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Evaluating the risks of clinical research: direct comparative analysis

Annette Rid1, Emily Abdoler, Roxann Roberson-Nay

  • 11 Department of Social Science, Health & Medicine, King's College London , United Kingdom .

Journal of Child and Adolescent Psychopharmacology
|September 12, 2014
PubMed

Insights

A new method, direct comparative analysis, helps determine minimal risk in research for children. It compares research risks to daily life risks, ensuring child protection while facilitating essential studies.

Area of Science:

  • Pediatric research ethics
  • Risk assessment methodologies

Background:

  • Current regulations permit minimal-risk research participation for minors without direct clinical benefit.
  • A lack of systematic methods for assessing minimal risk leads to inconsistent judgments and potential underprotection of children in research.

Purpose of the Study:

  • To introduce and validate a systematic method for implementing the "risks of daily life" standard for minimal risk in pediatric research.
  • To address variability in minimal risk determinations and enhance the protection of children in research.

Main Methods:

  • Conceptual and normative analysis.
  • Development of a "direct comparative analysis" method to compare research risks with risks from daily life activities.
  • Application of the method to an illustrative example involving anxiety induced by a CO2 challenge in children.

Main Results:

  • Risks can be systematically compared by analyzing their type, likelihood, and magnitude of harm.
  • Direct comparative analysis provides a framework for evaluating research procedures with risks similar to everyday life, such as psychological distress.
  • The method was successfully applied to assess the minimal risk status of a CO2 challenge in pediatric participants.

Conclusions:

  • Direct comparative analysis offers a systematic approach to applying the "risks of daily life" standard for minimal risk in research.
  • This method aids in protecting children and adolescents in research by providing consistent risk assessments.
  • The approach facilitates important research by clarifying risk levels, preventing unnecessary research blockage due to risk concerns.
Abstract

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