Current Edition

Compensation for Research Injuries: National Regulations and International Standards

Research regulations worldwide aim to prevent research injuries, as well as to provide remedies for injuries suffered by research participants, regardless of what or who may have caused those injuries. The ICH-GCP guidelines mandate that sponsors make provisions for compensation for research-related injuries, but largely leave compliance to applicable national or local regulatory requirements. Chitra Lele and Suhasini Sharma at Sciformix discuss the hotly- debated topic of how and why patients are to be compensated, and how worldwide regulations differ considerably.