Built for compliance, designed for trust.

BioStori recognizes that participant-facing recruitment and educational materials may require Institutional Review Board (IRB) review and approval prior to use. The FDA considers recruitment materials part of the participant recruitment and informed consent process, and IRBs commonly review advertising and recruitment content to ensure materials are accurate, balanced, and not coercive.

Our workflow is designed to streamline this process by organizing materials for review as complete content packages, including:

• Video scripts and interview questions
• Final edited videos
• Post copy and captions
• Comment response libraries
• Direct message response templates
• Landing page content
• Recruitment call-to-action language

By preparing these materials together, study teams can reduce administrative burden while maintaining appropriate oversight.

Protecting participant privacy is a foundational principle of clinical research.

BioStori does not publish participant information without appropriate authorization and approval. When participant stories, testimonials, images, or videos are used, we recommend obtaining written authorization that clearly defines:

• What information may be shared
• Where it may be shared
• How it may be used
• The participant's right to revoke authorization, when applicable

HIPAA generally requires authorization before protected health information (PHI) is used for marketing or promotional purposes, including testimonials, photos, and videos that identify a patient.

Patient experiences are often one of the most powerful tools for building trust and helping prospective participants understand what clinical trial participation may involve.

When incorporating patient perspectives, BioStori's approach emphasizes:

• Voluntary participation
• Written authorization and media release documentation
• Respectful and accurate storytelling
• Clear distinctions between personal experiences and study outcomes
• Avoidance of misleading efficacy claims

Patient stories are intended to provide perspective—not guarantees regarding treatment results.

Social media presents unique opportunities for participant education and engagement, but it also introduces regulatory considerations.

BioStori works with sponsors and research teams to establish predefined communication guidelines for:

• Public comments
• Direct messages
• Frequently asked questions
• Participant inquiries
• Escalation procedures

Where required, response libraries and communication templates can be submitted as part of the IRB review package to ensure consistency and compliance throughout the campaign lifecycle.