Institutional Review Board Submission Protocol

Step 1: Initial Application Submission

Step 1.1: Begin by completing the initial application with the Initial Application Form. This form assists applicants in deciding which forms are needed for IRB review. Prepare the following common forms using the predesigned templates/forms. All templates and forms are found on the forms page.

  • Informed Consent Waiver Form
  • International Research Form
  • Study Protocol Form
  • Consent/Assent Form or include an Informed Consent Waiver Form

Step 1.2: Review and ensure compliance with regulations and ethical guidelines. Again, prepare the following additional form documents using the predesigned templates/forms. All templates and forms are found on the forms page.

  • Vulnerable Populations Form
  • Drugs, Biologics, Supplements, Botanicals Form
  • International Research Form

Step 1.3. Prior to submission to the IRB, submit your proposal to your program chair for review and approval. If you are the chair of your program, please have your faculty director review your submission. If you are a faculty director, please have one of your department chairs review your submission. Once all required documents are approved and reviewed, continue to the next step.

Step 1.4: Compile all documents into a comprehensive submission package. Submit the package as a single PDF to the IRB. Do this by emailing this document to Please cc in this message the current IRB chair ( to alert him of your submission.

Step 2: IRB response and investigator acceptance, revision, and resubmission, or rejection:

An IRB committee member will review your application and determine the required review level (exempt, expedited, or full board review). From there the IRB will communicate with the applicant regarding the submission. The Montreat College IRB aims for efficient and timely responses to investigators. The expected turnaround time is 1-2 weeks for exempt responses and up to 3-4 weeks for a full board review.

Step 3: The IRB requires yearly updates for ongoing projects. If you are working on a long-term study or project, prepare the following documents annually:

  • Continuing Study Review Form
  • Include your original submission document as well for IRB.