Post Approval

After receiving an exempt determination or IRB approval, additional submissions may be required for your study, including modifications, renewals, reportable incidents, and closure reports.  

These must be submitted in Cayuse HE:

  1. Log in to Cayuse HE
  2. Ensure Product selection is set to Human Ethics
  3. In My Studies section, select the study  
  4. Click on New Submission
  5. Select Modification, Renewal, Incident, or Closure as appropriate

Screenshots and videos to assist with completing these submissions in Cayuse HE is also available here: Cayuse HE Training and Advising.

Modifications

Modifications to IRB-approved studies must be reviewed and approved prior to initiating the change(s). All applicable changes must be identified in the modification submission and incorporated into the relevant sections of the study application and any applicable attachments.

For studies determined to be exempt, many minor revisions do not need to be submitted for review. Please see the When to Submit Project Revisions sheet for more information.

The federal regulations allow for expedited review of minor changes to studies previously approved by the full board. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:

  • The level of risks to subjects
  • The research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change)
  • The number of subjects enrolled in the research (no greater than 10% of the total requested)
  • The qualifications of the research team (change in PI is not considered to be minor)
  • The facilities available to support safe conduct of the research, or
  • Any other factor which would warrant review of the proposed changes by the convened IRB or was used to initially to evaluate the risk: benefit ratio or any other criteria for approval

The HRPP will determine the appropriate review process upon receiving the modification.

Renewals

It is the responsibility of each investigator to be aware of when their study expires and to complete a renewal submission (or closure submission) to the HRPP at least 30 days prior to the expiration date. If a study expires prior to the submission of the renewal request, the study will be closed, and human subject research activities must stop, and a new application must be submitted for review and approval. No research activities, including data analysis, may be conducted in the absence of current IRB approval.

Exempt determinations are valid for five years. Renewals are not required for these projects, but if there is a plan to extend the study beyond five years, the investigator should submit a renewal. Final reports may be submitted before the end of the five-year period if the study is complete.

Incident reports

Reports related to protocol deviations, adverse events, and unanticipated problems must be submitted to the IRB within the required timeframe. Please see sections 12 and 13 of the HRPP Policy and Procedure Manual for more information.

Closure reports

Closure reports should be submitted by the study expiration date or sooner if all study activities, including data analysis, are complete.