[Irb] Change in frequency of progress reports

[Snyder, Hillary Morgan]

Greetings,
I want to inform you of a change in frequency of progress reports for studies that do not require continuing review.

Current Process:
To enable the UToledo HRPP to track which human subjects research studies remain active and ongoing, a brief ANNUAL progress report in IRB Manager has been required. The PI receives automatic due date notifications from the electronic system. The progress report involves answering a few questions.
Events which meet prompt reporting requirements are required to be submitted to the IRB via IRB Manager. These include events that are serious, unexpected, AND related/possibly related to the research; unanticipated problems involving risks to subjects or others; protocol deviations; etc.  For more information, see procedures on the HRPP website: https://www.utoledo.edu/research/rsp/irb/guidance.html
UToledo human subject policy (3364-70-05) requires that the PI submit this progress report or, if the study is complete, a Final Report form to close the study.  If the progress report is not submitted, the study is administratively closed and human subjects research may no longer be conducted as part of that study.  If a PI does not submit the progress report or final report, the UToledo IRB has the authority to withhold approval of subsequent research applications from that investigator.
Change to process:

  *   Progress reports will be required once every THREE years, instead of annually.

What you might notice:
To avoid all studies coming due for progress report in 2024, we are staggering the due dates for currently approved studies.  On or before July 2, 2021, you will notice that your progress report due date is in 2022, 2023 or 2024.  Thereafter, upon acknowledgment of your progress report, three years will be added to the next progress report due date.

Sincerely,
Hillary

Hillary Snyder, PhD, CIP
Associate Director, Research Compliance
2105 Center for Creative Education, Mail Stop 1035
3000 Arlington Ave.
Toledo, Ohio 43614-2598
419.383.6905

[3404D9F1]

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