Continue a Study
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The IRB is required to conduct continuing reviews to monitor the risk assessment of full board and expedited studies. This is to ensure continued protection of the rights and welfare of research participants and continued compliance with the approved protocol and research policies. This is accomplished through the continuing review submission form in iRIS.
Studies expire at 11:59 p.m. 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. If the study is still open at that time, the investigator will be required to submit a continuation request to extend the study.
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.
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 [PDF].
Attachments:
- Currently approved protocol.
- Currently approved consent/assent.
- Copy of last 5 signed consents/research authorizations and any assents that may go along with those 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 protocol/document changes are allowed at continuation. No serious adverse events (SAE) are to be submitted at continuation. These should be submitted separately using the form titled "Submit Serious Adverse Event Report." No major deviations/violations should be submitted at continuation. These should be submitted separately using the form titled "Submit Deviation/Violation/Misc."
- 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 participants enrolled.
- Participants– number of participants who have signed a consent (including screen failures). If there is a waiver of signed consent, it would be the number of participants you are obtaining data from.
- Number actively participating in the study procedures: Number of participants who are actively participating in the protocol procedures (including surveys, interventions, specimen collections, etc.), or you are currently still obtaining data from these people.
- Number completed: Number of participants who have completed all protocol procedures and you will no longer contact these people or obtain new data about them. This number should only reflect participants who completed ALL study procedures.
- Number withdrawn: Number of participants 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. This includes screen failures, voluntary withdraws, PI/Sponsor withdraws, participants who dies before completing all study procedures, etc.
- Number in follow-up only: Number of participants who have completed active treatment, however, you are accessing their data either by chart, in person, by home visits, or phone to gather data.
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.