Parental Permission/Assent from Children

Federal regulations do not provide specific information on parental permission/child assent. However, they do provide parental permission requirements. In addition, they also charge 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 in taking into account the ages, maturity, and psychological state of the children involved” [45 CFR 46.408]

The Samford University’s Institutional Review Board (IRB) guidelines with respect to obtaining consent from parents or legal guardians and assent from minors is specified below:

In most cases, parental consent must be obtained if the research involves minors under the age of 19. The requirement for parental consent may be inappropriate in some cases such as research on child abuse.

Minors 6 years of age or younger, verbal or written assent is typically not required. Consent is based on the permission of the parent(s)/guardian(s) and no assent is required. A brief verbal explanation of the research procedure should be explained to the child.

Minors 7 years or older should be involved in the decision to participate in a research projects unless: a) the subject is not capable or mentally/emotionally, of being consulted, b) the IRB specifically waives the requirement.

It is highly encouraged that a written assent form be used for children age 7 -12 years old to document assent. In general, it should briefly explain in basic terms:
- they are being asked to participate in a research study;
- the purpose of the study;
- an estimate of how much time is involved in participating;
- what will happen to them if they agree to participate (e.g., ‘draw some blood’);
- foreseeable risks/discomfort and any benefits they may experience;
- they should ask their parents and doctor/researcher any questions they have about participation;
- participation is voluntary and they can withdraw at any time

Both the child and the parents(s)/guardian(s) sign the form, with a signature line for the adolescent first. The signature line for parental consent/permission should follow.

However, for this age group IRB requirements for assent will be done on a case by case basis.

Typically, adolescents 13-18 years old should be fully informed about a study and give assent to their own participation in the research. Both the adolescent and the parents(s)/guardian(s) sign the form, with a signature line for the adolescent first. The signature line for parental consent/permission should follow.

NOTE: Assent expires when a child becomes an adult. At that time the subject must sign the IRB approved adult consent for the research