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Non-Clinical Human Subjects Research Ramp-up

Published July 8, 2020

To faculty, staff, and trainees involved in non-clinical human subjects research,

Effective immediately, Non-clinical Human Subjects Research* can begin ramping-up from red level to orange level. During this ramp-up phase, PIs can develop their plans including all precautions they will take, and once the plans have been approved, they may begin implementing them. Please note, if conditions or the situation changes, leadership may decide to return non-clinical research to red level, and PIs and research teams must be prepared for this eventuality.

The orange level is a transition first phase with approximately 25% of normal laboratory activity. A main goal of the orange level is to identify practices and procedures that are effective (or not effective) in reducing risks, not only to researchers and participants, but also to other members of the research environment (co-workers, graduate students, etc.).

Allowable non-clinical research activity during the orange level includes in-person research visits that only involves individuals already on campus, are not COVID-19 high risk populations, and only research that requires access to specific laboratory equipment that is only available on campus. All research work that can be done remotely, should continue to be done remotely.

Prior to transitioning, all of these requirements should be met:

  • Each PI must submit a plan for ramping up research operations to their Department Chair or Dean. The plan should describe a phased approach to ramping-up research operations.
  • Each PI’s plan must be integrated with a department or building level plan that addresses the number of research participants in the building at any one time, and integrates with other activities.
  • The ramp-up document should include a detailed plan for the transition, should be re-evaluated regularly, and updated as needed.
  • PIs should refer to “Guidelines for Non-Clinical Research Transitions – Red Level to Orange Level” for additional requirements and guidance.

*Non-clinical research are mainly fundamental, basic science research that occurs mostly in laboratories or offices, and involves human participants. This is distinct from a clinical trial, which is designed to test therapies for human diseases.

Jennifer Lodge, PhD
Vice Chancellor for Research