Guidelines for Payment for Research-Related Injury
The costs for care of a research-related injury when a subject is enrolled in a study sponsored by a commercial company (pharmaceutical company, device company, etc.) MUST be covered by the company. The contract concluded by the University, the investigator and the sponsor will include such language. The following is mandatory "in case of injury" language for industry-sponsored protocols:
"If you suffer any injury as a result of taking part in this research study the sponsor of this study, (enter sponsor's name), will pay for reasonable and necessary medical expenses if the injury is a direct result of taking the study medicine or undergoing study procedures, and not due to the natural course of any underlying disease or treatment process. You should report any such injury to (put the principal investigator's name and phone number here) and to the Committee for the Protection of Human Subjects at 713-500-7942. You will not give up any of your legal rights by signing this consent form."
Note: CPHS will not approve wording on a consent form that indicates that the sponsor will pay for research-related injury only if the subject’s insurance denies payment; the costs of treatment for the injury should NOT be sent to the subject and/or his insurance company
For other questions, please call us at 713-500-7942.