Office of Responsible Research Practices
The Ohio State University

ORRP 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