The CPHS reviews active protocols every 12 months unless it is determined that the research involves potential harm to human subjects that requires more frequent review. Note: Reviews must continue as long as identifiable data is being analyzed, even if subjects are no longer in contact with the study and all follow-up visits have ended.

PIs are notified via email when the next continuing review is due (due dates are also available in the protocol information in iRIS). Continuing review applications must be submitted by the fifteenth of the month prior to the expiration month of the protocol. If the continuing review materials are not submitted by this date, the PI is notified the protocol will expire and all enrollment and research activity must stop. There are exceptions in the event that stopping a study would be harmful to the human subjects enrolled, but the CPHS must approve any exceptions.

The continuing review considers the same criteria as in the initial full review as well as any modifications to the protocol, and they include the following.

1. A current risk-benefit assessment is made based on study results, including a review of all reported unanticipated problems and serious adverse events. CPHS shall determine whether the level of risk has changed from the last review.
   
2. Selection of subjects continues to be reasonable and impartial.
   
3. When reviewing the current informed consent document(s) the CPHS shall ensure the following:
   a. Whether the currently approved informed consent document is still accurate and complete;
   b. Any significant new findings that may relate to the participant’s willingness to continue participation are provided to the participant.
4. Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data are provided, when appropriate.
   
5. There continues to be adequate provision for monitoring the data collected to ensure the continued safety of the participants, when appropriate.
   
6. Appropriate safeguards for vulnerable populations are provided.
   

PIs are notified via iRIS as to the result of the CPHS review.

UTHealth’s Compliance Hotline (1-888-472-9868)
For other questions, please call us at 713-500-7943.