1. Create a new study in ICON, or utilize the “Create Modification” activity to make changes to an approved protocol.
   
   The ICON SmartForm will be completed in much the same manner as a typical protocol being submitted to the IRB, with some exceptions:
   
   
   1. In the “Basic Information” section of the ICON protocol, select “Collaborative study” in question #8 (“What kind of study is this?”)
      
      
   2. Answer “yes” to new question #9 (“Will your IRB act as the single IRB of record for other participating sites?”)
      
      
   3. In the “Study Team Members” section, make sure to add the external team members from relying institutions by completing and uploading the External Team Member template.
      
      
   4. In the “Study Scope” section, answer “yes” to question #1 (Are there other research sites where the investigator will conduct or oversee the research?)
      
      
   5. Add the external relying sites to the “Research Locations” section of the protocol.
      
      
   6. If you are requesting to use the UT System/TMC Reciprocity agreement, attach an “Application for Addition of a Site” form completed by the relying institution’s PI in the study documents section.
      
      
   7. If the relying institution is not in Texas, attach a completed “Local Context Information” Form completed by the relying institution’s PI or IRB.
      
      
   8. Attach consent forms, assent forms and recruitment materials specific to the relying site in the “Local Site Documents” section of the ICON submission.
      
      
2. The protocol document must include information regarding the relying site’s research activities and role in the project:
   
   
   1. Make sure to clarify the number of subjects to be enrolled locally and at the relying site in the "Number of Subjects" section.
      
      
   2. Make sure to include recruitment methods for both institutions in the "Recruitment Methods" section (if applicable). 
      
      
   3. Make sure to describe communication between UH and the relying site in the "Multi-Site Research Communication" section.
      
      
   4. Make sure the relying site's procedures are included in the "Procedures Involved" section. 
      
      
   5. Make sure to include data storage information for the relying site in the "Data Management" section.
      
      

Continuing Reviews:
The UH PI will need to collect from all relying sites the enrollment information as well as other information needed for the renewal submission to UH IRB. The UH PI will need to send a continuing review approval letter to the site PIs of all relying sites.

Modifications
The UH PI will need to send a modification review approval letter to the site PIs of all relying sites, as well as a copy of the approved updated full protocol and any updated documents (ex: consent forms) to be used.

The external site relying on the UH IRB must provide the UH IRB with:

• Any management plan put in place by the external institution to manage a financial conflict of interest related to the research project. This management plan must be uploaded into the ICON protocol prior to IRB approval of the study (or using the “Create Modification” activity of the interest is acquired during the course of the study).
  
  
• Any unanticipated events involving risk to subjects or others, or other issues of noncompliance. These should be reported to the UH IRB using the “Report New Information” activity in ICON.