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Table 7 Major content areas of vulnerability addressed within each policy/guideline

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

Policy/Guideline

Definition: What is vulnerability?

Groups/Sources: Who is vulnerable and why?

Justifications: What ethical concern(s) does vulnerability reflect?

Implications: How should we respond to vulnerability in research?

International

 Declaration of Helsinki

X

X

X

 CIOMS

X

X

X

X

 UNESCO Declaration

X

X

X

 EU Clinical Trials Directive

X

X

 EU Clinical Trials Regulation

X

X

 ICH GCP

X

X

X

National

 Australian National Statement

X

X

X

 TCPS2

X

X

X

X

 UK Research Governance Framework

X

X

 Belmont Report

X

X

X

 Common Rule

X

X

  1. 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