COVID-19 and Human Subjects Research Prior to June 21, 2021
The IRB’s primary responsibility is the protection of the rights and welfare of human participants. In line with that mission and in the face of the spread of COVID-19, face-to-face research procedures have been restricted and proceeding on a limited basis since Fall of 2020. Read through the topics below to learn more about continuing other methods of research with human participants, and please contact our staff if you have any questions about how to best carry out your research while protecting human participants.
Resuming In-Person Research
Why is the IRB pausing the collection of Resumption Requests?
With recent changes to the legal landscape surrounding COVID protections, the IRB and HRP leadership needs to re-evaluate how and whether to continue in-person research procedures. The IRB is gathering at the soonest opportunity to re-evaluate these new developments, and will ensure that its determinations are made available to researchers on this website as well as via the listserv (subscribe). If you are a PI on an active protocol, you are likely already on the listserv.
How long will Resumption Requests be paused?
The first available meeting date for the IRB is June 17, 2021. That was also going to be the first available date for processing Resumption Requests; any changes decided upon by the IRB will be implemented after that date, and after the IRB has had an opportunity to update its associated forms and guidance. Some of the basic understandings of the existing Framework (e.g. masks) are now outdated in light of recent legal changes in Utah, and the IRB is unable to enforce those requirements at this time.
What if I have an urgent need to resume in-person research interactions before June 17, 2021?
Please reach out to Nicole Vouvalis directly to discuss your situation: Nicole.email@example.com.
Is my existing Resumption Request approval still valid?
Yes. Please note that while the IRB can no longer require face coverings, if your approved Resumption Request details the use of face coverings, you must continue to adhere to the terms of your approved Resumption Request and any other protective measures outlined in your Resumption Request and your COVID-19 Supplemental Information document that you have distributed or will distribute to research participants. You may file an amendment to your Resumption Request seeking new terms of resuming in-person research if you would like to request changes to those previously-approved terms.
What is the background of the Resumption Request process?
The IRB began accepting resumption requests, via Kuali, for researchers who wish to resume in-person research procedures in Fall 2020. Please review the Framework for the Resumption of In-Person Human Subjects Research to learn more about the requirements and standards related to resuming in-person research procedures.
A webinar to guide researchers through the Framework and answer questions related to resumption was held on Friday, September 4, 2020. You can view a recording of that webinar. New, for Spring 2021, a briefer template was made available for projects where the participants and researchers are already interacting for non-research reasons.
You may view a blank template of the Kuali-based Resumption Request for typical protocols. This new, briefer template is for researchers who already interface with their participants in another context.
What is the process for requesting to resume in-person procedures?
(This information is provided for reference only; please see the notification above regarding the pause on these submissions) First, the PI should review the Framework for the Resumption of In-Person Research. It contains useful information about how to plan for resumption, including information that may help researchers to plan for their projects during the upcoming academic year. Next, the PI should review the original protocol to determine whether there are any areas where risk could be mitigated (i.e. moving certain procedures, like informed consent, to remote or oral consent processes; conducting screening procedures online or over the phone; lowering the upper age range for adult participants; etc.) without impacting the scientific integrity of the project. If changes can be made to the original protocol to mitigate risk, the PI should file an amendment to that protocol before proceeding to the next step. Finally, the PI should go to Kuali Protocols and complete a resumption request in that system (even for Protis protocols). A template of that request form is available above for ease of reference.
What happens once I submit my Resumption Request in Kuali Protocols?
The reviews will be completed by the Institutional Review Board, with expert advice brought in as necessary. The IRB meets as needed during the summer, and is scheduled to next meet on June 17, 2021.
What will I need to complete my Resumption Request?
Access to your original protocol, a process for screening for COVID-19, and supplemental Informed Consent documentation related to COVID-19. Please remember that Protis must be accessed either on-campus, or through the VPN.
Does vaccination status matter?
Per Utah law, the IRB is prohibited from asking about the vaccination status of any research personnel. Research personnel are not permitted to ask about the vaccination status of their research teams, and they are also prohibited from asking any prospective research participants about their vaccination status. Thus, unfortunately, the IRB is not permitted to take into account any information about vaccination status in determinations regarding resuming in-person research.
In-Person Procedures Paused
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.
What research activities can continue?
All research activities that do not involve in-person interactions can continue. If your in-person 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.
Is my entire protocol suspended? Do I need to notify my sponsor?
No. No entire protocols are suspended, and no sponsor notifications are necessary. The IRB is requiring a temporary stoppage of procedures that take place directly between researchers and participants, or which otherwise require a participant to interact with a person they would not otherwise interact with. 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. Guidance from other sponsors regarding COVID-19 flexibilities can be located on the Sponsored Programs website.
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 firstname.lastname@example.org.
What about a protocol that has been approved since the stoppage took effect?
Protocols that have been approved since March 16, 2020, are approved subject to the in-person procedures stoppage. This means that researchers can carry out the procedures in their protocols that do not involve in-person procedures, but may not carry out procedures that involve in-person interactions. If, at this time, researchers feel that it is safe and in the best interests of their participants to resume in-person research procedures, the PI may request resumption of those procedures by following the instructions in the first tab on this page.
Modifying Protocols & Other Considerations
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. Modifications to recruitment processes, informed consent processes and documentation, study procedures, or measures impacting 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.
Is the IRB granting any flexibility in the amendment process for changes related to COVID-19?
Yes. Typically, a shift from an in-person study to an online setting would require a new protocol, because such changes impact a great deal of approval-based determinations. At this time, the risks to participants and the number of protocols that would need to be replaced justifies using the amendment process, rather than the new protocol approval process, to support these changes. This does not, however, mean that researchers may implement changes without IRB approval. All changes to approved protocols must first be approved by the IRB, unless the change is taken to eliminate an immediate hazard to participants.
Do I have to obtain Informed Consent from participants to ensure they agree with the new procedures?
Yes, in most cases. As researchers plan the transition away from face-to-face procedures, it is important to update participants about changes to the study, no matter the cause. Our office has created a template that will assist you in updating your informed consent process/documentation related to COVID-19 or any other changes you are making in light of the virus. Prior to sending the new document to your participants, please take care to file the new document as an amendment to your protocol along with any other procedural changes.
Do I need to report to the IRB if a participant or member of the study staff tests positive for COVID-19 and/or is hospitalized or dies as a result?
In some cases, yes. If a participant becomes sick, is hospitalized, or dies as a result of COVID-19 and that is likely to be related to the research, you must report an Unanticipated Adverse Event within 24 hours of being notified of the hospitalization or death. If a member of the study team tests positive for COVID-19, it would be beneficial for the USU community (though not required) for you to complete the COVID-19 Questionnaire. If you or a member of your research team came into contact with research participants after likely acquiring COVID-19, please notify the IRB as soon as possible of the contact.
I do not need to change any of my procedures to comply with the stoppage. Are there other things I should be considering regarding my approved protocols?
COVID-19 has caused many disruptions to the lives of your participants and probably to yours, as well. You might consider whether the timelines in your protocol are still realistic in the face of potentially months of disruption to normal daily routines. You may also consider whether the challenges faced by COVID-19 would impact your findings; studies examining anxiety, sleep routines, relationships at work, shopping habits, etc. may have ongoing procedures that are capturing a new and omnipresent circumstances. Perhaps modifications to questionnaires or the addition of supplemental procedures will be necessary to adequately get at the original research questions; in some cases, new research questions or hypotheses might be appropriate.
IRB Operations during COVID-19
Is the IRB still operating and reviewing protocols?
Yes. Right now, the office staff are working as normal, using remote work procedures. Staff 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 is meeting remotely; our meeting schedule remains unaffected. Staff have also created a Slack instance that researchers can join for more immediate communication (akin to an office drop-in). Join the Slack instance with your usu.edu email address. Researchers are also encouraged to set up a protocol planning meeting with a Coordinator prior to submission of a protocol: Schedule a meeting with Sasha.
Our office staff are prioritizing protocols, amendments, and communications related to COVID-19 for the foreseeable future; then, those projects that have been funded and require rapid turnaround for the sponsor; next, protocols that can occur even with the current in-person procedure stoppage; and finally, projects that are unable to be carried out at this time. 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.
What is the USU IRB doing to support timely research regarding COVID-19?
The USU IRB is prioritizing research, amendments, and communications related to COVID-19. While no advanced notice of a protocol is required, if the project is related to COVID-19 and will receive Expedited review (rather than Exempt or Convened IRB), an email or phone call would be appreciated so that we can begin to seek or reserve an available scientific reviewer. Research related to COVID-19 is of greater benefit when done in a timely manner, which is why it is being prioritized over other submissions at this time.
Otherwise, research is being reviewed as normal. Exempt projects are still being turned around in the same week they are received; Reliance Agreements are being processed within two business days, and Expedited projects received since the start of the Spring semester are being assigned for review, on average, within three business day of receipt of a complete application.
Do I have to do anything to seek faster review for my COVID-19 project?
Please have COVID-19 or Coronavirus in the title of your protocol. Otherwise, there is nothing you must do. If your project will require Expedited (rather than Exempt or Convened IRB) review, an email or phone call would be appreciated so that we can make contact with an appropriate scientific reviewer to give them a head’s up about the upcoming submission, or to give us time to seek a consultant if necessary.
I received funding for my COVID-19 project and need IRB approval quickly. What should I do?
File your protocol as quickly as you are able while ensuring that the minimum requirements for review are in the protocol. You may set up a meeting with one of our staff over Zoom to discuss your protocol while you are drafting it; the IRB staff are always happy to offer guidance while a protocol is in process. The links to meeting requests are embedded within the protocol as well as provided above. Please also have COVID-19 or Coronavirus in the title so we can quickly identify the protocol as one to rush the review on.
My COVID-19 protocol requires Convened IRB review. What do I need to do?
The Convened IRB is meeting according to its typical semester schedule: the second and fourth Tuesday of each month. We’ll make every attempt to review these kinds of protocols as quickly as possible but please do note that the minimum required timeline between assigning a protocol to a meeting and reviewing a protocol in a meeting is one week, and that requirement is not flexible. If your project is funded research and it requires Convened IRB review, please contact Nicole Vouvalis as soon as possible.
How does this COVID-19 prioritization interface with the restrictions on in-person research procedures?
In-person research procedures are still paused for all projects (subject to the exceptions located in the Stoppage tab) due to the risks associated with in-person interactions at this time. Protocols involving a therapeutic benefit that cannot be delivered in another manner are permitted to seek an exception to this restriction; please contact Nicole Vouvalis to request an exception. Protocols that do not qualify for an exception can request to resume in-person research activities after the protocol has been approved; please click on the Resumption tab on the left for more information about that process.
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 covered by the USU IRB protocol review must temporarily stop, regardless of what institution the researchers are affiliated with. 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, absent an approved Resumption Request in Kuali Protocols.
I am listed as personnel on a protocol at another institution. What should I be doing?
You should immediately stop all in-person interactions between yourself and research participants. The USU IRB is notifying all institutions whose protocol reviews we have relied on that USU researchers are not permitted to engage with in-person research procedures involving participants at this time.
The protocol that I am listed on at another institution has been approved to continue in-person research interactions because it meets one of the three criteria for exceptions that the USU IRB has outlined. What do I need to do to continue my research?
If another institution’s IRB has determined that research interactions can continue because:
- the research delivers a therapeutic benefit that cannot be delivered outside of in-person interactions;
- The risks to participants would be greater if the in-person interactions were to stop; or
- Steps to eliminate immediate hazards to participants as a result of these stoppages are ongoing
Please contact Nicole Vouvalis immediately with documentation regarding the Reviewing IRB’s exception. If there is no documentation, please notify Nicole Vouvalis immediately so that she can confirm one of these exceptions with the Reviewing IRB. Research procedures involving in-person interactions may not proceed until an exception has been confirmed between the USU IRB and the Reviewing IRB.
Resumption Webinar Recording
On September 4, 2020, the Human Research Protections Office hosted a webinar on the process for resuming in-person human subjects research at Utah State University.
Last updated June 1, 2021