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. Regulation 45 CFR 46 sets forth specific provisions on research involving fetuses, pregnant women, and those involved in in vitro fertilization; prisoners; and children.
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 the subject must be reviewed and approved by the Secretary of Health and Human Services, in consultation with appropriate experts.
Additional protections for any vulnerable population should be detailed to the IRB in the protocol. Special consideration should be given to coercion and informed consent to ensure that subjects are participating willingly.
OHRP provides for investigators wishing to conduct research with vulnerable populations.