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COVID Related Restrictions on Human Subjects Research

Effective August 18, 2021

 

Page last updated: 08.23.2021, 09:24 AM PDT – Clarification on masking exceptions.

 

The University implemented a mandatory indoor mask policy for all individuals on August 13, 2021, regardless of vaccination status. A mask or other suitable face covering is required indoors when other people are present and in all public and common areas, such as lobbies, hallways, stairways, restrooms, elevators and shared vehicles. The masks must fit well and be of high quality.

Researchers are expected to comply with these requirements regardless of the location at which the in-person research interactions will occur. In addition, specific facilities and organizations (such as UW Medicine) may have their own, more restrictive, policies.

These are the minimum requirements. Individuals, investigators, or study teams may voluntarily choose to adopt additional safety measures.

See Questions and Answers below for additional information. New Q&A items are occasionally added.

See the UW EH&S webpage for general COVID information.

Masking. All study participants and research team members who will have in-person interactions must wear a mask, regardless of vaccination status.

  • Exception #1: Participants may be unmasked for an essential study procedure if the procedure cannot be performed with a mask, but study staff must always be masked. Examples of essential study procedures conducted in-person: study-required eating or drinking; bronchoscopy; dental procedures.
  • Exception #2: Participants who:
    • Are under the age of 2
    • Have a medical condition, mental health condition, developmental or cognitive condition, or disability that makes it hard for them to wear a mask
    • Are deaf and moves their face and mouth to communicate
    • Have trouble breathing, are unconscious, or are unable to remove a face covering with out help.
  • Exception #3: Studies that have worked with UW EH&S to adopt mitigation strategies when neither study staff nor the participant can be masked.

Social distancing (6 feet or more). If any study team members or study participants are not vaccinated, they must observe distancing when indoors and (when within a 6-foot distance from others) outdoors. All individuals are encouraged to distance if in a crowded setting or in areas that are not well-ventilated.

  • Exception: Unvaccinated participants are not required to observe social distancing during an essential study procedure if the procedure cannot be performed with social distancing. All participants must be masked unless an Exception described above applies.

Questions and Answers

Should you submit a modification to your IRB application before you return to pre-pandemic study procedures?

This is not required if any COVID-related modifications to your study procedures were described as additions to the study and the discontinuation of pre-pandemic procedures was described as temporary (i.e., not permanent) due to COVID-related restrictions on research.

Am I required to return to the pre-pandemic study procedures?

No. You can continue to use procedures that were approved because of the pandemic instead of, or in addition to, your pre-pandemic procedures. It is up to you, and you do not need to obtain IRB approval for your decision. For example, you may wish to keep doing remote consenting (say, by Zoom) and electronic consent signatures, for some or all of your participants.

Do you need to submit a modification to your IRB application in order to ask people about their vaccination status?

A modification is required only if vaccination status will:

  • Become an inclusion/exclusion criterion for participation – in other words, if your decision about whether to enroll someone will be partially based on their vaccination status, or
  • Affect which study procedures are conducted with participants

If you do submit a modification, be sure to describe it as a temporary inclusion/exclusion criterion that will exist only as long as required or appropriate for COVID pandemic conditions.

Are there any research studies or types of procedures that are still not allowed?

No. However, the requirements described above must be met. If this is not possible, contact HSD at hsdinfo@uw.edu.

What if the previous restrictions allowed me to do a study without having the participants wear masks for some or all of the study procedures? Can I still do the study, even if the participants are unvaccinated?

Yes, all ongoing studies that were allowed prior to these changes are still allowed and may still follow the same procedures, except that the masking and social distancing requirements above must be implemented.

There are some large building complexes that have a mix of clinical care, administration/business, education, and research activities. Examples: the Montlake medical complex and Health Sciences Building; the Harborview complex. How do I know which parts of these complexes are 'health-care facilities' where masks are required?

This is important because Washington State and University guidelines still require all people to wear masks in health-care facilities, including fully-vaccinated individuals. HSD’s understanding is that “health-care facilities” are specific locations at which healthcare is delivered or procedures are provided for clinical care purposes. The School of Medicine Dean’s Office has confirmed that, with the exception of the dental clinics, the Health Sciences Building (HSB) has typically been considered non-clinical. Plans are underway to post signage at entry points to UWMC from HSB (e.g., the Pacific Avenue elevator doorway leading into HSB from hospital floors 4, 5, and 6). For more specific information, contact Steve Marty (sbmarty@uw.edu) in the School of Medicine Dean’s Office. You may also check with the manager of the location you are using.

Is it legal to ask research study team members and study participants about their vaccination status?

Study participants: It is legal to ask study participants. Vaccination status is private and confidential information, but studies routinely ask participants to provide such information if necessary for study purposes. Participants can choose to not share that information. UW research team members: Per UW guidance only direct supervisors may ask study team members.

Is it OK to ask research study team members and study participants for documentation of their vaccination status?

It is not recommended. The University and Washington State are operating on an “honor” system regarding vaccination status.

Is it OK to exclude non-vaccinated individuals from a study?

The UW IRB strongly discourages this practice unless the purpose of the study is to specifically look at vaccinated individuals. Scientific rationale for including non-vaccinated participants: Groups of vaccinated versus non-vaccinated individuals may differ in significant ways that affect the outcomes and generalizability of studies. Ethical rationale for including non-vaccinated participants: The federal human subjects regulations and the ethical principles underlying them require an equitable selection of participants. The purpose is to ensure that (1) all interested individuals have the opportunity to participate in or contribute to the potential benefits of the research and (2) there is a fair distribution of the risks and benefits of research.

Are there any special restrictions for studies involving children?

There are no special restrictions. However, unvaccinated children older than 2 should wear masks for studies conducted at Washington State locations, per the WA State Secretary of Health guidelines.

Is it still required to screen study participants for COVID symptoms?

Generally, no. However, it is best practice to do this screening for participants who are not vaccinated.

Is in-person study monitoring and/or auditing now allowed?

Yes, if it is allowed by the facility at which the monitoring or auditing will occur. Any facility restrictions (such as masking) must be followed.

Is it still OK to obtain consent with electronic signatures?

Yes. The new methods developed during the COVID pandemic are permanently available.


Accompanying Document Changes

COVID-19 Relative Risk Tool: Retired
IRB Protocol form: Questions about COVID have been revised or deleted.