Suspension of Face-to-Face Human Subjects Research

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.
This is in keeping with the need to minimize social contact and applies to all domestic
and international human subjects research, including those studies employing enumerators.

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 17must stop immediately.

The following exceptions apply:

  • the research holds the potential for direct benefit to the subject (e.g., investigational drug, devices or surgical procedure) and the interaction is required to deliver that potential direct benefit; 
  • there is 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 wellbeing,
  • there is Emergency Use / Compassionate Use / Human Use Devices (HUDs); and/or
  • the research has direct relevance to the current COVID-19 pandemic and the researchcannot be conducted at another time (must be approved by the dean).

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.

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.

Modifying Studies with Face-To-Face Interactions to Allow Remote/Virtual Activities:
For studies that do not currently include remote/virtual participation, you may submit modifications to include this flexibility where appropriate to address the pause in in-person research activities related to COVID-19 precautions.

Please follow this guidance:

  • Include a statement to this effect in the modification description along with your explanation of what is being modified.
  • Add a comment to the eIRB submission stating that the submission is unrelated to COVID-19 restriction for paused in-person studies. Send the comment as an email notice to “IRB Coordinator.” 
  • Do not include other changes in modifications unrelated to COVID-19 preparations.

The IRB strongly advises researchers to use Tufts Technology Services (TTS) resources (e.g.,
Qualtrics and WebEx/Zoom conferencing) in lieu of other apps or software when requesting
changes to allow for remote participation; otherwise, researchers should be prepared for
delays in review and approval.

IRB Submissions for Human Subjects Research:

The Tufts SBER and HS IRBs are accepting and reviewing all submissions, including new studies
involving face-to-face interactions. For studies involving face-to-face interactions that do not
meet the exceptions above, the IRBs will approve the study, but explicitly note that enrollment
cannot start until restrictions on face-to-face research are lifted.

Please note, turnaround times may be impacted in order prioritize the reviews of new studies
directly related to COVID-19. When submitting a new COVID-19 related submission in eIRB,
please include COVID-19 in the short title and/or add a comment with notification to IRB
coordinator.

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
(617) 636-7512
irboffice@tuftsmedicalcenter.org

Tufts Social, Behavioral, and Educational Research IRB Office
(617) 627-8804
sber@tufts.edu


Thank you for your patience as we manage the rapidly evolving circumstances related to
COVID-19.

Susan Blanchard
Vice President
Research Administration
Tufts Medical Center


Heather Gipson-Cosier, JD
Associate Vice Provost for Research Compliance and Safety
Office of the Vice Provost for Research
Tufts University