PROGRESS REPORT: Annual Report or Continuing Review, and Final Report

 

All IRB protocols require periodic reporting as mandated by the committee during the approval.  Most protocols that have been assigned "exempt" do not require annual reporting.  However, the IRB or the Office of Compliance may require annual reporting or may direct the researchers to submit a report under certain conditions that require continuous IRB oversight.  

 

Annual Report or Continuing Review:

This can be treated as a project report.  Currently, Summer of 2017, researchers are required to submit an annual report for their study by the deadline posted in their approval notice.  Starting from Fall of 2017, the requirement will be spelled out more explicity.  Those protocols that do not require continuous IRB oversight will have the option to continue the protocol for the entire 3 years without having to request a continuing review.  Protocols that do not qualify for this exception would be required to submit a continuing review.   The researchers will be asked to provide interim status of the study with any results that have been generated during the reporting period.  The IRB will evaluate if the results of the finding could potentially harm the reputation or cause disadvantages to any of the participant pools.  

 

Final Report or Close out:

Researchers will use submit a detailed report explaining the entire project, important achievements or understanding, any issues faced during the research in the context of participant safety, main results of the research and other details.  The IRB will evaluate the study results to ensure that the finding would not constitute to any inadvertant harm to a study group or participant pool.  Once the IRB has approved the study results are safe for the participants, then the protocol will be closed at the request of the researcher. Depending on what was allowed in the protocol's data analysis section, the study investigators can disseminate the findings accordingly.  The investigators must store research and participant records as assured in their protocol for an additional three years starting from the date of protocol closure.  

 

Click here for Post-Approval Responsibiities

 

 

 

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