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