If you are a physician or researcher interested in working under an IRB in order to establish safe, compliant protocols for regenerative and cellular therapies, IRCM is fully accredited and capable of working with you. Our reviews are conducted by a sophisticated board with an in-depth knowledge of  regenerative medicine, from patient advocates to physicians to researchers.

Because our aim is to help and guide sponsors and investigators who wish to responsibly move this industry forward, we begin working with clients at the pre-submission stage. This allows us to determine, in advance, that final submissions will maintain patient safety and are rigorously compliant. This review of the protocol to make sure it meets criterion avoids the need for resubmissions and expedites the process.

Please call 888-664-8893 if you would like to discuss your proposed protocol and determine if it’s suitable for an IRB. Pricing is industry standard.

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Submitting an IRB: What is Required

A submission form is required for each protocol to be reviewed.

You will need the following information in order to complete the IRB submission.

We will work with you on making sure the submission is complete and accurate, but these elements are required:

Overview

  • Title of Study (Should be descriptive)
  • Protocol Number (This is your reference #)
  • Principle Investigator (Who bears legal responsibility)
  • Study Coordinator (Who will be running the trial)
  • Site (location & description; nearest ER)
  • Sponsor (Who is paying for the investigation)

Protocol Summary

  • Purpose (Safety? Efficacy? Device testing?)
  • Justification/Rationale (treatment feasibility)
  • Background/References (medical literature)
  • Current Standard of Care (alternate treatments)
  • Primary and Secondary Endpoints (data, timing)

Subject Population

  • Characteristics (Number, gender, age, ethnic background)
  • Inclusion & Exclusion Criteria (conflicting health conditions, etc.)
  • Vulnerable Population (if not excluded)
  • Enrollment (method of recruitment)
  • Risk Factors (minimal or greater than minimal)
  • Process of Consent (document, how obtained, timeline)
  • Cost to the Subject/Payment for Participation (if any)

Study Design

  • Pre-Treatment
  • Baseline Data Collection
  • Procedure Description (e.g. lipoaspiration, injections)
  • Risk/Benefit Assessment (safety assessment)
  • Follow Up (clinic visits, ongoing data collection)
  • Resolution (end points, time period)
  • Adverse Event Reporting
  • Data Storage/Maintenance of Records

Other

  • Roles of study team members substantially involved
  • Confirmation of adequate training for staff
  • Assurances of patient privacy protection
  • Mechanism for injury insurance

COST

  • Submission of first IRB application:  $1,500
  • Second study by same investigator:  $750
  • Additional sites for same IRB study: $500
  • Annual reviews and amendments:    $250
Submission Form

Full Name (required)

Company

Best Contact Number (required)

Email Address (required)

Subject

Your Message