The IRB is obligated to ensure that research studies do not endanger the safety or well-being of human subjects or undermine public confidence in the conduct of research. The special vulnerability of children makes consideration of involving them as research subjects particularly important. To safeguard their interests and to protect them from harm, special ethical and regulatory considerations are in place for reviewing research involving children. For research to which the Department of Health and Human Services, DHHS, regulations are applicable, the DHHS regulations set forth specific provisions on research involving children [45 CFR 46 Subpart D]. These regulations allow the IRB 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. Research that is contrary to the rights and welfare of child-subjects is prohibited.
When children or minors are involved in research, the regulations require the assent of the child or minor and the permission of the parent(s), in place of the consent of the subjects.
In addition, the regulations require that the IRB determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent [45 CFR 46.408(a)].
B. CONSENT PROCEDURES FOR MINORS WHO ARE EMANICIPATED
Minors may consent to participation in research without parental or guardian permission (i.e., as if adults) if legally emancipated. O.C.G.A. § 15-11-201 and 202 (2008). The IRB interprets Georgia law relating to emancipated minors as authorizing an "emancipated minor" to give consent to participation in research. To be emancipated, the minor must meet one of the following requirements set out in law O.C.G.A. § 15-11-201:
Adopted by the IRB committee on February 5, 2009
View Child Assent Form, Parental Permission Form