COVID-19 Human Subjects Research Requirements


The following information is for PIs and Student Collaborators who are conducting research on Human Subjects during the COVID-19 Pandemic. Please read the information below and follow all instructions related to protections for Human Subjects participating in your research.


1.     
Whenever feasible, pursue alternatives to in-person methods of data collection, such as phone or computer-mediated interviews and surveys;

 

2.     Pause study procedures that involve sustained in-person interaction with human subjects in vulnerable groups per CDC recommendations, including individuals older than 60, those with underlying health conditions, and those who are immunocompromised.

 

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

 

4.     Ensure adherence to any guidelines or restrictions specific to study sites, such as schools and programs, where research participants are located.

 

5.     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.    

 

6.     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 14 days of the 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 14 days of the research procedures.

 

7.     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. 

 

A printable Word doc is located here to reference: COVID-19 Human Subjects Research Requirements