Update: COVID-19 Guidelines for Human Subjects Research
Several changes to UNC guidelines and processes for the Clinical Research community have been announced recently.
A new quick reference guide for research faculty and staff has been published at med.unc.edu/crso/covid/som-guidelines-and-processes.
Changes of note include:
- Requirement to maintain at least 6 feet of distance from others – REMOVED (except when eating/drinking) (per OVCR)
Note: UNC Community Standards still require allowing 6 feet of distance from others in conference rooms and other centrally-managed meeting rooms
- Requirement to provide COVID information sheet – REMOVED (per OHRE)
- Requirement to conduct a participant wellness screening 24 hours in advance of a study visit – REMOVED (in alignment with UNCH policy)
Note: Study teams are still required to conduct and document a participant wellness screening at the initiation of each study visit
- Requirement for UNC staff to document individual daily wellness screenings – REMOVED (per UNC Community Standards)
Note: Any personnel reporting to any UNCH clinical space (e.g. study coordinator conducting a clinical visit) are still required to document a personal wellness screening on days that they will be working in those clinical spaces (per UNCH policy); this documentation may be completed in either of the UNCH portals or the UNC EHS portal
Why are we discontinuing the "COVID Information Sheet"?
Although COVID has not been eliminated, and risks are still present, compared to when COVID was emerging in March-June 2020, more is known by both researchers and the general public in regard to risks, treatment and prevention. These risks are no longer considered "new risks", similar to other infectious diseases or conditions, and by continuing to place emphasis on COVID there is concern that the actual risks of research will be minimized as the general public has a much higher level of COVID awareness, appropriate protections, and options for vaccines.
Do I need to submit a modification to "remove" the COVID information Sheet?
Provided that the consent template was used verbatim as outlined in our original communication and otherwise a modification was not submitted, then the discontinuation does not need to be submitted to the UNC IRB for approval. Please retain a copy of the "Discontinuation COVID Information Sheet Approval Letter" in your study files.
What if I think I need to keep using the "COVID Information Sheet"?
If at this time due to the study population, location, or other contributing factor you feel as though it is in the best interest to continue to use the templated COVID Information sheet, you may continue to do so but it is not an IRB requirement.
What if I submitted a study specific COVID Information Sheet?
If you submitted a modification to make study specific changes to the original COVID Information Sheet, a modification to remove or revise the COVID Information Sheet is required.
UNC's IRB is providing oversight for external institutions, organizations, or clinics
Do all of the sites that rely on the UNC IRB review need to stop using the COVID Information Sheet and do I need to submit a modification?
All sites should stop utilizing the COVID Information Sheet, unless there was either a study specific modification or the site as part of local context requires its use. If the site is required by local requirements to continue with a COVID Information Sheet, that otherwise has not already been approved by UNC through a study specific modification, then a modification should be submitted for the sites that want to use a new COVID Information Sheet or revise a previously approved COVID Information Sheet.
What if the external sites are not allowed to resume activities but UNC has resumed activities?
The sites should follow their local institution's directives with respect to resuming activities. Typically the more restrictive stance will prevail.
My study is relying on an external IRB
Do we need to submit the Information Sheet to the Commercial IRBs if we are relying on them?
The Office of Human Research Ethics has contacted Commercial IRB partners, and no further action by local study teams should be required.
Do I need to submit the Information Sheet to the reviewing IRB if I am not relying on a commercial IRB?
Discontinuation of the Information Sheet is considered a local institutional requirement and is part of UNC's local context. OHRE recommends reaching out to the lead/reviewing site and confirming if they would like this information to be reviewed by their IRB; please provide them a copy of the approval letter.
The external IRB has provided me with their own version of something like the Information Sheet. What do I do?
The OHRE recommends to share the Discontinued UNC Information Sheet letter with the external IRB, and request to no longer utilize the information sheet.