Human
Subjects Research >>
Post-Approval Activities: |
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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 submit an email to humansubjects@muohio.edu with the name/s being added along with their unique ID (eg. Smithjm), the CITI completion date, the approved IRB number, Principal Investigator, and the title of the approved project.) |
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| Protocol Modification or Amendment Form >
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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. |
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| Application
for Continuing Review>
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| 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. |
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If
you have any questions about the submission process, please
contact Terri Brosius
(brosiutt@muohio.edu): 529-3600. |
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