3. Considerations for Different Types of Human Subjects Research Studies
The following are different types of human subjects research studies that could continue once UNC resumes activities:
Non-interventional human subject research studies that do not include participant contact
- Non-interventional human subject research studies that do not include participant contact can continue, e.g. population health studies that utilizes EHR data. If the work is conducted in UNC facilities, the PI is responsible that all the guidance herein is adhered to with regards to workplace safety and social distancing.
Non-interventional human subject research studies that include participant interactions and can be completed virtually
- Non-interventional human subject research studies that include participant interactions but can be performed virtually can continue e.g. interviews handled remotely. As above, if the work is conducted in UNC facilities, the PI is responsible that all the guidance herein is adhered to.
Observational or interventional studies that include direct participant contact (in clinical or non-clinical spaces)
Studies that require face-to-face assessments or visits can continue, weighing risks and benefits for the participants. If the potential benefit of a face-to-face visit for a research participant exceeds the risk, visits are desirable. E.g., a patient who is doing well in a trial needs a blood test to monitor renal function or drug levels to be able to continue the study product safely. If it is the PI’s judgement that the potential benefit of the visit and continuation of the trial product exceeds the potential risk of the visit, the visit is allowed. The CDC recognizes nine high-risk groups for severe outcomes with COVID-19 such as those over age 65. As part of the ongoing consent process, research participants at high risk for severe outcomes should only be asked to participate if there are clear benefits to patients. They should understand the risks of breaking social distancing. Regardless of the location of the face-to-face visit (clinical versus non-clinical space), participants and research personnel must undergo the same screening procedures, and follow the same mask and visitor policies as described in the following pages and detailed in https://unchcs.intranet.unchealthcare.org/Pages/2020/novel-coronavirus.aspx. 1
1. Some key documents from the UNC Health websites are replicated on CRSO website for those without UNCHCS intranet access https://www.med.unc.edu/crso/unc-healthcare-guidelines-for-covid-19/.