University of Arkansas for Medical Sciences Requirements on Human Subjects Research Studies during COVID-19 Outbreak

With regard to the COVID-19 outbreak, UAMS has revised human subjects-related research requirements to protect research participants, research personnel, and the UAMS community from risk of infection with COVID-19. It will also ensure ongoing access to research which may provide essential support/care to participants. These requirements will be revised as appropriate.

The Winthrop P. Rockefeller Cancer Institute has implemented additional clinical research restrictions.. Researchers/staff conducting cancer-related human subject research should contact Dr. Kristin Zorn or Sandy Annis for further information.

Interim Requirements

NEW PARTICIPANTS

Enrollment of new participants has previously been restricted for certain types of clinical research studies requiring in-person participant interaction. At this time, enrollment is allowed for all research study types where in-person participant interaction occurs either in a UAMS facility or at a UAMS-sponsored community event (e.g., UAMS mobile vaccine events) with the condition that all study personnel, participants, and guests must fully comply with all UAMS entrance screening, masking, and other PPE requirements.

Research activities taking place in other community settings remain restricted. UAMS faculty research leaders are currently working with community partners to develop criteria and define appropriate conditions under which additional community-based research may resume.

ESTABLISHED RESEARCH PARTICIPANTS

UAMS investigators should consider performing research visits virtually when possible.

If a research visit cannot be performed remotely, onsite visits for participants already enrolled in a trial may continue according to the following guidance:
o Study teams will contact participants prior to any in-person visit to screen for COVID-19 symptoms using CDC guidance (https://www.cdc.gov/coronavirus/2019-ncov/index.html). Any participants experiencing symptoms will be referred to UAMS Health (https://uamshealth.com/coronavirus/) and the research visit will be postponed.
o Study teams will provide participants with information regarding the current COVID-19 pandemic and how best to reduce their risk of infection (see CDC Guidance above). If possible, this information will be shared before the research visit.
o All research participants arriving on campus will undergo screening for COVID-19 symptoms at a UAMS screening station.

Research visits in the community remain restricted as described above.

Research Personnel

All research personnel (faculty and staff) will receive appropriate training regarding proper research participant screening and participant triage should a research participant be deemed at risk for COVID-19 infection during an in-person research visit screening.

Guidance from the UAMS IRB on how to proceed with necessary protocol amendments (e.g., changing to remote visits) can be found here: https://irb.uams.edu/2020/03/12/human-subject-research-in-the-time-of-coronavirus-covid-19/.  For studies under the oversight of an external IRB, the policies of the IRB of record will govern such changes.

Study Sponsors

Principal Investigators or their designees are responsible to communicate to study sponsors any local restrictions or requirements that may impact the conduct of study activities, including requirements that may restrict on-site sponsor visits for site qualification, training, or monitoring.  At this time, it is recommended that sponsor visits be conducted remotely when objectives of the visit can reasonably be completed via virtual methods (e.g., EpicCare Link access for source data verification).

If a sponsor visit cannot reasonably be completed remotely, or if the scope of the research requires a sponsor representative to be in-person at essential study visits (e.g., for medical device programming), on-site visits may proceed with the condition that all sponsor representatives must fully comply with UAMS entrance screening, masking, and other PPE requirements.