COVID-19 Guidance

Updated 9/22/2020

COVID-19 research (new submissions) involving human subjects

  • Please submit a new study using IRBManager and email irbinfo@uwm.edu letting us know a study related to COVID-19 has been submitted and your target start date.

Amendments requiring priority review because of COVID-19 impacts

  • Please submit amendment using IRBManager and email irbinfo@uwm.edu letting us know a change is required because of COVID-19 and your target implementation date.

Regular (not COVID-related) IRB Submissions

  • Unless there are special circumstances (COVID-19 research, urgent changes as a result of COVID-19, etc.), research submissions will be reviewed in the order of receipt.
  • In addition to urgent issues related to COVID-19 research mentioned above, IRB office staff is supporting other research compliance functions during this time. This may result in the review of standard submissions being slower than normal. The IRB website will continue to be updated with expected times for initial review.

Ongoing Research

As restrictions on in-person human subjects research are gradually lifted, the following guidance will apply to all in-person activities that are permitted to resume.

    • You must have an approved Return to Research safety plan before beginning in-person procedures. See the Office of Research website for more details.
    • You must have IRB approval for any changes to the study procedures (see below for more details).
      • You can submit the two requests in any order or simultaneously, but both approvals must be in place before you begin in-person research activities.
    • Research procedures should be conducted remotely, whenever possible.
    • For studies requiring in-person procedures, consider whether activities such as determining eligibility, consent discussions, etc. can be done remotely ahead of the in-person visit to minimize contact time.
    • For individuals that may be more susceptible to serious COVID-19 complications due to age, pre-existing conditions, etc., the risk of participating in the study may be unacceptably high. Consider your study population when determining whether the research should move forward, and consult with the IRB as needed.
    • Research staff must self-monitor their own health to protect research participants. If a researcher becomes ill, they should notify any participants who may have had contact with that researcher.
    • Screening related to COVID-19 symptoms should be conducted remotely prior to in-person visits, using the questions below. No amendment is necessary, but report it to the IRB at the next continuing review.
      1. In the past 14 days, have you had any of the following symptoms (without confirmation as something other than COVID-19, such as a positive flu test, chronic medical condition, etc.)? [List symptoms of COVID-19, using the most current list found on the CDC website.]
      2. In the past 14 days, have you lived with, visited, cared for, or been in a room for a prolonged period of time with someone who is under investigation for or has tested positive for COVID-19?
    • If the answer to any question is “yes”, the visit should be rescheduled.
      1. Direct the participant to contact their physician.
      2. Document your conversation.
    • If the answer to all questions is “no”, the study visit may continue, and all screening questions should be verified again at the time of the in-person visit
  • Implement social distancing for the entire visit.
  • Disinfect space, equipment, and surfaces before and after visits.
  • Feel free to modify and use this “Caring for you during your research visit” info sheet for participants (does not require IRB review/approval). Many thanks to the Center for Cognitive Medicine at Vanderbilt University Medical Center and the University of Arizona for this document.

What requires an amendment?

  • No amendment needed: Changes to your procedures solely related to social distancing, sanitization, COVID-19 symptom screening, and personal protective equipment are public health precautions and don’t need to be submitted to the IRB as an amendment.
  • Amendment needed: Changes to research activities themselves do require IRB review and approval. Examples include:
    • Requesting approval for remote consenting procedures (see below for options).
    • Modifying in-person activities so they can be conducted virtually.
    • Eliminating or modifying activities that require close contact with individuals, such as drawing blood.
    • Changing eligibility criteria to exclude individuals considered to be high risk due to the pandemic.

Emergency Changes

  • If a change in study procedures is necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval, the change may be implemented prior to IRB approval.
  • The change must be submitted through an amendment as soon as possible after implementation, but no later than 72 hours.

Remote Consent Options

There are several options for obtaining consent remotely:

  • Request a waiver of documentation of consent. You still provide the consent information to participants (mail, email, online, verbal, etc.) but are not required to collect a signature. The fact that they complete the study procedures can be taken as indication of their consent.
    • This waiver can be granted if your study is minimal risk and doesn’t have any procedures where written consent would be required outside the research context.
    • This option cannot be used if your research involves accessing FERPA- or HIPAA-protected records. A written signature is required under those regulations.
  • Have participants sign and return a consent form to you, either electronically (print/sign/scan) or hard copy via mail.
    • Consider whether all your participants have the ability to print and scan materials before choosing this as the sole option.
  • Have participants sign an electronic consent form in Qualtrics, using the Signature question type.
    • Insert your consent information as a static text question, then insert additional questions for participants to type their name and to electronically sign on their device.
    • Remind participants to print or save the screen if they wish to keep a copy of the consent for their records.
    • DO NOT collect any study data in this survey. If you are collecting data via Qualtrics, you may include a link to a separate survey on the second page after they sign.
    • Consider whether all your participants have access to a device and internet before choosing this as the sole option.

Do I need to list the risk of COVID-19 in my consent document for in-person research?

The IRB discussed this question at a recent meeting. They came to the conclusion that the risk of contracting COVID-19 is a risk of daily life and so widespread that it doesn’t need to be specifically mentioned in consent forms. While the IRB did acknowledge that asking participants to meet in person does potentially increase this risk, they felt that including it in every consent form is unnecessary.

If we’re asked to give a participant’s name for contact tracing purposes, is that a breach of confidentiality?

In the vast majority of cases, no. Identifying who you’ve been in contact with doesn’t necessarily identify what study they were involved in, and in any case does not link their identity to the research data. Few of our studies involve such a sensitive topic that harm can arise simply by someone knowing they participated in the study. We encourage researchers to cooperate fully with university and public health officials in contact tracing efforts.

If you do have a study where the topic is so sensitive that even identifying who you met with would potentially cause harm, it would be best to explore alternate methods of data collection (e.g. virtual) or postpone conducting the research altogether.