Potential Penalties for Violating
National Clinical Research Standards
§ All research at an institution may be stopped until
corrective action has been taken
§ Approval granted by an IRB may be revoked by the IRB
or by a court case; a state court in Maryland recently
– Called for a higher level of accountability for risks in
research involving children than in that involving only
adults
– Questioned the ethics and legality of nontherapeutic
research protocols involving any risk to children
without direct benefit