Frequently Asked Questions

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How do I order Personal Protective Equipment (PPE)?

PPE such as face masks, gloves, and hand sanitizer may be requested online. Kindly limit orders to a 4-week supply.

Are there any study procedures that require elevated isolation?

Aerosol Generating Procedures (AGPs) require extra precaution.  Common AGPs include sputum induction, nebulizer treatments, broncoprovocation testing, and bronchoscopy.  Spirometry is NOT deemed an AGP.

For a full list of AGPs and specific requirements see  COVID-19 Pandemic: Performing *Aerosol Generating Procedures (AGPs) in Inpatient and Outpatient Settings (7/3/20)

When is hand hygiene required?

Hand hygiene is required:

  • Prior to entering and exiting a study participant’s room
  • Before touching a participant
  • Before clean/aseptic procedures
  • After body fluid exposure/risk, and
  • After touching a participant or their surroundings

What PPE should be used during face-to-face visits with study participants?

To conserve supplies, use the appropriate PPE commensurate with the level of interaction with the study participant. Refer to UW Health’s Guidance on Use and Reuse of PPE for additional information.

Is there an alternative to wearing a barrier mask so participants can see me speak and my facial expressions?

Yes, visible face masks are approved for use in patient/participant rooms

The following search terms are recommended for locating the masks within Oracle Cloud:  “BS1003+” or “ADULT BADGER SHIELD+ PK OF 5.”

Note: If you do not have Oracle access for ordering supplies, please contact your Department Administrator.

May UW employeees reuse PPE?

Please refer to UW Health’s Guidance on Use and Reuse of PPE which includes end of shift storage and cleaning recommendations.

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What are the PPE requirements when interacting with participants on the Clinical Research Unite (CRU)?

All CRU and study staff are required to wear a medical grade barrier mask and face shield while interacting with study participants.  Cloth face masks are NOT considered medical grade.

Please refer to the below UW Health resources for additional information.

Are study participants and their visitors/companions required to wear PPE?

Yes, study participants and their visitors/companions are required to wear personal face covering at ALL times with the following exceptions:

  • Participants may remove their personal face covering while alone in their room (i.e., behind a closed door).
  • Visitors or companions of the study participant who live in the same household may remove their face covering to eat and drink.

Do study participants need to be tested for COVID prior to their CRU OUTpatient visit?

If the CRU study visit includes an Aerosol Generating Procedure, participants will need to be tested for COVID.

May study particpants be tested for COVID even when their OUTpatient CRU visit does not ential an Aerosol Generating Procedures?

Study participants may elect to get tested at any of the free testing sites; however, the CRU does not require testing unless the individual fulfills testing criteria.  This is in effort to preserve space, staffing, and testing capacity for patient/participants who qualify for COVID-19 testing at UW Health.

Do study participants need to be tested for COVID prior to an INpatient CRU visit?

Yes, all study participants must have a negative COVID-19 test within 72 hours of an inpatient or overnight CRU visit.  If a negative COVID-19 test is not obtained prior to CRU admission, study interventions/procedures will be delayed until a negative test is resulted.

How many staff can enter a participant's room on the CRU?

While the number of staff who can enter a participant’s CRU room is not limited, please consider modifying workflows to minimize the number of staff present.  All staff are required to wear appropriate PPE and physically distance from one another when feasible.

If study staff need to step out of the participant’s room, where should they wait?

To support physical distancing, the number of people on the unit must be minimized.

For short durations, study staff may stand outside the participant’s room.  For longer durations, study staff are encouraged to return to their office and share their contact information with the CRU nurse and provide clear instructions on when to call.

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Can human subjects research study visits continue?

Effective March 15, 2020 and until at least May 15, 2020, the Office of the Vice Chancellor for Research and Graduate Education (OVCRGE) imposed a temporary hiatus from all in-person interactions on research studies except for therapeutic studies involving drugs or devices or those critical to the health and safety of patients or study participants.

Read the full message from OVCRGE to Human Subject Research Teams (March 15, 2020)

Can we continue study monitoring, site selection and site initiation visits?

In accordance with UW Health and SMPH directives, all in-person visits from study sponsors should be canceled.  Virtual site selection visits and site initiation visits are permissible.  See External Research Monitor REMOTE access to Health Link regarding remote Health Link access for research monitors.

For additional guidance, please refer to the Association of Clinical Research Organizations’ (ACRO)  Considerations to Support Clinical Trial Monitoring Oversight During COVID-19 (3-13-20).

Are there any special requirments for conducting COVID-19 human subjects research?

Yes, there are some new workflows for investigators who wish to conduct COVID-19 human subjects research.

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How do I request access to UW Health resources while telecommuting?

SMPH employees can contact their department administrator (DA) and provide the below information.  DAs will work with the SMPH Dean’s Office to prioritize and facilitate requests.

The following information is needed:

  • Name, Title, and Department
  • Description of UW Health resources needed
  • Type of device that will be used for remote access (e.g., SMPH owned/managed, personal)
  • Operational needs that will be addressed by gaining remote access

How can we communicate with research participants while telecommuting?

  • Phone calls placed using a VoIP services provided by UW Health or UW-Madison (ex: Cisco Jabber).  Alternatively, a cell phone or landline is permitted.  The *67 function may be used if you don’t want personal numbers visible to the caller.
  • Web conferencing conducted via UW Cisco WebEx.  NOTE:  Zoom is not permitted.
  • Email messages that comply with HS IRB Guidelines.

A comprehensive list of permitted tools for exchanging and storing PHI is posted at the Office of Compliance HIPAA webpage.

Please contact a HIPAA Privacy and Security Coordinator prior to using new tools or technologies.

Does the ClinicalTrials.gov record for my study need to be updated to reflect changes resulting from COVID-19?

If the status of your study has changed due to COVID-19 circumstances (e.g., suspended, permanently closed to accrual, terminated), the CT.gov record may need updating.

UW’s ClinialTrial.gov Reporting Service continues to provide complimentary assistance to investigators and study teams.  Email to request help.