Many of the documents in the Click IRB library have undergone recent revisions. Revised documents have a version date of September 2019 or later.

Why are Click Library documents revised?

  • Revisions to documents in the Click IRB library are required when there are regulatory/policy changes or content needs to be clarified.
  • Study teams should use the most recent library documents and should not use older versions. Using older versions may result in re-work for your study team or possibly being non-compliant with regulatory changes.
  • If you have questions about these changes, contact the IRB for more information.
    • Study teams should be familiar with the Revisions to the Common Rule.
      • The term “Common Rule” refers to the federal policy for the protection of human subjects that has been adopted by multiple federal agencies.
      • Revisions to the Common Rule changes are effective as of January 21, 2019.
        • Studies approved prior to January 21, 2019 fall under the previous Common Rule.
        • Studies approved on or after January 21, 2019 fall under the revised Common Rule
        • To see the content of the Common Rule, visit the OHRP website and select the “Regulations, Policy, and Posting” section, where you can access the previous and current regulations.
      • Highlights of the changes associated with the Common Rule Revisions include:
        • New required elements and structure of informed consent forms
        • New and revised exempt categories
        • New and revised definitions
        • Changes in requirements for consent waivers
    • Because studies approved prior to January 21, 2019 will still be subject to the previous Common Rule, the Click IRB library has content to support studies approved under both the previous and the revised rules. Study teams will need to know which Click IRB Library documents (or content within the document) are associated with their IRB studies.
    • If a Click IRB library document (or content within the document) is specific for either the previous or the revised Common Rule, the document or its content will be labeled to indicate which rule applies. Use the following as a guide to understand which document (or content within the document) is applicable to a particular study:
      • IRB study approved before January 21, 2019
        • Previous Common Rule applies
        • Terminology in Click IRB Library documents: “Pre-2018 Requirements” or “Old Regs”
      • IRB study approved on or after January 21, 2019
        • Revised Common Rule applies
        • Terminology in Click IRB Library documents: “2018 Requirements” or “New Regs”

Highlights of September 2019 Click IRB Library Revisions