COVID-19 and IRB

Federal regulation and OSU policy allow immediate protocol changes to eliminate hazards to human subjects (see SOP RR405). In light of COVID-19 health concerns, researchers are encouraged to modify research protocols to increase social distance and protect participant health. For studies approved at the Expedited or Full Board level, a modification should be submitted to the IRB in a timely manner after implementation. Exempt studies do not require a modification submission for protocol changes that reduce risks to subjects.

 

Recommendations to Reduce the Risk of COVID-19 for In-person Research Interventions or Materials Drop Off

 

FAQ's

My research requires study participant visits on campus. Should I  temporarily halt these visits?

As of July 7, 2020 on campus activities may resume after social distancing and cleaning measures are implemented. Please see the IRB guidance document for reducing risks.

If I need to stop study participants from coming in for study visits, do I need to submit a modification to the IRB to do so?

No. Investigators do not need to report to the IRB a voluntary halt or delay to enrollment because of public health recommendations, facility requirements or risk to participants,   

Do I need to modify my study to make changes for alternatives to in-person study visits?
Maybe. Changes made to eliminate an immediate hazard to participants AND in studies approved at the expedited or full level should be submitted via modification to the IRB in a timely manner after making the change.  Exempt studies do NOT require a modification submission for protocol changes to reduce risks to subjects.  
 
Is the OSU-Stillwater IRB operating as usual?

Yes. The OSU-Stillwater IRB staff is telecommuting and will continue to process IRB submissions. OSU-Stillwater IRB meetings are on schedule at this time. IRB meetings may be conducted online or by teleconference. The IRB mailbox will be monitored as usual as well as emails to individual IRB staff.