Updated guidance for face-to-face human subjects research (June 7, 2021)
Face-to-face human subjects research interactions require the use of face coverings by study teams and study participants at all times unless study procedures or participant characteristics contraindicate the use of face coverings. Face coverings must be used in all human subjects research settings (regardless of whether the research is related to health or occurring in a health care setting).
Remote methods of data collection for human subjects research remain an option but are not required. There is no maximum duration of contact for face-to-face research encounters, and no required square footage per person, as stipulated in prior guidance. Nevertheless, physical distancing is recommended when possible because the vaccination status of research participants and accompanying persons may not be known.
While we recommend being vaccinated, study team members cannot be required to provide information about their vaccination status and job duties cannot be assigned based on vaccination status, absent further guidance from the University. It is not appropriate to ask study participants, or potential study participants, about their vaccination status, unless COVID vaccination is an inclusion or exclusion criterion approved by the IRB for a particular study.
Furthermore, it is not appropriate to consider vaccination status as a criterion for participating in the study, unless this criterion is approved by the IRB for a particular study.
Please reschedule study visits if a research participant or necessary accompanying person has had a recent COVID-19 diagnosis, screens positive on a COVID-19 screening test, or has symptoms associated with COVID-19, except for IRB-approved studies related to COVID.
This guidance applies to research in all settings involving human subjects, both on- and off-campus. Please be aware of policies in place within your particular research settings and abide by those policies. When policies of the research setting are not consistent with UW-Madison guidance, study teams must abide by the set of policies that provides the greatest COVID-19 risk mitigation.
As public health conditions change, we will provide updated guidance to study teams.
Nadine P. Connor, PhD
Professor, Communication Sciences & Disorders; Surgery
Associate Vice Chancellor for Research Policy and Compliance
University of Wisconsin–Madison