UIHC in-person human subjects research allowed to resume today

In-person research visits occurring in UI Hospitals and Clinics facilities may resume beginning Monday, December 14, 2020, given the following conditions:

• Appropriate research personnel and PPE are readily available to ensure subject safety.
• The study team continues to minimize COVID related risks by following the Guidelines for In-Person Research Study Visits copied below.
• The study team continues to follow research plans approved by their associate deans for research and all institutional, state, and local public health guidance.
• Research teams retain plans to ramp down in the event of a COVID resurgence.

Units providing research support such as the Clinical Research Unit (CRU) may be short staffed because of clinical reassignments so we ask for your patience as the resumption of research activities may not occur immediately in these areas. 

The following guiding principles should be applied to all research conducted by UI researchers:

• Health and safety of research participants and study teams remain the priority
• Research study visits should continue to occur remotely whenever possible
• All UI, UIHC and state/local public health guidelines must be followed
• PPE must be available for a study before work begins.  Study teams should adhere to the PPE guidance in place at the location where the research is performed.
• Appropriate research personnel must be available to ensure subject safety.
• COVID-19 Research will continue to be prioritized, but care must be taken not to overburden subjects or put them at unnecessary risk.
• Health care systems, schools and other off-campus agencies/facilities must not be overburdened with research requests. The study teams must work closely with these entities to ensure that the research teams abide by all policies in place at each facility.
• Virtual consenting and monitoring processes should be followed whenever possible. The HSO has provided researcher guidance for Alternatives to an In Person Consent process. This guidance can be found on the Educational Tools page of the HSO website.

Please refer to the OVPR Responding to COVID-19 guidance for additional information. In addition, University of Iowa researchers should follow all institutional requirements as posted on the Campus Coronavirus Updates and guidance documents posted at The Loop.  IRB-specific guidance may be found in the COVID-19 Information section of the Human Subjects Office website.

Please address questions to the Office of the Vice President for Research at 319-335-2119 or jennifer-lassner@uiowa.edu, the Human Subjects Office irb@uiowa.edu or 319-335-6564, or visit the HSO website at hso.research.uiowa.edu.

Guidelines for In-Person Research Study Visits

*For study visits that will be conducted in person, study teams should contact participants within 24 hours prior to the visit:

• Staff should verbally confirm that the participant is well and explain the screening procedures, if any.
• For research occurring on campus or in institutional settings, screening procedures in place at the relevant location will be followed.
• The participant and any participating caregiver must be informed that they will be required to wear a mask throughout the visit (except when removal of the mask/covering is necessary for the research procedure), and whether the mask will be provided by the study team. Individuals at higher risk for serious illness from COVID-19 may also be asked to wear a face shield.
• Participants should be advised to wash their hands before and after entering the research space.  Hand sanitizer should be available if a restroom isn’t nearby.

*Participants should be asked to report a COVID positive diagnosis to the research team within 14 days from a research visit.

*Research participants should be advised not to bring guests to the visit. Children and adults who require assistance may be accompanied by one caregiver. If a caregiver is present, the caregiver should also be screened.

*Throughout the study visit, including during the screening process, research personnel should follow physical distancing guidelines (i.e., 6 feet of physical distancing), except as necessary to complete required procedures.

*Research related activities should be conducted by a minimum number of necessary people, with time limitations and minimal personnel density.

*Researchers should eliminate traditional waiting and common seating areas and utilize non-traditional alternatives, e.g., call ahead registration, waiting in car until called, moving participant directly to research room, etc.

*Ensure adequate supplies to minimize sharing of high-touch material to the extent possible. Discourage sharing of items that are difficult to clean or disinfect.

*Establish a cleaning procedure between research participants.