For research involving more than minimal risk, an explanation as to whether any compensation and/or whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

• UTHSC-H investigators must use the following wording in all Informed Consent Forms:

"If you suffer any injury as a result of taking part in this research study, please understand that nothing has been arranged to provide free treatment of the injury or any other type of payment. However, all needed facilities, emergency treatment and professional services will be available to you, just as they are to the community in general. 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 713-500-3985. You will not give up any of your legal rights by signing this consent form."

• HOWEVER, the costs for care of a research-related injury when a subject is enrolled in a study sponsored by a pharmaceutical company, MUST be covered by the company. The following is mandatory "in case of injury" language for pharmaceutical company 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 713-500-7943. You will not give up any of your legal rights by signing this consent form."