Table 3.

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

	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

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