*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: Investigators are responsible for submitting the 2018 Continuing review for each study.  If the continuing review is not submitted by the due date, the study will lapse and will not be eligible for the new regulation.  Please do not submit an amendment to obtain a determination from the IRB before the continuing review due date.

You can expect to see the following changes over the next month:

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: After the implementation date, the IRBs may choose to apply the new rules to minimize burden for investigators.

*WHAT YOU CAN DO*

  • Check this website periodically for new information.  We will continue to add information through January 2018, as it becomes available.   
  • Look for educational sessions on the IRB Office website.

*DECISIONS MADE TO DATE*

HHS Final Revisions to Common Rule

Exemptions – AU has decided to adopt the “limited IRB Review” under exemption #2 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 is determining if use of broad consent will e adopted under exemptions 7 & 8.

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

*RESOURCES*