Submit a Protocol

Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018

The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.

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If your project is BOTH Research and Research with Human Subjects, you are required to submit a protocol to the IRB for review and approval.

Protocols are reviewed by the IRB via 3 review processes: 1. Exempt, 2. Expedite or 3. Full-board. What type of review is appropriate for your research?

Check out the Exempt and Expedite/Full-Board sections of our website for complete details on the three review methods.

If you have questions about which review criteria fits your study, please feel free to contact an IRB Coordinator.

Types of Reviews

Exempt

  • Can be Submitted at any time
  • Exempt determination made by voting member of the IRB
  • 1 IRB Administrator and/or Voting Member of IRB
  • 2-4 week review (target time)

Expedite

  • Can be submitted any time
  • Expedite determination made by IRB
  • Minimum 2 voting members of the IRB
  • 3-5 week review (target time)

Full Board

  • Due by 5:00 p.m. on the 1st Thursday of each month.
  • 4-5 week turn-around; Comments to PI within 7-10 working days after full board committee meeting

eProtocol Tips & FAQs

Question Tip Sheet
eProtocol Homepage at a Glance Homepage at a Glance
Personnel Screen Managing Personnel
Basics of Creating a Protocol Creating a Protocol
How to Respond to the IRB’s Comments Respond to IRB
How to Create & Submit an Amendment Amendment
How to Create & Submit a Continuing Review Renewal
How to Create & Submit a Final Report Final Report
Why don’t I see the option for the form I would like to submit? What Forms Are Available
Where is my approval letter? Approval Letter