Review Requirements

Core materials

Physicians interested in presenting to the ICMS IRB should provide materials that allow the board to assess patient safety, scientific rationale, ethics, and physician readiness.

• Evidence of safety via animal models or other studies presented in peer-reviewed journals.
• Physician qualification and training.
• Patient informed consent.
• Inclusion and exclusion criteria.
• Scientific and medical rationale for the use of cell-based medicine.
• Adverse event reporting and continuing review plan.
• Any study protocol or clinical workflow documentation needed for review.

Meetings, pricing, and governance

Published ICMS instructions describe determinations in 48 hours to 14 days and require requesting physicians to present their study. Confirm current timing with ICMS.

Review schedule, meeting cadence, and fee structure should be confirmed with ICMS when requesting the application packet.

• Call ICMS for current IRB review pricing.
• Request current registration and oversight details directly from ICMS.
• ICMS members may apply to serve on the ICMS IRB.