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During the course of a study, researchers may become aware of new information that would impact a subject’s decision to participate, or continue participating in the research study. For example, interim analyses of data may identify a trend which impacts the safety of subjects, or may identify early efficacy (benefit) of one of the interventions under study. In addition, results from other research studies or changes in standards of practice or care may affect conduct of a study and would need to be communicated to research subjects.
Investigators must report any new information that may impact the willingness of subjects to participate to IRB-01, IRB-02, or IRB-03 using the Reportable Event Form (REF). This form includes a description of the new information and its potential impact on subjects. Reports from the investigator to the IRB must be submitted via HawkIRB within ten working days of the event or within 10 working days of the PI becoming aware of the event. In addition, a modification form must be submitted describing the investigator’s proposed method for providing this information to subjects.
Reports and modifications related to new information are reviewed by an IRB Chair to determine if the method and information provided to subjects is appropriate. If the Chair verifies that this information is correct and notification is appropriate, the Chair signs the report and modification through the HawkIRB system. The Chair refers the review to the full board when s/he believes the information or notification method is not appropriate, or if the new information significantly impacts the safety of current or potential subjects. When protocol changes are immediately required to eliminate apparent immediate hazards to subjects, the Chair may approve notifications prior to full board review.