BACKGROUND. Valid consent for research requires comprehensive and understandable information to be disclosed to participants. The way that information is shared varies, but regulatory bodies usually determine style. Some reports have suggested that although information may be all-inclusive, it does little to support understanding.
OBJECTIVE. To explore the impact of various information-sharing approaches on parents' understanding of a research study and the validity of their consent.
METHODS. This was a randomized, controlled trial. Parents of immature but well infants admitted to a large tertiary NICU in Edinburgh, Scotland, were randomly assigned within 72 hours of their infant's admission to receive 1 of 2 information leaflets, with or without a standardized verbal explanation, for a hypothetical intensive care research study. The leaflets differed in length and in the amount of detail in which the study process, risks, benefits, and patient rights were described. A questionnaire was used to elicit understanding about the purpose of the research, design of the study, procedures involved, and the consent process.
RESULTS. Forty-one parents participated in the study. Those who received the longer leaflet without verbal explanation gained only limited understanding of the purpose of the research. The procedures involved in the study were understood better by those who received the shorter leaflet. Issues relating to consent and study design were readily understood in all groups. Irrespective of documentation style, verbal explanation significantly improved understanding. Differences in understanding had little effect on whether a parent would enroll his or her infant into the study.
CONCLUSIONS. Verbal explanation significantly enhances understanding of the research process for participants regardless of the style of written documentation. However, shorter written information may lead to better understanding than lengthy, more complex documentation. Pediatrics 2009; 123: 1301-1305