The Office of Human Research Protections (OHRP) has announced changes to the federal regulations that protect the rights and welfare of human research participants, known as the Common Rule. 

Effective date for implementation of the Revised Common Rule was January 21, 2019. OHRP provides training videos and resources for investigators/researchers.

Changes to the Regulations

Please note: These changes only apply to new studies approved on/after January 21, 2019.

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.

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.