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Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the
1Northern and Yorkshire Clinical Trials and Research Unit, Leeds, UK. medsam@leeds.ac.uk
Insights
Obtaining informed consent for neonatal clinical trials is often invalid, with most parents encountering issues with competence, information, understanding, or voluntariness. Improvements are needed in the consent process for neonate research.
Area of Science:
- Neonatal research ethics
- Clinical trial consent validity
Background:
- Concerns exist regarding the validity of informed consent obtained from parents for neonatal clinical trials.
- A multi-country study was conducted to assess informed consent processes and identify potential improvements.
Purpose of the Study:
- To evaluate the validity of the informed consent process in neonatal clinical trials.
- To identify areas for practical improvement in obtaining parental consent for neonate research.
Main Methods:
- Semi-structured interviews with 200 parents of infants in neonatal trials and 107 neonatologists.
- Assessment of consent validity based on parental competence, information provided, understanding, and voluntariness.
Main Results:
- Only 59 out of 200 parents provided valid consent or refusal; the rest faced issues in at least one of the four assessed components.
- Impaired consent was more prevalent in emergency situations or trials involving greater risk/discomfort.
- Information sheets were minimally utilized by parents in their decision-making process.
Conclusions:
- Current standards for informed consent in neonatal research require enhancement.
- Recommendations include guidance for research personnel on legal/ethical constraints and simultaneous oral/written information delivery.
- Parents value their involvement in the informed consent process, and further research is needed to optimize this critical aspect of neonatal research.
Background:
Questions have been asked about whether the process of obtaining informed consent from parents to clinical trials on neonates leads to valid consent. We undertook a study in nine European countries to assess this issue and to seek any practical improvements.
Methods:
Semi-structured interviews were conducted with parents of 200 babies who had been asked for consent to neonatal trials and 107 neonatologists seeking consent. Analysis assessed the validity of the consent process against four components: parental competence; information given; parental understanding; and voluntariness of consent.
Findings:
59 of the 200 parents had given valid consent or refusal but the remainder had problems in one or more of the component areas (42 for competence, 43 for information, 44 for understanding, and 21 for voluntariness). The proportions with impaired consent were greatest for research in an emergency situation and for that associated with risk or discomfort greater than standard treatment. Information sheets were little used by parents in deciding whether to consent. Parents highly valued their involvement in the informed consent process, and clinicians generally agreed on the value of the process.
Interpretation:
Current standards of informed consent to neonatal research projects could be improved. Research personnel should receive guidance on legal and ethical constraints governing the process. Oral and written information should be given at the same time. Parents could be made aware that research projects have been examined by research ethics committees. Little support was found for the argument that informed consent should be relinquished for the parents' own good. Further study is needed to identify which elements of the process are valued by parents and clinicians in a process that has some unavoidable limitations.
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