Vulnerable Populations
Under the Former Common Rule, they were referred to as vulnerable populations and the revised Common Rule uses the term categories of subjects who are vulnerable to coercion or undue influence. 45 CFR 46.111(a)(3) (Common Rule). Below are the categories of human subjects that the regulations consider “vulnerable”:
Category |
Former Common Rule |
Revised Common Rule |
Children |
Vulnerable |
Vulnerable |
Prisoners |
Vulnerable |
Vulnerable |
Pregnant women |
Vulnerable |
|
Mentally disabled persons |
Vulnerable |
|
Economically disadvantaged |
Vulnerable |
Vulnerable |
Educationally disadvantaged |
Vulnerable |
Vulnerable |
Individuals with impaired decision making capacity |
|
Vulnerable |
The revised Common Rule has one additional category for which an IRB can waive documentation
of informed consent:
If the subjects or legally authorized representatives are members of a distinct cultural
group or community in which signing forms is not the norm, the IRB must find that
the research presents no more than minimal risk of harm to subjects and provided there
is an appropriate alternative mechanism for documenting that informed consent was
obtained. 45 CFR 46.117(c)(1)(iii).
For FDA-regulated research, the FDA regulations do not have similar provisions. As
such, investigators may need to request a waiver of documentation of consent in accordance
with 21 CFR 56.109(c).