Guidance Document on Waiver of Parental Permission

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The IRB may waive the requirement for obtaining consent from a parent or legal guardian for research that is not FDA-regulated if both of the following are true: the research meets the provisions for waiver in 45 CFR 46.116(d)(1-4); or the IRB determines that the research protocol is designed for conditions or a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), and an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with Federal State or local law.

A waiver of for obtaining parental consent (permission) may be approved by the IRB if the following evidence is provided:

• The research is minimal risk.
• The waiver will not adversely affect the rights and welfare of the subjects.
• The research could not be practicably carried out without the waiver or alteration; and
• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
• An appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and that the waiver is not inconsistent with Federal, State or local law. The choice of an appropriate mechanism depends on the type of research being conducted, the risk and anticipated benefit to the research subjects, and their age, maturity, status and condition.   

In some cases, the IRB may determine that the requirement for parental consent is inappropriate.  Examples may include research involving older adolescents and treatment for which they may, under applicable law, consent on their own behalf (e.g. treatment for sexually transmitted diseases or drug abuse).  In other research (e.g. research on child abuse or neglect), there may be serious doubt as to whether the parents’ interests adequately reflect the child’s interests.  In such types of research the children who are the research subjects should be given the full opportunity for informed consent as if they are adults, or the Principal Investigator should propose alternative procedures for protecting the rights and interests of children asked to participate.