Investigator Responsibilities
§ Obtain and maintain up-to-date IRB approval
§ Keep adequate records of IRB related activities
including correspondence with the IRB
§ Keep adequate records on study and research
activities, including field staff, data managers,
data analysts
§ Record keeping on study and research activities
is less burdensome, but not less important for
minimal risk protocols
§ Absence of a local IRB does not absolve
investigators of responsibility of obtaining
outside approval of their research