Children are considered by the Federal Code of Regulations to be a "vulnerable population" due to their (assumed) inability to fully understand how to weigh the risks and potential benefits of research (or what they are), as well as their susceptibility to undue influence.
Legally, children are not able to provide informed consent on their own behalf; therefore, obtaining informed consent for the involvement of children as research subjects is a two-step process: the investigator must obtain informed consent from the child's parent(s)/guardian(s), or legally authorized representative, as well as assent from the child, assuming s/he is capable.
Obtaining informed consent from a child's legally authorized representative involves the same process as does obtaining informed consent from an adult on their own behalf. The pertinent information regarding the research is reviewed with the legally authorized representative, and the legally authorized representative is encouraged to ask questions to ensure an informed decision is made. When appropriate, the legally authorized representative should discuss the research with the child.
After documented informed consent has been obtained from the legally authorized representative, the investigator must, assuming the child is capable, obtain informed assent from the child. In determining whether children are capable of assenting, the investigator should take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol or for each child individually. When a child is capable of providing assent, they should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity and condition.
Informed assent may be written or it may be verbal, depending on the age of the child and the appropriateness of requiring the child to give written assent: the assent process should be tailored to the age and capabilities of the child.
Note that for children who turn 18 during the course of the research, they must be re-consented, or give informed consent as an adult, and be given the opportunity to withdraw their participation in the research.
Waiver of Assent
An Institutional Review Board may waive the requirements for obtaining subject assent in circumstances in which the subject population does not have the capacity to comprehend the research or associated procedures. This judgment may be made for all subjects involved in the research or for each child individually. If the IRB determines either of the following to be true, then the assent of the child is not a necessary condition for proceeding with the research:
- The capability of some or all of the subjects is so limited that they cannot reasonably be consulted.
- When the research offers the subject the possibility of a direct benefit that is important to the health or well being of the subject and is available only in the context of the research.
The IRB will take into account the age, maturity and psychological state of the subjects involved in determining whether a waiver of assent is appropriate.
Waiver of Consent
An IRB may waive the requirements for obtaining legally authorized representative consent if the conditions for a general waiver of informed consent are met. Note that the research may involve no more than minimal risk to the children, however.
In addition, the IRB may, for the protection of the subjects, waive the requirements for obtaining legally authorized representative consent if the IRB determines that a research protocol is designed for conditions or for a subject population for which legally authorized representative permission is not a reasonable requirement (for example, neglected or abused children). In such cases, there must be another mechanism in place for the protection of the subjects.