As the COVID-19 virus continues to spread in the United States, researchers should evaluate their study protocols for the subject risk accordingly. Contacts with subjects in your study may have originally been low risk or classified as no more than the minimal risk encountered in practice. With uncertainty about COVID-19 exposure, routine contacts with subjects may no longer pose minimal risk. They also do not constitute a risk encountered in practice. Risks associated with COVID-19 exposure do not only include the most serious risk of sequela from the virus, but the impact that exposure has on day-to-day life.
As such, studies involving face-to-face interaction with participants are to be postponed until further notice, effective March 24, 2020. Research that is done online or through remote interactions (e.g., by phone, QuestionPro, SurveyMonkey, Zoom, or other means) that has already been approved to use these measures may continue. If you wish to transition your research protocol to remote interaction from direct contact, then an application modification will need to be submitted and reviewed by the IRB.
Temporary enrollment holds do not need to be reported to the IRB, however you may need to notify subjects already enrolled, study investigators or study sponsors. If you are planning human subjects research, you should take this into account when completing your application.
