Informed Consent/Assent

"Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied" [Belmont Report]. As stated in University Policy #2060, "no investigator may involve a human being as a subject in research unless the investigator has obtained informed consent of the subject or the subject's legally authorized representative." The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.

Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. In addition, Title 45 Code of Federal Regulations, Part 46 requires "the information that is given to the subject or their representative shall be in language that is understandable to them."