The ODH IRB Change/Renewal form should be used anytime that you need to alter or renew a protocol which has already been approved by the ODH IRB.  All requests for changes or renewals should clearly indicate your assigned ODH IRB number (20xx-xx) along with the nature of your request.  Please be sure to read the form carefully and provide any additional documentation requested.

Changes

Change applications fall under two categories:

1. Minor changes that can be approved by the Board Chair (i.e. adding an additional year’s worth of data, changes to research staff, or other small changes that do not affect the research subjects or their rights).

2. More significant changes that must go to the full IRB for approval (i.e. new components to the research, substantive changes to consent forms or questionnaires, or other large changes that affect the research subjects or their rights).

Change requests may be submitted at any time and are reviewed upon receipt.  However, if we determine that a change requires full board review, it will be subject to the same deadlines as new IRB applications.  It will be reviewed at the next meeting for which a deadline has not already passed.

Renewals

All ODH IRB approvals are good for one year from the date of issue.  The expiration date is indicated in the last paragraph of the approval letter.  Renewals can be approved by the Board Chair unless they include a request for substantive changes.

Researchers are responsible for tracking their expiration dates and submitting a request for renewal in a timely fashion.  We recommend filing for renewal at least two weeks prior to your expiration date.  One month or more should be allowed if you are also asking for substantive changes. 

We can accept renewal requests up to one year past the date of expiration.  Protocols more than one year past expiration must submit a new full application.

All Change or Renewal Applications must contain the following:

1. IRB Protocol Change or Renewal Form

2. A letter explaining the need for the change or renewal

3. Copies or any other documents (i.e. consents, questionnaires, scripts, etc.) being changed or added to the protocol.  If existing documents are being changed, please send both a track change version and a clean version of the revisions.

PLEASE NOTE:

• Change requests do not require that you revise your application form.
• Change requests do not require re-submission of any documents which haven't changed.