Related Experiment Video
Updated: Nov 21, 2025
19:15
Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
87.0K
Informed consent for neonatal trials: practical points to consider and a check list
Beate Aurich1, Eric Vermeulen2, Valéry Elie1
1Department of Paediatric Clinical Pharmacology and Pharmacogenetics, Robert Debré Hospital, 48 Boulevard Sérurier, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
BMJ Paediatrics Open
|January 13, 2021
Summary
Obtaining informed consent for critically ill neonates is complex. Open communication and trust-building are crucial for effective parental decision-making in neonatal research.
Area of Science:
- Neonatal Medicine
- Bioethics
- Clinical Research
Background:
- Informed consent for critically ill neonates presents unique ethical challenges.
- Parental decision-making is influenced by child's condition, risk-benefit analysis, emotional state, and clinical team relationship.
Purpose of the Study:
- To explore the complexities of obtaining informed consent from parents of critically ill neonates.
- To identify factors influencing parental decision-making and propose best practices for ethical consent processes.
Main Methods:
- Qualitative analysis of factors influencing parental consent.
- Review of ethical considerations in neonatal research consent.
- Discussion of communication strategies and continuous consent models.
Main Results:
- Parental consent is affected by perceived risks, benefits, and the parent-clinician relationship.
- Parents may prefer joint consent, regardless of legal requirements.
- Addressing misconceptions and fostering trust are vital for valid consent.
Conclusions:
- Informed consent in neonatal research is a dynamic process requiring trust and open dialogue.
- Effective communication training for investigators is recommended.
- Involving parents in the consent process development is essential for ethical neonatal research.
Related Concept Videos
01:27Nurses' Legal Responsibilities I
1.2K
In healthcare, informed consent is a crucial process that involves thoroughly communicating medical treatment options to patients, including benefits, risks, potential side effects, and alternatives. This process enables patients to make well-informed decisions about their care, ensuring they understand the implications of their choices before consenting to or refusing treatment.
The legal responsibilities of a nurse regarding informed consent include the following:
The legal responsibilities of a nurse regarding informed consent include the following:
1.2K
01:16Clinical Trials
10.0K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.0K
01:11Clinical Trials: Overview
4.3K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.3K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
267
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
267