COVID-19 Guidance for Research with Human Subjects

 
Non-Therapeutic Studies and Studies With Little-to-No Direct Benefit

These studies include observational activities (public or otherwise), in-person interviews, focus groups, or surveys/questionnaires, where stopping the research would not negatively impact the subjects.  These studies may continue if the procedures can be performed remotely.  The IRB would have to approve an amendment in order to change a study procedure that previously was to be performed in person to an on-line, telephone, or other remote means of participation.
 

Studies With Direct Benefit 

These studies include therapeutic interventions involving study drugs, medical devices, or cognitive/behavioral treatments, where stopping study procedures would cause harm to the subjects.  Investigators should still weigh the benefits of the treatment arm against the risks of COVID-19 exposure for research subjects and study staff as they make a decision about continuing these projects.  Any activities that can be conducted remotely by telephone or electronically should be implemented in such a manner to the fullest extent possible.  The IRB would have to approve an amendment in order to change a study procedure that previously was to be performed in person to an on-line, telephone, or other remote means of participation.
 
Note: Per federal regulations, changes to an approved protocol require prior IRB approval except in the rare circumstances when an investigator needs to deviate from the protocol to avoid an immediate apparent hazard to research participants.   Even in these rare cases, the PI must subsequently submit a Report New Information form to document the protocol deviation.
  


When and How to Modify Protocols to Add Remote Research Procedures

Exempt Protocols:
  • Study procedures can be moved to remote data collection without submission of a Modification. 
  • If the data previously were collected without identifiers (e.g. in-person paper survey), then the online survey also must be collected without identifiers (including email and IP addresses). 
  • Use of Qualtrics and REDCap is recommended, with changes to the default settings to anonymize responses.

 

Expedited or Full Board Protocols:
  • Research protocols or any single component of a research protocol may be delayed/paused for COVID-19 concerns without submitting a Modification to the IRB.
  • If there are changes to research procedures, a Modification should be submitted to the IRB prior to implementing the changes. When revising the study protocol, indicate whether the changes will be permanent or temporary.  For temporary changes, label them by using a header such as “Temporary COVID-19 Related Procedures.”       

Remote Data Collection

  • Protocol should describe how you will be collecting data, and the remote platform being used.  Include any changes in additional data you might be collecting (audio or video recordings).
  • Be sure to follow current best practices issued by CWRU UTech for these remote platforms to ensure privacy and data security.  
  • Recommendations:
  • For surveys:  Qualtrics and CWRU REDCap
  • For interviews:  CWRU Zoom and phone                    

Informed Consent Process

  • If you will be obtaining verbal consent for new participants, you will need to request a waiver of documentation of consent.  Indicate in a Modification this request within the Consent Process section of your study protocol. 
  • Add a new verbal informed consent script. If you will be returning to written consent form at a future time, keep your previously approved consent document in the protocol (do not remove or overwrite).
  • For HIPAA or FERPA protected data, you will need to either delay authorization until you can get written consent, or set up REDCap to obtain an electronic signature and date.  If you will delay authorization, remove this language from the verbal/online consent.         

Notification/re-consent for currently enrolled participants

  • Participants who already have consented to participation should be notified of any data collection changes and should be asked whether they wish to continue participation in the study as part of the ongoing consent process. 
  • Indicate in the Modification summary that participants will be notified/re-consented regarding these changes, and upload a document with the notification/script that will be given to the participants.

Data Storage

  • 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).
  • 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.), secure all paper locally following HIPAA principles and return to the IRB-approved location as soon as is practical.
  • If the data will be stored in a different storage location(s) than what is stated in the approved IRB protocol, indicate in a Modification where data will be stored.