研究表明 可以 be conducted with children as subjects:
1. 不涉及的研究 大于最小值 风险 (for example, most educational studies or studies in which behavior is 不 操纵) if it meets the following requirements:
2. 研究涉及 大于最小值 风险 but presenting the prospect of direct benefit to the individual subjects (for example, medical research in which the child receives treatment or therapy). 的 following requirements must be met:
3. 研究涉及 大于最小值 风险, and the research offers no prospect of direct benefit to individual subjects. 然而, 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:
同意/批准程序: Legally, children 可以不 give 同意 on their own behalf. 的 同意 of their parent(s) or a legal guardian is, 因此, required before they 可以 participate in any non-exempt (and some Exempt) research projects. Pregnancy does 不 confer majority status. 未成年人可以, 然而, 经审查委员会批准, legally 同意 on his/her own behalf (as a mature minor) if the research involves a treatment for which a minor's 同意 is permissible under applicable law (for example, 避孕药具的使用, treatment for venereal disease or drug abuse). If a subject under the age of 19 is legally declared to be emancipated he/she may 同意 to participate in research. If the subject is 18 years of age, registered as a student at the 内布拉斯加大学, and the proposed investigation is 不超过最低限度 风险 , parental 同意 may be waived by the IRB.
If the research involves 活动 that pose 最小的 的风险, 同意 of only one parent must be obtained. If, 然而, the research involves 大于最小值 风险, 活动, 同意 of both parents must be obtained unless one parent is deceased, 未知的, 不称职的, 或者不合理可用, 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 同意, the investigator must also solicit 同意 of minor subjects age 7 or older, unless the subject displays intellectual/emotional development below that of the average 7-year -old child. 当研究人员获得 同意 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.