When to File an IRB Amendment
§ When anything impacts potential risk status of study
§ When any change in procedures is made to an old
activity
Revamp mode of recruitment into an existing activity
Expand the age range being targeted for intervention
§ When a new, but related activity is being initiated (for
which research is planned) under an existing protocol
§ BEFORE new materials are used :
surveys/questionnaires
advertising materials, brochures
§ Before any change in study design or procedures