Non-indemnified Clinical Study Approval Process

The University of Kentucky (UK) Healthcare Risk Management Committee (UKHC RMC) administers a self-insurance program to protect its physicians from medical malpractice claims, which could result from their participation in the conduct of clinical studies. UKHC RMC review is required for all clinical studies where the sponsor does not provide indemnification or limits time or dollar amount of indemnification for medical malpractice liability, with the exception of studies that meet the exclusion criteria detailed below. UKHC RMC review assesses the medical malpractice liability for conducting a clinical study. UKHC RMC review also determines whether the protection of this program will be given to a clinical researcher for medical malpractice claims that may arise from participation in a particular clinical study. Medical malpractice liability protection is contingent on UKHC RMC review and approval of proposed clinical studies.

Risk Assessment Evaluation Form