MDHHS IRB Requirements Restrict In-Person Research Participant Interactions During COVID-19 Response

Effective March 19, 2020, the MDHHS IRB is requiring a pause in most in-person interaction with research subjects. Exceptions to this required pause are detailed below. This pause is temporary, applying only to research approved by the MDHHS IRB and to exempt human subjects research in which MDHHS is engaged. This required pause is meant to support the health and safety of research subjects and the MDHHS research community in response to ongoing COVID-19 transmission. The MDHHS IRB has not proposed an end-date for this restriction. The need for the restriction will be assessed on an ongoing basis. Please monitor for updates.

Researchers conducting research that includes in-person interactions should pause those interactions immediately. Where in-person interactions have already been scheduled with research participants, participants can be notified of the pause without a requirement to have the communication approved by the IRB. In general, the pause to in-person interactions itself does not require approval by the MDHHS IRB in advance of implementation. The MDHHS IRB encourages researchers with questions to contact the MDHHS IRB. Communication by email at is encouraged.

Please note that this restriction does not prohibit research activities that do not require in-person interaction with research subjects. Researchers that can transition planned in-person interactions into remote contact (e.g., through phone calls or secure electronic communication) are encouraged to do so.

Limited Exceptions to the Restriction:

An in-person research interaction may continue if all three of the following requirements are satisfied:

  1. The in-person interaction between the research subject and study personnel will occur for reasons independent of the research,
  2. The research component of the in-person interaction does not change the composition of persons with whom the research subject has close personal contact (relative to the situation if no research were taking place), and
  3. The research component of the interaction does not significantly alter the nature of the interaction between the research subject and the research personnel involved in the interaction (relative to the situation if no research were taking place).

The decision to continue interactions where those requirements are satisfied should be made in consultation with the MDHHS IRB, and should only occur if consistent with guidance offered by other entities within MDHHS and other institutions involved in the research.

Where an in-person research interaction may be necessary to provide a direct therapeutic benefit to the research subject, that research interaction may continue. The IRB should be consulted to confirm such continued interaction is appropriate for MDHHS IRB approved research. Any in-person interactions with research participants must be minimized and alternatives for in-person data collection should still be considered wherever feasible.

Additional Information:

This restriction is in no way meant to impede the conduct of non-research public health investigations or public health interventions. Those activities should continue as usual outside of the scope of MDHHS IRB oversight. Additionally, research that does not involve in-person interactions with research subjects may continue without change.

The MDHHS IRB acknowledges the significant impact this restriction will have and the difficulty this may pose to members of the research community. Do not hesitate to contact with questions or concerns. Thank you to the MDHHS research community for all you do to protect research subjects.