Guidance to restart direct person-to-person human subject research

Dear Colleagues,

We are pleased to provide guidance on the restart of direct person-to-person human subject research while in the Covid-19 environment. This guidance was developed by the Research Ramp-Up Thunder Committee and staff from the Committee on Use of Humans as Experimental Subjects (COUHES). Direct person-to-person human subject research may now restart, subject to certain restrictions as outlined in the guidance.

Please read the full Guidance and Restart Process Instructions for information on how to proceed. Initially, the restart will be limited to studies recruiting healthy adult subjects. Studies of additional categories of subjects will be permitted as soon as circumstances warrant.

• The procedures to restart direct person-to-person human subject research apply to ALL MIT human subject research, whether conducted on campus or off campus, and whether the research was exempt from COUHES review or formally reviewed and approved by COUHES.
• COUHES approval is necessary but not sufficient for the resumption of human subject research. Additional policies regarding access to space, visitors, travel, HR policy regarding paid staff, and regulations regarding student researchers must also be followed.
• Investigators must complete a self-certification procedure in COUHES Connect before restarting their study for each protocol. If an investigator is unable to meet ALL the certification requirements, then they must submit an Application to Restart Human Subjects Research and receive approval from COUHES before reopening their studies. Information about this process and a link to COUHES Connect are available on the COUHES website.
• In-person contact should be limited to activities that cannot be done in other ways, and the duration of contact must be as short as possible. Activities that can be conducted remotely (such as prescreening questionnaires, follow-up surveys) must continue to be conducted remotely, if feasible.
• All subjects must complete a Covid-19 consent form addendum certifying their health status. This form must be completed and reviewed by the research study staff no earlier than 24 hours before the subject arrives at the study site.
• For research at MIT, investigators must provide the subject with information about visit logistics. This should include information about the point of entry, that they will be escorted to and from the study site, and that subjects must wear facial coverings, observe social distancing, and follow bathroom use and elevator density policies.
• All subjects studied on campus must be factored into the space density planning (Planning Exercise A and B calculations). Human subjects count against the occupancy limits for a given space. It is the PI's responsibility to coordinate with all applicable departments, labs, or centers to ensure compliance with space density requirements.
• If a researcher learns that a subject that participated in a study tested positive for Covid-19, they must activate contact tracing. For on-campus research, this can be done by logging into the Covid Pass app and indicating that you and others may have been exposed to an individual who tested positive. Researchers can also contact MIT Medical directly at 617-253-4865 or covid19reports@mit.edu.
   

We want to thank all of the faculty and staff who have made this restart of direct person-to-person human subject research possible, including those serving on the Thunder Committee, those who provided advice and feedback, and the COUHES staff and the Research Administration Systems and Research Administration Support staff who have worked tirelessly to implement the decisions.

Please email COUHES@mit.edu with questions or concerns about this guidance.

Warm regards,

Maria T. Zuber
Vice President for Research

Chris Bourg
Director of MIT Libraries
Chair, Research Ramp-Up Thunder Committee

Leigh Firn
COUHES Chair