COVID-19 research continuity information and guidance for human-subject research

David Conover, Vice President for Research and Innovation, sent the following message on March 17, 2020, to the campus research community with COVID-19 research continuity information for all researchers and guidance for those conducting human-subject research


Dear University of Oregon researchers,

I want to acknowledge that this has been a difficult time for all of us at UO, and I appreciate all that you are doing in your work that continues to make our institution a top research destination in higher education.

As we all adapt to living and working in this evolving situation, we are working to keep you informed about how these developments affect you and your research. To that end, I am writing to provide updated guidance on two critical issues: guidance for all researchers and guidance for those conducting human-subject research.

  • While we do not know for certain how events will play out over the next few days, we want everyone to be prepared for the possibility that they may need to restrict their research operations on campus on short notice, perhaps as early as Monday, March 23. The more we can proactively prepare, the better off we will be if that eventuality happens. Taking these precautionary steps will also help you re-launch standard research activities as quickly as possible once normal operations resume.
  • We are making changes to some of the ways in which we approach human-subject and animal research in order to more significantly limit the potential spread of COVID-19 in our community. These measures will help protect faculty, staff, and the community of individuals who interact with our human-subject researchers or animals.

Guidance for all researchers

  • Effective immediately, all researchers and lab personnel who can work from home should begin to do so as soon as possible. Information Services has developed a website with resources for remote work.
  • Accordingly, if at all possible, please identify tasks that research personnel can perform remotely.
  • Prepare for a potentially more restrictive campus environment, including very limited access to labs.
  • Wrap up experiments already underway and do not start new experiments.
  • Choose at most two lab members to be designated as critical staff. These lab members will manage issues such as animal husbandry, cell culture management, or essential research activities and experiments. We consider essential experiments to be only those that, if discontinued, would generate significant financial or data loss, or harm to human subjects. The designated critical staff can be rotated if necessary. Please inform your institute/center director or department head about your critical staff plan.
  • Finalize your ramp-down plan, with the assumption that you may not be able to re-start research activities as usual for six to eight weeks.
  • If you have not already done so, please Complete a Phase I Continuity Plan Form, and let us know about access and other key needs by completing a Phase II Continuity Plan Form.

Guidance for those conducting human-subject research

  • Discontinue all face-to-face HSR as of end-of-day, Monday, March 23, unless such restrictions would: (a) cause harm to participants that outweigh the benefits of stopping face-to-face contact; or (b) lead to major and unrecoverable research disruption and/or loss of data that would have substantial negative consequences for future participants or society. To continue face-to-face HSR under either exception, you must request a waiver (see below).
  • If it is possible to convert face-to-face HSR interactions to remote alternatives, you may do so. IS has a helpful webpage with tips for remote work.

For those who are changing your human subject data collection methods, you should consider this a deviation and report it to the IRB via the Event Report Form.

You will only need to submit a protocol modification if you want to continue the revised plan after normal operations resume.

  • A waiver will be required to continue face-to-face HSR and must include significant provisions that ensure social distancing, screening participants prior to arrival and at arrival for illness, as well as enhanced cleaning of research workplaces and materials.

Waiver requests should be submitted to Research Compliance Services (RCS) via a Human Subjects Research Waiver form. We will communicate a final decision to the PI ideally within 24 business hours.

  • Effective today, no new participants may be enrolled in any face-to-face research activities until further notice, regardless of whether you have received a waiver or not.
  • IRB review and approval are required prior to making changes beyond a protocol deviation, including changes to research methods made due to COVID-19 or any other communicable disease (e.g., adopting changes for future use such as online surveys for the remainder of study when they were not previously approved or the research previously included in-person interviews only).
  • Researchers who conduct human subjects research that does not include any face-to-face activities may continue operating as usual.

Guidance for those conducting animal research

  • Please take steps to ramp down any current animal research activity beyond husbandry and veterinary care.
  • Even in the event of a research curtailment, authorized personnel will continue to provide animal husbandry, veterinary care, frozen sample storage, and animal shipments if necessary.
  • Care for animal subjects will be provided in accordance with established continuity plans and in compliance with all rules, regulations and policies governing the care and use of live vertebrate animals.

Please continue to pay close attention to your university email and frequently monitor the UO’s coronavirus website as the best place to get the latest information about the UO’s institution-wide response to COVID-19. For additional research-related information, stay tuned to the UO’s Coronavirus Information for Researchers website, which includes a helpful FAQ and an archive of research-related COVID-19 announcements.

It is also important for you to work with your graduate students and department heads to address any potential impacts to your students’ degree completion.

These are unprecedented times. But I know that if we continue to work collaboratively, diligently, and with purpose our research operation will be fine. We know numerous PIs have already voluntarily taken many of the steps described above. We thank you for your understanding as we confront these challenges together.

I appreciate all that you do in your work and during these difficult times. If you have any questions or concerns, please don’t hesitate to reach out to me at vpri@uoregon.edu. Take care.

 

David Conover

Vice President for Research and Innovation