Related Experiment Video

Updated: Jul 13, 2026

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure
15:18

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure

Published on: July 30, 2009

Issues related to children participating in clinical research

Christina A Knox1, Patricia V Burkhart

  • 1Kosair Children's Hospital, Louisville, KY, USA. christina.knox@nortonhealthcare.org

Journal of Pediatric Nursing
|July 25, 2007
PubMed

Insights

Pediatric nurses must understand the legal and ethical considerations when including children in clinical research. This ensures ethical research practices and bridges the gap in pediatric healthcare knowledge.

Area of Science:

  • Pediatric Nursing
  • Clinical Research Ethics
  • Child Health Studies

Background:

  • Historically, adult clinical trial data have been extrapolated to pediatric populations, creating a knowledge gap.
  • The National Institutes of Health mandates the inclusion of children in clinical trials.
  • Pediatric nurses play a crucial role in the implementation of pediatric research.

Purpose of the Study:

  • To examine the legal and ethical issues specific to children participating in clinical research.
  • To provide practical guidance for nurses involved in pediatric research.
  • To support the ethical integration of children into clinical trials.

Main Methods:

  • A comprehensive review of existing literature on pediatric research ethics was conducted.
  • Key legal and ethical principles relevant to child participants were identified.
  • Practical strategies for addressing these issues were synthesized.

Main Results:

  • Children's participation in research presents unique legal considerations, including informed consent and assent.
  • Ethical challenges involve balancing potential research benefits against risks to vulnerable populations.
  • Nurses require specific knowledge to navigate these complexities effectively.

Conclusions:

  • Addressing the legal and ethical dimensions of pediatric clinical research is essential.
  • Nurses are vital in upholding ethical standards and ensuring child participant safety.
  • This review provides a foundation for best practices in pediatric research.

More Related Videos

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research08:42

A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research

Published on: July 31, 2017

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting06:16

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

Published on: June 6, 2020

Related Concept Videos

Ethical Dilemmas I01:17

Ethical Dilemmas I

Ethical dilemmas in nursing are of utmost importance, as they often arise from the tension between adhering to core ethical principles and the practical realities of healthcare delivery. These dilemmas require nurses to navigate complex situations where competing ethical considerations pull them in different directions.
Let us explore some examples to understand the potentially complex moral decisions nurses face.
Take the case of caring for minors, particularly in areas related to reproductive...
Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
Clinical Trials01:16

Clinical Trials

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...
Ethical Issues01:27

Ethical Issues

Nurses are essential in patient care, upholding the ethical principles of their profession and effectively navigating ethical dilemmas. Neglecting ethical issues can lead to inadequate patient care, compromised therapeutic relationships, and moral distress among healthcare workers.
Ethical Concerns in Healthcare:
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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...