Subject-Facing Materials Requiring IRB Review

• Consent forms, assent forms, verbal or online scripts, consent addendums
  
  
• Recruitment materials, i.e., flyers, advertisements, website postings, letters, emails, social media posts, scripts for television or radio ads
  
  
• Study instruments, including:
• Questionnaires
• Interview questions
• Interview/focus group guides/scripts
• Drug diaries to be completed by subjects
• Tracking logs (temperature) to be completed by subjects
• Assessments specific to the study
  
  
• Communications/videos that will be shared with subjects that:
• Provide research-specific information to subjects including risks
• Disclose the study condition/treatment/arm to which they were assigned when a study has been unblinded
• Describe new information about study progress or study procedures
  
  

Depending on the study, the IRB may request additional documents required to make regulatory determinations.