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

Per current IRB policy, once a study is closed to enrollment (as indicated on the Renewal submission), it cannot be reopened for additional enrollment. To ensure that the research follows current UTD / IRB Policies and Procedures regarding the protection of participants, a new Initial application must be submitted to conduct any new data collection procedures. There are no exceptions to this process.

If a study is approved for data collection and no enrollment has been conducted over the past four (4) years, the research activities should be limited to data analysis only (as indicated on the Renewal submission) as the study materials may not reflect current UTD / IRB Policies and Procedures at that time. A new Initial application can be submitted when the study team is ready to proceed with enrollment / data collection procedures to ensure that the research follows the required guidelines to conduct human subjects research (Policies / Procedures, Regulations, State Laws, etc.).

Exception Request

An exception to this process may be requested by submitting the IRB Renewal Enrollment Exception Request. Please note that the exception requires a reasonable justification indicating why the study should remain open to enrollment when no enrollment has been conducted over the past four (4) years.

Once the Renewal Enrollment Exception Request has been submitted, the IRB will review and determine if an exception may be granted. If an exception is granted, the Renewal approval will be released with stipulations that a Modification must be submitted to address the stipulations outlined on the Renewal approval letter. These stipulations could include requiring updates to the application and study materials based on recent updates to UTD / IRB Policies and Procedures, Federal Regulations, State Laws, etc.

Expiration of IRB Approval

Federal regulations do not make provisions for any grace period extending the research beyond the expiration date. The study expires at midnight of the date specified on the approval letter.

If a research study is not renewed prior to expiration, all research activities must be paused until the study has been renewed (except when doing so would jeopardize the welfare of the human subjects). In addition, any lapse in approval could negatively impact funding.

Administrative Closures: If a Renewal or Closure is not submitted within 30 days of the expiration date, the research study will be administratively closed by the HSR. Once a study is closed, a new Initial application must be submitted to resume research activities.