Step 5: After Approval

Modifications 

If your study was approved at the expedited or committee level, the IRB must review and approve any modifications you plan to make to the IRB approved study (i.e., any change to the approved study protocol; recruitment or consent materials and processes; data collection instruments; etc).  To receive IRB approval, you must submit a Modification through CATS IRB.  The study team cannot enact the changes until the Modification is reviewed and approved by the IRB.  For study team members, this means that members cannot engage in any research activities until approval has been received by the IRB to do so. 

You do not have to get prior approval from the IRB for a modification intended to eliminate an apparent, immediate hazard to a subject, but you do have to report the change to the IRB as Reportable New Information according to the timeline outlined in the Investigator Manual. This will be handled by the IRB accordingly. 

If your study was determined to be exempt, only certain types of modifications are required to be submitted for prior review and approval by the IRB.  More information on modification requirements for studies determined to be exempt are outlined in the Investigator Manual.  

Reportable New Information 

Under some circumstances, you must submit reportable new information (RNI) to the IRB.  RNI includes but is not limited to the following:  

  • Information that indicates a new or increased risk to subjects or others 
  • A subject or others experiencing unexpected harm probably related to study procedures 
  • Non-compliance or allegations of non-compliance with federal regulations governing human research or with the IRB approved study protocol or determinations of the IRB 
  • A failure to follow the approved study protocol 
  • A breach in confidentiality 
  • A change in study procedures to eliminate an immediate hazard 
 

RNI must be submitted through CATS IRB within 5 business days after you have become aware of the information. For more information on Reportable New Information and reporting requirements please see the Investigator Manual.  

Continuing Reviews 

If your study was approved at the expedited or committee level, you must submit a Continuing Review at least once a year.  You will receive several automatic reminders from CATS IRB as your continuing review deadline approaches.  The continuing review is where you document the progress of the study, including enrollment status and enrollment numbers.  You can submit modifications as part of your continuing reviews, though certain limitations apply.  If you don’t get approval for your continuing review on time, you must stop all study procedures, because your IRB approval has lapsed.  If the Principal Investigator believes it is necessary to continue a subject or subjects in a lapsed study for safety reasons or otherwise, contact your IRB Analyst with a specific request and wait for official communication prior to such continuation.  

The IRB does not require continuing reviews for studies determined to be exempt. 

Clinicaltrials.gov

Federal law requires that certain studies involving a drug, device, or biologic be registered on clinicaltrials.gov. For certain NIH-funded studies, funding is contingent on registration, and for some journals, publication is contingent on registration. Learn more at our page on clinicaltrials.gov

Post-IRB Approval Reviews 

Any study approved or determined to be exempt by the IRB is subject to a post-IRB approval review.  Most of these reviews are not for-cause; they are what we call “routine” reviews. The purpose of these reviews is to help investigators stay in compliance or to monitor compliance.  Reviews may also be requested by the IRB or IRB Leadership to investigate allegations of non-compliance or other RNI, and these would be “for cause” reviews.     

To learn more about post-approval reviews, please see the Office for Research Protections Quality Management page

Closing a Study 

You can close a study with the IRB when it meets four conditions:  1) The study is permanently closed to enrollment; 2) you are no longer conducting study interventions with participants; 3) you are no longer collecting information that identifies participants; and 4) you have completed the analysis of identifiable information.  Request study closure by submitting a Continuing Review and indicating that these milestones have been met at any time during the course of a study, regardless of review level.