As of January 21, 2019, the federal regulations for the protection of human subjects at 45 CFR 46 (Common Rule) have changed.

Keep reading to determine how these changes may impact you and your research!

 1.      For studies that have received IRB approval by the UTA IRB prior to the compliance date of January 21, 2019:  Don’t worry, your study is still approved by the UTA IRB!  All studies that were approved prior to 1/21/2019 will remain approved by the UTA IRB under the previously determined IRB approval category, and no changes are needed to maintain IRB approval.  

In other words, studies which were previously determined to be exempt, expedited or full board under the “old” regulations will still be classified under the appropriate pre-2018 categories, and Continuing Review will still be required on an annual basis for both Expedited and Full Board studies approved under the “old” regulations. 

Studies which were approved under the UTA Internal IRB Review categories for “Minimal Risk” and “Greater than Minimal Risk” research will still be approved under those internal review categories as well.  However, if a study that was previously approved under the UTA internal categories receives federal funding after January 21, 2019, then the IRB protocol application must comply with the new federal requirements of the Final Revised Common Rule. 

Researchers are required to notify Regulatory Services when a study receives federal funding; Regulatory Services will then ensure that the study is in compliance with the applicable regulations.

 2.      For studies that are federally funded and are approved after the federal compliance date of January 21, 2019:  All new studies that are federally funded are required to be reviewed under the requirements of the Final Revised Common Rule as of January 21, 2019.  There are no exceptions to this requirement, regardless as to whether a study was originally submitted to the IRB and / or IRB Office prior to the January 21, 2019 compliance date.  This may result in studies being returned for revisions in order to comply with the full requirements of the Final Revised Common Rule.

 3.      For studies that are FDA regulated – i.e., involve a clinical investigation of an FDA-regulated product like a drug or medical device:  At this time, the FDA has not issued updated regulations to harmonize with the requirements of the Final Revised Common Rule.  Therefore, per Guidance issued by the FDA, UT Arlington will continue to review FDA-regulated studies in accordance with FDA’s regulations, 21 CFR parts 50 and 56 (which have not been changed).

In any cases where a study is both federally funded and FDA-regulated, then the study is subject to both 45 CFR 46 and 21 CFR parts 50 and 56. In these cases, where regulations differ, the regulations that offer the greater protection to human subjects will be followed.

4.      To find more information about the requirements that have changed due to the Final Revised Common Rule: The Office for Human Research Protections (OHRP) has compiled a list of resources about the Final Revised Common Rule.  Additionally, CITI has compiled a library of Final Rule Resources.

If you are submitting an IRB application after January 21, 2019, make sure to use the most current version of all IRB Forms and Templates to ensure compliance with the requirements of the Final Revised Common Rule!

If you have any questions about these regulatory changes, or if you would like to schedule a presentation for your class or department about these changes, please contact us at RegulatoryServices@uta.edu.