NOT-OH-04-001: ADDENDUM TO RFA-OH-04-004 WORLD TRADE CENTER RESPONDER HEALTH CONSORTIUM

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

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 (http://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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