Date of Award

Spring 11-6-2015

Document type

Dissertation

Degree Name

Masters theses/dissertations - taught courses

First Supervisor

Prof Gene Dempsey

Second Supervisor

Dr Kieran Doran

Funder/Sponsor

The HiP Trial

Keywords

Informed Consent, Neonatal, Parental, Clinical, Perceptions

Abstract

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.

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

File Size

9,958 KB

Comments

A dissertation submitted in partial fulfilment of the requirement for the Masters in Healthcare Ethics and Law

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