What do the signatures on the research informed consent document mean?
• Subject – The subject’s signature indicates that the person has voluntarily decided to participate in the study, and to the best of his/her ability, understands the meaning and requirements of the study. • Legally Authorized Representative – Tennessee state law does not address the issue of clinical research participation for a subject either too young or incapacitated to make informed decisions for themselves. Therefore, we look to policies and procedures for health care decision-making for incompetent patients for guidance. Surrogate consent is authorized utilizing the “legally authorized representative” with following hierarchy: conservator, guardian, attorney in fact, spouse, adult child, parent, adult siblings, other adult relative of the patient, or any other adult who has exhibited special care and concern for the patient, who is familiar with the patient’s personal values, who is reasonably available, and who is willing to serve. UTHSC policy requires the signature of the leg
