Vulnerable Populations/Special Classes of Subjects

The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, students, or economically or educationally disadvantaged persons [Federal Policy 45 CFR 46.111].

For research to which the DHHS regulations are applicable, the DHHS regulations set forth specific provisions on research involving fetuses, pregnant women, and human in vitro fertilization [45 CFR 46 Subpart B]; prisoners [45 CFR 46 Subpart C]; and children [45 CFR 46 Subpart D].

In general, these special regulations allow IRBs to approve research that is of minimal risk or that will benefit the subjects directly. Investigations involving these subjects that present significantly greater than minimal risk without direct benefit to them must be reviewed and approved by the Secretary of Health and Human Services, in consultation with appropriate experts.

The complete OHRP guidelines can be found at http://www.hhs.gov/ohrp/irb/irb_chapter6.htm