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Human Studies Research Ramp-up – Yellow Level

Published August 6, 2020

Dear Faculty, staff, and trainees involved in human subjects research,

We have posted guidelines for ramping up our clinical research and our non-clinical human subjects research from orange to yellow.

Because this research involves our valued research participants, we are encouraging all groups to develop their plans carefully, communicate their plans to all their research personnel, ramp up slowly, continuously monitor their plans and procedures for the effectiveness of how well those plans and procedures are being implemented, and revise as needed. PIs are strongly encouraged to engage their research personnel in the planning process.

The clinical research guidelines will be most applicable to much of the human subjects research that takes place on the Medical School campus, while the non-clinical human subjects research will most likely apply to most of the fundamental research on the Danforth campus. However, if there is research on the Danforth campus that uses clinical research cores or clinical spaces on the Medical school campus, the plan must also adhere to the clinical research guidelines for that portion of research that is done in the clinical cores/spaces.

Schools on the Danforth campus and Departments on Medical School campus should inform their faculty where to submit their plans. Schools and Departments are encouraged to develop a thoughtful process for reviewing the plans, perhaps involving a committee of faculty with expertise in clinical/human subjects research. It is expected that the review of the plans will be careful and thorough, to ensure that they meet the guidelines. Schools and departments can begin reviewing PI plans once they have their process in place.

Research groups can begin the ramp-up process once their plans have been approved and all preparations and requirements are in place (e.g. sufficient PPE, signage, tracking where the re earch participants will need to travel, communications with participants, communications with clinical research cores or clinical spaces, etc.). PIs are strongly encouraged to ramp up slowly. There are many moving pieces to human subjects/clinical research that need to be accommodated – our clinical research cores will need time to ramp up their activity, staff may need to be recalled to campus, given time to adjust their other obligations and to absorb the new procedures; communications to participants will need to be developed, describing the restart of the research and the new procedures that have been put into place for their safety, etc.; and there needs to be time to assess the effectiveness of the plans.

Even though we are announcing that we are moving to the yellow level, there is no requirement to transition immediately. We cannot emphasize enough that transitions to Yellow Level should not occur until after rigorous plans/controls have been put in place to ensure the safety of research participants, research personnel, and others both during initial ramp-up of in-person activity and the long term continuing activity, which will include diligent monitoring. It is anticipated that the duration of time spent in the planning process (prior to moving to Yellow Level) will vary substantially across research groups, Departments, or Schools, likely occurring over a period of several weeks for most areas.

Some may question the timing of this ramp-up, since the St. Louis area has been experiencing an increase in COVID over the past few weeks. The good news for our researchers and our research participants is that our experience here at WashU indicates that when our safety requirements have been diligently followed, COVID-19 transmission has been rare. For example, since the pandemic began, we have seen only two instances of workplace transmission among our research/non-clinical staff, and both of these occurred during social interactions closer than 6 feet without masks. To ensure continued s ccess, please follow our safety guidelines, ensure that our research participants do the same, monitor the effectiveness of your plans over time, and make any needed adjustments to enhance the safety of our research community.

Finally, I want to acknowledge the hard work of the committees involved in developing these guidelines. They wrestled with very complex issues, and have produced guidance that will be effective in allowing our important research to continue, while keeping our research community as safe as possible.

If you have questions, please do not hesitate to reach out to:

Jennifer Lodge, PhD
Vice Chancellor for Research