UW Research

Human Subjects Research Allowed During the COVID-19 Pandemic

Page updated August 14, 2020 12:40 PM PST – clarifications on participants older than 85.

Summary

  1. No already-active research is being halted. Already-started research that met the July 13, 2020 criteria for being conducted during the COVID-19 pandemic continues to be allowed.
  2. Identification of allowed research. All new and currently-halted research should be assessed against the revised criteria described below. The revision is based on significant improvements in knowledge about how to reduce the risk of COVID-19 infection.
  3. Research MRI facilities. The Department of Radiology has approved the resumption of research MRI scans at the Health Sciences 4.7 Tesla NMR Spectometry facility, with the concurrence of the UW Human Subjects Division. This means that all three UW research MRI facilities are now operational (DISC, BMIC, 4.7 T).
  4. The HSD Checklist for Human Subjects Research During the COVID-19 Pandemic has been eliminated.
  5. Requirements for all allowed in-person research. All research involving in-person interaction with participants, whether new or ongoing, must meet the basic infection control requirements described below.

Infection Control Requirements for All Research Interacting with Participants

Updated August 14, 2020

  • Essential in-person interactions. The only in-person interactions are those that cannot be adequately accomplished through a remote method such as a phone call, video conference (e.g., Zoom), email, etc.
  • Face coverings. Study team members and participants wear face coverings throughout all procedures. Study team members who are not able to wear a face covering should not interact with participants. HSD and UW infection control experts strongly recommend the use of surgical, medical/procedure, or N95 masks, instead of cloth coverings, during participant interactions. If cloth coverings are used, they should meet the requirements described by UW EH&S for effectiveness. Good fit of face coverings is vital.
  • COVID-19 screening. All study staff and participants are screened for COVID-19 just prior to each research visit. This means: (1) questions about symptoms and/or attestation that symptoms have not been experienced recently or currently and (2) they are not under self-isolation for COVID-19, self-quarantine for COVID-19 exposure, or have pending testing for the SARS-CoV-2 virus. Temperature measurement is not considered an adequate screening method. Just prior to means upon arrival or in the preceding 24 hours.
  • Participant age. No participants over the age of 85 years will be enrolled, if their in-person participation is not connected with a clinical care visit. UPDATE August 14, 2020.
  • Contact hsdinfo@uw.edu if one or more of these requirements is not possible for your research but you believe that you have equivalent alternative protections in your research.

Categories

How to use this information: Think of this as a Decision Tree, or a series of criteria to consider in sequence. Assess your research against the criteria in the sequence provided below.

CATEGORY 1: There are NO in-person interactions

There are no changes to this category of allowed research.

“In-person” means the study participant and study team members are physically in the same space, wherever that space is located.

All research in this category is allowed. No additional precautions are required.


CATEGORY 2: COVID-focused research

There are no changes to this category of allowed research.

Includes all procedures necessary for the research. Examples: Studies looking at diagnosis, treatment, interventions, or other activities directly-related to the novel coronavirus, including some social-behavioral research.

All research in this category is allowed if the facility and HSD requirements for safely conducting research during COVID-19 are met.


CATEGORY 3: Clinical trials

There are no changes to this category of allowed research.

“Clinical trials” are defined as research whose purpose is to test ways to improve diagnosis, treatment, stabilization, or self-management of a medical or psychological condition. This is NOT the same as the NIH definition of “clinical trial”. Allowable clinical trials must meet the criteria described below.

Facility permission (if required) and HSD requirements for safely conducting research during COVID-19 must be met.

Allowed research:

  1. COVID-focused clinical trials.
  2. Phase 2 and 3 clinical trials evaluating a therapeutic intervention, for which all research procedures will occur in a local clinical setting. The term “Phase 2 and 3” is intended to refer to clinical trials for which there is some independent scientific evidence in humans that the intervention works and is safe. “Local clinical setting” means a facility that is regularly used to provide healthcare services to patients that is located in the greater Puget Sound region. Consult with HSD at hsdinfo@uw.edu about other research locations.
  3. Phase 1 clinical trials evaluating a therapeutic intervention that meet ALL of the following criteria. “Phase 1” typically means a “first-in-human” or very early preliminary study.
    • The medical condition will inevitably and directly cause devastating physical or cognitive impairment, and/or death, of all participants
    • Other possible treatments or interventions do not exist or have significant serious side effects or significantly limited effectiveness

All other research

If your research does not fit into Category 1, 2, or 3, use HSD’s COVID-19 Relative Risk Tool for self-determining whether your research is allowed. Do not send the completed tool to HSD and do not upload it to your Zipline IRB application.

Extensive footnotes and explanatory information have been provided in the COVID-19 Relative Risk Tool. Please read them before contacting HSD at hsdinfo@uw.edu with questions or requests for help.