Office of Responsible Research Practices
The Ohio State University

ORRP News

New Ohio State guidance and FAQs on a staged approach to restarting human subjects research

Posted: June 1, 2020

Effective June 1, 2020

The Office of Research and Office of Responsible Research Practices (ORRP) continues to update guidance related to human subjects-related research visits, with the goal of protecting research participants, researchers, and the larger Ohio State community from risk of infection with COVID-19, as well as to ensure ongoing access to research that may provide essential support and care to participants.

A new stage of restarting on-campus research begins in June, as follows:

Staged approach to returning to on-campus human subjects research activities

The Office of Research has developed a guidance document, entitled Research Recovery Plan for Staged Reopening, and a webpage with many helpful resources. If after reviewing this information and working through your college you have additional questions, please direct emails to research@osu.edu.

For guidance specific to human subjects clinical research conducted at the Ohio State Wexner Medical Center or the James Cancer Hospital, please contact the following:

FAQS

Are ORRP and the Ohio State IRB’s operating as usual?
Yes, the Office of Responsible Research Practices and Ohio State’s IRBs are fully functional and operating at standard capacity.

Can I submit new studies during the COVID-19 outbreak?
Yes, you may submit new studies in Buck-IRB. New studies will be screened and forwarded for expedited or convened IRB review in accordance with standard ORRP procedures and timelines. Refer to the Research Recovery Plan for Staged Reopening for additional guidance on resuming on-campus research activities.

I may need to modify my study procedures in response to COVID-19 precautions. How do I do that?
COVID-19-related study modifications DO NOT REQUIRE the submission of an amendment in Buck-IRB if they meet ALL of the following criteria:

  • They involve postponing or changing in-person research activities to being conducted remotely;
  • The modifications are TEMPORARY and will last only for the duration of the COVID-19 outbreak; and
  • They do not pose a significant increased risk to the participant.

Although there is a risk of a breach of confidentiality with any internet communication, the temporary use of university recommended tools such as Qualtrics, Skype, Zoom, Box, and secure email do not require an amendment (as the risk of in-person visits offsets the limited risk of a breach of confidentiality).

Note: The use of remote platforms/applications may increase the possibility of participant identifiability and/or pose a risk to confidentiality. Please consult OCIO guidance.

Modifications to study procedures that do not meet the above criteria require IRB notification via an amendment in Buck-IRB.
ORRP will continue to prioritize screening COVID-related submissions.

I temporarily modified my study procedures in response to COVID-19 precautions, and now I want to go back to the way the study was conducted before the outbreak. Do I need to notify the IRB? (NEW 05/29/2020)
No, to continue with the study as it was approved before the outbreak, you do not need to notify the IRB of the re-start.

Category : IRB / ORRP