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March 12th, 2020
IRB & Research preparations for covid-19
The University of Utah IRB is heeding current guidelines from University leaders in response to the COVID-19 outbreak. This email is to provide the research community with information regarding the review and conduct of human subject research during this time.
The University of Utah IRB will be fully operational.
There will be no reduced IRB review or consultation services. There may be periods of time that the IRB staff are expected to work remotely to support social isolation efforts. Though it may not be possible for the IRB staff to meet with study teams in person, phone and web conferencing will be functional for all IRB staff members. The IRB staff will be unable to answer direct phone calls while working remotely; however, all IRB staff will receive voicemails and can return calls or respond to emails.
Researchers need to prepare their studies for possible interruptions or complications in conducting procedures.
Because of public and institutional self-isolation efforts, as well as possible quarantine of exposed individuals, it may be necessary to alter your research plans in order to keep study team members and research participants safe. Please make the following considerations for each active study:
- Additional clinical services, testing, and screening related to COVID-19 that need
to be performed for research participants do not need IRB approval prior to initiation. Such procedures would be considered usual care outside of the research context.
- Consider whether your study or parts of your study should be placed on hold during
this time. This hold may be for all research procedures. Perhaps placing a hold on
enrollment, study visits, data collection, or data analysis separately is reasonable.
It is recognized that discontinuing a participant’s care during this time may not
be safe or may dramatically jeopardize the results of the project. The decision to
place a hold on your study needs to be made on a study by study basis, likely in consultation
with your department leadership to ensure department and participant needs are met. You are not required to report study holds to the IRB; however, you must document
them in your research records and report them to sponsors as necessary.
- Any changes to your protocol or the conduct of your research procedures still requires
an amendment with the IRB. The IRB does not pre-approve deviations from protocol outside of the amendment process.
- There may be an urgency to deviate from the protocol or the conduct of research procedures
before an amendment can be approved by the IRB. Some deviations will be minor. Some
may have major effects on the welfare of participants and/or study validity. All deviations must be reported according to the IRB’s reporting policy.
The IRB acknowledges that the COVID-19 outbreak and isolation/quarantine requirements may result in deviations that are intended to eliminate apparent immediate hazard to a research participant. The IRB recognizes that some deviations pose little to no threat to participant safety or scientific integrity. For example, when the subject misses a clinic visit and the only available re-schedule date is outside the study visit window, though no study procedures or medication doses are missed. In this case, the subject may not incur possible harm from a missed dose or missed procedures meant to maintain or evaluate the subject's safety and welfare. As such, reporting is left to the discretion of the investigator within the context of the IRB’s reporting policy.
Though a deviation may not pose a conceivable threat or possible harm, it may represent possible continuing non-compliance if an amendment is not pursued with the IRB. All deviations must be documented in the research record, regardless of whether they meet the IRB’s reporting criteria.
- The IRB supports the use of home visits and phone calls for participant data collection
and monitoring, so long as no procedures would be performed that are unsafe in this
setting. Home visits and phone calls need to be conducted by a member of the study
team that is approved in the IRB application. Your IRB application should be amended
to include these methods if you choose to use them.
- Do not store electronic research data on unsecure devices in order to work remotely. The IRB encourages the use of University-approved cloud services and VPN access while working at home instead of storing data directly on your devices. Do not take home physical research records or data (paper consent forms, case report forms, questionnaires/surveys, etc.). All physical records must continue to be stored in IRB-approved, secure locations.
Updates on March 18, 2020
- The amendment and deviation instructions above are still in place in tandem with the University’s Temporary Policy on Human Subjects Research Related Visits During COVID-19.
- The FDA has released new guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic.
Updates and additional information will be posted here: https://irb.utah.edu/about/news/2020/irb-covid19-communications.php and via the IRB listserv. If you would like to be added to this email list:
- Send an email to email@example.com.
- In the "Subject" line, type "Subscribe irbalert <<yourname> >".
- <<yourname> > should be your first and last name (no space).
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