Vulnerable populations

Vulnerable populations (DHHS, FDA): Participants who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. Common Rule, 2018 Requirements: 45 CFR 46.111, Criteria for IRB approval of research; FDA: 21 CFR 56.11, Criteria for IRB Approval of Research

Vulnerable subjects (ICH GCP): Individuals whose willingness to volunteer in a study 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, minor(s), and those incapable of giving consent. ICH GCP, 1.61