32.2 In Focus: Clinical Trial Insurance and Indemnification

For clinical trials to proceed, an agreement on how to meet costs from possible injuries or deaths associated with a clinical study is needed. Health risks to clinical trial participants can result from administration of investigative vaccines, pharmaceuticals, or treatments during clinical research in emergency response settings, or from other injuries that occur at trial sites. Various risk management strategies are available in the form of insurance and indemnification. International examples relate to both commercial insurance and sponsor funding of injury and death claims from the 2014–2015 West Africa Ebola pandemic. The related subject of in-country back-up medical care and medical evacuation insurance for local and international medical and research personnel is also covered.