Office of Responsible Research Practices
The Ohio State University

Office of Responsible Research Practices News

Interim Ohio State Guidance and FAQs on Human Subjects-Related Research Visits during COVID-19 Outbreak

Posted: March 12, 2020

Effective March 12th, 2020 (REVISED 3/19/2020)

BACKGROUND

In the context of the rapidly evolving COVID-19 outbreak, the Office of Research and Office of Responsible Research Practices (ORRP) are providing guidance related to human subjects- related research visits. This guidance is being issued to protect 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.

As much as possible, we want to reduce exposure potential for study participants, researchers, research and clinical staff, and patients.  For clinical studies, it is important to reduce foot traffic to the medical center facilities (including research buildings and off-site clinical buildings). For non-clinical studies, it is similarly important to reduce foot traffic to campus sites to reduce exposure potential.

This COVID-19 guidance is effective immediately for all human subjects research at Ohio State. This guidance will be revised as needed pending new information

FAQS

Are ORRP and the Ohio State IRB’s operating as usual? (UPDATED 03/12/2020)

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?  (NEW – 03/18/2020)

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; however, enrollment of new participants must adhere to the following:

  • Therapeutic studies for the treatment of COVID-19 may commence after receiving appropriate approvals (e.g., IRB, FDA).
  • Other studies with in-person interactions may not commence enrollment until further notice.
  • Studies with no in-person participant interaction may commence after receiving IRB approval.

Can I still interact with my research participants in my ongoing study?  (UPDATED 03/19/2020)

New enrollment to existing studies:

  • Studies with no in-person participant interaction may continue to enroll participants.
  • Studies with in-person interactions must cease enrollment until further notice. Limited exceptions for life-saving clinical interventions must be approved beforehand:

Currently enrolled participants:

  • Face-to-face research interactions should be postponed during this time unless the interaction is essential to the health and well-being of the participant.
  • Both essential and non-essential research interactions should be performed remotely (e.g., by phone, Skype, Zoom, mail delivery of study medications, or other means) whenever possible.
  • Non-essential face-to-face visits to Ohio State campus facilities should be postponed until further notice.

What research interactions are considered “essential?” (UPDATED 03/18/2020)

Research interactions should be considered as essential or non-essential in the context of the participant’s health and/or well-being.

Essential interactions are those visits in ongoing therapeutic studies that are critical to the treatment of a significant and life-threatening condition or critical to the safety of participants.

Non-essential interactions include:

  • Therapeutic study visits for conditions that are not life-threatening in the near-term
  • Non-therapeutic interventional study visits intended to improve health, but not for the treatment of a specific disease
  • Observational study interactions
  • Behavioral or social science research interactions that are not critical to participant health or well-being

View examples to help determine suitability of in-person research visits(UPDATED 03/18/2020)


Who decides what procedures to halt or modify?  (UPDATED 03/14/2020)

Currently, the determination of whether or not a research visit is “essential to the health and/or well-being” of a participant is determined by the principal investigator of the research study, the participant, and the participant’s care provider (when applicable), and should be informed by current public health guidance regarding the COVID-19 outbreak.


How should essential research interactions go forward? (UPDATED 03/17/2020)

For research interactions deemed essential, opportunities for exposure should be reduced as much as possible without reducing the efficacy of the treatment or increasing risk to the participant.  Examples of exposure reduction may include: reducing non-essential visits, reducing the number of blood draws, eliminating non-essential visit time, or maximizing the use of remote technologies in lieu of “face-to-face” interactions.

Essential research visits that cannot be performed remotely may be performed in person, with the following additional guidance:

  • Participants should be screened for active COVID-19 symptoms just prior to the visit or at the start of the visit. If the research participant shows signs or symptoms related to an upper respiratory tract infection, they should be advised to not attend the study visit and contact their primary care provider. If the visit has started, they should be sent home with the same recommendation to contact their primary care provider.  See: https://wexnermedical.osu.edu/features/coronavirus/patient-care
  • Participants should be provided with information regarding the current COVID-19 pandemic and how best to reduce their risk of infection. This information may be provided in multiple forms suited to the type of contact, including a website link, a telephone script and an in-person handout. If possible, this information should be shared before the research visit.

If you anticipate needing to modify your study, follow the procedures below to notify the relevant IRB.


I may need to modify my study procedures in response to COVID-19 precautions. How do I do that? (UPDATED 03/18/2020)

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: Because 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 (either amendment or event report).

Use the following rubric to determine the appropriate actions for notifying the IRB of modified study procedures other than those described above related to COVID-19:

  • Immediate changes: My study modifications must be implemented within the next five days, to protect participant health.
    • Proceed with the changes without prior IRB approval.
    • Submit an event report in Buck-IRB within ten days of the deviation to notify the IRB of the COVID-19-related modifications.
    • If the modified procedures will continue beyond the next five days, also submit an amendment in Buck-IRB to formally amend the protocol and study materials.
  • Non-immediate changes: My study modifications do not need to be implemented within the next five days:
    • Submit an amendment in Buck-IRB for your COVID-related study modifications.
    • On the “Supplemental Questions” page, ensure that COVID-19 is noted as a rationale for the change(s).
    • Please restrict changes to COVID-19 related issues to ensure a prompt review. We will prioritize these amendments as much as possible to facilitate progress of the research.

Please restrict changes to COVID-19 related issues to ensure a prompt review. We will prioritize these amendments as much as possible to facilitate progress of the research.

If you have any questions about potential changes, contact ORRPcovid@osu.edu.   


What if my study is reviewed by an external IRB? (UPDATED 03/18/2020)

This COVID-19 guidance is effective immediately for all human subjects research conducted at Ohio State, regardless of reviewing IRB. If you need to make changes to your research, follow the reviewing IRB’s procedures for submitting amendments or deviations.


I would like to temporarily suspend my study recruitment. What do I do? (UPDATED 03/12/2020)

Some studies are voluntarily halting or delaying participant recruitment because of COVID-related public health recommendations, facility requirements, study team availability, and/or participants considered to be at high risk for susceptibility to COVID-19. These temporary suspensions do not need to be reported to the IRB.

Category : IRB / ORRP

IRB Overview for Graduate Students

Posted: February 25, 2020

The Office of Responsible Research Practices and the Research Commons is offering a workshop for graduate students on how to navigate the human subjects research submission process. The session will focus on the following key topics:

  • Understanding why we have an IRB process
  • Exploring types of research and levels of review
  • Reviewing application components
  • Tips for successful application completion
  • Finding out where to go for help

While the session will be tailored to social and behavioral sciences researchers, anyone preparing IRB submissions is welcome. The workshop will be held on Wednesday, March 25th, from 3:00 to 4:00 p.m. in the Research Commons, Third Floor, 18th Avenue Library, 175 West 18th Avenue.

Registration requested at:  https://library.osu.edu/researchcommons/event/irb-graduates0325

Contact Sandra Meadows at 688-8641 or meadows.8@osu.edu with questions.

 

Category : IRB / ORRP

Human Subjects Research 101: From Inspiration to Approval!

Posted: February 20, 2020

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, March 18 from 8 to 9:30 a.m. in the Biomedical Research Tower, Room 115, 460 West Twelfth Avenue.

Registration requested.

  • Live streaming available upon request. Please do not register if you plan to attend via live stream. Contact Sandra Meadows at 614-688-8641 or 8@osu.edu.
Category : Educational Offerings / IRB / ORRP

Updates to the Buck-IRB system

Posted: February 5, 2020

New update to the Buck-IRB submission system will go live on February 7, 2020.

This update involves the Radiation pages.

  • The “Radiation Exams/Procedures” page now includes the option to add radiation therapy procedures.
  • Instructions on the “Radiation”, “Radiation Exams/Procedures”, and “Radiation Dosage Totals” pages were revised for clarity.
  • Includes revised information about the dose calculator.

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Michael Donovan at donovan.6@osu.edu.

Category : Buck-IRB / IRB / ORRP

IRB Educational Session: Submitting Amendments in Buck-IRB

Posted: January 20, 2020

The Office of Responsible Research Practices and the Research Commons are offering an advanced workshop on amendments to approved human subjects research and the Buck-IRB system. The session will:

  • Describe the amendment process
  • Review relevant HRPP policies and regulations
  • Provide guidance and tips on amendment submission via Buck-IRB
  • Present strategies to facilitate the amendment screening and review processes

While the session will be tailored to behavioral and social sciences researchers, anyone preparing IRB submissions is welcome. The workshop will be held on Thursday, February 20th, from 10 to 11:30 a.m. in the Research Commons, Third Floor, 18th Avenue Library, 175 West 18th Avenue.

Registration requested at: https://library.osu.edu/researchcommons/event/irb-amendments0220

Contact: 614-688-8641 or meadows.8@osu.edu

Category : IRB / ORRP

Advarra Review of Human Subjects Research

Posted: January 9, 2020

The Office of Responsible Research Practices, Advarra, and the Center for Clinical and Translational Science are offering an educational session about Advarra oversight of Ohio State human subjects research with Advarra representative, Kathleen Rankin, and Jessica Mayercin-Johnson from ORRP.  The presentation will:

  • Provide an overview of the Ohio State and Advarra submission processes
  • Navigate within the Ohio State and Advarra platforms
  • Describe required submission components
  • Review tips for successful submissions

The session will be held on Thursday, January 30 from 11 a.m. to 12:30 p.m. in the James Cancer Hospital, Room L045, 460 West Tenth Avenue.

Registration requested.

  • Live streaming available upon request. Please do not register if you plan to attend via live stream. Contact Sandra Meadows at 614-688-8641 or meadows.8@osu.edu.
Category : Educational Offerings / IRB / ORRP

Animal Care and Use Newsletter (Fall 2019) now available

Posted: November 19, 2019

The Fall 2019 edition of the “Animal Care and Use Newsletter” is now available.  The new issue includes information about how to document analgesics on rodent survival surgery cards, plans to replace e-protocol system, reporting adverse events to IACUC, semiannual inspection reminders, IACUC policy updates, reminders and helpful e-Protocol tips.

Animal Care and Use Newsletter – Fall 2019

For additional information on the newsletter or any topics contained therein, please contact the IACUC office at IACUCinfo@osu.edu

Category : IACUC / ORRP