FAQs related to the Temporary UNC Policy on Human Subjects-Related Research Visits at UNC-Chapel Hill during COVID-19 Outbreak
Effective March 13th, 2020
The policy states that in-person study visits that do not provide an immediate benefit to participant health or well-being should be postponed. Can you clarify what is meant by immediate benefit?
Studies that provide immediate benefit to participant health or well-being includes clinical research interventions that are provided in the place of clinical care, designed to treat, cure, or mitigate illness or disease. Additionally, a study visit to collect laboratory values to assess ongoing patient safety following an intervention would be considered essential.
Studies that would generally qualify as not providing immediate benefit to participant health or well-being include healthy-subject studies, behavioral intervention studies, observational studies, registry studies, and sample-collection studies. With that said, if a sample collection is being completed in conjunction with an otherwise scheduled clinical visit where the subject is already being screened by UNC Health employees, the study visit may occur.
As stated in the policy, any questions or uncertainly about the designation of a study activity qualifying as providing immediate benefit to health or well-being should be made by the PI, the participant, the participant’s healthcare provider, and should be informed by current public health guidance.
Please refer to the table at the end of the policy for additional information.
We have a number of ongoing studies where previously recruited subjects come into clinic for a routine visit, and have a blood draw or complete a survey Are these research activities still permissible?
Yes, if you already have a ‘regularly scheduled’ clinic visit for routine care and the research procedure(s) will just ‘piggyback’ on the regular clinic visit then it is fine to proceed with those. Same is true for enrolling new patients. The only caveat that I would offer is that the regular clinic visit must still conform with any guidance that originates from UNC Health Care, meaning if they change their protocols for clinic visits then their standards will apply.
Where can I get training for screening research participant for COVID-19?
UNC Health is willing to provide the appropriate training to University staff on screening study subjects prior to a face to face visit. More information to come as soon as it is available.
What if my study subject displays or reports symptoms?
If the patient is already physically in the clinic they should be masked, isolated, and the clinic should call infection prevention. If the patient is being contacted on the phone, they should be screened according to the standard UNCHCS Epic screening questions. Only if the patient screens into a high risk group (i.e.; screens positive) should they be directed to stay home and call Health Link at 1-888-850-2684 who may direct them to the respiratory diagnostic center or direct them to return home.
What about field work or outside clinics?
The policy applies to all research studies managed by UNC or UNC Health personnel, and therefore applies to any in-person study visits that may occur at off-campus locations.
I have already scheduled an enrollment visit for a patient on a phase 1 study in the coming days. Can we proceed with that visit since it is already scheduled?
A phase 1 study new enrollment visit would generally not meet the requirements of “essential for health or well-being” and the enrollment visit should be postponed (or performed virtually, if possible).
We have a study that does provide direct benefit to the health of our participants, but our study coordinator is unable to report to campus to perform the study visits. What should we do?
In cases where a member of the study team is unable to perform his/her regular duties, the PI is responsible for ensuring the study protocol is appropriately followed and may delegate authority as allowed per study protocol. Any changes in typical procedures or authority should be documented appropriately.
My study sponsor is requesting that study activities continue as planned, which contradicts this new policy. What should I do?
The policy stated here takes precedent over study-sponsor requests that may contradict the policy. The written policy may be provided to the sponsor as documentation supporting the required changes in operations.
Does this policy apply to UNC research studies that use secondary data received from an international partner where the human contact occurs outside of this country (in Peru to be precise)?
This only applies to research visits where we (UNC) would be in direct contact with the human participant.
What do I need to do if my study does not provide immediate benefit and I’m going to postpone or suspend activities for the entire study?
Please submit a modification in IRBIS and in the Coversheet, state “Suspension of Activities-COVID RELATED”, please do not include other modifications in this submission. If you are only requesting to suspend certain activities and continue to conduct research activities that do not include direct involvement please submit a modification to the IRB and if this alters the consent process, please provide appropriate details.
Can PIs and/or qualified clinical staff may provide direct training to the research staff?
Yes, following the guidelines set by UNC Health.