Office of Responsible Research Practices News

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, August 13^th, from 9 to 11:00 a.m. via CarmenZoom.

Registration requested.

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

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:

• 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 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.

It’s inevitable: research doesn’t always go as planned. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a session on when to notify the IRB about unexpected events or other problems. The session will:

• Provide an overview of the newly revised event reporting policy
• Differentiate between investigator, sponsor, and IRB reporting requirements
• Provide definitions and discuss case examples

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, June 23^rd, 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.

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 Center for Clinical and Translational Science 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 medical researchers and research staff, anyone preparing IRB submissions is welcome. The session will be held on Wednesday, May 20 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.

The IBC is supportive of research efforts involving SARS-CoV-2.  Any research that includes handling samples with the virus or research with the virus requires IBC review.  To help expedite these reviews, the IBC is meeting on an as needed basis via videoconferencing to review these new protocols and amendments.

A guidance document is available to assist with protocol preparation.  Please be sure to read this document to ensure you are providing the information required by the IBC. The IBC consists of faculty members who are also experienced researchers. Your help in preparing a well-designed research protocol is appreciated. The IBC also recommends that a new protocol be submitted rather than amending an already approved protocol if the work is not related.

Examples of Activities that require IBC review

• Creating recombinant or synthetic nucleic acid molecules  (vector plus gene) or inserting these molecules into cell lines/tissue cultures, whole animals, humans, or plants
• Using or creating transgenic or knock-out animals
• Using a microorganism that is pathogenic to humans (including immunocompromised individuals), plants, or animals (based on wild-type organism)

Examples related to SAR-CoV-2:

• Using or collecting human or non-human primate materials (body fluids, tissues, cells and established cell lines, etc.)
• Isolation of SARS-CoV-2 virus (BSL3)
• Propagation of SARS-CoV-2 virus (BSL3)
• Expression of SARS-CoV-2 proteins in non virus systems (typically BSL2)
• Expression of SARS-CoV-2 proteins in heterologous virus systems (BSL2-BSL3)
• Vaccination studies with SARS-CoV-2 proteins (BSL2)
• Isolation of viral nucleic acids from clinical or environmental samples (BSL2)
• Blood serology for antibodies to SARS-CoV-2 (BSL2)
• Nucleic acid-based intestinal microbiome studies of infected individuals (BSL2)

The Office of Responsible Research Practices IACUC staff presents a training webinar for investigators and lab personnel on the IACUC Rodent Survival Surgery Policy.

Although this webinar is for PIs and lab personnel with IACUC approved protocols involving rodent survival surgery activities, anyone who may be considering adding a rodent survival surgery activity is welcome.

IACUC Rodent Survival Surgery Policy Workshop: How to Stay Compliant
Recorded: April 29, 2020
View the presentation video
Download the IACUC Rodent Survival Surgery Policy Training slide deck with Q & A

Contact Justin Lahmers at 614-292-0409 or lahmers.6@osu.edu with questions.

Updated March 30, 2020

BACKGROUND

It is imperative during this time that we minimize the number of individuals coming to campus.  However, we must also ensure the safety and welfare of our research animals and maintain colonies where possible. Experimental activities should have been discontinued at this time, and access to the vivarium is limited to activities required for colony maintenance (with the exception of approved COVID-19 research activities).

ULAR staff are continuing to work and are currently on a split schedule to maximize physical distancing.

FAQS

Can I come in to the vivarium to wean and genotype my mice?
Essential colony maintenance to ensure continuity of research once this crisis passes is allowed.  Labs should have one designated essential personnel lab member, approved by the appropriate Associate or Vice Dean for Research or CCC leadership, who will be responsible for doing all the lab’s weaning/cage separation/genotyping activities on a weekly or twice weekly basis depending upon the colony size. If more than one designated staff member is needed, the number of individuals can be increased with approval from the appropriate Associate or Vice Dean for Research or CCC leadership as appropriate for the size of the colony(s). The designated lab member should plan to do the work at a time when the animal care staff will not be present in the room to promote social distancing.  If you wish to access the vivarium, please contact the ULAR team lead for your area, or the clinical veterinarian assigned to your area (see link below).  They will work with you to arrange access times that do not overlap with animal care staff and/or other investigators, to maintain appropriate social distancing.

We need you to delay all non-necessary genotyping at this time recognizing that this may need to be done depending on how long the restrictions are ongoing. If genotyping must occur, approval is needed by the respective college or the CCC as applicable. ULAR technical support can provide weaning service for your lab. Download the Request for Technical Services form.

My animals are enrolled in a long term study that started before the COVID crisis. Can I continue this study or do I need to terminate it?
Study timepoints should be altered to delay activities until the State of Emergency is lifted. If that is not feasible and/or there are concerns for animal welfare then you must speak with your college or CCC leadership, as applicable, and ULAR, for approval for an exception. If an exception is approved, you must limit the number of personnel doing animal work and conduct the work at a time when the animal care staff will not be present in the room to promote social distancing. If tissue harvesting is required, a designated laboratory staff member must be approved by the appropriate college or CCC. Please store tissues appropriately in your freezers and do not perform experiments or start primary cultures until restrictions are lifted. Work with your Associate or Vice Dean for Research to avoid overlap in personnel entering the research spaces.

Do I need to greatly reduce the number of cages I have to reduce the workload on ULAR staff?
ULAR staff are considered essential personnel, and are fully staffed to provide the animal care.  Staff are now working a split shift (morning team or afternoon team) to reduce the number of personnel present in the vivarium and support areas at any one time. At this time, ULAR does not anticipate staffing shortages that would impact their ability to provide adequate animal care. Changes in staffing may occur over time, and if services are impacted, investigators will be notified.

My IACUC protocol says I will do weekly measurement of tumors and weighing of mice. Will IACUC take action against me for not doing this during this Emergency State?
The IACUC recognizes the State of Emergency declared by the University restricts the ability of research personnel to conduct routine activities therefore the IACUC will not penalize researchers for not conducting routine monitoring during this period. ULAR technical staff can help monitor the animals condition if you anticipate that your research interventions may result in welfare issues during the State of Emergency. Download the Request for Technical Services form.

Can ULAR euthanize animals that they identify meet ERC, or have health issues for me?
Certainly.  If you have special needs for tissue collection for animals that ULAR euthanizes, please arrange with the ULAR technical staff pre-emptively so that supplies can be readily available. Download the Request for Technical Services form. If you are performing tissue harvesting for an animal that meets ERC, please follow guidelines noted above for mice in long-term studies. Euthanasia that is needed due to a welfare concern is done at no charge to the investigators. Euthanized animals will be handled at the investigator’s discretion, e.g., placed in a refrigerator for essential personnel to retrieve, frozen, discarded or placed in formalin. Retrieval can be done with approval in advance as above.

If I cannot come to campus to access the vivarium for colony maintenance, can ULAR help with this?
For any issues where a PI or team member cannot come to campus to access the vivarium, contact the ULAR team lead or the clinical veterinarian for your area. They will assist in ensuring that the necessary colony maintenance occurs. View ULAR team members and clinical veterinarians at each vivarium facility.

For all other questions:  Contact Dr. Valerie Bergdall (bergdall.1@osu.edu)