Graduate School

Consider the following before submission:

Do not submit a "RENEWAL" if other details of your project may need amending. 

*It is likely some aspect of your protocol may need amending -- such as updating your CITI training, extending the original Anticipated Project End Date, etc. If you need to amend any aspect of your protocol as well as renew it, please choose the "Renew and Amend" option.

1.     DETERMINE WHETHER CONTINUING REVIEW OR RENEWAL IS NEEDED

The “Renew” selection in Kuali is used to accomplish two different protocol processes; an investigator needs to submit a Continuing Review report for a full board or expedited protocol or they need to Renew a protocol about to expire.

• A Continuing Review report is federally required under §46.109 for all full board protocols and some expedited protocols the IRB deems as necessary. An investigator will submit this report no less than on an annual basis for research continuing more than 12 months, up to 3 years. In this report, the IRB considers aspects such as risk assessment and monitoring, adequacy of the process for obtaining informed consent, if any issues have arisen during the project and research progress.  Kuali will send an email notification reminder to the investigator 30 days prior to the date the Continuing Review report is due.
• At SIUE, a Renewal is required to continue research activities on protocols whose 3-year term is set to expire. The renewal process applies to all protocols reviewed as exempt, expedited or full board. Kuali will send an email notification reminder to the investigator at 60 days, 30 days, 10 days and 1 day prior to the date the protocol term expires. Submission 15 days prior to the expiration date is strongly encouraged to prevent a stop on research.

2.     SUBMIT CONTINUING REVIEW INFORMATION PRIOR TO EXPIRATION DATE

• It is the investigator’s responsibility to submit information for continuing review by the due date or incomplete submissions may not be reviewed by the IRB in time to obtain approval.
• The continuation of research after expiration of IRB approval is a violation of federal regulations. If the IRB has not reviewed and approved a research study by the study’s current expiration date, research activities must stop. No new subjects may be accrued.
• If the investigator is actively pursuing renewal with the IRB and believes that an over-riding safety concern exists or ethical issue is involved, the investigator must seek IRB permission to continue study procedures for the brief time required to complete the review process.

3.     PROTOCOL RENEWAL PERIODS

• Human research protocols may be renewed one time for an additional three-year period. If the research activities have not concluded by the end of the second three-year term and the investigator would like to further extend the project's end date, a new protocol must be submitted.
• A Classroom protocol is only valid for three years. At the end of the three-year term, the instructor must complete a new Classroom protocol. For further guidance, see SIUE's Classroom Protocols Guidelines.