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Resources :: Guide : :Vulnerable and risk sensitive participants :: Vulnerable participants :: Minors in research :: Minor participating in a study

Can a Minor Participate in My Study ?

Minors are only allowed to participate in a study if the study fits one of the following categories:

  1. Research is not greater than minimal risk. You are required to obtain permission from the parent/legally authorized representative and assent from the child.
  2. Research is greater than minimal risk but presents direct benefit to participant. In order for the Board to approve this study, you must demonstrate that the risk is justified by the anticipated benefit to the child and the relation of the anticipated benefit to the risk is at least as favorable to the child as another approach. You are required to obtain permission from the parent/legally authorized representative and assent from the child.
  3. Research is greater than minimal risk but will yield generalizable knowledge about disorders or conditions affecting the minor. In order for the Board to approve this study, you must demonstrate that the risk is only a minor increase over minimal risk, the procedure could reasonably occur in the child’s normal care (i.e. medical, dental, psychological, social, or education situation), and the information gathered from the study will provide valuable information for the child’s condition or disorder. You are required to obtain permission from the parent/legally authorized representative and assent from the child.
  4. Research not otherwise approvable but presents opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. In order for the Board to approve this study, you must justify that this study presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles. You are required to obtain permission from the parent/legally authorized representative and assent from the child.  

Wards of the State
Children who are wards of the state (or similar institutions or entities) require additional restrictions in order to include them in a study.  The children can only be included in the study if the research is related to their status as wards or if the study is conducted in a setting where the majority of the participants are not wards (i.e. school, camps, hospitals, institutions).  The IRB is required to appoint an advocate for each child in addition to other individuals acting on behalf of the child.  One individual may serve as an advocate for more than one child; this person should have adequate experience to act in this capacity and can have no association with the study, the researchers, and the guardian organization. 

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