If the IRB determines that regular review is required for a study, the PI, PI Proxy and Primary Contact will receive notification of approaching continuing review deadline in advance of study expiry. If the study indicates an expiration date or you receive notifications from the system, submission of a continuing review request is required to maintain IRB approval.
This submission is used only to provide an update to the IRB when required. Changes to an existing study must be proposed via a separate modification submission. Please see What to include in a Modification SmartForm for steps to complete a modification submission.
Important! Updating the SmartForm does not send the submission for review. The PI or PI Proxy must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on for the next state of review.
To submit a continuing review or closure request to the IRB:
1. Log in to irb.harvard.edu
2. Navigate to an approved study workspace (see Accessing a Submission for more information)
3. Click the “Continue or Close Study” button
4. In the SmartForm, select the “Continuing Review” type of submission
5. Select “Continue” and complete the Continuing Review / Study Closure Information SmartForm Page
6. On this page of the SmartForm, complete the following items:
1. Specify enrollment totals. Enrollment includes the subjects who have undergone the initial informed consent process and who have agreed to participate in the research; or where a waiver has been approved by the IRB, enrollment includes the number of individuals whose data, documents, records, and/or specimens were utilized. Indicate enrollment totals in the table provided. This section is required and a value must be entered in every space.
Note: For studies with sites (created after December 2017) which have separate workspaces, visit the site workspaces to additionally complete the Report Continuing Review Data to report site-specific update details (including enrollment totals).
2. Research milestones for enrollment / analysis. The IRB will determine the mode of review (including if study closure is appropriate) based on what is marked in this space. Mark all items that currently apply. If subjects will continue to be enrolled or if no items apply, leave this section blank. To prepare, note that the following prompts appear in this space to mark, as appropriate:
- Study is permanently closed to enrollment OR was never open for enrollment
- All subjects have completed all study-related interventions OR not applicable (e.g. study did not include interventions, no subjects were enrolled)
- Collection of private identifiable information is complete OR not applicable (no subjects were enrolled)
- Analysis of private identifiable information is complete OR not applicable (no subjects were enrolled)
- Remaining study activities are limited to data analysis
- Study remains active only for long-term follow-up of subjects
Important! If the first four milestones are selected here, you will be required to confirm that you intend to close the study. If you do not intend to close the study, de-select the most appropriate item from the first four milestones.
3. Do any investigators or research staff have a financial interest related to the research that was not described in a previous application? Indicate yes or no in this space. Attach any relevant documentation to question 5 on this page of the SmartForm.
4. Check the items that are true since the last IRB review (initial review or last continuing review) for all sites approved by the Harvard IRB. Mark all true items and provide an explanation of any unmarked items in the progress report attached to question 5 on this page of the SmartForm.
5. Attach a brief summary of the study progress. Address each item left unchecked in question 4 by attaching documentation. Use the optional template provided in the Library to, as applicable, attach a progress report along with any other supporting documents that contribute to the review of the submission.
Reference the Library for any templates/forms that are requested within the SmartForm, along with guidance materials.
7. Follow the remaining steps to Edit a Submission or Save & Exit when edits are complete.
8. The PI or PI Proxy must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on to the IRB for review.