Development of an instrument to investigate parents' perceptions of research with newborn babies

Neonatal intensive care nurses are often involved in research protocols as investigators, research assistants or staff nurses implementing the protoco l and providing support and explanations to families. It is important, ther efore, that nurses have information about parents' understanding of and att itudes towards the research process. The purpose of this study was to begin an exploration of parents' perceptions about research with newborn babies through the development and validation of a survey instrument. The question naire included: demographic questions; scaled items about research with new born babies; scenarios describing research studies that varied in degree of risk and benefit to the newborn baby; questions about parents' willingness to enrol their newborn baby in the studies described; and questions regard ing circumstances under which consent should be sought. Content and face va lidity were established by an expert panel and a pilot test conducted with a small group of health care professionals and lay persons. A convenience s ample of 231 parents of newborn babies completed the final version of the q uestionnaire. Factor analysis revealed seven factors corresponding to issue s identified in the literature, providing evidence of construct validity. P arents appeared to have no difficulty in completing the instrument and all questions were answered by the majority of participants. It was concluded t hat the questionnaire had adequate psychometric properties and that a mixed method approach can be fruitful in exploring sensitive issues.