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Neonatal research: the parental perspective
B J Stenson1, J-C Becher, N McIntosh
1Simpson Centre for Reproductive Health, Royal Infirmary, Little France, Edinburgh EH16 4SU, Scotland, UK. ben.stenson@luht.scot.nhs.uk
Insights
Many parents of infants in neonatal research trials do not recall giving consent, yet most value the consent process. Ensuring informed consent remains crucial for ethical research practices.
Area of Science:
- Neonatal research ethics
- Parental consent in clinical trials
Background:
- Informed consent is a cornerstone of ethical research involving human subjects, particularly vulnerable populations like neonates.
- Understanding parental recall and perspectives on consent is vital for maintaining trust and ethical standards in pediatric research.
Purpose of the Study:
- To assess parental memory of the consent process for infant participation in neonatal research.
- To evaluate parents' views on the necessity and importance of obtaining consent for such studies.
Main Methods:
- A survey was administered to parents of 154 infants enrolled in a neonatal randomized trial, 18 months post-enrollment.
- The survey assessed recall of the consent procedure and parental satisfaction with their decision to consent.
- Response rate was 64%, with follow-up questionnaires for non-responders.
Main Results:
- 18% of responding parents did not recall or were unsure about consenting to their infant's study participation.
- The majority of parents (79%) were content with their decision to consent, with no reported feelings of undue pressure.
- 83% of parents would oppose waiving the consent process for ethically approved trials.
Conclusions:
- A notable percentage of parents lack recall of the consent process for neonatal research, highlighting potential memory gaps.
- Parents value the informed consent procedure and would prefer it to be maintained even for studies with ethics committee approval.
Objectives:
To investigate the recollections of parents consenting for their infants to be research subjects and determine their views about the need for consent.
Subjects:
Parents of 154 sick newborn infants enrolled in a randomised trial in the early neonatal period. All parents had given written consent and received printed information.
Methods:
A questionnaire and accompanying letter was sent to the parental home 18 months later. Non-responders were sent a further questionnaire and letter.
Results:
Response rate was 64% (99/154). Some respondents (12%) did not remember being asked to consent to their baby joining a study, and a further 6% were unsure. Most of the respondents (79%) were happy, 13% neutral, and 8% unhappy with their decision to give consent. None felt heavy pressure to agree. Entering the trial caused 24% of respondents to feel more anxious, 56% neutral, and 20% less anxious about their baby. Most of the respondents (83%) would be unhappy to forgo the consent process for trials passed by the institutional ethics committee.
Conclusions:
A significant proportion of parents who give written consent for a trial in the early neonatal period do not later remember having done so. Parents who have had experience of neonatal research would be unhappy for their baby to be enrolled in a study that had ethics committee approval without their consent being obtained.
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