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Table 3 Content on the ethical justification of vulnerability and its normative status in each policy

From: The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines

 

Policy/Guideline

Justification for vulnerability

Normative status of vulnerability

Intl

 Intl

ICH GCP

Consideration for ethics review

CIOMS

The protection of dependent or vulnerable persons and populations is described itself as a principle; additionally, concerns relating to vulnerability are grounded in both the principles of respect for persons and justice

Fundamental principle/application of other principles

UNESCO Declaration

Respect for human vulnerability and personal integrity is itself a fundamental principle in this framework

Fundamental principle

Declaration of Helsinki

Concerns related to vulnerability are themselves principles in this framework

Fundamental principle

 EU

Clinical Trials Directive

Consideration for ethics review

Clinical Trials Regulation

Consideration for ethics review

National

 AUS

Australian National Statement

Considerations related to vulnerability are discussed in relation to the principles of principles of respect for persons, research merit and integrity, justice, and beneficence

Application of other principles

 CA

TCPS2

The principles of respect for persons, justice (fairness and equity), and concern for welfare all entail special obligations regarding vulnerability

Application of other principles

 UK

Research Governance Framework

Consideration for ethics review

 US

Belmont Report

The principles of respect for persons, beneficence, and justice all entail special obligations relating to vulnerability

Application of other principles

Common Rule

Consideration for ethics review

  1. Intl international, EU European Union, AUS Australia, CA Canada, JP Japan, UK United Kingdom, US United States, CIOMS Council for International Organizations of Medical Sciences, TCPS2 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, ICH GCP International Conference on Harmonisation, Good Clinical Practice