COLLABORATIVE PROGRAM FOR THE IDENTIFICATION AND PREVENTION OF WORK-RELATED MUSCULOSKELETAL DISORDERS Release Date: March 15, 2000 RFA: OH-00-003 National Institute for Occupational Safety and Health Letter of Intent Receipt Date: April 12, 2000 Application Receipt Date: May 15, 2000 PURPOSE The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2000 funds for cooperative agreement (U01) applications from single institutions or consortia of institutions who are capable of, and interested in, participating in a Musculoskeletal Disorders Consortium (MSDC). The goal of the MSDC is to conduct a prospective cohort study to quantify the risk for upper limb and low back MSDs at varying levels of exposure to physical job stressors (repetitive, forceful exertion, awkward postures, vibration, manual handling, etc.). This research will involve multiple work sites from the service and manufacturing industries with job tasks that represent a range of exposures to physical job stressors that can result in carpal tunnel syndrome (CTS), hand-wrist tendinitis, medial and lateral epicondylitis, hand-arm vibration syndrome (HAVS), and low back pain. HEALTHY PEOPLE 2010 CDC 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 announcement is related to the focus area of occupational safety and health. For information on the conference on Healthy People 2010, visit the internet site: http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by 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, including small, minority and/or women-owned businesses. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), an assistance mechanism, in which substantial NIOSH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIOSH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total project period for an application submitted in response to this present RFA may not exceed five (5) years. The anticipated award date is September 1, 2000. The award and level of support depends on receipt of applications of high scientific merit. For this RFA, an applicant may only submit applications that are limited in scope to one of the three topics for this RFA. On the face page of the application, line two, the applicant must indicate the research area of the 1) upper limb MSDs (CTS, hand-wrist tendinitis, epicondylitis) at varying levels of hand activity, exertion, and other physical stressors in job tasks, 2) HAVS in relation to use of vibrating tools, and 3) low back pain in relation to physical demands of lifting and manual handling tasks. If an applicant wishes to apply for more than one research area, you must submit a separate and independent application. Applications which address more than one of the RFA topics will be returned as non-responsive. AVAILABILITY OF FUNDS Approximately $900,000 is available in FY 2000 to fund three awards. The maximum amount that maybe requested is $350,000 total cost (direct and facilities and administrative (F&A) costs) per year. Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds. Use of Funds Recipient should allocate funds for travel for two project staff to attend annual meeting held during each project year. RESEARCH OBJECTIVES Background Work-related Musculoskeletal Disorders (MSDs) remain a large and costly disease to our society even though there have been many advances in understanding the ergonomics of work. In 1996, a total of 600,390 work-related musculoskeletal injury cases resulting in work absence or restriction were reported to be caused by overexertion and repetitive motion by the Bureau of Labor Statistics (BLS). Because the BLS annual survey does not cover approximately one-third of workers, this figure significantly underestimates the overall incidence of MSDs in the American workforce. Of all MSD cases, sixty-nine percent were low back or distal upper limb disorders. The magnitude of the problem in today’s workforce is confirmed by workers compensation data. For instance, in Washington State between 1990 and 1997, 27% of all workers compensation claims and 46% of the cost of all claims resulted from non-traumatic musculoskeletal disorders of the neck, upper extremity or back. The results from this research program will provide practitioners in occupational health critical data that will facilitate their identification of job tasks that represent low, moderate and high risk for MSDs, and that will provide a knowledge base for effective job design changes or interventions. Because of the limitations of cross- sectional and retrospective studies, it widely agreed that a prospective study design is the best approach for this problem. An integral part of this initiative is the establishment of a Musculoskeletal Disorders Consortium (MSDC). For this program, it is important that data elements which will be shared between awardees are managed in a uniform and compatible format. In addition, because much of the shared data elements are centered on job tasks and workers, a critical role of the MSDC will be to assure that job tasks are studied using uniform exposure assessment methods and that workers undergo standard health tests to identify MSDs. In order to accomplish that goal, the MSDC will establish a Coordination Committee (CC), comprised of one voting representative from each member of the consortium, to serve as the main governing board for the conduct of this research program. In addition, the CC will serve as an advisory body for the common or shared protocols to be used in the studies. NIOSH staff will serve as non-voting members of the CC. Through the MSDC, it is anticipated that an outcome of this research program will be better defined exposure-response relationships between job physical stressors and musculoskeletal disorders across industries. These data, when complete, will be used to test and expand existing guidelines for limiting exposure to physical job stressors, and for developing new guidelines where none exist. In addition, it is anticipated that practitioners in occupational health will be able to use the results from this study to more quickly and reliably discriminate job tasks that represent low, moderate and high risk for MSDs. With such knowledge effective job design changes or interventions can be developed that reduce the burden of work-related MSDs. The MSDC will combine the expertise and resources of NIOSH research staff with those of external collaborators. It is anticipated that this consortium will involve up to three extramural partners that demonstrate expertise in one or more of the following research areas: 1) upper limb MSDs (CTS, hand-wrist tendinitis, epicondylitis) at varying levels of hand activity, exertion, and other physical stressors in job tasks, 2) HAVS in relation to use of vibrating tools, and 3) low back pain in relation to physical demands of lifting and manual handling tasks. Individual investigators are encouraged to analyze and publish data from the work sites they study as soon as they are able to. In addition, each investigator will be responsible for providing data to a data coordinating center in a uniform fashion. The site for the center will be one of the awardees who is selected by CC. The awardee selected as the data center will be allowed to request, for consideration of funding, a small administrative supplement to support this activity. This center will serve as the data resource for the analysis by the consortium investigators of the pooled data from all work sites in collaboration with the MSDC. Objectives and Scope The intent of this initiative is to assemble a cross-disciplinary, multi-institutional consortium to define the relationships between physical job stressors and upper limb and low back MSDs. To accomplish this objective, it is envisioned that the following research areas be examined: 1) upper limb MSDs (CTS, hand-wrist tendinitis, epicondylitis) at varying levels of hand activity, exertion, and other physical stressors in job tasks, 2) HAVS in relation to use of vibrating tools, and 3) low back pain in relation to physical demands of lifting and manual handling tasks. There is evidence of causal relationships between job physical stressors (repetitive or static exertion, forcefulness, awkward postures, e.g.) and MSDs, and some quantitative information is available on how much rates of MSDs change at varying levels of exposure to each stressor and combination of stressors (exposure- response relationships). Additional information would foster the further development of effective intervention strategies. It is projected that this consortium would consist of three interrelated projects previously identified for three independent awards. It is important that the applicant include in their application not only the number of subjects to be included in the study, but also a justification for the subject number. 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. Musculoskeletal Disorders and Workplace Factors. 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.97-141 (http://www.cdc.gov/niosh/ergosci1.html). APPLICANT CAPABILITIES Applicants with established resources and facilities to recruit study sites and to enroll workers willing to participate in the study in a cost effective manner are encouraged. The following should be addressed in a clear and organized manner (see also peer review criteria section): o Time line: a detailed time line for the proposed study must be included in the application. o In a separate section labeled ,Participant Notification of Study Results, the applicant should describe plans for notifying participants about their individual results and the overall results of the study. Applicants should highlight unique expertise and/or unusual opportunities as related to the purpose of this RFA. Examples include, but are not limited to: o Expertise in specialized areas with potential applications to the issues/questions considered in this RFA, such as health effects assessment of hand-arm vibration, field studies of working populations experiencing work-related MSDs and experience utilizing the NIOSH lifting equation, o Access to specific work sites and working populations that are willing to participate in studies of work-related MSDs, o Expertise in assessing work situations and individual job tasks in relation to the development of work-related MSDs, and/or o Expertise in interviewing workers and negotiating with work site management - in field settings. COORDINATION COMMITTEE AND ANNUAL MSDC MEETINGS Applicants should include in their budget support for themselves and for at least one other person from their institutions integrally involved in the project to attend an annual program meeting of all members of the MSDC. The meeting will be of one or two days duration and will be held at a site mutually acceptable to study collaborators. The initial meeting will be in Washington, DC. The applicant should also budget for attendance at four Coordination Committee (CC) meetings of the MSDC during the first year and two in each subsequent year. For budget preparation and project planning purposes, it should be assumed that these meetings will be held in Cincinnati, Ohio. However, the CC will determine later where and when recurring CC meetings will be held. The CC chair will coordinate the meetings to review and assess overall progress and provide the opportunity for investigators to exchange information and discuss research issues. TERMS AND CONDITIONS OF AWARD The Terms and Conditions of Award, below, will be incorporated in all awards issued as a result of this RFA. It is critical that each applicant include specific plans for responding to these terms. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and PHS Grants Policy Statement. Under the cooperative agreement, the NIOSH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIOSH collaborators where appropriate, including the following. 1. Recipient Responsibilities The recipient will coordinate project activities, scientifically and administratively at the awardee institution and at the other sites that may be supported by sub-contractors to this award. The applicant will have primary authority and responsibility to define objectives and approaches, to plan, conduct, and analyze data, and to publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award. In addition, the applicant is responsible for coordination of the individual study with the CC. Recipient will a. enroll and follow-up of the study participants and establish and maintain mechanisms to ensure that data collection and management procedures have necessary quality control and assure confidentiality of data, b. provide study participants with individual notification letters when medical tests are performed, c. serve as a permanent member of the CC, d. develop and submit semiannual progress reports, e. collaborate in the scientific reporting of findings, f. provide program management oversight for the project, and g. notify study participants of the overall study results. 2. NIOSH Responsibilities NIOSH anticipates having substantial scientific programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination. a. serve as a scientific liaison between the awardee and other program staff at NIOSH with experience in the occupational health issues of MSDs and epidemiology, b. provide expert consultation in the area of occupational epidemiology, c. provide technical advice on monitoring of field data collection, developing operating guidelines, quality control procedures, and developing policies/protocols for dealing with recurrent situations, d. facilitate collaborative efforts to compile and disseminate program results through presentations and publications, e. assist in the development of human subjects protocols for the CDC Institutional Review Board (if required) and in the preparation of OMB (and other) clearances that may be required during the conduct of the study, 3. Collaborative Responsibilities The CC will serve as the main governing board for the cooperative agreements making up the MSDC. NIOSH staff and one external scientist at the recipient organizations representing the three project areas will have membership on the CC. One critical role of the CC is to ensure that the study designs and data collection protocols are uniform and compatible across the MSDC. The CC may, when it deems it to be necessary, invite additional, non- voting scientific advisors to the meetings at which research priorities and opportunities are discussed. It is anticipated that there will be four CC meetings during the first year and two in each subsequent year, but the actual number and locations of the meetings will be determined by the CC itself. The initial planning meeting will be organized by NIOSH and held in Cincinnati soon after the award, but subsequent meetings will be organized by the CC. The committee chair will schedule the meetings and will be responsible for developing the meeting agenda, chairing the meetings, and producing CC reports. At the Planning Meeting, the CC may: o discuss the required populations and recruitment approaches to be used, o discuss and set initial recruiting targets and schedules, At the second and subsequent meetings, the CC may: 1) make recommendations on the study protocols and data collection approaches, 2) discuss the study populations that have been/will be recruited for the three studies, 3) identify and recommend solutions to unexpected study problems and 4) discuss ways to efficiently coordinate and combine common study activities. 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 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. 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. LETTER OF INTENT Prospective applicants are asked to submit, by April 12, 2000, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NIOSH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Ann M. Cronin National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3070B, MS D-40 Atlanta, GA 30333 Telephone 404-639-2277 Fax 404-639-0035 Email: axc2@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 301/710-0267, Email: grantsinfo@nih.gov. Application kits are also available at: http://grants.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. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in 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: Ann M. Cronin National Institute for Occupational Safety and Health Centers for Disease Control and Prevention 1600 Clifton Road, N.E. Building 1, Room 3070B, MS D-40 Atlanta, GA 30333 Applications must be received by May 15, 2000. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Those applications that are complete and responsive, will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer 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. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as the importance and timeliness of the proposed study, access to the study population, and the interdisciplinary nature of the studies, will be part of the evaluation criteria. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review. Following the scientific review, competitive applications will be reviewed for programmatic importance by a NIOSH Secondary Review Committee. Peer Review Criteria Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the cooperative study and their specific protocols and are expected to address issues identified under SPECIAL CONSIDERATIONS AND REQUIREMENTS of the RFA. The review group will assess the scientific merit of the protocols and related factors as follows: Significance: Does this study address an important problem in the area of work-related musculoskeletal disorders? If the aims of the applications 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? Approach: Are the conceptual framework, design, 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? Are the plans for the recruitment and retention of subjects adequate? Is there adequate consideration of follow up of study participants? Is the plan for assembling work sites and participants suitable for this study? Is the time line for the studies appropriate and well described? Are the methods for assuring privacy and maintaining confidentiality of participant records, including specific protections for computerized data systems adequate? 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? Investigators: Are the Principal Investigator, Co-Principal Investigators and their teams appropriately trained and have adequate experience to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and his/her collaborators? Environment: Does the scientific environment in which the work will be done significantly 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 evidence of institutional support? Does the proposed project utilize an existing resource or constitute a new one? In addition to the above criteria, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of plans to include both genders, minorities and their subgroups, for the scientific goals of the research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Programmatic Review Criteria: o Magnitude and severity of the problem the worker population. o Likelihood of developing technical knowledge for the prevention of occupational safety and health hazards on a national or regional basis. AWARD CRITERIA Applications will be considered for award based upon (a) scientific and technical merit, (b) program importance, (c) program balance (at least one award will be made for each area), and (d) availability of funds. SCHEDULE Letter of Intent Receipt Date: April 12, 2000 Application Receipt Date: May 15, 2000 Anticipated Award Date: September 1, 2000 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael J. Galvin, Jr. Ph.D. 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: mtg3@cdc.gov Direct inquiries regarding grants management to: Sheryl L. Heard, Grants Management Specialist Grants Management Branch, Procurement and Grants Office Announcement 00044 Centers for Disease Control and Prevention 2920 Brandywine Road, Room 3000 Atlanta, Georgia 30341 Telephone: (770) 488-2723 Email address: slh3@cdc.gov PAPERWORK REDUCTION ACT Projects that involve the collection of information from 10 or more individuals and funded by cooperative agreement will be subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. 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. 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 sub-tier 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. SMOKE-FREE WORKPLACE The CDC strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the CDC mission to protect and advance the physical and mental health of the American people.


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