University of Arizona IRB Update on COVID-19 Response
March 16, 2020
Dear Research Community,
In response to President Robin’s email, we have chosen as an office to be proactive and work from home. Please note, operations will continue as normal and work will continue to be processed in a timely fashion. If you need to get in touch with a staff, please email them directly to set up a call. For emergency purposes, you may reach me on my cell at (520) 427-8214. Mariette Marsh is also available by cell at (520) 989-1758.
Please remember, changes made to eliminate immediate risks to subjects can be made without prior IRB approval (see below for further instruction). The recommendation is to move as many things online as possible, and if necessary, stopping certain activities.
If an amendment is submitted and urgent due to the ever changing COVID-19 situation, please identify such in your submission email.
I want to remind you the information that was sent out in the listserv yesterday:
Frequently Asked Questions:
What if a participant cannot make their study visit due to illness?
If a participant is unable to complete a required study related activity per the approved protocol, this is not considered a protocol deviation per our guidance. Only protocol violations due to investigator or research staff are considered protocol violations and must be reported to the UA IRB.
Can the study procedures be modified to address the potential impacts COVID-19?
During this time, we are encouraging and supporting decreasing the number of protocol-mandated in-person study visits to healthcare facilities or replacing protocol-mandated visits to healthcare facilities with home visits or telemedicine options, if these are feasible and do not negatively impact participant safety. This modification to the protocol must be approved by the UA IRB prior to implementation.
Please note, there are situations in which decisions have to be made without IRB approval first. Regulations allow this to an extent. Please see below:
- Protocol deviations can be made to eliminate immediate risks to subjects: If changes need to be made to studies in response to the current COVID-19, including but not limited to:
*Decreasing the number of protocol-mandated in-person study visits to healthcare facilities
*Replacing protocol-mandated visits to healthcare facilities with home visits, telephone, Zoom, or telemedicine, etc.
*allowing blood draws at remote or commercial laboratories
*Shipping investigational products directly to research participants
*Canceling a study visit in general due to low research staff support
…the IRB would need to review those changes. However, FDA regulations require that:
Each IRB shall … (a) Follow written procedures for ensuring that changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except where necessary to eliminate apparent immediate hazards to the human subjects. 21 CFR 56.108(a)(4).
Therefore, if a sponsor or investigator needs to make a change to research plans in order to eliminate apparent immediate hazards to research participants, these changes can be made and then reported to the IRB within 5 days, as per UA IRB guidance. If a full revised protocol cannot be completed in that time, a document that describes the changes and explains how they will protect subjects can be submitted, along with copies of any new or revised subject-facing materials.
Again, investigators should consider whether at any point their research procedures should be revised to limit personal contacts. Whether and when this may be advisable will vary depending on your protocol and the subjects with whom you are working. If you are considering using a virtual video platform for your study visits, and you are dealing with HIPAA protected data, Zoom for Health provides a university-approved way to conduct online meetings and audio conference calls involving health information, including Protected Health Information (PHI) regulated by the Health Insurance Portability and Accountability Act (HIPAA). With Zoom for Health, you log into a separate environment with your UA NetID to schedule meetings or calls that require additional privacy and security controls. Participants join as they do any other Zoom meetings.
Getting Started with ZOOM Health
Users must complete the ZOOM for Health training before using the application. Training is available in UAccess Learning at https://learning.uaccess.arizona.edu/.
Once you have completed the training, you can begin scheduling meetings. To schedule or begin a meeting with the Zoom for Health scheduler, login with your NetID to this site:https://hipaa-zoom.arizona.edu/
- Select HIPAA ZOOM Login
- Log in with your NetID and password
A step-by-step guide and training videos for ZOOM for Health are available at: /compliance/hipaa-privacy-program/zoom-health
If you have questions related specifically to hosting meetings where HIPAA data may be present, please contact the University of Arizona Privacy Office at firstname.lastname@example.org.
- If an amendment is being made to work around the COVID-19 virus, please notify the IRB in the submission email and in the subject line. The HSPP office will expedite these requests as much as possible.
Please let me know if you have any questions.
Christine Melton-Lopez, MS, CIP
Director, Human Subjects Protection Program
The University of Arizona
1618 E. Helen Street
Cell: (520) 427- 8214