An evaluation of the process of consent in neonatal medicine
Research type
Research Study
Full title
An evaluation of the process of consent in neonatal intensive care medicine from an ethical and legal perspective (The CoNe Study)
IRAS ID
202806
Contact name
Vimal Vasu
Contact email
Sponsor organisation
East Kent Hospitals University NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
It is widely accepted that healthcare professionals are legally and ethically obliged to seek consent for treatment of adult patients with capacity. The situation is more complex in newborn infants, who by virtue of their age and stage of development cannot provide consent. Therefore, healthcare providers rely on the "proxy" consent of parents/carers to provide treatment unless this is thought to be emergency in nature. Approximately 10% of babies born in the UK are admitted to neonatal units. In many instances, babies admitted to neonatal units require treatments that are urgent and important (to a lesser or greater degree and in the eyes of the healthcare professionals). Many of these treatments are provided under the umbrella of implied consent whereby the parent/care agreement to admit a baby to the neonatal unit tacitly unlocks consent for a number of other tests and procedures (such as administration of antibiotics, nasogastric tube feeding, and insertion of central lines). Though many of these tests and treatments are urgent, they are not necessarily emergency in nature and often there is time for the healthcare professional to discuss potential tests and treatment with the family prior to initiating them. The purpose of this study is to establish parental and professional medical views on consent for babies admitted to neonatal units for a number of tests and procedures. I will do this using questionnaires for professionals and a telephone interview for parents of babies who have been admitted to a neonatal unit and were born with a gestation of greater than 32 weeks. The a priori hypothesis is that there will be significant discordance in the views of parents and professionals and that this, in turn, will help raise the profile and better inform the discussion of consent issues in neonatal medicine.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0152
Date of REC Opinion
20 Apr 2016
REC opinion
Further Information Favourable Opinion