WORLD TRADE CENTER RESPONDER HEALTH CONSORTIUM RELEASE DATE: November 12, 2003 RFA Number: RFA-OH-04-004 (see addendum NOT-OH-04-001) Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: Centers for Disease Control and Prevention (CDC) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute for Occupational Safety and Health (NIOSH) (http://www.cdc.gov/niosh) NOTE: THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.262 LETTER OF INTENT RECEIPT DATE: December 22, 2003 APPLICATION RECEIPT DATE: January 23, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites applications for cooperative agreements from single institutions or consortia of institutions to investigate the health status of responders (workers and volunteers) involved in the World Trade Center (WTC) response. The targeted study population includes all responders including the Fire Department of New York City (FDNY) responders, who provided rescue, recovery, clean-up and restoration of essential services at the WTC disaster site following the September 11, 2001 attack. RESEARCH OBJECTIVES Background Following the collapse of the WTC on September 11, 2001, thousands of workers and volunteers (responders) provided rescue, recovery, clean-up and restoration of essential services. In 2002, the Centers for Disease Control and Prevention funded two medical screening programs for these responders. It is anticipated that when the baseline screening programs are complete in the winter of 2004, over 12,000 FDNY responders and over 12,000 other responders will have been evaluated. Results from these screening programs have found elevated rates of persistent upper and lower respiratory and mental health conditions. Exposure measurements from the WTC site confirm elevated levels of exposure to combustion products and other particulate matter in the period following September 11, 2001. Long-term follow-up of the exposed responders who have participated in the baseline screening program will provide important information regarding the long-term effects of these exposures and will provide an efficient method for early determination of the need for additional medical testing and notification of exposed responders. Program Objectives This RFA builds on the results of previous projects which focused on the establishment of the patient cohort and the initial health screening. This patient cohort has been divided into the FDNY responders and other responders because of the unique health and exposure characteristics of the two groups. The goal for this initiative is to establish four to eight (4-8) Clinical Centers (CC) that will provide the follow-up health assessments for the responders. One CC will be responsible for the FDNY responders, and a group of CCs will be responsible for the other responder cohort. It is anticipated that a CC would have adequate facilities to provide patient tracking, clinical screening, basic mental health assessment, patient data management, and referral to physicians for patients requiring follow-up care. The CC should be able to assist both insured and uninsured responders. Data from this patient group will help define the long term health care needs for the responder population, and also provide important information on the consequences of air pollutants, physical stressors, emotional stress, musculoskeletal exertions, and other occupational and environmental measures. Each CC will be responsible for providing data electronically to a data center (see below) in a uniform fashion. There will be two Data and Coordination Centers (DCC) that will provide data management and coordination. It is envisioned that the clinical center for the FDNY responders will be served by one DCC and the clinical centers for the other responders will be served by the other DCC. The two Data and Coordination Centers (DCCs) will be established to provide study coordination functions, data management support and other services. One DCC will be responsible for the FDNY responder data and the other DCC will be responsible for the other responder data. The applicants selected as the data center will be responsible for basic statistical analysis, outreach coordination, outlier follow-up, data monitoring, quality assurance and other coordinating functions. The DCCs will serve as a data collection resource, enabling the consortium investigator to analyze data from the CCs. Because of the unique characteristics of the two responder cohorts maintained by the two DCCs, a merged data set of all responders is not part of this initiative. The two DCCs will work together, and the Scientific Program Administrator will resolve differences between the DCCs if any arise. All of the CCs and the two DCCs will be coordinated through a World Trade Center Responder Health Consortium (WTCRHC), which is to provide a comprehensive and integrated program for the conduct of the follow-up studies of the current responder population as well as other responders who may be identified. It is important that data elements which will be shared between awardees are managed in a uniform and compatible format. In addition, because many of the shared data elements are based on clinical diagnosis, a critical role of the WTCRHC will be to assure that clinical diagnosis are conducted and interpreted in a uniform manner across the CCs. In order to accomplish this goal, the WTCRHC will establish a Steering Committee (SC) which is described under the PROGRAM ORGANIZATION section of this announcement. Project Organization The WTCRHC will consist of the following components: four to eight (4-8) Clinical Centers, two Data and Coordinating Centers, NIOSH, a Steering Committee (SC), a Data Safety and Monitoring Board (DSMB), and an External Advisory Panel. The Principal Investigator at each CC will have primary responsibility to participate in the standardized study design and implementation to be used at all clinical locations, including subject recruitment and safety. With the assistance of Co-Investigators as appropriate, the Principal Investigator will hire and supervise relevant personnel, obtain Institutional Review Board (IRB) approval for WTCRHC protocols, oversee data collection and adherence to quality assurance measures, and prepare budgets and annual reports. The Principal Investigator (or designated alternate) will serve as a voting member of the SC. A Clinical Coordinator at each CC will set up training systems, certify personnel, and establish procedures to ensure adherence to protocols, collection of high quality data, and accurate transmission of data to the DCC. The application for a CC will be supported in two levels and should consist of the following: a. Administrative and Planning Core An administrative and Planning Core will provide the basic organizational structure for the clinical work. It will be responsible for tracking patient’s contact information, verifying eligibility for examinations, benefits information/patient referral, maintaining patient records, transferring core data to DCC, informed consent, Health Insurance Portability and Accountability Act (HIPAA) compliance, and participation in a quality assurance program. The estimated direct cost for this component is $50-300K per year. The Administrative and Planning Core must have a leader who is capable of providing clinical and scientific leadership and who is willing to accept responsibility for the administration and integration of the health assessment program. Assessment of the ability of the program principal investigator to lead a tightly integrated clinical program will be a significant consideration in the evaluation of the application. b. Clinical Services Core The Clinical Services Core will be funded on a per patient basis (capitation), and the current plan is for an examination of the cohort approximately every 18 months (a minimum of three examinations per patient) over the five-year project period. Based on the fees for similar services, NIOSH anticipates a capitation rate of $300-$800 depending on the final protocol approved by the SC and NIOSH. Due to the unique characteristics of the fire fighter and other responder cohorts, the capitation rates, frequency of examinations and core elements may be different. The NIOSH Scientific Program Administrator will establish the capitation rate and resolve any differences in the protocols for the FDNY responders and other responders. Applicants should provide in their application the capitation rate that their CC would require for the health screening model described below and fully describe a patient protocol based on this model. The current clinical protocol model consists of four components: core medical exam; basic mental health screening; patient referral; and data entry. The core medical exam consists of an updating of the exposure and medical history, a complete physical examination with emphasis on the upper and low respiratory tract, routine blood and urine screening, a standard chest x-ray (if indicated), and pulmonary function testing. The basic mental health screening designed to identify those patients at risk for WTC-related mental health disorders such as anxiety disorders, depression and post traumatic stress disorders. Patients presenting with conditions that require medical follow-up are to be referred to an appropriate health care provider. A CC should have in place a system for the referral of patients whether they have insurance or not. The data is to be stored in a standardized format that is established by the SC, and transmitted electronically to the DCCs. The data management system must be Health Insurance Portability and Accountability Act (HIPAA) compliant. Data and Coordinating Centers A DCC will provide statistical support, a web-based or other electronic data entry site for the clinical data, quality assurance, follow-up for patients that do not self identify a clinical site, and coordination of follow-up for patients outside the geographical service areas of the CCs. In general, a DCC will operate under the guidance of the SC. It is envisioned that the clinical centers for the FDNY responders will be served by one DCC and the other clinical centers will be served by the other DCC. The two DCCs will work together, and the Scientific Program Administrator will resolve differences between the DCCs if any arise. Because of the unique characteristics of the two responder cohorts maintained by the two DCCs, a merged data set of all responders is not part of this initiative. With SC guidance, the DCCs will develop data collection forms and operation manuals; assist in defining outcomes; and develop procedures for quality control, training, and data management. They will monitor the quality and quantity of data received from the CCs; provide relevant reports to the NIOSH, the CCs, and the Steering Committee; and serve as a central repository for study data, with the exception of any individual research projects. The DCC in consultation with the SC, will determine the appropriate capitation rates and will arrange contracts to provide services for examinations being provided outside of the geographic area of the CCs. The DCCs will prepare confidential data analyses and reports for the DSMB. They will support manuscript preparation through data analysis, statistical consultation, editorial support, and meeting coordination. The DCCs will schedule and make arrangements for all meetings of World Trade Center Responder Health Study’s committees and boards. The DCCs will be subject to annual administrative review by NIOSH. Specifically, the DCCs will work in collaboration with the WTCRHC members and NIOSH program staff to: 1. Coordinate with the SC on the selection of the common data collection protocols, and standardized forms, and the data entry system for the creation and maintenance of the Common Data Sets for measurements to be done in common by the CCs. The two DCCs will maintain separate Common Data Sets which due to unique characteristics of each cohort would not necessarily need to be identical. Prepare, disseminate, and update the WTCRHC Common Data Sets, maintain a Manual of Procedures (MOP), data collection forms, databases, and results reporting summaries for the CC sites, and maintain and verify for correctness the resulting Common Data Sets. 2. Provide or arrange for training to all CC site personnel as needed on data management and analysis, HIPAA, and quality control and quality assurance. 3. Collaborate with the CC sites (conditional on approval by the Steering Committee and the NIOSH Scientific Program Administrator) in the analysis of common data both for internal use by the study sites and for publications. 4. Provide the NIOSH Scientific Program Administrator, the DSMB, and the Steering Committee with reports based on statistical and other analyses of issues related to the two core data sets (FDNY and Other responders), or other needs arising during the course of studies. 5. Prepare detailed reports in standardized formats on progress of study- specific recruitment, patient screenings, compliance, and adverse events, for use by the Steering Committee and DSMB. 6. Prepare a list of all CC site-specific data items that are used. 7. Maintain a database on adverse events and responses to them. 8. Support the activities of the CC sites, the SC, and the DSMB through provision of materials, documentation support, meeting planning and logistics, and conference call coordination. This includes attendance at Steering Committee, subcommittee, and DSMB meetings to perform the functions listed above. 9. Prepare and distribute the minutes and action items from the SC and DSMB meetings and conference calls, CC Site visits, and SC Subcommittee meetings, and provide timelines for the completion of actions items and updates on the status of action items as required. 10. Assist the NIOSH Scientific Program Administrator in written, telephone, and electronic communications with the CC sites and with various committees as requested. 11. Establish databases that catalogue and disseminate information about all WTCRHC publications. 12. Develop and maintain a public and private (secured, password-protected) WTCRHC Web page. 13. Translate written materials into Spanish, Polish and other required languages. 14. Develop, maintain, and coordinate the dissemination of information on benefits, occupational safety and health related to WTC and referrals. NIOSH. The Scientific Program Administrator will monitor subject recruitment and study progress, ensure disclosure of conflicts of interest and adherence to award policies. The NIOSH Scientific Program Administrator and CDC Grants Management Specialist will be responsible for fiscal management of the network, including calculation of capitation budget rates and awards. NIOSH will appoint the Chairperson of the Steering Committee and the external advisory committee members with advice from the SC. NIOSH will provide technical assistance as requested. Steering Committee Voting members of the Steering Committee will include the Principal Investigator from each CC (or designated alternate), the Principal Investigator from each DCC (or designated alternate), representative for the external advisory committee (selected by NIOSH), and a Chairperson appointed by NIOSH. The Chairperson of the Steering Committee (who may or may not be a Principal Investigator of a participating CC) will oversee its functions and conduct the Steering Committee meetings. The NIOSH, National Cancer Institute and other National Institutes of Health Components Scientific Program Administrators will be non-voting members of this committee. The Steering Committee will develop and ensure compliance with clinical policies and procedures, identify and prioritize topics for investigation, and evaluate protocols proposed by the CCs. The Steering Committee will ensure that studies are properly conducted and monitored, that data are appropriately analyzed and interpreted, and that study results are reported in the scientific literature in a timely manner and disseminated to physicians involved in the care of WTCRHC participants. Subcommittees, consisting of qualified individuals from the CCs, the DCC, and NIOSH, may be established by the Steering Committee to perform specific functions such as publications and presentations or quality control. The DCC supporting the other responder CCs will provide support for this committee. An executive committee consisting of one FDNY CC representative, one other responder CC representative (selected by NIOSH with advice from the SC) and the NIOSH Scientific Program Administrator will resolve differences in the health assessment protocols for the two cohorts and other issues that cannot be resolved by the SC. Data and Safety Monitoring Board. An independent group of experts in areas such as lung disease, mental health, biostatistics, clinical trials and ethics, who are not otherwise involved in the study, as well as lay persons, will be selected to evaluate the protocol prior to implementation, to review periodically the progress of the health assessments, and to ensure patient safety. The DCC supporting the other responder CCs will provide support for this committee. External Advisory Committee An external advisory committee of 10-20 members will be established for this program. The members will be appointed by the Director, NIOSH with the advice of the SC. The DCC supporting the other responder CCs will provide support for this committee. Research Projects The clinical and analytical activities supported by this RFA may be complemented by research projects at the clinical sites that are funded through individual research projects submitted to the NIH or NIOSH. These projects would be conducted by the individual CCs, and the data would be housed at the project site. These projects will be approved by the SC with advice from the external advisory committee. MECHANISM OF SUPPORT The mechanism of support for this RFA is the NIOSH U10 cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIOSH staff being substantially involved as a partner with the Principal Investigator. This relationship is described under the section "Cooperative Agreement Terms and Conditions of Award", below. The project period for studies supported through this RFA will be 5 years. The anticipated award date is March 15, 2004. This RFA uses just-in-time concepts. It does not use the modular budgeting formats. Follow the instructions for a detailed budget research grant application. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIOSH intends to commit approximately $15 million annually over a 5-year period to the support of the World Trade Center Worker Health Study, (Total Costs include Direct Costs and Facility & Administrative Costs, also called indirect costs or overhead). It is anticipated that four to eight CCs and two DCCs will be established under this program. Approximately $5 million each year will be committed to the fire fighter CC and DCC and $10 million to the other responder CCs and DCC. The proposed direct cost budget of a CC should not exceed $300,000 plus capitation. As the number of patients to be seen is uncertain, an applicant should only state a proposed capitation rate and number of patients projected. NIOSH and the CDC Procurement and Grants Office will determine the amount for capitation. The proposed budget of a DCC applicant may not exceed $1,000,000 Direct Costs in the first year, and $750,000 in the subsequent years. Applications exceeding the funding limits detailed above in any year will be considered unresponsive and returned without further consideration. Specific instructions for budget preparation are in the SUPPLEMENTAL INSTRUCTIONS, below. Designated funding levels are subject to change at any time prior to award due to unforeseen budgetary, administrative, or scientific developments. At this time, NIOSH does not plan to reissue this RFA. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations o Faith-based and community based organizations o Indian Tribes, Tribal Government, College and/or Organizations Foreign institutions are not eligible to apply. An institution may apply for both a CC and the DCC, but there must be minimal overlap of key personnel to ensure that data acquisition is independent of data quality assurance and analysis. Therefore, the principal investigators for a CC and DCC must be different. The application for the DCC must be separate and independent from the CC application. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Women, individuals in underrepresented racial and ethnic groups, and individuals with disabilities are always encouraged to apply for NIOSH programs. SPECIAL REQUIREMENTS The WTCRHC will be a collaborative effort that will require frequent interactions of awardees among themselves and with NIOSH. Applicants should explicitly indicate their willingness to o Participate in Steering Committee meetings (expected to occur approximately three to six times per year in or near New York, NY), site visits required by NIOSH, and regular telephone conference calls, o Cooperate with the Clinical Coordinators in the development and design of health assessment protocols (however, it is anticipated that there may be some differences between the firefighter responder and other responder protocols), o Abide by common definitions; common methods for patient selection and enrollment; and common protocols (as appropriate), procedures, tests, and reporting forms as chosen by majority vote of the Steering Committee or Executive Committee (however, it is anticipated that there may be some differences between the firefighter responder and other responder protocols), o Actively seek to implement approved protocols, o Comply with study policies and quality assurance measures, o Agree to the oversight of the study in collaboration with the NIOSH Scientific Program Administrator, o Accept awards for the support of clinical assessments based on per-patient (capitated) rates and the actual numbers of patients served. (CCs only), o Transmit study data to a DCC in a timely and accurate manner (CCs only), o Report all adverse events in accordance with procedures established by the Steering Committee and NIOSH policies to the DSMB, o Cooperate with other awardees in the publication of study results and the eventual release to the scientific community of study procedures and other resources, o Develop and implement plans for the dissemination of study results to physicians involved in the care of World Trade Center workers and volunteers from the September 11, 2003 event, and o Accept the Cooperative Agreement Terms and Conditions of Award given below. Cooperative Agreement Terms and Conditions of Award The cooperative agreement is an award instrument establishing an "assistance" relationship (in contrast to an "acquisition" relationship) between NIOSH and a recipient, in which substantial NIOSH scientific and/or programmatic involvement with the recipient is anticipated during performance of the activity. The purpose of NIOSH involvement is to support and/or stimulate the recipient's activity by acting as a "partner", while avoiding a dominant role, direction, or prime responsibility. The terms and conditions below, elaborate on these actions and responsibilities, and the awardee agrees to these collaborative actions with the NIOSH Scientific Program Administrator to achieve the project objectives. It is anticipated that these terms and conditions will enhance the relationship between the NIOSH staff and the principal investigator(s), and will facilitate the successful conduct and completion of the study. These agreements will be in addition to, and not in lieu of, the relevant NIOSH procedures for grants administration. The terms will be as follows: 1. The awardee(s) will have lead responsibilities in all aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. 2. The NIOSH Scientific Program Administrator will serve on the Steering Committee as non-voting members; he/she or other NIOSH scientists may serve on other study committees, when appropriate, but if other NIOSH scientists are identified, they will also be non-voting members. The NIOSH Scientific Program Administrator (and other NIOSH scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, adherence to protocol, assessment of problems affecting the study and possible changes in protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment. 3. Awardee(s) agree to the governance of the study through a Steering Committee. Steering Committee voting membership shall consist of the Principal Investigators (i.e., cooperative agreement awardees), and the Chairperson. Meetings of the Steering Committee will ordinarily be held by telephone conference call or in the metropolitan New York Area. 4. Awardees will retain custody of and have primary rights to their data consistent with current HHS, PHS, and NIOSH policies. The collaborative protocol and governance policies will call for the continued submission of data centrally to the coordinating centers for collaborative databases, one for the firefighter and one for the other responder cohort; the submittal of copies of the collaborative datasets to each principal investigator upon completion of the study; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NIOSH Scientific Program Administrator on behalf of NIOSH, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee. 5. Awardees are encouraged to publish and to publicly release and disseminate results, data and other products of the study, concordant with study protocols and governance, and the approved plan for making data and materials available to the scientific community and to NIOSH. 6. The NIOSH reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable collaborative protocol, (b) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control, (c) major breach of the protocol or substantive changes in the agreed-upon protocol with which NIOSH cannot concur, or (d) human subject ethical issues that may dictate a premature termination. 7. 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 part 74 and 92, and other HHS, PHS, CDC and NIOSH grant administration policy statements. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/health assessment issues to: Michael J. Galvin Jr., Ph.D. Scientific Program Administrator Office of Extramural Programs Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 1600 Clifton Road, N.E. Building 24, Room 1537, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2524 FAX: (404) 498-2571 Email: mgalvin@cdc.gov o Direct your questions about peer review issues to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov o Direct inquiries about financial or grants management matters to: Mr. John Columbia, Contract Specialist Acquisition and Assistance Field Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Announcement Number OH-04-001 Telephone: (412) 386-4458 Email: jcolumbia@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of an application, the information that it contains is used to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document and should be sent to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: 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. Supplemental Instructions for the Data and Coordinating Center: Applicants for the Data and Coordinating Center should address the potential requirements of the CCs, and how they would be satisfied by the DCC. Plans for collection and handling of data consistent with the projected needs of the study sites should be discussed. Plans for ensuring data integrity and quality control should be discussed. Personnel: The application for a DCC must describe the expertise of key scientific, technical and administrative personnel and include a mechanism for replacing key professional or technical personnel should the need arise. The Principal Investigator of the DCC should be a professional with experience in directing a coordinating center for large-scale collaborative multi-site clinical studies or other large-scale epidemiological research project involving multiple institutions. Staff needs may be modified as the WTCRHC studies progress; however, adequate support staff should be designated to manage routine tasks: o PI of the DCC should provide overall scientific and biostatistical guidance. o Project Manager to attend to day-to-day details and communicate necessary information to study sites and/or to the other WTCRHC organizational components. Staff training is also a responsibility of the Project Manager. o Statisticians to help in data analysis. o System analysts to help with developing and managing the database programs. o Computer programmers to develop computer database. o Clerks and administrative assistants to help in administrative work and data entry. Budget: The budgets for the DCC application should be based on the applicant's best judgment of activities likely to be involved during the different Phases of the WTCRHC studies. The Phase 1 budget (Year 1) should include costs of establishing the DCC staff, as required to carry out the DCC functions (including costs of training personnel of CC sites for management and analyses, and quality control and quality assurance of common data). Phase 1 also will involve development of the protocols and manuals of operations by the CC sites, in conjunction with the Steering Committee for the CC studies and creation of a database for the common measures between the CC sites. During Phase 2, the budgets should include projected data handling costs, reporting functions, meetings and other communications costs, and the projected expense of performing any interim analyses that may be requested by the DSMB. Budgets should also include costs of organizing three joint meetings of the Steering and External Advisory Committees per year and providing for attendance of necessary Data and Coordinating Center staff. For planning purposes, the applicant should assume no travel expenses for the Steering committee, and $5,000 per meeting for the External Advisory Committee travel expenses. The Phase 3 (Year 5) budget should be concerned with study closeout, analysis of study data, and reporting of results in collaboration with the study sites. Budgets should also include costs of organizing three joint meetings of the Steering and External Advisory Committees USING THE RFA LABEL: The RFA label, available in the PHS 398 (rev.5/2001) application form, must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO NIOSH: Submit a signed, typewritten 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 and all copies of appendix material must also be sent to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: pmajor@cdc.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of the RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIOSH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a scientific review group convened by NIOSH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applicants deemed to have the highest scientific or technical merit, generally the top half of the applications under review, will be discussed and assigned a priority score. o Receive a written critique. o Receive a second level of review by the NIOSH Secondary Review Committee. REVIEW CRITERIA The goals of NIOSH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example it may propose to carry out important work that by its nature is not innovative but essential to move a field forward. Clinical Center Review Criteria for the Administrative Core/overall program are: o Responsiveness to the objectives of the cooperative agreement program, including the applicant's understanding of the objectives of the proposed cooperative agreement and the relevance of the proposal to the objectives. o Feasibility of meeting the proposed goals of the cooperative agreement program. o Degree to which the program design addresses the distinct characteristics, specific populations, and needs of the target population. o Leadership ability and scientific stature of the Clinical Center Director and his/her ability to meet the program's demands of time and effort. o Effectiveness of the Center in establishing or continuing a health screening program for WTC responders. o Institutional commitment to the Center. Review Criteria for the Clinical Core are: SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? The final design of the protocols (site-specific and common) will be developed collaboratively by the CC sites and the Steering Committee. In assessing applications for the Clinical Center, the scientific review group will focus on whether the applicant recognizes the significance of the issues involved and has the knowledge necessary to contribute meaningfully to the final design, including understanding of the scientific, ethical, and practical issues underlying the studies. APPROACH: Does the applicant provide evidence of cooperation with the target population? Does the applicant have demonstrated support from and experience with the target population? Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Did the applicant fully describe the health screening model and provide the capitation rate that their CC would require their model? Does the applicant have an appropriate patient referral program for patients who require medical follow-up? Does the applicant describe a reasonable health screening model for the target population? Does the applicant address patient confidentiality and data security? Does the applicant propose appropriate health screening approaches? INNOVATION: Does your project employ novel concepts, approaches or methods? Is the health screening design innovative and efficient? Does the project challenge existing paradigms or develop new methodologies or technologies? Does the proposal address problems that may arise during the study and provide innovative solutions to such problems? INVESTIGATOR: Is the principal investigator appropriately trained and well suited to carry out this work? Does the investigator team have experience working with World Trade Center Responders? Is the work proposed appropriate to the experience level of the principal investigator and to that of other researchers? Does the application provide evidence of specific competence and relevant experience of professional, technical, and administrative staff pertinent to the operation of a Clinical Center for multi-site studies? Prior experience collecting patient data and should be demonstrated. Does the PI have appropriate clinical experience to conduct the study? Is there evidence of experience in and willingness to participate appropriately in a collaborative study as described in this RFA? Are there adequate assurances that the Clinical Center personnel have experience in utilizing procedures that insure the safety and confidentiality of medical records? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed protocols take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Has the application documented the adequacy of the proposed facility, technical hardware, and working relationship with a DCC? Evidence of institutional support and commitment for the proposed program should be provided. RECRUITMENT EXPERIENCE AND CAPABILITIES: What is the likelihood, based on experience and patient base, that the PI will be successful in recruiting an adequate number of responders with the desired clinical characteristics and with an acceptable level of participation by women and individuals from racial and ethnic minority populations? Does the CC have experience with the target population? Review Criteria for the Data and Coordination Center are: SIGNIFICANCE: Does the study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Did the investigator acknowledge potential problem areas and consider alternative tactics? Does the proposed approach in managing the logistical and data coordination have scientific and technical merit? Are the proposed plans and experience relating to data collection, management, editing, processing, analysis, and reporting adequate? Are the plans for coordination with the study site investigators adequate? Is the approach to developing a cooperative relationship among the study sites and between the various WTCRHC organizational components adequate? Are the plans for exercising appropriate leadership in matters of study design, data acquisition, data management, and data analysis demonstrated? 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 for health data management? Does the applicant for the DCC Center offer innovative ideas on how to achieve the goals of the WTCRHC studies with regard to its design and administration? INVESTIGATORS: Is the principal investigator appropriately trained and well suited to carry out this work? Does the principal investigator have experience in directing a DCC for large-scale collaborative multi-site clinical studies or other large-scale epidemiological research project involving multiple institutions? Are the other members of the DCC appropriate for the scope of work proposed? ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed protocols take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there an appropriate organizational and administrative structure to the proposed DCC? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: Scientific Review Criteria PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from all genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). (CCs only) DATA SHARING: The adequacy of the proposed plans to share data and disseminate study results. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed study. Programmatic Review Criteria o Experience with the target population. o Size of target population likely to be captured. o Geographic area and target population served. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 22, 2003 Application Receipt Date: January 23, 2004 Earliest Anticipated Start Date: March 15, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit o Availability of funds o Programmatic priorities o Geographic balance REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks of the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I), efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. NIOSH follows the NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43, and NIOSH adheres to this policy. All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. For this announcement NIOSH follows this policy. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIOSH policy requires education on the protection of human subject participants for al investigators submitting NIOSH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIOSH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 HHS 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. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered lobbying. That is lobbying for or against pending legislation, as well as indirect or grass roots: lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, NIOSH/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use NIOSH/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training; and foster safe and healthful environments. Recipients of NIOSH/CDC grants and cooperative agreements need to be careful to prevent NIOSH/CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and grass roots activities that relate to specific legislation, recipients of NIOSH/CDC funds should give attention to isolating and separating the appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds. NIOSH/CDC also cautions recipients of NISOH?CDC funds to be careful not to give the appearance that NIOSH/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law. HEALTHY PEOPLE 2010: CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national activity for reducing morbidity and mortality and improve the quality of life. This RFA is related to one or more focus areas. Potential applicants may obtain a copy of "Healthy People 2010" http://www.healthypeople.gov. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. And under the Occupational Safety and Health Act of 1970, Section 20(a) (29 USC 669(a)). All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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