Protocol Modification

Your research activities must be carried out as described in your approved IRB protocol. Any change to protocols approved under expedited or full board guidelines requires an official modification request to and approval by the IRB.

A request for modification of an approved protocol in IRBManager must be made by completing the Protocol Modification Request Form available in theIRBManager. Changes to any of the following must be submitted as modifications:

• Project Title
• Principal Investigators
• Advisor
• Sponsor (Funding source)
• Subject population
• Estimated # of Subjects
• Subject recruitment
• Inclusion/Exclusion Criteria
• Research Site
• Research Procedures
• Consent Form
• Assent Form

If you are unsure if the change you need to make requires an official modification request, please contact the IRB office at 405.744.3377 orirb@okstate.edu. Modification of a protocol does not change the original approval expiration date.

• Modification Review

Unanticipated Problems & Adverse Event Reporting

Federal regulations at45 CFR46.103 (b)(5)require written procedures for the prompt reporting of any unanticipated problems or adverse events involving risks to subjects, serious noncompliance, or suspension or termination of IRB approval to the appropriate institutional officials and the sponsoring agency, if there is one.

Adverse events are those which cause unanticipated harm to subjects or others. Unanticipated problems involve risks that are not explained in the consent process. To insure compliance with the federal regulations, the OSU IRB requires investigators to report any such occurrence to the IRB Chair within 24 hours of the event. A form for reporting these events and problems is available in theFormssection of this website.

Unanticipated Problems & Adverse Event Procedures