UW Research
Single Patient Emergency Use

COVID Related Requirements for Human Subjects Research

Most UW Restrictions Lifted March 28th – Face Coverings Still Required for Clinical Activities

In line with state, local and UW health policies, most UW-imposed restrictions on human subjects research have been lifted effective March 28, 2022.

For research conducted in WA State, researchers and study participants must continue to wear masks in indoor healthcare settings, and correctional and jail facilities. Healthcare setting includes any public or private setting in WA State that is primarily used for the delivery of in-person healthcare services (e.g., hospital, outpatient clinic, pharmacy) and other indoor settings that are not primarily used for the delivery of healthcare services (e.g., school classroom, food processing facility, private residence) but where in-person patient care/clinical activities occur.

Researchers and study participants must also still abide by any other requirements imposed where the in-person research activities will occur (e.g., institutional or facility requirements, local government, or public health agency). This includes research conducted in international settings. For example, UW Medicine currently requires that visitors to its hospital facilities must be either vaccinated or have a negative COVID test. These requirements would apply to any in-person research visits conducted there.

NOTE – If public health conditions worsen once more, we may reinstate some or all restrictions until the health situation improves again.

 

Page last updated: 06.14.2022, 10:00 AM PDT – Updated to reflect changes to federal requirements

 

Current Requirements

Face Coverings – WA State. In accordance with WA State Department of Health, researchers and study participants must continue to wear masks in healthcare settings, and correctional and jail facilities. UW Environmental Health & Safety has additional information on what constitutes a ‘healthcare setting’, which includes any setting in WA State where in-person patient care/clinical activities occur, including those conducted in association with a research study. See the Questions and Answers below for more details on where and how this requirement applies.

Other Local Site Restrictions. Researchers and study participants must abide by any requirements imposed where the in-person research activities will occur (e.g., institutional or facility requirements, local government, or public health agency). This includes research conducted in international settings. For example, UW Medicine currently requires that visitors to its hospital facilities must be either vaccinated or have a negative COVID test. These requirements would apply to any in-person research visits conducted there.

These are the minimum requirements. Researchers may find a risk assessment of their study warrants 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.

The University’s current face covering requirements may be found here.

Check the UW coronavirus website for current information about UW and state requirements, COVID testing, facts, and resources, including links to any campus-wide communications.


Questions and Answers

In what circumstances does the UW face covering policy apply to research? (updated 06.14.2022)

Current UW policy and WA State Department of Health requires face coverings in indoor healthcare settings. This includes any public or private setting in WA State that is primarily used for the delivery of in-person health care services to people (e.g., hospital, outpatient clinic, pharmacy, dental office, long-term care facility, mobile clinic, massage therapy clinic, drug rehabilitation center, etc.). Researchers and study participants in these settings must be masked, regardless of the nature of the activity being performed. For example, conducting a survey of patient attitudes towards healthcare in the lobby of Harborview Medical Center would require everyone to be masked.

UW policy also requires face coverings in other indoor settings that are not primarily used for the delivery of healthcare services (e.g., school classroom, food processing facility, private residence) but where in-person patient care/clinical activities occur. This means that if your research includes these activities, masks must be worn by all parties.

Finally, face coverings are also required in correctional and jail facilities (WA State Department of Health).

What constitutes a patient care/clinical activity under the UW face covering policy?

Patient care/clinical activities are any activities requiring healthcare professional credentialing or licensing to perform, under WA State Department of Health. This includes investigational biomedical or behavioral interventions. It also includes activities conducted in association with a research study such as blood draws, diagnostic imaging (e.g., x-ray, MRI), IV placement, etc. It includes these activities regardless of intention (e.g., research only, treatment) or whether they are clinically billable. Contact UW EH&S (covidehc@uw.edu) if you have questions.

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.

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

Participants: It is not illegal to ask participants for documentation of their vaccination status and may be necessary to comply with local site restrictions. Note that vaccination status is generally considered to be private and confidential information and should be protected accordingly.

Study team members: UW students and personnel are required to be fully vaccinated or receive an exemption. This has been verified and documented for each individual by a UW-wide verification process. There are important privacy protections that limit requests about, and disclosure of, vaccination information for UW students and personnel. These are described in the Privacy Protections section of the UW COVID-19 Vaccination Requirement webpage.

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.

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.