Table 3.
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