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Reframing Consent for Clinical Research: A Function-Based Approach.

Neal W Dickert1, Nir Eyal2, Sara F Goldkind3

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Summary
This summary is machine-generated.

Informed consent in clinical research has multiple ethical functions beyond autonomy, including transparency, control, value concordance, welfare, trust, regulatory compliance, and research integrity. Understanding these seven functions can improve consent processes, especially when barriers exist.

Keywords:
informed consentresearch ethics

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Area of Science:

  • Bioethics
  • Clinical Research Ethics
  • Research Methodology

Background:

  • Informed consent is crucial in clinical research but its necessity, requirements, and methods remain debated.
  • The traditional view emphasizes informed consent's role in respecting individual autonomy.
  • Consent processes are complex and fulfill multiple ethical functions, particularly when consent barriers are present.

Purpose of the Study:

  • To identify and elaborate on the distinct ethical functions of informed consent in clinical research.
  • To propose a reframed understanding of informed consent based on these functions.
  • To guide context-sensitive and goal-maximizing approaches to obtaining consent.

Main Methods:

  • Conceptual analysis of informed consent in research ethics.
  • Identification and categorization of seven ethically important functions of consent.
  • Argumentation for a multidimensional view of consent's role.

Main Results:

  • Informed consent serves seven key ethical functions: transparency, control/authorization, value concordance, welfare protection, trust promotion, regulatory compliance, and research integrity.
  • Four functions primarily benefit individual participants, while three focus on systemic or policy aspects.
  • Existing consent frameworks may not fully capture these diverse functions.

Conclusions:

  • Reframing informed consent around its seven distinct functions offers a more comprehensive ethical framework.
  • This functional approach can lead to more context-sensitive consent processes.
  • Maximizing the achievable goals of consent requires acknowledging its multidimensional ethical roles.