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.
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