COVID-19 Considerations for Human Subject Research

The following FAQs and guidance are provided for researchers engaged in human subject research. Researchers should be prepared for potential disruptions to normal research operations depending on how the ongoing situation with COVID-19 evolves. This page will be updated as new information or recommendations become available.

Effective March 16, Dell Medical School is implementing specific policies and procedures for the conduct of human subject research. In-person study interactions may only occur if the research is essential for the health and well-being of the research participant. All other non-essential in-person research interactions should be postponed or conducted remotely when possible. Read the full policy here.

The UT IRBs and IRB staff will continue operations regardless of potential disruptions caused by an outbreak of COVID-19 at UT Austin or in the Austin area. Researchers are encouraged to conduct communications with the IRB office via email, online chat, and telephone to maximize social distancing.

Should it be necessary, IRB staff will work remotely and continue to monitor email and IRB chat as usual. The IRB phone line will continue to be monitored for voicemails throughout each business day. Any updates to this plan will be communicated promptly here and via the IRB listserv.

Through May 31, the university is in Level 4 of the research restart plan, which means all in-person human subject research has been paused, with the exception of subjects needing medication for clinical treatment with such exceptions approved on a case-by-case basis through the former research exemption request process. Remote or virtual interactions with participants can continue if approved by the IRB.

Beginning June 1, the university will move to Level 3 of the research restart plan, which continues to pause all in-person research participant interactions except those determined to provide medication essential for clinical treatment. Members of the research team may come to campus to carry out any research procedures that do not involve in-person interactions with participants. All non-remote or non-virtual research activities must be approved through the administrative process established in the PI’s college, school or unit, even if the research was previously granted an exemption or has been approved by the IRB. Read more about the research approval process.

For studies approved for in-person interactions, consider measures that can be undertaken to minimize exposure during face-to-face visits. Some specific considerations include:

  • Implement participant screening to minimize exposure risk. See below for possible screening questions. Such screenings do not require IRB approval as long as the information will not be added to the research data set.
  • Ensure that hand sanitizer and hand washing facilities are readily available and encouraged.
  • Establish rigorous disinfecting protocols for any equipment, manipulatives, or other study equipment that will be used with multiple participants. Contact the Office of Environmental Health and Safety if you need guidance on appropriate disinfection.

For studies not approved for in-person research interventions, consider whether some study interactions can be conducted remotely. Specific considerations include:

  • Study interactions such as interviews or simple study follow-up visits may be able to be done by phone or video.
  • Reach out to study sponsors to inquire about procedures for modifying protocol schedules.
  • If your study requires signed informed consent, consider whether you can modify study procedures by requesting a waiver of documentation of consent so that consent may be obtained without requiring a signature.
    • To be approved to waive documentation of consent, the study must present no more than minimal risk of harm to participants and involve no procedures for which written consent is normally required outside the research context.

Participant screening questions might include the following as appropriate, depending on the study population, nature of the interaction, and location of the study interaction. Implement extra precautions or postpone study visits especially for participants falling into a high-risk category:

  • Over 60 years of age
  • Underlying health conditions including heart disease, lung disease, and diabetes
  • Weakened immune system
  • Pregnant
  1. Have you had any of the following symptoms in the past 2 weeks, even if they were mild?
    1. Fever
    2. Cough
    3. Shortness of breath
    4. Sore throat
    5. Loss of smell or taste
  2. Have you had close contact with a person who is under investigation for possible COVID-19? Close contact is defined by the CDC as (a) being within approximately 6 feet of a COVID-19 case for a prolonged period of time. Close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-10 case or (b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed or sneezed on).

No. The IRB’s role is to approve research that meets the federal regulatory criteria for approval, such as having an acceptable informed consent process, reasonable risk-benefit ratio, and adequate privacy and confidentiality provisions. IRB approval does not grant the investigator permission to conduct research that does not fall within the current level of the university’s research restart plan. Approval to proceed with study conduct must also be granted by the investigator’s college, school, or unit administration through the designated approval process. Read more about the restart plan and approval process.

Some ongoing clinical studies require in-person follow-up visits to monitor participant safety. For example, a treatment and intervention trial may require physical examinations, laboratory tests, or interviews.

Participants in clinical (treatment) trials should be managed remotely whenever possible. If participants require in-person evaluation to receive treatment or medication or for clinical safety, the PI is responsible for providing this service in the safest way possible, based on good clinical practice and optimal social distancing.

You should plan for the possibility that in-person visits may not be possible or practical. Consider some of the following as possibilities that may or may not work for your study:

  • If your study is sponsored, contact the sponsor for recommendations and/or changes in procedures that are being implemented study-wide.
  • Conduct interviews by phone, video, or email questionnaires.
  • Consider conducting physical examinations at participants’ homes or other alternative location.
  • Attempt to combine follow-up visit procedures with other clinical visits participants’ may already be doing (i.e., visit with another physician specialist).

Any changes to study procedures made to eliminate apparent immediate hazards to research participants, including those to reduce potential exposure to SARS-CoV-2, or to continue to provide medically necessary study care to participants who have been placed in isolation do not need prior approval by the IRB. All such changes should be reported to the IRB as an unanticipated problem involving risk to subjects or others within 5 days.

Related FAQs:

  • Any planned modifications to study procedures, such as a shift from in-person to remote interactions, should be submitted to the IRB as an amendment, unless the study is approved as exempt. Indicate on the amendment cover sheet that the change is being implemented as a COVID-19 safety precaution to help the IRB prioritize the submission.
  • Any changes to study procedures made to eliminate apparent immediate hazards to research participants, including those to reduce potential exposure to SARS-CoV-2, or to continue to provide medically necessary study care to participants who have been placed in isolation do not need prior approval by the IRB. All such changes should be reported to the IRB as an unanticipated problem involving risk to subjects or others within 5 days.
  • If you need to change your consent procedures to waive the requirement for a signature so that consent can be done remotely, you should submit a study modification requesting to waive documentation of consent if your study is no greater than minimal risk and meets the criteria for qualifying for a waiver of documentation of consent. Waiver of documentation of consent criteria can be found in Section 6.7 of the IRB Policies and Procedures.
  • A decision to suspend study procedures where participants are actively receiving clinical treatment should be reported to the IRB within 10 days, along with a plan for managing safety and follow-up with actively enrolled participants.

The Office of Environmental Health and Safety (EHS) offers a number of recommendations for laboratory work that must continue during the current situation. Please contact EHS with any specific questions.

UT Austin allows for paying research participants, including UT employees, via Tango Card, an electronic gift card service provider. Participants receive an email notifying them that they have an electronic gift card to claim in the amount designated by the PI / study coordinator. Read Tango Card details and instructions on the IRB Guidance page.

In response to the COVID-19 outbreak face-to-face human subject research that does not provide a direct benefit to the subjects is paused. Where possible, the Office of Research Support and Compliance is assisting researchers transition their methods from in-person interactions to remote interactions, regardless of benefit, to limit potential exposure. Depending on your circumstance this transition may require an amendment to be submitted to the IRB.

Studies that were previously determined to be exempt can transition to remote interactions without officially amending the protocol if such a change will not affect the category of exempt determination, risk benefit analysis, change the PI, or significantly change the rationale under which you received a waiver of HIPAA authorization. Simply upload your updated protocol to IRB Access and go forward with your revised data collection methods. If you have questions as to whether or not your exempt study requires an official amendment, please email irb@austin.utexas.edu or use our website’s chat feature (https://research.utexas.edu/ors/human-subjects/) for a more rapid response.

If your study requires an official amendment because it is expedited, full board, or you have been instructed by an IRB Analyst to submit an amendment, follow normal amendment procedures using an amendment summary form and submit your amendment through IRB Access. Please be aware that an amendment will need to be filed for each study you wish to modify. To expedite the review of a significant volume of similar modifications, the Office of Research Support and Compliance has developed a template amendment summary specific to COVID-19. Use of this document will expedite you and your colleagues’ modifications to get your data collection back online.