Office of Responsible Research Practices News

On November 24, 2021, the USDA APHIS issued a final rule in response to the 21^st Century Cures Act for the Institutional Animal Care and Use Committee at each facility to conduct a continuing review of research activities involving animals and review of such activities at least every three years. This change aligns with NIH OLAW timeline for completing a review. Therefore, the IACUC voted to eliminate annual reviews for approved protocols with the exception of studies funded by U.S. Department of Defense (DoD). This change is effective December 27, 2021.

In addition, the Institutional Biosafety Committee evaluated the annual review process and voted to eliminate submitting a form annually. In its place, an email notice will be sent requesting an annual protocol self-assessment to be performed to help determine if a protocol amendment is needed or changes to the study team. A list of items to review will be provided in the instructions of the notice. This change is effective January 13, 2022.

A renewal protocol is still required to be submitted. These changes do not affect the 3-year renewal process for IACUC protocols nor the 5-year renewal process for IBC protocols.

Are you new to human subjects research and in need of information to help you navigate the submission and review processes? If so, the Office of Responsible Research Practices and the University Libraries Research Commons are offering an introductory presentation for you or anyone who needs a refresher. By the end of the session, participants will be able to:

• Explain why we have an IRB process
• List types of human subjects research and levels of review
• Outline Ohio State’s IRB Review process, from pre-submission to approval
• Generate an action plan for completing a successful Buck-IRB application

While the presentation will be tailored to new social and behavioral sciences researchers and graduate students, anyone preparing IRB submissions is welcome. The session will be held on Tuesday, September 28th, from 1:00 to 2:30 p.m. via CarmenZoom

Registration requested

For more information, contact Sandra Meadows at 688-8641 or meadows.8@osu.edu.

Beginning in January 2021, a new question will be added to the Continuing Review (CR), Annual Status Report (ASR), and Final Study Report (FSR) applications to capture changes made to research to eliminate apparent immediate hazards due to the COVID-19 pandemic. The question will remain in place for approximately 1 year, and then will be removed. The question will be located in the Research Progress section as follows:

Identify any changes made to the research procedures in response to the COVID-19 pandemic that were not previously submitted via amendment. Check all that apply.

* In-person activities were changed to remote visits
* Surveys were deployed instead of face-to-face interactions
* Consent/HIPAA authorization procedures were modified to obtain remotely
* Research procedures (e.g., laboratory blood draws) were missed or delayed
* Research data storage location was changed (e.g., from laboratory/office to home)
* Other (specify)

As a reminder, temporary changes to certain study procedures in response to the pandemic do not require an amendment if they meet specific criteria, as described in Ohio State’s guidance and FAQs on the impact of COVID-19 on human subjects research.

Please contact IRBinfo@osu.edu with questions.

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. 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:

• For cancer-related clinical studies, PIs should contact Dr. William Carson at william.carson@osumc.edu
• For all other clinical studies, PIs should contact Dr. Brad Rovin at brad.rovin@osumc.edu

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.

Are you new to human subjects research and in need of information to help you navigate the submission and review processes? If so, the Office of Responsible Research Practices and the Research Commons are offering an introductory presentation for you or anyone who needs a refresher. By the end of the session, participants will be able to:

• Explain why we have an IRB process
• List types of human subjects research and levels of review
• Outline Ohio State’s IRB review process, from pre-submission to approval
• Generate an action plan for completing a successful Buck-IRB application

While the session will be tailored to new social and behavioral sciences researchers and graduate students, anyone preparing IRB submissions is welcome. The session will be held on Wednesday, September 23 from 11 a.m. to 12:30 p.m. via CarmenZoom.

Registration requested.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an FDA series. This second session will focus on research involving medical devices and the special considerations associated with obtaining IRB approval. By the end of the session, participants will be able to:

• Explain common regulatory terms in the context of FDA-regulated device studies
• Differentiate between clinical investigations requiring Investigational Device Exemptions (IDEs), Nonsignificant Risk (NSR) device investigations, and IDE-exempt investigations
• Identify and complete Buck-IRB application sections and documents required for medical device research
• Recognize how and when to consult the FDA

Please note, this intermediate-level webinar assumes a basic familiarity with the IRB approval process and Buck-IRB, and will not cover emergency use, expanded access, or Humanitarian Use Device (HUD) protocols. While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome. The workshop will be held on Tuesday, February 2nd from 9 to 10:30 a.m. via CarmenZoom.

Registration requested.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.

Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an FDA series. This first session will focus on research involving drugs and how to navigate the IRB approval process. By the end of the session, participants will be able to:

• Explain common regulatory terms in the context of FDA-regulated drug studies
• Assess which regulations apply to clinical investigations involving drugs or biologics, including when an Investigational New Drug Application (IND) is required
• Identify and complete Buck-IRB application sections and documents required for FDA-regulated drug research
• Recognize how and when to consult the FDA

Please note, this intermediate-level session assumes a basic familiarity with the IRB review process and Buck-IRB, and will not cover emergency use or expanded access protocols. While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome. The workshop will be held on Thursday, September 10^th, from 9 to 11:00 a.m. via CarmenZoom.

For more information, contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.