COMPARING THE COMPREHENSION OF PARENTAL INFORMED CONSENT AND THE CORRESPONDING MINOR ASSENT DOCUMENT

Abstract

The informed consent process has had a long history which led to the development of explicit requirements regarding the information disclosed to adult subjects in clinical trials. There are very few similar requirements for the information that is disclosed to a minor who participates in the same research. This study aims to examine the difference in the understanding of an adult consent document as compared to its respective child assent document from the same trial. Two document pairs were selected based upon the presence of the 14 required and additional elements of informed consent as described in 21 CFR 50.25. In the first pair ("consistent"), there was very little difference in the number of these elements presented; the second pair ("inconsistent") had a far greater difference. A total of 131 volunteers each read one of the documents and answered a series of written questions designed to analyze their understanding of the trial and their feelings about participation. Results were tabulated, and the difference in understanding between each consent and its respective assent was calculated. Then, the differences in understanding between the two pairs were compared. Analysis showed an approximate 20% difference in understanding between the pairs. Data was also analyzed to determine how the lack of elements in the assent documents would affect the volunteer s willingness to participate. Close to 40% of the individuals in both assent groups who declined to participate in the described trial attributed this decision to the lack of at least one element. This diminished understanding and difference in participation suggest that a reevaluation of the assent process may be useful in order to respect the autonomy of the minor clinical trial participant.