Table 2 Content regarding definitions of vulnerability and detailing the use of qualifying language

 Intl

Declaration of Helsinki

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• Some groups and individuals are “particularly vulnerable” ([17], Art. 19)

CIOMS

“‘Vulnerability’ refers to a substantial incapacity to protect one’s own interests owing to such impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being a junior or subordinate member of a hierarchical group” ([18], p. 18)

• Persons with serious, potentially disabling or life-threatening diseases are “highly vulnerable” ([18], p. 65)

• Selection of the “least vulnerable” subjects required for research ([18], p. 18)

UNESCO Declaration

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• Certain individuals and groups are of “special vulnerability” ([19], Art. 8)

 EU

Clinical Trials Directive

–

–

Clinical Trials Regulation

–

–

 US, EU, JP, AUS, CA

ICH GCP

Glossary defines vulnerable subjects as “[i]ndividuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate” ([23], Art. 1.61)

–

 AUS

National Statement

–

• Where “potential participants [in dependent or unequal relationships] are especially vulnerable” special measures may be required ([23], p. 53)

• Neonates in intensive care have a “unique developmental vulnerability” ([23], p. 56)

• People with a cognitive impairment, intellectual disability, or mental illness have “distinctive vulnerabilities as research participants” and are “more-than-usually vulnerable to various forms of discomfort or stress” ([23], p. 58)

 CA

TCPS2

“Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specific research project. This may be caused by limited decision-making capacity or limited access to social goods, such as rights, opportunities and power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on their circumstances. See also ‘Autonomy’” ([24], p. 210)

• Participants, researchers, and research ethics board members may be rendered “more vulnerable” during publicly declared emergencies ([24], p. 90)

• “The least organisationally developed communities are the most vulnerable to exploitation” ([24], p. 130)

• Participants may be “in highly vulnerable circumstances” because of social or legal stigmatisation ([24], p. 141)

 UK

Research Governance Framework

–

–

 US

Belmont Report

–

• “Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable” ([26], Part C.1)

Common Rule

–

–