Obtaining valid consent for neonatal research requires that comprehensive and understandable information be disclosed to parents. Researchers use different methods, including verbal and written explanations, to convey this information. Little is known, however, about the effect of different information-sharing approaches on parents' understanding of a research study and the validity of their consent.

Freer and colleagues1 conducted a randomized controlled trial of parents' understanding of a hypothetical research study after information was given either by a short or a long leaflet or by verbal explanation. The longer leaflet contained more information about the study process, risks, benefits, and patient rights than did the short leaflet. Parents' understanding of the purposes of the research, study design, procedures, and the consent process was assessed with a questionnaire.

Of the 41 parents who participated in the study, parents who reviewed the longer leaflet (without any verbal explanation) gained only limited understanding of the purpose of the research. Parents who reviewed the short leaflet had a better understanding of study procedures. Issues relating to study design and consent were understood by all groups. Verbal explanation significantly improved parents' understanding.

This study supports the use of verbal explanation during the informed consent process for neonatal research. If written information is used, "less is more." Lengthy, complex information does not lead to greater understanding on the part of the parents.

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