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.