Children

Children
Research involving children is governed by 45 CFR 46:401-409 (48 Fed. Reg. 9818, March 8 1993). To safeguard their interests, special regulatory considerations are in place for conducting research involving children.

Children

Research studies that can be conducted with children as subjects:

1. Research not involving greater than minimal risk (for example, most educational studies or studies in which behavior is not manipulated) if it meets the following requirements:

The potential risks must be outweighed or balanced by the potential benefits to the subject and/or society

Adequate provisions must be made for soliciting assent of the children and consent of the parents or guardians

2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects (for example, medical research in which the child receives treatment or therapy). The following requirements must be met:

The risk is justified by the anticipated benefit to the subjects

The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches

Adequate provisions are made for soliciting the assent of the children and consent of their parents or guardians

3. Research involving greater than minimal risk, and the research offers no prospect of direct benefit to individual subjects. However, the research is likely to yield generalizable knowledge about the subject's disorder or condition (for example, research on an untreatable medical condition), which must meet the following requirements:

The risk represents a minor increase over minimal risk

The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations

The interventions or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or improvement of the subjects' disorder or condition

Adequate provisions are made for soliciting assent of the children and consent of their parents and guardians

Consent/Assent Procedures: Legally, children cannot give consent on their own behalf. The consent of their parent(s) or a legal guardian is, therefore, required before they can participate in any non-exempt (and some Exempt) research projects. Pregnancy does not confer majority status. A minor may, however, with IRB approval, legally consent on his/her own behalf (as a mature minor) if the research involves a treatment for which a minor's consent is permissible under applicable law (for example, use of contraceptives, treatment for venereal disease or drug abuse). If a subject under the age of 19 is legally declared to be emancipated he/she may consent to participate in research. If the subject is 18 years of age, registered as a student at the University of Nebraska, and the proposed investigation is no more than minimal risk , parental consent may be waived by the IRB.

If the research involves activities that pose minimal risk, consent of only one parent must be obtained. If, however, the research involves greater than minimal risk, activities, consent of both parents must be obtained unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has the legal responsibility for the care and custody of the child.

In addition to the obtainment of parental/legal guardian consent, the investigator must also solicit assent of minor subjects age 7 or older, unless the subject displays intellectual/emotional development below that of the average 7-year -old child. When researchers obtain assent of underage subjects, it shows respect for a child's developing autonomy.

In non-therapeutic research a child's deliberate objection should be regarded as a veto to their involvement in the research.

In the state of Nebraska, a minor attains majority at age 19 or upon marriage. This means that research using subjects 18 years of age and younger is considered research with children.