SUSPENSION OR TERMINATION OF RESEACH PROJECT OR PRIVILEGES

Decisions about suspensions or terminations are generally specific to a particular project or Principal Investigator. These decisions have a serious and dramatic impact on the subjects, the investigators, your IRB and your institution. Any decisions benefit from impartial counsel and advice. We can assist with these delicate issues through

1. Advice and counsel regarding reporting and notification responsibilities of an IRB upon suspension or termination of a research project
2. Advice and counsel regarding what actions are appropriate on discovery of any unanticipated problems involving risks to subjects or others, serious or continuing noncompliance with applicable Federal regulations or the requirements or determinations of the IRB and any suspension or termination of IRB approval.
3. Advice with respect to whether incidents must be reported to OHRP and the requirements applicable to required reporting