As a rule of thumb, we can take any person under 18 years old to be a child. There may be occasional exceptions to this rule, but it will serve as the most general driving point between children and adults under the human subjects regulations.

The regulations define a child as a person who has not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. In some areas of medical treatment and social services, various state laws and court precedents have set reliable guidelines for using an age other than 18 as the age of consent. However, most research procedures do not fall clearly under such guidelines. In the absence of other guidelines, the Secretary of DHHS has set 18 as the age of adulthood for all research eligible for expedited review and, by extension, for all other research covered by the regulations.

Since some human subjects requirements, such as the need for children to secure parental permission to participate in a research project, come in conflict with specific laws and precedents governing emancipation, CRP will consider requests to deviate from the general definition of a child. If you wish to treat persons under 18 years old as adults within a research project, provide a complete and convincing rationale of Form B. Cite the laws, legal precedents, agency rules and regulations, or similar justification for treating the subjects as adults. Additionally, describe the situation of the research and the role of the subjects within it so that the Committee can determine that the research will not exceed the scope of the emancipation provisions cited.

Children fall into two categories: ordinary children and wards of the state or other agencies, institutions, or entities. Although we can include ordinary children in numbers research activities, we cannot use wards unless the research meets certain conditions. The research must relate to the status of the children as wards or it must occur in schools, camps, hospitals, or institutions in which the majority of child subjects are not wards. In any research using wards as subjects, CRP must direct the researcher to appoint for each ward an advocate with the background and experience to act in the best interests of the child for the duration of the research.




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