IRB Approval Does Not Offer Complete
Immunity from Court Prosecution
§ Local IRBs are guided by national regulations issued
through the federal register
§ Local IRBs are independent entities and may take
different positions on a multi-institutional study
§ Courts may override institutional IRB actions
§ Courts have shown particular interest in research
involving child subjects
§ IRB approval and parental consent did not prevent a
court from intervening on behalf of the welfare of
child subjects in a Maryland IRB approved research
project