Investigators must ensure prompt reporting to the IRB of proposed changes in a research activity and ensure that such changes in approved research, during the period for which IRB approval has already been given, will not be initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subjects. This reporting is required for all approved research, whether the determination was exempt, expedited or full. Note that changes to the research may affect the original determination and, therefore, must be submitted for review and subsequent determination.
Investigators must ensure prompt reporting to the IRB of any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance with federal regulations or determinations of the IRB.
Investigators must report progress of approved research to the IRB as often as, and in the manner, prescribed by the IRB.
IRB conducts continuing review of ongoing research (except protocols determined by the IRB to qualify for exempt status) at intervals appropriate to the degree of risk, but not less than once per year. For approved research, the IRB determines which activities require continuing review more frequently than every 12 months.