It is the IRB’s expectation that all concluded studies will be officially closed with the IRB.
This applies to exempt research, expedited research that does not require continuing review, student research, internally funded studies as well as industry sponsored clinical studies.
When May a Study Be Closed?
The IRB considers a study concluded when the following conditions are met:
- All subjects have completed all research related visits and procedures
- There is no further contact with subjects needed for reasons related to research
- Any data sets under analysis for manuscript and publication writing have been stripped of all identifiers and further access to identifiable subject data is no longer required, and
- If the study is investigator-initiated and posting on clinicaltrials.gov was required: the results have been posted on clinicaltrials.gov and a copy of the confirmation that results were received is being submitted to the IRB.
How To Submit A Closure Request
Below are instructions for how to close a study that underwent expedited or convened review.
- Download the closure form from the IRB Forms page.
- After completing the submission form, have it signed by the PI, and scan it.
- Compile electronic versions of any other relevant study documents as well.
- Email the signed closure form and any other documents to the IRB PO box so that the closure submission may be reviewed electronically.
- Download the closure request form
- Complete the form. PI Signature on the form is NOT required when submitting in HSERA. The PI signs off electronically in HSERA.
- Sign in to HSERA
- On the Blue left side Menu click “Create” under “My Submissions”
- On the next screen choose “Continuing Review”
- On the next screen set the filter for the study you would like to create a submission for
- When the appropriate study appears in the list, click the select button on the far right.
- On page 1 of the Continuing Review application, choose “Expedited” level of review and attach your completed Closure form instead of attaching a continuing review form.
- On page 2 answer the Conflict-of-Interest question.
- On page 3 attach any additional documents needed for the closure (such as Sponsor communications that support the closure of the study)
- Click “I Accept” at the bottom of page 3 – your closure submission is now complete.
How to Close an Exempt Study
To close a study that received an exemption from ongoing review, it is not necessary to submit a closure form in HSERA. You may email the IRB PO Box and state that the study is closed.