Submit promptly a Problem Event Report to the JHSPH IRB via hard copy or email in accordance with IRB Policy No. 103.06, “Reports of Unanticipated Problems Involving Risks to Participants or to Others” if, during the course of the study, a negative event or problem occurs that includes all three of these characteristics:
1. Problem or event harms or poses risk to participants or others
2. Is caused by, or related to, the study-related procedures or processes
3. Is unanticipated, meaning that the risk was not included in the research plan or consent form, or that its severity or frequency is higher than expected at the beginning of the study
The IRB will review these reports at a convened meeting. Problems and Events include things such as losing a laptop with study identifiers on it or discovering that a supply of drug for a study is tainted or unavailable. It may include missed study procedures, such as pregnancy testing, without which a participant might be put at increased risk of harm. It includes enrolling someone who does not meet study eligibility criteria. Please see the Policy for more examples.