COVID-19 and Human Subjects Research at USU

After an assessment of the ongoing and yet unknown risks to participants presented by the novel coronavirus, COVID-19, the USU IRB is requiring a temporary stoppage of in-person research interactions with participants.

We are working to identify all of the protocols where these procedures are present and ongoing, and we will be in touch with Principal Investigators to confirm these stoppages. For now, please temporarily pause all in-person interactions with research participants. If you would like to modify your research procedures to replace in-person interactions with indirect contacts, please file an amendment to your protocol.

What research procedures fall under the temporary stoppage?

  • All in-person research procedures (including recruitment, informed consent, data collection, and analytic efforts involving in-person interactions such as member checking or meaning-making processes) between researchers and participants must temporarily stop. The IRB will notify you when these procedures are once again permitted.
  • Where possible, researchers should adjust research procedures that are conducted in person. For example, in-person interviews can be moved online in many cases. Video conferencing software can be utilized in place of larger meetings.
    • Please note that these modifications should be filed as an amendment to your protocol before they are implemented, so that the IRB can assess the risk associated with any changes. Office staff are prioritizing COVID-19 related communications and amendments.

I’d like to modify my in-person study procedures so that my research can continue without posing any additional risks to my participants. What do I do?

To change your procedures, please file an amendment to your protocol. You can find instructions on amending your Protis protocols here, and instructions on amending your Kuali protocols here. IRB members are prioritizing amendments and communications that are related to COVID-19 changes or concerns. Modifications to recruitment processes, informed consent processes and documentation, study procedures, or measures in place to protect privacy or confidentiality must be approved by the IRB before they are implemented, unless they are taken to eliminate an immediate hazard to the health, safety, or welfare of a participant.

What research activities can continue?

  • All research activities that do not involve in-person interactions can continue. If your data collection efforts are complete and your data analysis does not require in-person meetings between researchers and participants, you may continue work on your project, even if it initially involved in-person data collection efforts.
  • Researchers are reminded that changes to procedures to accommodate these new restrictions must be approved by the IRB before they are carried out, unless needed to eliminate an immediate hazard to a participant.

My protocol has a Reliance Agreement or Authorization Agreement in place. How should I advise my colleagues at other institutions?

If the protocol is reviewed and approved at Utah State University, all in-person interactions between researchers and participants must temporarily stop, regardless of what institution the researchers are affiliated with. If the protocol was reviewed and approved elsewhere, you must follow the most restrictive guidelines that are in place. No researcher affiliated with Utah State University may, at this time, carry out in-person research interactions (from recruitment through data analysis efforts) for research purposes.

What do I do to confirm with the IRB that I’ve stopped my in-person research procedures?

  • Right now, focus on connecting with your participants and research staff. Let them know that the IRB has determined that the known and unknown risks related to COVID-19 transmission are too high to allow in-person research procedures to continue at this time. If you have sessions scheduled with participants, cancel those sessions.
  • The IRB will be in touch with you to confirm stoppage of in-person research procedures for your Active protocols.

Is my entire protocol suspended? Do I need to notify my sponsor?

No. No entire protocols are suspended. The IRB is requiring a temporary stoppage of procedures that take place in person.  You may wish to notify your sponsor of the IRB’s decision to require temporary stoppage of these kinds of activities if you are on a reporting timeline that is impacted by this decision. Your sponsor is welcome to contact our office with any concerns or questions.

Office of Research funding opportunities (GRCO, URCO, SPARC, GEM, and Research Catalyst awards) will have flexibility in carrying out and meeting the terms of their awards where human subjects research stoppages took place. We are working to identify and contact other sponsors, and will update you on their positions as soon as we hear back.

Are there exceptions to the temporary stoppage?

The IRB will consider exceptions to the temporary stoppage in any of the following circumstances:

  • There are direct benefits to participants in your research that are of therapeutic value, and there is no alternative way to deliver those benefits.
  • In-person procedures are required to immediately eliminate hazards to participants or others.
  • It would increase the long-term risk of participation to participants to stop in-person research procedures.

If any of these circumstances are present in your protocol, please contact Nicole Vouvalis to discuss an exception to the temporary stoppage: (435) 797-0567 or nicole.vouvalis@usu.edu.

Is the IRB still operating and reviewing protocols? 

Yes. Right now, the office staff are working normal hours and at full staffing. Staff are promoting social distancing as much as possible, but are more than happy to set up a Zoom meeting in place of in-person meetings. Our staff are equipped to work remotely to minimize disruptions to Utah State University’s research mission. The Convened IRB has met remotely using Zoom in the past and can continue to do so as long as needed; our meeting schedule remains unaffected.

Our office staff are prioritizing changes and communications related to COVID-19 for at least the next week. Please note that our faculty reviewers might be experiencing disruptions in their lives as they work to accommodate the changes brought on by COVID-19, so scientific reviews may take longer than usual. We thank you for your patience as we assist our stakeholders in working through these critical and dynamic circumstances.

Last updated March 16, 2020 at 11:50 a.m.