Neonatal intensive care nurses are often involved in research protocols as investigators, research assistants or staff nurses implementing the protocol and providing support and explanations to families. It is important, therefore, that nurses have information about parents’ understanding of and attitudes 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 questionnaire included: demographic questions; scaled items about research (...) with newborn 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 regarding circumstances under which consent should be sought. Content and face validity were established by an expert panel and a pilot test conducted with a small group of health care professionals and lay persons. A convenience sample of 231 parents of newborn babies completed the final version of the questionnaire. Factor analysis revealed seven factors corresponding to issues identified in the literature, providing evidence of construct validity. Parents appeared to have no difficulty in completing the instrument and all questions were answered by the majority of participants. It was concluded that the questionnaire had adequate psychometric properties and that a mixed method approach can be fruitful in exploring sensitive issues. (shrink)

The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have a moral obligation to compensate (...) and reward some of its members who assume the risk of research subjects for the benefit of society as a whole. On the other hand, the promise of aftercare may provide an inducement to volunteers which, under certain conditions may be considered morally wrong and scientifically unsound. (shrink)