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Nursing Ethics
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Development of an Instrument to Investigate Parents’ Perceptions of Research with Newborn Babies

Kathleen Oberle

University of Calgary, Calgary, Canada

Nalini Singhal

University of Calgary, Calgary, Canada

Joelene Huber

University of Calgary, Calgary, Canada

Ellen Burgess

University of Calgary, Calgary, Canada

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.

Key Words: informed consent • medical ethics • paediatric clinical research • parent decision making • proxy/surrogate consent

Nursing Ethics, Vol. 7, No. 4, 327-338 (2000)
DOI: 10.1177/096973300000700406
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A. Maayan-Metzger, P. Kedem-Friedrich, and J. Kuint
Motivations of Mothers to Enroll Their Newborn Infants in General Clinical Research on Well-Infant Care and Development
Pediatrics, March 1, 2008; 121(3): e590 - e596.
[Abstract] [Full Text] [PDF]