Consent Processes for Isolation Rooms
The Office for Human Research Ethics (OHRE) has worked with the Office of Clinical Trials (OCT) and the Clinical Trial Quality Assurance (CTQA) program to create the following information when consenting subjects for a greater than minimal risk and FDA regulated study in isolation rooms.
Consent Process Algorithm for In-Patient Subjects and FDA Regulated Research
This algorithm serves as a decision tree in determining what consent processes are available to subjects in isolation for greater than minimal risk and FDA regulated research.View algorithm (pdf)
Consent Process Checklist for Isolation Areas
This checklist is an aid when alternate consent documentation processes are required for studies when a signed informed consent document cannot be collected from the subject's location and included in the study records (e.g., a COVID patient's isolation room).
This consent process is permissible for all studies including FDA regulated (FDA March 2020 Guidance - pdf) for the duration of the public health emergency in relation to COVID-19. A modification to utilize this process does not need to be submitted to the IRB. However, the OHRE does recommend utilization of the checklist and that the documentation steps are followed.View checklist (pdf)
NOTE: Utilizing this process is not to be considered the standard consent process. An adequate reason for utilization (e.g. spread of COVID in COVID patient's room) must be documented in the utilization checklist.
These documents do not change or alter the COVID-19 for Clinical Research statement that provides an immediate benefit for the health and well-being of a participant. This work is subject to guidance and direction from UNC Health. The UNC Health coronavirus website should be consulted for direction regarding such research.
Please refer to the Office of the Vice Chancellor for Research COVID-19 for additional information.