COVID-19/Pandemic FAQs

Please follow institutional policy, see “seeking medical care”.

UNLESS the study hold is initiated at the request of an external funding agency or the study’s Data and Safety Monitoring group (if there is one). You have the option to renew your study through Cayuse Human Ethics if your approval has expired. If your prior study was not submitted through Cayuse Human Ethics and you wish to renew that, please complete this form to request the transfer of your project to Cayuse Human Ethics for renewal and modification if necessary.

We recommend all in-person contact be suspended. If you need to meet with someone, send an email to ask if there is potential for exposure to the novel coronavirus (COVID-19) or symptoms of illness before any study-related visits and in-person interactions and plan accordingly.

The CDC (or whoever) recommends that research participants with possible exposure or symptoms of illness should not participate in in-person interactions until after the time recommended by the current public health recommendations.

might include the following, which could be modified to fit your participant population and the location of in-person interactions. Any YES answer should be considered sufficient reason to postpone in-person visits. Decisions about in-person visits should be especially conservative for people at higher risk per public health recommendations:

1.) Have you had any of the following symptoms in the past two weeks, even if they were mild?
Fever
New cough
Runny nose
New shortness of breath
Muscle aches

2.) Have you had close contact* with a person who is under investigation for possible COVID-19?
3.) In the past three weeks, have you visited a country or facility with sustained (ongoing) occurrence of COVID-19, such as the following (and any other locations consider Level 3 by the CDC):
China
Iran
Most of Europe
Japan
South Korea
Long-term care facilities in the area.

*Close contact is defined by the CDC as (a) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time. Close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case OR (b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).

Consider the study population and the location before. Assuming that populations and locations with few reported cases are free of novel coronavirus (COVID-19), you should consider the possible impact of the study on care providers, their institutions, and their patients/consumers who will likely be dealing with a significant increase in workload. Also if you are doing research at external research sites, it may be possible they are prohibiting visitors or closed altogether.

If there is a compelling reason you cannot postpone in-person interactions, you should:

Consider remote meetings (e.g., Zoom) as an option. This adjustment in your project proposal does not require an IRB amendment.
Screen all participants for possible exposure to the novel coronavirus or symptoms of exposure to respiratory illness before scheduling any in-person interactions. Participants with possible exposure or symptoms of illness should not participate in person. This screening procedure does not require IRB approval or a submission of modification.
Ensure that hand sanitizer, hand washing facilities and/or cleaning wipes are readily available for participants and study personnel, when in-person interactions will occur.
Abide by all recommendations and actions of the appropriate public health authorities (e.g., District of Columbia Department of Health and Gallaudet and CDC) such as social distancing.
Ensure every day that study personnel who will interact with participants are symptom-free and have not had possible exposure to COVID-19.

Consider prioritization of tasks within your research project. Depending upon the nature of your research, you might consider prioritizing work that can only be carried out in your research facility, and work that could be done by remote support, such as data analysis. You may want to postpone work that requires in-person interaction until conditions are less risky for all. Stockpiling results and data now that could be analyzed remotely in the future is a potential option that might create future flexibility. (adapted from: https://www.washington.edu/research/announcements/mitigating-impacts-to-research-activities-due-to-covid-19/)

At this time, the IRB does not believe it is necessary for most studies. We recommend that study personnel do not bring participants to a facility in which there has been a positive or presumptive-positive case of COVID-19.

If your protocols have changed to accommodate the ongoing situation to ensure everyone’s safety, IRB approval is not required. Please do submit any changes via email or through Cayuse Human Ethics to document your changes. This can be done by uploading the new forms or a short memo describing the changes. If you have any questions about this, you may reach out to us via email at Contact here.

First, consider the safety of your study team and participants. If any in-person interactions can be postponed, please do so. Immediately communicate your plan with all relevant parties. Make sure communication is accessible – consider everyone’s communication preferences and needs. Encourage your study personnel and participants to follow all precautions recommended by health professionals (e.g., District of Columbia Department of Health and CDC, also see resources at Gallaudet’s site for novel coronavirus (COVID-19). Establish remote access for your work.

Consider this checklist developed by University of Washington, Office of Research.

Checklist:

• Identify emergency personnel and ensure they know what to do in the event of suspended operations
• Remind lab personnel of your communication plan or create one if not in place
• Identify priorities in case of restricted access
• Ensure remote access to files, data, servers, etc.
• Prioritize experiments
• Plan for remote proposal submission
• Check travel restrictions before making travel plans.