Vulnerable Populations

The HHS regulations contain certains sets of rules that apply to protect 3 groups that are considered vulnerable populations: 45 CFR part 46 subpart B contains regulations protecting pregnant women, human fetuses, and certain neo-nates; 45 CFR 46 subpart C contains regulations protecting prisoners; and 45 CFR 46 subpart D contains regulations protecting children.  However, there are many types of research subjects who could be vulnerable that do not fall within those three categories, and researchers should consider the potential vulnerabilities of individuals who may be recruited to participate in a study.

In its IRB Guidebook at Chapter VI, the HHS Office for Human Research Protections lists the following as examples of potentially vulnerable populations: (1) children and minors; (2) cognitively impaired persons; (3) prisoners; (4) traumatized patients; (5) terminally ill patients; (6) elderly and aged persons; (7) economically disadvantaged persons; (8) underrepresented or at-risk persons; (9) students or employees whose instructors or employers are engaged in research; (10) international, non-English speaking persons; and (11) fetuses, human in vitro fertilization and pregnant women.