COVID-19 and Human Subjects Research
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 paused since March; the IRB is now implementing a process for requesting resumption of face-to-face procedures. 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.
The IRB is now accepting resumption requests, via Kuali, for researchers who wish to resume in-person research procedures. 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. When you have reviewed the Framework in its entirety, you may request resumption by filing an application in Kuali Protocols. The Task Force (a subcommittee of the IRB, plus a few external experts in areas like ventilation, schools, etc.) delegated to review resumption requests will meet as resumption requests are submitted, on a weekly basis.
A webinar to guide researchers through the Framework and answer questions related to resumption was held on Friday, September 4. You can view a recording of that webinar by selecting the last tab on the left side of this page.
You may view a blank template of the Kuali-based Resumption Request here.
What is the process for requesting to resume in-person procedures?
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 IRB has determined that resumption requests should be reviewed by a Task Force made up of IRB members and some outside experts (facilities, school partners, virologists, etc.). This allows for IRB members to weigh in on the decision without having to meet the requirements of a quorum for an IRB meeting, which can sometimes prove difficult. That Task Force will meet weekly, based on members’ availability and the submission of Resumption Requests to review.
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 (available here).
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. 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. 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 email@example.com.
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 notify USU’s COVID-19 Response Team. 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.
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 or WebEx 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 several times already, and can continue to do so as long as needed; 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). Click here to 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: Click here to schedule a meeting with Ani, here to schedule a meeting with Sasha, and here to schedule a meeting with Val.
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 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.
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 or 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 or WebEx to discuss your protocol while you are drafting it; the IRB staff are always happy to offer guidance while a protocol is in process. 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 as required, which is the typical summer schedule for the Board. 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. Please also remember that your colleagues who serve on the IRB are largely off contract during the summer, so obtaining a quorum takes some time. If your project is funded research and it requires Convened IRB review, please contact Nicole Vouvalis as soon as possible.
How does this 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.
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.
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.
How is the Human Research Protections Office preparing for the resumption of all human subjects research?
Several steps have been initiated to articulate the processes for the safe and appropriate resumption of all forms of human subjects research. Those planning steps, which are ongoing, include:
- Active participation in national working groups examining the safe and appropriate resumption of human subjects research; especially those focused on social, behavioral, and educational research (as distinct from biomedical research, which comprises less than 2% of USU’s human subjects research portfolio)
- Meetings of the Human Subjects Research Resumption Working Group, which is developing a framework for the safe and appropriate resumption of face-to-face human subjects research for use by the IRB and other institutional committees (now complete; final draft is circulating)
What has the Human Research Protections Office already done to facilitate safe and appropriate research during COVID-19?
Pausing in-person research procedures was an important step in protecting human research participants during this uncertain time. While USU and most other institutions in the United States remain in this paused state, several things have occurred to support the safe conduct of human subjects research:
- A new informed consent template designed specifically to update participants on changes related to COVID-19 has been developed and released. (March 2020)
- Standard Operating Procedures limiting amendments to minor modifications were relaxed to permit researchers to transition in-person research to online or other indirect procedures without needing a new protocol. (March 2020)
- Kuali Protocols has been reconfigured to assist investigators in articulating any changes to their research related to COVID-19. (March 2020)
- Our office has contacted every school district in the state of Utah to discuss whether they will permit in-person research in the fall and if so, under what conditions. Responses are still coming in, though many school districts have requested that we contact them again in August. (May 2020)
- The USU HRP Office initiated a Business Associate’s Agreement with both Qualtrics and WebEx, which allows researchers to utilize online platforms for the conduct of their HIPAA-related research that previously were not authorized to be used for HIPAA-related research. (April 2020)
- The Human Subjects Research Resumption Working Group has completed a draft of a framework for resuming in-person research. The final draft is being circulated for final edits, and then will be proposed to the IRB. The Working Group is comprised of epidemiologists, biostatisticians, representatives from the largest health care provider in the State of Utah, local school districts, and people who work with community populations that are frequently targeted for participation in USU research. (May – July 2020)
- The HRP has made new CITI Training modules available regarding the spread and mitigation of COVID-19 tailored to academic environments and operations (registration instructions are available here). (June 2020)
- Finally, protocols are still being actively reviewed, regardless of the procedures (though review resources are being prioritized to research that can get off the ground immediately, research related to COVID-19, and research that has been funded). (Ongoing)
What is the status of the Human Subjects Research Resumption Working Group?
The Human Subjects Research Resumption Working Group (HSRR Working Group) met on June 12. A framework was discussed for the resumption of in-person human subjects research. A final draft is currently circulating, and as soon as final edits are complete, it will be delivered to the Institutional Review Board as well as the Research Stabilization Committee. After both entities have reviewed the framework, it will be released to researchers.
How will researchers use the framework to resume in-person research interactions?
The framework will identify the types of projects that are permitted to seek resumption of in-person activities. Please note that the HSRR Working Group did determine that if research procedures can be done remotely, they should be done remotely for the foreseeable future. From there, the IRB will consider the resumption of in-person research activities.
The Human Research Protections Office plans to reopen in-person research in phases as outlined by the framework; researchers will self-identify their projects as falling within the “open” part of the framework, and request re-initiation with appropriate updates related to COVID-19.
Can researchers get those COVID-19 updates in place now?
That is not advised. Every day we are learning more about COVID’s risk factors, spread, mitigation strategies, and lasting impacts, among other important factors related to this virus. Our goal is to provide you with the most up-to-date requirements at the time that we begin to permit in-person activities once more. At this time, it is not advised that you file amendments related to COVID, unless those amendments are for the purpose of moving completely away from in-person procedures. We understand and appreciate your desire to plan ahead, and know that your research is important; however, to best protect our existing and prospective participants, we want to be sure we are acting on the best and most recent information.
These sample screening documents have been compiled from school-based settings across the country. The IRB is making them available as a resource on which you may base your screener documents when requesting resumption:
- Building Pre-Entry Screening Form – Employee Health Services
- Initial Screening Form
- COVID Screening Form Summer
- COVID Screening Form Summer 2020
- COVID Screening Form Summer 2020
- Daily Home Screening for Students
- Logistics Screener
- ICHD Work Health Screening
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. You may view that webinar at this link.
Last updated September 14, 2020 at 4:00 pm