Revised Guidance for Human Participant Research During COVID-19

Published May 10, 2021

Dear Researchers,

In recent months, Washington University has cautiously ramped back up human participant research within the parameters of the Yellow Level 2 guidelines that were issued last summer. The pandemic continues to evolve across the U.S. and locally – although the risk level is likely to gradually reduce as vaccination rates increase, new surges in infection remain possible in part due to the community prevalence of new, more transmissible viral variants. For this reason, continued vigilance and respect for federal and regional public health recommendations are necessary. On the positive side, we have learned a great deal about the transmission of the virus and about the effectiveness of our precautions. When we all “mask up”, keep physically distant, and follow public health recommendations, we do not see frequent viral transmission. Because of these encouraging observations, we are now revising and simplifying our guidance for researchers. We remain in Yellow Level, but we are making changes that reflect an updated sense of how to optimize both safety and the success of our research mission.

The guidance below supersedes previously published guidance for human participant research (both clinical research and non-clinical human participant research, as previously defined). It is effective immediately, though researchers should remember that research core facilities will continue to have substantial discretion to adjust their schedules and procedures to support safe and efficient workflow.

Best regards,

Suresh Vedantham, MD
Assistant Dean for Clinical Research
vedanthams@wustl.edu

Yi Zhang, RN, JD
Assistant Dean for Clinical Research
yizhang@wustl.edu

Summary:

  • This guidance is for on-campus human participant research only.
  • Universal masking, 6 feet physical distancing, and hand hygiene are emphasized as the major mechanisms to prevent viral transmission. Frequently touched surfaces should be cleaned once or twice daily but the requirement for frequent general surface sanitization has been removed.
  • There can be no unmasked gatherings – eating and drinking with others is a high risk activity.
  • There is no restriction on the types of research studies that may proceed or on study initiation, as long as studies do not burden clinical care providers or interfere with clinical workflow on the medical campus, or interfere with other activities on the Danforth campus.
  • Personnel, participants, and family members must still follow relevant screening guidelines.
  • Remote communication, including remote monitoring of externally-sponsored clinical studies, is still strongly preferred but in-person team meetings may occur when important to support study progress – with masking, physical distancing, and no food or drink.
  • Faculty are responsible for monitoring their study teams and for complying with this guidance.
  • Approval of study/unit-specific monitoring plans is no longer required by the University (but may be required at the discretion of School/Department/Division leaders).
  • All pertinent BJC, WashU, and FPP requirements must continue to be followed.
  • Vaccinations do not impact on-campus guidance.
  • No COVID-related restrictions on types of personnel who may participate in on-campus research activities, as long as screening guidelines are followed.
  • Non-essential travel is still not permitted (exceptions are possible for essential research-related travel).

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 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.

Masking:
Masks must be worn on campus when indoors in all public and shared spaces, unless you are alone in a room. 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:
Physical distancing will be the only density restriction in place. Pre-COVID activity or occupancy levels are no longer a factor. Six feet physical distancing is still recommended by the CDC and directives from the city and county both call for 6 feet physical distancing in workplaces. Therefore, we continue to require a minimum of 6 feet between persons and occupied workstations during research activities. If people 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.

“The virus that causes COVID-19 can land on surfaces. It’s possible for people to become infected if they touch those surfaces and then touch their nose, mouth, or eyes. In most situations, the risk of infection from touching a surface is low. The most reliable way to prevent infection from surfaces is to regularly wash hands or use hand sanitizer.”

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.

Break Rooms:
Eating and drinking with others is the major activity that has resulted in workplace transmission. 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. Any in-person gatherings or discussions should be masked and not include food and drink. 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.

In-Person Meetings:
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 facility guidelines, including wearing masks and staying 6 feet apart. Do not exceed the occupancy limits of the room, which are determined by the size of the room. Importantly, no food or drink is allowed.

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 research.wustl.edu/covid19/report-concerns/.

Vaccinations:
COVID-19 vaccinations are still voluntary. Not all of our personnel are vaccinated and the city and county have not relaxed their mandates for organizations or businesses that have achieved certain vaccination rates. CDC guidance on interactions between vaccinated people is only for private, not workplace, interactions. Therefore, on-campus guidelines will not be relaxed based on vaccination status. Washington University strongly encourages all personnel to get vaccinated and is now providing vaccines to all University personnel per state guidelines: covid19.med.wustl.edu/vaccines/washu-employee-student-vaccination/. Email covidvaccine@wustl.edu or consult occupational/student health or your physician if you have questions regarding COVID-19 vaccinations.

Self-Screening:
All personnel should continue to self-screen daily before coming to campus using the website: screening.wustl.edu/symptom-screener and follow their campus guidelines at covid19.med.wustl.edu/working-on-campus/campus-access-screening/ and covid19.wustl.edu/health-safety/daily-self-screening.

Personnel:
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. 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.

Travel:
Non-essential university sponsored travel is still suspended. Exceptions are made for essential, research-related travel: covid19.wustl.edu/operations/travel.