View source for Theme:25c2d875-d1fe-456d-acd0-05d62f7a31be

{{Theme
|Theme Type=Misconduct & Misbehaviors
|Has Parent Theme=Theme:39868075-a4e2-4f56-829d-6ccfdc288bdf
|Title=Ethical Principles of Informed Consent in Research with Children
|Is About=This topic is about the ethical principles for involving children in research. Because children often cannot make fully informed decisions on their own, parents or caregivers provide informed consent.Proper informed consent protect children, respect their autonomy, providing a framework for responsible and ethical research.
|Important Because=Children are a vulnerable population in research, as they cannot make participation decisions on their own. For this reason, informed consent from parents or legal caregivers is typically documented through a written, signed, and dated form. In pediatric research, informed consent ensures that parents or caregivers receive all relevant information and can voluntarily decide whether their child will participate. Failure to follow ethical standards can have legal, professional, and reputational consequences, particularly when data are not securely protected or informed consent procedures are ignored. Following proper ethical procedures, including informed consent, helps protect children and promotes responsible research practices. In all research involving children, maintaining the highest ethical standards is essential, regardless of the research context.
|Important For=Research Ethics Expert; Research Supervisor / Mentor; Researcher; Researchers, Research Ethics Committee Member
|Has Best Practice=Performing research with children requires careful attention to ethical principles to protect this vulnerable population. Researchers should provide understandable explanations of the study, including its purpose, procedures, risks, and benefits. Informed consent from parents or legal caregivers from the child should always be obtained, ensuring that participation is voluntary.

In retrospective studies, researchers use existing data, such as medical records or archived samples, to perform their analyses. Since the data has already been collected, new informed consent from parents is usually not required. However, obtaining ethical approval from a review board or ethics committee is essential to ensure that participants’ privacy and confidentiality are protected.

In contrast, prospective studies involve collecting new data from children over time. In these studies, informed consent from parents or legal caregivers is a critical ethical requirement and must be obtained before any data collection or intervention to ensure participation is voluntary and the child’s rights are protected. In longer or longitudinal studies, informed consent are often obtained in stages, with the process periodically reviewed to ensure that children and their caregivers can stop participation at any time.

In case studies, even when only a single child is involved, informed consent from parents or legal caregivers is required for participation and for the use of any identifiable information. When publishing details such as medical history, treatment progress, or images, researchers must anonymize data whenever possible and obtain explicit consent for any information that could potentially reveal the child’s identity.

Informed consent from parents or legal caregivers is required not only for participation but also for the use of any identifiable information, such as medical records, photographs, or videos. Researchers must anonymize data whenever possible and obtain explicit permission for any material that could reveal the child’s identity.
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{{Related To
|Related To Resource=Resource:H5P-498
|Related To Theme=Theme:6feb603b-78db-43b6-9722-a8833ef0d8c7
|Related To Instruction=Instruction:80fa8990-1fa1-4aac-8fca-fef85a054a22
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{{Tags
|Has Good Practice And Misconduct=Ethics
|Related To Research Area=LS 07.08 - Health services, health care research
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