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  1. Home
  3. Research Domains
  5. Law And Legal Studies
  7. Law In Context
  9. Family Law
  11. Ethical Challenges With The Informed Consent Process In Pediatric Research Studies.
  1. Home
  3. Research Domains
  5. Law And Legal Studies
  7. Law In Context
  9. Family Law
  11. Ethical Challenges With The Informed Consent Process In Pediatric Research Studies.

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Ethical Challenges with the Informed Consent Process in Pediatric Research Studies.

Thabit S Alotaibi1

  • 1Department of Emergency Medicine, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.

Medical Archives (Sarajevo, Bosnia and Herzegovina)
|March 14, 2024

View abstract on PubMed

Summary
This summary is machine-generated.

Obtaining informed consent (IC) in pediatric research presents ethical challenges, despite regulations. Addressing issues like coercion and compensation is vital for advancing child health research.

Keywords:
45 CFR 46Belmont ReportEthical ChallengesInformed Consent

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Area of Science:

  • Pediatric Research Ethics
  • Clinical Trials
  • Bioethics

Background:

  • Informed Consent (IC) is a cornerstone of ethical pediatric research, rooted in the National Research Act of 1974 and the Belmont Report.
  • Current regulations, such as 45 CFR 46, mandate specific safeguards for pediatric participants in research studies.
  • Historical context and legislative milestones have shaped the framework for IC in child research.

Purpose of the Study:

  • To explore the multifaceted ethical challenges inherent in obtaining informed consent for pediatric research.
  • To analyze contemporary issues in pediatric research IC through a review of relevant literature and regulatory frameworks.
  • To understand the historical evolution and legislative underpinnings of IC in pediatric studies.

Main Methods:

Legislation
Literature Review
Pediatric Research
Public Engagement
  • A comprehensive literature review was conducted, primarily utilizing the PubMed database.
  • Examination of pediatric research and IC practices was informed by guidelines from the American Academy of Pediatrics.
  • Relevant regulations from the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) were referenced.

Main Results:

  • There is a critical need for more pediatric-specific research, as many drugs are initially studied in adult populations.
  • Despite legislative advancements like the Food and Drug Administration Modernization Act (FDAMA) and the Pediatric Research Equity Act, significant ethical hurdles remain in pediatric IC.
  • Existing research highlights persistent challenges in the process of securing informed consent from pediatric subjects.

Conclusions:

  • Pediatric research requires tailored approaches to informed consent, actively involving parents, guardians, and children.
  • Key ethical considerations, including potential coercion and appropriate compensation, demand careful attention within pediatric study designs.
  • Adherence to established guidelines and enhanced public engagement are recommended to foster trust and promote advancements in pediatric health.