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.
- If eligible for ramp-up, develop a mitigation plan to reduce COVID-19 exposure risk in the protocol by following the Tufts University Research Infection Control Manual, the Guidance for Face-to-Face Human Subjects Research Ramp Up, and the Policy for Research Participant Visits and Face-to-Face Interactions.
- Review the Human Subjects Research Ramp-Up Approval Process.
- Submit a request to resume face-to-face research activities in the protocol to your respective Research/School Dean or Designee using the Ramp Up Request Form.
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
- Suspension of Face-to-Face Human Subjects Research
- Policy for Research Participant Visits and Face-to-Face Interactions Policy
- Guidance for Face-to-Face Human Subjects Research Ramp Up
Required Research Participant Tools
- Research Participant COVID-19 Screening Questionnaire
- Research Participant COVID-19 Information Sheet
Ramp Up Process