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Children as Research Subjects

A study is considered to include children when a person who is under the age of majority participates in a Human Research study through interaction or intervention with the research team, or collection of a child’s identifiable data.

A child subject engaged in a study at a site or location in Pennsylvania would include anyone who is 17 years of age or younger. If you are conducting research in a state or states other than Pennsylvania, please check the local and state laws regarding age of majority as they do vary from state to state.

Investigators must provide protocol specific justification to the IRB so that the IRB may make a determination that the enrollment of children in the research is justified. 

Definitions

Children are 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.

Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

Parent means a child's biological or adoptive parent.

Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. 

Categories of Research Involving Children

There are four categories of research with children under Federal regulations:

  1. No greater than minimal risk to children is presented.
  2. The research involves greater than minimal risk to subjects with prospect of direct benefit to individual subjects.
  3. The research involves greater than minimal risk to children presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, by a monitoring procedure which is not likely to contribute to the well being of the subject.
  4. The research does not meet the requirement of any of the above categories, and the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children. 

Most research involving children conducted at Swarthmore by Swarthmore investigators falls under categories 1 and 3 but the IRB will determine whether the proposed research fits within the regulatory categories during the initial review using the justification provided by the investigator.

Obtaining Child Assent and Parental Consent

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.

Consent must be obtained from the parent(s) or guardian(s) of children involved in human subjects research prior to the child's participation in the research.

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