Human Subjects Research

Last Updated August 14, 2020

On March 13, 2020, face-to-face human subjects research was suspended given the rapidly evolving COVID-19 pandemic and our shared goal to reduce the risk of infection within our community. The only exceptions have been for studies where there is the potential for direct benefit for the participant, if canceling or postponing the activities would increase the risk to the subject’s safety or well-being, emergency use/compassionate use and Humanitarian Use Devices (HUDs). Face-to-face research activities taking place in these for-benefit studies may continue.

Now as part of Phase 2 of research ramp up, OVPR has released a new Policy for Research Participant Visits and Face-to-Face Interactions that applies to all face-to-face human subjects research activities conducted by Tufts researchers. Face-to-face human subjects research will begin to resume in a gradual manner based on COVID-19 Exposure Risk in the research: Lower Risk, Medium Risk, & Higher Risk. Please use the Face-to-Face Human Subjects Research and Risk of COVID-19 Exposure table in the Guidance for Face-to-Face Human Subjects Research Ramp Up document to determine the highest potential level of COVID-19 exposure risk in each protocol, for both study personnel and participants.

 

Studies in the following COVID-19 exposure risk categories are eligible to apply for face-to-face research ramp-up approval*: LOWER RISK

*Studies in other risk categories continue to be suspended until further notice and are not eligible to apply for ramp-up approval.

 

Policies and resources to support the ramp up of face-to-face human subjects research can be found below.

 

Policy and Guidance

Required Research Participant Tools

Ramp Up Process

Additional Resources