Guidelines for Human Subjects Research During COVID-19

The following information is provided as guidance for principal investigators and collaborators conducting human subjects research activities during the Fall 2021 semester. Fresno State remains committed to safeguarding the health and well-being of research participants, faculty, staff, and students. Developed in accordance with public health guidelines, the following apply to all research activities, on and off campus, for the Fall 2021 semester. Please consult the University‚Äôs Fall 2021 Repopulation/COVID-19 website for the latest information and updates should conditions change. 

Protocol Requirements: 

Effective Fall 2021, Research, Scholarly, and Creative Activities Ramp Up proposals will no longer be required. Whenever feasible, pursue alternatives to in-person methods of data collection, such as phone or computer-mediated interviews and surveys. Ensure adherence to any guidelines or restrictions specific to study sites, such as schools and programs, where research participants are located.

Protocols should define how physical distancing and other safety recommendations consistent with public health directives will be maintained (wearing personal protective equipment, hand washing, disinfecting study site surfaces, etc.).

In study protocols and consent documentation, risk-benefit assessments and steps taken to mitigate risks must account for any COVID-19 related physical, emotional, social, and economic risks to human subjects.  

Informed consent procedures must include acknowledgment and sufficient information about increased risks associated with in-person and on-campus research. Consent documents should request that research participants notify study personnel of any COVID-19 diagnoses within seven days of in-person research procedures and give information about how to report this. Consent documents should also promise research participants that they will be informed of any COVID-19 diagnoses among research personnel within seven days of in-person research procedures.

Prior to On-Campus Research Activities: 

Researchers and research participants should complete the Daily Health Screening Questionnaire in advance of coming to campus. If they receive a red X, they should not come to campus. 

Face Coverings: 

Indoor research activities: All students, faculty, staff, and research fellows, vaccinated and unvaccinated, will be required to wear face coverings while conducting or participating in research in classrooms and labs on campus where more than one person is present. 

Outdoor research activities: Although face coverings are not required regardless of vaccination status, they are highly encouraged.

Physical Distancing: 

Physical distancing is no longer required in labs and other spaces where research activities occur; however, six feet of distance must be maintained when faculty, staff, students, or research subjects remove their face coverings for any reason (e.g., eating, drinking, research procedures that require mask removal).  

Reporting Requirements: 

Any unanticipated problems or adverse events related to COVID-19 exposure as part of approved study protocols should be reported to the University CPHS immediately.