Continuing Review/Protocol Renewals

The Renewal Submission electronic form in Cayuse Human Ethics is used for multiple purposes:

  • Submitting an annual administrative check-in (for studies without an expiration date).
  • Submitting a request for continuing review (for studies with an expiration date).
  • To allow for expiration date or administrative check-in date change, when requested by ORCA.

How often do studies need to be renewed?

Exempt and (in most cases) minimal risk non-exempt human subjects research studies will no longer be given expiration dates. However, yearly administrative check-ins will be required, as these studies must be reviewed by the IRB on an ongoing basis to ensure that the research continues to meet exemption criteria or criteria for IRB approval under the Common Rule (45 CFR 46).

Human subjects research studies that are determined to involve greater than minimal risk, and some (based on the IRB’s discretion) minimal risk non-exempt human subjects research studies, will be given expiration dates to allow for annual continuing review. Continuing review may also be required more often than annually, at the IRB’s discretion - for example, due to the nature of the study, degree of uncertainty regarding the risks involved, the vulnerability of the subject population, the inexperience of the investigator, prior noncompliance with the investigator or sponsor, or use of novel therapies.

Where can I find the administrative check-in date or expiration date for my study?

You can find the date on your approval/exemption letter. You can also find it by looking at the Study Details page in Cayuse Human Ethics. Cayuse Human Ethics will send reminder emails to the study Principal Investigator as the due date approaches, but it is ultimately the Principal Investigator’s responsibility to obtain continued approval. Failure to submit an administrative check-in may result in a processing hold being placed on all submissions from the Principal Investigator.

Creating a Renewal Submission

Renewal Submissions should be submitted at least 30 days prior to the study administrative check-in date or expiration date to allow time for processing and responding to ORCA/IRB feedback. It is strongly suggested that investigators begin the submission process 45 days prior to administrative check-in date or expiration date.

  • Log in to Cayuse Human Ethics.
  • Find your study on the dashboard in “Approved Studies” and select it.
  • In the top right corner select the “+ New Submission” button.
  • Choose “Renewal.”
  • Select the “Complete Submission” link and follow the instructions to fill out the submission.
  • When the submission is complete, follow the instructions for submitting.
  • The PI and the Co-PI (if applicable) will be sent emails with instructions for certifying the submission in Cayuse. Once all certifications are entered, the submission will be routed to ORCA.
  • Once ORCA has received the submission, you will receive an acknowledgment email. 
  • If a RUSH review is necessary for a study, e.g., to meet a funding award deadline, forward the Submission Received email to orca@ucsc.edu adding “RUSH Review Request” to the beginning of the email subject line and including a clear justification for the request in the body of the email. ORCA will review the request and may reach out to the Primary Contact/PI for additional information in order to determine if a rush review is warranted.

What does the IRB consider during continuing review?

When conducting an administrative check-in, the IRB/ORCA starts with the working presumption that the research, as previously approved, does satisfy the requirements at 45 CFR 46.111 or, for exempt studies, that the research meets the criteria for exemption. By conducting an administrative check-in, the IRB/ORCA ensures that the research continues to meet exemption criteria or the criteria for IRB approval. The IRB/ORCA may request clarification, revisions, and/or documents during administrative check-in. Research may be restricted, modified, or halted altogether based on administrative check-in by the IRB/ORCA. By regulation, the IRB has the authority and the responsibility to take appropriate steps such as terminating or suspending approval/exemption of research that is not being conducted in accordance with the IRB’s requirements.

When conducting continuing reviews, the IRB starts with the working presumption that the research, as previously approved, does satisfy the requirements at 45 CFR 46.111. By conducting a continuing review, the IRB ensures that the research continues to meet the criteria for IRB approval. During continuing review the IRB will review:

  • Risk assessment and monitoring: is any new information provided that would alter the IRB’s previous conclusion that (1) the risks to subjects are minimized, and (2) the risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result ?
  • Adequacy of the process for obtaining informed consent
  • Investigator and institutional issues
  • Research progress

See OHRP Continuing Review Guidance (2010) for more information.

The IRB may request clarification, revisions, and/or documents during continuing review. Continued IRB approval is not granted until all requested changes are made by the investigators and reviewed by the IRB. 

Research may be restricted, modified, or halted altogether based on continuing review by the IRB. By regulation, the IRB has the authority and the responsibility to take appropriate steps such as terminating or suspending approval/exemption of research that is not being conducted in accordance with the IRB’s requirements.

If a Study Expires Before Renewal

Investigators may not continue to conduct research activities involving human subjects beyond the study expiration date without IRB approval. Studies that have expired before a request to renew has been reviewed must cease all human subjects research activities until the IRB review has been completed and the study renewal has been approved.