UW Research

Resuming Some Human Subjects Research (July Information)

Information on this page is superseded by new page “Human Subjects Research Allowed During the COVID-19 Pandemic” as of August 12, 2020.

 

The categories below describe the types of research that are allowed as of July 13.

Summary of July 13 changes

  1. The descriptions of currently allowed research have been consolidated across dates.
  2. Category 4 has been revised to now allow these types of imaging: ultrasound; X-ray imaging that occurs in a clinical facility; CT-scans that occur in a clinical facility; and MRI imaging conducted at a clinical facility, the Health Sciences DISC facility, or the South Lake Union BMIC facility. Note that the brief duration requirement has not changed.
  3. Additional information about the meaning of “brief” has been added to the description of Category 4 allowed research.

Research outside of Washington State. Research that is allowable in Washington State and as described below may not be appropriate in other locations. UW researchers should consider the local public health and pandemic context as well as local requirements.

Required Checklist. Research involving in-person interactions must meet the requirements described in the HSD Checklist for Human Subjects Research During the COVID-19 Pandemic. This applies to current on-going research as well as research that will now begin/resume.

How to use this information: Think of the Categories as a Decision Tree, or a series of steps. Assess your research against each category, in the sequence described below.

CATEGORY 1: There are NO in-person interactions

“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

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

“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

CATEGORY 4: Brief procedure(s) to obtain biospecimen, physical measurement, and/or exam

This category focuses on assessments that cannot be conducted remotely or as part of an allowed COVID study or allowed clinical trial.

“Brief” is intended to mean in-person interactions measured in minutes rather than hours. Example: A single veni-puncture for a blood sample is acceptable, but repeated sampling during a day from an indwelling venous catheter will likely not be “brief”. Other acceptable examples: measurement and rating of healing surgical site; measurement of knee flexibility.

Imaging (new information as of July 15).

  • Ultrasound procedures are allowed.
  • X-ray, CT-scans, and MRI imaging are allowed if they and the other research procedures of a visit involve brief in-person interactions and the imaging occurs in a clinical facility. MRI imaging may also occur at the Health Sciences DISC imaging center or the South Lake Union BMIC imaging center, after the researcher receives specific approval from the MRI facility. The requirement to register DISC studies with the HSD Director has been dis-continued.

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

Allowed research must meet the criteria described in 1, 2, 3, OR 4 below.

  1. COVID-focused research OR
  2. The research procedures will be performed in association with a clinical care visit at the clinical care location, OR
  3. Longitudinal research procedures for participants who had completed at least one study session prior to March 23, 2020. Except for certain kinds of imaging (see italicized notes above), the procedures can occur in any location, OR
  4. The research procedures are for necessary in-person safety monitoring procedure that cannot be eliminated or done in an alternative manner. This applies only to participants who were already participating in study procedures prior to March 23, 2020.

CATEGORY 5: All other research

Not allowed.

A COVID-19 Risk Map tool is being developed for assessment. It will be available in late July.