UNANTICIPATED PROBLEMS AND SERIOUS ADVERSE EVENTS

Federal regulations impose reporting requirements for some, but not all, unanticipated problems and serious adverse events. We can help you determine your obligations, responsibilities and possible liabilities arising from these events. We offer advice regarding;

1. A serious adverse event or unanticipated problem relating to a research project approved by or operated under the supervision of your IRB
2. Suspension or termination, because of a serious adverse event or unanticipated problem, of a research project approved by or operated under the supervision of your IRB
3. Determination of reporting requirements to OHRP or other federal agencies, sponsors and subjects