Methods and practices of investigators for determining participants' decisional capacity and comprehension of protocols.

ETHICISTS RECOMMEND THAT investigators assess subjects' comprehension prior to accepting their consent as valid. Because children represent an at-risk population, ensuring adequate comprehension in pediatric research is vital. We surveyed all corresponding authors of research articles published over a six-month period in five leading adult and pediatric journals. Our goal was to assess how often subject's comprehension or decisional capacity was assessed in the consent process, whether there was any difference between adult and pediatric research projects, and the rate at which investigators use formal or validated tools to assess capacity. Responses from 102 authors were analyzed (response rate 56%). Approximately two-thirds of respondents stated that they assessed comprehension or decisional capacity prior to accepting consent, and we found no difference between adult and pediatric researchers. Nine investigators used a formal questionnaire, and three used a validated tool. These findings suggest that fewer than expected investigators assess comprehension and decisional capacity, and that the use of standardized and validated tools is the exception rather than the rule.