Modifications

All changes to an approved research protocol (including changes to consent forms, recruitment scripts / flyers, study measures, personnel, protocol procedures / activities, etc.) must be reviewed and approved prior to the changes taking effect, except when necessary to eliminate immediate hazards to subjects. 

Modifications must be submitted through Cayuse. All changes must be outlined and explained in enough detail for Reviewers to understand the intent and purpose for all changes. If the needed modification affects protocol documents, such as recruitment scripts, consent forms, study measures, the updated or new versions must be uploaded to replace the previous versions (as appropriate).

Once submitted, the Human Subjects Research Office (HSR) will conduct a pre-review of the modification application and work with the PI to ensure the submission is complete and all required documentation has been uploaded. Once the pre-review process has concluded, the HSR will initiate the appropriate review.

Renewals

Effective January 21, 2019, the Revised Common Rule removes the requirement to conduct annual continuing reviews (Renewal applications) of ongoing research for studies approved through the expedited review process.  The requirement for annual renewal applications for studies approved under the Revised Common Rule is determined by the IRB on a study-by-study basis.

If the IRB determines an annual renewal application is not required, the study will be approved for a 2-year period. Investigators are required to complete the renewal application in order to continue the research every 2 years.

To allow adequate time for IRB review and to avoid any unnecessary delays, it is recommended that the PI submit a Renewal application through Cayuse 30 – 45 days prior to the study’s expiration date. The Renewal includes a status report on the progress of the research, including confirmation of or an explanation relating to the following (as appropriate):

• Current status of enrollment
• Number of participants consented to date
• Number of participants consented since the previous IRB Renewal
• Signed consent documents are on file and available for inspection
• Changes, reportable events, participant complaints, etc. were processed / reported consistent with UTD IRB policy and procedures
• Detailed description of the progress of the study, including summary of any interim findings and plans for the next approval period
• Any other relevant information, especially that may impact the risk / benefit ratio

Expiration of IRB Approval

There is no grace period extending the conduct of the research beyond the expiration date of IRB approval. The study expires at midnight of the date specified on the approval letter.

If the research is not re-approved by the study’s specified expiration date, all activities must cease, pending re-approval.

Administrative Closures: in cases where a PI does not submit a Renewal or a Final Report within 30 days of the expiration date, these studies will be administratively closed by the HSR. Once closed, a new initial application must be submitted to resume research activities.