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).