Federal law defines "children" as persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted.
Under Pennsylvania law, persons under the age of eighteen (18) generally meet this definition of "children" with the exceptions noted below. As a result, permission of the child's parent(s) or guardian(s) must generally be obtained prior to the participation of that child in research.
The following exceptions to the general rule apply where a person under the age of 18 does not meet the federal definition of "child" and may provide legally effective consent to participate in research if either:
- The research involves the provision of medical care or treatment AND if the person:
- has graduated from high school, or
- is married, or
- is or has been pregnant.
- The person is an emancipated minor.
If the emancipated minor provides consent for him or herself, the court order must be copied and included in the research records with the consent document.
The general requirement is that explicit parental consent be obtained in writing for each participant. However, parental consent may be waived by the IRB if it is not a reasonable requirement to protect the subjects (e.g. neglected or abused children). Investigators requesting the waiver must propose an alternative mechanism for protecting the children who will be participating in the study.
If the research involves minimal risk, the permission of one parent is sufficient.
If the research involves GREATER than minimal risk, consent of both parents must be obtained unless one parent is deceased, incompetent, not reasonably available, or when parent has legal responsibility for the care and custody of the child.
A template for parental consent can be found on the Guides and Templates page of the IRB website.
Assent means a child's affirmative agreement to participate in research. In all instances where children are capable of providing assent, the investigator shall develop a separate assent form written at a developmental level appropriate to the child's age, maturity, and experience. As a guideline, children age seven and older are considered capable of assenting. A template for child assent forms for use by children and minors is available on the Guides and Templates page.
Any research proposal involving children must include the following:
- How assent will be obtained (what the investigator will say to the child and whether or not the child's parent(s) or guardian(s) will be present.
- How the child's verbal assent will be documented. The child must either sign a brief assent form and/or verbally indicate a willingness to participate (typically this is the mode of assent for children younger the age of 9 years).
- Signed assent forms are required for children age 9 years or older; optional for children younger than 9 years.
If research is being conducted in schools or other education settings, investigators should inform teachers and administrators of the following:
- Written parent consent is required for children to be given the option to participate.
- Administrators and teachers may invite but should not instruct children to participate.
- Children are allowed to decline participation with no repercussions.