Legal aspects of clinical trial insurance are discussed. Other forms contain misleading, inaccurate, incomplete or inconsistent information. Not enough attention is paid to the rights of research subjects to compensation in trial-related injury or death. The historical use of prisoners as subjects is discussed. The prevalence of mental disorders is much higher among inmates than among the general population.
Drug misuse is a major ongoing problem in the prison system.
ICH defines people in detention as a vulnerable subject group, thereby raising ethical issues of consent when using prisoners as trial subjects. Awareness of GCP is almost non-existent among prison healthcare professionals. There are problems with source data verification, tracking subjects and re-recruitment, as well as access to specialist laboratories and equipment. The ICH-GCP guidelines on audits and audit reports are defined. A standard format is suggested, along with classifications of audit findings, remedial actions and subject areas.