ASSESSMENT OF RISK IN RESEARCH ON CHILDREN
ASSESSMENT OF RISK IN RESEARCH ON CHILDREN
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DOI：
10.1016/s0022-3476(81)80865-7
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发表时间：
1981-01-01
影响因子：
5.1
通讯作者：
STARFIELD, B
中科院分区：
文献类型：
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作者：
JANOFSKY, J;STARFIELD, B
关于临床研究的拟议联邦法规要求机构审查委员会确定涉及儿童的研究项目是否合理，如果合理，在儿童成为研究对象之前是否需要儿童的同意和父母的许可。IRB决定的一个关键因素是评估儿童参与研究的风险。由于缺乏临床研究中可能采用的许多儿科手术相关风险频率的数据，因此对儿科主任和儿科临床研究中心主任进行了一项调查，以确定他们对不同年龄儿童的某些手术风险的看法。虽然大多数这些程序被认为是最小或低于最小的风险，少数（某些类型的静脉穿刺，动脉穿刺，胃和肠插管）被认为是造成大于最小的风险，特别是在幼儿。受访者还被要求指出用于决定一个孩子是否有能力同意参加实验程序的标准。在大多数机构（73%）中，这一决定似乎取决于研究者或研究小组成员的临床判断。
Proposed federal regulations regarding clinical research require that institutional review boards determine whether a research project involving children is justified and, if so, whether the child's assent and parent's permission should be required before the child becomes a research subject. A key factor in the IRB's decision is assessment of the risk to the child from participation in the research. Since data on frequency of risks associated with many pediatric procedures that may be employed in clinical research is lacking, a survey of pediatric department chairmen and pediatric clinical research center directors was conducted to ascertain their opinions of the risks of some procedures at various ages of childhood. Although most of these procedures were thought to be of minimal or less than minimal risk, a few (certain types of venipuncture, arterial puncture, and gastric and intestinal intubation) were thought to pose greater than minimal risk, especially in young children. Respondents were also asked to indicate the criteria used to decide whether a child is capable of giving assent to participate in an experimental procedure. In the majority of institutions (73%), it appears that this decision is left to the clinical judgment of the investigator or a member of the research group.