PLEASE SUBMIT YOUR CONTINUATION REVIEW NO MORE THAN 30 DAYS (no later than 21 days) PRIOR TO EXPIRATION. THIS IS TO ENSURE THAT YOUR STUDY IS REVIEWED BEFORE EXPIRATION AND REMAINS COMPLIANT WITH FEDERAL REGULATIONS.
Continuation of a study
FDA and DHHS regulations require full board human subjects research studies to be reviewed on an ongoing basis throughout the life of the study. While the IRB may require an alternate schedule depending on the risks and nature of the study, the review interval may not exceed one year. Protocols approved under Expedited review are subject to IRB continuing review. For expedited studies approved on or after January 21, 2019 where the reviewer determines continuing review is not required, the IRB analyst will set an expiration date of three years minus a day from the approval date. If the study is still open at that time, the investigator will be required to submit a continuation request to extend the study.
Studies expire at 11:59pm on the expiration date. Once a study expires, all research activities must stop, including enrollment of new participants, interaction with current participants, and analysis of identifiable data unless the IRB finds it is in the best interest of individual subjects to continue participation in research interventions or interactions.
During the continuation review, the IRB considers all new information provided by the investigator, and determines whether it results in a change to the risk/benefit ratio of the research study. This review is a significant part of the IRB’s duty to continuously monitor a study.
The IRB reviews the recruitment process, the informed consent process, and the continuing safety of the subjects. Federal regulations require the continuing review to be performed at least annually, but may also be performed at intervals specified by the IRB depending on the risk level associated with a research study. For multi-year research, the investigator is responsible for submitting the continuation application prior to the expiration date of the current IRB approval in order for the IRB to make these determinations.
If closing a study STOP, please use the study Closure Button.
Steps for a successful submission for continuation:
When you complete a Continuing Review Application in iRIS, It’s local policy for the consent documents (if the study is open to enrollment) and the protocol to be attached to the continuing review application for the IRB to review. These documents are already existing in iRIS and should be pulled into the continuation review submission from iRIS rather than uploading new external documents. The stamped consent forms/assent forms and current protocol can be pulled into the submission follow the instructions outlined in Guide 38.
- Currently approved protocol.
- Currently approved consent/assent (for medical studies, the combined consent/authorization must now be used).
- Copy of last 5 signed consents/RA’s and any assents that may go along with those consents. We prefer 5 different subject consents.
- If the study is industry sponsored, a copy of all monitor visit reports.
- If the study has a DSMB/DSMC, a copy of the interim analysis reports.
No changes are allowed at continuation.
No SAE’s are to be submitted at CR. These should be submitted separately using the Serious Adverse Event Reporting form.
No major Deviations/Violations should be submitted at CR. These should be submitted separately using the IRB Deviation/Violation/Misc. form.
How to calculate your subject totals:
- Total number enrolled –
- Chart/Data study – number of people’s data accessed.
- Specimen study – number of specimens obtained or if there is a consent, number of subjects enrolled.
- Subjects – number of subjects who have signed a consent (including screen failures). If there is a waiver of signed consent, it would be the number of subjects you are obtaining data from.
- Number of subjects currently under study: Number of subjects who are actively participating in the protocol procedures, or you are currently still obtaining data from these people.
- Total number of subjects completed: Number of subjects who have completed all protocol procedures and you will no longer contact these people or obtain new data about them.
- Number of subjects withdrawn: Number of subjects who have not completed all the protocol procedures, or who are screen failures and you will not have any further contact with them or their data.
- Number of subjects in followup: Number of subjects who have completed active treatment, however, you are accessing their data either by chart, in person, by home visits, or phone to gather data.
Lapse in Approval
If an investigator has failed to provide continuing review information to the IRB by the required date, and the research has expired before the annual review approval has been issued by the IRB, all research must stop. The investigator will be sent a notice that the research has expired and that no human subjects activity, including enrollment or recruitment, may take place on or after the expiration date. The investigator will have 30 working days from the date of the expiration notice to obtain continuing review approval for the research, or it will be administratively closed by the IRB and the Dean/department chair will be notified of the non-compliance. After closure, the study must be submitted as a new study. For more information on this topic, please refer to the HSPPO Policy Manual.