Vulnerable Subjects

Vulnerable subjects are individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation (whether justified or not) of benefits associated with participation, or by some form of perceived retaliation from senior members of a hierarchy (if the individual refuses to participate). Other vulnerable potential participants include those with incurable diseases, persons in nursing homes, unemployed or impoverished persons, persons in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, prisoners, minors, and those incapable of giving consent. (CDISC)