The Uganda National Drug Authority introduced the Guidelines for the Provision of Insurance Cover for Research Participants in Clinical trials in October 2019. This guideline is in conformity with the National Drug Policy and Authority (Conduct of Clinical Trials) Regulations, 2014.
The guideline aims to provide clarity on the clinical trials insurance requirements in Uganda. Unless specifically exempted, all sponsors and researchers involved in clinical studies are required to provide insurance cover for potential research subjects enrolled in clinical trials. The required insurance is on a no-fault basis, which means “proof of negligence or other wrongful conduct need not be established. However, the causal connection between the trial and harm/bodily injury/death shall have to be established to trigger the obligation to make compensation payment.”
The required insurance cover must be obtained from a local insurance firm registered and operating in Uganda.