ADDENDUM TO RFA-OH-04-004 WORLD TRADE CENTER RESPONDER HEALTH CONSORTIUM RELEASE DATE: December 16, 2003 NOTICE: NOT-OH-04-001 National Institute for Occupational Safety and Health (NIOSH) (http://www.cdc.gov/niosh) This addendum is to inform potential applicants of six changes/clarifications in RFA-OH-04-004 (https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-04-004.html): 1. Purpose (page 1). The purpose of this RFA is to support a clinical services (health screening) program to monitor the health status of responders. This RFA does not provide funds for research studies. 2. Steering Committee (page 5). NIOSH recognizes the important role of worker representation on the steering committee. Therefore on this committee there will be representation of worker groups impacted by the World Trade Center disaster and they will have the same status, rights and privileges as the other members. Representation may include the New York State AFL/CIO, the Uniformed Fire Fighters Association, and others; and will be appointed by NIOSH in collaboration with the WTC principal investigators. 3. Research Projects (page 6). Research projects using the responder cohort or the DCC dataset will be approved by separate Research Oversight Committees (ROC) administered by the two Data and Coordination Centers (DCCs). The Research Oversight Committees will be established by the Steering Committee with advice from the Clinical Centers (CCs), the External Advisory Committee and the Data Safety and Monitoring Board. 4. Funds Available (page 7). The amount of funds available for this five year program is $81.5 million. 5. Cooperative Agreement Terms and Conditions of Award, term 4 (page 9). The collaborative datasets provided each clinical center principal investigator at the end of the study will consist of the data collected by their Clinical Center. In addition, the datasets of the two Data and Coordination Centers will not be combined. At the end of the project, each data set will be placed in separate repositories which will be established by NIOSH. Because of the complexity of the human subject issues, if able, these repositories will be established at the DCCs. The repositories must follow the OHRP guidance for Repositories. These repositories will include a research oversight committee or equivalent group with representation from the target population, and will oversee the utilization of these datasets by investigators. The Research Oversight Committees will be established by the principal investigators with concurrence of NIOSH. 6. Review Criteria for the Data and Coordination Center: Environment (page 15). Is there evidence of a relationship with and responsiveness to the target population?
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