COVID-19 FAQs

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The IRB is fully operational. We expect this to continue even if the University suspends operations for contagion control purposes. All of the IRB members are active and all IRB meetings are being held remotely via Zoom. The IRB email address continues to be monitored with the same or greater frequency.  

Since we have already moved to Cayuse Human Ethics - we no longer accept hard-copy applications due to COVID-19.  Please submit any study via Cayuse Human Ethics. For more information on how to submit - please click this link - How do I submit and reach out to IRB@gallaudet.edu if you need further support. 

At this time, the IRB office is closed to walk-ins visitors. But email and Zoom meetings are options. Virtual office hours will be held every Friday except when board meetings (see dates on website). Please use this appointment calendar to book your time.

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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.

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Test your recording materials, and make sure that your video data is being recorded onto a device that has sufficient storage.  Please be aware that many video conferencing software record only audio. You can make screen recordings using QuickTime or similar software, and you can back-up your data using a camera that is also filming your screen. 

Some video conferencing software like Zoom allow for recording. You can directly store these in the cloud through your Zoom professional account for example and if linked to your ECHO360 account, the recording will show up there as well. If stored directly to your local computer, Gallaudet grants 1TB space size to faculty using Google Drive and Microsoft OneDrive to store your information. You may need to drag and move your important files and documents from your office computer. It is recommended that you consider multiple backups of your data (both online using cloud storage and offline using external hard drives). 

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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 IRB@gallaudet.edu. 

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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/)

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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.

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As has already been in effect, we are not accepting paper-based applications for any new research.  You can submit your study for IRB review through Gallaudet Cayuse Human Ethics. Please refer to How Do I Submit to learn how to submit electronically via Cayuse Human Ethics. If you are a student or a new or short-term staff/faculty member, please request a Cayuse Human Ethics account.

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There are several ways to make forms electronic by converting them into a PDF or creating digital versions (e.g., using Google forms). This means you can send your participant's study forms via email and do not need to collect them in person. Be prepared to discuss any questions or concerns your participants have via email or their preferred video communication platforms like Zoom or Skype. Research teams should establish best practices for storing those forms in a secure password-protected storage device with back-ups. As a resource, University personnel has access to Adobe Sign through my.gallaudet.edu. Other online resources like Google forms can also be used if you describe how you keep information secure. 

If paper forms are required for whatever reason, handle them with care. Similarly, if you are creating digital resources but still handling them in person via tablet or laptop, sanitize your devices as recommended by health professionals.

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We recommend you follow the same protocols as issued by Gallaudet University for all faculty, staff and students as described here. Starting on August 16th, all faculty, staff and students will be required to be vaccinated or seek a waiver. For more, visit the website.
All human subjects from off-campus follow the same protocols for visitors and contractors as specified on the website here
Request a Campus Access permit from your on-campus host Complete the online Health Self-Assessment
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).

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Any changes to a non-exempt study must be approved in advance by the IRB as a modification to the study unless they are necessary to eliminate immediate apparent hazards to participants. Modifications should be submitted through the regular process in Cayuse Human Ethics. 

You your application if the study is not exempt and the application specifies in-person visits. 

You need to modify the application in order to hold visits remotely or change the schedule of study visits if the study is exempt or if the IRB application does not describe whether the visit would be in-person or remote or give specifics about visit schedule.

If you submit a modification related to COVID-19, you should email IRB to prioritize these modifications. Please contact irb@gallaudet.edu with questions.

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You can send your questions to the IRB at irb@gallaudet.edu.