Allowable Human Participant Research Activity
There is no categorical restriction on the types of research studies that may proceed. Remote research visits/functions are still encouraged when concordant with institutional and protocol-specific IRB guidance. With the end of the winter surge, the BJC hospitals have moved past the previously needed contingent staffing model. Therefore, it is reasonable to proceed with studies that delayed initiation during the surge. However, attention should still be given to ensuring excellent communication with hospital staff and clinical research core/facility managers, to minimizing reliance on clinical personnel for research activities, and avoiding interference with clinical care activities. Research teams should be prepared to make adjustments again should circumstances warrant a return to crisis-level staffing.
Before conducting an in-person research visit, research teams should still assess whether it may put participants or others at undue risk of coronavirus infection or related consequences. However, the observed effectiveness of full vaccination and the on-campus precautions that have been used (and that should be applied during the visit) are reasonable to consider in making this determination. Participants must still pass through a visitor screening checkpoint upon arrival to campus, but telephone pre-screening is only needed if required by the clinical area or research core the patient will visit. If a visitor screening checkpoint is not available, the study team should perform the screening. Family members who accompany the participant are subject to WU/BJC policies on visitors and on the use of face masks, in addition to the specific requirements of any clinics or research cores/facilities that they will visit.
Research core/facility directors still have authority to set the procedures and policies for their unit’s function, considering resource/staff availability, social distancing and cleaning needs, and other issues. Research teams should respect these limitations and address specific issues with the core directors.
Please see updated institutional policy on masking for vaccinated and non-vaccinated people. The CDC recommends masks with two or more layers that cover the nose and mouth and fit snugly: CDC – Your Guide to Masks. Washington University recommends disposable masks in settings that contain biological, chemical, or radioactive hazards, which includes some human participant research spaces. Do not use neck gaiters, poorly fitting or thin masks with low thread counts or loosely woven material.
Density Restrictions and Physical Distancing
Individuals who are not fully vaccinated should maintain 6 feet physical distancing If people who are not fully vaccinated have to work with others in closer proximity for more than 15 minutes, surgical/isolation masks are recommended and encounters should be documented for future contact tracing if it is needed. With adherence to these guidelines, the use of cohorts and non-overlapping shifts may no longer be needed.
Hand Hygiene and Disinfecting Surfaces
The CDC has recently updated its guidance to emphasize hand hygiene and de-emphasize frequent surface cleaning: CDC – Cleaning and Disinfecting Your Facility.
Therefore, we continue to recommend frequent hand washing and once or twice per day sanitizing of frequently touched surfaces (e.g. doorknobs, elevator buttons, coffee machines), and are eliminating the recommendations for general surface sanitization.
Eating and drinking with others is a high-risk activity for individuals who are not fully vaccinated. Investigators, staff managers, and departments should ensure that personnel have adequate space for taking a break that is at least 6 feet from others. With the nicer weather, personnel are strongly advised to take eating and drinking breaks outdoors. Items like coffee machines are allowed in break rooms, and personnel are encouraged to wash hands after touching shared surfaces and before eating or drinking.
Remote communications are still strongly encouraged when possible. However, in-person meetings for research purposes (not social activities) are now permitted when important to support study process as long as all participants adhere to institutional and facility guidelines.
Plans, Monitoring, and Compliance
Investigators and research unit managers are responsible for ensuring that everyone on their team, including new personnel, are adequately trained and are following these guidelines. The University no longer requires plans for pandemic-related research unit function, or revisions to such plans, to be submitted to the School or Department for approval. However, Department/Division leaders remain responsible for ensuring/monitoring the safety of their personnel, operations, and facilities, and may choose to continue to require study/unit-specific plans or other measures to support safety and research success in their areas. Research teams should internally communicate plans for remote versus in-person research functions to team members and monitor their impact upon safety, participant satisfaction, and research progress. Research team members may discuss concerns with their study principal investigator, research unit manager, division director, department chair, the Senior Associate Dean for Research, or submit concerns to the OVCR.
There are no COVID-19 specific restrictions on the types of personnel that can work on human participant research, provided there is sufficient space for them to work with 6 feet physical distancing for individuals who are not fully vaccinated. Until schools and daycares are operating at near normal hours, investigators should continue to be sensitive to the needs and concerns of research personnel, such as those related to childcare or transportation.
Washington University students and visiting students who are enrolled in formal Washington University programs may participate in human participant research but must be oriented to the COVID-19 related guidelines of any research cores or other areas they will visit on the medical school campus, and any school-specific guidelines on the Danforth campus. Non-WU students must go through Human Resources onboarding procedures, must follow all Washington University regulations, and their presence must be approved by the hosting Department/School. At this time, non-WU students are not allowed in clinical care environments, including for shadowing, unless part of a pre-approved and formalized program.
HRPO has set up a dedicated phone line and email account for questions about IRB requirements related to COVID-19.
Amanda Cashen, MD
IRB Executive Chair
Suresh Vedantham, MD
Assistant Dean for Clinical Research