HOW WILL THE REVISED COMMON RULE AFFECT YOUR RESEARCH?

By law, the transition to the revised Common Rule is based on the status of initial applications on January 21, 2019. The IRBNet system shows the application status under BOARD Action located in the fifth column of your "My Projects" page.

THE “IN BETWEEN” APPLICATIONS FOR NEW STUDIES AS OF 1/21/2019

Application Status for New Studies
Version of the Common Rule

Work in Progress (Not Submitted)

Revised (2018 Requirements)

Pending Review

Revised (2018 Requirements)

Modifications Required

Revised (2018 Requirements)

Information Required

Revised (2018 Requirements)

Approved with Conditions

Revised (2018 Requirements)

Approved (studies prior to January 21, 2019)

Original (Pre- 2018 Requirements)

WHAT YOU CAN EXPECT

Continuing Review for Expedited Studies

No longer required for some minimal risk research, including studies where the only remaining activity is analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.  

Please note: These changes only apply to new studies that are not approved as of January 21, 2019 OR new studies submitted on/after January 21, 2019.  

You can expect to see the following changes:

1.  IRBNet Smart Form and Supplemental Form Changes
2.  Informed Consent Template and Optional Language Glossary Revisions
3.  IRB Policy Revisions
4.  For existing studies: There will be no change in process.  These studies will fall under the pre-2018 requirements. 

WHAT YOU CAN DO

  • Check this website periodically for new information.  We will continue to add information as it becomes available.   
  • Look for educational sessions on the IRB Office website.

DECISIONS MADE TO DATE

Exemptions – AU has decided to adopt the “limited IRB Review” under exemption #2 and #3 only.

sIRB - AU IRBs will continue to assess its criteria for whether AU will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.

Broad Consent - AU will not be adopting use of broad consent under exemptions #7 and #8 at this time.

Any changes made to IRBNet documents will still be housed in the IRBNet system under Forms and Templates.

RESOURCES