Step 5: After Approval

Modifications

Expedited or Committee Level Studies Exempt Studies The IRB must review some, but not all, modifications to exempt submissions. More information on modification requirements for exempt studies are outlined in the Investigator Manual. The IRB must review and approve any planned modifications (i.e.,any change to the approved study protocol recruitment or consent materials and processes; data collection instruments, etc.) for studies approved at the expedited or committee level. The study team cannot enact the changes until the modification is reviewed and approved by the IRB. Study team members cannot engage in any research activities until approval is received from the IRB.

Reportable New Information

A Reportable New Information (RNI) submission is generally required when an unexpected occurrence takes place during the course of a study. An RNI must be submitted through CATS IRB within 5 business days after the Principal Investigator (PI) has become aware of the information.

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

To find out more about information to be reported to the IRB, see the Investigator Manual.

 

Prior IRB approval is not required for modifications intended to eliminate an apparent, immediate hazard to a subject. These changes must be reported to the IRB as Reportable New Information.

Ongoing IRB Reviews

The IRB does not require Continuing Reviews or Annual Administrative reviews for studies determined to be exempt.

Studies approved at the expedited or committee level require completion of either a Continuing Review or Administrative Review at least annually or as otherwise determined by the IRB. The IRB approval letter for a study indicates which periodic review is required. Several reminders will be sent to the PI, PI Proxy, and Primary Contact as the Continuing Review or Administrative Review deadline approaches.

Continuing Review

For the Continuing Review, the IRB requires information on

  • the progress of the study,
  • enrollment status & numbers,
  • information that may affect continued approval.

Modifications can be submitted with a Continuing Review, though certain limitations apply.

Administrative Review

If an expedited study does not require Continuing Review, the investigator will be required to submit an Administrative Review form. The Administrative Review does not require the IRB to re-review the study but allows the IRB to track ongoing studies and ensure that investigators are following all other reporting requirements, such as submitting modifications and/or submitting RNI.

Post-IRB Approval

All studies, regardless of review level, may be subject to a post-IRB approval review. The purpose of these reviews is to help investigators stay in compliance and to monitor compliance with the IRB approved protocol.Most of these reviews are routine “not for cause” reviews. Reviews requested by the IRB or IRB Leadership to investigate allegations of non-compliance or other RNI are “for cause” reviews.

 

If the Continuing Review or Administrative Review form is not completed and submitted to the IRB by the due date provided by the IRB, the study will be closed. If the study is closed, the study cannot be re-opened and all human research activities must stop. 

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 about clinical research requirements.

Closing a Study 

In order to close a study, a Continuing Review must be submitted in CATS IRB (even when Continuing Review is not a requirement for the study). In the Continuing Review form, indicate that the following four milestones have been met:

  1. The study is permanently closed to enrollment
  2. Study interventions with participants have ceased 
  3. No identifiable information is being collected
  4. The analysis of the identifiable information has concluded

Checking these four boxes will trigger the study closure.