It is the IRB's expectation that all concluded studies will be officially closed with the IRB. The IRB considers a study concluded when the following conditions are met:

  • All subjects have completed all study 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.

This applies to student projects that recieved IRB review, internally funded studies as well as industry sponsored clinical studies.

How to submit a closure request:

Start by downloading the the closure request form (required after June 1, 2016)

Paper Studies: Download the closure form by clicking the highlighted text above. After completing the submission form, please print and send to the IRB office with one copy of each required supporting document. Documentation can be mailed to the address noted at the top of our submission forms or sent via University Intramural mail service to mailing code 6009. PI signature is required for all paper submissions.

HSERA Studies:

1. Download  the closure form by clicking the highlighted text above.

2. Complete the form. PI Signature is NOT required when submitting in HSERA.

3. Sign in to HSERA

4. On the Blue left side Menu click "Create" under "My Submissions"

5. On the next screen choose "Continuing Review"

6. On the next screen set the filter for the study you would like to create a submission for

7. When the appropriate study appears in the list, click the select button on the far right

8.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

9.On page 2 answer the Conflict of Interest question.

10. On page 3 attach any additional documents needed for the closure (such as Sponsor communications that support the closure of the study)

11. click "I Accept" at the bottom of page 3 - your closure submission is now complete.

 

 If you have questions about whether your study can be closed with the IRB , please contact any IRB administrator.