June 2007

The Code of Federal Regulations Part A of 45 CFR 46 defines children as a vulnerable population that requires additional protections. One specific protection afforded a child participating in research is the permission of the parent(s). As required, all information that is normally provided to a research participant must be given to the parent in order for the parent to make an informed decision. However, under certain circumstances it is possible to waive the permission by the parent.

Part A of 45 CFR 46 provides four criteria for waivers of any or all of the elements of informed consent (these same criteria apply to waivers of parental permission). However, in order to waive any or all of the elements of informed consent, the Institutional Review Board (IRB) must determine that all criteria listed below have been met.

• The research involves no more than minimal risk. Minimal risk means “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
• The waiver or alteration will not adversely affect the rights and welfare of the subjects. Since neither “rights and welfare” nor “adverse affect” are defined in the regulations, the IRB must make this determination based on interpretation of the proposed research study. It is important to remember that other laws protect the rights of the child and the parent. For example, The Protection of Pupil Rights Amendment (PPRA) may require written parental permission for research on sensitive topics. In other words even though a waiver could be made under 45 CFR 46, the PPRA would not allow such a waiver if the topic presented to the child were of a sensitive nature.
• The research could not practicably be carried out without the waiver or alteration. Inconvenience and expense are not factors that are considered acceptable when considering a waiver. Scientific validity can be considered a viable factor.
• Whenever appropriate, the participants will be provided with additional pertinent information after participation. However, this requirement may also be waived due to the specific wording of “whenever appropriate” and may not be practical for the researcher or the participant.

Although a waiver of any or all of the elements of informed consent exists, it is important to remember that researchers must respect the rights of parents with regard to their child’s research experience and be committed to protect those children who are central to that research project.

*Hicks, L (2006). Research in Public Schools. In E. A. Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (pp. 341-345). Sudbury, MA: Jones and Bartlett.