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 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 you recieve approval from the IRB to do so. 

If your study was determined exempt, the IRB must review some, but not all, modifications. The modifications that need IRB approval vary depending on the nature of the research. More information on modification requirements for studies determined exempt are outlined in the Investigator Manual.  

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.

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 and Administrative Reviews

If your study was approved at the expedited or committee level, you must submit either a Continuing Review or Administrative Review form at least once a year. The IRB approval letter for a study indicates which periodic review is required. You will receive several reminders as your continuing review or administrative review deadline approaches.  

If the study requires continuing review, the IRB must re-approve the study on a regular basis, usually once a year. For the continuing review, you provide information on the progress of your study, such as enrollment status and enrollment numbers, and the IRB takes this information into account as it re-assesses the study to decide whether and under what circumstances it can extend approval for the research. You can also submit modifications as part of your continuing reviews, though certain limitations apply. If approval of a continuing review is not granted prior to the end approval date, all study procedures must stop because IRB approval has lapsed. If a study is in a lapsed state for 45 days, the study will be closed with the IRB and cannot be re-opened. 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.

If an expedited or committee level study does not require continuing review, the investigator will be required to submit an administrative review form annually. The administrative review does not require the IRB to re-review the study, but is a process by which the IRB will track ongoing studies and ensure that investigators are following all other reporting requirements. If the form is not completed and submitted to the IRB by the due date provided by the IRB, the study will be closed with the IRB. If the study is closed, the study cannot be re-opened and all human research activities must stop because the study no longer has IRB approval.

The IRB does not require continuing reviews or annual administrative 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, 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, please see the Office for Research Protections Quality Management page on post-IRB approval reviews.

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. At any time, close a study by submitting a Continuing Review, even if continuing reviews are not required for the study. In the submission, indicate that the four milestones have been met.