Date of Award
Masters theses/dissertations - taught courses
Prof Gene Dempsey
Dr Kieran Doran
The HiP Trial
Informed Consent, Neonatal, Parental, Clinical, Perceptions
D. Abstract Objectives: To systematically explore the perceptions parents and clinicians have of the informed consent process in neonatal research. Methods: A comprehensive literature review of peer reviewed studies, all of which are related to the topic of this dissertation. Additionally, an original questionnaire based study was conducted. The study recruited parents of newborn infants who had been an inpatient of the Neonatal Intensive Care Unit of the Cork University Maternity Hospital and clinicians currently employed in either a paediatric or neonatal setting. Results: Parent perception of informed consent in neonatal research is a relatively well studied area. Parents have a lack of understating of certain study procedures including the element of randomisation. 72% of clinicians believe approaching parents antenatally with information about a neonatal study leads to a greater uptake in consent and 57% of parents stated a preference to being approached with information prior to the birth of their baby. Parents expressed confusion to some content in the consent forms and junior clinicians expressed a lack of understanding of good clinical practice. Parental vulnerability during the informed consent process was highlighted. Discussion/conclusion: Parents are generally supportive of neonatal research. They are aware of their vulnerability during the neonatal period. They take part in neonatal studies for altruistic reasons such as helping babies of the future and stressed the importance of protecting parents in a similar situation. There is a need for increased consultant support during the informed consent process for parents and junior clinicians. It is essential junior clinicians receive training in the acquisition of informed consent from senior colleagues. The establishment of consenting guidelines for junior doctors to assist them during in the informed consent process is recommended. There is a need for further research to be completed in this complex legal and ethical area to ensure valid, informed consent is obtained and to enhance the consenting experience for this vulnerable cohort.
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O'Shea N. Parental and Clinical Perception of Informed Consent in Neonatal Research. [Masters dissertation]. Dublin: Royal College of Surgeons in Ireland; 2015