Human Subjects Research COVID-19 Guidance
Given the rapidly evolving COVID-19 pandemic and our shared goal to reduce the risk of infection within our community, Susan Blanchard and Heather Gipson-Cosier, JD, the Institutional Officials at Tufts Medical Center and Tufts University, have determined that most research activities involving face-to-face interactions with subjects must stop until further notice. The only exceptions are 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). This is in keeping with the need to minimize social contact.
From a regulatory perspective, this is considered a temporary pause in human subjects research activities for those studies impacted.
Ongoing Human Subjects Research Activities that Involve Face-to-Face Interactions:
Face-to-face interactions with human research subjects must stop immediately. This applies to domestic and international human subjects research, including those studies employing enumerators.
The following exceptions apply:
- The research holds the potential for direct benefit to the subject/patient (e.g., investigational drug, devices or surgical procedure) and the interaction is required to deliver that potential direct benefit.
- Collection of safety data (based on clinical judgment of the importance of the visit to detect potential adverse events)
- The PI determines that an in-person visit is vital to the subject’s safety and/or well-being.
Of note, all Tufts University SBER IRB-approved human subject research activities involving face-to-face interactions must stop immediately. No exceptions apply to this work.
Ongoing Human Subjects Research Activities that Do Not Involve Face-To-Face Interactions:
Research activities that do not involve face-to-face interactions with human research subjects may continue. This includes non-direct benefit studies that can be managed remotely/virtually as long as that process is part of your IRB-approved protocol. For studies that do not currently include remote/virtual participation, you may submit modifications to include this flexibility where appropriate.
New Enrollment into Existing Human Subjects Research with Face-to-Face Interactions:
New enrollment for studies involving face-to-face human subjects research must stop immediately unless enrollment provides the potential for direct benefit, that is, benefits that are not available through standard of care.
Pending IRB Submissions for Human Subjects Research:
The IRBs will continue to review and approve pending submissions. For studies involving face-to-face interactions that do not meet the above exceptions, the IRB will approve the study, but explicitly note that enrollment cannot start until the above restrictions are lifted. Please note, turnaround time may be impacted due to the need for IRB Office staff to focus on managing the impact of COVID-19 on our human subjects research program.
New IRB Submissions for Human Subjects Research:
Due to the need to focus on managing the impact of COVID-19 on human subjects research, the IRBs will not review new submissions until further notice. The HS and SBER IRB Offices request that investigators wait to submit new studies and any modifications that are not essential to research continuity in paused studies.
The only exceptions are emergency use/compassionate use and Humanitarian Use Devices (HUDs). An exception can be requested by contacting your respective IRB Office. Requests will be reviewed by the Institutional Official and IRB Chair (HS IRB) or Manager of IRB Operations (SBER IRB).
Notification of Research Sponsors, Funders, and Other Oversight Bodies:
If the study needs to be paused, please notify any sponsors and funding agencies based on guidance in your award notice, agreement or contract. You may also be required to notify the FDA under certain circumstances, for example, if the PI is the sponsor of the IND/IDE.
If you have any questions, please contact the applicable IRB Office:
- Tufts Health Sciences IRB Office
- Tufts Social, Behavioral, and Educational Research IRB Office
Thank you for your patience as we manage the rapidly evolving circumstances related to COVID-19.