The federal regulations create special protections for children involved in research. In reviewing research involving children, an IRB must make a determination of the proposed study's risk versus benefit ratio and decide whether, based on the risks to the child, one or both parents should sign the informed consent document (ICD). Both parents must sign the ICD if the IRB determines that the research involves more than minimal risk with no prospect of direct benefit for the child. In most studies, children should also be asked to decide whether they want to participate. If a child age 7 or older decides to participate, the child should assent to his or her participation. Depending on the age of the child, the child should be asked to sign a separate assent document (for ages 7-11) or to sign an assent signature line on the main ICD (for ages 12-majority). In certain studies, however, where it is in the best interest of the child, Schulman may waive the requirement to obtain assent.
Investigators should be cautious in allowing legal guardians to consent for children as guardianship documents may not address the issue of consent to participate in research studies and would, therefore, be insufficient for this purpose. The investigator is advised to obtain and review a copy of the guardianship document to determine if the guardian is authorized to consent to the child's participation in research. A copy of the guardianship document should be attached to the ICD.Each site should be familiar with its own state law regarding the legal age of consent. Currently all states except Nebraska and Alabama consider persons age 17 and under to be children. In Nebraska and Alabama, persons age 18 and under are considered children. In Maryland, a parent cannot consent to his/her child's participation in non-therapeutic research involving more than minimal risk.
In an attempt to avoid undue influence in the recruitment of children for research, Schulman does not allow recruitment materials for studies involving children to contain references to specific compensation amounts. For example, a site may state in its recruitment materials, "You will be compensated for participation in this study" or "You may be reimbursed for time and travel".