Related Experiment Video
Updated: Sep 26, 2026
Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Guidelines for informed consent in biomedical research involving paediatric populations as research participants
1The Children's Hospital, IRL Dublin I, Temple Street, Ireland. gilld@iol.ie.
Insights
Paediatricians must ensure children and parents understand biomedical research for ethical participation. Guidelines address child assent, consent, cultural factors, and legal conditions for informed consent processes.
Area of Science:
- Pediatric Research Ethics
- Bioethics
- Child Health
Background:
- Protecting minors in biomedical research requires ensuring informed consent and assent.
- Ethical guidelines are crucial for paediatricians navigating research involving children.
Framework:
- Development of child-specific informed consent guidelines compatible with international standards.
- Guidelines emphasize respecting patient willingness and socio-cultural backgrounds.
Implementation:
- Assessing a child's capacity to understand and provide informed assent.
- Ensuring clear communication between researchers, children, and parents/legal representatives.
Implications:
- Upholding the rights and best interests of children in research.
- Standardizing ethical review processes for paediatric biomedical research by ethics committees.
Abstract:
To promote and protect the best interests of children involved in biomedical research, paediatricians have to ensure that participating minors and their parents/legal representatives have understood and assented/consented to the research. Therefore guidelines providing child-specific guidance that are compatible with other international guidelines on informed consent are laid down. Special regard is paid to the willingness to participate and the social and cultural background of the patients, the legal conditions of the countries, the capacity of the child to understand and give his/her informed assent, the adequate communication with the child and the parents, the respect of the will of the patient, the understandable written informed consent of legal representatives and to the evaluation of the informed consent/assent process by competent ethics committees.
Related Concept Videos
01:56Ethics in Research
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:11Blinding
02:07Blind Procedures