Abstract

Decisions to enroll in research must be voluntary and should be based on an unbiased presentation of all information required to reasonably assess risks, benefits, and procedures involved. This means that not only must potential participants understand the words used in consent documents, but that the semantic content of these words be similar, if not identical, for all parties. However, in both consent documents and the oral consent process, different words are often used to describe the same protocol. In this pilot study, we distributed questionnaires to parents of children being treated in the emergency department of a pediatric hospital. The questionnaires measured demographics, past participation in research, and willingness to enroll a child in a “research project,” “research study,” “research experiment,” “medical experiment,” and “medical study”—all terms used in consent language that are considered semantically equivalent. According to the data collected, approximately 63% of the respondents rated the protocol descriptors as reflecting different levels of risk, safety, and inclusion of untested treatments, procedures, and medicines. Accordingly, they were unwilling to allow their children to participate in protocols defined by perceived negative descriptions