The Independent IRB, Inc. accommodates each client with individualized procedures for protocol submission within the boundaries of regulatory compliance. Our goal is to simplify the IRB review process through proactive communication and personalized service. We are available for consultation throughout the protocol and informed consent form development process.

The following information and documentation is necessary for initial review of research study:

• Study Setup Form
• A brief Submission Letter requesting review and approval. Sample Submission Letter
• Research Protocol
• Investigator’s Brochure/Product Information
• Draft Informed Consent Form (or request the Independent IRB, Inc. to draft an ICF)

The following information and documentation is necessary for site approval:

• Complete Site Questionnaire
• Signed and dated Form FDA 1572 (if applicable)
• Copy of the current CV, License, and Human Research Protection Training (as applicable) for all Investigators listed on the Form FDA 1572 or the Site Questionnaire
• Advertisements, study materials, or subject material (if applicable)

We are glad to accept electronic submissions at submissions@iirb.com or by fax at (954) 327-5778. The Independent IRB, Inc. leadership is available for consultation to accommodate special request or unique considerations related to the research project.