Factors that influence parents' assessments of the risks and benefits of research involving their children.

OBJECTIVE

The ability to assess accurately the risks and benefits of a study are important to ensure that the subject can make an informed decision regarding his or her own or his or her surrogate's participation. This study was designed to examine factors that influence parents' assessments of the risks and benefits of anesthesia and surgery research involving their children.

METHODS

The study population consisted of parents of 505 children who had been approached to participate in 1 of several ongoing clinical studies. Regardless of their decision to allow or decline their child's participation in a study, parents completed a questionnaire that elicited information regarding their perceptions of the risks and benefits of the study and factors that had influenced their decision.

RESULTS

Factors that influenced positive risk/benefit assessments by the parents included use of a placebo, the designated risk category of the study, the clarity of information given, the parents' perceptions of the amount of time provided to make a decision, and the amount of privacy afforded them in making a decision. Furthermore, positive risk/benefit assessments were associated with low decisional uncertainty and greater trust in the medical system.

CONCLUSIONS

Identification of factors that influence parents' perceptions of the risks and benefits of a research study is important as a means to optimize the manner in which consent information is disclosed and to ensure that parents and subjects can assess accurately the relative importance of the risks and benefits.