Application
IRB Review
Independent IRB Review for Cell-Based Medicine
Physicians may present studies for review by requesting an Application for Review. ICMS provides a structured path for independent peer review conducted by people who understand cell-based medicine.
Determination
Confirm Timing
Timing is not a guarantee of approvalPresentation
Physician-Led
Requesting physician presents the studyOversight
Continuing Review
Includes adverse event reportingOverview
How IRB Review Works
ICMS gives physicians and researchers a structured path to independent peer review conducted by people who work in cell-based medicine and hold each protocol to shared standards.
The review process is built around patient safety, scientific rationale, informed consent, transparent oversight, and continuing accountability after approval.
Process
Review Pathway
Review brings together the study rationale, safety evidence, physician qualifications, and protections for participants.
Request the Application
Begin by requesting an Application for Review, then confirm the materials, review cycle, and presentation expectations for your submission.
Submit Required Materials
Provide safety evidence, physician qualifications, informed consent, inclusion and exclusion criteria, and the scientific and medical rationale.
Present for Determination
The requesting physician presents the study to the board, which evaluates it against patient-safety, ethical, and standards-based requirements.
Maintain Oversight
Oversight continues after approval through continuing review and serious adverse event reporting, keeping studies accountable over time.
Note: Submissions that are incomplete or materially changed during review may require additional documentation or board discussion.
Submission Materials
What Physicians Should Prepare
Ask ICMS for the application packet and confirm the materials required for your proposed study.
Study Protocol
Treatment plan, study objectives, clinical workflow, and supporting medical rationale.
Safety Evidence
Published evidence, risk analysis, and monitoring plan appropriate to the proposed therapy.
Physician Qualifications
Relevant training, clinical experience, facility information, and team credentials.
Informed Consent
Patient-facing consent language that communicates risks, alternatives, costs, and follow-up expectations.
Participant Criteria
Inclusion, exclusion, contraindication, and withdrawal criteria for the proposed study population.
Adverse Event Plan
Process for reporting serious adverse events and maintaining continuing review obligations.
Supporting Materials
Documents That Support Review
Explore the standards, consent guidance, and reporting materials that support study review.
Pricing & Timing
Confirm Pricing Before Submitting
Review pricing and schedule details should be confirmed directly with ICMS before submitting materials.
When are applications due?
Published instructions specify the first day of the review month. Confirm the current deadline and meeting schedule with ICMS.
How long does review take?
Published instructions describe determinations in 48 hours to 14 days. Ask ICMS for a current estimate; this is not a guaranteed turnaround.
Who presents the study?
The requesting physician should be prepared to present the study and respond to board questions.
What does review cost?
Contact ICMS for current review fees and payment instructions before submitting materials.
Request Review
Request an Application for Review
Contact ICMS to request an Application for Review and confirm whether your proposed study can be considered. Do not send patient records or confidential study materials with an initial inquiry.
- Tell ICMS who is requesting review and what study is being proposed.
- Receive the current application packet and submission instructions.
- Confirm review-cycle timing, materials, and any current fee schedule.
Contact ICMS by Email
Online submissions are not available. Email ICMS to confirm current availability and request instructions.
Do not send patient-identifying information, medical records, payment details, or confidential protocols in an initial inquiry.