**VA PITTSBURGH HEALTHCARE SYSTEM**

**INSTITUTIONAL REVIEW BOARD (IRB)**

APPLICATION FOR VAPHS TO BE THE COORDINATING SITE

FOR A RESEARCH STUDY CONDUCTED AT MULTIPLE SITES

  --------------------- ---------------------------------- -- -- -- ----- -- -- ---- -- --
  Title of Protocol:                                                                    

  Sponsor:                                                                              

  Coordinating                                                                          
  Investigator:                                                                         

  Date of Application:                                                                  

                                                                                        

  Number of currently                                                                   
  participating                                                                         
  institutions/sites                                                                    
  (including VAPHS, if                                                                  
  applicable):                                                                          

  *Information for                                                                      
  participating                                                                         
  institution(s) to be                                                                  
  provided on following                                                                 
  page(s).*                                                                             

                                                                                        

  Are research                                                      Yes         No      
  activities at                                                                         
  [all]{.underline}                                                                     
  participating                                                                         
  institutions/sites                                                                    
  defined as engagement                                                                 
  (see below)?                                                                          

  *\"The participating                                                                  
  facility is engaged                                                                   
  in human subjects                                                                     
  research if its                                                                       
  employees or agents                                                                   
  intervene or interact                                                                 
  with living                                                                           
  individuals for                                                                       
  research purposes or                                                                  
  obtain release or                                                                     
  access to                                                                             
  individually                                                                          
  identifiable private                                                                  
  information for the                                                                   
  purpose of research.                                                                  
  A facility is not                                                                     
  considered engaged in                                                                 
  human subjects                                                                        
  research when, for                                                                    
  example, a VA                                                                         
  investigator from                                                                     
  another facility is                                                                   
  collecting                                                                            
  observational data                                                                    
  (e.g., a survey) from                                                                 
  subjects at the                                                                       
  facility and there is                                                                 
  no participation from                                                                 
  staff at that                                                                         
  facility.\"*                                                                          

                                                                                        

  Method for assuring                                                                   
  all participating                                                                     
  institutions/sites                                                                    
  have the most current                                                                 
  version of the                                                                        
  protocol:                                                                             

                                                                                        

                                                                                        

  Method for confirming                                                                 
  that all amendments                                                                   
  and modifications in                                                                  
  the protocol have                                                                     
  been communicated to                                                                  
  participating                                                                         
  institutions/sites:                                                                   

                                                                                        

                                                                                        

  Method for                                                                            
  communicating to                                                                      
  participating                                                                         
  facilities any                                                                        
  serious adverse                                                                       
  events and                                                                            
  unanticipated                                                                         
  problems involving                                                                    
  risks to subjects or                                                                  
  others:                                                                               

                                                                                        

                                                                                        

  Method of                                                                             
  communicating                                                                         
  regularly with                                                                        
  participating                                                                         
  institutions/sites                                                                    
  about other study                                                                     
  events (e.g., data                                                                    
  safety and monitoring                                                                 
  reports, external                                                                     
  monitoring visits to                                                                  
  be conducted):                                                                        

                                                                                        
  --------------------- ---------------------------------- -- -- -- ----- -- -- ---- -- --

APPLICATION FOR VAPHS TO BE COORDINATING SITE

  --------------------- -------------------------- ------------ -- ---------------
  List ALL                                                         
  Participating                                                    
  Institutions/Sites                                               
  (including VAPHS, if                                             
  applicable):                                                     

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                                            

                                                   E-mail:         

                                                   Telephone:      

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                                            

                                                   E-mail:         

                                                   Telephone:      

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                                             

                                                   E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------

APPLICATION FOR VAPHS TO BE COORDINATING SITE

(please delete unnecessary pages)

  --------------------- -------------------------- ------------ -- ---------------
  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   

  **Name of                                                        
  Institution/Site:**                                              

  FWA Number:                                                      

  Check box if                                                     
  study-related                                                    
  research activities                                              
  at this site are NOT                                             
  defined as                                                       
  engagement:                                                      

  Investigator Name:                                               

  Investigator Address:                            E-mail:         

                                                   Telephone:      

                                                                   

  IRB-of-Record Contact                                            
  Name:                                                            

  IRB Contact Address:                             E-mail:         

                                                   Telephone:      

                                                                   

                                                                   
  --------------------- -------------------------- ------------ -- ---------------