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研究涉及 children is governed by 45 CFR 46:401-409 (48 Fed. 注册. 9818(1993年3月8日). To safeguard their interests, special regulatory considerations are in place for conducting research involving children.

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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:

潜在的风险 must be outweighed or balanced by the potential benefits to the subject and/or society

Adequate provisions must be made for soliciting 同意孩子们同意 of the parents or guardians

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:

的风险 is justified by the anticipated benefit to the subjects

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

Adequate provisions are made for soliciting the 同意孩子们同意 of their parents or guardians

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:

的风险 represents a minor increase over 最小的风险

的 intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, 牙科, 心理, social, 或者教育环境

的 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 同意孩子们同意 of their parents and guardians

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.