IRB Issuing a “Pause” in Human Subjects Research

Due to the potential or perceived risks of COVID-19, Indiana State University has paused human subjects research studies involving direct subject contact that provide little or no potential direct benefit to subjects. Only the IRB can render a definitive decision on the level of direct benefit; principal investigators should not make this decision themselves. NO face-to-face research can take place without IRB approval for its continuation, during this pause.

This pause is to take place immediately. These studies will be able to maintain telephone or online contact and remote data collection activities during this pause and may resume when the risk of COVID-19 has passed. This pause is in effect until IRB makes a decision for the campus to resume face-to-face research and communicates with the campus community that the pause is lifted.

We are currently experiencing a global pandemic in which the real or perceived risk of exposure and risk/benefit ratio for research participation must be reassessed for each protocol. Federal regulations and ethical principles of research require an acceptable risk/benefit ratio.

Some researchers will need to communicate this “pause” directly with participants. In this instance, there is NO requirement to file a Modification Request in order to (1) communicate with current study participants and inform them of a pause in research, or (2) to modify data collection procedures in a way that transitions from face-to-face interaction to telephone or online interaction for data collection purposes.

Researchers who believe that the direct benefits to participants of current research outweigh the risks of COVID-19 coronavirus transmission, or who believe appropriate social distancing protocol might mitigate risks in those cases of direct benefit, are required to contact IRB and receive permissions to continue with the research.

To clarify for Principal Investigators who do not have face-to-face protocol in their studies, research that does not involve direct contact with participants may continue at this time.
The IRB always welcomes questions from Principal Investigators, Student Researchers, and/or Faculty Co-Investigators (Sponsors, Chairs, etc.) at irb@indstate.edu, or to IRB Chair Ryan Donlan at ryan.donlan@indstate.edu and IRB Vice Chair Anne Foster at anne.foster@indstate.edu.