Do I have to notify the CWRU IRB if I am pausing recruitment of subjects, or all study activities, due to COVID-19?
No. This is not a change to the protocol, but a temporary pause in enrollment and/or study activities, so notification is not required at this time.
- You do need to notify the study sponsor.
- You should document the pause in your study file.
- Track all missed visits, procedures, appointments, and other relevant study activities.
- For research approved by another IRB: Please contact that IRB for their instruction.
Do I need to notify my currently enrolled study subjects of the pause in procedures?
If the pause in procedures affects the already enrolled subject(s), they should be notified. We recommend that you do this by phone, but mail and e-mail (if you have consent for email contact) can also be used if needed under these circumstances. You do not need an IRB modification for this notification.
When do I need to submit a modification to the CWRU IRB?
You need to submit a modification to the CWRU IRB if you would like to change any aspect of the study that is described in the currently IRB approved protocol and/or consent forms. For example, if you would like to move to remote-delivery study activities that are currently described in your IRB approved protocol as being performed in-person, you will need to submit a modification to the CWRU IRB. These can be added as additional procedures in the protocol, so that you can return to in-person activities at a future time, after all CWRU, federal, state and local or other applicable COVID-19 research restrictions are lifted for the kinds of the research activities in your study. Please include any changes in the consent process and data collection, as well as data storage. You may also need to update your consent document, if it is specific for in-person activities.
How should I manage remote communication or data collection with subjects?
Privacy and confidentiality provisions remain critically important at all times, even when working remotely. Please note: collection, transmission, or access to private identifiable data or protected health information, must comply with university and other policies for security of research data.
Remote interactions that will collect or transfer private identifiable information or protected health information should use technology that is IT secure or HIPAA compliant (e.g., CWRU REDCap, CWRU Box, or a restricted Zoom account– which is different than the standard CWRU version).
Do not store private identifiable information or protected health information on unsecure devices in order to work remotely. Use University-approved BOX services and VPN access while working at home instead of storing data directly on personal devices.
If making copies of physical research records or data (paper consent forms, case report forms, questionnaires/surveys, etc.), double-lock all paper records (such as a locked drawer in a locked home). Return paper records to the IRB-approved location as soon as it is practical.
Can I submit a new study to the IRB that has in-person study activities?
Yes, the IRB is continuing to review and approve new studies, although COVID-19 submissions will be prioritized. You will be asked for a statement that in-person activities will not be conducted until all CWRU, federal, state and local or other applicable COVID-19 research restrictions are lifted for the kinds of the research activities in your study. Your protocol can describe alternative approaches or remote activities that will occur during the research restrictions, and also in-person activities that will take place in the future.
Has NIH provided formal guidance on human subjects research activities?
Yes, although the guidance is broad and geared predominately at administrative issues. Guidance can be found on the NIH web page for Natural Disasters:
What if an external IRB is the IRB of record for my study?
Check with reviewing IRB on reporting requirements as they may differ with the CWRU IRB policies.
What if I have additional questions about my study?
For general IRB or Human Research questions: You may contact the Office of Research Compliance by email at email@example.com or phone at (216) 368-0134. If your question is about a particular study, please include the IRB protocol number and PI name.