Other Materials That Do NOT Require IRB Review

Some documents do not require IRB review as long as they contain information that is consistent with the protocol or other IRB reviewed documents and do not include new information that would affect subjects’ willingness to take part in the study. These include:

• Appointment reminders
  
  
• Case report forms
  
  
• Course curriculum content
• When the content of the course is established and will not be altered for the research study
  
  
• Data collection forms
• Note: This does NOT include surveys and other instruments which are used to collect data directly from subjects. These do require IRB review.
• However, the data collected on these forms does need to be described in the application/ protocol.
  
  

• Eligibility determination sheets/forms/checklists to be completed by the study team
  • Note: This does not include telephone screening scripts. These do require IRB review.
    
    
• Instructional materials for subjects
  • If the materials are limited to the technical description of procedures (e.g. specimen collection) or medications described in the study protocol and do not contain information about study risks.
    
    

• Newsletters/press releases
  
  • When the content does not include recruitment information, or describe study results specific to a participant(s), or unpublished findings/results of initial data analysis. However, participants may be sent, without IRB review, information on the number of subjects enrolled, study status, and publications resulting from the study or lay language summaries of such publications.
    
    

• Internet postings of study descriptions limited to CT.gov-style content (i.e., study title, purpose, procedures, basic eligibility criteria, and how to get in touch with the study team) as long as the methods used to recruit subjects are described in the application/protocol (e.g. The Internet must be an approved tool for recruitment).
• This does NOT include descriptions of risks/benefits or why someone would want to be in the study.