Office of Responsible Research Practices
The Ohio State University

ORRP News

Ohio State guidance and FAQs on the impact of COVID-19 on human subjects research

Posted: November 12, 2020

The Office of Research and Office of Responsible Research Practices (ORRP) continues to update guidance pertaining 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.

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 IRBs 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 regarding on-campus research activities.

I 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:

  • The modifications are being made to comply with state, local, or institutional requirements such as the use of face masks or pre-visit mandated health screenings, or involve postponing or changing in-person research activities to being conducted remotely (see below if making changes to the consent process);
  • 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 use of remote platforms/applications may increase the possibility of participant identifiability and/or pose a risk to confidentiality, 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).

Modifications to study procedures that do not meet the above criteria require IRB notification via an amendment in Buck-IRB.

How do I make changes to the consent process?
Unless the IRB has previously approved a waiver of consent documentation or a waiver of the consent process, investigators MUST continue to obtain a written signature from participants when conducting the consent process remotely. The signed consent form can be sent to the investigators via email, mail, or signed in-person upon arrival to the first in-person study visit. Changes to any other method of documentation (e.g., DocuSign, REDCap) require the submission of an amendment.

Investigators must incorporate all elements of consent into the discussion and document the remote consent discussion in the study files.

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? 
No. To continue with the study as it was approved before the outbreak, you do not need to notify the IRB of that change.

What additional requirements must be met in order to include prisoners or prisoner data in my study?
In addition to the regulatory requirements outlined in HRPP policy Research Involving Prisoners, all projects involving Ohio Department of Rehabilitation and Correction (ODRC) offenders, including non-interventional record review studies, must first be reviewed and approved by the ODRC Human Subject Research Review Committee (HSRRC). ORRP will facilitate the ODRC review process. For more information, contact Tish Denlinger at Denlinger.33@osu.edu.

Category : IRB / ORRP