientific review, applications will receive a review for programmatic importance. Scientific Review Criteria o Significance - Does this study address an important problem related to the topical research issues outlined in this solicitation? 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, 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. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Programmatic 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 CRITERIA Final funding decisions are based on the recommendations of the scientific and programmatic reviews, balance of awards across the areas of research goals of this RFA, and availability of funds. In addition, special consideration for funding will be given to applications that are collaborations between academic investigators and industry, membership groups or state health departments. 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 (http://www.cdc.gov) under the "Funding" section (see AGrants and Cooperative Agreements scroll down to AOccupational Safety and Health). This RFA can also be found on the NIOSH HomePage (http://www.cdc.gov/niosh) under "Extramural Programs, ACurrent 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: [email protected] Direct inquiries regarding grants management matters to: Joanne Wojcik Grants Management Branch Procurement and Grants Office CDC Announcement 00035 Centers for Disease Control and Prevention 2920 Brandywine Road, Suite 3000 Atlanta, GA 30341-4146 Telephone: 770/488-2717 FAX: 770/488-2777 Email: [email protected] 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 CDC 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. 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.
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