[Irb] Change in frequency of progress reports

Thu Jun 24 11:51:49 EDT 2021

Hillary,

Thank you for the email.  I have read the Procedure for Reporting of Protocol Deviations, Violations and Exception Requests. Again, I find this procedure wanting.  I need to know if there is a standardized report form or if this is in a paragraph form. I also need to know where to submit this deviation report.

Thank you,

Karen

Karen L. Hoblet, PhD, MSN, RN, CNL
________________________________
From: irb-bounces at mailman.utoledo.edu <irb-bounces at mailman.utoledo.edu> on behalf of Snyder, Hillary Morgan <Hillary.Snyder at utoledo.edu>
Sent: Thursday, June 24, 2021 11:27 AM
To: IRB/HRPP related notifications <irb at mailman.utoledo.edu>
Subject: [Irb] Change in frequency of progress reports

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<https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.utoledo.edu%2Fresearch%2Frsp%2Firb%2Fguidance.html&data=04%7C01%7CKaren.Hoblet%40utoledo.edu%7Cf95b697a291948e000c808d937248f15%7C1d6b1707baa94a3da8f8deabfb3d467b%7C0%7C0%7C637601453147759090%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C2000&sdata=1oz24QyMJBJsJDCo25y%2BKpiwG%2F3%2Fvly383G7B0sRKQs%3D&reserved=0>

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]

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <https://mailman.utoledo.edu/pipermail/irb/attachments/20210624/606ad640/attachment-0001.html>
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image001.png
Type: image/png
Size: 12758 bytes
Desc: image001.png
URL: <https://mailman.utoledo.edu/pipermail/irb/attachments/20210624/606ad640/attachment-0001.png>