The concept of informed consent is central to the tenet of all human subjects'research. While the Belmont report stipulates that consent must be informed, voluntary and understood, we have provided evidence to suggest that many research subjects, particularly parents and children, have inadequate understanding of the elements of consent or assent for research. This is critical since a lack of understanding may render subjects vulnerable to misinterpretation of the risks and benefits and potentially jeopardize their safety. Although several strategies have been employed to improve the presentation of understandable consent information, none have proven uniformly effective. Traditionally, both verbal and written presentations of consent information are """"""""standardized"""""""" with little regard for differences in the participants'characteristics and individual learning abilities. This proposal, therefore, will examine the effects of multiple message combinations (both verbal and written) on parents'understanding of consent information for pediatric research.
Aim 1 of this proposal will occur in two phases. Study 1 will employ a large internet survey to examine parents'gist and verbatim understanding of 4 different graphical options for the presentation of research risks and benefits. In Study 2, we will select the two most promising graphical options identified in study 1 and randomize a targeted sample of parents to receive risk/benefit information presented in either of the two formats. Parents will then be tested for their understanding of the two selected options. Based on the information obtained from aim 1 together with data from our preliminary studies, Aim 2 will use a novel fractional factorial design to screen for the effect of combinations of five of the most promising communication messages on parent understanding of consent information. We will also examine how these interactions are moderated by the individual characteristics of the subject (e.g., numeracy, literacy). These five messages will include: readability (8th grade vs. 12th grade);message length (short vs. long);processability (low vs. high);use of graphics (yes vs. no - type based on aim 1), and;extended discussion (yes vs. no).
This aim will be critical in identifying which communication messages (or combinations thereof) optimize parent understanding of consent information for studies involving their children. We believe that this proposal will provide unprecedented data to further our understanding of how to optimize the consent message and to ensure that the ethical and legal rights of the research participant are protected. Furthermore, while this information will have important implications for other research participants including children and adults, it will also serve to optimize the presentation of consent information to patients requiring treatment interventions and diagnoses.
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