Vulnerable subjects

Vulnerable subjects are individuals who may have limited capacity to protect their interests or provide autonomous informed consent due to factors that may unduly influence their expectation of benefits associated with participation in a clinical trial.

Definitions

ICH E6(R2)

1.61 Vulnerable Subjects:

Individuals 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. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent .

Examples of vulnerable populations

Conditions defining vulnerability can vary, including age, cognitive impairments, socioeconomic status, or institutionalization. Examples of vulnerable populations include children, elderly individuals, prisoners, pregnant women, economically disadvantaged individuals, those with mental or physical disabilities, etc.

Regulatory requirements

From a regulatory perspective, researchers can ethically and legally conduct studies involving vulnerable populations, but ensuring the protection of such participants requires additional regulatory measures.

Conducting research on these populations requires strict adherence to ethical guidelines and regulatory requirements to protect their rights and well-being. Strict compliance with relevant local, national, and international regulations and guidelines (such as Common Rule (45 CFR 46) and the Declaration of Helsinki) is paramount when conducting studies involving these populations.

Additional protections

Additional safeguards must be implemented to minimize risks and protect the interests of vulnerable subjects. These measures may involve careful benefit-risk assessments of research, closer monitoring, tailored communication strategies, and thorough ethical review by institutional review boards (IRB) or ethics committees (EC).

See also

Another relevant pages

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