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Post-Approval Activities:


Any changes to an approved protocol that could effect the risk level or consent process must be reviewed and approved of by the IRB prior to the initiation of those changes. An example of changes that would not effect the risk level would be the decision to remove some questions from a survey. Examples of changes that would change the risk level or consent process include: adding questions to a survey, altering the consent form content in any way, or increasing the number of interventions with the subjects. (If you are ONLY adding project personnel, please use the new Personnel Form and submit by email attachment to humansubjects@MiamiOH.edu.

 
Protocol Modification or Amendment Form >
Personnel Form

No protocol can be approved for a period exceeding 1 year without review by the IRB. Submit a status report to the IRB approximately 11 months following the most recent review. Continuing projects include any project for which data is being collected or researchers are actively working with the data. Using this form, researchers can also request that a protocol be closed (data is not being collected and retained data does not include information that would identify subjects). In some circumstances, protocols may be closed while maintaining identifying information.

 

Application for Continuing Review>

Any protocol not reviewed within that 1 year period will automatically expire. Continuation of the regulated research beyond 365 days since the last review will require research to stop and a new protocol application and complete review.

If you have any questions about the submission process, please contact Jennifer Sutton (suttonja@MiamiOH.edu): 513-529-0454.

 

Please contact The Office for the Advancement of Research and Scholarship if you have questions about this web site:
513-529-3600 or email: sullivnh@miamioh.edu

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